Duloxetine hydrochloride is a serotonin-norepinephrine reuptake inhibitor (SNRI) used to treat major depressive disorder, generalized anxiety disorder, fibromyalgia, and chronic musculoskeletal pain. It works by increasing levels of serotonin and norepinephrine, which are neurotransmitters involved in mood regulation and pain perception. The synthesis of duloxetine hydrochloride involves several steps, including the reaction of a chiral amine with a substituted benzaldehyde to form an imine, followed by reduction with sodium borohydride. The resulting secondary amine is then reacted with a substituted benzoic acid to form the final product. Duloxetine hydrochloride is studied for its potential therapeutic benefits in various conditions, including depression, anxiety, pain, and urinary incontinence. It is an important drug due to its efficacy and safety profile, particularly in managing chronic pain and improving quality of life for patients with fibromyalgia and chronic musculoskeletal pain.'
Duloxetine Hydrochloride: A thiophene derivative and selective NEUROTRANSMITTER UPTAKE INHIBITOR for SEROTONIN and NORADRENALINE (SNRI). It is an ANTIDEPRESSIVE AGENT and ANXIOLYTIC, and is also used for the treatment of pain in patients with DIABETES MELLITUS and FIBROMYALGIA.
(S)-duloxetine hydrochloride : A duloxetine hydrochloride in which the duloxetine moiety has S configuration.
ID Source | ID |
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PubMed CID | 60834 |
CHEMBL ID | 1200328 |
CHEBI ID | 31526 |
MeSH ID | M0473681 |
Synonym |
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AC-924 |
2-thiophenepropanamine, n-methyl-gamma-(1-naphthalenyloxy)-, hydrochloride, (s)- |
ariclaim |
2-thiophenepropanamine, n-methyl-gamma-(1-naphthalenyloxy)-, hydrochloride, (gammas)- |
duloxetine hydrochloride [usan] |
xeristar |
c18h19nos.hcl |
(+)-(s)-n-methyl-gamma-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride |
ly-264453 |
duloxetine hydrochloride |
(s)-duloxetine hydrochloride |
(3s)-n-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propan-1-amine hydrochloride |
cymbalta |
CHEBI:31526 , |
(3s)-n-methyl-3-(naphthalen-1-yloxy)-3-(2-thienyl)propan-1-amine hydrochloride |
smr000469136 |
duloxetine hcl |
MLS001401452 |
cpd000469136 , |
136434-34-9 |
cymbalta (tn) |
D01179 |
yentreve (tn) |
duloxetine hydrochloride (jan/usp) |
NCGC00164559-01 |
(3s)-n-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine hydrochloride |
nsc-759112 |
duloxetine mylan |
ly248686 hcl |
CHEMBL1200328 |
duloxetine (as hydrochloride) |
ly-248686 hcl |
duloxetine hydrochlorise |
nsc744012 |
nsc-744012 |
(+)-(s)-n-methyl-.gamma.-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride |
dtxcid7026443 |
dtxsid9046443 , |
cas-136434-34-9 |
tox21_112188 |
pharmakon1600-01505387 |
nsc759112 |
D4223 |
(s)-(+)-n-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine hydrochloride |
c18h20clnos |
CCG-101106 |
unii-9044sc542w |
dulane 20 |
nsc 759112 |
ly 248686 hcl |
9044sc542w , |
duloxetine boehringer ingelheim |
(s)-n-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine hydrochloride |
duloxetine hydrochloride [ep monograph] |
duloxetine hydrochloride [orange book] |
duloxetine hydrochloride [usp-rs] |
duloxetine hydrochloride [mart.] |
duloxetine hydrochloride [who-dd] |
duloxetine lilly |
duloxetine hydrochloride [jan] |
duloxetine hydrochloride [usp monograph] |
drizalma sprinkle |
duloxetine hydrochloride [mi] |
2-thiophenepropanamine, n-methyl-.gamma.-(1-naphthalenyloxy)-, hydrochloride, (s)- |
S2084 |
AKOS016340453 |
(s)-(+)-duloxetine hydrochloride |
(s)-(+)-n-methyl-3-(1-naphthalenyloxy)-3-(2-thienyl) propanamine hydrochloride |
BFFSMCNJSOPUAY-LMOVPXPDSA-N |
duloxetine.hcl |
duloxetine (hydrochloride) |
CS-1993 |
HY-B0161A |
MLS006010054 |
(s)-n-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine hcl |
NC00356 |
NCGC00164559-03 |
tox21_112188_1 |
KS-1168 |
(+)-(s)-n-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propanamine hydrochloride |
Q-102508 |
duloxetine hydrochloride, pharmaceutical secondary standard; certified reference material |
(3s)-n-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine;hydrochloride |
hcl, duloxetine |
hydrochloride, duloxetine |
ly-248686 hydrochloride |
duloxetine hydrochloride, united states pharmacopeia (usp) reference standard |
duloxetine for system suitability, european pharmacopoeia (ep) reference standard |
duloxetine hydrochloride, european pharmacopoeia (ep) reference standard |
(s)-duloxetine hydrochloride, >=98% (hplc) |
duloxetine hydrochloride 1.0 mg/ml in methanol (as free base) |
SW197393-3 |
HB1806 |
(+)-(s)-n-methyl-3-(1-naphthyloxy)- 3-(2-thienyl)propanamine hydrochloride |
duloxetine hcl (cymbalta) |
AMY12420 |
(3s)-n-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amin hydrochloride. |
D-170 |
(gammas)-n-methyl-gamma-(1-naphthalenyloxy)-2-thiophenepropanamine hydrochloride |
methyl[3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl]amine hydrochloride |
duloxetine for system suitability |
BD165546 |
duloxetine hydrochloride- bio-x |
cloridrato de duloxetina |
clorhidrato de duloxetina |
chlorhydrate de duloxetine |
duloxetina cloridrato |
(gammas)-2-thiophenepropanamine, n-methyl-gamma-(1-naphthalenyloxy)hydrochloride (1:1) |
Z1575081875 |
duloxetinedr |
duloxetine hcldr |
duloxetine hydrochloride20 mg |
duloxetine hydrochloride (ep monograph) |
duloxetine hydrochloride60 mg |
duloxetin hydrochloride |
duloxetinedelayed-release |
duloxetine delayed-releasedelayed-release |
duloxetine hydrochloride30 mg |
duloxetine delayed-release capsules |
duloxetine hydrochloride (usp-rs) |
duloxetine hydrochloride (mart.) |
duloxetine hydrochloride delayed release |
duloxetine hydrochloride (usp monograph) |
irenka |
(s)-n-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine monohydrochloride |
duloxetine.hcl, 1mg/ml in methanol |
Duloxetine hydrochloride is a balanced selective serotonin and norepinephrine reuptake inhibitor. It is used to treat depression, generalized anxiety disorder, neuropathic pain, and stress incontinence in women.
Excerpt | Reference | Relevance |
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"Duloxetine hydrochloride (DUL) is a drug used to treat depression and anxiety. " | ( Three Spectrophotometric Methods for Quantitative Analysis of Duloxetine in Presence of its Toxic Impurity: 1-Naphthol. Abdelhamid, NS; Anwar, BH; Magdy, MA; Naguib, IA, 2020) | 2 |
"Duloxetine hydrochloride (DH) is a serotonin-norepinephrine reuptake inhibitor (SSNRI) indicated for the treatment of depression. " | ( Formulation and optimization of duloxetine hydrochloride buccal films: in vitro and in vivo evaluation. El Sharawy, AM; Elshafeey, AH; Shukr, MH, 2017) | 2.18 |
"Duloxetine hydrochloride is a reuptake inhibitor of 5-hydroxytryptamine and norepinephrine used to treat depression, generalized anxiety disorder, neuropathic pain, and stress incontinence in women. " | ( Duloxetine for painful diabetic neuropathy and fibromyalgia pain: systematic review of randomised trials. Derry, S; Gaskell, H; Moore, RA; Sultan, A, 2008) | 1.79 |
"Duloxetine hydrochloride is a balanced selective serotonin and norepinephrine reuptake inhibitor. " | ( Pharmacokinetics of duloxetine hydrochloride enteric-coated tablets in healthy Chinese volunteers: a randomized, open-label, single- and multiple-dose study. Cheng, G; Peng, WX; Song, J; Tang, J; Zhao, RK, 2009) | 2.12 |
"Duloxetine hydrochloride (HCl) is an antidepressant drug prescribed for major depressive disorders, pain related to diabetic peripheral neuropathy, and stress urinary incontinence. " | ( Stress degradation studies on duloxetine hydrochloride and development of an RP-HPLC method for its determination in capsule formulation. Bhinge, JR; Kumria, R; Sinha, VR, 2009) | 2.08 |
"Duloxetine hydrochloride (1) is an important antidepressant that acts as a serotonin and noradrenaline reuptake inhibitor that has only recently been characterized by single-crystal X-ray diffraction. " | ( Polymorphism and a metastable solvate of duloxetine hydrochloride. Bhadbhade, M; Hook, JM; Marjo, CE; Rich, AM, 2011) | 2.08 |
"Duloxetine hydrochloride is a dual reuptake inhibitor of serotonin and norepinephrine and has been licensed by the Food and Drug Administration in the US for major depressive disorder (MDD), generalised anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain." | ( Duloxetine versus other anti-depressive agents for depression. Barbui, C; Cipriani, A; Furukawa, TA; Koesters, M; Nosè, M; Omori, IM; Purgato, M; Trespidi, C, 2012) | 1.1 |
"Duloxetine hydrochloride is a dual reuptake inhibitor of both serotonin and norepinephrine. " | ( Duloxetine versus routine care in the long-term management of diabetic peripheral neuropathic pain. D'Souza, DN; Iyengar, S; Pritchett, YL; Raskin, J; Smith, TR; Wernicke, JF; Wong, K, 2006) | 1.78 |
Excerpt | Reference | Relevance |
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"Duloxetine hydrochloride has recently been approved by the US Food and Drug Administration for the treatment of major depressive disorder (MDD). " | ( Duloxetine hydrochloride: a new dual-acting medication for the treatment of major depressive disorder. Bettinger, TL; Crismon, ML; Hunziker, ME; Suehs, BT, 2005) | 3.21 |
Excerpt | Reference | Relevance |
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"The aim of this study was to describe a potential drug-drug interaction between duloxetine and acenocoumarol in a patient with Alzheimer's disease." | ( Potential drug-drug interaction between duloxetine and acenocoumarol in a patient with Alzheimer's disease. Camarda, C; Camarda, R; Monastero, R, 2007) | 0.34 |
"This case report suggests a possible drug-drug interaction between duloxetine and acenocoumarol." | ( Potential drug-drug interaction between duloxetine and acenocoumarol in a patient with Alzheimer's disease. Camarda, C; Camarda, R; Monastero, R, 2007) | 0.34 |
" Here a duloxetine overdose case, in combination with other antidepressants and benzodiazepines, is reported and the chemical-clinical correlations discussed; this is probably the first detailed report of such a case." | ( Non-fatal overdose of duloxetine in combination with other antidepressants and benzodiazepines. Gozzi, BF; Menchetti, M; Mercolini, L; Petio, C; Raggi, MA; Saracino, MA, 2009) | 0.35 |
"A number of antidepressants inhibit the activity of the cytochrome P450 2D6 enzyme system, which can lead to drug-drug interactions." | ( An assessment of drug-drug interactions: the effect of desvenlafaxine and duloxetine on the pharmacokinetics of the CYP2D6 probe desipramine in healthy subjects. Burczynski, ME; Connolly, SM; Fatato, P; Guico-Pabia, C; Isler, JA; Jiang, Q; Nichols, AI; Patroneva, A; Paul, J; Pedersen, R, 2008) | 0.35 |
"The purpose of this study was to determine whether duloxetine [a serotonin (5-HT)-norepinephrine reuptake inhibitor] combined with transcutaneous foot stimulation or WAY-100635 (a 5-HT1A antagonist) can enhance inhibition of bladder overactivity in cats." | ( Inhibition of bladder overactivity by duloxetine in combination with foot stimulation or WAY-100635 treatment in cats. de Groat, WC; Matsuta, Y; Roppolo, JR; Schwen, Z; Shen, B; Tai, C; Wang, J, 2013) | 0.39 |
"The frequency and financial impact of potential drug-drug interactions (DDIs) and drug-condition interactions (DCIs) in patients with painful diabetic peripheral neuropathy (DPN) treated with either pregabalin or duloxetine were compared." | ( Cost comparison of drug-drug and drug-condition interactions in patients with painful diabetic peripheral neuropathy treated with pregabalin versus duloxetine. Cappelleri, JC; Chu, BC; Johnson, BH; Johnston, SS; Shrady, G; Silverman, SL; Udall, M, 2013) | 0.39 |
"Potential DDI measured using clinical software that identifies co-prescription of medications that potentially interact with pregabalin or duloxetine." | ( Potential drug-drug and drug-condition interactions among fibromyalgia patients initiating pregabalin or duloxetine: prevalence and health care expenditure impact. Cappelleri, JC; Chu, BC; Johnson, BH; Johnston, SS; Shrady, G; Silverman, SL; Udall, M, 2014) | 0.4 |
"Anticipating and controlling drug-drug interactions (DDIs) in older patients with painful diabetic peripheral neuropaty (pDPN) presents a significant challenge to providers." | ( A retrospective, matched cohort study of potential drug-drug interaction prevalence and opioid utilization in a diabetic peripheral neuropathy population initiated on pregabalin or duloxetine. Cappelleri, JC; Ellis, JJ; Mudumby, P; Ndehi, L; Parsons, B; Sadosky, AB; Suehs, BT; Ten Eyck, LL, 2015) | 0.42 |
" However, sitagliptin was observed to have no effect when administered alone or in combination with the other three drugs." | ( Drug combinations in diabetic neuropathic pain: an experimental validation. Mehta, AK; Tripathi, CD; Yadav, AM, 2016) | 0.43 |
" The magnitude of drug-drug interaction between dextromethorphan and paroxetine was higher in homozygous than in heterozygous subjects (14." | ( Impact of CYP2D6 Functional Allelic Variations on Phenoconversion and Drug-Drug Interactions. Daali, Y; Desmeules, J; Lenglet, S; Matthey, A; Storelli, F; Thomas, A, 2018) | 0.48 |
"The aim of this work was to predict the extent of Cytochrome P450 2D6 (CYP2D6)-mediated drug-drug interactions (DDIs) in different CYP2D6 genotypes using physiologically-based pharmacokinetic (PBPK) modeling." | ( Physiologically-Based Pharmacokinetic Modeling for the Prediction of CYP2D6-Mediated Gene-Drug-Drug Interactions. Daali, Y; Desmeules, J; Storelli, F, 2019) | 0.51 |
" However, evidence regarding the efficacy of IA injection of HA+CS combined with duloxetine for pain management in patients with OA of the knee is lacking." | ( Duloxetine combined with intra-articular injection versus intra-articular injection alone for pain relief in knee osteoarthritis: a study protocol for a randomised controlled trial. Han, R; Li, DY; Luo, F; Zhao, ZG, 2020) | 0.56 |
" The participants will be randomly allocated to receive either a single IA injection of HA+CS combined with duloxetine or a single IA injection of HA+CS alone, and both groups will complete a 24-week follow-up to assess pain and functional improvements." | ( Duloxetine combined with intra-articular injection versus intra-articular injection alone for pain relief in knee osteoarthritis: a study protocol for a randomised controlled trial. Han, R; Li, DY; Luo, F; Zhao, ZG, 2020) | 0.56 |
"This randomized study was aimed at evaluating the additional analgesic effect of Okada Purifying Therapy (OPT) when administered in combination with duloxetine in patients with Temporomandibular Disorders (TMDs) and Fibromyalgia (FM)." | ( Okada Purifying Therapy in combination with duloxetine vs. duloxetine alone in patients with TMD and fibromyalgia: a randomized clinical study. Atencio, MR; Bruti, G; D'Urso, A; Di Giacomo, P; Di Paolo, C, 2020) | 0.56 |
" Since activated microglia, impaired serotonergic and noradrenergic neurotransmission and overexpressed sodium channels are implicated in oxaliplatin-induced pain, this in vivo study assessed the effect of minocycline, a microglial activation inhibitor used alone or in combination with ambroxol, a sodium channel blocker, or duloxetine, a serotonin and noradrenaline reuptake inhibitor, on oxaliplatin-induced tactile allodynia and cold hyperalgesia." | ( The Microglial Activation Inhibitor Minocycline, Used Alone and in Combination with Duloxetine, Attenuates Pain Caused by Oxaliplatin in Mice. Furgała-Wojas, A; Sałat, K; Sałat, R, 2021) | 0.62 |
" It is worth noting that doses of drug combination in FST and TST did not change the motor activities of mice in the open-field test (OFT)." | ( The Potential Antidepressant Action of Duloxetine Co-Administered with the TAAR1 Receptor Agonist SEP-363856 in Mice. Chen, Y; Liang, L; Ren, X; Xiong, J; Zhang, G, 2022) | 0.72 |
"To observe the clinical effect of flunarizine combined with duloxetine in the treatment of chronic migraine with comorbid depression and anxiety disorders and to provide a reference for clinical treatment." | ( Clinical effect of flunarizine combined with duloxetine in the treatment of chronic migraine comorbidity of depression and anxiety disorder. Chen, J; Zhang, K; Zhu, J, 2022) | 0.72 |
" The control group was treated with flunarizine combined with loxoprofen sodium, and the observation group was treated with flunarizine combined with duloxetine." | ( Clinical effect of flunarizine combined with duloxetine in the treatment of chronic migraine comorbidity of depression and anxiety disorder. Chen, J; Zhang, K; Zhu, J, 2022) | 0.72 |
"Flunarizine combined with duloxetine in the treatment of chronic migraine with depression and anxiety disorder can effectively improve neuroelectrophysiological indexes, reduce inflammation, and reduce depression and anxiety." | ( Clinical effect of flunarizine combined with duloxetine in the treatment of chronic migraine comorbidity of depression and anxiety disorder. Chen, J; Zhang, K; Zhu, J, 2022) | 0.72 |
" Therefore, we investigated the effect of an antimuscarinic (oxybutynin) on OSA severity when administered with either duloxetine or milnacipran, two dual noradrenergic/serotonergic reuptake inhibiters." | ( A single dose of noradrenergic/serotonergic reuptake inhibitors combined with an antimuscarinic does not improve obstructive sleep apnoea severity. Adam, M; Beatty, CJ; Cheung, T; Edwards, BA; Hamilton, GS; Joosten, SA; Landry, SA; Mann, DL; Thomson, LDJ; Wong, AM, 2022) | 0.72 |
Duloxetine hydrochloride has been found to react with polymer degradation products or residual free acids. It can form succinamide and phthalamide impurities, respectively.
Excerpt | Relevance | Reference |
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"Duloxetine hydrochloride ((S)-N-methyl-3-(1-naphthalenyloxy)-2-thiophenepropanamine hydrochloride) has been found to react with polymer degradation products or residual free acids present in the enteric polymers hydroxypropyl methylcellulose acetate succinate (HPMCAS) and hydroxypropyl methylcellulose phthalate (HPMCP) in dosage formulations to form succinamide and phthalamide impurities, respectively." | ( Characterization of impurities formed by interaction of duloxetine HCl with enteric polymers hydroxypropyl methylcellulose acetate succinate and hydroxypropyl methylcellulose phthalate. Baertschi, SW; Jansen, PJ; Kemp, CA; Maple, SR; Oren, PL, 1998) | 1.74 |
" TYR PD30 increased significantly with desipramine dosing (p<0." | ( Duloxetine increases serotonin and norepinephrine availability in healthy subjects: a double-blind, controlled study. Bieck, PR; Bymaster, FP; Chalon, SA; Granier, LA; Hirth, C; Joliat, MJ; Potter, WZ; Vandenhende, FR, 2003) | 0.32 |
" These findings suggest that there should not be a need for routine adjustment of tolterodine dosage in the presence of duloxetine." | ( Effect of duloxetine on tolterodine pharmacokinetics in healthy volunteers. Chan, C; Gonzales, CR; Hua, TC; Knadler, MP; Pan, A; Poo, YK; Skinner, MH; Wise, SD, 2004) | 0.32 |
" The dose of intravenous tyramine required to raise systolic blood pressure by 30 mm Hg (PD30) increased dose-dependently with duloxetine and was significant at the end of the 120-mg/d dosage (P<0." | ( Clinical assessment of norepinephrine transporter blockade through biochemical and pharmacological profiles. Bieck, PR; Black, BK; Bymaster, FP; Garland, EM; Gonzales, C; Loghin, C; Potter, WZ; Robertson, D; Vincent, S, 2004) | 0.32 |
" In this study, the effects of two dosing regimens of duloxetine on sleep electroencephalography (EEG) were investigated at steady-state plasma concentrations in young, healthy, male subjects." | ( Comparative effects of duloxetine and desipramine on sleep EEG in healthy subjects. Chalon, S; Granier, LA; Lainey, E; Pereira, A; Staner, L; Vandenhende, F; Watkin, JG, 2005) | 0.33 |
" While approved dosing ranges have not yet been determined, studies support the efficacy and safety of 40-60 mg twice daily for the treatment of acute MDD." | ( Duloxetine: a dual reuptake inhibitor. Dugan, SE; Fuller, MA, 2004) | 0.32 |
"The rate of duloxetine elimination is reduced for cirrhotic subjects, making dosage adjustments appropriate." | ( Duloxetine pharmacokinetics in cirrhotics compared with healthy subjects. Branch, RA; Gonzales, C; Knadler, MP; Reddy, S; Skinner, MH; Suri, A, 2005) | 0.33 |
"Duloxetine exhibits linear, dose-dependent pharmacokinetics across the approved oral dosage range of 40 to 60 mg/d." | ( Duloxetine hydrochloride: a new dual-acting medication for the treatment of major depressive disorder. Bettinger, TL; Crismon, ML; Hunziker, ME; Suehs, BT, 2005) | 1.77 |
"The pharmacology, pharmacokinetics, efficacy, safety, drug interactions, dosage and administration, cost, and place in therapy of duloxetine for major depression, pain from diabetic peripheral neuropathy, and stress urinary incontinence are reviewed." | ( Duloxetine: a balanced and selective norepinephrine- and serotonin-reuptake inhibitor. Gayken, J; Haight, R; Westanmo, AD, 2005) | 0.33 |
" The recommended dosage of duloxetine is 40-80 mg daily, depending on the indication, preferably split into two doses per day." | ( Duloxetine: a balanced and selective norepinephrine- and serotonin-reuptake inhibitor. Gayken, J; Haight, R; Westanmo, AD, 2005) | 0.33 |
"Positron emission tomography (PET) has been utilized for determining the dosage of antipsychotic drugs." | ( A dose-finding study of duloxetine based on serotonin transporter occupancy. Ikoma, Y; Kosaka, J; Nozaki, S; Ota, M; Suhara, T; Suzuki, K; Takano, A; Tanada, S, 2006) | 0.33 |
" Adverse event rates were based on spontaneous reports and differential dose-response effects were not evaluated." | ( Duloxetine in the treatment of major depressive disorder: comparisons of safety and tolerability in male and female patients. Kornstein, SG; Mallinckrodt, CH; Stewart, DE; Watkin, JG; Wohlreich, MM, 2006) | 0.33 |
" Whereas the target dose for the majority of patients is 60 mg/day, higher duloxetine doses (up to 120 mg/day) have been studied using a twice-daily dosing schedule." | ( Duloxetine for the treatment of major depressive disorder: safety and tolerability associated with dose escalation. Carter, WP; Mallinckrodt, CH; Prakash, A; Watkin, JG; Wohlreich, MM, 2007) | 0.34 |
" An evaluation of increments in effect size between doses consistently showed that the most notable gain in effect size for efficacy was the 40-60mg/day dosage range." | ( Use of effect size to determine optimal dose of duloxetine in major depressive disorder. Berzon, RA; Corey-Lisle, PK; Desaiah, D; Detke, MJ; Marciniak, MD; Pritchett, YL, ) | 0.13 |
" The varying sensitivity of scales that measure the severity of depression is one of the many factors affecting the evaluation of the dose-response relationship with antidepressants." | ( Dose-response relationship of duloxetine in placebo-controlled clinical trials in patients with major depressive disorder. Bech, P; Kajdasz, DK; Porsdal, V, 2006) | 0.33 |
" Duloxetine, in a dosage of 60 mg x 1 or x 2 daily, significantly reduces, from the first week of administration, the pain of DPN, when compared with a placebo." | ( [Duloxetine, a new therapeutic option for diabetic peripheral neuropathic pain]. Ziegler, D, 2006) | 0.33 |
" The patient took 20 mg daily for five days and then decided, on her own, to decrease the dosage after experiencing insomnia, a common adverse effect of duloxetine." | ( Facial flushing associated with duloxetine use. Ezzo, DC; Patel, PN, 2007) | 0.34 |
"Data were combined from two similarly designed, multicenter, randomized, double-blind, parallel group studies in which patients with major depressive disorder were randomized to either duloxetine 60 mg/day or venlafaxine extended release (XR) 150 mg/day (75 mg/day for the first 2 weeks) for a 6-week fixed dosing period followed by an additional 6 weeks of treatment in which the dose could be increased up to 120 mg/day for duloxetine and 225 mg/day for venlafaxine." | ( A randomized, double-blind comparison of duloxetine and venlafaxine in the treatment of patients with major depressive disorder. Bauer, M; Froud, DM; Jain, R; Kajdasz, DK; Perahia, DG; Pritchett, YL; Raskin, J; Russell, JM; Spencer, KA; Thase, ME; Walker, DJ, 2008) | 0.35 |
"047) experienced sustained elevations of systolic blood pressure during the fixed dosing period." | ( A randomized, double-blind comparison of duloxetine and venlafaxine in the treatment of patients with major depressive disorder. Bauer, M; Froud, DM; Jain, R; Kajdasz, DK; Perahia, DG; Pritchett, YL; Raskin, J; Russell, JM; Spencer, KA; Thase, ME; Walker, DJ, 2008) | 0.35 |
" Duloxetine produced increases in supine systolic and diastolic blood pressures, which reached maximums of approximately 12 mm Hg and approximately 7 mm Hg above baseline, respectively, during dosing at 120 mg BID and then stabilized." | ( The effects of supratherapeutic doses of duloxetine on blood pressure and pulse rate. Callaghan, JT; Chappell, JC; Derby, MA; Ereshefsky, L; Gonzales, CR; Hoelscher, D; Leese, PT; Leibowitz, M; Mitchell, MI; Zhang, L, 2007) | 0.34 |
" Significant improvements versus placebo in core emotional symptoms as well as painful physical symptoms associated with depression, were seen in most, but not all, appropriately designed studies; results of meta-analyses suggested that improvements in these efficacy measures were apparent after 1-2 weeks' treatment with the highest recommended dosage of 60 mg once daily." | ( Duloxetine: a review of its use in the treatment of major depressive disorder. Frampton, JE; Plosker, GL, 2007) | 0.34 |
"Duloxetine pharmacokinetics in healthy Chinese subjects given a 60 mg once-daily dosing regimen were well characterised and consistent with known duloxetine pharmacokinetics in healthy Caucasian and Japanese subjects." | ( Pharmacokinetics and tolerability of duloxetine following oral administration to healthy Chinese subjects. Knadler, MP; Liang, S; Lim, MT; Lobo, ED; Pan, AX; Teng, L; Tianmei, S; Yeo, KP, 2007) | 0.34 |
"Participants in a major depressive episode (N=249) began duloxetine treatment at 30 or 60 mg daily for the first week, followed by up to 11 weeks of flexibly dosed duloxetine (60, 90, or 120 mg daily)." | ( The efficacy and tolerability of duloxetine in the treatment of anxious versus non-anxious depression: a post-hoc analysis of an open-label outpatient study. Brown, E; Chen, L; Fava, M; Greist, J; Marangell, LB; Martinez, JM; Wohlreich, MM, ) | 0.13 |
" A secondary analysis of dose-response relationships indicated that this advantage was not attributable to the studies using higher doses of duloxetine." | ( Efficacy of duloxetine and selective serotonin reuptake inhibitors: comparisons as assessed by remission rates in patients with major depressive disorder. Detke, MJ; Ossanna, MJ; Pritchett, YL; Swindle, RW; Thase, ME; Xu, J, 2007) | 0.34 |
"14]) but did not resolve urinary incontinence, with no significant dose-response association." | ( Systematic review: randomized, controlled trials of nonsurgical treatments for urinary incontinence in women. Kane, RL; Shamliyan, TA; Wilt, TJ; Wyman, J, 2008) | 0.35 |
"Fifty-five women with PMDD were treated with a 60 mg/day dosage of duloxetine for two menstrual cycles." | ( Duloxetine for premenstrual dysphoric disorder: a pilot study. Bria, P; Catalano, V; Harnic, D; Janiri, L; Mazza, M, 2008) | 0.35 |
" Duloxetine was administered in dosage 60 mg per day during 8 weeks to 40 patients." | ( [Efficacy of duloxetine in the treatment of chronic daily headache]. Artemenko, AR; Filatova, EG; Kurenkov, AL, 2007) | 0.34 |
" Cymbalta was used as a monotherapy in dosage 60 mg daily during 6 weeks simultaneously with traditional non-pharmacological therapy." | ( [Treatment of chronic back pain with antidepressant cymbalta: an experimental study]. Kaverina, IV; Leonova, AR; Voznesenskaia, TG, 2007) | 0.34 |
" Adverse effects were evaluated using the Dosage Record Treatment Emergent Symptom Scale." | ( Efficacy and tolerability of duloxetine in the treatment of patients with borderline personality disorder: a pilot study. Bellino, S; Bogetto, F; Bozzatello, P; Paradiso, E, 2010) | 0.36 |
" Fifteen individuals with panic disorder with or without agoraphobia received 8 weeks of open label duloxetine flexibly dosed from 60 to 120 mg per day." | ( Open-label support for duloxetine for the treatment of panic disorder. Herlands, NN; Hoge, EA; Kaufman, RE; Owens, ME; Pollack, MH; Simon, NM; Worthington, JJ, 2009) | 0.35 |
" Patients received cymbalta in dosage 60 mg daily during 2 months." | ( [Cymbalta (duloxetine) in the treatment of anxiety-depressive disorders in patients with discirculatory encephalopathy]. Bobrova, MV; Listopadov, IuI; Rzheusskaia, GV; Umrudina, AG, 2009) | 0.35 |
"The objectives of this analysis were to characterize the pharmacokinetics of duloxetine at steady state in patients, estimate the variability, identify significant covariates that may influence duloxetine pharmacokinetics and provide appropriate dosing recommendations for patients on duloxetine treatment." | ( Population pharmacokinetics of orally administered duloxetine in patients: implications for dosing recommendation. Heathman, M; Knadler, MP; Lobo, ED; O'Brien, L; Quinlan, T, 2009) | 0.35 |
" Covariates including bodyweight, age, sex, ethnicity, smoking status, disease condition, dose, dosing regimen and creatinine clearance were tested for their influence on duloxetine pharmacokinetics." | ( Population pharmacokinetics of orally administered duloxetine in patients: implications for dosing recommendation. Heathman, M; Knadler, MP; Lobo, ED; O'Brien, L; Quinlan, T, 2009) | 0.35 |
" The significant improvements in efficacy that occurred in patients with fibromyalgia during 8 weeks of open-label treatment with duloxetine 60 mg/day were generally maintained during 52 weeks of subsequent blinded treatment at the same dosage in a phase III trial." | ( Duloxetine: in patients with fibromyalgia. Curran, MP, 2009) | 0.35 |
"This study evaluated the pharmacodynamics and pharmacokinetics of once-daily dosing of warfarin at steady state when taken concomitantly with once-daily doses of duloxetine." | ( Effects of duloxetine on the pharmacodynamics and pharmacokinetics of warfarin at steady state in healthy subjects. Chappell, J; He, J; Knadler, MP; Lee, D; Lobo, E; Mitchell, M, 2009) | 0.35 |
"Many women received lower duloxetine doses than expected based on evidence-based dosing recommendations." | ( How are women with SUI-symptoms treated with duloxetine in real life practice? - preliminary results from a large observational study in Germany. Gotsch, U; Gross, A; Manning, M; Methfessel, HD; Michel, MC; Minarzyk, A; Pages, I; Quail, D, 2009) | 0.35 |
" At week 7, the duloxetine dosage was increased, in a blinded fashion, to 120-mg QD in patients reporting < 30% pain reduction." | ( A double-blind, randomized, placebo-controlled study of the efficacy and safety of duloxetine for the treatment of chronic pain due to osteoarthritis of the knee. Belenkov, Y; Brown, JP; Chappell, AS; Desaiah, D; Liu-Seifert, H; Skljarevski, V; Zhang, S, ) | 0.13 |
" Opioid utilization including total days, number of prescriptions filled, and morphine equivalent dosage was assessed for overall, long-acting, and short-acting opioids." | ( Opioid utilization and health-care costs among patients with diabetic peripheral neuropathic pain treated with duloxetine vs. other therapies. Boulanger, L; Chen, SY; Fraser, KA; Hallett, LA; Patel, CK; Wu, N; Zhao, Y, ) | 0.13 |
" This study examined the association between initial prescription dosage of duloxetine and its adherence and persistence." | ( Initial duloxetine prescription dose and treatment adherence and persistence in patients with major depressive disorder. Able, SL; Faries, DE; Gelwicks, S; Liu, X, 2010) | 0.36 |
" The author reviews the major medications used, dosing schedules, and data from randomized controlled trials." | ( Treatment of neuropathic pain. Jefferies, K, 2010) | 0.36 |
" A month after the aripiprazole dosage was increased to 50 mg daily, the patient developed confusion and loss of coordination." | ( Increased aripiprazole concentrations in an HIV-positive male concurrently taking duloxetine, darunavir, and ritonavir. Aung, GL; Kawamoto, LS; O'Brien, JG; Tien, PG, 2010) | 0.36 |
"A reproducible gradient reversed-phase ultra-performance liquid chromatographic method is developed for quantitative determination of duloxetine hydrochloride in pharmaceutical dosage forms." | ( Analysis of duloxetine hydrochloride and its related compounds in pharmaceutical dosage forms and in vitro dissolution studies by stability indicating UPLC. Chakole, D; Mukkanti, K; Rao, DD; Reddy, AM; Reddy, YR; Sait, SS, 2010) | 0.94 |
"A stability-indicating HPLC assay method was developed for the quantitative determination of duloxetine (DLX) in a pharmaceutical dosage form in the presence of its degradation products, and kinetic determinations were evaluated in acid conditions and UV-C radiation exposure." | ( Stress degradation studies and kinetic determinations of duloxetine enteric-coated pellets by HPLC. Gomes, P; Paim, CS; Schapoval, EE; Steppe, M; Wingert, NR, ) | 0.13 |
" However, given that the study had several limitations, including the lack of a comparison group and a flexible dosage design, further research is needed to replicate and extend these findings." | ( Clinical and demographic predictors of improvement during duloxetine treatment in patients with major depression: an open-label study. Chiesa, A; De Ronchi, D; Mencacci, C; Nasso, ED; Serretti, A, 2011) | 0.37 |
"It is necessary to warn patients who take benzodiazepines in therapy that reinforcement of irritability may occur in case of higher dosage of benzodiazepines, which may be misinterpreted as worsening in mental condition." | ( Reinforcement of irritability during therapy with benzodiazepines. Kozumplik, O; Uzun, S, 2011) | 0.37 |
" We described a patient with tremor, mydriatic pupils, clonus, and ataxia after a single dose of duloxetine; on the dosage of admission." | ( Serotonin syndrome due to duloxetine. Gelener, P; Gorgulu, U; Inan, LE; Kutlu, G; Ucler, S, ) | 0.13 |
" The CGI-Improvement, CGI-Effectiveness Index and Dosage Record Treatment Emergent Symptom Scale were administered at T1 and T2." | ( Duloxetine for the treatment of mood disorder in cancer patients: a 12-week case-control clinical trial. Borio, R; Castelli, L; Leombruni, P; Torta, R, ) | 0.13 |
"To examine medication dosing patterns of duloxetine and pregabalin among patients with fibromyalgia." | ( Medication dosing patterns associated with duloxetine and pregabalin among patients with fibromyalgia. Sun, P; Watson, P; Zhao, Y; Zhao, Z, 2011) | 0.37 |
"Among patients with fibromyalgia, duloxetine and pregabalin initiators had different dosing patterns." | ( Medication dosing patterns associated with duloxetine and pregabalin among patients with fibromyalgia. Sun, P; Watson, P; Zhao, Y; Zhao, Z, 2011) | 0.37 |
"The purpose of our study was to examine dosing patterns and pretreatment predictors of high-dose duloxetine therapy for patients with MDD in the usual clinical setting." | ( Dosing patterns for duloxetine and predictors of high-dose prescriptions in patients with major depressive disorder: analysis from a United States third-party payer perspective. Ball, T; Cui, Z; Faries, DE; Johnstone, B; Liu, X; Niu, L, 2011) | 0.37 |
" Dosing patterns and predictors of high-dose therapy with duloxetine were examined." | ( Dosing patterns for duloxetine and predictors of high-dose prescriptions in patients with major depressive disorder: analysis from a United States third-party payer perspective. Ball, T; Cui, Z; Faries, DE; Johnstone, B; Liu, X; Niu, L, 2011) | 0.37 |
" Nonblinded, flexibly dosed treatment was used to mimic clinical practice." | ( A pragmatic 12-week, randomized trial of duloxetine versus generic selective serotonin-reuptake inhibitors in the treatment of adult outpatients in a moderate-to-severe depressive episode. Edwards, SE; Greist, JH; Katon, W; Kroenke, K; Marangell, LB; Martinez, JM; Meyers, AL; Shoemaker, S; Swindle, R; Thase, ME, 2012) | 0.38 |
"Study limitations include a short timeframe and using data from different dosage schemes for GBP and PGB." | ( Economic evaluation of duloxetine as a first-line treatment for painful diabetic peripheral neuropathy in Mexico. Carlos, F; Dueñas, H; Galindo-Suárez, RM; Ramírez-Gámez, J; Ramos, E, 2012) | 0.38 |
"To compare medication dosing patterns of duloxetine and pregabalin among patients with diabetic peripheral neuropathic pain (DPNP)." | ( Dosing pattern comparison between duloxetine and pregabalin among patients with diabetic peripheral neuropathic pain. Bernauer, M; Sun, P; Watson, P; Zhao, Y; Zhao, Z, 2012) | 0.38 |
" healthcare claims database, we examined the dosing patterns of duloxetine and pregabalin among commercially insured patients with DPNP aged 18 to 64 who initiated (a 90-day medication gap) duloxetine or pregabalin therapy in 2006." | ( Dosing pattern comparison between duloxetine and pregabalin among patients with diabetic peripheral neuropathic pain. Bernauer, M; Sun, P; Watson, P; Zhao, Y; Zhao, Z, 2012) | 0.38 |
"The commercially insured patients with DPNP who initiated duloxetine or pregabalin therapy had different dosing patterns." | ( Dosing pattern comparison between duloxetine and pregabalin among patients with diabetic peripheral neuropathic pain. Bernauer, M; Sun, P; Watson, P; Zhao, Y; Zhao, Z, 2012) | 0.38 |
" We here review the evidence for the efficacy of 60 mg once-daily dosing of duloxetine for chronic pain conditions." | ( A review of duloxetine 60 mg once-daily dosing for the management of diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain due to chronic osteoarthritis pain and low back pain. Langley, P; Nalamachu, S; Pergolizzi, JV; Raffa, RB; Rodriguez, G; Taylor, R, 2013) | 0.39 |
"The studies reviewed report that duloxetine 60 mg once-daily dosing is an effective option for the management of diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain due to chronic OA pain and chronic LBP." | ( A review of duloxetine 60 mg once-daily dosing for the management of diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain due to chronic osteoarthritis pain and low back pain. Langley, P; Nalamachu, S; Pergolizzi, JV; Raffa, RB; Rodriguez, G; Taylor, R, 2013) | 0.39 |
"The Tekscan(®) WB measurement system was used in MIA rats to examine the acute and chronic dosing effects of drugs that targeted different mechanisms." | ( Pharmacological validation of early and late phase of rat mono-iodoacetate model using the Tekscan system. Elmes, SJ; McIntosh, F; Perkins, MN; Rashid, MH; Theberge, Y, 2013) | 0.39 |
" Rates of change (slopes) were estimated from the fitted model and differences in the cost trajectory among dosing cohorts were tested using the F-test." | ( Longitudinal analysis of healthcare costs: a case study of patients with major depressive disorder treated with duloxetine. Able, SL; Cui, Z; Faries, DE; Novick, D; Shen, W, 2013) | 0.39 |
" Duloxetine has a generally favorable side effect profile and dosing is simple." | ( [Duloxetine for chronic pain management: pharmacology and clinical use]. Itoh, M; Masuda, R; Suzuki, T, 2013) | 0.39 |
" Concerning the emotional pain responses revealed with USVs, we assumed that the antinociceptive effects were almost completely derived from duloxetine, since celecoxib was ineffective when administered alone or reduced the dosage of duloxetine when given in combination." | ( Synergistic analgesia of duloxetine and celecoxib in the mouse formalin test: a combination analysis. Dong, YL; Gu, ZX; Lu, GJ; Sun, YH; Wang, W; Wang, YT; Wu, SX; Yang, J; Zhao, GL, 2013) | 0.39 |
" The results of this study indicate that the analgesic effect of repeated dosing of AS1069562 but not duloxetine is persistent even after a 1-week drug discontinuation in STZ-induced diabetic rats." | ( AS1069562, the (+)-isomer of indeloxazine, but not duloxetine has a curative-like analgesic effect in a rat model of streptozotocin-induced diabetic neuropathy. Aoki, T; Hamakawa, N; Matsuoka, N; Murai, N; Tamura, S; Yamamoto, H, 2014) | 0.4 |
"Mean median daily dosage over 6 months was 53." | ( Effectiveness of duloxetine compared with pregabalin and gabapentin in diabetic peripheral neuropathic pain: results from a German observational study. Birklein, F; Boess, FG; Happich, M; Schacht, A; Schneider, E; Wilhelm, S; Ziegler, D, 2014) | 0.4 |
" Rates of treatment-emergent sexual dysfunction (TESD) in the vortioxetine dosing groups were similar to placebo." | ( A randomised, double-blind, placebo-controlled, duloxetine-referenced study of the efficacy and tolerability of vortioxetine in the acute treatment of adults with generalised anxiety disorder. Chen, Y; Jacobsen, PL; Mahableshwarkar, AR; Simon, JS, 2014) | 0.4 |
" Here, the in vivo effects of dosing with duloxetine 60 mg once daily for 11 days in healthy subjects were assessed in 2 studies: (1) centrally (n = 11), by measuring concentrations of 5-hydroxyindoleacetic acid, 3,4-dihydroxyphenylglycol (DHPG), and NE in cerebrospinal fluid, and (2) versus escitalopram 20 mg/d (n = 32) in a 2-period crossover study by assessing the ΔDHPG/ΔNE ratio in plasma during orthostatic testing and by pharmacokinetic/pharmacodynamic modeling of reuptake inhibition using subjects' serum in cell lines expressing cloned human 5-HTT or NET." | ( Effects of duloxetine on norepinephrine and serotonin transporter activity in healthy subjects. Chappell, JC; Dean, RA; Detke, MJ; Eisenhofer, G; Haber, H; Iyengar, S; Knadler, MP; Lachno, DR; Lobo, ED; Mitchell, MI; Nemeroff, CB; Owens, MJ; Pangallo, B, 2014) | 0.4 |
" The methods were successfully applied for the determination of this drug in pharmaceutical dosage form." | ( Development of sensitive spectrofluorimetric and spectrophotometric methods for the determination of duloxetine in capsule and spiked human plasma. Önal, A; Sagirli, O; Toker, SE, 2014) | 0.4 |
" However, cost-analysis is only part of the equation when treating chronic pain patients and undervalues the relationships of enhanced compliance due to single-daily dosing and stable and reliable pharmacokinetics associated with extended-duration preparations using either retentive technologies or delayed absorption strategies." | ( Can Chronic Pain Patients Be Adequately Treated Using Generic Pain Medications to the Exclusion of Brand-Name Ones? Anantamongkol, U; Candido, KD; Chiweshe, J; Knezevic, NN, ) | 0.13 |
" By univariate and multivariate analysis, the patient's age, tumor origin, regimen of chemotherapy, accumulated doses of paclitaxel or carboplatin, previous medication, maintenance dosage and timing of treatment with duloxetine were found not to be associated with the effectiveness of duloxetine treatment." | ( Usefulness of duloxetine for Paclitaxel-induced peripheral neuropathy treatment in gynecological cancer patients. Egawa-Takata, T; Fujita, M; Isobe, A; Kimura, T; Kobayashi, E; Mabuchi, S; Matsuzaki, S; Otake, A; Sawada, K; Ueda, Y; Yoshino, K, 2015) | 0.42 |
" Effects of orally dosed standard analgesics on CRANE were examined 48 h following bilateral CFA injection." | ( Complete Freund's adjuvant-induced reduction of exploratory activity in a novel environment as an objective nociceptive endpoint for sub-acute inflammatory pain model in rats. Bannon, AW; Joshi, SK; Zhu, CZ, 2015) | 0.42 |
"Youth aged 7 through 17 years with a primary diagnosis of GAD were treated with flexibly dosed duloxetine (30-120 mg daily, n = 135) or placebo (n = 137) for 10 weeks, followed by open-label duloxetine (30-120mg daily) for 18 weeks." | ( A randomized, placebo-controlled study of duloxetine for the treatment of children and adolescents with generalized anxiety disorder. Cai, N; Findling, RL; Pangallo, BA; Prakash, A; Strawn, JR; Stroud, CE; Zhang, Q, 2015) | 0.42 |
" Systemic intraperitoneal injections at a higher dosage (10 mg) had smaller analgesic effects (reduced by approximately 53%-69%), whereas contralateral SC injections (10 mg) were ineffective." | ( R-Duloxetine and N-Methyl Duloxetine as Novel Analgesics Against Experimental Postincisional Pain. Russell, G; Strichartz, GR; Wang, CF; Wang, GK; Wang, SY, 2016) | 0.43 |
" Then, duloxetine dosage was reduced to 30 mg/day." | ( Duloxetine-induced Sleep Bruxism in Fibromyalgia Successfully Treated With Amitriptyline. Malas, FÜ; Şahin Onat, S, ) | 0.13 |
" The mean dosage of duloxetine was 55 mg/day (range 40-60 mg/day) and the mean dosage of sertraline was 146 mg/day (range 50-200 mg/day)." | ( Comparing the Effects of Sertraline with Duloxetine for Depression Severity and Symptoms: A Double-Blind, Randomized Controlled Trial. Dastgheib, SA; Mowla, A; Razeghian Jahromi, L, 2016) | 0.43 |
" The aim of this article was to characterize the relevant classification of drug impurities and to review the methods of impurities determination for atorvastatin (ATV) and duloxetine (DLX) (both in active pharmaceutical ingredients and in different dosage forms)." | ( Impurities in Drug Products and Active Pharmaceutical Ingredients. Frankowski, M; Kątny, M, 2017) | 0.46 |
" The mean dosage of duloxetine was 44." | ( Duloxetine Augmentation in Resistant Obsessive-Compulsive Disorder: A Double-Blind Controlled Clinical Trial. Boostani, S; Dastgheib, SA; Mowla, A, 2016) | 0.43 |
" The patients in the duloxetine group received doxazosin 4 mg + duloxetine 30 mg once a day, and the dosage of duloxetine was increased to 60 mg after a week." | ( Clinical study of duloxetine hydrochloride combined with doxazosin for the treatment of pain disorder in chronic prostatitis/chronic pelvic pain syndrome: An observational study. Dong, D; Ji, Z; Li, H; Yan, S; Zhang, M, 2017) | 0.79 |
" Thus, taking into account the observed high interindividual variability of SCD, our findings suggest that for MDD patients treated with duloxetine, SCD could be a useful tool to guide the treatment by optimizing the oral dosage in order to increase the AR rate." | ( Duloxetine plasma level and antidepressant response. Conca, A; De Donatis, D; Florio, V; Mercolini, L; Porcelli, S; Saria, A; Serretti, A, 2019) | 0.51 |
" Unlike the selective serotonin (5-HT) reuptake inhibitors (SSRIs), most of these antidepressants have an ascending rather than a flat dose-response curve." | ( Serotonin and Norepinephrine Reuptake Inhibitors. Shelton, RC, 2019) | 0.51 |
" This study compared the efficacy and safety of switching patients with treatment-resistant depression from an ineffective antidepressant to flexibly dosed esketamine nasal spray plus a newly initiated antidepressant or to a newly initiated antidepressant (active comparator) plus placebo nasal spray." | ( Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study. Bajbouj, M; Cooper, K; Daly, EJ; Drevets, WC; Hough, D; Lane, R; Lim, P; Manji, H; Mazzucco, C; Molero, P; Popova, V; Shelton, RC; Singh, JB; Thase, ME; Trivedi, M; Vieta, E, 2019) | 0.51 |
"Eighteen healthy women signed informed consent, however, one dropped out before dosing and one dropped out after the first period, therefore, 16 subjects completed the study." | ( Effect of a 5-HT Cernus, D; Klarskov, N; Sawyer, W; Van Till, O, 2019) | 0.51 |
" However, further studies are still needed to find out the optimal dosage for OA and examine its long-term efficacy and safety." | ( The short-term effect and safety of duloxetine in osteoarthritis: A systematic review and meta-analysis. Chen, HY; Gao, SH; Huang, JH; Huo, JB; Li, XW; Pan, QM, 2019) | 0.51 |
"To raise awareness and demonstrate the importance of a thorough assessment of smoking status, we present a case in which the temporal relationship of smoking cessation to the emergence of nausea, vomiting, and tachycardia 3 days later (day 3); the development of myoclonic jerks by day 5; and the resolution of symptoms on reduction of duloxetine dosage on day 44 implicates duloxetine toxicity in a patient with ischemic cardiomyopathy awaiting implantation of a left ventricular assist device." | ( Smoking cessation and duloxetine toxicity: A case report. Kohli, N; Tancredi, N, ) | 0.13 |
" Baseline paw withdrawal thresholds (PWTs) were determined in the ipsilateral (injured side) and contralateral hindpaws immediately prior to dosing and at scheduled times for 3 h post dosing in individual animals." | ( Assessment of the anti-allodynic efficacy of a glycine transporter 2 inhibitor relative to pregabalin and duloxetine in a rat model of prostate cancer-induced bone pain. Corradini, L; Imam, MZ; Kuo, A; Nicholson, JR; Smith, MT, 2020) | 0.56 |
"Aim of the study was to reduce the dose and dosing frequency of duloxetine HCl (DXT) by complexation with sulfobutylether-β-cyclodextrin (SBEβCD), an anionic cyclodextrin through permeation enhancement for more effective management of depression." | ( Transdermal delivery of duloxetine-sulfobutylether-β-cyclodextrin complex for effective management of depression. Dahiya, L; Kumar, R; Sarwal, A; Sinha, VR, 2021) | 0.62 |
" The mechanism underpinning pain relief induced by the GlyT2 inhibitor at 10 mg/kg is likely due to increased glycinergic inhibition in the lumbar spinal cord, although the bell-shaped dose-response curve warrants further translational considerations." | ( Assessment of the Anti-Allodynic and Anti-Hyperalgesic Efficacy of a Glycine Transporter 2 Inhibitor Relative to Pregabalin, Duloxetine and Indomethacin in a Rat Model of Cisplatin-Induced Peripheral Neuropathy. Corradini, L; Kuo, A; Nicholson, JR; Smith, MT, 2021) | 0.62 |
" Western blot and immunohistochemistry suggested that a cumulative dosage of PTX (8 mg/kg) upregulated TRPV1 expression in the lumbar DRG and spinal dorsal horn (SDH) at day 14 post treatment." | ( Participation of transient receptor potential vanilloid 1 in the analgesic effect of duloxetine for paclitaxel induced peripheral neuropathic pain. Feng, S; Mao, M; Wang, J; Wang, X; Zhang, S; Zhou, F, 2022) | 0.72 |
Role | Description |
---|---|
antidepressant | Antidepressants are mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions. |
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res] |
Class | Description |
---|---|
duloxetine hydrochloride | |
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res] |
Protein | Taxonomy | Measurement | Average (µ) | Min (ref.) | Avg (ref.) | Max (ref.) | Bioassay(s) |
---|---|---|---|---|---|---|---|
glp-1 receptor, partial | Homo sapiens (human) | Potency | 11.2202 | 0.0184 | 6.8060 | 14.1254 | AID624417 |
RAR-related orphan receptor gamma | Mus musculus (house mouse) | Potency | 19.3351 | 0.0060 | 38.0041 | 19,952.5996 | AID1159521; AID1159523 |
Fumarate hydratase | Homo sapiens (human) | Potency | 35.4813 | 0.0030 | 8.7949 | 48.0869 | AID1347053 |
TDP1 protein | Homo sapiens (human) | Potency | 19.3486 | 0.0008 | 11.3822 | 44.6684 | AID686978; AID686979 |
GLI family zinc finger 3 | Homo sapiens (human) | Potency | 3.2937 | 0.0007 | 14.5928 | 83.7951 | AID1259369; AID1259392 |
AR protein | Homo sapiens (human) | Potency | 21.3567 | 0.0002 | 21.2231 | 8,912.5098 | AID1259243; AID1259247; AID743035; AID743042; AID743054; AID743063 |
Smad3 | Homo sapiens (human) | Potency | 22.3872 | 0.0052 | 7.8098 | 29.0929 | AID588855 |
caspase 7, apoptosis-related cysteine protease | Homo sapiens (human) | Potency | 33.4915 | 0.0133 | 26.9810 | 70.7614 | AID1346978 |
estrogen receptor 2 (ER beta) | Homo sapiens (human) | Potency | 9.4392 | 0.0006 | 57.9133 | 22,387.1992 | AID1259378 |
nuclear receptor subfamily 1, group I, member 3 | Homo sapiens (human) | Potency | 26.9434 | 0.0010 | 22.6508 | 76.6163 | AID1224838; AID1224839; AID1224893 |
progesterone receptor | Homo sapiens (human) | Potency | 33.4915 | 0.0004 | 17.9460 | 75.1148 | AID1346795 |
cytochrome P450 family 3 subfamily A polypeptide 4 | Homo sapiens (human) | Potency | 9.2451 | 0.0123 | 7.9835 | 43.2770 | AID1346984; AID1645841 |
glucocorticoid receptor [Homo sapiens] | Homo sapiens (human) | Potency | 22.5978 | 0.0002 | 14.3764 | 60.0339 | AID720691; AID720692 |
retinoic acid nuclear receptor alpha variant 1 | Homo sapiens (human) | Potency | 22.0846 | 0.0030 | 41.6115 | 22,387.1992 | AID1159552; AID1159553; AID1159555 |
retinoid X nuclear receptor alpha | Homo sapiens (human) | Potency | 9.5205 | 0.0008 | 17.5051 | 59.3239 | AID1159527; AID1159531 |
estrogen-related nuclear receptor alpha | Homo sapiens (human) | Potency | 33.4915 | 0.0015 | 30.6073 | 15,848.9004 | AID1224841; AID1224842; AID1224848; AID1224849; AID1259401; AID1259403 |
farnesoid X nuclear receptor | Homo sapiens (human) | Potency | 30.0450 | 0.3758 | 27.4851 | 61.6524 | AID743217; AID743220 |
pregnane X nuclear receptor | Homo sapiens (human) | Potency | 20.2855 | 0.0054 | 28.0263 | 1,258.9301 | AID1346982; AID1346985 |
estrogen nuclear receptor alpha | Homo sapiens (human) | Potency | 22.0444 | 0.0002 | 29.3054 | 16,493.5996 | AID1259248; AID743069; AID743078; AID743079; AID743080; AID743091 |
cytochrome P450 2D6 | Homo sapiens (human) | Potency | 0.4365 | 0.0010 | 8.3798 | 61.1304 | AID1645840 |
polyprotein | Zika virus | Potency | 35.4813 | 0.0030 | 8.7949 | 48.0869 | AID1347053 |
peroxisome proliferator-activated receptor delta | Homo sapiens (human) | Potency | 30.0450 | 0.0010 | 24.5048 | 61.6448 | AID743212; AID743215 |
peroxisome proliferator activated receptor gamma | Homo sapiens (human) | Potency | 20.5256 | 0.0010 | 19.4141 | 70.9645 | AID743094; AID743191 |
vitamin D (1,25- dihydroxyvitamin D3) receptor | Homo sapiens (human) | Potency | 10.6822 | 0.0237 | 23.2282 | 63.5986 | AID743223 |
caspase-3 | Homo sapiens (human) | Potency | 33.4915 | 0.0133 | 26.9810 | 70.7614 | AID1346978 |
IDH1 | Homo sapiens (human) | Potency | 16.3601 | 0.0052 | 10.8652 | 35.4813 | AID686970 |
aryl hydrocarbon receptor | Homo sapiens (human) | Potency | 11.8832 | 0.0007 | 23.0674 | 1,258.9301 | AID743085 |
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_a | Homo sapiens (human) | Potency | 33.4915 | 0.0017 | 23.8393 | 78.1014 | AID743083 |
nuclear factor of kappa light polypeptide gene enhancer in B-cells 1 (p105), isoform CRA_a | Homo sapiens (human) | Potency | 16.9301 | 19.7391 | 45.9784 | 64.9432 | AID1159509 |
v-jun sarcoma virus 17 oncogene homolog (avian) | Homo sapiens (human) | Potency | 15.4521 | 0.0578 | 21.1097 | 61.2679 | AID1159526; AID1159528 |
potassium voltage-gated channel subfamily H member 2 isoform d | Homo sapiens (human) | Potency | 5.0119 | 0.0178 | 9.6374 | 44.6684 | AID588834 |
thyroid hormone receptor beta isoform 2 | Rattus norvegicus (Norway rat) | Potency | 7.6445 | 0.0003 | 23.4451 | 159.6830 | AID743065; AID743067 |
heat shock protein beta-1 | Homo sapiens (human) | Potency | 26.6011 | 0.0420 | 27.3789 | 61.6448 | AID743210 |
importin subunit beta-1 isoform 1 | Homo sapiens (human) | Potency | 29.0929 | 5.8048 | 36.1306 | 65.1308 | AID540253 |
snurportin-1 | Homo sapiens (human) | Potency | 29.0929 | 5.8048 | 36.1306 | 65.1308 | AID540253 |
nuclear factor erythroid 2-related factor 2 isoform 1 | Homo sapiens (human) | Potency | 16.7842 | 0.0006 | 27.2152 | 1,122.0200 | AID743202 |
GTP-binding nuclear protein Ran isoform 1 | Homo sapiens (human) | Potency | 29.0929 | 5.8048 | 16.9962 | 25.9290 | AID540253 |
urokinase-type plasminogen activator precursor | Mus musculus (house mouse) | Potency | 10.0000 | 0.1585 | 5.2879 | 12.5893 | AID540303 |
plasminogen precursor | Mus musculus (house mouse) | Potency | 10.0000 | 0.1585 | 5.2879 | 12.5893 | AID540303 |
urokinase plasminogen activator surface receptor precursor | Mus musculus (house mouse) | Potency | 10.0000 | 0.1585 | 5.2879 | 12.5893 | AID540303 |
geminin | Homo sapiens (human) | Potency | 12.4438 | 0.0046 | 11.3741 | 33.4983 | AID624296; AID624297 |
Interferon beta | Homo sapiens (human) | Potency | 21.0071 | 0.0033 | 9.1582 | 39.8107 | AID1347407 |
Cellular tumor antigen p53 | Homo sapiens (human) | Potency | 31.6704 | 0.0023 | 19.5956 | 74.0614 | AID651631; AID720552 |
Alpha-synuclein | Homo sapiens (human) | Potency | 5.6234 | 0.5623 | 9.3985 | 25.1189 | AID652106 |
Spike glycoprotein | Severe acute respiratory syndrome-related coronavirus | Potency | 14.1254 | 0.0096 | 10.5250 | 35.4813 | AID1479145 |
ATPase family AAA domain-containing protein 5 | Homo sapiens (human) | Potency | 23.7101 | 0.0119 | 17.9420 | 71.5630 | AID651632 |
Ataxin-2 | Homo sapiens (human) | Potency | 23.7101 | 0.0119 | 12.2221 | 68.7989 | AID651632 |
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023] |
Protein | Taxonomy | Measurement | Average | Min (ref.) | Avg (ref.) | Max (ref.) | Bioassay(s) |
---|---|---|---|---|---|---|---|
ATP-binding cassette sub-family C member 3 | Homo sapiens (human) | IC50 (µMol) | 133.0000 | 0.6315 | 4.4531 | 9.3000 | AID1473740 |
Multidrug resistance-associated protein 4 | Homo sapiens (human) | IC50 (µMol) | 133.0000 | 0.2000 | 5.6774 | 10.0000 | AID1473741 |
Bile salt export pump | Homo sapiens (human) | IC50 (µMol) | 133.0000 | 0.1100 | 7.1903 | 10.0000 | AID1473738 |
Canalicular multispecific organic anion transporter 1 | Homo sapiens (human) | IC50 (µMol) | 133.0000 | 2.4100 | 6.3433 | 10.0000 | AID1473739 |
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023] |
Assay ID | Title | Year | Journal | Article |
---|---|---|---|---|
AID1296008 | Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening | 2020 | SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1 | Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening. |
AID1346987 | P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen | 2019 | Molecular pharmacology, 11, Volume: 96, Issue:5 | A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein. |
AID1346986 | P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen | 2019 | Molecular pharmacology, 11, Volume: 96, Issue:5 | A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein. |
AID1347093 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347105 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347107 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347092 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347099 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID651635 | Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression | |||
AID1347086 | qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal | 2020 | Antiviral research, 01, Volume: 173 | A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity. |
AID1745845 | Primary qHTS for Inhibitors of ATXN expression | |||
AID1347097 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347108 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347154 | Primary screen GU AMC qHTS for Zika virus inhibitors | 2020 | Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49 | Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors. |
AID1347103 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347425 | Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1) | 2019 | The Journal of biological chemistry, 11-15, Volume: 294, Issue:46 | Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens. |
AID1347104 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347424 | RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1) | 2019 | The Journal of biological chemistry, 11-15, Volume: 294, Issue:46 | Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens. |
AID1347100 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347101 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347095 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1508630 | Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay | 2021 | Cell reports, 04-27, Volume: 35, Issue:4 | A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome. |
AID1347407 | qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection | 2020 | ACS chemical biology, 07-17, Volume: 15, Issue:7 | High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle. |
AID1347098 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347089 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347096 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347082 | qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal | 2020 | Antiviral research, 01, Volume: 173 | A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity. |
AID1347094 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347090 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347091 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347083 | qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen | 2020 | Antiviral research, 01, Volume: 173 | A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity. |
AID1347102 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347106 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID588501 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set | 2010 | Current protocols in cytometry, Oct, Volume: Chapter 13 | Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening. |
AID588501 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set | 2006 | Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5 | Microsphere-based protease assays and screening application for lethal factor and factor Xa. |
AID588501 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set | 2010 | Assay and drug development technologies, Feb, Volume: 8, Issue:1 | High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors. |
AID588499 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set | 2010 | Current protocols in cytometry, Oct, Volume: Chapter 13 | Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening. |
AID588499 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set | 2006 | Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5 | Microsphere-based protease assays and screening application for lethal factor and factor Xa. |
AID588499 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set | 2010 | Assay and drug development technologies, Feb, Volume: 8, Issue:1 | High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors. |
AID588497 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set | 2010 | Current protocols in cytometry, Oct, Volume: Chapter 13 | Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening. |
AID588497 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set | 2006 | Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5 | Microsphere-based protease assays and screening application for lethal factor and factor Xa. |
AID588497 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set | 2010 | Assay and drug development technologies, Feb, Volume: 8, Issue:1 | High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors. |
AID1473741 | Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay | 2013 | Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1 | A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development. |
AID511218 | Binding affinity to human serum albumin at pH 8.5 | 2010 | European journal of medicinal chemistry, Sep, Volume: 45, Issue:9 | Study on the binding of chiral drug duloxetine hydrochloride to human serum albumin. |
AID1473738 | Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay | 2013 | Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1 | A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development. |
AID1473739 | Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay | 2013 | Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1 | A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development. |
AID1473740 | Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay | 2013 | Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1 | A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development. |
AID511217 | Binding affinity to human serum albumin at pH 7.4 | 2010 | European journal of medicinal chemistry, Sep, Volume: 45, Issue:9 | Study on the binding of chiral drug duloxetine hydrochloride to human serum albumin. |
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023] |
Timeframe | Studies, This Drug (%) | All Drugs % |
---|---|---|
pre-1990 | 1 (0.06) | 18.7374 |
1990's | 25 (1.43) | 18.2507 |
2000's | 536 (30.72) | 29.6817 |
2010's | 890 (51.00) | 24.3611 |
2020's | 293 (16.79) | 2.80 |
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] |
According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.
| This Compound (72.57) All Compounds (24.57) |
Publication Type | This drug (%) | All Drugs (%) |
---|---|---|
Trials | 441 (23.37%) | 5.53% |
Reviews | 382 (20.24%) | 6.00% |
Case Studies | 258 (13.67%) | 4.05% |
Observational | 10 (0.53%) | 0.25% |
Other | 796 (42.18%) | 84.16% |
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Effects of Duloxetine on Postoperative Wound Complication of Total Knee Arthroplasty(TKA) in Central Sensitization Patient [NCT03880916] | 80 participants (Anticipated) | Interventional | 2019-03-30 | Not yet recruiting | |||
Duloxetine (Cymbalta) in the Reduction of Pain Severity in Patient With Systemic Lupus Erythematosus: A Pilot Study [NCT01269866] | 26 participants (Actual) | Interventional | 2010-12-31 | Completed | |||
Randomized Double-blind Study Comparing the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component [NCT01166048] | Phase 4 | 41 participants (Actual) | Interventional | 2010-05-31 | Completed | ||
A Pilot Study of Duloxetine in Psychological Resilience and Its Correlation With Blockade of Serotonin and Norepinephrine Transporter [NCT00331799] | Phase 2 | 18 participants (Actual) | Interventional | 2007-04-30 | Completed | ||
Mechanism-based Choice of Therapy for Neuropathic Pain: Can Treatments Success in Neuropathic Post-operative Pain be Coupled to Psychophysical Pain Modulation Profile? [NCT01359514] | 32 participants (Actual) | Interventional | 2008-04-30 | Completed | |||
Duloxetine(Cymbalta) for Fibromyalgia: An Open-Label Pilot Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic Responsiveness to Duloxetine [NCT01127490] | 25 participants (Actual) | Interventional | 2010-05-05 | Completed | |||
Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy : a Phase 3 Randomized Multicentric Open-label Study. [NCT05840562] | Phase 3 | 274 participants (Anticipated) | Interventional | 2023-09-30 | Not yet recruiting | ||
A Double-blind, Randomised, Multicenter, Comparative Study of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder [NCT01148472] | Phase 4 | 294 participants (Actual) | Interventional | 2005-09-30 | Completed | ||
A Novel Drug Combination for Alcohol-Use Disorders: A Human Laboratory Study [NCT03575403] | Phase 1 | 19 participants (Actual) | Interventional | 2018-09-01 | Completed | ||
A PHASE IV, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO DETERMINE THE BIOEQUIVALENCE OF DULOXETINE HYDROCHLORIDE HARD GELATINOUS CAPSULE WITH DELAYED RELEASE MICROGRANULES (60 MG; PFIZER S.R.L - ARGENTINA.) COMPARED TO CYMBALTA (REGISTER [NCT03794154] | Phase 4 | 0 participants (Actual) | Interventional | 2020-03-30 | Withdrawn(stopped due to This study has been cancelled prior to FSFV due to business reasons) | ||
Pre-emptive Effect of Duloxetine in the Second Knee in Staged Total Knee Arthroplasty: A Randomized Controlled Study [NCT03792828] | Phase 4 | 90 participants (Anticipated) | Interventional | 2019-01-31 | Not yet recruiting | ||
A PHASE IV, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO DETERMINE THE BIOEQUIVALENCE OF DULOXETINE HYDROCHLORIDE HARD GELATINOUS CAPSULE WITH DELAYED RELEASE MICROGRANULES (60 MG; PFIZER S.R.L - ARGENTINA) COMPARED WITH CYMBALTA(REGISTER [NCT03729284] | Phase 4 | 0 participants (Actual) | Interventional | 2020-03-30 | Withdrawn(stopped due to This study has been cancelled prior to FSFV due to business reasons) | ||
Efficacy, Safety, Tolerability and Pharmacokinetics of Concomitant Administration of Tramadol With Duloxetine or Pregabalin: a Randomized Controlled Flexible-dose Study in Patients With Neuropathic Pain [NCT01116531] | Phase 4 | 0 participants (Actual) | Interventional | 2010-04-30 | Withdrawn | ||
Mechanism-based Choice of Therapy: Can Treatments Success in Fibromyalgia Patients be Coupled to Psychophysical Pain Modulation Profile? [NCT01268631] | 150 participants (Anticipated) | Interventional | 2011-01-31 | Not yet recruiting | |||
Pretreatment Identification of Duloxetine Success in Neuropathic Pain Patients Based on Assessment of Endogenous Analgesia Capabilities [NCT01363284] | 51 participants (Actual) | Interventional | 2010-06-30 | Completed | |||
EEG Signal Processing as a Predictor of Antidepressant Response [NCT01369290] | 150 participants (Anticipated) | Observational | 2009-10-31 | Recruiting | |||
A Long-term Safety Study of Duloxetine Hydrochloride in the Treatment of Japanese Children and Adolescents With Depressive Disorder [NCT03395353] | Phase 3 | 151 participants (Actual) | Interventional | 2018-01-29 | Terminated(stopped due to Business decision) | ||
A Double-blind, Efficacy and Safety Study of Duloxetine Hydrochloride Versus Placebo in the Treatment of Japanese Children and Adolescents With Depressive Disorder [NCT03315793] | Phase 3 | 149 participants (Actual) | Interventional | 2017-12-04 | Completed | ||
A Prospective, Triple-Blind, Randomized Controlled Trial Evaluating Duloxetine on Post-Operative Outcomes Following Primary Total Knee Arthroplasty in Patients With and Without Central Sensitization [NCT05086393] | Phase 4 | 504 participants (Anticipated) | Interventional | 2021-11-01 | Recruiting | ||
Effect of Preoperative Duloxetine on Quality of Recovery After Outpatient Laparoscopic Surgery [NCT02351440] | Phase 4 | 0 participants (Actual) | Interventional | 2016-04-30 | Withdrawn | ||
Clinical Psychopharmacology Division,Institute of Mental Health,Peking University [NCT03148522] | 120 participants (Anticipated) | Interventional | 2017-06-01 | Recruiting | |||
Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty: A Double-blinded Randomized Control Trial [NCT03271151] | Phase 4 | 160 participants (Actual) | Interventional | 2017-09-28 | Completed | ||
Brain Morphometric Study in Knee Osteoarthritis Patients Treated With Duloxetine [NCT02903238] | 21 participants (Actual) | Interventional | 2011-07-31 | Completed | |||
A Randomized Phase II Study Comparing Lorcaserin Versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin [NCT03812523] | Phase 2 | 50 participants (Anticipated) | Interventional | 2019-06-30 | Not yet recruiting | ||
Effects of Duloxetine on Postoperative Pain Control and Knee Rehabilitation After Open Reduction Internal Fixation of Tibial Plateau Fractures [NCT04639011] | Phase 4 | 0 participants (Actual) | Interventional | 2022-10-31 | Withdrawn(stopped due to Study was not conducted because funding was not obtained.) | ||
Maintenance Therapies in Late-Life Depression: MTLD III [NCT00177671] | Phase 4 | 220 participants (Actual) | Interventional | 2003-12-31 | Completed | ||
Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy: Randomized Trial [NCT03549026] | 70 participants (Anticipated) | Interventional | 2018-01-05 | Recruiting | |||
The BEST Trial: Biomarkers for Evaluating Spine Treatments [NCT05396014] | Phase 4 | 820 participants (Anticipated) | Interventional | 2022-09-12 | Recruiting | ||
A Randomized, Double-Blind, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly-dosed Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New S [NCT03852160] | Phase 3 | 0 participants (Actual) | Interventional | 2019-12-01 | Withdrawn(stopped due to New design was developed to better fit company strategy, a new study has replaced 5413541TRD3011 study) | ||
Psychiatric Orders in Psychoanalytic Treatment of ASD [NCT05930912] | 1 participants (Actual) | Observational | 2023-06-01 | Active, not recruiting | |||
A Feasibility and Pilot Study of Combined Treatment Protocol Using Aerobic Exercise and Duloxetine in Older Adults With Symptomatic Knee Osteoarthritis and Comorbid Depression [NCT04111627] | Phase 2 | 30 participants (Anticipated) | Interventional | 2021-10-07 | Recruiting | ||
An Open-label Feasibility Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome: A Pilot Study [NCT01089621] | Phase 4 | 0 participants (Actual) | Interventional | 2010-03-31 | Withdrawn(stopped due to Terminated due to study design changes; zero patients enrolled.) | ||
Initial Severity and Antidepressant Efficacy for Anxiety Disorders: an Individual Patient Data Meta-analysis [NCT02476136] | 8,800 participants (Anticipated) | Observational | 2015-05-31 | Active, not recruiting | |||
Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization [NCT03548454] | Phase 4 | 320 participants (Anticipated) | Interventional | 2018-09-20 | Recruiting | ||
A Ten-week, Randomized, Double-blind Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily Versus Placebo in Outpatients With Major Depressive Disorder and Pain (EU-Pain Enriched Study) [NCT02232555] | Phase 3 | 327 participants | Interventional | 2005-05-31 | Completed | ||
A Multicenter, Randomized, Double-Blind, Active Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients With Treatment Resistant Major Depression (TRD). [NCT01369095] | Phase 2 | 976 participants (Actual) | Interventional | 2011-07-31 | Completed | ||
Single Dose Crossover Comparative Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg in Healthy Adult Human Subjects Under Fasting Conditions [NCT02291367] | Phase 1 | 76 participants (Actual) | Interventional | 2008-05-31 | Completed | ||
A Multi-center, Randomized, Double-blind, Double-simulation, Duloxetine Hydrochloride Enteric-coated Positive-control Phase III Study of Desvenlafaxine Succinate Sustained-Release in the Treatment of Major Depressive Disorder. [NCT04364997] | Phase 3 | 420 participants (Actual) | Interventional | 2020-06-18 | Completed | ||
A Prediction Study of Multiple Indexes of the Effect of Different Mechanisms of Antidepressants Treatment on Depression [NCT03623711] | Early Phase 1 | 200 participants (Anticipated) | Interventional | 2018-08-01 | Recruiting | ||
A Prospective Randomized Controlled Study Comparing the Efficacy of Pelvic Floor Muscle Training and Oral Duloxetine in the Recovery of Continence After Robotic Assisted Radical Prostatectomy [NCT02367404] | Phase 3 | 240 participants (Anticipated) | Interventional | 2015-05-31 | Recruiting | ||
A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression [NCT02493868] | Phase 3 | 719 participants (Actual) | Interventional | 2015-10-01 | Completed | ||
The Clinical Effect of Pregabalin on Neuropathic Pain in Central Sensitized Patients Who Are Treated With Duloxetine After Total Knee Arthroplasty: Randomized Controlled Trial. [NCT05254652] | 90 participants (Anticipated) | Interventional | 2022-05-31 | Not yet recruiting | |||
The Effect of Preoperative Duloxetine on the Occurance of Postoperative Delirium in Patients Undergoing Cancer Surgery . [NCT05949229] | Phase 1/Phase 2 | 42 participants (Anticipated) | Interventional | 2023-08-31 | Not yet recruiting | ||
The Cymbalta Pregnancy Registry [NCT01074151] | 144 participants (Actual) | Observational | 2009-07-31 | Completed | |||
Tolerability and Safety of 40 mg and 100 mg Duloxetine BID Given Over 7 Days in Healthy Female Subjects. A Randomised, Placebo-controlled Double-blind Trial. [NCT02232542] | Phase 1 | 32 participants (Actual) | Interventional | 2003-06-30 | Completed | ||
Comparison of the Efficacy and Safety of Duloxetine Augmented With Gabapentin and Duloxetine Augmented With Amitriptyline vs Duloxetine Alone in Chemotherapy -Induced Neuropathy: A Randomized Controlled Trial [NCT06091553] | Phase 2 | 160 participants (Anticipated) | Interventional | 2023-10-20 | Not yet recruiting | ||
A Novel Drug Combination as a Pharmacotherapeutic for Methamphetamine-Use Disorder [NCT04178993] | Phase 1 | 8 participants (Actual) | Interventional | 2019-09-01 | Completed | ||
Risk of Phenoconversion in Genetic Extensive Metabolizers Healthy Volunteers Carriers of One Fully-Functional and One Non-Functional Allele Versus Carriers of Two Fully-Functional Alleles [NCT03054220] | 34 participants (Actual) | Interventional | 2016-07-31 | Completed | |||
Duloxetine Potentiates the Analgesic Efficacy of Intrathecal Morphine in Major Abdominal Cancer Surgery [NCT03560427] | 60 participants (Actual) | Interventional | 2018-09-10 | Completed | |||
University of Michigan Mechanistic Research Center -The Back Pain Consortium Research Program [NCT04870957] | Phase 4 | 500 participants (Anticipated) | Interventional | 2021-06-09 | Recruiting | ||
A Global, Multicenter, Randomized, Double-Blind Placebo Controlled Study Comparing the Safety and Efficacy of ABT-894, Duloxetine and Placebo in Subjects With Diabetic Neuropathic Pain [NCT00507936] | Phase 2 | 280 participants (Actual) | Interventional | 2007-08-31 | Completed | ||
A Randomized, Double-blind, Placebo Controlled, Dose Escalation Pilot Study Evaluating the Efficacy of Two Doses of Duloxetine and Amitriptyline in Interstitial Lung Disease-related Cough [NCT05120934] | Phase 2 | 25 participants (Anticipated) | Interventional | 2021-11-01 | Recruiting | ||
Functional Brain Imaging to Understand the Mechanisms of Pain Relief in Knee Osteoarthritis [NCT02208778] | Phase 4 | 77 participants (Actual) | Interventional | 2014-12-31 | Completed | ||
An Eight-week, Randomized, Double-blind, Two Parallel Groups, Study to Assess Clinical Response of Duloxetine 60 mg and 120 mg Per Day in Patients Hospitalized for Severe Depression [NCT02229825] | Phase 4 | 339 participants (Actual) | Interventional | 2007-02-09 | Completed | ||
Open Label Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial [NCT00071708] | 0 participants | Expanded Access | No longer available | ||||
A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating the Efficacy of Two Doses of Duloxetine & Amitriptyline in Subjects With Refractory Chronic Cough [NCT05110144] | Phase 2 | 50 participants (Anticipated) | Interventional | 2021-11-01 | Recruiting | ||
Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury [NCT02320240] | 3,255,526 participants (Actual) | Observational | 2013-06-30 | Completed | |||
Sensation and Psychiatry: Linking Age-Related Hearing Loss to Late-Life Depression and Cognitive Decline [NCT03321006] | Phase 4 | 25 participants (Actual) | Interventional | 2018-05-30 | Completed | ||
Continuation Electroconvulsive Therapy Associated With Pharmacotherapy Versus Pharmacotherapy Alone for Relapse Prevention in Major Depression. A Clinical, Controlled, Prospective and Randomized Trial [NCT01305707] | Phase 4 | 104 participants (Actual) | Interventional | 2009-07-31 | Terminated(stopped due to Difficulties in recruiting) | ||
Duloxetine Versus Placebo in the Acute Treatment of Patients With Major Depressive Disorder and Associated Painful Physical Symptoms [NCT01070329] | Phase 4 | 527 participants (Actual) | Interventional | 2010-03-31 | Completed | ||
Effect of Duloxetine 30/60 mg Once Daily Versus Placebo in Adolescents With Juvenile Primary Fibromyalgia Syndrome [NCT01237587] | Phase 3 | 184 participants (Actual) | Interventional | 2011-03-31 | Completed | ||
A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer [NCT01598298] | Phase 3 | 299 participants (Actual) | Interventional | 2013-05-15 | Completed | ||
A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Generalized Anxiety Disorder [NCT01226511] | Phase 3 | 281 participants (Actual) | Interventional | 2011-06-30 | Completed | ||
An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder [NCT00961298] | Phase 4 | 17 participants (Actual) | Interventional | 2009-09-30 | Completed | ||
A Phase 4 Comparison of Duloxetine Dosing Strategies in the Treatment of Korean Patients With Major Depressive Disorder [NCT00960986] | Phase 4 | 249 participants (Actual) | Interventional | 2009-08-31 | Completed | ||
A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients [NCT02857244] | Phase 2 | 0 participants (Actual) | Interventional | 2016-11-30 | Withdrawn(stopped due to Site did not obtain LIRB approval due to medication usage.) | ||
A Phase 4, 8-Week, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily in Outpatients With Major Depressive Disorder and Associated Painful Physical Symptoms [NCT01000805] | Phase 4 | 528 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
TRY FIRST: A 12-Week, Randomized, Open-Label Trial of Duloxetine Versus Generic SSRIs in the Treatment of a Severe Depressive Episode [NCT00666757] | Phase 4 | 750 participants (Actual) | Interventional | 2008-05-31 | Completed | ||
A Superiority Study of LY248686 Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain - Extension Phase [NCT00641719] | Phase 3 | 258 participants (Actual) | Interventional | 2008-03-31 | Completed | ||
A Randomized, Double-Blind Comparison of Duloxetine 30 mg QD and Placebo in Adult Patients With Fibromyalgia [NCT00965081] | Phase 4 | 308 participants (Actual) | Interventional | 2009-09-30 | Completed | ||
A Mechanism Based Proof of Concept Study of the Effects of Duloxetine in the Treatment of Patients With Osteoarthritic Knee Pain [NCT04224584] | Phase 2 | 40 participants (Actual) | Interventional | 2020-01-01 | Completed | ||
A Multicenter, Randomized, Double-blind, Active-Controlled Study of the Efficacy and Safety of Flexibly-Dosed BMS-820836 in Patients With Treatment Resistant Major Depression [NCT01309945] | Phase 2 | 889 participants (Actual) | Interventional | 2011-04-30 | Completed | ||
Duloxetine Versus Placebo in the Treatment of Patients With Generalized Anxiety Disorder in China [NCT00803361] | Phase 3 | 210 participants (Actual) | Interventional | 2008-12-31 | Completed | ||
Clinical Psychopharmacology Division [NCT03294525] | 400 participants (Anticipated) | Observational | 2016-01-31 | Recruiting | |||
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Subjects With Treatment-resistant Depression [NCT02422186] | Phase 3 | 139 participants (Actual) | Interventional | 2015-08-20 | Completed | ||
Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study [NCT04412876] | Phase 3 | 0 participants (Actual) | Interventional | 2020-05-31 | Withdrawn(stopped due to Failed to pass the Ministry of Science and Technology.) | ||
A Comparison Between Qutenza and Duloxetine for the Treatment of Painful Chemotherapy-induced Peripheral Neuropathy: a Pragmatic Randomized Controlled Trial [NCT05560516] | 102 participants (Anticipated) | Interventional | 2022-12-01 | Recruiting | |||
The Effect of Duloxetine on Bone Metabolism [NCT05550506] | 102 participants (Anticipated) | Observational | 2022-07-27 | Recruiting | |||
Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome [NCT00114127] | Phase 3 | 28 participants (Actual) | Interventional | 2004-06-30 | Completed | ||
Duloxetine for Patients With Low Back Pain Who Fail to Improve With Oral NSAIDs. A Randomized Placebo-controlled Exploratory Study [NCT05851976] | Phase 4 | 120 participants (Anticipated) | Interventional | 2023-10-04 | Recruiting | ||
A Open Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Safety of Duloxetine in Chinese Han Healthy Subjects [NCT00933452] | Phase 1 | 36 participants (Anticipated) | Interventional | 2009-07-31 | Completed | ||
A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain [NCT04504812] | Phase 3 | 2,700 participants (Anticipated) | Interventional | 2021-02-01 | Recruiting | ||
A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy [NCT00489411] | Phase 3 | 231 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
"Cardiac Transfer of SARS-CoV-2 Spike Protein Circulation Techniques - Medicine Induced Hemodialysis on Vaccinated Immune Attacks" [NCT05711810] | Phase 4 | 1 participants (Actual) | Interventional | 2023-01-02 | Completed | ||
Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction [NCT00398632] | Phase 4 | 6 participants (Actual) | Interventional | 2006-11-30 | Terminated(stopped due to Unable to recruit subjects) | ||
A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Three Dosages of [Vortioxetine] Lu AA21004, in Acute Treatment of Major Depressive Disorder [NCT00635219] | Phase 3 | 766 participants (Actual) | Interventional | 2008-02-29 | Completed | ||
Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain [NCT00424593] | Phase 3 | 236 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
Single Dose Crossover Comparative Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg in Healthy Adult Human Subjects Under Fed Conditions [NCT02291341] | Phase 1 | 76 participants (Actual) | Interventional | 2008-05-31 | Completed | ||
Duloxetine for the Treatment of Major Depression in Midlife Women: Effects on Brain Structure and Functioning, Mood, and Quality of Life [NCT00889369] | Phase 4 | 70 participants (Anticipated) | Interventional | 2009-05-31 | Recruiting | ||
A 12-Week, Double-Blind, Placebo-Controlled, Trial of Duloxetine Versus Placebo in the Treatment of Binge Eating Disorder and Comorbid Depressive Disorder. [NCT00607789] | Phase 4 | 40 participants (Actual) | Interventional | 2006-10-31 | Completed | ||
Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE) [NCT04395001] | Phase 4 | 280 participants (Anticipated) | Interventional | 2021-02-24 | Recruiting | ||
Assessment of Cognitive Functioning Before and After Treatment With Duloxetine [NCT00933439] | 30 participants (Actual) | Interventional | 2005-02-28 | Completed | |||
A Single-Blind Placebo Run-in Study of Duloxetine for Activity-Limiting Osteoarthritis Pain [NCT00609557] | Phase 4 | 25 participants (Actual) | Interventional | 2004-09-30 | Completed | ||
Effects of Duloxetine on Pain Relief After Total Knee Arthroplasty in Central Sensitization Patient : A Randomized, Controlled, Double-Blind Trial [NCT02600247] | 100 participants (Anticipated) | Interventional | 2015-11-30 | Not yet recruiting | |||
Pilot Study of the Efficacy of Duloxetine in Treating Adults With Attention Deficit Hyperactivity Disorder: a Randomized, Controlled Trial. [NCT00940693] | Phase 2 | 40 participants (Anticipated) | Interventional | 2009-08-31 | Completed | ||
Shifting Pain Modulation From Pro-to Anti-nociceptive: Individualized Prevention of Post Operative Pain [NCT02672202] | 9 participants (Actual) | Interventional | 2016-02-29 | Terminated(stopped due to Recruitment rate was slow so we could not complete the study.) | |||
Pharmacological Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy): Pharmacodynamics (PD) and Pharmacokinetics (PK) [NCT00990067] | Phase 1 | 16 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
Qualification of Single Dose Administration of Analgesic Therapy in the Treatment of Chronic Neuropathic Pain in Patients With Painful Diabetic Neuropathy [NCT00837941] | Phase 2 | 0 participants (Actual) | Interventional | 2009-04-30 | Withdrawn | ||
A Phase 3, Randomized, Double-Blind Study Comparing the Efficacy and Safety of SAGE-217 Plus an Antidepressant Versus Placebo Plus an Antidepressant in Adults With Major Depressive Disorder [NCT04476030] | Phase 3 | 440 participants (Actual) | Interventional | 2020-11-09 | Completed | ||
An Open-Label, Randomized Comparison of Duloxetine, Pregabalin, and the Combination of Duloxetine and Gabapentin Among Patients With Inadequate Response to Gabapentin for the Management of Diabetic Peripheral Neuropathic Pain [NCT00385671] | Phase 4 | 407 participants (Actual) | Interventional | 2006-09-30 | Completed | ||
Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China [NCT00408993] | Phase 3 | 215 participants (Actual) | Interventional | 2006-12-31 | Completed | ||
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Duloxetine-Referenced, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50mg, 100mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depress [NCT00384033] | Phase 3 | 638 participants (Actual) | Interventional | 2006-09-30 | Completed | ||
Duloxetine Versus Placebo in Patients With Major Depressive Disorder (MDD): Assessment of Energy and Vitality in MDD [NCT00536471] | Phase 4 | 776 participants (Actual) | Interventional | 2007-09-30 | Completed | ||
Therapeutic Drug Monitoring (TDM) in Child & Adolescent Psychiatry [NCT01057329] | 200 participants (Actual) | Observational | 2010-01-31 | Completed | |||
Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy [NCT00810069] | Phase 4 | 840 participants (Actual) | Interventional | 2008-11-30 | Completed | ||
Cymbalta for Depression as a Complication of Bereavement [NCT00658931] | Phase 4 | 20 participants (Anticipated) | Interventional | 2008-04-30 | Active, not recruiting | ||
A 12 Weeks Open Label Two Parallel Groups Study to Assess the Efficacy of Orally Administered Duloxetine 60 mg and 120 mg Per Day on Treatment Outcomes in Patients With Diabetic Peripheral Neuropathic Pain With and Without Co-morbid Major Depressive Disor [NCT00844194] | Phase 4 | 108 participants (Actual) | Interventional | 2009-02-28 | Completed | ||
An Open Label Pilot Study on the Tolerability of Duloxetine in the Treatment of Depressed Patients With Parkinson's Disease [NCT00437125] | Phase 4 | 151 participants (Actual) | Interventional | 2007-03-31 | Completed | ||
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Duloxetine and Methadone for the Treatment of HIV-Associated Painful Peripheral Neuropathy [NCT00863057] | Phase 2 | 15 participants (Actual) | Interventional | 2009-05-31 | Terminated(stopped due to Due to slow rate of enrollment, which compromised the ability to meet study objectives in a timely manner.) | ||
The Depression and Memory Trial [NCT02590874] | Phase 4 | 19 participants (Actual) | Interventional | 2016-01-31 | Completed | ||
Efficacy and Safety of Duloxetine Compared With Placebo in Subjects With Stress Urinary Incontinence [NCT00475358] | Phase 3 | 120 participants | Interventional | 2003-04-30 | Completed | ||
A Phase 2a, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study to Assess the Safety and Efficacy of ADL5859 100 mg BID in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy [NCT00603265] | Phase 2 | 226 participants (Actual) | Interventional | 2007-11-30 | Completed | ||
A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Lu AA21004 (15 and 20 mg/Day) in the Acute Treatment of Adult Patients With Major Depressive Disorder [NCT01140906] | Phase 3 | 607 participants (Actual) | Interventional | 2010-05-31 | Completed | ||
A Phase 3b Study to Assess the Efficacy of Duloxetine 60 mg Once Daily Compared With Placebo on the Reduction of Pain Caused by Osteoarthritis of the Knee, in a 13-week, Double-blind, Randomized Study [NCT00945945] | Phase 3 | 424 participants (Actual) | Interventional | 2009-07-31 | Completed | ||
Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness [NCT00817011] | 1,000 participants (Anticipated) | Interventional | 2006-04-30 | Recruiting | |||
Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain [NCT00408421] | Phase 3 | 231 participants (Actual) | Interventional | 2006-11-30 | Completed | ||
A Randomized, Placebo-Controlled Trial of Duloxetine Added to Nonsteroidal Anti-inflammatory Drugs in Patients With Knee Pain Due to Osteoarthritis Who Have Had Suboptimal Response to Nonsteroidal Anti-inflammatory Drug Treatment. [NCT01018680] | Phase 3 | 524 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy [NCT00619983] | Phase 4 | 22 participants (Actual) | Interventional | 2008-02-29 | Terminated(stopped due to Study terminated due to low enrollment) | ||
Inflammatory Markers and Cognitive Function in Major Depression:a Pilot Study [NCT01391221] | Phase 4 | 20 participants (Anticipated) | Interventional | 2011-07-31 | Recruiting | ||
Flexible Dosed Duloxetine Versus Placebo in the Treatment of Fibromyalgia [NCT00673452] | Phase 4 | 530 participants (Actual) | Interventional | 2008-06-30 | Completed | ||
Maintenance of Effect of Duloxetine 60 mg Once Daily in Patients With Diabetic Peripheral Neuropathic Pain [NCT00322621] | Phase 4 | 216 participants (Actual) | Interventional | 2006-04-30 | Completed | ||
Effects of Duloxetine on Fear Conditioning in PTSD [NCT00763178] | Early Phase 1 | 26 participants (Actual) | Interventional | 2007-02-28 | Completed | ||
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder [NCT00672620] | Phase 3 | 611 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed Dose Study Comparing the Efficacy and Safety of [Vortioxetine] Lu AA21004 in Acute Treatment of Major Depressive Disorder in Elderly Patients [NCT00811252] | Phase 3 | 453 participants (Actual) | Interventional | 2009-01-31 | Completed | ||
Duloxetine in Patients With Central Neuropathic Pain Due to Multiple Sclerosis. [NCT00755807] | Phase 3 | 239 participants (Actual) | Interventional | 2008-10-31 | Completed | ||
Randomized Clinical Trial: 03 (Methylphenidate and Duloxetine) [NCT02700711] | Phase 1 | 13 participants (Actual) | Interventional | 2016-02-29 | Completed | ||
Pain Relieving Potentials of Preoperative Combination of Single Dose Oral Duloxetine and Intravenous Magnesium Sulphate in Acute and Chronic Post Mastectomy Pain: A Randomized Controlled Trial [NCT06087211] | Phase 4 | 90 participants (Anticipated) | Interventional | 2023-10-10 | Recruiting | ||
An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache [NCT00531895] | Phase 4 | 30 participants (Actual) | Interventional | 2006-04-30 | Completed | ||
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder [NCT00730691] | Phase 3 | 781 participants (Actual) | Interventional | 2008-06-30 | Completed | ||
Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence [NCT00190632] | Phase 3 | 600 participants | Interventional | 2001-03-31 | Completed | ||
The Effectiveness of Duloxetine Compared With Placebo in the Treatment of Predominant Stress Urinary Incontinence [NCT00190827] | Phase 3 | 500 participants | Interventional | 2003-09-30 | Completed | ||
Study of Duloxetine HCl in Women of Different Demographic Characteristics and Co-Morbidities With Stress Urinary Incontinence: Evaluation of Efficacy and Safety [NCT00190905] | Phase 4 | 4,000 participants | Interventional | 2004-02-29 | Completed | ||
A Comparison of Duloxetine Dosing Strategies in The Treatment of Patients With Major Depression [NCT00191061] | Phase 4 | 640 participants | Interventional | 2004-10-31 | Completed | ||
Protocol F1J-MC-HMFG Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain [NCT00433290] | Phase 3 | 256 participants (Actual) | Interventional | 2007-02-28 | Completed | ||
Protocol F1J-MC-HMEO Duloxetine Versus Placebo in the Treatment of Chronic Low Back Pain [NCT00408876] | Phase 3 | 404 participants (Actual) | Interventional | 2006-12-31 | Completed | ||
Duloxetine Versus Placebo in the Long-Term Treatment of Patients With Late-Life Major Depression [NCT00406848] | Phase 4 | 370 participants (Actual) | Interventional | 2006-11-30 | Completed | ||
An Eight-Week, Randomized, Double Blind, Two Parallel Groups, Study to Assess Clinical Response of Duloxetine 60 mg and 120 Per Day in Patients Hospitalized for Severe Depression [NCT00422162] | Phase 4 | 339 participants (Actual) | Interventional | 2007-02-28 | Completed | ||
An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome Without Comorbid Major Depressive Disorder [NCT00401258] | Phase 4 | 15 participants (Actual) | Interventional | 2006-11-30 | Completed | ||
A Double-blind, Randomized, Placebo Controlled Clinical Trial on Comparing Escitalopram and Duloxetine add-on for Negative Symptoms in Schizophrenic Subjects With Neuregulin-1 (NRG1) Risk Genotype [NCT01078870] | Phase 4 | 75 participants (Anticipated) | Interventional | 2010-02-28 | Active, not recruiting | ||
Duloxetine 60/120mg Versus Placebo in the Treatment of Fibromyalgia Syndrome [NCT00233025] | Phase 3 | 320 participants | Interventional | 2005-09-30 | Completed | ||
A Double-Blind, Stratified, Randomised, Parallel, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy and Safety of Duloxetine (20 mg Bid for 2 Weeks Escalating to 40 mg Bid) for up to 12 Weeks, Compared to Placebo, in Community-Dwelling Elderly [NCT00244296] | Phase 4 | 276 participants | Interventional | 2005-10-31 | Completed | ||
Effects of Escitalopram vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control [NCT00215228] | Phase 2/Phase 3 | 26 participants (Anticipated) | Interventional | 2005-07-31 | Completed | ||
Comparison of Opioid and Duloxetine for Postoperative Pain Control After Total Knee Arthroplasty: Randomized Controlled Trial [NCT04719585] | 160 participants (Anticipated) | Interventional | 2021-01-31 | Not yet recruiting | |||
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Active Controlled, Parallel Group, Multicenter Study to Assess the Safety and Efficacy of 2 Fixed Dose Groups of TC-5214 (S-mecamylamine) as Monotherapy Treatment in Patients With Major Depressive [NCT01288079] | Phase 2 | 145 participants (Actual) | Interventional | 2011-02-28 | Terminated | ||
[NCT02020122] | 5 participants (Actual) | Interventional | 2014-01-31 | Completed | |||
The Effect of Transcutaneous Posterior Tibial Nerve Stimulation on Pain and Quality of Life in Patients With Fibromyalgia: a Single-blind, Randomized Controlled Trial [NCT05937711] | 64 participants (Actual) | Interventional | 2020-11-02 | Completed | |||
Duloxetine for Post Operative Analgesia After Modified Radical Mastectomy:A Randomized Controlled Study [NCT05442268] | 40 participants (Anticipated) | Interventional | 2022-07-16 | Recruiting | |||
A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Duloxetine-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (15 and 20 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder [NCT01153009] | Phase 3 | 614 participants (Actual) | Interventional | 2010-06-30 | Completed | ||
Prophylactic Duloxetine Administration During Acute Herpes Zoster Prevents Postherpetic Neuralgia [NCT04313335] | 750 participants (Anticipated) | Interventional | 2021-03-01 | Recruiting | |||
A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Effectiveness and Safety of AZD2066 After 6 Weeks of Treatment in Patients With Major Depressive Disorder - D0475C00020 [NCT01145755] | Phase 2 | 131 participants (Actual) | Interventional | 2010-05-31 | Terminated | ||
A Study of the Effectiveness and Tolerability of Duloxetine (Cymbalta) in the Treatment of PTSD. [NCT00583193] | Phase 3 | 20 participants (Anticipated) | Interventional | 2005-12-31 | Recruiting | ||
Pilot Study of the Efficacy and Tolerability of Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction). [NCT00471315] | Phase 3 | 18 participants (Actual) | Interventional | 2006-07-31 | Completed | ||
Comparison of the Efficacy of Duloxetine and Pregabalin in Patients With Knee Osteoarthritis With Mix Type Pain [NCT04532684] | Phase 4 | 66 participants (Actual) | Interventional | 2016-10-31 | Completed | ||
Mechanisms of Neuromuscular Fatigue Post Stroke [NCT01688570] | Early Phase 1 | 27 participants (Actual) | Interventional | 2011-08-31 | Completed | ||
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies [NCT02893371] | 1,037,352 participants (Actual) | Observational | 2016-09-30 | Completed | |||
Attributes of Response in Depressed Patients Switched to Treatment With Duloxetine (ARDENT Study) [NCT00696774] | Phase 4 | 242 participants (Actual) | Interventional | 2008-06-30 | Completed | ||
F1J-MC-HMFN (a) An Open-Label Study of Tolerability, Safety, and Pharmacokinetics of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder [NCT00529789] | Phase 2 | 72 participants (Actual) | Interventional | 2007-08-31 | Completed | ||
A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder [NCT00849693] | Phase 3 | 463 participants (Actual) | Interventional | 2009-03-31 | Completed | ||
Duloxetine in the Treatment of Postpartum-onset and Non-Postpartum Onset Major Depressive Disorder [NCT00617045] | 0 participants (Actual) | Interventional | 2007-07-31 | Withdrawn(stopped due to poor patient recruitment) | |||
"Use of Duloxetine or Pregabalin in Monotherapy Versus Combination Therapy of Both Drugs in Patients With Painful Diabetic Neuropathy The COMBO - DN (COmbination vs Monotherapy of pregaBalin and dulOxetine in Diabetic Neuropathy) Study" [NCT01089556] | Phase 3 | 811 participants (Actual) | Interventional | 2010-03-31 | Completed | ||
Duloxetine for Menopausal Depression [NCT01117857] | Phase 4 | 29 participants (Actual) | Interventional | 2009-08-31 | Completed | ||
Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China: Duloxetine Versus Placebo [NCT01179672] | Phase 3 | 405 participants (Actual) | Interventional | 2011-04-30 | Completed | ||
[NCT02711215] | Phase 4 | 80 participants (Anticipated) | Interventional | 2015-05-31 | Active, not recruiting | ||
Efficacy of Perioperative Duloxetine as a Part of Multimodal Analgesia in Laparoscopic Colorectal Cancer Surgery [NCT04294953] | Phase 2 | 60 participants (Anticipated) | Interventional | 2020-03-01 | Not yet recruiting | ||
Predicting Treatment Outcome in Major Depressive Disorder [NCT02869035] | Phase 1 | 100 participants (Anticipated) | Interventional | 2016-08-31 | Completed | ||
The Role of Central Serotonergic and Adrenergic Systems in the Effectiveness of DNIC (Diffuse Noxious Inhibitory Control [NCT00660751] | 64 participants (Actual) | Interventional | 2007-08-31 | Completed | |||
UMCC 2008.62: Prospective Pilot Study Evaluating the Use of Duloxetine for Treatment of Aromatase Inhibitor-associated Musculoskeletal Symptoms in Breast Cancer Patients [NCT01028352] | 35 participants (Actual) | Interventional | 2008-10-31 | Completed | |||
Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin [NCT02612233] | Phase 4 | 81 participants (Actual) | Interventional | 2013-09-30 | Completed | ||
A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder [NCT00849901] | Phase 3 | 337 participants (Actual) | Interventional | 2009-03-31 | Completed | ||
Duloxetine Versus Placebo in the Treatment of Elderly Patients With Generalized Anxiety Disorder [NCT01118780] | Phase 4 | 291 participants (Actual) | Interventional | 2010-10-31 | Completed | ||
DULOPLASM Study: Pilot Study on Mechanisms of Analgesic Action of Duloxetine: Effective Dosage of Duloxetine at the Peak and at the Lowest Plasma Concentrations [NCT02846701] | Phase 4 | 8 participants (Actual) | Interventional | 2016-11-17 | Completed | ||
Predicting Medication Response in Obsessive Compulsive Disorder [NCT01404871] | 26 participants (Actual) | Interventional | 2009-04-30 | Completed | |||
Duloxetine in the Treatment of Melancholic Depression: An 8-Week Open-Label Dose Study [NCT00191685] | Phase 3 | 200 participants | Interventional | 2004-05-31 | Completed | ||
Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+ [NCT00552682] | Phase 3 | 10 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
[NCT01425827] | 288 participants (Actual) | Interventional | 2010-11-30 | Completed | |||
Combining Data Sources to Identify Effect Moderation for Personalized Mental Health [NCT05267873] | 14,146 participants (Anticipated) | Observational | 2015-01-01 | Active, not recruiting | |||
A Double-blind, Double-dummy, Placebo-controlled, Incomplete Block, Two Period Crossover Study of the Histamine H3 Antagonist GSK189254 and Duloxetine in the Electrical Hyperalgesia Model of Central Sensitisation in Healthy Volunteers [NCT00387413] | Phase 1 | 40 participants (Actual) | Interventional | 2006-10-02 | Completed | ||
Efficacy of Duloxetine in Conjunction With Tramadol for Chronic Cancer Pain [NCT05311774] | 400 participants (Anticipated) | Interventional | 2022-04-30 | Not yet recruiting | |||
Effect of Duloxetine 60 mg Once Daily Versus Placebo in Patients With Chronic Low Back Pain [NCT00767806] | Phase 3 | 401 participants (Actual) | Interventional | 2008-09-30 | Completed | ||
Bioavailability of a Formulation of Duloxetine 60 mg Capsules With Enteric Coated Granules With Regards to the Marketed Reference Product [NCT04723238] | Phase 1 | 36 participants (Actual) | Interventional | 2021-01-23 | Completed | ||
A Comparison of Duloxetine Hydrochloride, Venlafaxine Extended Release, and Placebo in the Treatment of Generalized Anxiety Disorder [NCT00122837] | Phase 3 | 560 participants | Interventional | 2005-04-30 | Completed | ||
Efficacy and Safety of Duloxetine Compared With Placebo in Subjects Electing Surgery for Severe Pure Genuine Stress Incontinence [NCT00190619] | Phase 3 | 100 participants | Interventional | 2001-05-31 | Completed | ||
Efficacy and Safety of Duloxetine Compared With Placebo in Women With Symptoms of Mixed Urinary Incontinence. [NCT00190814] | Phase 3 | 600 participants | Interventional | 2003-09-30 | Completed | ||
Effect of Duloxetine on Valsalva Leak Point Pressure and Quantitative Rhabdosphincter Electromyography Measures in Women With Stress Urinary Incontinence [NCT00190853] | Phase 3 | 93 participants | Interventional | 2005-01-31 | Completed | ||
Long Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence [NCT00191204] | Phase 3 | 363 participants | Interventional | 2001-09-30 | Completed | ||
Open-Label Duloxetine Extension Phase in Patients Who Have Completed the HMDG Clinical Trial [NCT00191594] | Phase 3 | 105 participants | Interventional | 2005-03-31 | Completed | ||
A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial [NCT01360866] | Phase 3 | 2,944 participants (Actual) | Interventional | 2011-10-31 | Completed | ||
A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine [NCT00989157] | Phase 3 | 20 participants (Actual) | Interventional | 2009-09-30 | Completed | ||
Comparison of Aripiprazole Augmentation vs Switching to Different Class of Antidepressants for Patients With MDD Who Are Partially/Minimally Responsive to Current Antidepressants:Randomized, Rater-blinded, Prospective Study [NCT01488266] | 90 participants (Anticipated) | Interventional | 2011-11-30 | Active, not recruiting | |||
RCT of Duloxetine & Pregabalin for the Treatment of Gulf War Illness in Veterans [NCT01846182] | Phase 2 | 112 participants (Actual) | Interventional | 2015-06-24 | Terminated(stopped due to Terminated by Funder) | ||
Neurobiological Correlates of Antidepressant Response After Duloxetine Hydrochloride Treatment in Subjects With Major Depressive Disorder [NCT01051466] | Phase 4 | 60 participants (Actual) | Interventional | 2010-01-31 | Completed | ||
Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder [NCT00105989] | Phase 3 | 514 participants (Actual) | Interventional | 2005-03-31 | Completed | ||
Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced, Dose-finding Study of Lu AA24530 in Major Depressive Disorder [NCT00599911] | Phase 2 | 652 participants (Actual) | Interventional | 2007-10-31 | Completed | ||
Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study [NCT00491348] | 23 participants (Actual) | Interventional | 2007-04-30 | Terminated(stopped due to Change of MRI mode) | |||
Comparative Evaluation of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Treatment-resistant Burning Mouth Syndrome: a Prospective Longitudinal Clinical Trial With Treatment Response Prediction [NCT06025474] | Phase 3 | 203 participants (Anticipated) | Interventional | 2023-01-01 | Recruiting | ||
Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy [NCT04560673] | Phase 2 | 380 participants (Anticipated) | Interventional | 2020-07-10 | Recruiting | ||
[NCT02934035] | 10,000 participants (Anticipated) | Observational | 2016-09-30 | Active, not recruiting | |||
Impact of Therapeutical Strategies on Emotional Processing in Depression: Neurofunctional and Clinical Issues in the Context of Affective Bias [NCT00596986] | 30 participants (Anticipated) | Interventional | 2008-10-31 | Active, not recruiting | |||
'Fix the Dysfunction' Concept for Mechanism-based Pharmacological Treatment of Neuropathic Pain by Drug [NCT03276689] | 300 participants (Actual) | Interventional | 2017-10-19 | Completed | |||
"Preoperative Oral Duloxetine: Does it Affect Duration of Spinal Anesthesia and Early Postoperative Pain After Arthroscopic ACL Repair? a Prospective, Randomized, Double-blind Controlled Trial" [NCT05050656] | Phase 4 | 70 participants (Actual) | Interventional | 2021-03-15 | Completed | ||
A Double-blind, Randomised, Parallel Groups Investigation Into the Effects of Pregabalin, Duloxetine and Amitriptyline on Aspects of Pain, Sleep, and Next Day Performance in Patients Suffering From Diabetic Peripheral Neuropathy [NCT00370656] | Phase 2/Phase 3 | 90 participants (Anticipated) | Interventional | 2007-02-28 | Completed | ||
Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee: A Randomized Open Labelled Clinical Trial [NCT05486026] | Phase 2 | 200 participants (Actual) | Interventional | 2022-08-20 | Completed | ||
[NCT01470339] | 200 participants (Actual) | Interventional | 2011-12-31 | Completed | |||
[NCT01470352] | 179 participants (Actual) | Interventional | 2011-11-16 | Completed | |||
Comparison of Duloxetine Versus Pregabalin in Post-mastectomy Pain Syndrome: a Randomized Controlled Trial [NCT04727502] | Phase 2 | 70 participants (Anticipated) | Interventional | 2020-12-20 | Recruiting | ||
Comparative Responses to 15 Different Antidepressants in Major Depressive Disorder - Results From a Long-term Nation-wide Population-based Study Emulating a Randomized Trial [NCT05952713] | 73,336 participants (Actual) | Observational | 2022-10-01 | Completed | |||
A Comparison of Duloxetine Hydrochloride, Venlafaxine Extended Release, and Placebo in the Treatment of Generalized Anxiety Disorder. [NCT00122850] | Phase 3 | 480 participants | Interventional | 2004-10-31 | Completed | ||
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled and Active-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained-Release (SEROQUEL®) as Monotherapy in the Treatment of Patients With MDD [NCT00321490] | Phase 3 | 600 participants | Interventional | 2006-04-30 | Completed | ||
A 1-Year Safety Study of Duloxetine in Patients With Fibromyalgia Syndrome [NCT00125892] | Phase 3 | 320 participants | Interventional | 2005-07-31 | Completed | ||
A Study of the Effects of Paroxetine vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control [NCT00136383] | Phase 2/Phase 3 | 40 participants (Anticipated) | Interventional | 2005-03-31 | Completed | ||
A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major [NCT00351910] | Phase 3 | 494 participants (Actual) | Interventional | 2006-05-31 | Completed | ||
Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Bladder Overactivity [NCT00475696] | Phase 2 | 300 participants | Interventional | 2002-11-30 | Completed | ||
Duloxetine Hydrochloride Once Daily Compared With Placebo in the Treatment of Generalized Anxiety Disorder [NCT00475969] | Phase 3 | 327 participants | Interventional | 2004-08-31 | Completed | ||
Duloxetine Versus Placebo in the Treatment of Fibromyalgia Patients With or Without Major Depressive Disorder [NCT00489073] | Phase 3 | 345 participants | Interventional | 2002-11-30 | Completed | ||
Duloxetine Versus Paroxetine in the Acute Treatment of Major Depression [NCT00489775] | Phase 3 | 480 participants | Interventional | 2004-01-31 | Completed | ||
Duloxetine Versus Duloxetine Plus Non-Pharmacological Intervention in the Treatment of Depression [NCT00494377] | Phase 4 | 940 participants | Interventional | 2004-02-29 | Completed | ||
Identifying and Treating Depression in the Orthopaedic Trauma Population [NCT05976347] | Phase 4 | 100 participants (Anticipated) | Interventional | 2024-02-29 | Not yet recruiting | ||
The Role of SNRI's in the Prophylaxis of Depression in the First Year Following Lower Extremity Fragility Fractures in Geriatric Patients [NCT05851898] | Phase 4 | 100 participants (Anticipated) | Interventional | 2024-02-29 | Not yet recruiting | ||
A Single-Center, Open Label Pilot Study Examining The Use Of Duloxetine In The Prevention Of Episodic Migraine [NCT00443352] | Phase 4 | 27 participants (Actual) | Interventional | 2007-08-31 | Completed | ||
Evaluation of the Effect of Duloxetine on the Pharmacodynamics of Warfarin at Steady-State in Healthy Subjects [NCT00533026] | Phase 1 | 60 participants (Actual) | Interventional | 2007-07-31 | Completed | ||
Dose Response Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome [NCT00190866] | Phase 3 | 210 participants | Interventional | 2005-06-30 | Completed | ||
A Ten-Week, Randomized, Double-Blind Study Evaluating the Efficacy of Duloxetine 60mg Once Daily Versus Placebo in Outpatients With Major Depressive Disorder and Pain [NCT00191919] | Phase 3 | 310 participants | Interventional | 2005-05-31 | Completed | ||
Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence. [NCT00191087] | Phase 3 | 458 participants | Interventional | 2001-04-30 | Completed | ||
Duloxetine Combined With Intra-articular Injection of Corticosteroid and Hyaluronic Acid Reduces Pain in the Treatment of Knee Osteoarthritis Patients [NCT04117893] | Phase 4 | 150 participants (Actual) | Interventional | 2019-10-01 | Completed | ||
Efficacy and Safety of Duloxetine Compared With Placebo in Subjects With Stress Urinary Incontinence [NCT00475397] | Phase 3 | 120 participants | Interventional | 2003-12-31 | Completed | ||
Lilly's Emotional and Physical Symptoms of Depression Study [NCT00479726] | Phase 4 | 8,000 participants | Interventional | 2004-08-31 | Completed | ||
Duloxetine for Perimenopausal Depression [NCT00517985] | Phase 4 | 7 participants (Actual) | Interventional | 2007-02-28 | Completed | ||
An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression [NCT02497287] | Phase 3 | 802 participants (Actual) | Interventional | 2015-09-30 | Completed | ||
A Randomised, Controlled Trial to Investigate the Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. [NCT05973786] | Phase 4 | 418 participants (Anticipated) | Interventional | 2023-11-01 | Not yet recruiting | ||
Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression [NCT00042562] | Phase 3 | 0 participants | Interventional | 2002-12-31 | Completed | ||
[NCT00399022] | 40 participants (Anticipated) | Interventional | Withdrawn(stopped due to Funding was not recieved) | ||||
Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder [NCT00067912] | Phase 4 | 480 participants | Interventional | 2003-04-30 | Completed | ||
Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder [NCT00071695] | Phase 4 | 320 participants | Interventional | 2003-07-31 | Completed | ||
Duloxetine Versus Escitalopram and Placebo in the Treatment of Patients With Major Depression [NCT00073411] | Phase 3 | 675 participants | Interventional | 2003-11-30 | Completed | ||
Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder [NCT00036309] | Phase 3 | 0 participants | Interventional | 2002-05-31 | Completed | ||
Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy [NCT00058968] | Phase 3 | 660 participants | Interventional | 2002-10-31 | Completed | ||
Duloxetine Versus Placebo in the Treatment of Elderly Patients With Major Depressive Disorder [NCT00062673] | Phase 3 | 311 participants | Interventional | 2003-03-31 | Completed | ||
Duloxetine Hydrochloride (LY248686) Protocol F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain [NCT00036335] | Phase 3 | 286 participants | Interventional | 2002-03-31 | Completed | ||
Protocol F1J-US-HMBY Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression [NCT00042575] | Phase 3 | 120 participants | Interventional | 2002-06-30 | Completed | ||
Duloxetine Hydrochloride 60 mg or 120 mg Once Daily Compared With Placebo in Patients With Generalized Anxiety Disorder. [NCT00122824] | Phase 3 | 480 participants | Interventional | 2004-06-30 | Completed | ||
Duloxetine 60 to 120 mg Once Daily Compared With Placebo in the Prevention of Relapse in Generalized Anxiety Disorder [NCT00122863] | Phase 3 | 380 participants | Interventional | 2005-01-31 | Completed | ||
"The CHRONOS Study: Can the Sleep-deprivation Induced Antidepressive Effect in Patients With Major Depression be Sustained by Correction of Diurnal Rhythms, Long Term Light Treatment and Duloxetine Treatment?" [NCT00149110] | 75 participants (Actual) | Interventional | 2005-09-30 | Completed | |||
Duloxetine for the Treatment of Dysthymia [NCT00185575] | 24 participants (Anticipated) | Interventional | 2004-09-30 | Completed | |||
Biomechanical Effects of Duloxetine on Bladder Function and Sphincter Resistance During the Emptying Phase and on Urethral Function During the Filling Phase of the Micturition Cycle in Women With Pure Genuine Stress Incontinence [NCT00190567] | Phase 2 | 50 participants | Interventional | 2001-10-31 | Completed | ||
Efficacy and Safety of Duloxetine Compared With Placebo,Pelvic Floor Muscle Training, and Combined Duloxetine/Pelvic Floor Muscle Training in Subjects With Moderate to Sever Stress Urinary Incontinence [NCT00190606] | Phase 2 | 200 participants | Interventional | 2002-01-31 | Completed | ||
Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence [NCT00190645] | Phase 3 | 600 participants | Interventional | 2001-02-28 | Completed | ||
The Safety and Effectiveness of Duloxetine Compared With Placebo and Its Long-Term Safety and Efficacy in the Treatment of Predominant Stress Urinary Incontinence [NCT00190996] | Phase 3 | 2,765 participants | Interventional | 2003-01-31 | Completed | ||
Switching to Duloxetine From Other Antidepressants: A Regional Multicentre Trial Comparing Two Switching Techniques [NCT00191932] | Phase 4 | 360 participants | Interventional | 2004-08-31 | Completed | ||
Treatment of Major Depressive Episodes During the Course of Psychotic Disorders With Duloxetine [NCT00224302] | Phase 4 | 20 participants (Anticipated) | Interventional | 2005-08-31 | Completed | ||
A Randomized, Placebo-Controlled, Double-Blind Trial of Duloxetine in the Treatment of Patients With Chronic Fatigue Syndrome [NCT00375973] | Phase 2/Phase 3 | 60 participants (Actual) | Interventional | 2006-09-30 | Completed | ||
The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder [NCT00438971] | Phase 4 | 15 participants (Actual) | Interventional | 2006-08-31 | Completed | ||
Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion (LEAP-DB): A Multicenter, Randomized, Blinded Outcome Study of EEG-guided Treatment With Duloxetine Versus Bupropion in Adults With Major Depressive Disorder [NCT04388189] | Phase 4 | 0 participants (Actual) | Interventional | 2020-10-15 | Withdrawn(stopped due to No participants enrolled) | ||
Optimizing Outcomes in Older Adults With Low Back Pain and Depression [NCT00696293] | Phase 4 | 30 participants (Actual) | Interventional | 2007-05-31 | Completed | ||
[NCT03110172] | Phase 1/Phase 2 | 32 participants (Anticipated) | Interventional | 2017-01-31 | Active, not recruiting | ||
A Randomized, Open-Label, Crossover, Drug Interaction Study to Evaluate the Effects of DVS SR And Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects [NCT00366652] | Phase 3 | 20 participants (Anticipated) | Interventional | 2006-09-30 | Completed | ||
Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients [NCT05510856] | Phase 4 | 90 participants (Anticipated) | Interventional | 2022-09-01 | Recruiting | ||
[NCT02655354] | 635 participants (Actual) | Interventional | 2015-10-31 | Completed | |||
A Comparison of Strategies for Switching Patients From Amitriptyline to Duloxetine for the Management of Diabetic Peripheral Neuropathic Pain [NCT00266643] | Phase 4 | 205 participants | Interventional | 2005-12-31 | Completed | ||
Post-Marketing Surveillance Study on the Safety and Efficacy of Cymbalta (Duloxetine) on Diabetic Peripheral Neuropathic Pain Among Filipino Patients [NCT02215798] | 269 participants (Actual) | Observational | 2006-07-31 | Completed | |||
Evaluation of the Effects of Duloxetine on Norepinephrine Transporter Inhibition in Healthy Subjects [NCT00414323] | Phase 1 | 35 participants (Actual) | Interventional | 2006-11-30 | Completed | ||
A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression [NCT00296699] | Phase 4 | 20 participants (Actual) | Interventional | 2005-03-31 | Completed | ||
Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease [NCT01504178] | Phase 3 | 28 participants (Actual) | Interventional | 2011-05-31 | Completed | ||
Duloxetine (Cymbalta): for Fibromyalgia: An Open Label Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therpeutic Responsiveness to Duloxetine. [NCT01619566] | Phase 4 | 0 participants (Actual) | Interventional | 2012-06-30 | Withdrawn(stopped due to Sponsor related) | ||
A Randomized Trial of Sequenced Treatment Using Placebo Without Deception Followed by Open-Label Antidepressant Versus Immediate Open-Label Antidepressant Treatment for Major Depressive Disorder [NCT01650740] | 1 participants (Actual) | Interventional | 2012-08-31 | Terminated(stopped due to Poor recruitment results.) | |||
Efficacy of Variable Doses of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain: A Comparative Study [NCT05292066] | Early Phase 1 | 126 participants (Anticipated) | Interventional | 2022-10-31 | Not yet recruiting | ||
Algorithm Guided Treatment Strategies for Major Depressive Disorder [NCT01764867] | Phase 4 | 1,080 participants (Anticipated) | Interventional | 2012-06-30 | Recruiting | ||
Antidepressant Treatments During Pregnancy and Lactation: Prediction of Drug Exposure Through Breastfeeding and Evaluation of Drug Effect on the Neonatal Adaptation and the Development of the Young Child [NCT01796132] | Phase 4 | 500 participants (Anticipated) | Interventional | 2012-08-31 | Recruiting | ||
Efficacy of Pregabalin and Duloxetine in Patients With Painful Diabetic Peripheral Neuropathy (PDPN): the Effect of Pain on Cognitive Function, Sleep and Quality of Life (BLOSSOM) [NCT04246619] | Phase 4 | 254 participants (Actual) | Interventional | 2019-11-12 | Terminated(stopped due to The statistical analysis will still provide relevant results with the same statistical power as initially planned.COVID-19 pandemic prolonged the recruiting period and consequently affected the costs of the clinical trial.) | ||
Intravenous Lidocaine Infusion Versus Oral Duloxetine For The Prevention And Treatment Of Chemotherapy Induced Peripheral Neuropathy Among Breast Cancer Patients [NCT04732455] | 60 participants (Actual) | Interventional | 2021-01-15 | Completed | |||
Hyperbaric Oxygen vs. Standard Pharmaceutical Therapies for Fibromyalgia Syndrome - Prospective, Randomized Crossover Clinical Trial [NCT03325959] | 76 participants (Actual) | Interventional | 2017-03-01 | Completed | |||
Brain Morphometries in OA Patients Treated With Duloxetine [NCT01558700] | Phase 4 | 40 participants (Actual) | Interventional | 2012-03-31 | Completed | ||
Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty? [NCT02005601] | Phase 4 | 106 participants (Actual) | Interventional | 2013-11-30 | Completed | ||
Prevention of Depression and Enhancement of Cognitive Recovery Following Traumatic Brain Injury With Duloxetine [NCT01223001] | Phase 2 | 8 participants (Actual) | Interventional | 1996-09-30 | Terminated(stopped due to Most potential subjects had already been prescribed Cymbalta.) | ||
[NCT01443520] | Phase 4 | 12 participants (Actual) | Interventional | 2011-10-31 | Completed | ||
A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. [NCT05603104] | Phase 3 | 1,254 participants (Anticipated) | Interventional | 2023-08-01 | Not yet recruiting | ||
The Efficacy and Safety of the Shugan Dingtong Decoction in the Treatment of Fibromyalgia [NCT05508516] | Early Phase 1 | 72 participants (Anticipated) | Interventional | 2022-09-01 | Not yet recruiting | ||
Duloxetine Role in Reducing Opioid Consumption After Thoracotomy [NCT03618225] | Phase 4 | 60 participants (Actual) | Interventional | 2018-08-15 | Completed | ||
Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery [NCT02535000] | Phase 4 | 60 participants (Actual) | Interventional | 2014-01-01 | Completed | ||
Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty? [NCT02307305] | Phase 2 | 168 participants (Anticipated) | Interventional | 2014-08-31 | Recruiting | ||
Duloxetine for Treatment of Painful Temporomandibular Joint Disorder [NCT00981149] | 24 participants (Actual) | Interventional | 2009-05-31 | Completed | |||
Biomarkers for Prediction of Analgesic Efficacy Based on Interrelations Between Pain Modulation and EEG vs. Drugs' Mode of Action in Knee OA [NCT05256342] | 100 participants (Anticipated) | Interventional | 2021-12-30 | Recruiting | |||
Efficacy of Interpersonal Psychotherapy in Treatment Resistant Depression [NCT01896349] | 74 participants (Anticipated) | Interventional | 2013-04-30 | Recruiting | |||
Evaluating Duloxetine's Analgesic Effectiveness in Chronic Pelvic Pain [NCT01451606] | Phase 4 | 34 participants (Actual) | Interventional | 2011-07-11 | Terminated(stopped due to Adequate recruitment was not achieved in the time frame allowed.) | ||
The Effect of Duloxetine on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients [NCT02443194] | Phase 3 | 50 participants (Actual) | Interventional | 2015-05-31 | Terminated(stopped due to principle investigator decision due to many adverse events in patients) | ||
An Open Treatment Trial of Duloxetine in Elderly Patients With Dysthymic Disorder [NCT01852383] | Phase 4 | 30 participants (Actual) | Interventional | 2006-01-31 | Completed | ||
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression [NCT02418585] | Phase 3 | 236 participants (Actual) | Interventional | 2015-08-07 | Completed | ||
Effect of Combination of Duloxetine and Pregabalin to Improve Pain After Liposuction Surgery [NCT04862845] | Phase 1 | 72 participants (Anticipated) | Interventional | 2021-05-15 | Not yet recruiting | ||
A Randomized Controlled, Single-blind, Esketamine Adjuvant Therapy for the Efficacy and Safety of Patients With Chronic Visceral Pain Comorbid Major Depressive Disorder [NCT04847245] | 80 participants (Anticipated) | Interventional | 2021-05-01 | Not yet recruiting | |||
Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy in Women With Stress Urinary Incontinence: a Randomized Controlled Study. [NCT05677295] | Phase 3 | 90 participants (Anticipated) | Interventional | 2023-04-18 | Recruiting | ||
A Japan Post-Marketing, Randomized, Double-Blind, Parallel-Group, Flexible Dose Comparative Study to Assess the Non-Inferiority of Duloxetine Compared With Pregabalin in Patients With Diabetic Peripheral Neuropathic Pain [NCT02417935] | Phase 4 | 304 participants (Actual) | Interventional | 2015-04-30 | Completed | ||
Investigation Into the Diversity and Dynamic Succession of Gut Flora Pre- and Post-remission in Major Depressive Disorder [NCT04347577] | 40 participants (Anticipated) | Observational | 2020-04-10 | Recruiting | |||
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain [NCT01579279] | Phase 2 | 1 participants (Actual) | Interventional | 2012-04-30 | Terminated(stopped due to Study Stopped) | ||
Effect of Combined Morphine and Duloxetine on Chronic Pain [NCT03249558] | Phase 4 | 81 participants (Actual) | Interventional | 2018-03-12 | Completed | ||
Duloxetine for Acute Post-mastectomy Pain: Placebo Controlled Dose Ranging Study [NCT03468348] | 88 participants (Actual) | Interventional | 2018-04-01 | Completed | |||
Effect of Duloxetine 60 mg Versus Placebo in Patients With Chronic Low Back Pain in Japan [NCT01855919] | Phase 3 | 458 participants (Actual) | Interventional | 2013-05-31 | Completed | ||
Antidepressant Response in Older Adults With Comorbid PTSD and MDD [NCT04697693] | Phase 4 | 1 participants (Actual) | Interventional | 2021-03-03 | Terminated(stopped due to Unable to recruit participants in a timely fashion due to COVID pandemic) | ||
Functional Change and Efficacy of Duloxetine in Patients With Major Depression and Co-Morbid Soft Tissue Discomfort Symptoms [NCT01035073] | Phase 4 | 22 participants (Actual) | Interventional | 2006-04-30 | Completed | ||
A Comparative Study Of Botulinum Toxin Type A Versus Conventional Oral Therapy As A Second Line Treatment Of Diabetic Neuropathy [NCT05296759] | Phase 4 | 30 participants (Actual) | Interventional | 2021-02-01 | Completed | ||
Comparison of Antidepressants in the Real-World: Retrospective Cohort Study Using Big Data [NCT04446039] | 405,349 participants (Actual) | Observational | 2022-07-04 | Completed | |||
A Study to Identify Predictors of Response to Duloxetine in Breast Cancer Patients With Chronic Pain [NCT01912612] | Phase 2 | 82 participants (Actual) | Interventional | 2013-10-30 | Completed | ||
An Open Label Extension Study of Phase 3 Trial of Duloxetine in Patients With Osteoarthritis and Knee Pain [NCT02335346] | Phase 3 | 93 participants (Actual) | Interventional | 2015-01-31 | Completed | ||
Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults [NCT01973283] | Phase 4 | 100 participants (Actual) | Interventional | 2014-02-19 | Completed | ||
Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS) [NCT02260388] | Phase 4 | 402 participants (Actual) | Interventional | 2014-10-31 | Completed | ||
A Superiority Study of LY248686 Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain [NCT00552175] | Phase 3 | 339 participants (Actual) | Interventional | 2007-11-30 | Completed | ||
Impact of Duloxetine on Male Fertility [NCT03038867] | Phase 2 | 69 participants (Actual) | Interventional | 2016-12-12 | Completed | ||
Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) a Multicentre Open-label Randomized Controlled Trial Protocol [NCT05814640] | Phase 1/Phase 2 | 520 participants (Anticipated) | Interventional | 2023-02-20 | Recruiting | ||
Investigation of the Effect of Initial Central Sensitization Severity on Treatment Response in Patients With Fibromyalgia [NCT05020600] | 40 participants (Anticipated) | Observational | 2021-08-19 | Recruiting | |||
Hyperbaric Oxygen Therapy vs. Pharmaceutical Therapy in Patients Suffering From Fibromyalgia That Was Induced by Emotional Trauma: Prospective, Randomized, Two Active Arms Clinical Trial [NCT04316702] | 60 participants (Anticipated) | Interventional | 2020-03-01 | Active, not recruiting | |||
A Phase III Clinical Trial of Duloxetine in Participants With Fibromyalgia [NCT01552057] | Phase 3 | 393 participants (Actual) | Interventional | 2012-03-31 | Completed | ||
Predictors of Antidepressant Treatment Response: The Emory CIDAR [NCT00360399] | 344 participants (Actual) | Interventional | 2006-08-31 | Completed | |||
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Flexible Dose Study on the Efficacy of Lu AA21004 on Cognitive Dysfunction in Adult Subjects With Major Depressive Disorder (MDD) [NCT01564862] | Phase 2 | 602 participants (Actual) | Interventional | 2012-04-30 | Completed | ||
Altering The Transition From Acute to Chronic Pain (ATTAC-Pain): A Randomized Clinical Trial of Duloxetine for the Treatment and Prevention of Musculoskeletal Pain [NCT03315533] | Phase 2 | 76 participants (Actual) | Interventional | 2018-01-19 | Completed | ||
Neurobiology of Non-Specific and Specific Treatment Responses in Major Depression [NCT03068247] | Phase 3 | 0 participants (Actual) | Interventional | 2021-11-30 | Withdrawn(stopped due to Institution was unable to manufacture radiotracer that was central to the protocol. Study transferred to another institution.) | ||
A Single-Center, Single-Arm Clinical Trail Evaluating Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients With Taxanes-induced Painful Peripheral Neuropathy [NCT04970121] | Phase 2 | 100 participants (Anticipated) | Interventional | 2021-08-21 | Recruiting | ||
Effectiveness of the Norepinephrine and Serotonin Reuptake Inhibitor Levomilnacipran in Healthy Males [NCT03249311] | Phase 4 | 36 participants (Actual) | Interventional | 2018-03-02 | Active, not recruiting | ||
Postoperative Duloxetine Impact on Pain Control and Patient Outcomes Following Lateral Lumbar Interbody Fusion: A Randomized Controlled Trial [NCT05611749] | Phase 2 | 130 participants (Anticipated) | Interventional | 2022-11-15 | Not yet recruiting | ||
Efficacy of Hydroxyzine Versus Treatment as Usual for Panic Disorder: An Eight-Week, Open Label, Pilot, Randomized Controlled Trial. [NCT05737511] | Phase 4 | 80 participants (Anticipated) | Interventional | 2023-12-30 | Not yet recruiting | ||
Pharmacovigilance in Gerontopsychiatric Patients [NCT02374567] | Phase 3 | 407 participants (Actual) | Interventional | 2015-01-31 | Terminated | ||
Incorporating Drug Metabolism by the Human Gut Microbiome Into Personalized Medicine [NCT05065671] | Phase 1 | 14 participants (Anticipated) | Interventional | 2022-02-01 | Recruiting | ||
Bioavailability of a Formulation of Duloxetine 60 mg Enteric Coated Granules With Regards to Reference Product in Feeding Conditions [NCT04751318] | Phase 1 | 36 participants (Actual) | Interventional | 2021-02-27 | Completed | ||
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression [NCT02417064] | Phase 3 | 346 participants (Actual) | Interventional | 2015-08-10 | Completed | ||
A Phase 4, 8-week, Double-blind, Randomized Study Comparing Switching to Duloxetine or Escitalopram in Patients With Major Depressive Disorder and Residual Apathy in the Absence of Depressed Mood [NCT00985504] | Phase 4 | 483 participants (Actual) | Interventional | 2009-09-30 | Completed | ||
Pilot Study of Use of Duloxetine for the Treatment of Phantom Limb Pain [NCT00425230] | 15 participants (Anticipated) | Interventional | 2007-01-31 | Terminated(stopped due to No patients were enrolled in this study. The study onset was delayed due to problems with drug acquisition.) | |||
Effectiveness of Adding Duloxetine to Pregabalin in Treatment of Acute Postoperative and Prevention of Chronic Pain Following Thoracotomy Surgeries; Randomized Controlled Study [NCT04782310] | Phase 4 | 75 participants (Anticipated) | Interventional | 2021-03-10 | Recruiting | ||
Factors of Treatment Response in Major Depressive Disorder [NCT00200902] | Phase 4 | 88 participants (Actual) | Interventional | 2005-08-31 | Completed | ||
Duloxetine for Chronic Depression: a Double-blind Study [NCT00360724] | Phase 4 | 65 participants (Actual) | Interventional | 2006-08-31 | Completed | ||
Duloxetine for the Treatment of Obsessive Compulsive Disorder [NCT00464698] | Phase 4 | 20 participants (Actual) | Interventional | 2005-12-31 | Completed | ||
Functional MRI Neural Correlates of Medication Efficacy in Patients With Chronic Low Back Pain [NCT00388414] | 14 participants (Actual) | Interventional | 2006-09-30 | Completed | |||
Duloxetine Effects on Brain fMRI Response to Emotionally Valenced Pictures in the Treatment of Patients With Major Depression [NCT00532480] | Phase 4 | 10 participants (Actual) | Interventional | 2007-09-30 | Completed | ||
A Comparison of Non-Surgical Treatment Methods for Patients With Lumbar Spinal Stenosis [NCT01943435] | 259 participants (Actual) | Interventional | 2013-11-20 | Completed | |||
Duloxetine Versus Pregabalin for Alcohol Dependence [NCT00929344] | Phase 2 | 150 participants (Actual) | Interventional | 2009-07-31 | Completed | ||
Effects of Treatment on Decision-making in Major Depression [NCT01916824] | Phase 4 | 53 participants (Actual) | Interventional | 2013-08-31 | Completed | ||
Impact of Duloxetine on Succinylcholine-induced Postoperative Myalgia During Direct Microlaryngoscopic Surgeries: Randomized Controlled Double-blind Study [NCT03037073] | Phase 2/Phase 3 | 70 participants (Actual) | Interventional | 2017-04-15 | Completed | ||
Phase 3 Clinical Study of Duloxetine Hydrochloride in Patients With CLBP - Open Label Long Term Extension Study [NCT01914666] | Phase 3 | 151 participants (Actual) | Interventional | 2013-09-30 | Completed | ||
A Randomized Placebo Controlled Trial of Duloxetine for Central Pain in Multiple Sclerosis [NCT00457730] | Phase 2/Phase 3 | 38 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
A Phase 1, Single-center, Open-label, Sequential Drug Interaction Study Between AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [DM]/Quinidine Sulfate [Q]) and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects [NCT02174822] | Phase 1 | 56 participants (Actual) | Interventional | 2014-01-31 | Completed | ||
Open Trial of Duloxetine in Outpatients With Irritable Bowel Syndrome Symptoms and Co-Morbid Major Depression [NCT01754493] | Phase 4 | 17 participants (Actual) | Interventional | 2008-12-31 | Completed | ||
Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy: A Prospective Randomized Placebo-controlled Study [NCT03350334] | 100 participants (Actual) | Interventional | 2017-12-04 | Completed | |||
Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD) [NCT04245748] | Phase 4 | 84 participants (Anticipated) | Interventional | 2020-03-01 | Recruiting | ||
Acute, Double-blind, Adaptively Randomized Treatment With Duloxetine or Escitalopram, Followed by Open-label Naturalistic Follow-up. [NCT04245436] | Phase 4 | 60 participants (Anticipated) | Interventional | 2020-01-01 | Recruiting | ||
Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain [NCT04747314] | Phase 2/Phase 3 | 300 participants (Anticipated) | Interventional | 2021-03-31 | Recruiting | ||
Efficacy and Safety of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression: A Multicenter, Randomized, Double-blind, Double-dummy, Active- and Placebo-controlled, Parallel-group, Phase II Study [NCT05018013] | Phase 2 | 240 participants (Anticipated) | Interventional | 2021-08-21 | Recruiting | ||
Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study [NCT04137107] | Phase 2/Phase 3 | 348 participants (Anticipated) | Interventional | 2020-05-01 | Suspended(stopped due to Protocol-specified safety stopping rule) | ||
Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia [NCT03487211] | Phase 2/Phase 3 | 200 participants (Actual) | Interventional | 2018-04-09 | Completed | ||
Effect of Duloxetine 60 mg Versus Placebo in Patients With Chronic Osteoarthritis and Knee Pain in Japan [NCT02248480] | Phase 3 | 354 participants (Actual) | Interventional | 2014-10-31 | Completed | ||
Duloxetine Efficacy and Tolerability for Pain Management in Patients Undergoing Laparoscopic Cholecystectomy [NCT05115123] | Phase 2 | 60 participants (Actual) | Interventional | 2022-03-02 | Completed | ||
Genetic Variants Associated With the Occurrence of Localized Low Back Pain or Low Back Pain With Widespread Pain Symptoms, and Their Response to Treatment With Duloxetine or Propranolol [NCT03364075] | Phase 2 | 10 participants (Actual) | Interventional | 2017-09-01 | Terminated(stopped due to Recruitment issue) | ||
Efficacy and Safety of Duloxetine Among Individuals With Depressive Disorder in a 12 Weeks Trial [NCT03121573] | 30 participants (Actual) | Interventional | 2014-12-15 | Completed | |||
A Randomized, Double-blind, Multicenter Active-controlled Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depressio [NCT03434041] | Phase 3 | 252 participants (Actual) | Interventional | 2018-05-25 | Completed | ||
Preoperative Duloxetine to Prevent Postoperative Shoulder Pain After Gynecological Laparoscopies [NCT03249168] | Phase 3 | 60 participants (Actual) | Interventional | 2017-10-01 | Completed | ||
An Open Label Extension Study of Phase 3 Trial of Duloxetine in Patients With Fibromyalgia [NCT01621191] | Phase 3 | 149 participants (Actual) | Interventional | 2012-06-30 | Completed | ||
Effect of Duloxetine 60mg Once Daily in Patients With Chronic Pain Due to Osteoarthritis in China [NCT01931475] | Phase 3 | 407 participants (Actual) | Interventional | 2013-09-30 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30. (NCT00105989)
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Intervention | units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sum Items 1 to 5 Baseline (N=117,N=97) | Sum Items 1 to 5 Change to Endpoint | Sum Items 1&2 Baseline (N=135, N=109) | Sum Items 1&2 Change to Endpoint | Item 1-Sex Drive Baseline (N=136,N=109) | Item 1-Sex Drive Change to Endpoint | Item 2-Arousal Baseline (N=135, N=109) | Item 2-Arousal Change to Endpoint | Item 3-Lubrication/Erection Baseline (N=124,N=99) | Item 3-Lubrication Change to Endpoint | Item 4-Orgasm Baseline (N=120,N=98) | Item 4-Orgasm Change to Endpoint | Item 5-Satisfaction Baseline (N=118,N=97) | Item 5-Satisfaction Change to Endpoint | |
Duloxetine - Acute Phase | 17.57 | 0.13 | 7.47 | -0.19 | 3.91 | -0.15 | 3.56 | -0.02 | 3.43 | -0.02 | 3.38 | 0.32 | 3.36 | 0.05 |
Duloxetine - Continuation Phase | 17.26 | -0.67 | 7.16 | -0.39 | 3.68 | -0.21 | 3.48 | -0.18 | 3.27 | -0.04 | 3.60 | -0.15 | 3.32 | -0.15 |
Number of participants who experienced a depressive recurrence at any time during the double-blind maintenance therapy phase. (NCT00105989)
Timeframe: Every Visit from Week 35 up to Week 86 (Maintenance Phase)
Intervention | participants (Number) |
---|---|
Duloxetine | 21 |
Placebo | 47 |
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00105989)
Timeframe: Week 86 (Maintenance Phase)
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 1.72 |
Placebo | 2.34 |
(NCT00105989)
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Intervention | kilograms (Mean) | |
---|---|---|
Weight Baseline | Weight Change from Baseline to Endpoint | |
Duloxetine - Acute Phase | 74.74 | -0.69 |
Duloxetine - Continuation Phase | 74.22 | 0.88 |
(NCT00105989)
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Intervention | beats per minute (Mean) | |
---|---|---|
Pulse Baseline | Pulse Change from Baseline to Endpoint | |
Duloxetine - Acute Phase | 71.76 | 1.42 |
Duloxetine - Continuation Phase | 72.79 | 1.75 |
(NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | mm Hg (Least Squares Mean) | |
---|---|---|
Change from Baseline: Systolic Blood Pressure | Change from Baseline: Diastolic Blood Pressure | |
Duloxetine | 1.70 | -0.23 |
Placebo | -1.11 | -0.11 |
(NCT00105989)
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Intervention | mm Hg (Mean) | |||
---|---|---|---|---|
Systolic Blood Pressure Baseline | Systolic Blood Pressure Change to Endpoint | Diastolic Blood Pressure Baseline | Diastolic Blood Pressure Change to Endpoint | |
Duloxetine - Acute Phase | 125.03 | 0.25 | 77.52 | 0.72 |
Duloxetine - Continuation Phase | 124.72 | 0.77 | 78.28 | -0.57 |
(NCT00105989)
Timeframe: Every Visit from Week 10 up to Week 34 (Continuation)
Intervention | participants (Number) | |||||
---|---|---|---|---|---|---|
Patients with >= 1 Adverse Event | Headache | Nasopharyngitis | Hyperhidrosis | Back pain | Diarrhoea | |
Duloxetine 120 mg | 59 | 6 | 9 | 5 | 8 | 2 |
Duloxetine 60 mg | 102 | 21 | 7 | 8 | 7 | 10 |
Duloxetine 90 mg | 83 | 12 | 10 | 12 | 4 | 6 |
(NCT00105989)
Timeframe: Every Visit from Week 0 up to Week 10 (Acute)
Intervention | participants (Number) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Patients with >= 1 Adverse Event | Nausea | Headache | Dry mouth | Hyperhidrosis | Fatigue | Constipation | Dizziness | Diarrhoea | Vomiting | Insomnia | Decreased appetite | |
Duloxetine - Acute Phase | 349 | 150 | 79 | 76 | 76 | 60 | 48 | 41 | 38 | 28 | 27 | 26 |
(NCT00105989)
Timeframe: Week 0 and Week 10
Intervention | micromoles per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Acute Phase | 297.05 | -10.64 |
(NCT00105989)
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Intervention | grams per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Continuation Phase | 72.47 | -0.38 |
(NCT00105989)
Timeframe: Week 0 and Week 10
Intervention | grams per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Acute Phase | 73.59 | -1.18 |
(NCT00105989)
Timeframe: Week 0 and Week 10
Intervention | millimoles per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Acute Phase | 141.21 | -0.64 |
(NCT00105989)
Timeframe: Week 0 and Week 10
Intervention | Giga per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Acute Phase | 261.08 | 4.23 |
(NCT00105989)
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Intervention | Giga per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Continuation Phase | 0.35 | 0.02 |
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00105989)
Timeframe: Week 10 (Acute) and Week 34 (Continuation)
Intervention | units on a scale (Mean) |
---|---|
Duloxetine - Acute Phase | 2.12 |
Duloxetine - Continuation Phase | 1.76 |
(NCT00105989)
Timeframe: Week 0 and Week 10
Intervention | millimoles per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Acute Phase | 103.73 | -0.29 |
Loss of response was defined as a HAMD-17 total score >9 and a CGI-Severity score >2 at any one time during the double-blind maintenance phase of the study regardless of whether or not they subsequently regained response or not. (NCT00105989)
Timeframe: Every Visit from Week 35 up to Week 86 (Maintenance Phase)
Intervention | participants (Number) |
---|---|
Duloxetine | 44 |
Placebo | 66 |
The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity. (NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 0.79 |
Placebo | 0.81 |
(NCT00105989)
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Intervention | femtoliters (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Continuation Phase | 89.33 | 0.45 |
(NCT00105989)
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Intervention | millimoles per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Continuation Phase | 20.73 | -0.18 |
(NCT00105989)
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Intervention | millimoles per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Continuation Phase | 3.61 | -0.14 |
(NCT00105989)
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Intervention | Giga per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Continuation Phase | 6.40 | 0.17 |
(NCT00105989)
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Intervention | millimoles per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Continuation Phase | 8.73 | -0.14 |
(NCT00105989)
Timeframe: Week 0 and Week 10
Intervention | millimoles per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Acute Phase | 8.81 | -0.07 |
(NCT00105989)
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Intervention | Actual count (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Continuation Phase | 0.42 | -0.00 |
(NCT00105989)
Timeframe: Week 0 and Week 10
Intervention | actual count (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Acute Phase | 0.43 | -0.00 |
(NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | millimoles per Liter (Mean) | |||
---|---|---|---|---|
Fasting Glucose Baseline (N=120,N=112) | Fasting Glucose Change to Endpoint | Non-Fasting Glucose Baseline (N=41,N=39) | Non-Fasting Glucose Change to Endpoint | |
Duloxetine | 5.40 | 0.07 | 5.68 | -0.20 |
Placebo | 5.47 | 0.03 | 5.74 | 0.62 |
(NCT00105989)
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Intervention | Units per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Continuation Phase | 24.13 | 2.11 |
(NCT00105989)
Timeframe: Week 0 and Week 10
Intervention | Units per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Acute Phase | 29.25 | -5.12 |
(NCT00105989)
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Intervention | Tera per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Continuation Phase | 4.74 | -0.06 |
(NCT00105989)
Timeframe: Week 0 and Week 10
Intervention | Giga per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Acute Phase | 0.13 | 0.01 |
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. (NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 0.24 |
Placebo | 0.84 |
(NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | millimoles per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine | 2.43 | -0.04 |
Placebo | 2.43 | -0.01 |
(NCT00105989)
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Intervention | millimoles per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Continuation Phase | 2.45 | -0.01 |
(NCT00105989)
Timeframe: Week 0 and Week 10
Intervention | millimoles per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Acute Phase | 2.46 | -0.01 |
(NCT00105989)
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Intervention | micromoles per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Continuation Phase | 8.68 | -0.50 |
(NCT00105989)
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Intervention | micromoles per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Continuation Phase | 2.03 | -0.12 |
(NCT00105989)
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Intervention | millimoles per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Continuation Phase | 24.41 | 1.04 |
(NCT00105989)
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Intervention | grams per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Continuation Phase | 42.43 | -0.57 |
(NCT00105989)
Timeframe: Week 0 and Week 10
Intervention | grams per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine - Acute Phase | 43.05 | -0.61 |
(NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | Units per Liter (Mean) | |
---|---|---|
Baseline | Change to Endpoint | |
Duloxetine | 21.81 | 2.52 |
Placebo | 22.12 | -0.38 |
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. (NCT00105989)
Timeframe: Week 34 through Week 86 (Maintenance Phase)
Intervention | visits (Least Squares Mean) | ||||
---|---|---|---|---|---|
Primary Health Care Provider Visits (N=47,N=47) | Psychiatrist Visits (N=33,N=23) | Psychologist/Therapist Visits (N=8,N=7) | Other Specialist Physician Visits (N=25,N=25) | Other (Specified by Patient) Visits (N=5,N=3) | |
Duloxetine | -0.00 | -0.01 | -0.02 | 0.00 | 0.04 |
Placebo | -0.00 | -0.01 | -0.01 | -0.00 | 0.00 |
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. (NCT00105989)
Timeframe: Week 0 through Week10 (Acute) through Week 34 (Continuation)
Intervention | visits (Mean) | ||||
---|---|---|---|---|---|
Primary Health Care Provider Visits (N=94,N=99) | Psychiatrist Visits (N=91,N=65) | Psychologist/Therapist Visits (N=19,N=11) | Other Specialist Physician Visits (N=42,N=38) | Other (Specified by Patient) Visits (N=3,N=3) | |
Duloxetine - Acute Phase | -0.00 | 0.03 | 0.01 | -0.00 | 0.04 |
Duloxetine - Continuation Phase | -0.00 | -0.03 | -0.00 | 0.01 | -0.07 |
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. (NCT00105989)
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Intervention | hours (Mean) | |
---|---|---|
Number of Missed Paid Work Hours Baseline | Change in Number of Missed Paid Work Hours | |
Duloxetine - Acute | 1.77 | 0.46 |
Duloxetine - Continuation Phase | 2.67 | -0.52 |
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. (NCT00105989)
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Intervention | hours (Mean) | |
---|---|---|
Average Number of Hours Worked In a Week Baseline | Change in Average Number of Hours Worked In a Week | |
Duloxetine - Acute Phase | 0.36 | 0.00 |
Duloxetine - Continuation Phase | 0.36 | 0.01 |
Worsening occurs if patient had a >=50% increase from baseline on the 17-Item Hamilton Depression Rating Scale (HAMD-17) total score and a Clinical Global Impression-Severity (CGI-S) score >=3 at any time during the double-blind maintenance therapy phase. (NCT00105989)
Timeframe: Every Visit from Week 34 up to Week 86 (Maintenance Phase)
Intervention | percentage of participants (Number) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
t=7 days (N=142, N=140) | t=14 days (N=140, N=138) | t=21 days (N=136, N=130) | t=28 days (N=132, N=125) | t=56 days (N=124, N=105) | t=84 days (N=114, N=88) | t=112 days (N=105, N=81) | t=140 days (N=100, N=72) | t=168 days (N=95, N=70) | t=196 days (N=93, N=67) | t=224 days (N=90, N=65) | t=252 days (N=84, N=60) | t=280 days (N=81, N=60) | t=308 days (N=78, N=59) | t=336 days (N=77, N=56) | t=364 days (N=75, N=51) | |
Duloxetine | 2.07 | 3.45 | 5.53 | 7.63 | 11.89 | 16.99 | 21.48 | 23.02 | 24.61 | 26.19 | 28.57 | 31.04 | 31.88 | 31.88 | 31.88 | 33.65 |
Placebo | 1.41 | 1.41 | 7.12 | 9.30 | 22.57 | 31.86 | 35.07 | 40.82 | 42.47 | 44.14 | 45.80 | 45.80 | 45.80 | 46.71 | 49.42 | 51.33 |
Recurrence: Clinical Global Impression-Severity (CGI-S) score >=4 and met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD); had 3 consecutive visits where re-emergence criteria met; had total of 10 visits where re-emergence criteria was satisfied; discontinued due to lack of efficacy. (NCT00105989)
Timeframe: Every Visit from Week 34 up to Week 86 (Maintenance Phase)
Intervention | percentage of participants (Number) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
t=7 days (N=145, N=139) | t=14 days (N=143, N=138) | t=21 days (N=141, N=137) | t=28 days (N=140, N=135) | t=56 days (N=136, N=120) | t=84 days (N=131, N=106) | t=112 days (N=122, N=96) | t=140 days (N=119, N=89) | t=168 days (N=115, N=86) | t=196 days (N=111, N=86) | t=224 days (N=108, N=85) | t=252 days (N=105, N=82) | t=280 days (N=99, N=77) | t=308 days (N=96, N=75) | t=336 days (N=95, N=74) | t=364 days (N=93, N=73) | |
Duloxetine | 0.68 | 1.37 | 1.37 | 2.07 | 4.19 | 6.33 | 8.58 | 9.34 | 10.89 | 11.69 | 12.50 | 13.32 | 13.32 | 13.32 | 14.23 | 16.03 |
Placebo | 2.11 | 2.11 | 2.82 | 3.54 | 12.97 | 21.15 | 25.79 | 28.98 | 28.98 | 28.98 | 29.80 | 32.28 | 34.00 | 34.86 | 34.86 | 35.74 |
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain). (NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | units on a scale (Least Squares Mean) | |||||
---|---|---|---|---|---|---|
Change from Baseline to Endpoint in Overall Pain | Change from Baseline to Endpoint in Headache | Change from Baseline to Endpoint in Back Pain | Change from Baseline to Endpoint in Shoulder Pain | Change: Interference with Daily Activities | Change from Baseline in Pain While Awake | |
Duloxetine | 3.92 | 4.77 | 1.77 | 0.51 | 3.16 | 3.64 |
Placebo | 4.57 | 2.80 | 3.40 | 3.02 | 2.81 | 4.69 |
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain). (NCT00105989)
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Intervention | units on a scale (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Overall Pain Baseline (N=450, N=410) | Overall Pain Change from Baseline to Endpoint | Headache Baseline (N=450, N=410) | Headache Change from Baseline to Endpoint | Back Pain Baseline (N=450, N=410) | Back Pain Change from Baseline to Endpoint | Shoulder Pain Baseline (N=446, N=410) | Shoulder Pain Change from Baseline to Endpoint | Interference-DailyActivities Baseline(N=445,N=410) | Intereference Change from Baseline to Endpoint | Pain While Awake Baseline (N=446, N=410) | Pain While Awake Change from Baseline to Endpoint | |
Duloxetine - Acute Phase | 34.36 | -16.34 | 29.74 | -14.83 | 28.79 | -13.64 | 24.06 | -10.47 | 33.28 | -16.79 | 38.18 | -17.66 |
Duloxetine - Continuation Phase | 17.29 | 1.16 | 14.80 | 0.04 | 15.61 | -0.00 | 13.49 | -0.39 | 15.59 | 1.00 | 19.22 | 0.06 |
The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity. (NCT00105989)
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline to Endpoint | |
Duloxetine - Acute Phase | 12.64 | -5.37 |
Duloxetine - Continuation Phase | 6.88 | -0.35 |
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10. (NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Change from Baseline to Endpoint in Global Score | Change from Baseline to Endpoint in Work/School | Change from Baseline to Endpoint in Social Life | Change from Baseline to Endpoint in Family Life | |
Duloxetine | -0.05 | 0.03 | 0.02 | -0.10 |
Placebo | 2.06 | 0.83 | 0.56 | 0.67 |
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10. (NCT00105989)
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Intervention | units on a scale (Mean) | |||||||
---|---|---|---|---|---|---|---|---|
Global Score Baseline (N=449,N=378) | Global Score Change from Baseline to Endpoint | Work/School Item Baseline (N=452,N=378) | Work/School Item Change from Baseline to Endpoint | Social Life Item Baseline (N=452,N=378) | Social Life Item Change from Baseline to Endpoint | Family Life Item Baseline (N=452,N=378) | Family Life Item Change from Baseline to Endpoint | |
Duloxetine - Acute Phase | 19.30 | -7.88 | 6.52 | -2.61 | 6.45 | -2.69 | 6.35 | -2.59 |
Duloxetine - Continuation Phase | 10.72 | -2.01 | 3.64 | -0.71 | 3.50 | -0.64 | 3.54 | -0.63 |
Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood item (0-4). (NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | units on a scale (Least Squares Mean) | |||||
---|---|---|---|---|---|---|
Change from Baseline to Endpoint in Anxiety | Change from Baseline to Endpoint in Core | Change from Baseline to Endpoint in Maier | Change from Baseline to Endpoint in Retardation | Change from Baseline to Endpoint in Sleep | Change from Baseline to Endpoint in Depressed Mood | |
Duloxetine | 0.46 | 0.75 | 0.91 | 0.59 | 0.13 | 0.27 |
Placebo | 1.54 | 1.74 | 2.25 | 1.49 | 0.71 | 0.67 |
Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood Item (0-4). (NCT00105989)
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Intervention | units on a scale (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Anxiety Baseline | Anxiety Change from Baseline to Endpoint | Core Baseline | Core Change from Baseline to Endpoint | Maier Baseline | Maier Change from Baseline to Endpoint | Retardation Baseline | Retardation Change from Baseline to Endpoint | Sleep Baseline | Sleep Change from Baseline to Endpoint | Depressed Mood Baseline | Depressed Mood Change from Baseline to Endpoint | |
Duloxetine - Acute Phase | 7.71 | -4.52 | 8.81 | -5.97 | 11.44 | -7.46 | 7.76 | -4.61 | 3.80 | -2.37 | 2.78 | -1.86 |
Duloxetine - Continuation Phase | 2.51 | -0.11 | 2.00 | -0.29 | 2.91 | -0.29 | 2.43 | -0.48 | 1.11 | -0.07 | 0.64 | -0.05 |
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). (NCT00105989)
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline to Endpoint | |
Duloxetine - Acute Phase | 4.49 | -2.30 |
Duloxetine - Continuation Phase | 1.83 | -0.07 |
A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30. (NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | units on a scale (Least Squares Mean) | ||||||
---|---|---|---|---|---|---|---|
Change from Baseline: Sum Items 1 to 5 (N=35,N=29) | Change from Baseline: Sum Items 1&2 (N=39,N=29) | Item 1-Sex Drive (N=39,N=29) | Item 2-Arousal (N=39,N=29) | Item 3-Lubrication/Erection (N=38,N=29) | Item 4-Orgasm (N=36,N=29) | Item 5-Satisfaction (N=35,N=29) | |
Duloxetine | -0.97 | -0.25 | -0.17 | -0.09 | -0.32 | -0.08 | -0.13 |
Placebo | -0.77 | 0.03 | -0.02 | 0.07 | -0.10 | -0.43 | -0.04 |
A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30. (NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | units on a scale (Least Squares Mean) | ||||||
---|---|---|---|---|---|---|---|
Change from Baseline:Sum Items 1 to 5 (N=63,N=66) | Change from Baseline:Sum Items 1&2 (N=77,N=79) | Item 1 - Sex Drive (N=77,N=79) | Item 2 - Arousal (N=77,N=79) | Item 3 - Lubrication/Erection (N=63,N=67) | Item 4 - Orgasm (N=63,N=67) | Item 5 - Satisfaction (N=63,N=67) | |
Duloxetine | -0.65 | -0.19 | -0.08 | -0.12 | -0.21 | -0.10 | -0.05 |
Placebo | -0.47 | 0.34 | 0.18 | 0.16 | -0.15 | -0.15 | -0.40 |
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (absent, mild, moderate, severe, very severe) or a 3-point scale (absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). (NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 1.40 |
Placebo | 4.36 |
A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30. (NCT00105989)
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Intervention | units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sum Items 1 to 5 Baseline (N=220,N=197) | Sum Items 1 to 5 Change to Endpoint | Sum Items 1&2 Baseline (N=285,N=239) | Sum Items 1&2 Change to Endpoint | Item 1-Sex Drive Baseline (N=286,N=239) | Item 1-Sex Drive Change to Endpoint | Item 2-Arousal Baseline (N=286,N=239) | Item 2-Arousal Change to Endpoint | Item 3-Lubrication/Erection Baseline (N=224,N=198) | Item 3-Lubrication/Erection Change to Endpoint | Item 4-Orgasm Baseline (N=224,N=198) | Item4-Orgasm Change to Endpoint | Item 5-Satisfaction Baseline (N=226,N=198) | Item 5-Satisfaction Change to Endpoint | |
Duloxetine - Acute Phase | 21.41 | -1.31 | 9.31 | -0.69 | 4.92 | -0.46 | 4.40 | -0.22 | 3.97 | -0.19 | 4.33 | -0.13 | 3.93 | -0.18 |
Duloxetine - Continuation Phase | 19.31 | -0.99 | 8.42 | -0.56 | 4.34 | -0.31 | 4.08 | -0.25 | 3.57 | -0.10 | 4.06 | -0.28 | 3.58 | -0.10 |
Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning. (NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | units on a scale (Least Squares Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Change from Baseline-Physical Component Summary | Change from Baseline-Mental Component Summary | Change from Baseline-Physical Functioning | Change from Baseline-Bodily Pain | Change from Baseline-Role Limitations: Physical | Change from Baseline-Role Limitations: Emotional | Change from Baseline-General Health Perceptions | Change from Baseline-Mental Health | Change from Baseline-Social Function | Change from Baseline-Vitality | Change from Baseline-Rate Current Health | Change from Baseline-Health Compared to Year Ago | |
Duloxetine | -0.45 | -1.11 | 0.06 | -0.42 | 0.01 | -0.03 | -0.23 | -0.44 | -0.14 | -0.77 | 0.03 | 0.19 |
Placebo | 0.33 | -5.74 | -0.07 | -0.19 | -0.41 | -0.46 | -0.61 | -2.60 | -0.50 | -1.38 | 0.08 | 0.34 |
Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning. (NCT00105989)
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Intervention | units on a scale (Mean) | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Physical Component Summary Baseline (N=455,N=377) | Physical Component Summary Change to Endpoint | Mental Component Summary Baseline (N=455,N=377) | Mental Component Summary Change to Endpoint | Physical Functioning Baseline (N=457,N=377) | Physical Functioning Change to Endpoint | Bodily Pain Baseline (N=460,N=377) | Bodily Pain Change from Baseline to Endpoint | Role Limitations:Physical Baseline (N=457,N=377) | Role Limitations:Physical Change to Endpoint | Role Limitations:Emotional Baseline (N=456,N=377) | Role Limitations:Emotional Change to Endpoint | General Health Perceptions Baseline(N=456,N=377) | General Health Perceptions Change to Endpoint | Mental Health Baseline (N=456,N=377) | Mental Health Change from Baseline to Endpoint | Social Function Baseline (N=460,N=377) | Social Function Change from Baseline to Endpoint | Vitality Baseline (N=457,N=377) | Vitality Change from Baseline to Endpoint | Rate Current Health Baseline (N=460,N=377) | Rate Current Health Change to Endpoint | Health Compared to Year Ago Baseline (N=460,N=377) | Health Compared to Year Ago Change to Endpoint | |
Duloxetine - Acute Phase | 43.55 | 3.86 | 23.93 | 14.67 | 23.59 | 2.39 | 6.83 | 1.61 | 5.24 | 1.06 | 3.42 | 1.11 | 13.66 | 2.93 | 12.62 | 6.45 | 4.77 | 2.12 | 8.85 | 4.51 | 3.88 | -0.72 | 3.67 | -1.18 |
Duloxetine - Continuation Phase | 48.05 | 0.03 | 39.83 | 3.98 | 26.28 | 0.28 | 8.61 | 0.07 | 6.48 | 0.20 | 4.65 | 0.34 | 17.03 | 0.58 | 19.60 | 1.30 | 7.05 | 0.65 | 13.84 | 0.84 | 3.03 | -0.01 | 2.37 | -0.34 |
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). (NCT00105989)
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline to Endpoint | |
Duloxetine - Acute Phase | 23.07 | -14.37 |
Duloxetine - Continuation Phase | 6.64 | -0.61 |
(NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | kilograms (Least Squares Mean) |
---|---|
Duloxetine | 0.88 |
Placebo | 0.39 |
(NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | beats per minute (Least Squares Mean) |
---|---|
Duloxetine | -1.86 |
Placebo | -1.72 |
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. (NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | hours (Least Squares Mean) |
---|---|
Duloxetine | 0.27 |
Placebo | -0.75 |
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. (NCT00105989)
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Intervention | hours (Least Squares Mean) |
---|---|
Duloxetine | -0.00 |
Placebo | -0.00 |
The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations with higher scores representing increased social anxiety. The LSAS contains three total scores: 1) total fear score (0-72), 2) total avoidance score(0-72), 3) and total overall score (0-144). Suggested interpretations: 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, Greater than 95 - Very severe social phobia. (NCT00114127)
Timeframe: 6 months
Intervention | Scores on a scale (Mean) |
---|---|
Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) | 67.9 |
Duloxetine 120mg/Day for 18 Weeks (Phase 2) | 53.7 |
"The Clinician Global Impression-Severity Scale (CGI-S) is a clinician-rated instrument used to assess global severity of symptoms (Guy, 1976). The CGI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).~Baseline collected for Phase 1 at week 0 and for Phase 2 at week 6." (NCT00114127)
Timeframe: 6 months
Intervention | Scores on a scale (Mean) |
---|---|
Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) | 4.42 |
Duloxetine 120mg/Day for 18 Weeks (Phase 2) | 3.60 |
Recurrence of major depressive episodes as determined by SCID/DSM IV: two weeks of low mood and/or anhedonia, together with at least five of the following symptoms: suicidal ideation, low energy, sleep disturbance, appetite disturbance, psychic anxiety or somatic anxiety. In addition, a diagnosis of major depression requires evidence of distress or impairment. (NCT00177671)
Timeframe: 2 years
Intervention | participants (Number) |
---|---|
Donepezil | 19 |
Placebo | 11 |
The PASS (a performance-based assessment of instrumental activities of daily living)generates a composite measure of 13 cognitive IADL items capturing performance on activities such as shopping, bill paying, medication management, and home safety. We report the percentage of subjects at each assessment point adjudged to have independent functioning. This was determined by a clinician rater observing subjects perform each task and rating them according to predetermined criteria on a 4 point scale, ranging from 0 (unable) to 3 (independent). (NCT00177671)
Timeframe: baseline, year 1 and year 2
Intervention | Percentage of participants (Number) | ||
---|---|---|---|
Baseline (N=33; N=34) | Year 1 (N=23; N=25) | Year 2 (N=11; N=17) | |
Donepezil | 54.10 | 62.16 | 36.67 |
Placebo | 61.82 | 54.35 | 47.22 |
Cognitive performance was assessed with 17 well established and validated individual tests measuring multiple domains. We transformed raw scores for individual tests into Z-scores using the baseline distribution of a non-depressed, cognitively normal, older adult comparison group (N=36)of similar age, education, and medical health recruited concurrently with the depressed participants. These Z-scores were averaged within each neuropsychological area to produce domain scores and then averaged over all 17 tests to calculate a global cognition performance score. (NCT00177671)
Timeframe: Measured at baseline and Years 1 and 2 in maintenance
Intervention | Z-score (Mean) | ||
---|---|---|---|
Baseline (N=67;N=63) | Year 1 (N=45; N=57) | Year 2 N=42; N=49) | |
Donepezil | -0.47 | -0.23 | -0.31 |
Placebo | -0.47 | -0.65 | -0.56 |
Conversion to dementia was ascertained by the University of Pittsburgh Alzheimer Disease Research Center (ADRC), using data on neuropsychological performance and IADL functioning, as well as other relevant clinical data. Diagnoses were made according to National Alzheimer Coordinating Center criteria. (NCT00177671)
Timeframe: 2 year
Intervention | Percent of Participants (Number) |
---|---|
Donepezil | 10 |
Placebo | 33 |
Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.Response is defined as a 50% decrease in HAMD-17 scoring. Remission defined as a HAMD-17 score of 7 or less. (NCT00200902)
Timeframe: Baseline, Week 8
Intervention | Participants (Count of Participants) | |
---|---|---|
Responders | Remitters | |
Interpersonal Clinical Interaction (ICI) | 1 | 0 |
MEDICATIONS | 17 | 9 |
Placebo (PBO) | 11 | 9 |
Patient Attitudes and Expectations Form used for assessing expectation. The California Pharmacotherapy Alliance Scale, a measure associated with outcomes of antidepressant pharmacotherapy, used to measure participants' perceptions of: (a) participants' commitment to treatment; (b) participants' working capacity; (c) treatment providers' understanding and involvement; and (d) goal and working strategy consensus between participant and treatment provider. This is a 24-item questionnaire with a 7-point Likert scale (1 = not at all, 7 = very much so). Total score ranges from a minimum of 0 and a maximum of 120. The score is determined by a combination of negative and positive items. To assure negative items are reflected, subtract each of the negative item ratings from 8; for example, a rating of 1 becomes 7 (8 minus 1). The scores are computed by summing the items and dividing the total by 6 to procure the mean rating. A lower score indicates a worse outcome. (NCT00200902)
Timeframe: Averaged over 3 time points (Baseline, randomization, and end of lead-in)
Intervention | units on a scale (Mean) |
---|---|
Medication (MED) | 3.55 |
Placebo (PBO) | 3.94 |
Interpersonal Clinical Interaction (ICI) | 3.17 |
Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression/worse outcome. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52. (NCT00200902)
Timeframe: Baseline,Week 8
Intervention | HAMD score (Mean) | |
---|---|---|
Percent Change in HAM-D | Change in HAM-D | |
Interpersonal Clinical Interaction (ICI) | -0.05 | -1.37 |
Medication (MED) | -0.46 | -10.05 |
Placebo (PBO) | -0.36 | -7.59 |
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | -0.10 |
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00322621)
Timeframe: Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | 3.04 |
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | -0.93 |
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | 0.59 |
(NCT00322621)
Timeframe: Baseline (Week 8) to Week 34
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Entering at Week 8 | Continuing at Week 12 | Continuing at Week 16 | Continuing at Week 24 | Completing at Week 34 | |
All Maintenance / Rescue Participants | 184 | 171 | 142 | 128 | 119 |
Maintenance Arm (Later Dose Increase) | 12 | 12 | 11 | 10 | 9 |
Maintenance Arm (No Dose Increase) | 103 | 96 | 92 | 84 | 77 |
Rescue Arm | 69 | 63 | 39 | 34 | 33 |
(NCT00322621)
Timeframe: Baseline (Week 0), Week 34
Intervention | mm Hg (Mean) |
---|---|
Duloxetine 60 mg | -0.1 |
Duloxetine 120 mg | -1.0 |
(NCT00322621)
Timeframe: Baseline (Week 0), Week 34
Intervention | mm Hg (Mean) |
---|---|
Duloxetine 60 mg | -4.2 |
Duloxetine 120 mg | 0.7 |
(NCT00322621)
Timeframe: Baseline (Week 0), Week 34
Intervention | kilograms (kg) (Mean) |
---|---|
Duloxetine 60 mg | -1.3 |
Duloxetine 120 mg | 0.2 |
Maintenance effect of duloxetine 60 mg in patients with diabetic peripheral neuropathic pain (DPNP) was assessed by the change in BPI 24-hour average pain item score from baseline of the maintenance therapy arm (week 8) to 34 week endpoint in patients who achieved at least a 30 percent reduction on the BPI 24-hour average pain item after 8 weeks of acute therapy (Acute Therapy Phase). BPI is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | 0.35 |
(NCT00322621)
Timeframe: Baseline (Week 0), Week 34
Intervention | beats per minute (Mean) |
---|---|
Duloxetine 60 mg | 2.4 |
Duloxetine 120 mg | 0.4 |
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | -0.82 |
A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | 0.28 |
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | 0.35 |
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | 0.11 |
A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | 0.22 |
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | 0.39 |
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | 0.63 |
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | 0.13 |
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00322621)
Timeframe: Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | 2.32 |
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00322621)
Timeframe: Baseline (Week 0), Week 34
Intervention | participants (Number) |
---|---|
Maintenance Arm | 76 |
This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | 0.31 |
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | -0.11 |
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | 0.29 |
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | 0.48 |
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Maintenance Arm | 0.24 |
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | -0.97 |
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | -0.53 |
A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | -0.59 |
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | -1.39 |
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | 0.19 |
(NCT00322621)
Timeframe: Baseline (Week 0) to Week 8
Intervention | participants (Number) | ||
---|---|---|---|
Initiating at Week 0 | Continuing at Week 1 | Continuing at Week 8 | |
Acute Phase | 216 | 201 | 184 |
A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | -1.01 |
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | -0.29 |
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | -0.12 |
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | -0.84 |
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | -1.15 |
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | -1.12 |
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | -1.33 |
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | -0.46 |
This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe). (NCT00322621)
Timeframe: Baseline (Week 8), Week 34
Intervention | units on a scale (Mean) |
---|---|
Rescue Arm | -1.38 |
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00322621)
Timeframe: Baseline (Week 0), Week 34
Intervention | participants (Number) |
---|---|
Rescue Arm | 21 |
CD-RISC has been psychometrically validated, studied in the general population, as well as in clinical samples. Changes in CD-RISC score have been found to be sensitive to the effect of treatment, and impaired resilience has been demonstrated in subjects with depression relative to normal controls using this scale (Connor and Davidson, 2003). The total score ranges from 0-100, with higher scores indicating greater resilience. (NCT00331799)
Timeframe: baseline and 8 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 52.62 |
The percentage of participants who achieved remission from a major depressive episode. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) after 10 weeks and 12 weeks of the assigned study treatment was considered to be remission from depression. (NCT00360399)
Timeframe: Measured at Weeks 10 and 12
Intervention | percentage of participants (Number) |
---|---|
Escitalopram | 44.2 |
Duloxetine | 51.9 |
Cognitive Behavioral Therapy (CBT) | 43.5 |
The percentage of participants who achieved remission from a major depressive episode, using a last observation carried forward (LOCF) dataset, defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) at the last observation was considered to be remission from depression. (NCT00360399)
Timeframe: Up to 12 Weeks
Intervention | percentage of participants (Number) |
---|---|
Escitalopram | 46.7 |
Duloxetine | 54.7 |
Cognitive Behavioral Therapy (CBT) | 41.9 |
The number of participants experiencing a recurrence of depression after they had been in remission with the monotherapy treatment they were randomized to receive. (NCT00360399)
Timeframe: Measured at 6, 9, 12, 15, 18, 21, and 24 months
Intervention | participants (Number) | ||||||
---|---|---|---|---|---|---|---|
6 Months | 9 Months | 12 Months | 15 Months | 18 Months | 21 Months | 24 Months | |
Cognitive Behavioral Therapy (CBT) | 1 | 1 | 3 | 5 | 5 | 5 | 5 |
Duloxetine | 0 | 2 | 2 | 4 | 4 | 5 | 5 |
Escitalopram | 0 | 1 | 1 | 1 | 2 | 3 | 3 |
"Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the Week 10 and Week 12 visits:~Non-response: <30% reduction from baseline~Partial Response: 30-49% reduction from baseline~Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7~Remission: HDRS score ≤7" (NCT00360399)
Timeframe: Measured at Weeks 10 and 12
Intervention | participants (Number) | |||
---|---|---|---|---|
Non-Response | Partial Response | Response without remission | Remission | |
Cognitive Behavioral Therapy (CBT) | 15 | 13 | 11 | 30 |
Duloxetine | 10 | 12 | 16 | 41 |
Escitalopram | 15 | 10 | 23 | 38 |
"Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the last observation:~Non-response: <30% reduction from baseline~Partial Response: 30-49% reduction from baseline~Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7~Remission: HDRS score ≤7" (NCT00360399)
Timeframe: Up to 12 Weeks
Intervention | participants (Number) | |||
---|---|---|---|---|
Non-Response | Partial Response | Response without remission | Remission | |
Cognitive Behavioral Therapy (CBT) | 32 | 19 | 10 | 44 |
Duloxetine | 21 | 16 | 11 | 58 |
Escitalopram | 26 | 12 | 18 | 49 |
The number of participants achieving remission from major depressive episode after 12 weeks of combined treatment consisting of antidepressant plus cognitive behavioral therapy (CBT) treatments. Those originally randomized to receive one of the antidepressants remained on that medication and had CBT sessions added. Participants originally randomized to CBT had escitalopram added at a dose of 10 to 20 mg per day for 12 weeks (NCT00360399)
Timeframe: Measured after 12 weeks of combined treatment
Intervention | participants (Number) |
---|---|
Escitalopram | 22 |
Duloxetine | 10 |
Cognitive Behavioral Therapy (CBT) | 18 |
"Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.~When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7]~0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.~Higher total scores indicate more severe depressive symptoms." (NCT00360724)
Timeframe: Baseline
Intervention | Scores on a scale (Mean) |
---|---|
Duloxetine (Cymbalta) | 12.7 |
Placebo Treatment | 15.5 |
"Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.~When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7]~0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.~Higher total scores indicate more severe depressive symptoms." (NCT00360724)
Timeframe: Week 10
Intervention | Scores on a scale (Mean) |
---|---|
Duloxetine (Cymbalta) | 8.5 |
Placebo Treatment | 10.1 |
"The Clinical Global Impression - Improvement(CGI-I) is a 7-point scale that rate patient's total improvement whether or not comparing to his/her condition at baseline.~0 = Not assessed~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse Higher score=greatest worsening" (NCT00360724)
Timeframe: 10 weeks
Intervention | Scores on a scale (Mean) |
---|---|
Duloxetine (Cymbalta) | 2.4 |
Placebo Treatment | 3 |
"CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms).~Scores from 0 to 82 with higher score indicating worse depression" (NCT00360724)
Timeframe: Baseline
Intervention | Scores on a scale (Mean) |
---|---|
Duloxetine (Cymbalta) | 36.9 |
Placebo Treatment | 37.4 |
"CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms).~Scores from 0 to 82 with higher score indicating worse depression" (NCT00360724)
Timeframe: Week 10
Intervention | scores on a scale (Mean) |
---|---|
Duloxetine (Cymbalta) | 19.1 |
Placebo Treatment | 28.5 |
"A commonly used rating scale for global social function.~Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).~61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others~1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death.~0 Inadequate information" (NCT00360724)
Timeframe: Baseline
Intervention | points on rating scale (Mean) |
---|---|
Duloxetine (Cymbalta) | 62.6 |
Placebo Treatment | 58.3 |
"A commonly used rating scale for global social function.~Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).~61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others~1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death.~0 Inadequate information" (NCT00360724)
Timeframe: Week 10
Intervention | points on rating scale (Mean) |
---|---|
Duloxetine (Cymbalta) | 69.9 |
Placebo Treatment | 65.7 |
HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression (NCT00360724)
Timeframe: Baseline
Intervention | Scores on a scale (Mean) |
---|---|
Duloxetine (Cymbalta) | 14.1 |
Placebo Treatment | 14.9 |
To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density. (NCT00360724)
Timeframe: Baseline
Intervention | percentage of connecting nods (Mean) |
---|---|
Duloxetine (Cymbalta) | 0.21 |
Placebo Treatment | 0.24 |
To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density. (NCT00360724)
Timeframe: Follow up
Intervention | percentage of connecting nods (Mean) |
---|---|
Duloxetine (Cymbalta) | 0.16 |
Placebo Treatment | 0.19 |
HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression (NCT00360724)
Timeframe: Week 10
Intervention | Scores on a scale (Mean) |
---|---|
Duloxetine (Cymbalta) | 5 |
Placebo Treatment | 10 |
Clinician rated assessment of severity on a 1 (normal)-7 (extremely ill) scale. A decrease in the score indicates improvement. (NCT00375973)
Timeframe: baseline to endpoint at 12 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | -1.1 |
Placebo | -0.4 |
The BPI is a self-administered scale that measures the severity of pain. Pain severity is rated on a 0 [no pain] to 10 [pain as bad a you can imagine] scale. Average pain is rated over the previous 24 hours. Higher scores indicate greater pain severity. A decrease in the score indicates improvement (i.e. decrease in pain severity). (NCT00375973)
Timeframe: Baseline to endpoint at 12 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | -1.6 |
Placebo | -0.8 |
Paticipants who dropped out of the study because of intolerable adverse events. (NCT00375973)
Timeframe: Any time after randomization up to 12 weeks.
Intervention | participants (Number) |
---|---|
Duloxetine | 3 |
Placebo | 0 |
Patient rated assessment of change on a 1 (very much better) to 7 (very much worse) scale. (NCT00375973)
Timeframe: baseline to endpoint at 12 weeks.
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 3.2 |
Placebo | 3.3 |
"The MFI is a self-reported instrument that contains 20 statements covering different aspects of fatigue. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced concentration. Each subscale includes 4 items with 5-point Likert scales. Scores on each subscale range from 4-20 with higher scores indicating greater fatigue. A decrease in the score indicates improvement.~The general fatigue subscale (primary measure) includes general statements about tiredness, feeling rested, and overall feelings of being fit." (NCT00375973)
Timeframe: Baseline to endpoint at 12 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | -3.3 |
Placebo | -1.8 |
Description of discontinuation rates of participants; all participants who dropped out of the study after randomization were included. The reasons for drop outs included lack of efficacy, adverse event, lost to follow-up, personal conflict or other patient decision, withdrawal of informed consent, and non-compliance. (NCT00375973)
Timeframe: Any time after randomization up to 12 weeks.
Intervention | participants (Number) |
---|---|
Duloxetine | 10 |
Placebo | 2 |
The HADS is a self-reported instrument designed as a brief assessment tool of anxiety and depression in nonpsychiatric populations. It is a 14-item questionnaire that consistes of 2 subscales of 7 items designed to measure levels of both anxiety and depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate greater levels of anxiety or depression. A decrease in the score indicates improvement. (NCT00375973)
Timeframe: baseline to endpoint at 12 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | -1.6 |
Placebo | -1.9 |
HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0 = none/absent and 4 = most severe, for a maximum total score of 50. (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | Units on a Scale (Mean) |
---|---|
Placebo | -8.68 |
DVS SR 50 mg | -9.75 |
DVS SR 100 mg | -10.5 |
Duloxetine 60 mg | -10.3 |
MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | Units on a Scale (Mean) | |
---|---|---|
Baseline | Change at Week 8 or FOT | |
Duloxetine 60 mg | 30.80 | -14.40 |
DVS SR 100 mg | 30.70 | -14.40 |
DVS SR 50 mg | 30.10 | -12.70 |
Placebo | 31.10 | -11.00 |
HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | Units on a Scale (Mean) | |
---|---|---|
Baseline | Change at Week 8 or FOT | |
Duloxetine 60 mg | 8.38 | -3.80 |
DVS SR 100 mg | 8.51 | -3.92 |
DVS SR 50 mg | 8.43 | -3.66 |
Placebo | 8.38 | -3.13 |
Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help. (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | Units on a Scale (Mean) | |
---|---|---|
Baseline | Change at Week 8 or FOT | |
Duloxetine 60 mg | 3.50 | -1.26 |
DVS SR 100 mg | 3.70 | -1.54 |
DVS SR 50 mg | 3.53 | -1.39 |
Placebo | 3.49 | -1.27 |
VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI. (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | mm (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Overall pain (Baseline) | Stomach pain (Baseline) | Back pain (Baseline) | Chest pain (Baseline) | Arms, legs or joint pain (Baseline) | Overall pain (Change at Week 8 or FOT) | Stomach pain (Change at Week 8 or FOT) | Back pain (Change at Week 8 or FOT) | Chest pain (Change at Week 8 or FOT) | Arms, legs or joint pain (Change at Week 8 or FOT) | |
Duloxetine 60 mg | 26.10 | 14.00 | 25.50 | 6.60 | 22.40 | -8.84 | -4.38 | -9.33 | -1.67 | -8.35 |
DVS SR 100 mg | 25.90 | 17.00 | 28.30 | 10.40 | 28.70 | -10.30 | -6.42 | -12.80 | -3.90 | -11.90 |
DVS SR 50 mg | 30.80 | 19.40 | 32.90 | 10.90 | 29.10 | -9.08 | -4.98 | -10.70 | -3.34 | -8.98 |
Placebo | 26.30 | 16.70 | 25.90 | 9.40 | 25.80 | -5.61 | -1.86 | -7.04 | -1.95 | -6.99 |
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale relative to the baseline assessment. Higher score = more affected. (NCT00384033)
Timeframe: Week 8 or FOT
Intervention | Participants (Number) | ||||
---|---|---|---|---|---|
1 = Very much improved | 2 = Much improved | 3 = Minimally improved | 4 = No change | 5 = Minimally worse | |
Duloxetine 60 mg | 45 | 35 | 37 | 37 | 3 |
DVS SR 100 mg | 45 | 37 | 28 | 37 | 2 |
DVS SR 50 mg | 27 | 38 | 47 | 34 | 2 |
Placebo | 31 | 32 | 35 | 57 | 5 |
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected. (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | Units on a Scale (Mean) |
---|---|
Placebo | -1.10 |
DVS SR 50 mg | -1.25 |
DVS SR 100 mg | -1.44 |
Duloxetine 60 mg | -1.41 |
COVI anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, to 5 = Very much. Worst value is 15 and best value is 3. (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | Units on a Scale (Mean) | |
---|---|---|
Baseline | Change at Week 8 or FOT | |
Duloxetine 60 mg | 6.30 | -1.47 |
DVS SR 100 mg | 6.30 | -1.35 |
DVS SR 50 mg | 6.30 | -1.15 |
Placebo | 6.50 | -1.02 |
HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe). (NCT00384033)
Timeframe: Baseline and Week 8 or FOT
Intervention | Units on a Scale (Mean) | |
---|---|---|
Baseline | Change at Week 8 or FOT | |
Duloxetine 60 mg | 12.90 | -5.91 |
DVS SR 100 mg | 12.90 | -6.15 |
DVS SR 50 mg | 12.80 | -5.41 |
Placebo | 13.00 | -4.82 |
14-item subject-rated scale assessing changes in sexual activity and functioning; structured interview/questionnaire, designed to measure medication related changes in sexual functioning. 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Total score: obtained across all 5 dimensions, ranges from 14 to 70. Subscale scores: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Categories: better=positive change in score; same=no change in score; worse=negative change in score. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
male, total, better; n=62, n=67, n=66 | male, total, same; n=62, n=67, n=66 | male, total, worse; n=62, n=67, n=66 | female, total, better; n=39, n=42, n=43 | female, total, same; n=39, n=42, n=43 | female, total, worse; n=39, n=42, n=43 | male, pleasure, better; n=64, n=67, n=69 | male, pleasure, same; n=64, n=67, n=69 | male, pleasure, worse; n=64, n=67, n=69 | female, pleasure, better; n=40, n=42, n=43 | female, pleasure, same; n=40, n=42, n=43 | female, pleasure, worse; n=40, n=42, n=43 | male, desire/frequency, better; n=65, n=67, n=69 | male, desire/frequency, same; n=65, n=67, n=69 | male, desire/frequency, worse; n=65, n=67, n=69 | female, desire/frequency, better; n=42, n=42, n=43 | female, desire/frequency, same; n=42, n=42, n=43 | female, desire/frequency, worse; n=42, n=42, n=43 | male, desire/interest, better; n=65, n=67, n=70 | male, desire/interest, same; n=65, n=67, n=70 | male, desire/interest, worse; n=65, n=67, n=70 | female, desire/interest, better; n=42, n=42, n=45 | female, desire/interest, same; n=42, n=42, n=45 | female, desire/interest, worse; n=42, n=42, n=45 | male, arousal, better; n=65, n=67, n=70 | male, arousal, same; n=65, n=67, n=70 | male, arousal, worse; n=65, n=67, n=70 | female, arousal, better; n=40, n=42, n=45 | female, arousal, same; n=40, n=42, n=45 | female, arousal, worse; n=40, n=42, n=45 | male, orgasm, better; n=64, n=67, n=69 | male, orgasm, same; n=64, n=67, n=69 | male, orgasm, worse; n=64, n=67, n=69 | female, orgasm, better; n=40, n=42, n=43 | female, orgasm, same; n=40, n=42, n=43 | female, orgasm, worse; n=40, n=42, n=43 | |
Duloxetine | 26 | 9 | 32 | 23 | 5 | 14 | 11 | 40 | 16 | 16 | 21 | 5 | 20 | 29 | 18 | 12 | 21 | 9 | 18 | 19 | 30 | 18 | 14 | 10 | 24 | 29 | 14 | 18 | 10 | 14 | 18 | 31 | 18 | 17 | 13 | 12 |
Gabapentin + Duloxetine | 31 | 11 | 24 | 18 | 7 | 18 | 21 | 32 | 16 | 6 | 32 | 5 | 24 | 23 | 22 | 12 | 24 | 7 | 26 | 17 | 27 | 16 | 17 | 12 | 23 | 33 | 14 | 15 | 16 | 14 | 17 | 29 | 23 | 11 | 16 | 16 |
Pregabalin | 24 | 9 | 29 | 13 | 5 | 21 | 13 | 39 | 12 | 10 | 23 | 7 | 12 | 36 | 17 | 11 | 21 | 10 | 20 | 19 | 26 | 13 | 12 | 17 | 20 | 28 | 17 | 11 | 14 | 15 | 12 | 29 | 23 | 15 | 13 | 12 |
The Resource Utilization Scale measures direct and indirect costs (collected only for US sites). Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Inpatient costs include costs associated with hospitalizations and time spent in emergency rooms and psychiatric rooms. Outpatient costs include costs associated with visits to various health care providers, home health care by health care providers, and partial care. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
hours worked, greater, n=86, n=90, n=83 | hours worked, same, n=86, n=90, n=83 | hours worked, lower, n=86, n=90, n=83 | hours volunteered, greater, n=86, n=91, n=82 | hours volunteered, same, n=86, n=91, n=82 | hours volunteered, lower, n=86, n=91, n=82 | psychiatric visits, greater, n=92, n=93, n=90 | psychiatric visits, same, n=92, n=93, n=90 | psychiatric visits, lower, n=92, n=93, n=90 | outpatient group visits, greater, n=91, n=92, n=91 | outpatient group visits, same, n=91, n=92, n=91 | outpatient group visits, lower, n=91, n=92, n=91 | outpatient ind. visits, greater, n=91, n=88, n=90 | outpatient ind. visits, same, n=91, n=88, n=90 | outpatient ind. visits, lower, n=91, n=88, n=90 | days of partial care, greater, n=93, n=95, n=90 | days of partial care, same, n=93, n=95, n=90 | days of partial care, lower, n=93, n=95, n=90 | nights of partial care, greater, n=92, n=95, n=91 | nights of partial care, same, n=92, n=95, n=91 | nights of partial care, lower, n=92, n=95, n=91 | ER visits-psychiatric, greater, n=93, n=94, n=91 | ER visits-psychiatric, same, n=93, n=94, n=91 | ER visits-psychiatric, lower, n=93, n=94, n=91 | ER visits-nonpsychiatric, greater,n=91, n=95, n=88 | ER visits-nonpsychiatric, same,n=91, n=95, n=88 | ER visits-nonpsychiatric, lower,n=91, n=95, n=88 | phone mental health, greater,n=94, n=95, n=90 | phone mental health, same,n=94, n=95, n=90 | phone mental health, lower,n=94, n=95, n=90 | nonpsychiatric visits, greater, n=89, n=94, n=83 | nonpsychiatric visits, same, n=89, n=94, n=83 | nonpsychiatric visits, lower, n=89, n=94, n=83 | unpaid care, greater, n=84, n=87, n=86 | unpaid care, same, n=84, n=87, n=86 | unpaid care, lower, n=84, n=87, n=86 | missed work caregiver, greater, n=6, n=9, n=5 | missed work caregiver, same, n=6, n=9, n=5 | missed work caregiver, lower, n=6, n=9, n=5 | paid care, greater, n=60, n=58, n=58 | paid care, same, n=60, n=58, n=58 | paid care, less, n=60, n=58, n=58 | |
Duloxetine | 12 | 66 | 12 | 8 | 77 | 6 | 0 | 91 | 2 | 0 | 92 | 0 | 1 | 84 | 3 | 1 | 94 | 0 | 1 | 94 | 0 | 0 | 94 | 0 | 4 | 85 | 6 | 1 | 93 | 1 | 20 | 46 | 28 | 0 | 87 | 0 | 0 | 8 | 1 | 0 | 58 | 0 |
Gabapentin + Duloxetine | 13 | 59 | 11 | 10 | 66 | 6 | 2 | 84 | 4 | 1 | 89 | 1 | 4 | 81 | 5 | 2 | 87 | 1 | 2 | 89 | 0 | 0 | 91 | 0 | 4 | 78 | 6 | 2 | 87 | 1 | 18 | 45 | 20 | 0 | 85 | 1 | 0 | 5 | 0 | 0 | 58 | 0 |
Pregabalin | 10 | 65 | 11 | 7 | 66 | 13 | 2 | 88 | 2 | 0 | 90 | 1 | 3 | 84 | 4 | 2 | 91 | 0 | 1 | 91 | 0 | 0 | 91 | 2 | 3 | 83 | 5 | 1 | 92 | 1 | 24 | 44 | 21 | 2 | 82 | 0 | 0 | 6 | 0 | 0 | 60 | 0 |
The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. Categories: better=negative change in score; same=no change in score; worse=positive change in score. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | participants (Number) | ||||||||
---|---|---|---|---|---|---|---|---|---|
better, total; n=122, n=126, n=128 | same, total; n=122, n=126, n=128 | worse, total; n=122, n=126, n=128 | better, cognitive toxicity; n=126, n=129, n=128 | same, cognitive toxicity; n=126, n=129, n=128 | worse, cognitive toxicity; n=126, n=129, n=128 | better, somatomotor toxicity; n=122, n=126, n=129 | same, somatomotor toxicity; n=122, n=126, n=129 | worse, somatomotor toxicity; n=122, n=126, n=129 | |
Duloxetine | 84 | 5 | 37 | 80 | 6 | 43 | 74 | 19 | 33 |
Gabapentin + Duloxetine | 86 | 4 | 38 | 82 | 5 | 41 | 74 | 19 | 36 |
Pregabalin | 68 | 8 | 46 | 75 | 9 | 42 | 60 | 15 | 47 |
This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. (NCT00385671)
Timeframe: baseline through 12 weeks
Intervention | days (Median) |
---|---|
Pregabalin | 35.0 |
Duloxetine | 28.0 |
Gabapentin + Duloxetine | 28.0 |
This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. (NCT00385671)
Timeframe: baseline through 12 weeks
Intervention | days (Median) |
---|---|
Pregabalin | 56.0 |
Duloxetine | 35.0 |
Gabapentin + Duloxetine | 28.0 |
Number of participants who discontinued. The reasons for discontinuation are presented in the participant flow. (NCT00385671)
Timeframe: baseline through 12 weeks
Intervention | participants (Number) |
---|---|
Pregabalin | 38 |
Duloxetine | 51 |
Gabapentin + Duloxetine | 36 |
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00385671)
Timeframe: 12 weeks
Intervention | units on a scale (Mean) |
---|---|
Pregabalin | 3.03 |
Duloxetine | 3.01 |
Gabapentin + Duloxetine | 2.83 |
Presented are numbers of participants who discontinued due to a change from baseline in laboratory analytes or vital signs. (NCT00385671)
Timeframe: baseline through 12 weeks
Intervention | participants (Number) | |
---|---|---|
Increased blood creatinine | Increased blood glucose | |
Duloxetine | 0 | 0 |
Gabapentin + Duloxetine | 1 | 0 |
Pregabalin | 0 | 1 |
Elevated heart rate: >=100 beats per minute (bpm) + an increase of >=10 bpm if baseline <100 bpm. (NCT00385671)
Timeframe: baseline through 12 weeks
Intervention | participants (Number) |
---|---|
Pregabalin | 2 |
Duloxetine | 9 |
Gabapentin + Duloxetine | 6 |
This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | participants (Number) |
---|---|
Pregabalin | 59 |
Duloxetine | 64 |
Gabapentin + Duloxetine | 68 |
This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | participants (Number) |
---|---|
Pregabalin | 65 |
Duloxetine | 68 |
Gabapentin + Duloxetine | 72 |
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily worst pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Pregabalin | -2.59 |
Duloxetine | -3.08 |
Gabapentin + Duloxetine | -2.86 |
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily nighttime pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Pregabalin | -2.30 |
Duloxetine | -2.71 |
Gabapentin + Duloxetine | -2.49 |
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Pregabalin | -2.12 |
Duloxetine | -2.62 |
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Gabapentin + Duloxetine | -2.39 |
Duloxetine | -2.62 |
This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | participants (Number) |
---|---|
Pregabalin | 48 |
Duloxetine | 50 |
Gabapentin + Duloxetine | 47 |
Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline through 12 weeks
Intervention | kilogram (Least Squares Mean) |
---|---|
Pregabalin | 1.00 |
Duloxetine | -2.39 |
Gabapentin + Duloxetine | -1.06 |
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Pregabalin | -2.57 |
Duloxetine | -3.13 |
Gabapentin + Duloxetine | -2.54 |
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 4.97 | -2.12 |
Gabapentin + Duloxetine | 5.40 | -2.50 |
Pregabalin | 4.91 | -2.29 |
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 3.08 | -1.27 |
Gabapentin + Duloxetine | 3.29 | -1.17 |
Pregabalin | 2.96 | -0.97 |
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 4.98 | -1.86 |
Gabapentin + Duloxetine | 5.15 | -1.88 |
Pregabalin | 4.61 | -1.63 |
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 4.08 | -1.85 |
Gabapentin + Duloxetine | 4.10 | -1.43 |
Pregabalin | 3.42 | -1.46 |
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 4.63 | -2.09 |
Gabapentin + Duloxetine | 5.02 | -2.33 |
Pregabalin | 4.38 | -1.82 |
Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline through 12 weeks
Intervention | millimeter mercury (Least Squares Mean) | |
---|---|---|
Diastolic | Systolic | |
Duloxetine | 2.24 | -3.08 |
Gabapentin + Duloxetine | -0.79 | -2.08 |
Pregabalin | 0.18 | -3.31 |
Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline through 12 weeks
Intervention | beats per minute (Least Squares Mean) |
---|---|
Pregabalin | -1.30 |
Duloxetine | 0.80 |
Gabapentin + Duloxetine | 1.05 |
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 4.18 | -1.55 |
Gabapentin + Duloxetine | 4.07 | -1.54 |
Pregabalin | 4.23 | -1.27 |
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. De novo: use of gabapentin for <56 contiguous days prior to randomization. Prior use: use of gabapentin for >=56 contiguous days prior to randomization. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
de novo, baseline | de novo, week 1 | de novo, week 2 | de novo, week 3 | de novo, week 4 | de novo, week 5 | de novo, week 6 | de novo, week 7 | de novo, week 8 | de novo, week 9 | de novo, week 10 | de novo, week 11 | de novo, week 12 | prior use, baseline | prior use, week 1 | prior use, week 2 | prior use, week 3 | prior use, week 4 | prior use, week 5 | prior use, week 6 | prior use, week 7 | prior use, week 8 | prior use, week 9 | prior use, week 10 | prior use, week 11 | prior use, week 12 | |
Duloxetine | 5.39 | -0.71 | -1.22 | -1.83 | -2.35 | -2.65 | -2.64 | -2.73 | -2.78 | -2.89 | -2.86 | -2.98 | -3.08 | 5.99 | -0.48 | -0.99 | -1.32 | -1.61 | -1.95 | -2.03 | -2.14 | -2.16 | -2.38 | -2.45 | -2.46 | -2.46 |
Gabapentin + Duloxetine | 5.49 | -0.38 | -1.10 | -1.62 | -1.67 | -1.81 | -1.88 | -2.07 | -2.06 | -2.10 | -1.92 | -2.09 | -2.10 | 5.92 | -0.65 | -1.28 | -1.68 | -1.75 | -1.96 | -1.98 | -2.17 | -2.31 | -2.37 | -2.44 | -2.41 | -2.53 |
Pregabalin | 5.24 | -0.22 | -0.39 | -0.71 | -0.84 | -0.95 | -1.09 | -1.08 | -1.26 | -1.21 | -1.42 | -1.48 | -1.62 | 5.91 | -0.30 | -0.70 | -1.18 | -1.64 | -1.72 | -1.92 | -1.93 | -1.89 | -2.04 | -2.14 | -2.27 | -2.39 |
Ordinal scale: 0=no pain, 10=worst possible pain. Data=weekly mean of scores of average pain severity over last 24 hours (h). Scores: daily assessments recorded by patients in diaries. Only patients adhering to key protocol criteria included: baseline Weekly Mean 24h Average Pain Score ≥4; 80-120% compliant with study Drug, each visit; baseline Michigan Neuropathy Screening Instrument Physical Assessment Total Score ≥3; gabapentin taper ≤14 days, no HbA1c ≥12% post randomization; no contraindicated medications used. Least-squares means=adjustment due to baseline severity + investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 6.02 | -2.58 |
Gabapentin + Duloxetine | 5.74 | -2.40 |
Pregabalin | 5.74 | -2.12 |
(NCT00385671)
Timeframe: baseline through 12 weeks
Intervention | participants (Number) | ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Nausea | Peripheral Oedema | Insomnia | Somnolence | Anxiety | Dizziness | Dysuria | Headache | Hyperhidrosis | Sedation | Allergic Oedema | Anorgasmia | Increased Blood Creatine | Increased Blood Glucose | Bruxism | Cerebrovascular Accident | Chest Discomfort | Depression | Dermatitis | Diarrhoea | Dry mouth | Enterovirus Infection | Fatigue | Generalized Oedema | Facial Hypoaesthesia | Lacunar Infarction | Loss of Consciousness | Lymphoma | Mental Impairment | Muscular Weakness | Myoclonus | Pollakiuria | Pulomnary Embolism | Rash | Sleep Disorder | Urticaria | Vomiting | |
Duloxetine | 4 | 0 | 4 | 2 | 1 | 0 | 2 | 2 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
Gabapentin + Duloxetine | 4 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 0 |
Pregabalin | 0 | 5 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Contribution to reduction in pain directly by treatment and indirectly by treatment through the reduction of depressive symptoms using path analysis. The direct treatment effect estimates the mean drug difference in pain reduction directly through treatment; the indirect treatment effect estimates the contribution that treatment plays to the mean drug difference in pain reduction indirectly through the reduction in mood symptoms; the total effect estimates the drug difference in reducing pain in sum through the specified path of direct and indirect treatment effects. (NCT00385671)
Timeframe: baseline through 12 weeks
Intervention | coefficient (Number) | ||
---|---|---|---|
Direct Treatment Effect | Indirect Treatment Effect | Total Treatment Effect | |
Ordinary Coefficient | -0.449 | 0.014 | -0.435 |
Treatment-emergent: within range at baseline, out of range after baseline. Ranges in Units/Liter (U/L). Aspartate Aminotransferase (AST): female (f): >34, male (m): >36. Alanine Aminotransferase (ALT): f:<69 years (yr) >34, ≥69yr >32; m: <69yr >43, ≥69yr >35. Total Bilirubin (TBili): >21. Gamma Glutamyl Transferase (GGT): f: <59yr >49, ≥59yr >50; m: <59yr >61, ≥59yr >50. Fasting Plasma Glucose (FPG): <59yr >6.4, ≥59yr >6.7. Hemoglobin A1C (HbA1C) >6%. Alkaline Phosphatase (AlkPhos): f: 18-50yr >106, 50-70yr >123, 70-80yr >164, ≥80yr >221; m: 18-50yr >129, 50-70yr >131, 70-80yr >156, ≥80yr >187 (NCT00385671)
Timeframe: baseline through 12 weeks
Intervention | participants (Number) | ||||||
---|---|---|---|---|---|---|---|
AST, n=113, n=116, n=109 | ALT, n=111, n=104, n=110 | TBili, n=119, n=121, n=116 | GGT, n=102, n=105, n=96 | FPG, n=33, n=30, n=36 | HbA1C, n=17, n=18, n=29 | AlkPhos, n=112, n=114, n=113 | |
Duloxetine | 6 | 6 | 0 | 6 | 11 | 2 | 3 |
Gabapentin + Duloxetine | 4 | 10 | 0 | 6 | 18 | 10 | 4 |
Pregabalin | 4 | 3 | 2 | 2 | 7 | 6 | 4 |
"Elevated systolic blood pressure: >=130 millimeter mercury (mm Hg) + an increase of >=10 mm Hg if baseline <130 mm Hg.~Elevated diastolic blood pressure: >=85 mm Hg + an increase of >=10 mm Hg if baseline <85 mm Hg." (NCT00385671)
Timeframe: baseline through 12 weeks
Intervention | participants (Number) | |
---|---|---|
diastolic, n=94, n=98, n=100 | systolic, n=42, n=39, n=56 | |
Duloxetine | 12 | 15 |
Gabapentin + Duloxetine | 13 | 16 |
Pregabalin | 11 | 20 |
"Treatment-emergent high body weight: weight at last visit >=107% of baseline weight.~Treatment-emergent low body weight: weight at last visit <=93% of baseline weight." (NCT00385671)
Timeframe: baseline through 12 weeks
Intervention | participants (Number) | |
---|---|---|
high | low | |
Duloxetine | 1 | 10 |
Gabapentin + Duloxetine | 3 | 8 |
Pregabalin | 6 | 2 |
(NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | micromole/liter (Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 8.07 | -0.28 |
Gabapentin + Duloxetine | 8.23 | -0.42 |
Pregabalin | 8.43 | -0.51 |
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30, higher values indicate greater disruption in the patient's life. Item 1 assesses the effect of the patient's symptoms on their work/school schedule, Item 2 on their social life/leisure activities, and Item 3 on their family life/home responsibilities. Subscales scores range: 0-10, higher values indicate greater disruption in the patient's life. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Total | Item 1 | Item 2 | Item 3 | |
Duloxetine | -3.47 | -1.21 | -1.12 | -1.17 |
Gabapentin + Duloxetine | -4.54 | -1.95 | -1.53 | -1.54 |
Pregabalin | -4.96 | -1.96 | -1.64 | -1.70 |
14-item subject-rated scale assessing medication related changes in sexual activity + functioning. Structured interview/questionnaire. It measures five dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; and orgasm. The total score is obtained across all 5 dimensions, ranging from 14 to 70. Subscale score ranges: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Least-squares means: adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
male, total; n=62, n=67, n=66 | female, total; n=39; n=42, n=43 | male, pleasure; n=64, n=67, n=69 | female, pleasure; n=40, n=42, n=43 | male, desire/frequency; n=65, n=67, n=69 | female, desire/frequency; n=42, n=42, n=43 | male, desire/interest; n=65, n=67, n=70 | female, desire/interest; n=42, n=42, n=45 | male, arousal; n=65, n=67, n=70 | female, arousal; n=40, n=42, n=45 | male, orgasm; n=64, n=67, n=69 | female, orgasm; n=40, n=42, n=43 | |
Duloxetine | 0.48 | 1.12 | -0.06 | 0.47 | 0.06 | 0.26 | -0.19 | 0.34 | 0.52 | 0.07 | 0.18 | -0.05 |
Gabapentin + Duloxetine | 1.29 | -0.61 | 0.13 | -0.09 | 0.16 | 0.30 | 0.05 | 0.01 | 0.52 | -0.30 | 0.17 | -0.85 |
Pregabalin | -0.53 | -0.01 | 0.08 | 0.15 | -0.02 | 0.21 | -0.27 | -0.17 | 0.17 | -0.11 | -0.39 | 0.31 |
The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. The total score ranges from 15-135 with higher scores indicating more toxicity. The cognitive toxicity score ranges from 10-90 and the somatomotor toxicity score ranges from 5-45, for both higher scores indicate more toxicity. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | ||
---|---|---|---|
total, n=122, n=126, n=128 | cognitive toxicity, n=126, n=129, n=128 | somatomotor toxicity, n=122, n=126, n=129 | |
Duloxetine | -8.92 | -6.23 | -2.58 |
Gabapentin + Duloxetine | -7.29 | -5.29 | -1.91 |
Pregabalin | -6.27 | -5.12 | -1.36 |
The LSEQ assesses the effects of psychoactive compounds on sleep and early morning behavior. Participants mark a series of 100 mm line analogue scales, indicating the direction and magnitude of any changes in behavioral state they experience following administration of the drug. Scores are represented in millimeters, higher scores indicate better sleep and better early morning behavior. Subscale score ranges: GTS=0-300, QOS=0-200, AFS=0-200, BFW=0-300. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
GTS, n=122, n=119, n=118 | QOS, n=121, n=118, n=118 | AFS, n=122, n=118, n=118 | BFW, n=124, n=115, n=118 | |
Duloxetine | 17.40 | 7.39 | 8.14 | 21.04 |
Gabapentin + Duloxetine | 14.75 | 9.64 | 11.86 | 14.33 |
Pregabalin | 10.96 | 9.32 | 10.02 | 19.67 |
Aspartate aminotransferase = AST Alanine aminotransferase = ALT Gamma glutamyl transferase = GGT Alkaline phosphatase = AlkPhos (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units/liter (Mean) | |||||||
---|---|---|---|---|---|---|---|---|
baseline, AST, n=119, n=121, n=118 | change, AST, n=119, n=121, n=118 | baseline, ALT, n=120, n=122, n=120 | change, ALT, n=120, n=122, n=120 | baseline, GGT, n=121, n=123, n=120 | change, GGT, n=121, n=123, n=120 | baseline, AlkPhos, n=121, n=123, n=120 | change, AlkPhos, n=121, n=123, n=120 | |
Duloxetine | 22.84 | -0.52 | 25.04 | -0.16 | 34.29 | -3.03 | 83.74 | 0.55 |
Gabapentin + Duloxetine | 23.42 | -0.48 | 24.39 | 0.03 | 43.93 | -2.55 | 82.18 | 1.78 |
Pregabalin | 22.55 | 1.12 | 23.88 | -0.13 | 40.80 | 1.17 | 84.97 | 2.80 |
(NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | percent (Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 7.51 | -0.01 |
Gabapentin + Duloxetine | 7.16 | 0.07 |
Pregabalin | 7.57 | -0.12 |
(NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | millimole/liter (Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 8.45 | 0.19 |
Gabapentin + Duloxetine | 7.99 | 0.67 |
Pregabalin | 8.24 | 0.16 |
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 4.47 | -1.16 |
Gabapentin + Duloxetine | 4.40 | -1.13 |
Pregabalin | 4.27 | -1.06 |
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 Weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 6.87 | -3.02 |
Gabapentin + Duloxetine | 7.00 | -2.64 |
Pregabalin | 6.73 | -2.34 |
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 5.03 | -2.24 |
Gabapentin + Duloxetine | 5.36 | -2.19 |
Pregabalin | 4.98 | -1.77 |
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 5.65 | -2.44 |
Gabapentin + Duloxetine | 5.75 | -2.29 |
Pregabalin | 5.53 | -1.80 |
The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 4.61 | -2.00 |
Gabapentin + Duloxetine | 4.83 | -1.90 |
Pregabalin | 4.25 | -1.62 |
A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 5.03 | -2.38 |
Gabapentin + Duloxetine | 5.03 | -1.86 |
Pregabalin | 4.24 | -1.51 |
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 5.52 | -2.56 |
Gabapentin + Duloxetine | 5.79 | -2.09 |
Pregabalin | 5.25 | -1.88 |
"Brief Pain Inventory (BPI) scores were obtained at baseline, weeks 1, 2, 6, 7, 8, and 12, and a follow-up visit one week after completing the study.~Responses are rated on a scale from 0-10, with 0 = no pain and 10 = pain as bad as you can imagine.~Placebo and duloxetine pain scores calculated by averaging pain scores from each visit after baseline.~Values were converted to percent change in pain: [(baseline pain - end point pain)/baseline pain] x 100." (NCT00388414)
Timeframe: 3 months
Intervention | Percentage change from baseline to end (Mean) |
---|---|
Placebo - Sugar Pill | -1 |
Duloxetine | -43 |
"Scores reflect the average connectivity strength of that region of interest to the rest of the cortex.~There were no minimum or maximum values on this scale. Higher scores reflect stronger connectivity, and lower scores reflect less connectivity (all scores fell within -3 and 3).~Subscales are averaged." (NCT00388414)
Timeframe: 3 months
Intervention | Units on a scale (Mean) | |
---|---|---|
Ventral Default Mode Networks | Dorsal Default Mode Networks | |
Baseline | 0.521 | 0.485 |
Duloxetine | 0.468 | 0.469 |
Placebo - Sugar Pill | 0.466 | 0.492 |
The GCI-I score is a global clinical impression score regarding a patient's symptom severity change rated by the treating clinician. The score can be 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse). In this study clinicians made ratings based on interviewing the patient and reviewing the patient's self ratings on the the Arizona Sexual Experiences Scale (ASEX). No formal cut point scores on the ASEX were established. The ASEX is a 5-item slef rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach organism, and satisfaction from orgasm. Each item is rated from 1 to 6 (total scores from 5 to 30), with higher scores indicating greater sexual dysfunction. (NCT00398632)
Timeframe: baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)
Intervention | participants (Number) | |||
---|---|---|---|---|
CGI sexual functioning much improved | CGI sexual functioning minimally improved | CGi-I sexual functioning unchanged | CGI sexual functioning much worse | |
Duloxetine | 1 | 3 | 1 | 1 |
The IDS-C is a 30-item inventory designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes. Scores less than or equal to 6 indicated remission in this study. (NCT00398632)
Timeframe: Last observation (4 subjects at end of week 12, 2 subjects at end of week 6)
Intervention | Participants (Count of Participants) |
---|---|
Duloxetine | 5 |
"The Brief Pain Inventory is a self-administered questionnaire used to evaluate the severity of a patient's pain and its interference with their life.~Four items measure pain severity on a scale of 0-10, with 0 being absence of pain and 10 being severe pain. Seven items measure pain interference on a scale of 0-10, with 0 being absence of interference and 10 being severe interference.~The sub scale of both sub scores ranges 0-40, with 0 indicating no pain/interference and 40 indicating severe pain/interference.~The primary analysis for this outcome was assessed at each visit with a longitudinal repeated-measures random regression analysis assessing the rate of change of the measure during the treatment period. The model for the mean included a term for time (modeled as a continuous variable) and the measure effect was the estimated change in the outcome at week 12." (NCT00401258)
Timeframe: At each visit
Intervention | units on a scale (Mean) | |
---|---|---|
Average pain severity | Average pain interference | |
Duloxetine, 60 mg Daily | -1.5 | -1.6 |
"The Short Form McGill Pain Questionnaire is a self-administered questionnaire that measures pain intensity experienced by the patient. Scores on 15 descriptors are rated on an intensity scale of 0-3 (with 0 being no pain to 3 being severe pain), and has an overall score of between 0-45, with 0 being no pain and 45 being worst possible pain.~The primary analysis for this outcome was assessed at each visit with a longitudinal repeated-measures random regression analysis assessing the rate of change of the measure during the treatment period. The model for the mean included a term for time (modeled as a continuous variable) and the measure effect was the estimated change in the outcome at week 12." (NCT00401258)
Timeframe: At each visit
Intervention | units on a scale (Mean) |
---|---|
Duloxetine, 60 mg Daily | -2.37 |
"The Irritable Bowel Syndrome (IBS) Quality of Life Scale is a self-report quality of life measure specific to Irritable Bowel Syndrome that can be used to assess the impact of IBS and its treatment. There are 34 items summed and averaged for a total score between 0-100, with higher scores indicating better IBS specific quality of life.~Each item measures one of eight sub scales - dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationships - and is rated on a scale of 1-5 indicating how much the subject agrees with the statement (1 is no agreement, 5 is extreme agreement).~The primary analysis of this scale was an endpoint analysis of the change from baseline." (NCT00401258)
Timeframe: At baseline and week 12
Intervention | units on a scale (Mean) |
---|---|
Duloxetine, 60 mg Daily | 14.8 |
The Hamilton Depression Rating Scale is a clinician-rated scale consisting of 17 questions designed to assess depressive symptoms. Scores of 0-7 are considered normal, 8-16 suggest mild depression, 17-23 moderate depression, and scores over 24 are indicative of severe depression. 52 is the maximum score. (NCT00401258)
Timeframe: At first visit only
Intervention | units on a scale (Mean) |
---|---|
Duloxetine, 60 mg Daily | 6.7 |
"The Clinical Global Impression Scale is a clinician-rated scale that evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).~The primary analysis for this outcome was assessed at each visit with a longitudinal repeated-measures random regression analysis assessing the rate of change of the measure during the treatment period. The model for the mean included a term for time (modeled as a continuous variable) and the measure effect was the estimated change in the outcome at week 12." (NCT00401258)
Timeframe: At each visit
Intervention | units on a scale (Mean) |
---|---|
Duloxetine, 60 mg Daily | -1.7 |
"The Hamilton Anxiety Rating Scale is a clinician-administered scale designed to assess the severity of symptoms of anxiety. There are 14 items, scored on a scale of 0 (not present) to 4 (severe). The total score range is 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe.~The primary analysis of this scale was an endpoint analysis of the change from baseline." (NCT00401258)
Timeframe: At baseline and week 12
Intervention | units on a scale (Mean) |
---|---|
Duloxetine, 60 mg Daily | -3.3 |
"The Sheehan Disability Scale is a brief, 5-item self-report tool that assess functional impairment in work/school, social life, and family life. Scores range from 0-10 in each subset, with 0 being unimpaired and 10 being highly impaired.~The primary analysis of this scale was an endpoint analysis of the change from baseline." (NCT00401258)
Timeframe: At baseline and week 12
Intervention | units on a scale (Mean) | ||
---|---|---|---|
Work/School | Social | Family | |
Duloxetine, 60 mg Daily | -2.5 | -1.8 | -2.2 |
Subjects rated abdominal pain daily on a scale of 0-10 (0 being no pain and 10 being worst pain). The pain score at each visit represented the mean score from all days since the previous visit. (NCT00401258)
Timeframe: baseline and week 12
Intervention | Units on a scale (Mean) |
---|---|
Duloxetine, 60 mg Daily | -1.5 |
Remission (visitwise binary outcome, yes/no) is defined as HAMD-17 Total Score ≤7 and ≤10. HAMD-17 measures depression severity. The total score can range from 0 (normal) to 52 (severe depression). The visitwise probability of patients meeting criteria for remission (either Total Score ≤7 or ≤10) was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis included the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score. (NCT00406848)
Timeframe: Week 13, Week 25
Intervention | probability of remission (Least Squares Mean) | |||
---|---|---|---|---|
Remission (HAMD17 ≤ 7) - Week 13 | Remission (HAMD17 ≤ 7) - Week 25 | Remission (HAMD17 ≤ 10) - Week 13 | Remission (HAMD17 ≤ 10) - Week 25 | |
Duloxetine | 0.37 | 0.54 | 0.54 | 0.70 |
Placebo | 0.33 | 0.49 | 0.53 | 0.72 |
"The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is very much improved, a score of 4 indicates that the patient has experienced no change, and a score of 7 indicates that the patient is very much worse." (NCT00406848)
Timeframe: Week 13, Week 25
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Week 13 | Week 25 | |
Duloxetine | 2.74 | 2.38 |
Placebo | 3.02 | 2.85 |
Successful treatment outcome defined as: Participant completed the study and being in remission (HAMD-17 Total score ≤7 and ≤10) at least for the last two visits (4 weeks)of the study. The HAMD-17 is used to assess the severity of depression. The total score ranges from 0 (not at all depressed) to 52 (severely depressed). (NCT00406848)
Timeframe: Baseline (Week 1) through Week 25
Intervention | participants (Number) | |
---|---|---|
Successful Treatment Outcome (with HAMD17 ≤ 7) | Successful Treatment Outcome (with HAMD17 ≤ 10) | |
Duloxetine | 55 | 74 |
Placebo | 17 | 21 |
"A patient has a treatment-emergent elevated supine systolic blood pressure if the value is ≥140 with an increase ≥10 from baseline. A patient has a treatment-emergent elevated supine diastolic blood pressure if the value is ≥90 with an increase ≥10 from baseline. A patient has a treatment-emergent elevated supine pulse if the value is ≥100 with an increase ≥10 from baseline.~A patient has abnormal weight change if the gain or loss is ≥7% compared to baseline." (NCT00406848)
Timeframe: Baseline (Week 1) through Week 25
Intervention | Participants (Number) | ||||
---|---|---|---|---|---|
Diastolic Blood Pressure - High (n=210, n=98) | Pulse - High (n=243, n=115) | Systolic Blood Pressure - High (n=119, n=58) | Weight Change (gain) | Weight Change (loss) | |
Duloxetine | 22 | 10 | 28 | 11 | 15 |
Placebo | 5 | 4 | 7 | 2 | 6 |
The number of participants with abnormal laboratory values at any time during the study period. Results are reported for laboratory analytes that exhibited statistically significantly different proportions of participants who had abnormal values between treatment groups. Statistical significance was considered at the 0.05 level. The lower limit of normal for leukocyte count is 3.8 Billion/Liter. Participants who had a value below that number were considered to have abnormally low leukocyte count. (NCT00406848)
Timeframe: baseline (Week 1) through Week 13
Intervention | participants (Number) |
---|---|
Leukocyte Count (Low) | |
Duloxetine | 11 |
Placebo | 0 |
Sustained Hypertension is defined as supine systolic BP >= 140 (or diastolic BP >= 90) mm Hg and increase from baseline (highest value in baseline visit interval) >= 10 mm Hg for 3 or more consecutive visits in postbaseline visit interval. Orthostatic Hypotension is defined as standing diastolic BP at least 10 mm Hg less than the supine diastolic BP or the standing systolic BP at least 20 mm Hg less than the supine systolic BP at any time in postbaseline visit interval and a patient does not meet this criterion at any visit in baseline interval. (NCT00406848)
Timeframe: baseline (Week 1) through Week 25
Intervention | Participants (Number) | |
---|---|---|
Sustained Hypertension | Orthostatic Hypotension (n=183, n=90) | |
Duloxetine | 5 | 57 |
Placebo | 1 | 21 |
The 30-item Geriatric Depression Scale (GDS) is a self-administered test of 30 questions to measure the severity of depression. The yes/no questions result in a range of scores from 0 (normal) to 30 (severe depression). (NCT00406848)
Timeframe: baseline (Week 1), Week 13, Week 25
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Week 13 change | Week 25 change | |
Duloxetine | -6.01 | -7.02 |
Placebo | -4.53 | -3.66 |
The cognitive assessment battery is composed of four tests: Verbal Learning (score 0-15)and Delayed Recall(score 0-15) test, SDST(Score 0-133),2DCT(score 0-40),Trail Making(Part B)(score 0-180).They are designed to challenge the patient's abilities in the following areas: verbal learning and memory; attention to visually presented material; and working memory and executive function. Composite Cognitive score(0-51)is derived from normalized individual test scores. For Trail Making Test,lower number indicates better cognition. For all other test scores,higher number indicates better cognition. (NCT00406848)
Timeframe: baseline (Week 1), Week 9, Week 25
Intervention | units on a scale (Least Squares Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Composite Cognitive Score Week 9 | Composite Cognitive Score Week 25 | Learning Trials Score Week 9 | Learning Trials Score Week 25 | Delayed Recall Score Week 9 | Delayed Recall Score Week 25 | SDST Score Week 9 | SDST Score Week 25 | 2DCT Score Week 9 | 2DCT Score Week 25 | Trail Making Test (Part B) Week 9 | Trail Making Test (Part B) Week 25 | |
Duloxetine | -0.38 | 0.96 | -0.06 | 0.34 | -0.65 | 0.12 | 1.98 | 5.60 | 0.30 | 0.87 | -5.60 | -1.59 |
Placebo | 0.01 | 0.31 | -0.04 | 0.06 | -0.59 | -0.36 | 3.99 | 3.61 | 0.94 | 1.01 | -3.09 | -6.86 |
(NCT00406848)
Timeframe: baseline (Week 1), Week 13, Week 25
Intervention | kilograms (kg) (Least Squares Mean) | |
---|---|---|
Week 13 Change | Week 25 Change | |
Duloxetine | -0.86 | -0.69 |
Placebo | 0.06 | -0.03 |
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) measures the degree of enjoyment and satisfaction experienced in various areas of daily life. The short version is a self-administered 16 item scale evaluating satisfaction of general activities on a 5-point Likert scale that indicates the degree of enjoyment or satisfaction achieved during the past week (1 = very poor and 5 = very good). (NCT00406848)
Timeframe: baseline (Week 1), Week 13, Week 25
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Week 13 Change | Week 25 Change (n=168, n=82) | |
Duloxetine | 6.58 | 7.44 |
Placebo | 5.27 | 4.79 |
Mini-Mental State Examination (MMSE)is a widely used rating measure of cognitive ability. Scores range from 0 to 30. The MMSE will be used to categorize patients as with or without dementia. Higher number indicates better cognitive ability. Patients with a MMSE score of 20 to 23 will be categorized as having mild dementia, while those with a score of ≥ 24 will be categorized as having no dementia. (NCT00406848)
Timeframe: baseline (Week 1), Week 9, Week 25
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Week 9 Change (n=159, n=69) | Week 25 Change (n=161, n=71) | |
Duloxetine | 0.12 | 0.29 |
Placebo | 0.24 | 0.35 |
Total Score assess depression severity (scores 0-52). Core, Maier and Bech subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier; 0-22=Bech). Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher numbers indicate more severe symptoms. (NCT00406848)
Timeframe: baseline (Week 1), Week 13, Week 25
Intervention | units on a scale (Least Squares Mean) | ||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Total - Week 13 Change | Total - Week 25 Change | Maier subscale Week 25 Change | Bech subscale Week 13 Change | Bech subscale Week 25 Change | Core Mood subscale Week 13 Change | Core Mood subscale Week 25 Change | Anxiety/Somatization subscale Week 13 | Anxiety/Somatization subscale Week 25 | Sleep subscale Week 13 Change | Sleep subscale Week 25 Change | Retardation subscale Week 13 Change | Retardation subscale Week 25 Change | Item 1: Depressed Mood - Week 13 Change | Item 1: Depressed Mood Week 25 Change | Item 2: Feelings of Guilt Week 13 Change | Item 2: Feelings of Guilt Week 25 Change | Item 3: Suicide Week 13 Change | Item 3: Suicide Week 25 Change | Item 4: Insomnia Early Week 13 Change | Item 4: Insomnia Early Week 25 Change | Item 5: Insomnia Middle Week 13 Change | Item 5: Insomnia Middle Week 25 Change | Item 6: Insomnia Late Week 13 Change | Item 6: Insomnia Late Week 25 Change | Item 7: Work and Activities Week 13 Change | Item 7: Work and Activities Week 25 Change | Item 8: Retardation Week 13 Change | Item 8: Retardation Week 25 Change | Item 9: Agitation Week 13 Change | Item 9: Agitation Week 25 Change | Item 10: Anxiety/Psychic Week 13 Change | Item 10: Anxiety/Psychic Week 25 Change | Item 11: Anxiety (Somatic) Week 13 Change | Item 11: Anxiety (Somatic) Week 25 Change | Item 12: Somatic Symptom/Gastrointestinal Week 13 | Item 12: Somatic Symptom/Gastrointestinal Week 25 | Item 13: Somatic Symptoms/General Week 13 Change | Item 13: Somatic Symptoms/General Week 25 Change | Item 14: Genital Symptoms Week 13 Change | Item 14: Genital Symptoms Week 25 Change | Item 15: Hypochondriasis Week 13 Change | Item 15: Hypochondriasis Week 25 Change | Item 16: Loss of Weight Week 13 Change | Item 16: Loss of Weight Week 25 Change | Item 17: Insight Week 13 Change | Item 17: Insight Week 25 Change | |
Duloxetine | -7.42 | -8.98 | -5.31 | -4.35 | -5.36 | -3.29 | -4.08 | -2.38 | -2.90 | -1.14 | -1.37 | -2.70 | -3.42 | -1.13 | -1.36 | -0.70 | -0.91 | -0.16 | -0.19 | -0.37 | -0.42 | -0.40 | -0.49 | -0.36 | -0.45 | -0.82 | -1.12 | -0.48 | -0.57 | -0.39 | -0.45 | -0.81 | -0.98 | -0.49 | -0.70 | -0.16 | -0.23 | -0.41 | -0.52 | -0.29 | -0.41 | -0.47 | -0.49 | -0.02 | -0.13 | -0.09 | -0.07 |
Placebo | -7.15 | -7.00 | -4.17 | -3.98 | -4.07 | -3.02 | -3.00 | -2.26 | -2.44 | -1.14 | -1.35 | -2.73 | -2.77 | -1.02 | -1.02 | -0.60 | -0.65 | -0.18 | -0.11 | -0.29 | -0.41 | -0.47 | -0.46 | -0.41 | -0.53 | -0.81 | -0.87 | -0.51 | -0.54 | -0.32 | -0.53 | -0.75 | -0.85 | -0.55 | -0.60 | -0.20 | -0.26 | -0.40 | -0.59 | -0.46 | -0.47 | -0.32 | -0.39 | -0.09 | -0.01 | -0.10 | -0.11 |
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). (NCT00406848)
Timeframe: baseline (Week 1), Week 13, Week 25
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Week 13 Change | Week 25 Change | |
Duloxetine | -1.25 | -1.65 |
Placebo | -1.04 | -1.17 |
The Brief Pain Inventory (severity and interference scales) (BPI) is a self-reported scale that measures the severity of pain and the interference of pain on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. (NCT00406848)
Timeframe: baseline (Week 1), Week 13, Week 25
Intervention | units on a scale (Least Squares Mean) | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Worst Pain - Week 13 | Worst Pain - Week 25 | Least Pain - Week 13 | Least Pain - Week 25 | Average Pain - Week 13 | Average Pain - Week 25 | Pain Right Now - Week 13 | Pain Right Now - Week 25 | Interference with General Activity - Week13 | Interference with General Activity - Week 25 | Interference with Mood - Week 13 | Interference with Mood - Week 25 | Interference with Walking Ability - Week 13 | Interference with Walking Ability - Week 25 | Interference with Normal Work - Week 13 | Interference with Normal Work - Week 25 | Int. with Relations with other people- Week 13 | Int. with Relations with other people-Week 25 | Interference with Sleep - Week 13 | Interference with Sleep - Week 25 | Interference with Enjoyment of Life- Week 13 | Interference with Enjoyment of Life- Week 25 | Average Interference Score - Week 13 | Average Interference Score - Week 25 | |
Duloxetine | -0.66 | -0.74 | -0.47 | -0.54 | -0.83 | -0.87 | -0.78 | -0.86 | -0.58 | -0.65 | -0.82 | -0.95 | -0.74 | -0.75 | -0.72 | -0.79 | -0.60 | -0.73 | -0.77 | -0.94 | -0.93 | -1.04 | -0.76 | -0.86 |
Placebo | -0.18 | -0.36 | -0.00 | -0.26 | -0.14 | -0.37 | -0.26 | -0.46 | -0.03 | -0.23 | -0.03 | -0.25 | -0.19 | -0.24 | -0.01 | -0.19 | -0.03 | -0.18 | -0.17 | -0.26 | 0.03 | -0.08 | -0.07 | -0.19 |
(NCT00406848)
Timeframe: baseline (Week 1), Week 13, Week 25
Intervention | mmHg (Least Squares Mean) | |||
---|---|---|---|---|
Systolic BP Week 13 Change | Diastolic BP Week 13 Change | Systolic BP Week 25 Change | Diastolic BP Week 25 Change | |
Duloxetine | 0.19 | 1.89 | 2.22 | 2.44 |
Placebo | -0.58 | -1.58 | 0.54 | 0.65 |
(NCT00406848)
Timeframe: baseline (Week 1), Week 13, Week 25
Intervention | beats per minute (bpm) (Least Squares Mean) | |
---|---|---|
Week 13 Change | Week 25 Change | |
Duloxetine | 0.03 | 2.10 |
Placebo | -1.56 | -0.87 |
Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level. (NCT00406848)
Timeframe: baseline (Week 1), Week 13, Week 25
Intervention | micromole/liter (Mean) | |
---|---|---|
Week 13 Change | Week 25 Change | |
Duloxetine | -11.63 | -9.93 |
Placebo | 9.30 | 10.26 |
Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level. (NCT00406848)
Timeframe: baseline (Week 1), Week 13, Week 25
Intervention | billions per liter (bill/L) (Mean) | |
---|---|---|
Platelet Count Week 13 Change | Platelet Count Week 25 Change | |
Duloxetine | 7.92 | 10.58 |
Placebo | -4.66 | -6.11 |
Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level. (NCT00406848)
Timeframe: baseline (Week 1), Week 25
Intervention | Micromole/liter (Fe) (Mean) | |
---|---|---|
Hemoglobin Week 25 Change | Mean Cell Hemoglobin Concentration Week 25 Change | |
Duloxetine | -0.11 | -0.20 |
Placebo | 0.01 | -0.02 |
Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level. (NCT00406848)
Timeframe: baseline (Week 1), Week 25
Intervention | Trillion/Liter (Mean) |
---|---|
Erythrocyte Count | |
Duloxetine | -0.04 |
Placebo | 0.01 |
Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level. (NCT00406848)
Timeframe: baseline (Week 1), Week 25
Intervention | millimole/liter (Mean) | |
---|---|---|
Chloride Week 25 Change | Fasting Glucose Week 25 Change (n=155, n=67) | |
Duloxetine | -0.63 | 0.37 |
Placebo | 0.01 | -0.11 |
The Electrocardiogram measures include the following time intervals: QT interval, QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF), QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB), PR interval and QRS interval. (NCT00406848)
Timeframe: baseline (Week 1), Week 25
Intervention | millisecond (msec) (Least Squares Mean) | ||||
---|---|---|---|---|---|
QT Interval Week 25 Change | QTcF Interval Week 25 Change | QTcB Interval Week 25 Change | PR Interval Week 25 Change | QRS Interval Week 25 Change | |
Duloxetine | -11.80 | -5.02 | -1.38 | -5.91 | -1.11 |
Placebo | -10.95 | -5.91 | -3.78 | -1.34 | -3.25 |
Patients are considered to have met onset (visitwise binary outcome, yes/no) criteria at a particular visit if they had at least 20% reduction from baseline in the HAMD-17 Maier subscale at that visit and at all subsequent visits in the acute phase. Maier subscale measures core symptoms of depression and scores range from 0 (normal) to 24 (severe). The visitwise probability of patients meeting onset criteria was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. (NCT00406848)
Timeframe: Week 3
Intervention | Probability of onset (Least Squares Mean) |
---|---|
Duloxetine | 0.43 |
Placebo | 0.30 |
The Maier subscale (Items 1,2,7,8,9,10) represents symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). (NCT00406848)
Timeframe: baseline (Week 1), Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -4.34 |
Placebo | -3.90 |
Numeric Rating Scales (Semantic Differential Scales) for Pain are 6 self-administered scales that assesses experience of overall pain, back pain, headache, shoulder pain, time in pain while awake, and pain interference with daily activities, during the past week. Each item is scored on a numeric 11-point semantic differential scale (0-10) from 0 = no pain to 10 = pain as severe as you can imagine; or 0 = none of the time to 10 = all of the time; or 0 = no interference to 10 = unable to do any activities at all. (NCT00406848)
Timeframe: baseline (Week 1), Week 13, Week 25
Intervention | units on a scale (Least Squares Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Overall Pain - Week 13 | Overall Pain - Week 25 | Headaches - Week 13 | Headaches - Week 25 | Back Pain - Week 13 | Back Pain - Week 25 | Shoulder Pain - Week 13 | Shoulder Pain - Week 25 | Pain Interference with Daily Activities - Week 13 | Pain Interference with Daily Activities - Week 25 | Time in Pain While Awake - Week 13 | Time in Pain While Awake - Week 25 | |
Duloxetine | -0.65 | -0.67 | -0.32 | -0.28 | -0.63 | -0.75 | -0.54 | -0.55 | -0.84 | -0.91 | -0.75 | -0.80 |
Placebo | -0.05 | -0.40 | 0.01 | 0.01 | 0.00 | -0.15 | -0.22 | -0.30 | -0.20 | -0.34 | -0.04 | -0.33 |
Adverse Events and Serious Adverse Events leading to study discontinuation. (NCT00406848)
Timeframe: baseline (Week 1) through Week 25
Intervention | participants (Number) | |||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Total Discontinued due to Adverse Events | Diarrhoea | Fatigue | Headache | Nausea | Constipation | Dizziness | Hypertension | Memory impairment | Urinary Tract Infection | Vomiting | Alopecia | Anxiety | Blood pressure increased | Chills | Depression | Erectile dysfunction | Faecal incontinence | Gastrooesophageal reflux disease | Hip fracture | Insomnia | Intracranial aneurysm | Lethargy | Oesophageal adenocarcinoma metastatic | Palpitations | Paranasal sinus hypersecretion | Pneumoperitoneum | Presyncope | Rash pruritic | Renal failure acute | Suicidal ideation | Tremor | |
Duloxetine | 38 | 3 | 3 | 1 | 3 | 2 | 2 | 1 | 2 | 2 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 1 |
Placebo Non-rescue | 7 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
Placebo Rescue | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Response (visitwise binary outcome, yes/no) is defined as ≥ 50% reduction from baseline in the HAMD-17 total score. HAMD-17 measures depression severity. The total score can range from 0 (normal) to 52 (severe depression). The visitwise probability of patients meeting criteria for response was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis included the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score. (NCT00406848)
Timeframe: Week 13, Week 25
Intervention | probability of response (Least Squares Mean) | |
---|---|---|
Week 13 | Week 25 | |
Duloxetine | 0.44 | 0.61 |
Placebo | 0.48 | 0.72 |
Remission defined as HAMD-17 Total Score ≤7 and ≤10. HAMD-17 measures depression severity. Total score ranges: 0 (normal) to 52 (severe depression). Visitwise probability of patients achieving remission was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. CIRS-G evaluates 14 organ-specific categories using a rating strategy of 0=no problems; 1=current mild problem/past significant problem; 2=moderate disability/morbidity; 3=severe/constant significant disability; and 4=extremely severe/immediate treatment required/end organ failure. Total score ranges: 0 to 56. (NCT00406848)
Timeframe: Week 13, Week 25
Intervention | probability of remission (Least Squares Mean) | |||||||
---|---|---|---|---|---|---|---|---|
Remission HAMD-17 ≤ 7 Week 13 (CIRS-G ≥ 6) | Remission HAMD-17 ≤ 7 Week 13 (CIRS-G < 6) | Remission HAMD-17 ≤ 10 Week 13 (CIRS-G ≥ 6) | Remission HAMD-17 ≤ 10 Week 13 (CIRS-G <6) | Remission HAMD-17 ≤ 7 Week 25 (CIRS-G ≥ 6) | Remission HAMD-17 ≤ 7 Week 25 (CIRS-G <6) | Remission HAMD-17 ≤ 10 Week 25 (CIRS-G ≥ 6) | Remission HAMD-17 ≤ 10 Week 25 (CIRS-G <6) | |
Duloxetine | 0.44 | 0.33 | 0.53 | 0.53 | 0.52 | 0.53 | 0.71 | 0.63 |
Placebo | 0.44 | 0.20 | 0.52 | 0.57 | 0.42 | 0.45 | 0.65 | 0.72 |
This is an ordinal scale assessing the 24-hour average pain with scores from 0 (no pain) to 10 (worst possible pain). (NCT00408421)
Timeframe: Over 13 Weeks
Intervention | units on a scale (Least Squares Mean) | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 1 (Change from Baseline): N=119, N=103 | Week 2 (Change from Baseline): N=112, N=101 | Week 3 (Change from Baseline): N=110, N=97 | Week 4 (Change from Baseline): N=109, N=96 | Week 5 (Change from Baseline): N=107, N=90 | Week 6 (Change from Baseline): N=108, N=92 | Week 7 (Change from Baseline): N=107, N=92 | Week 8 (Change from Baseline): N=86, N=78 | Week 9 (Change from Baseline): N=98, N=81 | Week 10 (Change from Baseline): N=99, N=80 | Week 11 (Change from Baseline): N=99, N=81 | Week 12 (Change from Baseline): N=98, N=80 | Week 13 (Change from Baseline): N=97, N=75 | |
Duloxetine 60mg /120mg | -0.84 | -1.54 | -1.85 | -2.10 | -2.29 | -2.41 | -2.60 | -2.60 | -2.73 | -2.74 | -2.89 | -2.93 | -2.92 |
Placebo | -0.36 | -0.95 | -1.23 | -1.42 | -1.55 | -1.61 | -1.72 | -1.93 | -1.89 | -1.94 | -1.94 | -1.98 | -2.08 |
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 4.23 | -2.18 |
Placebo | 4.16 | -1.57 |
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 5.72 | -2.80 |
Placebo | 6.00 | -2.36 |
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 2.71 | -0.70 |
Placebo | 2.62 | -0.21 |
The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement. (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 0.68 | 0.14 |
Placebo | 0.70 | 0.07 |
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 4.59 | -1.15 |
Placebo | 5.36 | -0.93 |
A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) has been constructed based on the 8 SF-36 domains. (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 56.43 | 1.06 |
Placebo | 56.58 | -1.03 |
A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains. (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 31.56 | 7.71 |
Placebo | 30.57 | 6.36 |
Systolic blood pressure measured in the sitting position. (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | mm Hg (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 128.27 | 1.04 |
Placebo | 129.42 | -2.29 |
Pulse rate (heart rate) measured in the sitting position. (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | beats per minute (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 69.75 | 2.02 |
Placebo | 70.07 | 1.26 |
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 4.42 | -2.38 |
Placebo | 4.04 | -1.39 |
A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 5.50 | -2.63 |
Placebo | 5.55 | -1.97 |
(NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | kilograms (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 85.39 | -0.79 |
Placebo | 85.56 | -0.33 |
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 4.06 | -1.95 |
Placebo | 4.22 | -1.69 |
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). This value is the change from baseline in the weekly mean of the 24-hour average pain score on the scale. (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Group 2 - Duloxetine 60mg | 5.96 | -2.46 |
Group 3 - Duloxetine 120mg | 6.22 | -3.44 |
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale. (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 7.45 | -2.81 |
Placebo | 7.54 | -2.01 |
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 10.98 | -4.62 |
Placebo | 10.95 | -3.19 |
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 39.10 | -16.46 |
Placebo | 38.50 | -11.58 |
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 4.74 | -1.97 |
Placebo | 4.80 | -1.37 |
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale. (NCT00408421)
Timeframe: Over 13 Weeks
Intervention | units on a scale (Least Squares Mean) | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 1 (Change from Baseline): N=119, N=103 | Week 2 (Change from Baseline): N=112, N=101 | Week 3 (Change from Baseline): N=110, N=97 | Week 4 (Change from Baseline): N=109, N=96 | Week 5 (Change from Baseline): N=107, N=90 | Week 6 (Change from Baseline): N=108, N=92 | Week 7 (Change from Baseline): N=107, N=92 | Week 8 (Change from Baseline): N=86, N=78 | Week 9 (Change from Baseline): N=98, N=81 | Week 10 (Change from Baseline): N=99, N=80 | Week 11 (Change from Baseline): N=99, N=81 | Week 12 (Change from Baseline): N=98, N=80 | Week 13 (Change from Baseline): N=97, N=75 | |
Duloxetine 60mg /120mg | -0.82 | -1.57 | -1.99 | -2.26 | -2.40 | -2.58 | -2.82 | -2.82 | -2.94 | -3.00 | -3.12 | -3.14 | -3.19 |
Placebo | -0.31 | -0.92 | -1.20 | -1.41 | -1.49 | -1.57 | -1.71 | -1.95 | -1.90 | -1.97 | -2.03 | -2.04 | -2.18 |
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 53.72 | -22.19 |
Placebo | 53.36 | -15.93 |
Diastolic blood pressure measured in the sitting position. (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | mm Hg (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 77.00 | 0.95 |
Placebo | 76.44 | -0.38 |
Change from baseline to endpoint in alkaline phosphatase using central laboratory reference ranges. (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | Units/Liter (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 78.59 | 2.08 |
Placebo | 76.97 | -1.94 |
Change from baseline to endpoint in uric acid using central laboratory reference ranges. (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | micromole/Liter (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 322.77 | -5.00 |
Placebo | 314.57 | 6.82 |
Number of participants who experienced a response to treatment, which was defined as having a >=30% reduction of the weekly mean in 24-hour average pain severity ratings. Response to treatment over the last 6 weeks of the trial (after patients were re-randomized) were compared to baseline measures. (NCT00408421)
Timeframe: Over 13 Weeks
Intervention | participants who responded (Number) |
---|---|
Group 2 - Duloxetine 60mg | 26 |
Group 3 - Duloxetine 120mg | 32 |
Number of participants who experienced a response to treatment, which was defined as having a >=30% reduction of the weekly mean in 24-hour average pain severity ratings. This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). (NCT00408421)
Timeframe: Over 13 Weeks
Intervention | participants who responded (Number) |
---|---|
Placebo | 53 |
Duloxetine 60mg /120mg | 64 |
A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00408421)
Timeframe: 13 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | 2.91 |
Duloxetine 60mg /120mg | 2.38 |
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 5.63 | -2.66 |
Placebo | 5.80 | -2.25 |
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 3.05 | -1.43 |
Placebo | 3.27 | -1.30 |
A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 4.66 | -2.29 |
Placebo | 4.72 | -1.79 |
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 7.60 | -3.17 |
Placebo | 7.64 | -2.15 |
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 5.77 | -2.94 |
Placebo | 6.02 | -2.26 |
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 5.07 | -2.30 |
Placebo | 5.09 | -1.60 |
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 6.19 | -2.71 |
Placebo | 6.25 | -1.77 |
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. (NCT00408421)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine 60mg /120mg | 5.49 | -1.26 |
Placebo | 5.64 | -0.97 |
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.30 |
Duloxetine 60 mg | -2.06 |
Duloxetine 120 mg | -2.16 |
Placebo | -1.51 |
(NCT00408876)
Timeframe: Baseline to Week 13
Intervention | participants (Number) |
---|---|
Duloxetine 20 mg | 12 |
Duloxetine 60 mg | 38 |
Duloxetine 120 mg | 40 |
Placebo | 33 |
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.63 |
Duloxetine 60 mg | -2.67 |
Duloxetine 120 mg | -2.61 |
Placebo | -1.74 |
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.78 |
Duloxetine 60 mg | -2.77 |
Duloxetine 120 mg | -2.78 |
Placebo | -2.09 |
(NCT00408876)
Timeframe: Baseline to Week 13
Intervention | participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Patients Discontinued for Any Adverse Event | Insomnia | Nausea | Vomiting | Anxiety | Constipation | Diarrhoea | Dizziness | Dyspepsia | Erectile dysfunction | Hepatic enzyme increased | Somnolence | Abdominal pain | Abdominal pain upper | Apathy | Bursitis | Confusional state | Coordination abnormal | Decreased appetite | Disturbance in attention | Dysphoria | Ejaculation disorder | Fatigue | Gastroenteritis | Glaucoma | Headache | Hepatitis | Hot flush | Hyperhidrosis | Hypertension | Irritability | Lethargy | Loss of libido | Muscular weakness | Myocardial infarction | Palpitations | Peritonsillar abscess | Pregnancy | Rash | Restless legs syndrome | Sedation | Testicular pain | Trismus | |
Duloxetine 120 mg | 27 | 3 | 1 | 1 | 2 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 |
Duloxetine 20 mg | 9 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Duloxetine 60 mg | 17 | 1 | 2 | 2 | 0 | 1 | 1 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Placebo | 10 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 2), with scores ranging from 0 (no pain) to 10 (worst possible pain). (NCT00408876)
Timeframe: Baseline, Week 2
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -0.84 |
Duloxetine 60 mg | -0.91 |
Duloxetine 120 mg | -1.22 |
Placebo | -0.75 |
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 13), with scores ranging from 0 (no pain) to 10 (worst possible pain). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.74 |
Duloxetine 60 mg | -2.50 |
Duloxetine 120 mg | -2.42 |
Placebo | -2.10 |
(NCT00408876)
Timeframe: Baseline, Week 13
Intervention | kilograms (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -0.59 |
Duloxetine 60 mg | -0.35 |
Duloxetine 120 mg | -0.72 |
Placebo | 0.10 |
(NCT00408876)
Timeframe: Baseline, Week 13
Intervention | mm Hg (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -0.64 |
Duloxetine 60 mg | -1.18 |
Duloxetine 120 mg | 1.00 |
Placebo | -1.04 |
(NCT00408876)
Timeframe: Baseline, Week 13
Intervention | beats per minute (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.10 |
Duloxetine 60 mg | 2.79 |
Duloxetine 120 mg | 1.90 |
Placebo | 0.29 |
(NCT00408876)
Timeframe: Baseline, Week 13
Intervention | mm Hg (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -0.51 |
Duloxetine 60 mg | -0.79 |
Duloxetine 120 mg | 2.94 |
Placebo | -0.68 |
The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient. (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | 0.04 |
Duloxetine 60 mg | 0.07 |
Duloxetine 120 mg | 0.08 |
Placebo | 0.05 |
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | 0.01 |
Duloxetine 60 mg | 0.57 |
Duloxetine 120 mg | -1.26 |
Placebo | -0.45 |
The 11-point Likert scale was used for assessment of 24-hour worst pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.77 |
Duloxetine 60 mg | -2.46 |
Duloxetine 120 mg | -2.40 |
Placebo | -2.10 |
The 11-point Likert scale was used for assessment of 24-hour night pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.77 |
Duloxetine 60 mg | -2.15 |
Duloxetine 120 mg | -2.47 |
Placebo | -1.91 |
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.24 |
Duloxetine 60 mg | -1.54 |
Duloxetine 120 mg | 0.37 |
Placebo | -1.02 |
Roland-Morris questionnaire was completed by the patient and measured the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient was instructed to put a mark next to each appropriate statement. The number of statements marked was added up by the clinician and a total score was given. The total score ranges from 0 (no disability) to 24 (severe disability). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -2.29 |
Duloxetine 60 mg | -2.74 |
Duloxetine 120 mg | -2.88 |
Placebo | -1.33 |
(NCT00408876)
Timeframe: Baseline, Week 13
Intervention | Units/Liter (Mean) |
---|---|
Duloxetine 20 mg | -1.19 |
Duloxetine 60 mg | 3.27 |
Duloxetine 120 mg | 1.11 |
Placebo | -1.43 |
(NCT00408876)
Timeframe: Baseline, Week 13
Intervention | millimole/Liter (Mean) |
---|---|
Duloxetine 20 mg | -0.02 |
Duloxetine 60 mg | 0.00 |
Duloxetine 120 mg | 0.06 |
Placebo | -0.08 |
(NCT00408876)
Timeframe: Baseline, Week 13
Intervention | micromole/Liter (Mean) |
---|---|
Duloxetine 20 mg | -11.43 |
Duloxetine 60 mg | -0.66 |
Duloxetine 120 mg | 1.34 |
Placebo | 2.02 |
(NCT00408876)
Timeframe: Baseline, Week 13
Intervention | millimole/Liter (Mean) |
---|---|
Duloxetine 20 mg | -0.04 |
Duloxetine 60 mg | -0.09 |
Duloxetine 120 mg | 0.01 |
Placebo | -0.22 |
(NCT00408876)
Timeframe: Baseline, Week 13
Intervention | millimole/Liter (Mean) |
---|---|
Duloxetine 20 mg | -0.22 |
Duloxetine 60 mg | -0.54 |
Duloxetine 120 mg | -0.99 |
Placebo | -0.47 |
(NCT00408876)
Timeframe: Baseline, Week 13
Intervention | micromole/Liter (Mean) |
---|---|
Duloxetine 20 mg | -1.05 |
Duloxetine 60 mg | -0.23 |
Duloxetine 120 mg | -0.58 |
Placebo | 0.18 |
(NCT00408876)
Timeframe: Baseline, Week 13
Intervention | micromole/Liter (Mean) |
---|---|
Duloxetine 20 mg | -0.29 |
Duloxetine 60 mg | -0.13 |
Duloxetine 120 mg | -0.13 |
Placebo | 0.07 |
(NCT00408876)
Timeframe: Baseline, Week 13
Intervention | millimole/Liter (Mean) |
---|---|
Duloxetine 20 mg | 1.04 |
Duloxetine 60 mg | 1.18 |
Duloxetine 120 mg | 1.72 |
Placebo | 1.35 |
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -0.30 |
Duloxetine 60 mg | -0.81 |
Duloxetine 120 mg | -0.91 |
Placebo | -0.68 |
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -0.53 |
Duloxetine 60 mg | -0.94 |
Duloxetine 120 mg | -1.06 |
Placebo | -0.53 |
(NCT00408876)
Timeframe: Baseline, Week 13
Intervention | micromole/Liter (Mean) |
---|---|
Duloxetine 20 mg | -9.48 |
Duloxetine 60 mg | -11.08 |
Duloxetine 120 mg | -11.31 |
Placebo | 8.20 |
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 8), with scores ranging from 0 (no pain) to 10 (worst possible pain). (NCT00408876)
Timeframe: Baseline, Week 8
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.68 |
Duloxetine 60 mg | -2.29 |
Duloxetine 120 mg | -2.49 |
Placebo | -1.65 |
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 7), with scores ranging from 0 (no pain) to 10 (worst possible pain). (NCT00408876)
Timeframe: Baseline, Week 7
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.68 |
Duloxetine 60 mg | -2.17 |
Duloxetine 120 mg | -2.36 |
Placebo | -1.57 |
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 6), with scores ranging from 0 (no pain) to 10 (worst possible pain). (NCT00408876)
Timeframe: Baseline, Week 6
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.64 |
Duloxetine 60 mg | -2.10 |
Duloxetine 120 mg | -2.28 |
Placebo | -1.34 |
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 5), with scores ranging from 0 (no pain) to 10 (worst possible pain). (NCT00408876)
Timeframe: Baseline, Week 5
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.45 |
Duloxetine 60 mg | -1.94 |
Duloxetine 120 mg | -2.25 |
Placebo | -1.26 |
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 4), with scores ranging from 0 (no pain) to 10 (worst possible pain). (NCT00408876)
Timeframe: Baseline, Week 4
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.20 |
Duloxetine 60 mg | -1.70 |
Duloxetine 120 mg | -2.17 |
Placebo | -1.02 |
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 3), with scores ranging from 0 (no pain) to 10 (worst possible pain). (NCT00408876)
Timeframe: Baseline, Week 3
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.05 |
Duloxetine 60 mg | -1.58 |
Duloxetine 120 mg | -1.71 |
Placebo | -1.01 |
(NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.79 |
Duloxetine 60 mg | -2.50 |
Duloxetine 120 mg | -2.45 |
Placebo | -1.87 |
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.79 |
Duloxetine 60 mg | -2.33 |
Duloxetine 120 mg | -1.89 |
Placebo | -1.43 |
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.59 |
Duloxetine 60 mg | -2.48 |
Duloxetine 120 mg | -2.12 |
Placebo | -1.63 |
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.33 |
Duloxetine 60 mg | -1.86 |
Duloxetine 120 mg | -1.27 |
Placebo | -0.94 |
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -2.20 |
Duloxetine 60 mg | -2.67 |
Duloxetine 120 mg | -2.38 |
Placebo | -1.95 |
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.75 |
Duloxetine 60 mg | -2.52 |
Duloxetine 120 mg | -1.96 |
Placebo | -1.70 |
A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.99 |
Duloxetine 60 mg | -2.52 |
Duloxetine 120 mg | -2.36 |
Placebo | -1.97 |
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.84 |
Duloxetine 60 mg | -2.49 |
Duloxetine 120 mg | -1.86 |
Placebo | -1.76 |
A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.84 |
Duloxetine 60 mg | -2.40 |
Duloxetine 120 mg | -1.92 |
Placebo | -1.61 |
Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24. (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.43 |
Duloxetine 60 mg | -2.30 |
Duloxetine 120 mg | -0.93 |
Placebo | -1.23 |
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Vitality scores range from 4-24 (higher scores indicate better health status). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | 0.69 |
Duloxetine 60 mg | 1.43 |
Duloxetine 120 mg | 0.44 |
Placebo | 0.91 |
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Social functioning scores range from 2-10 (higher scores indicate better health status). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | 0.75 |
Duloxetine 60 mg | 0.46 |
Duloxetine 120 mg | 0.38 |
Placebo | 0.50 |
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Role-physical scores range from 4-8 (higher scores indicate better health status). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | 0.81 |
Duloxetine 60 mg | 0.80 |
Duloxetine 120 mg | 0.85 |
Placebo | 0.80 |
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Role-emotional scores range from 3-6 (higher scores indicate better health status). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | 0.10 |
Duloxetine 60 mg | 0.19 |
Duloxetine 120 mg | 0.14 |
Placebo | 0.08 |
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Physical functioning scores range from 10-30 (higher scores indicate better health status). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | 1.80 |
Duloxetine 60 mg | 2.55 |
Duloxetine 120 mg | 3.11 |
Placebo | 2.23 |
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | 6.07 |
Duloxetine 60 mg | 7.01 |
Duloxetine 120 mg | 7.85 |
Placebo | 6.11 |
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Mental health scores range from 5-30 (higher scores indicate better health status). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | 0.21 |
Duloxetine 60 mg | 0.98 |
Duloxetine 120 mg | 0.46 |
Placebo | 0.38 |
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). General health scores range from 5-25(higher scores indicate better health status). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | 0.70 |
Duloxetine 60 mg | 1.24 |
Duloxetine 120 mg | 0.81 |
Placebo | 0.66 |
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Bodily pain scores range from 2-11 (higher scores indicate better health status). (NCT00408876)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | 1.51 |
Duloxetine 60 mg | 1.95 |
Duloxetine 120 mg | 2.11 |
Placebo | 1.36 |
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 12), with scores ranging from 0 (no pain) to 10 (worst possible pain). (NCT00408876)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.87 |
Duloxetine 60 mg | -2.34 |
Duloxetine 120 mg | -2.46 |
Placebo | -1.91 |
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 11), with scores ranging from 0 (no pain) to 10 (worst possible pain). (NCT00408876)
Timeframe: Baseline, Week 11
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.88 |
Duloxetine 60 mg | -2.32 |
Duloxetine 120 mg | -2.62 |
Placebo | -1.79 |
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 10), with scores ranging from 0 (no pain) to 10 (worst possible pain). (NCT00408876)
Timeframe: Baseline, Week 10
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.77 |
Duloxetine 60 mg | -2.24 |
Duloxetine 120 mg | -2.58 |
Placebo | -1.73 |
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain). (NCT00408876)
Timeframe: Baseline, Week 1
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -0.54 |
Duloxetine 60 mg | -0.53 |
Duloxetine 120 mg | -0.71 |
Placebo | -0.39 |
(NCT00408876)
Timeframe: Baseline, Week 13
Intervention | Units/Liter (Mean) |
---|---|
Duloxetine 20 mg | -1.39 |
Duloxetine 60 mg | 0.25 |
Duloxetine 120 mg | 2.20 |
Placebo | -0.06 |
(NCT00408876)
Timeframe: Baseline to Week 13
Intervention | participants (Number) |
---|---|
Duloxetine 20 mg | 23 |
Duloxetine 60 mg | 59 |
Duloxetine 120 mg | 63 |
Placebo | 49 |
"A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from~1 (very much better) to 7 (very much worse)." (NCT00408876)
Timeframe: Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | 2.72 |
Duloxetine 60 mg | 2.44 |
Duloxetine 120 mg | 2.66 |
Placebo | 2.93 |
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain). (NCT00408876)
Timeframe: Baseline, Week 9
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 20 mg | -1.57 |
Duloxetine 60 mg | -2.21 |
Duloxetine 120 mg | -2.45 |
Placebo | -1.71 |
Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version (sum of items 1-8) ranges from 0-24, while total score of the 5-item (sum of items 1-5) ranges from 0-15. (NCT00408993)
Timeframe: Baseline and 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
5-Item Score | 8-Item Score | |
Duloxetine | -2.27 | -3.58 |
Placebo | -1.97 | -3.31 |
(NCT00408993)
Timeframe: over 12 weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 15 |
Placebo | 4 |
The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement. (NCT00408993)
Timeframe: Baseline and 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 0.12 |
Placebo | 0.10 |
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. (NCT00408993)
Timeframe: Baseline and 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -1.24 |
Placebo | -0.99 |
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00408993)
Timeframe: Baseline and 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -2.69 |
Placebo | -2.31 |
Change from baseline to endpoint in body weight. (NCT00408993)
Timeframe: Baseline and 12 weeks
Intervention | kilograms (Least Squares Mean) |
---|---|
Duloxetine | -0.17 |
Placebo | -0.03 |
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00408993)
Timeframe: baseline, over 12 weeks
Intervention | units on a scale (Least Squares Mean) | ||||
---|---|---|---|---|---|
Week 1 (N=5, N=2) | Week 2 (N=98, N=107) | Week 4 (N=94, N=101) | Week 8 (N=91, N=95) | Week 12 (N=87, N=92) | |
Duloxetine | 3.45 | 2.91 | 2.57 | 2.29 | 2.27 |
Placebo | 3.51 | 3.23 | 2.83 | 2.76 | 2.58 |
Change from baseline to endpoint in systolic and diastolic blood pressure. (NCT00408993)
Timeframe: Baseline and 12 weeks
Intervention | mm Hg (Least Squares Mean) | |
---|---|---|
Systolic Blood Pressure | Diastolic Blood Pressure | |
Duloxetine | -0.48 | 0.45 |
Placebo | -1.47 | -0.21 |
Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10). (NCT00408993)
Timeframe: Baseline and 12 weeks
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Worst Pain Score | Least Pain Score | Pain Right Now Score | Average Interference Score | |
Duloxetine | -3.48 | -1.69 | -2.72 | -2.28 |
Placebo | -2.93 | -1.37 | -1.99 | -1.88 |
Change from baseline to endpoint in pulse rate. (NCT00408993)
Timeframe: Baseline and 12 weeks
Intervention | beats per minute (Least Squares Mean) |
---|---|
Duloxetine | 1.71 |
Placebo | 0.32 |
Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events. (NCT00408993)
Timeframe: over 12 weeks
Intervention | participants (Number) | ||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abdominal discomfort | Abdominal distension | Abdominal pain upper | Anorexia | Arthralgia | Asthenia | Chest discomfort | Constipation | Cough | Decreased appetite | Diarrhoea | Dizziness | Dry mouth | Dyslipidaemia | Dysuria | Fatigue | Headache | Hyperhidrosis | Hypersomnia | Hypoglycaemia | Insomnia | Lethargy | Nausea | Pain | Palpitations | Pruritus | Somnolence | Stomach discomfort | Therapeutic response unexpected | Thirst | Vomiting | |
Duloxetine - Evening Dosing | 1 | 2 | 4 | 7 | 0 | 4 | 3 | 7 | 0 | 3 | 6 | 11 | 4 | 3 | 4 | 5 | 2 | 5 | 2 | 5 | 2 | 5 | 18 | 1 | 3 | 1 | 8 | 3 | 3 | 1 | 3 |
Duloxetine - Morning Dosing | 3 | 7 | 0 | 4 | 1 | 2 | 2 | 4 | 2 | 0 | 4 | 5 | 2 | 1 | 5 | 3 | 4 | 4 | 0 | 5 | 3 | 6 | 14 | 1 | 7 | 2 | 9 | 4 | 6 | 4 | 3 |
Placebo - Evening Dosing | 4 | 3 | 0 | 1 | 2 | 1 | 0 | 4 | 1 | 1 | 1 | 3 | 2 | 1 | 1 | 6 | 2 | 2 | 3 | 2 | 2 | 2 | 5 | 0 | 3 | 4 | 4 | 0 | 6 | 1 | 3 |
Placebo - Morning Dosing | 2 | 4 | 2 | 1 | 3 | 0 | 1 | 5 | 4 | 0 | 5 | 9 | 1 | 1 | 0 | 2 | 4 | 1 | 2 | 3 | 3 | 2 | 8 | 3 | 2 | 4 | 2 | 5 | 6 | 0 | 2 |
Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides. (NCT00408993)
Timeframe: Baseline and 12 weeks
Intervention | millimole/Liter (Mean) | |||||||
---|---|---|---|---|---|---|---|---|
Chloride Baseline | Chloride Change to Endpoint | High Density Lipoprotein Cholesterol Baseline | High Density Lipoprotein Change to Endpoint | Sodium Baseline | Sodium Change to Endpoint | Triglycerides Baseline | Triglycerides Change to Endpoint | |
Duloxetine | 102.94 | -1.15 | 1.30 | 0.03 | 143.03 | -1.25 | 1.76 | -0.05 |
Placebo | 102.87 | -0.20 | 1.33 | -0.04 | 142.76 | -0.19 | 1.40 | 0.26 |
Significantly different laboratory values between the two groups in baseline to endpoint changes (NCT00408993)
Timeframe: Baseline and 12 weeks
Intervention | micromole/Liter (Mean) | |
---|---|---|
Uric Acid Baseline | Uric Acid Change to Endpoint | |
Duloxetine | 293.24 | -7.46 |
Placebo | 283.98 | 2.49 |
Number of participants using medication for anxiety and sleep disturbances. (NCT00422162)
Timeframe: over 8 weeks
Intervention | participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Medication Taken Before Start of Study (Week -1) | Medication Taken Between Week -1 and Week 0 | Medication Taken Between Week 0 and Week 1 | Medication Taken Between Week 1 and Week 2 | Medication Taken Between Week 2 and Week 3 | Medication Taken Between Week 3 and Week 4 | Medication Taken Between Week 4 and Week 6 | Medication Taken Between Week 6 and Week 8 | Medication Taken After Week 8 | Medication Not Taken Between Consecutive Visits | |
Duloxetine (120 mg) | 59 | 88 | 89 | 84 | 67 | 58 | 49 | 52 | 10 | 8 |
Duloxetine (60 mg) | 65 | 93 | 95 | 80 | 62 | 55 | 47 | 51 | 18 | 8 |
"The RFL questionnaire is an instrument that evaluates patient's reasons for not committing suicide using a 6-point rating scale, where 1 is not at all important and 6 is extremely important. The questionnaire required participants to rate how important each item would be for living, if suicide was contemplated. Mean scores could range from 0 to 6." (NCT00422162)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) | ||
---|---|---|---|
Week 0 (Baseline) (n=96, n=66, n=106, n=61) | Week 8 (n=93, n=63, n=100, n=59) | Change from Baseline (n=93, n=59, n=100, n=57) | |
Duloxetine 120 mg (All) | 3.7 | 4.3 | 0.6 |
Duloxetine 120 mg Non-Responder | 3.7 | 3.8 | 0.1 |
Duloxetine 120 mg Responder | 3.7 | 4.6 | 0.8 |
Duloxetine 60 mg (All) | 3.8 | 4.4 | 0.6 |
Duloxetine 60 mg Non-Responder | 3.6 | 4.0 | 0.4 |
Duloxetine 60 mg Responder | 4.0 | 4.6 | 0.7 |
Patients with reduction in MADRS score ≥50% after 4 weeks were to stay on previous dose of duloxetine. Those with reduction in MADRS <50% were to receive 120 mg for remaining 4 weeks of treatment (up-titration from 60 mg to 120 mg for those randomized to 60 mg, and addition of placebo to 120 mg dose for those randomized to 120 mg). However, 2/70 patients randomized to 60 mg and then up-titrated to 120 mg after 4 weeks had reduction in MADRS ≥50% after 4 weeks, and 3/64 patients randomized to 120 mg and then given placebo in addition after 4 weeks had reduction in MADRS ≥50% after 4 weeks. (NCT00422162)
Timeframe: 4 to 8 weeks
Intervention | percentage of participants (Number) | |||||
---|---|---|---|---|---|---|
≥50% Reduction in MADRS Week 4 | ≥50% Reduction in MADRS Week 6 | ≥50% Reduction in MADRS Week 8 | ≥50% Reduction in HAMD-6 Week 4 | ≥50% Reduction in HAMD-6 Week 6 | ≥50% Reduction in HAMD-6 Week 8 | |
Duloxetine 120 mg Non-Responders | 4.7 | 39.1 | 54.7 | 12.5 | 31.3 | 46.9 |
Duloxetine 120 mg Responders | 100.0 | 98.1 | 98.1 | 85.8 | 90.6 | 95.3 |
Duloxetine 60 mg Non-Responders | 2.9 | 52.9 | 65.7 | 10.0 | 47.1 | 60.0 |
Duloxetine 60 mg Responders | 100.0 | 94.8 | 93.8 | 88.5 | 90.6 | 92.7 |
"The HAMD-6 (Items 1,2,7,8,10,13 from the 17-item HAMD) evaluates core symptoms of Major Depressive Disorder (MDD). Total scores range from 0 (normal) to 22 (severe)." (NCT00422162)
Timeframe: Baseline to Weeks 1, 2, 3, 4, 6, 8
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Change in Score at Week 1 | Change in Score at Week 2 | Change in Score at Week 3 | Change in Score at Week 4 | Change in Score at Week 6 | Change in Score at Week 8 | |
Duloxetine 120 mg (All) | -2.7 | -5.2 | -6.8 | -8.1 | -9.4 | -10.3 |
Duloxetine 120 mg Non-Responder | -1.7 | -3.0 | -3.6 | -3.8 | -5.5 | -6.7 |
Duloxetine 120 mg Responder | -3.3 | -6.5 | -8.7 | -10.7 | -11.8 | -12.5 |
Duloxetine 60 mg (All) | -3.1 | -5.8 | -7.2 | -8.0 | -9.4 | -10.3 |
Duloxetine 60 mg Non-Responder | -1.9 | -3.4 | -4.1 | -3.9 | -6.4 | -7.6 |
Duloxetine 60 mg Responder | -3.9 | -7.5 | -9.4 | -11.0 | -11.6 | -12.3 |
Major Depressive Disorder remission was defined as a total MADRS score ≤12 at Week 8. (NCT00422162)
Timeframe: Week 8
Intervention | participants (Number) | |
---|---|---|
Remission at Week 8 - Yes | Remission at Week 8 - No | |
Duloxetine 120 mg Non-Responders | 18 | 46 |
Duloxetine 120 mg Responders | 94 | 12 |
Duloxetine 60 mg Non-Responders | 29 | 41 |
Duloxetine 60 mg Responders | 85 | 11 |
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00422162)
Timeframe: Weeks 1, 2, 3, 4, 6, 8
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Week 1 (n=164, n=170) | Week 2 (n=164, n=170) | Week 3 (n=165, n=170) | Week 4 (n=165, n=170) | Week 6 (n=165, n=170) | Week 8 (n=165, n=170) | |
Duloxetine (120 mg) | 3.1 | 2.6 | 2.4 | 2.2 | 2.0 | 1.9 |
Duloxetine (60 mg) | 3.0 | 2.6 | 2.3 | 2.3 | 2.1 | 2.0 |
Laboratory results that were potentially clinically significant. (NCT00422162)
Timeframe: over 8 weeks
Intervention | participants (Number) | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Decreased Haematocrit (n=155, n=159) | Decreased Haemoglobin (n=156, n=160) | Decreased Red Cell Count (n=156, n=160) | Increased Mean Cell Volume (n=155, n=159) | Decreased White Cell Count (n=156, n=160) | Decreased Sodium (n=160, n=163) | Increased Potassium (n=159, n=163) | Increased Aspartate Transaminase (n=158, n=161) | Increased Alanine Transaminase (n=159, n=161) | Increased Alkaline Phosphatase (n=161, n=163) | Increased Gamma-Glutamyl Transferase (n=161,n=163) | Increased Creatine Kinase (n=159, n=161) | Decreased Glucose (n=158, n=162) | Increased Cholesterol (n=160, n=163) | Increased Total Bilirubin (n=159, n=161) | Increased Uric Acid (n=160, n=163) | Decreased Albumin (n=158, n=161) | |
Duloxetine (120 mg) | 1 | 2 | 1 | 1 | 2 | 0 | 1 | 0 | 1 | 1 | 0 | 3 | 1 | 0 | 1 | 2 | 1 |
Duloxetine (60 mg) | 0 | 2 | 0 | 0 | 1 | 1 | 0 | 2 | 3 | 0 | 2 | 6 | 1 | 1 | 0 | 0 | 0 |
Systolic and diastolic blood pressure and pulse rate were measured after 2 minutes rest in a supine position. High values were: diastolic blood pressure ≥90 mm Hg and increase from baseline of ≥10 mm Hg; systolic blood pressure ≥140 mm Hg and increase from baseline of ≥10 mm Hg; pulse rate ≥100 beats per minute (bpm) and an increase of ≥10 bpm from baseline. (NCT00422162)
Timeframe: over 8 weeks
Intervention | participants (Number) | ||
---|---|---|---|
High Systolic Blood Pressure | High Diastolic Blood Pressure | High Pulse Rate | |
Duloxetine (120 mg) | 25 | 37 | 14 |
Duloxetine (60 mg) | 23 | 28 | 10 |
The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. (NCT00422162)
Timeframe: Baseline and Weeks 4 and 8
Intervention | units on a scale (Mean) | ||
---|---|---|---|
Week 0 (Baseline) (n=166, n=170) | Week 4 (n=165, n=168) | Week 8 (n=165, n=168) | |
Duloxetine (120 mg) | 27.0 | 13.4 | 9.8 |
Duloxetine (60 mg) | 26.0 | 13.0 | 9.6 |
"Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) and 6-Item Hamilton Depression Scale (HAMD-6) total scores were evaluated following dose up-titration in those patients who did not achieve the minimum 50% response for primary endpoint. MADRS is a rating scale for severity of depressive mood symptoms. Total scores range from 0 (low severity of symptoms) to 60 (high severity of symptoms). The HAMD-6, derived by the sum of HAMD-17 items 1, 2, 7, 8, 10 and 13, evaluates core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe)." (NCT00422162)
Timeframe: 4 to 8 weeks
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
Change in MADRS Score from Week 4 to Week 6 | Change in MADRS Score from Week 4 to Week 8 | Change in HAMD-6 Score from Week 4 to Week 6 | Change in HMAD-6 Score from Week 4 to Week 8 | |
Duloxetine 120 mg Non-Responder | -5.8 | -8.9 | -2.2 | -3.8 |
Duloxetine 120 mg Responder | -2.6 | -4.0 | -1.1 | -1.8 |
Duloxetine 60 mg Non-Responder | -7.2 | -10.9 | -3.2 | -4.7 |
Duloxetine 60 mg Responder | -1.0 | -2.6 | -0.6 | -1.3 |
Listing of adverse events (AE) that led to treatment discontinuation (DC). (NCT00422162)
Timeframe: over 8 weeks
Intervention | participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Total Number of Patients With AEs Leading to DC | Suicide Attempt | Suicidal Ideation | Hypothyroidism | Depression | Major Depression | Psychotic Disorder | Schizoaffective Disorder | Self-Injurious Behaviour | Headache | Nausea | Irritability | Brain Neoplasm | Dizziness | Sedation | Serotonin Syndrome | Upper Abdominal Pain | Drug Eruption | Renal Failure | Urinary Retention | |
Duloxetine (120 mg) | 9 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Duloxetine (60 mg) | 11 | 3 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). (NCT00422162)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 8
Intervention | units on a scale (Mean) | ||||||
---|---|---|---|---|---|---|---|
Week 0 (Baseline) | Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 | |
Duloxetine (120 mg) | 5.1 | 4.4 | 3.8 | 3.4 | 3.1 | 2.7 | 2.4 |
Duloxetine (60 mg) | 5.0 | 4.4 | 3.6 | 3.2 | 3.0 | 2.7 | 2.3 |
Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse). (NCT00422162)
Timeframe: Weeks 1, 2, 3, 4, 6, 8
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 | |
Duloxetine (120 mg) | 3.2 | 2.6 | 2.3 | 2.1 | 2.0 | 1.9 |
Duloxetine (60 mg) | 3.1 | 2.5 | 2.3 | 2.3 | 2.0 | 1.9 |
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). (NCT00422162)
Timeframe: Baseline to Week 4
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine (120 mg) | 36.0 | -19.9 |
Duloxetine (60 mg) | 36.1 | -20.1 |
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). (NCT00422162)
Timeframe: Baseline to Weeks 1, 2, 3, 4, 6, 8
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Change in Score at Week 1 | Change in Score at Week 2 | Change in Score at Week 3 | Change in Score at Week 4 | Change in Score at Week 6 | Change in Score at Week 8 | |
Duloxetine 120 mg (All) | -7.6 | -13.5 | -16.9 | -19.9 | -23.1 | -24.9 |
Duloxetine 120 mg Non-Responder | -5.6 | -8.9 | -10.3 | -10.5 | -14.8 | -17.2 |
Duloxetine 120 mg Responder | -8.8 | -16.3 | -20.9 | -25.5 | -28.1 | -29.5 |
Duloxetine 60 mg (All) | -8.3 | -14.7 | -18.1 | -20.1 | -23.1 | -25.2 |
Duloxetine 60 mg Non-Responder | -5.6 | -9.4 | -11.1 | -10.4 | -16.1 | -19.0 |
Duloxetine 60 mg Responder | -10.3 | -18.7 | -23.2 | -27.2 | -28.3 | -29.8 |
Change in weight = Post-baseline visit minus baseline. (NCT00422162)
Timeframe: Baseline to Weeks 4 and 8
Intervention | kilograms (Mean) | |
---|---|---|
Change from Baseline to Week 4 (n=163,n=167) | Change from Baseline to Week 8 (n=163, n=168) | |
Duloxetine (120 mg) | 0.0 | 0.1 |
Duloxetine (60 mg) | 0.1 | 0.5 |
(NCT00424593)
Timeframe: Baseline, Week 13, Week 54
Intervention | mm Hg (Mean) | |||||||
---|---|---|---|---|---|---|---|---|
Systolic Blood Pressure (SBP) Week 13 Baseline | SBP Week 13 Change from Baseline | SBP Week 54 Baseline (n=76, n=90) | SBP Week 54 Change from Baseline | Diastolic Blood Pressure (DBP) Week 13 Baseline | DBP Week 13 Change from Baseline | DBP Week 54 Baseline (n=76, n=90) | DBP Week 54 Change from Baseline | |
Duloxetine | 127.44 | -0.94 | 127.04 | -1.42 | 79.92 | 0.32 | 81.53 | -2.00 |
Placebo | 127.62 | -1.24 | 127.07 | 0.77 | 80.38 | -1.25 | 79.74 | 0.50 |
(NCT00424593)
Timeframe: Baseline, Week 13, Week 54
Intervention | beats per minute (bpm) (Mean) | |||
---|---|---|---|---|
Week 13 Baseline | Week 13 Change from Baseline | Week 54 Baseline (n=76, n=90) | Week 54 Change from Baseline | |
Duloxetine | 72.21 | 2.05 | 74.95 | -2.46 |
Placebo | 72.31 | -0.90 | 71.03 | 1.46 |
(NCT00424593)
Timeframe: Baseline, Week 13, Week 54
Intervention | kilograms (kg) (Mean) | |||
---|---|---|---|---|
Week 13 Baseline | Week 13 Change from Baseline | Week 54 Baseline (n=81, n=97) | Week 54 Change from Baseline | |
Duloxetine | 76.63 | -0.64 | 76.57 | 1.42 |
Placebo | 76.29 | 0.08 | 75.34 | -0.38 |
"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores are indicative of greater impairment.~Absenteeism=(Q2/(Q2+Q4))*100~Presenteeism=(Q5/10)*100~Work productivity loss=(Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)])*100~Activity Impairment=(Q6/10)*100" (NCT00424593)
Timeframe: Baseline, Week 13, Week 54
Intervention | units on a scale (Mean) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Absenteeism Score Week 13 Baseline (n=35, n=32) | Absenteeism Score Week 13 Change from Baseline | Absenteeism Score Week 54 Baseline (n=24, n=32) | Absenteeism Score Week 54 Change from Baseline | Presenteeism Score Week 13 Baseline (n=37, n=31) | Presenteeism Score Week 13 Change from Baseline | Presenteeism Score Week 54 Baseline (n=24, n=34) | Presenteeism Score Week 54 Change from Baseline | Work Productivity Loss Week 13 Baseline(n=33,n=29) | Work Productivity Loss Week 13 Change | Work Productivity Loss Week 54 Baseline(n=24,n=32) | Work Productivity Loss Week 54 Change | Activity Impairment Week 13 Baseline (n=103,n=105) | Activity Impairment Week 13 Change from Baseline | Activity Impairment Week 54 Baseline (n=70, n=86) | Activity Impairment Week 54 Change from Baseline | |
Duloxetine | 0.17 | -0.14 | 0.03 | 0.01 | 0.42 | -0.17 | 0.19 | -0.05 | 0.47 | -0.19 | 0.21 | -0.04 | 0.54 | -0.20 | 0.32 | -0.06 |
Placebo | 0.05 | 0.03 | 0.02 | 0.01 | 0.36 | -0.06 | 0.30 | -0.13 | 0.38 | -0.06 | 0.32 | -0.13 | 0.57 | -0.11 | 0.45 | -0.16 |
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30. (NCT00424593)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mental Component Summary Baseline | Mental Component Summary Change from Baseline | Physical Component Summary Baseline | Physical Component Summary Change from Baseline | Bodily Pain Baseline | Bodily Pain Change from Baseline | General Health Baseline | General Health Change from Baseline | Mental Health Baseline | Mental Health Change from Baseline | Physical Functioning Baseline | Physical Functioning Change from Baseline | Role-Emotional Baseline | Role-Emotional Change from Baseline | Role-Physical Baseline | Role-Physical Change from Baseline | Social Functioning Baseline | Social Functioning Change from Baseline | Vitality Baseline | Vitality Change from Baseline | |
Duloxetine | 49.69 | 2.05 | 33.39 | 5.69 | 5.48 | 1.55 | 16.27 | 1.73 | 22.06 | 1.19 | 19.53 | 2.59 | 4.57 | 0.44 | 5.24 | 0.63 | 7.83 | 0.51 | 15.16 | 1.08 |
Placebo | 49.60 | -0.49 | 32.62 | 4.12 | 5.42 | 0.95 | 15.75 | 0.82 | 21.95 | 0.28 | 19.87 | 1.61 | 4.67 | 0.12 | 5.07 | 0.48 | 7.57 | 0.14 | 14.79 | 0.21 |
The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient. Scores presented used the UK Based Index Score. (NCT00424593)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 0.49 | 0.16 |
Placebo | 0.49 | 0.11 |
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' (NCT00424593)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
Anxiety Subscale Baseline (n=102, n=104) | Anxiety Subscale Change from Baseline | Depression Subscale Baseline (n=103, n=105) | Depression Subscale Change from Baseline | |
Duloxetine | 4.94 | -0.70 | 3.65 | -0.27 |
Placebo | 4.41 | 0.11 | 3.87 | 0.10 |
24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients should complete the electronic diary at bedtime. The 11-point Likert scale will also be used for assessment of night pain and worst pain each day, and evaluated as weekly means. Average interference was calculated as the average of non-missing scores of individual interference items. (NCT00424593)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Average Pain Score Baseline | Average Pain Score Change from Baseline | Worst Pain Score Baseline | Worst Pain Score Change from Baseline | Night Pain Score Baseline | Night Pain Score Change from Baseline | |
Duloxetine | 5.94 | -1.92 | 6.91 | -1.97 | 5.46 | -1.82 |
Placebo | 6.05 | -1.16 | 7.02 | -1.31 | 5.50 | -1.15 |
(NCT00424593)
Timeframe: Baseline, Week 13
Intervention | millimole per Liter (mmol/L) (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 24.90 | 0.57 |
Placebo | 25.10 | -0.28 |
(NCT00424593)
Timeframe: Baseline, Week 13
Intervention | micromole per Liter (μmol/L) (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 303.23 | -6.27 |
Placebo | 298.07 | 8.68 |
Serious adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0. (NCT00424593)
Timeframe: Week 13 though Week 54
Intervention | participants (Number) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Patients with ≥1 Serious Adverse Event | Accidental overdose | Acute tonsillitis | Angiopathy | Back pain | Femur fracture | Hand fracture | Osteoarthritis | Road traffic accident | Suicidal ideation | Syncope | Tonsillitis | |
Duloxetine | 9 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Treatment-emergent adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0. (NCT00424593)
Timeframe: Week 13 through Week 54
Intervention | participant (Number) | |||
---|---|---|---|---|
Headache | Nausea | Abdominal pain upper | Hyperhidrosis | |
Duloxetine | 22 | 17 | 13 | 11 |
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. (NCT00424593)
Timeframe: Baseline, Week 13, Week 54
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
Week 13 Baseline | Week 13 Change from Baseline | Week 54 Baseline (n=80, n=97) | Week 54 Change from Baseline (n=80, n=97) | |
Duloxetine | 6.94 | -0.51 | 5.93 | -0.64 |
Placebo | 6.81 | 0.68 | 7.69 | -1.01 |
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00424593)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -2.32 |
Placebo | -1.50 |
Response to treatment was defined as at least a 30% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented. (NCT00424593)
Timeframe: Week 13
Intervention | participants (Number) |
---|---|
Duloxetine | 58 |
Placebo | 46 |
Response to treatment was defined as at least a 50% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented. (NCT00424593)
Timeframe: Week 13
Intervention | participants (Number) |
---|---|
Duloxetine | 42 |
Placebo | 31 |
A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00424593)
Timeframe: Week 13
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 2.81 |
Placebo | 3.23 |
Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24. (NCT00424593)
Timeframe: Baseline, Week 13, Week 54
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
Week 13 Baseline | Week 13 Change from Baseline | Week 54 Baseline (n=71, n=86) | Week 54 Change from Baseline (n=71, n=86) | |
Duloxetine | 8.03 | -2.01 | 5.42 | -0.37 |
Placebo | 8.29 | -1.50 | 6.70 | -1.05 |
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. (NCT00424593)
Timeframe: Baseline, Week 13, Week 54
Intervention | units on a scale (Mean) | |||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Worst Pain Score Week 13 Baseline | Worst Pain Score Week 13 Change from Baseline | Worst Pain Score Week 54 Baseline (n=80, n=97) | Worst Pain Score Week 54 Change from Baseline | Least Pain Score Week 13 Baseline | Least Pain Score Week 13 Change from Baseline | Least Pain Score Week 54 Baseline (n=80, n=97) | Least Pain Score Week 54 Change from Baseline | Average Pain Score Week 13 Baseline | Average Pain Score Week 13 Change from Baseline | Average Pain Score Week 54 Baseline (n=80, n=97) | Average Pain Score Week 54 Change from Baseline | Pain Right Now Score Week 13 Baseline | Pain Right Now Score Week 13 Change from Baseline | Pain Right Now Score Week 54 Baseline (n=80, n=97) | Pain Right Now Score Week 54 Change from Baseline | General Activity Week 13 Baseline | General Activity Week 13 Change from Baseline | General Activity Week 54 Baseline (n=80, n=97) | General Activity Week 54 Change from Baseline | Mood Week 13 Baseline | Mood Week 13 Change from Baseline | Mood Week 54 Baseline (n=80, n=97) | Mood Week 54 Change from Baseline | Walking Ability Week 13 Baseline | Walking Ability Week 13 Change from Baseline | Walking Ability Week 54 Baseline (n=80, n=97) | Walking Ability Week 54 Change from Baseline | Normal Work Week 13 Baseline | Normal Work Week 13 Change from Baseline | Normal Work Week 54 Baseline (n=80, n=97) | Normal Work Week 54 Change from Baseline | Relations With People Week 13 Baseline | Relations With People Week 13 Change from Baseline | Relations With People Week 54 Baseline (n=80,n=97) | Relations With People Week 54 Change from Baseline | Sleep Week 13 Baseline | Sleep Week 13 Change from Baseline | Sleep Week 54 Baseline (n=80, n=97) | Sleep Week 54 Change from Baseline | Enjoyment of Life Week 13 Baseline | Enjoyment of Life Week 13 Change from Baseline | Enjoyment of Life Week 54 Baseline (n=80, n=97) | Enjoyment of Life Week 54 Change from Baseline | Average Interference Week 13 Baseline | Average Interference Week 13 Change from Baseline | Average Interference Week 54 Baseline (n=80, n=97) | Average Interference Week 54 Change from Baseline | |
Duloxetine | 7.43 | -2.55 | 4.49 | -1.31 | 4.22 | -1.72 | 2.36 | -0.81 | 5.91 | -2.08 | 3.40 | -1.05 | 5.42 | -2.29 | 2.75 | -0.76 | 5.07 | -1.83 | 3.11 | -0.86 | 3.89 | -1.70 | 1.89 | -0.44 | 4.49 | -2.01 | 2.49 | -0.51 | 5.01 | -2.10 | 2.85 | -0.71 | 2.75 | -1.28 | 1.48 | -0.51 | 4.12 | -1.66 | 2.38 | -1.13 | 3.57 | -1.72 | 1.61 | -0.70 | 4.13 | -1.76 | 2.26 | -0.69 |
Placebo | 7.34 | -1.72 | 5.67 | -1.78 | 4.22 | -0.83 | 3.33 | -0.93 | 5.93 | -1.43 | 4.45 | -1.35 | 5.55 | -1.43 | 4.11 | -1.25 | 5.60 | -1.51 | 4.05 | -1.32 | 4.30 | -1.03 | 3.24 | -0.93 | 4.83 | -1.34 | 3.53 | -1.27 | 5.39 | -1.58 | 3.81 | -1.09 | 3.39 | -0.92 | 2.53 | -0.77 | 4.59 | -1.30 | 3.40 | -1.08 | 3.41 | -0.81 | 2.61 | -0.93 | 4.50 | -1.21 | 3.31 | -1.06 |
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). (NCT00424593)
Timeframe: Baseline, Week 13, Week 54
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
Week 13 Baseline | Week 13 Change from Baseline | Week 54 Baseline (n=81, n=97) | Week 54 Change from Baseline (n=81, n=97) | |
Duloxetine | 3.23 | -0.94 | 2.21 | -0.23 |
Placebo | 3.27 | -0.74 | 2.60 | -0.52 |
Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). (NCT00424593)
Timeframe: Baseline, Week 13, Week 54
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
13 Week Baseline | 13 Week Change from Baseline | 54 Week Baseline (n=59, n=82) | 54 Week Change from Baseline (n=59, n=82) | |
Duloxetine | 10.39 | -3.13 | 7.83 | -1.14 |
Placebo | 10.87 | -1.53 | 9.59 | -2.40 |
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme). (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 4.27 | -1.63 |
Placebo | 4.50 | -1.36 |
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 3.66 | -1.91 |
Placebo | 4.02 | -1.91 |
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | -0.63 |
Placebo | -0.32 |
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00433290)
Timeframe: 13 Weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 2.85 |
Placebo | 3.09 |
Response was defined as a >=30% reduction from baseline to endpoint in Brief Pain Inventory average pain score. Nonresponders were defined as participants with a <30% reduction from baseline to Visit 4 (7 Weeks) in Brief Pain Inventory average pain score. (NCT00433290)
Timeframe: 13 Weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 9 |
Response to treatment was defined as a ≥ 30% reduction from baseline to endpoint in Brief Pain Inventory (BPI) average pain score. The BPI measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00433290)
Timeframe: 13 Weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 79 |
Placebo | 56 |
(NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | kilograms (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 81.01 | -0.65 |
Placebo | 80.49 | 0.47 |
A 14-item questionnaire with 2 subscales: anxiety (7 items) and depression (7 items). Each item is rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety subscale. Scores of 11 or more are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 4.26 | -1.11 |
Placebo | 4.16 | -0.69 |
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 2.36 | -1.16 |
Placebo | 2.37 | -0.89 |
(NCT00433290)
Timeframe: over 13 weeks
Intervention | participants (Number) | |||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Nausea | Insomnia | Arthralgia | Asthenia | Constipation | Abdominal pain upper | Abnormal dreams | Anxiety | Atrial fibrillation | Diarrhoea | Drug intolerance | Dyspepsia | Ejaculation disorder | Erectile dysfunction | Haemorrhoids | Hot flush | Lethargy | Memory impairment | Palpitations | Pyelonephritis acute | Sleep disorder | Supraventricular tachycardia | |
Duloxetine | 5 | 1 | 2 | 2 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 1 |
Placebo | 0 | 2 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 3.91 | -1.93 |
Placebo | 4.13 | -1.62 |
Nonresponders were defined as participants with a <30% reduction from baseline to Visit 7 (7 weeks) in Brief Pain Inventory average pain score. (NCT00433290)
Timeframe: over 13 Weeks
Intervention | participants (Number) | ||
---|---|---|---|
Arthralgia | Constipation | Nausea | |
Duloxetine | 1 | 1 | 1 |
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 4.29 | -0.82 |
Placebo | 5.35 | -1.25 |
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 7.49 | -2.74 |
Placebo | 7.50 | -1.94 |
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 4.77 | -2.43 |
Placebo | 4.88 | -1.56 |
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 3.35 | -1.59 |
Placebo | 3.60 | -1.72 |
(NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | Units/Liter (Mean) | |||||
---|---|---|---|---|---|---|
Alkaline Phosphatase Baseline (n=120,n=126) | Alkaline Phosphatase Change from Baseline | Aspartate Amino Transaminase (AST) Baseline | AST Change from Baseline (n=117,n=124) | Gammaglutamyl Transpeptidase (GGT) Baseline | GGT Change from Baseline (n=120,n=126) | |
Duloxetine | 77.33 | 2.38 | 22.61 | 1.44 | 25.56 | 5.33 |
Placebo | 75.90 | -3.43 | 24.23 | -1.37 | 30.55 | -2.10 |
(NCT00433290)
Timeframe: Baseline and 13 Week Endpoint
Intervention | millimole per Liter (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 104.38 | -0.83 |
Placebo | 104.18 | -0.08 |
MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores:general health=5-25, physical functioning=10-30, Role-physical=4-8, Role-emotional=3-6, social functioning=2-10, bodily pain=2-11, vitality=4-24, mental health=5-30. (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mental Component Summary Baseline (n=119, n=121) | Mental Component Summary Change from Baseline | Physical Component Summary Baseline (n=119, n=121) | Physical Component Summary Change from Baseline | Bodily Pain Baseline (n=121, n=124) | Bodily Pain Change from Baseline | General Health Baseline (n=120, n=122) | General Health Change from Baseline | Mental Health Baseline (n=121, n=124) | Mental Health Change from Baseline | Physical Functioning Baseline (n=120, n=125) | Physical Functioning Change from Baseline | Role-Emotional Baseline (n=121, n=125) | Role-Emotional Change from Baseline | Role-Physical Baseline (n=121, n=125) | Role-Physical Change from Baseline | Social Functioning Baseline (n=121, n=125) | Social Functioning Change from Baseline | Vitality Baseline (n=121, n=124) | Vitality Change from Baseline | |
Duloxetine | 55.86 | 0.35 | 30.59 | 7.26 | 5.77 | 1.64 | 17.02 | 1.15 | 24.13 | 0.64 | 17.48 | 2.95 | 5.05 | 0.35 | 5.31 | 1.03 | 8.18 | 0.44 | 16.10 | 1.04 |
Placebo | 54.47 | 1.10 | 28.70 | 4.76 | 5.58 | 1.12 | 16.61 | 0.64 | 23.67 | 0.56 | 16.38 | 2.16 | 4.76 | 0.40 | 4.96 | 0.70 | 7.78 | 0.44 | 15.43 | 0.81 |
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Changes are timepoint minus baseline. (NCT00433290)
Timeframe: Baseline, Week 4, Week 7, Week 13
Intervention | units on a scale (Least Squares Mean) | ||
---|---|---|---|
Week 4 Change from Baseline (n=121, n=127) | Week 7 Change from Baseline (n=106, n=119) | Week 13 Change from Baseline (n=100, n=116) | |
Duloxetine | -1.80 | -2.47 | -2.72 |
Placebo | -1.12 | -1.41 | -1.88 |
A self-reported scale that measures the interference of pain in the past 24 hours for general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 4.70 | -2.26 |
Placebo | 5.17 | -1.92 |
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme). (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 10.24 | -4.27 |
Placebo | 10.35 | -3.49 |
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme). (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 35.05 | -13.78 |
Placebo | 36.82 | -10.75 |
This assesses the weekly mean of the average pain and worst pain experienced over the last 24-hours. This is an ordinal scale with scores for each subscale (average pain and worst pain) ranging from 0 (no pain) to 10 (worst possible pain). Change = endpoint minus baseline. (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
Baseline Weekly 24-Hour Average Pain | Change in Weekly 24-Hour Average Pain | Baseline Weekly 24-Hour Worst Pain | Change in Weekly 24-Hour Worst Pain | |
Duloxetine | 6.05 | -2.39 | 7.58 | -2.57 |
Placebo | 6.08 | -1.78 | 7.53 | -2.05 |
"A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).~Non-Responders were defined as patients with a <30% reduction from baseline to visit 4 (7 weeks) in Brief Pain Inventory (BPI) average pain score." (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 5.30 | -0.76 |
(NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | beats per minute (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 68.74 | 2.55 |
Placebo | 69.73 | 0.06 |
(NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | mm Hg (Mean) | |||
---|---|---|---|---|
Systolic Blood Pressure (SBP) Baseline | SBP Change from Baseline | Diastolic Blood Pressure (DBP) Baseline | DBP Change from Baseline | |
Duloxetine | 132.20 | -1.03 | 79.73 | 0.09 |
Placebo | 131.42 | 0.89 | 79.83 | 0.45 |
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 3.10 | -1.53 |
Placebo | 3.29 | -1.23 |
The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement. (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 0.68 | 0.09 |
Placebo | 0.66 | 0.08 |
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 5.45 | -2.57 |
Placebo | 5.36 | -1.80 |
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 4.70 | -1.95 |
Placebo | 4.63 | -1.24 |
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 6.09 | -2.54 |
Placebo | 6.16 | -1.78 |
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00433290)
Timeframe: Baseline and 13 Weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 5.41 | -2.63 |
Placebo | 5.54 | -2.07 |
For each participant, changes across individual visits were averaged to obtain 1 measurement per participant. (NCT00437125)
Timeframe: baseline through 12 weeks
Intervention | millimeter mercury (Mean) | |||
---|---|---|---|---|
systolic blood pressure, standing; n=146 | diastolic blood pressure, standing; n=146 | systolic blood pressure, supine; n=145 | diastolic blood pressure, supine; n=145 | |
Duloxetine | -0.17 | 0.12 | -0.30 | -0.45 |
For each participant, changes across individual visits were averaged to obtain 1 measurement per participant. (NCT00437125)
Timeframe: baseline through 12 weeks
Intervention | beats per minute (Mean) | |
---|---|---|
standing, n=145 | supine, n=145 | |
Duloxetine | 1.61 | 1.16 |
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. Scoring: 1=very much better; 2=much better; 3=low better; 4=no change; 5=low worse; 6=much worse; 7=very much worse. (NCT00437125)
Timeframe: 12 weeks
Intervention | participants (Number) | ||||||
---|---|---|---|---|---|---|---|
score=1 | score=2 | score=3 | score=4 | score=5 | score=6 | score=7 | |
Duloxetine | 5 | 63 | 38 | 10 | 3 | 0 | 0 |
Rating tool to follow the longitudinal course of Parkinson's Disease. It is composed of Section I: Mentation, Behavior, and Mood; Section II: Activities of Daily Living; Section III: Motor Examination; Section IV: Complications of therapy. These are evaluated by interview. Some sections require that multiple grades be assigned to each extremity. Only Sections II and III were rated in this study. A total of 160 points are possible (52 in Section II and 108 in Section III), where 0 represents no disability and 160 indicates maximal grade of disability. (NCT00437125)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Mean) | |
---|---|---|
baseline; n=151 | change; n=149 | |
Duloxetine | 32.0 | -0.3 |
Clinician-rated scale, providing side effect ratings of psychopharmacological medications. 48 items, each item is rated on a 4-point scale (0=not present; 1=mild; 2=moderate; 3=severe). The test is divided in 6 subscales, total scores for each subscale are calculated based on a weighted secondary scoring system. Subscales: psychic (score range:0-30), neurological (score range:0-24), autonomic (score range:0-33), other (score range:0-75), global assesment by subject (score range:0-3), and global assessment by doctor (score range:0-3). Higher ratings indicate greater impairment. (NCT00437125)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Psychic subscale, baseline; n=136 | Psychic subscale, change; n=114 | Neurological subscale, baseline; n=132 | Neurological subscale, change; n=112 | Autonomic subscale, baseline; n=132 | Autonomic subscale, change; n=113 | Other subscale, baseline; n=49 | Other subscale, baseline; n=35 | Global assessment by participant, baseline; n=150 | Global assessment by participant, change; n=129 | Global assessment by doctor, baseline; n=150 | Global assessment by doctor, change; n=129 | |
Duloxetine | 6.8 | -3.5 | 4.2 | -1.2 | 1.9 | -0.6 | 0.9 | 0.2 | 0.2 | 0.1 | 0.1 | 0.1 |
The PDQ-39 has 39 items. Higher scores reflect lower quality of life. The PDQ-39 has eight subscales: mobility (10 items), activities of daily living (six items), emotional wellbeing (six items), stigma (four items), social support (three items), cognition (four items), communication (three items), and bodily discomfort (three items). Items in each subscale, as well in the total scale, can be summarized into an index and transformed linearly to a 0-100 scale. (NCT00437125)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Mean) | |
---|---|---|
baseline; n=147 | change; n=118 | |
Duloxetine | 32.9 | -7.7 |
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain). Here, the line was only 93 mm long due to an error on the clinical research form and scores were adjusted to 0 to 93. (NCT00437125)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Overall pain, baseline; n=147 | Overall pain, change; n=146 | Headaches, baseline; n=147 | Headaches, change; n=146 | Back ache, baseline; n=147 | Back ache, change; n=146 | Shoulder pain, baseline; n=147 | Shoulder pain, change; n=146 | Interference, baseline; n=147 | Interference, change; n=146 | Pain while awake, baseline; n=147 | Pain while awake, change; n=146 | |
Duloxetine | 30.5 | -5.1 | 15.9 | -5.4 | 34.9 | -10.2 | 26.7 | -10.3 | 30.4 | -8.2 | 31.7 | -9.9 |
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). (NCT00437125)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 19.2 | -10.1 |
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). (NCT00437125)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Mean) | |
---|---|---|
baseline | change | |
Duloxetine | 4.0 | -1.5 |
"Self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. 19 individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The subject self-rates each of these seven areas of sleep. Scoring of answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. The total score is the sum of the 7 component scores (total score range: 0-21)." (NCT00437125)
Timeframe: baseline, 4 weeks, 8 weeks, 12 weeks
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
baseline, n=147 | 4 weeks change, n=134 | 8 weeks change, n=134 | 12 weeks change, n=134 | |
Duloxetine | 8.6 | -2.8 | -3.3 | -3.2 |
Included were participants with normal ECG at baseline who developed abnormal ECGs during the study. (NCT00437125)
Timeframe: baseline through 12 weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 3 |
Response was defined as a >= 50% reduction in 17-item Hamilton Depression rating scale (HAMD) scores. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). (NCT00437125)
Timeframe: 12 weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 90 |
Remission was defined as reaching a 17-item Hamilton Depression Rating Scale (HAMD) total score <=7. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). (NCT00437125)
Timeframe: 12 weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 68 |
The results reported are the number of participants who discontinued the study as a result of an adverse event (serious or other) or death. (NCT00437125)
Timeframe: baseline through 12 weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 13 |
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. (NCT00437125)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Mean) | |
---|---|---|
baseline, n=149 | change, n=122 | |
Duloxetine | 21.6 | -12.0 |
The PAS is a measure that assesses participants' total number of panic attacks (situational and unexpected with full and limited symptoms), as well as anticipatory anxiety, since last visit. There is no total score. (NCT00438971)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 0.90 |
The SDS is a 3-item measure with each item rated on a 10-point scale. The SDS measures the extent to which work/school, social life, and home life or family responsibilities are impaired by symptoms. Total scores range from 0 to 30, with higher scores reflecting greater impairment. (NCT00438971)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 9.40 |
The Q-LES-Q is a self-report measure of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. Only the first 14 items are included in scoring, which ranges from 14 to 70, with higher scores reflecting greater enjoyment and satisfaction. The last two items are not included in the total score but are standalone items. (NCT00438971)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 49.3 |
The PDSS contains seven items assessing multiple dimensions of panic disorder severity, including (a) frequency of panic attacks, (b) distress during panic attacks, (c) anticipatory anxiety, (d) agoraphobic fear and avoidance, (e) interoceptive fear and avoidance, (f) impairment of work functioning, and (g) impairment of social functioning. The PDSS ranges from 0 to 28, with higher ratings reflecting greater degrees of symptom severity. (NCT00438971)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 9.13 |
The MADRS is a 10-item clinician rating of depressive symptoms. Scores range from 0 to 60, with higher scores reflecting greater symptom severity. (NCT00438971)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 9.07 |
The LIFE-RIFT is a brief measure of psychosocial functioning in work, interpersonal relations, satisfaction, and recreation. Scores on the LIFE-RIFT can range from 4, indicating very good functioning (no impairment) in all of the 4 component areas, to 20, indicating very poor functioning (severe impairment) in all of the 4 areas. (NCT00438971)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 9.33 |
The CGI-S is a clinician-rated instrument used to assess global severity of symptoms. The CGI-S ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Remission was defined strictly as a CGI-S score of 1 or 2 (not at all ill or borderline ill) and zero panic attacks at endpoint. (NCT00438971)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 3.47 |
The BAI is a 21-item self-report measure of anxiety with a focus on somatic symptoms. Total scores range from 0 to 63, with higher scores reflecting greater symptom severity. (NCT00438971)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 14.7 |
Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study). (NCT00443352)
Timeframe: Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).
Intervention | days (Mean) |
---|---|
Duloxetine | 4.5 |
Weekly mean of 24 hour Worst Pain Score, percent change from baseline. Range is 0-10 with 0= no pain and 10= worst possible pain. (NCT00457730)
Timeframe: at week 6
Intervention | percent reduction on 0-10 analog scale (Mean) |
---|---|
Duloxetine | -29.1 |
Placebo | -11.5 |
Percent change in Weekly mean of 24 hour Average pain Score, Week 6 vs. baseline. Range is 0-10 with 0= no pain and 10= worst possible pain. (NCT00457730)
Timeframe: at week 6
Intervention | percent reduction on 0-10 analog scale (Mean) |
---|---|
Duloxetine | -38.5 |
Placebo | -10.4 |
"global impression: How do you feel about the effects of the medication over the past 7 days? 7 point scale, 7 = delighted, 1= terrible" (NCT00457730)
Timeframe: Week 6 vs baseline
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 4.77 |
Placebo | 3.94 |
"Quality of life, such that lower score reflects poorer quality of life~Minimum score: 16 Maximum score: 80" (NCT00464698)
Timeframe: Week 0 to 17
Intervention | units on a self-report questionnaire (Mean) | |
---|---|---|
Baseline Q-LES-Q (Week 0) | Final Visit Q-LES-Q (Week 17) | |
Duloxetine | 70.14 | 74.55 |
"Global severity of illness, such that a higher score reflects worse global severity~Minimum score: 2 Maximum score: 14" (NCT00464698)
Timeframe: Week 3 to 17
Intervention | units on a self-report questionnaire (Mean) | |
---|---|---|
Baseline CGI (Week 3) | Final Visit CGI (Week 17) | |
Duloxetine | 4.0 | 2.70 |
"Depression severity, such that higher scores on the BDI are reflective of more severe depression.~BDI minimum score: 0 MDI maximum score: 63" (NCT00464698)
Timeframe: Week 0 to 17
Intervention | units on a self-report questionnaire (Mean) | |
---|---|---|
Baseline BDI (Week 0) | Final Visit BDI (Week 17) | |
Duloxetine | 10.30 | 6.95 |
"Anxiety severity, such that a higher score on the BAI reflects more severe anxiety.~Minimum value: 0 Maximum value: 63" (NCT00464698)
Timeframe: Week 0 to 17
Intervention | units on a self-report questionnaire (Mean) | |
---|---|---|
Baseline BAI (Week 0) | Final Visit BAI (Week 17) | |
Duloxetine | 10.70 | 6.75 |
OCD symptom change. This is the intention-to-treat analyses (with all 20 subjects included) rather than just the subjects who completed the treatment. (NCT00464698)
Timeframe: Week 0 to 17
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline YBOCS score | Final YBOCS score | |
Duloxetine | 27.45 | 20.45 |
The primary outcome measure was a Patient Global Assessment of Change (PGIC) scale which reports the patient's overall view of any changes in their overall status since their sphincterotomy treatment. (1=Very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). Success was defined as 3-month PGIC score of much or very much improved (PGIC of either 1 or 2). Patients missing the 3 month visit were considered failures for the primary outcome. (NCT00471315)
Timeframe: 3 months
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 3.3 |
The secondary outcome measure of the study was number of patients who remained on Duloxetine at the completion of the study. (NCT00471315)
Timeframe: 3 Months
Intervention | participants (Number) |
---|---|
Duloxetine | 10 |
Change in average pain from Week 1 to Week 5, measured on day 1 of Weeks 1 and 6 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach's alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the initial treatment period. (NCT00489411)
Timeframe: Day 1 of Week 1 to Day 1 of Week 6
Intervention | units on a scale (Mean) |
---|---|
Arm I/Group A (Duloxetine Then Placebo) | 1.06 |
Arm II/Group B (Placebo Then Duloxetine) | 0.34 |
Change in average pain from Week 8 to Week 12, measured on day 1 of Weeks 8 and 13 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 8 minus value at Day 1 of Week 13 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach's alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the crossover treatment period. (NCT00489411)
Timeframe: Day 1 of Week 8 to Day 1 of Week 13
Intervention | units on a scale (Mean) |
---|---|
Arm I/Group A (Duloxetine Then Placebo) | 0.41 |
Arm II/Group B (Placebo Then Duloxetine) | 1.42 |
Change in pain-related functional interference score during the initial treatment period (Week 1 to Week 5), as measured by the BPI-SF interference score: Using an accepted method for accessing the influence of pain on function, 7 BPI-SF items were used to quantify the degree to which pain interfered with daily activities or function (0, does not interfere; 10 completely interferes). The 7 items were summed to obtain a total interference score, which ranged from 0 to 70, with lower scores meaning less interference. The mean change in pain-related functional interference score during the initial treatment period are reported below for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values. (NCT00489411)
Timeframe: Day 1 of Week 1 to Day 1 to Week 6
Intervention | units on a scale (Mean) |
---|---|
Arm I/Group A (Duloxetine Then Placebo) | 7.9 |
Arm II/Group B (Placebo Then Duloxetine) | 3.5 |
Patient-reported QOL was assessed using the Functional Assessment of Cancer Treatment, Gynecologic Oncology Group Neurotoxicity (FACT/GOG-Ntx) subscale on day 1 of weeks 1, 6, 8, and 13. The instrument contains 11 questions, assessing numbness, tingling, and discomfort in the hands or feet; difficulty hearing; tinnitus; joint pain or muscle cramps; weakness; or trouble walking, buttoning buttons, or feeling small shapes when placed in the hand. Items are scored from 0 to 4 (o, not at all; 4, very much) and summed (total score range, 0-44, with higher scores indicating a worse outcome). A 2- to 3-point change is defined as a clinically meaningful improvement in QOL per published recommendations specific to similar measures. The Mean Change During Initial Treatment Period in the FACT/GOG-Ntx total score are reported for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values. (NCT00489411)
Timeframe: Day 1 of Week 1 to Day 1 of Week 6
Intervention | units on a scale (Mean) |
---|---|
Arm I/Group A (Duloxetine Then Placebo) | 2.44 |
Arm II/Group B (Placebo Then Duloxetine) | 0.87 |
Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression. Baseline is the same timepoint (Week 0) for both comparisons, but due to differences in number of patients in both periods (II/III vs IV), the baseline values may be slightly different. (NCT00529789)
Timeframe: Week 0 (Baseline), 18 Weeks, 30 Weeks
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
18 Week Baseline (n=72) | 18 Week Change from Baseline (n=72) | 30 Week Baseline (n=45) | 30 Week Change from Baseline (n=45) | |
Duloxetine | 61.69 | -32.11 | 61.8 | -38.8 |
A listing of adverse events leading to discontinuation from the study. Abbreviation in data table: ADHD = Attention-Deficit/Hyperactivity Disorder. (NCT00529789)
Timeframe: Week 0 (Baseline) to 30 Weeks
Intervention | participants (Number) | |||
---|---|---|---|---|
Period II/III: Nausea | Period II/III: Worsening of ADHD | Period II/III: Rash | Period IV: Irritability | |
Duloxetine | 1 | 1 | 1 | 1 |
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Baseline is the same timepoint (Week 0) for both comparisons, but due to differences in number of patients in both periods (II/III vs IV), the baseline values may be slightly different. (NCT00529789)
Timeframe: Week 0 (Baseline), 18 Weeks, 30 Weeks
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
18 Week Baseline (n=72) | 18 Week Change from Baseline (n=72) | 30 Week Baseline (n=45) | 30 Week Change from Baseline (n=45) | |
Duloxetine | 4.5 | -2.11 | 4.5 | -2.7 |
The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline. (NCT00529789)
Timeframe: Between 18 and 30 Weeks
Intervention | participants (Number) | ||
---|---|---|---|
Completed suicide | Non-fatal suicide event | Worsening of Suicidal Ideation | |
Duloxetine | 0 | 0 | 1 |
The results shown are for all laboratory analytes where PCS criteria were met, based on criteria used for adult studies. Criteria: High Alanine transaminase (>165 Units/Liter [U/L]); High Creatine Phosphokinase (females: >507 U/L; males:>594 U/L); Low Glucose (<2.498 millimoles/L); Low Hematocrit (females: <0.32; males <0.37); Low Hemoglobin (females <5.896 millimoles/L [mmol/L] iron; males <7.137 mmol/L iron); High Inorganic Phosphorus (>1.776 millimoles/L); Low Leukocyte Count (<2.8 X10^9/L). (NCT00529789)
Timeframe: Baseline to 18 Weeks
Intervention | participants (Number) | ||||||
---|---|---|---|---|---|---|---|
High Alanine Transaminase (N=69)) | High Creatine Phosphokinase (N=69) | Low Glucose (N=69) | Low Hematocrit (N=60) | Low Hemoglobin (N=67) | High Inorganic Phosphorus (N=62) | Low Leukocyte Count (N=68) | |
Duloxetine | 1 | 6 | 1 | 8 | 1 | 16 | 1 |
The results shown are for all laboratory analytes where PCS criteria were met, based on criteria used for adult studies. Criteria: High Alkaline Phosphatase (>420 Units/Liter [U/L]); Low Hematocrit (females <0.32; males <0.37); High Inorganic Phosphorus (>1.776 millimoles/L). (NCT00529789)
Timeframe: Between 18 and 30 Weeks
Intervention | participants (Number) | ||
---|---|---|---|
High Alkaline Phosphatase (N=42) | Low Hematocrit (N=39) | High Inorganic Phosphorus (N=39) | |
Duloxetine | 1 | 1 | 3 |
Total number of patients with any abnormal post-baseline values, based on all values at scheduled and unscheduled visits. Criteria: High QRS Interval = ≥100 milliseconds (msec); High QTc Bazette's or Fredericia's correction - Female = ≥470 msec; High QTc Bazette's or Fredericia's correction - Male = ≥450 msec. (NCT00529789)
Timeframe: Baseline to 18 Weeks
Intervention | participants (Number) | ||
---|---|---|---|
High QRS Interval (N=63) | High QTc Bazette's Correction (N=64) | High QTc Fredericia's Correction (N=65) | |
Duloxetine | 1 | 2 | 0 |
Total number of patients with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Criteria: High Diastolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Systolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Pulse = increase of at least 25 to a value of at least 110. (NCT00529789)
Timeframe: Baseline to 18 Weeks
Intervention | participants (Number) | ||
---|---|---|---|
High Diastolic Blood Pressure | High Systolic Blood Pressure | High Pulse | |
Duloxetine | 22 | 25 | 2 |
Total number of patients with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Criteria: High Diastolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Systolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Pulse = increase of at least 25 to a value of at least 110. (NCT00529789)
Timeframe: Between 18 and 30 Weeks
Intervention | participants (Number) | ||
---|---|---|---|
High Diastolic Blood Pressure | High Systolic Blood Pressure | High Pulse | |
Duloxetine | 3 | 1 | 0 |
Plasma samples were obtained at steady state, and approximately 95% of duloxetine concentrations were within the 24 hour dosing interval. (NCT00529789)
Timeframe: Weeks 2, 4, 6, 8, 10, 14, 18
Intervention | nanograms per milliliter (ng/mL) (Mean) |
---|---|
Duloxetine Dose - 20 mg | 15.2 |
Duloxetine Dose - 30 mg | 20.8 |
Duloxetine - 60 mg | 41.1 |
Duloxetine Dose - 90 mg | 57.6 |
Duloxetine - 120 mg | 77.6 |
Total number of patients with any abnormal post-baseline values, based on all values at scheduled and unscheduled visits. Criteria: High QRS Interval = ≥100 milliseconds (msec); High QTc Bazette's or Fredericia's correction - Female = ≥470 msec; High QTc Bazette's or Fredericia's correction - Male = ≥450 msec. (NCT00529789)
Timeframe: Between 18 and 30 Weeks
Intervention | participants (Number) | ||
---|---|---|---|
High QRS Interval (N=39) | High QTc Bazette's Correction (N=41) | High QTc Fredericia's Correction (N=41) | |
Duloxetine | 1 | 1 | 0 |
Emergence of Any Suicidal Ideation: Item 13 of Children's Depression Rating Scale-Revised (CDRS-R) has possible scores of 1 (no thoughts of suicide) to 7 (contemplation of suicide). Emergence of suicidal ideation was defined as an increase in severity of suicidal ideation for those patients who did not have suicidal ideation at baseline (Week 0). (NCT00529789)
Timeframe: Baseline to 18 weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 2 |
Emergence of Any Suicidal Ideation: Item 13 of Children's Depression Rating Scale-Revised (CDRS-R) has possible scores of 1 (no thoughts of suicide) to 7 (contemplation of suicide). Emergence of suicidal ideation was defined as an increase in severity of suicidal ideation for those patients who did not have suicidal ideation at baseline (Week 0). (NCT00529789)
Timeframe: Week 0 and Between 18 and 30 Weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 0 |
The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline. (NCT00529789)
Timeframe: Baseline to 18 Weeks
Intervention | participants (Number) | ||
---|---|---|---|
Completed suicide | Non-fatal suicide event | Worsening of Suicidal Ideation | |
Duloxetine | 0 | 1 | 1 |
Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50. (NCT00532480)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline 17-item HDRS | Post-treatment 17-item HDRS | |
Duloxetine | 19 | 10 |
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. (NCT00536471)
Timeframe: Baseline, 9 months
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Work Life (n=22, n=8, n=22, n=7) | Social Life (n=29, n=9, n=33, n=10) | Family Life (n=29, n=9, n=33, n=10) | Total Score (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -3.88 | -4.15 | -3.46 | -11.60 |
Group A - Placebo | -4.01 | -4.35 | -2.99 | -11.15 |
Group B - Duloxetine | -2.26 | -3.88 | -3.30 | -9.42 |
Group B - Placebo | -2.16 | -3.66 | -3.07 | -8.67 |
Relative contribution of improvement on the mood states, defined by BPOMS total score (calculated from subscales) to overall improvement in work and activities, HAMD-24 item 7 using path analysis. (NCT00536471)
Timeframe: Over 12 weeks
Intervention | coefficient (Number) | ||
---|---|---|---|
Direct Treatment Effect | Indirect Treatment Effect from BPOMS Total Score | Total Treatment Effect | |
Group A - Ordinary Coefficient | -0.032 | 0.376 | 0.343 |
Group A - Standardized Coefficient | -0.012 | 0.145 | 0.132 |
Group B - Ordinary Coefficient | 0.219 | 0.209 | 0.428 |
Group B - Standardized Coefficient | 0.087 | 0.083 | 0.170 |
For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated. (NCT00536471)
Timeframe: over 12 weeks
Intervention | percent of total effect (Number) | ||
---|---|---|---|
Direct Treatment Effect | Indirect Treatment Effect from BPOMS Total Score | Total Treatment Effect | |
Group B - Percent of Total Effect | 51.14 | 48.86 | 100.00 |
For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated. (NCT00536471)
Timeframe: Over 12 weeks
Intervention | percent of total effect (Number) | ||
---|---|---|---|
Direct Treatment Effect | Indirect Treatment Effect from BPOMS Total Score | Total Treatment Effect | |
Group B - Percent of Total Effect | 35.17 | 64.83 | 100.00 |
Relative contribution of improvement on the mood states, defined by BPOMS total score (determined from subscales) to overall improvement in SDS total score using path analysis. (NCT00536471)
Timeframe: over 12 weeks
Intervention | coefficient (Number) | ||
---|---|---|---|
Direct Treatment Effect | Indirect Treatment Effect from BPOMS Total Score | Total Treatment Effect | |
Group A - Ordinary Coefficient | -0.577 | 2.754 | 2.177 |
Group A - Standardized Coefficient | -0.032 | 0.151 | 0.120 |
Group B - Ordinary Coefficient | 0.955 | 1.761 | 2.716 |
Group B - Standardized Coefficient | 0.052 | 0.095 | 0.147 |
Probability of remission as measured by the HAMD17 Total Score ≤ 7 and by the QIDS16SR Total Score ≤ 5. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for remission (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score. (NCT00536471)
Timeframe: 12 weeks, 9 months
Intervention | probability of remission (Least Squares Mean) | |||
---|---|---|---|---|
12 Week HAMD-17 Total (n=194,n=59,n=195,n=64) | 12 Week QIDS16 Total Score (n=194,n=58,n=194,n=62) | 9 Month HAMD-17 Total Score (n=29,n=9,n=33,n=10) | 9 Month QIDS16 Total Score (n=29,n=9,n=33,n=9) | |
Group A - Duloxetine | 0.38 | 0.30 | 0.63 | 0.71 |
Group A - Placebo | 0.35 | 0.30 | 0.62 | 0.54 |
Group B - Duloxetine | 0.35 | 0.33 | 0.70 | 0.71 |
Group B - Placebo | 0.18 | 0.19 | 0.57 | 0.64 |
Probability of response as measured by ≥ 50% Improvement in the HAMD17 Total Score and ≥ 50% Improvement in the QIDS16SR Total Score. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for response (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score. (NCT00536471)
Timeframe: 12 weeks
Intervention | probability of response (Least Squares Mean) | |
---|---|---|
HAMD-17 Total Score (n=194,n=59,n=195,n=64) | QIDS16 Total Score (n=194,n=58,n=194,n=62) | |
Group A - Duloxetine | 0.63 | 0.44 |
Group A - Placebo | 0.60 | 0.41 |
Group B - Duloxetine | 0.63 | 0.45 |
Group B - Placebo | 0.46 | 0.34 |
(NCT00536471)
Timeframe: 9 months
Intervention | participants (Number) | |
---|---|---|
Lymphocytes - High (n=189,n=59,n=196,n=66) | Hemoglobin - Low (n=184,n=54,n=184,n=63) | |
Group A - Duloxetine | 1 | 5 |
Group A - Placebo | 4 | 2 |
Group B - Duloxetine | 1 | 2 |
Group B - Placebo | 1 | 4 |
(NCT00536471)
Timeframe: over 9 months
Intervention | participants (Number) | |
---|---|---|
Lymphocytes - High (n=189,n=59,n=196,n=66) | Potassium - Low (n=194,n=59,n=202,n=67) | |
Group A - Duloxetine | 1 | 0 |
Group A - Placebo | 4 | 0 |
Group B - Duloxetine | 2 | 1 |
Group B - Placebo | 1 | 3 |
The number of participants with statistically significant abnormal lab values at anytime and at 12 week endpoint were the same. (NCT00536471)
Timeframe: over 3 months
Intervention | participants (Number) | |
---|---|---|
Lymphocytes - High (n=186,n=57,n=195,n=66) | Potassium - Low (n=191,n=57,n=201,n=66) | |
Group A - Duloxetine | 1 | 0 |
Group A - Placebo | 3 | 0 |
Group B - Duloxetine | 2 | 1 |
Group B - Placebo | 1 | 3 |
(NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | micromole per Liter (Least Squares Mean) | ||||
---|---|---|---|---|---|
Bilirubin - 12 Week Change | Creatinine - 12 Week Change | Uric Acid - 12 Week Change | Bilirubin - 9 Month Change (n=193,n=60,n=202,n=66) | Uric Acid - 9 Month Change (n=193,n=60,n=202,n=66) | |
Group A - Duloxetine | 0.10 | -1.56 | -2.77 | -0.13 | -2.11 |
Group A - Placebo | -0.19 | -0.85 | 5.74 | -0.12 | -2.25 |
Group B - Duloxetine | -0.51 | -1.21 | -12.36 | -0.56 | -8.66 |
Group B - Placebo | 0.13 | 0.82 | 7.05 | 0.25 | 6.50 |
(NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | millimole per Liter (Least Squares Mean) | ||||
---|---|---|---|---|---|
Chloride - 12 Week Change | Urea Nitrogen - 12 Week Change | Chloride - 9 Month Change (n=193,n=60,n=202,n=66) | Cholesterol - 9 Month (n=193,n=60,n=202,n=66) | Sodium - 9 Month Change (n=193,n=60,n=202,n=66) | |
Group A - Duloxetine | -0.80 | -0.06 | -0.74 | -0.06 | -1.67 |
Group A - Placebo | 0.24 | 0.26 | 0.54 | -0.30 | -0.73 |
Group B - Duloxetine | -0.91 | 0.01 | -0.82 | 0.04 | -1.86 |
Group B - Placebo | -0.39 | 0.15 | -0.31 | -0.08 | -1.73 |
(NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | Proportion of 1.0 (Least Squares Mean) | |
---|---|---|
Hematocrit - 12 Week Change | Hematocrit - 9 Month Change (n=194,n=59,=197,n=67) | |
Group A - Duloxetine | -0.00 | -0.00 |
Group A - Placebo | -0.01 | -0.00 |
Group B - Duloxetine | 0.00 | 0.00 |
Group B - Placebo | -0.01 | -0.01 |
(NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | femtoliter (Least Squares Mean) | |
---|---|---|
MCV - 12 Week Change | MCV - 9 Month Change (n=194,n=59,n=197,n=67) | |
Group A - Duloxetine | 0.98 | 1.07 |
Group A - Placebo | 1.30 | 1.66 |
Group B - Duloxetine | 0.71 | 0.88 |
Group B - Placebo | -0.47 | -0.31 |
(NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | Billions per Liter (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=191, n=58, n=194, n=67) | |
Group A - Duloxetine | 8.11 | 8.06 |
Group A - Placebo | -7.10 | -10.17 |
Group B - Duloxetine | 10.55 | 5.96 |
Group B - Placebo | 12.02 | 10.18 |
(NCT00536471)
Timeframe: over 9 months
Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Nausea | Dizziness | Headache | Rash | Fatigue | Insomnia | Suicide attempt | Weight increased | Abdominal pain lower | Abnormal dreams | Asthma | Blood pressure increased | Chest pain | Completed suicide | Constipation | Crying | Depression | Diarrhoea | Disturbance in attention | Dry mouth | Dysgeusia | Hepatic function abnormal | Hernia | Hyperhidrosis | Hypertension | Influenza | Irritability | Lower gastrointestinal haemorrhage | Lower limb fracture | Mania | Migraine | Muscular weakness | Non-cardiac chest pain | Paranoia | Pregnancy | Restlessness | Road traffic accident | Ruptured cerebral aneurysm | Pneumonia | Tremor | Urinary hesitation | Urinary retention | Wound infection staphylococcal | Anorgasmia | Astigmatism | Cardiac failure congestive | Depressive symptom | Dyspepsia | Gamma-glutamyltransferase increased | Hepatic enzyme increased | Libido decreased | Night sweats | Myocardial infarction | Nightmare | Palpitations | Pruritus | Sexual dysfunction | Somnolence | Sedation | Vomiting | |
Duloxetine (Escalated) | 0 | 1 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 |
Duloxetine (Not Escalated) | 5 | 2 | 1 | 2 | 2 | 2 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 2 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Placebo (Not Rescued) | 0 | 1 | 2 | 1 | 0 | 0 | 1 | 2 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Placebo (Rescued) | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 0 |
Measures obsessional and compulsive symptoms on a scale of 0 (absent) to 2 (severe). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.08 | -0.60 |
Group A - Placebo | -0.06 | -0.54 |
Group B - Duloxetine | -0.04 | -0.63 |
Group B - Placebo | -0.06 | -0.56 |
Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss). (NCT00536471)
Timeframe: baseline, 8 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Group A - Duloxetine | -1.32 |
Group A - Placebo | -1.07 |
Group B - Duloxetine | -1.37 |
Group B - Placebo | -0.93 |
Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss). (NCT00536471)
Timeframe: Baseline, 9 months
Intervention | units on a scale (Least Squares Mean) |
---|---|
Group A - Duloxetine | -2.43 |
Group A - Placebo | -2.55 |
Group B - Duloxetine | -1.66 |
Group B - Placebo | -1.50 |
(NCT00536471)
Timeframe: baseline, 9 months
Intervention | Units per Liter (Least Squares Mean) |
---|---|
Group A - Duloxetine | -0.18 |
Group A - Placebo | -2.30 |
Group B - Duloxetine | 0.23 |
Group B - Placebo | -3.75 |
(NCT00536471)
Timeframe: Baseline, 9 months
Intervention | millimoles per Liter (iron) (Least Squares Mean) |
---|---|
Group A - Duloxetine | -0.13 |
Group A - Placebo | -0.19 |
Group B - Duloxetine | -0.01 |
Group B - Placebo | -0.17 |
(NCT00536471)
Timeframe: 12 weeks
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Sitting Pulse Rate - High | Weight - Gain | Weight - Loss | Sitting Systolic Blood Pressure - High | Sitting Diastolic Blood Pressure - High | |
Group A - Duloxetine | 0 | 0 | 0 | 0 | 0 |
Group A - Placebo | 0 | 0 | 1 | 0 | 0 |
Group B - Duloxetine | 1 | 0 | 2 | 4 | 0 |
Group B - Placebo | 0 | 0 | 0 | 0 | 1 |
(NCT00536471)
Timeframe: 9 months
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Sitting Pulse - High | Weight - Gain | Weight - Loss | Sitting Systolic Blood Pressure - High | Sitting Diastolic Blood Pressure - High | |
Group A - Duloxetine | 0 | 2 | 5 | 1 | 0 |
Group A - Placebo | 0 | 0 | 1 | 0 | 0 |
Group B - Duloxetine | 1 | 3 | 4 | 4 | 0 |
Group B - Placebo | 0 | 0 | 0 | 0 | 1 |
(NCT00536471)
Timeframe: over 12 weeks
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Sitting Pulse Rate - High | Weight - Gain | Weight - Loss | Sitting Systolic Blood Pressure - High | Sitting Diastolic Blood Pressure - High | |
Group A - Duloxetine | 1 | 0 | 0 | 3 | 2 |
Group A - Placebo | 0 | 0 | 1 | 1 | 0 |
Group B - Duloxetine | 1 | 0 | 2 | 6 | 2 |
Group B - Placebo | 0 | 0 | 0 | 0 | 3 |
(NCT00536471)
Timeframe: over 9 months
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Sitting Pulse - High | Weight - Gain | Weight - Loss | Sitting Systolic Blood Pressure - High | Sitting Diastolic Blood Pressure - High | |
Group A - Duloxetine | 1 | 2 | 5 | 4 | 2 |
Group A - Placebo | 0 | 0 | 1 | 2 | 0 |
Group B - Duloxetine | 2 | 3 | 5 | 7 | 4 |
Group B - Placebo | 0 | 0 | 0 | 0 | 3 |
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -1.93 | -2.14 |
Group A - Placebo | -1.58 | -1.97 |
Group B - Duloxetine | -1.97 | -2.61 |
Group B - Placebo | -1.25 | -2.23 |
A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity. (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=9) | |
Group A - Duloxetine | -6.31 | -8.41 |
Group A - Placebo | -5.65 | -6.85 |
Group B - Duloxetine | -6.54 | -7.17 |
Group B - Placebo | -5.21 | -6.15 |
Sitting systolic and diastolic blood pressure. (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | mm Hg (Least Squares Mean) | |||
---|---|---|---|---|
Systolic Blood Pressure (SBP) - 12 Week Change | Diastolic Blood Pressure (DBP) - 12 Week Change | SBP - 9 Month Change (n=28, n=9, n=33, n=10) | DBP - 9 Month Change (n=28, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.12 | 0.48 | -1.18 | -2.25 |
Group A - Placebo | 0.05 | -0.58 | -0.44 | 1.46 |
Group B - Duloxetine | 0.73 | 1.97 | -2.22 | -1.52 |
Group B - Placebo | -2.95 | -0.50 | -0.54 | -1.05 |
Measures anxiety on a scale of 0 (no difficulty) to 4 (fears expressed) (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -1.15 | -1.23 |
Group A - Placebo | -0.90 | -1.13 |
Group B - Duloxetine | -1.15 | -1.41 |
Group B - Placebo | -0.81 | -1.70 |
Measures physiological concomitants of anxiety on a scale of 0 (absent) to 4 (incapacitating). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.61 | -0.98 |
Group A - Placebo | -0.65 | -0.94 |
Group B - Duloxetine | -0.68 | -1.20 |
Group B - Placebo | -0.57 | -1.18 |
Measures gastrointestical somatic symptoms on a scale of 0 (none) to 2 (difficulty eating, requires medication for symptoms). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.44 | -0.98 |
Group A - Placebo | -0.52 | -0.94 |
Group B - Duloxetine | -0.40 | -0.46 |
Group B - Placebo | -0.32 | -0.47 |
Measures general somatic symptoms on a scale of 0 (none) to 2 (any clear-cut symptoms). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.91 | -1.36 |
Group A - Placebo | -0.88 | -1.18 |
Group B - Duloxetine | -0.75 | -0.94 |
Group B - Placebo | -0.49 | -0.83 |
Measures genital symptoms (loss of libido, menstrual disturbances) on a scale of 0 (absent) to 2 (severe). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.57 | -0.89 |
Group A - Placebo | -0.54 | -0.77 |
Group B - Duloxetine | -0.55 | -0.68 |
Group B - Placebo | -0.40 | -0.30 |
Measures hypochondriasis on a scale of 0 (not present) to 4 (hypochondriacal delusions). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.36 | -0.44 |
Group A - Placebo | -0.41 | -0.53 |
Group B - Duloxetine | -0.52 | -0.61 |
Group B - Placebo | -0.41 | -0.41 |
Measures weight loss since last visit on a scale of 0 (no weight loss) to 2 (definite weight loss caused by present illness). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.21 | -0.44 |
Group A - Placebo | -0.20 | -0.53 |
Group B - Duloxetine | -0.25 | -0.61 |
Group B - Placebo | -0.24 | -0.41 |
Measures insight on a scale of 0 (acknowledges being depressed and ill) to 2 (denies being ill at all). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.08 | -0.44 |
Group A - Placebo | -0.07 | -0.53 |
Group B - Duloxetine | -0.01 | -0.61 |
Group B - Placebo | -0.01 | -0.41 |
Measures whether symptoms are worse in morning or evening on a scale of 0 (no variation), 1 (worse in morning), or 2 (worse in evening). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.32 | -0.56 |
Group A - Placebo | -0.36 | -0.26 |
Group B - Duloxetine | -0.45 | -0.77 |
Group B - Placebo | -0.13 | -0.70 |
Measures the severity of the diurnal variation on a scale of 0 (none) to 2 (severe). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=8, n=32, n=10) | |
Group A - Duloxetine | -0.43 | -0.60 |
Group A - Placebo | -0.49 | -0.54 |
Group B - Duloxetine | -0.42 | -0.63 |
Group B - Placebo | -0.21 | -0.56 |
Measures feelings of unreality on a scale of 0 (absent) to 4 (incapacitating). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.19 | -0.60 |
Group A - Placebo | -0.21 | -0.54 |
Group B - Duloxetine | -0.15 | -0.63 |
Group B - Placebo | -0.14 | -0.56 |
Measures feelings of guilt on a scale of 0 (absent) to 4 (very guilty). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -1.19 | -1.32 |
Group A - Placebo | -1.06 | -1.21 |
Group B - Duloxetine | -1.15 | -1.37 |
Group B - Placebo | -0.89 | -1.16 |
Measures paranoid symptoms on a scale of 0 (none) to 2 (severe). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.15 | -0.60 |
Group A - Placebo | -0.12 | -0.54 |
Group B - Duloxetine | -0.13 | -0.63 |
Group B - Placebo | -0.11 | -0.56 |
Measures feelings of helplessness on a scale of 0 (absent) to 4 (severe). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.95 | -1.16 |
Group A - Placebo | -0.88 | -0.90 |
Group B - Duloxetine | -0.98 | -1.34 |
Group B - Placebo | -0.81 | -1.24 |
Measures feelings of hopelessness on a scale of 0 (absent) to 4 (expresses feelings of discouragement, despair, and/or pessimism about the future which cannot be dispelled). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.87 | -1.23 |
Group A - Placebo | -0.74 | -1.34 |
Group B - Duloxetine | -0.80 | -0.92 |
Group B - Placebo | -0.51 | -0.85 |
Measures feelings of worthlessness on a scale of 0 (absent) to 4 (severe). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -1.00 | -1.23 |
Group A - Placebo | -0.95 | -1.34 |
Group B - Duloxetine | -0.95 | -0.92 |
Group B - Placebo | -0.79 | -0.85 |
Measures thoughts of suicide on a scale of 0 (absent) to 4 (attempts suicide). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 Months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n= 9, n=33, n=10) | |
Group A - Duloxetine | -0.46 | -1.32 |
Group A - Placebo | -0.30 | -1.21 |
Group B - Duloxetine | -0.40 | -1.37 |
Group B - Placebo | -0.29 | -1.16 |
Measures early insomnia on a scale of 0 (no difficulty falling asleep) to 2 (complains of nightly difficulty falling asleep). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.72 | -0.85 |
Group A - Placebo | -0.61 | -0.77 |
Group B - Duloxetine | -0.68 | -0.71 |
Group B - Placebo | -0.46 | -0.86 |
Measures middle insomnia on a scale of 0 (no difficulty) to 2 (waking during the night). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.69 | -0.99 |
Group A - Placebo | -0.74 | -0.92 |
Group B - Duloxetine | -0.66 | -0.99 |
Group B - Placebo | -0.59 | -0.67 |
Measures late insomnia on a scale of 0 (no difficulty) to 2 (unable to fall asleep again if gets out of bed). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.66 | -0.94 |
Group A - Placebo | -0.49 | -0.87 |
Group B - Duloxetine | -0.57 | -0.78 |
Group B - Placebo | -0.45 | -0.52 |
Measures slowness of thought and speech; impaired ability to concentrate; decreased motor activity on a scale of 0 (normal speech and thought) to 4 (complete stupor). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.72 | -0.89 |
Group A - Placebo | -0.69 | -0.90 |
Group B - Duloxetine | -0.66 | -1.66 |
Group B - Placebo | -0.51 | -1.50 |
Measures agitation on a scale of 0 (none) to 4 (hand-wringing, nail-biting) (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.47 | -0.53 |
Group A - Placebo | -0.48 | -0.61 |
Group B - Duloxetine | -0.44 | -0.57 |
Group B - Placebo | -0.41 | -0.78 |
Item 1=Average musculoskeletal pain severity over the last week as measured by an 11-point Likert scale. Scores range from 0 (no pain) to 10 (worst possible pain). Item 7=How much they have been bothered by pain over the last week. Scores range from 0 (not bothered at all)to 10 (extremely bothered). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Item 1 - 12 Week Change | Item 7 - 12 Week Change | Item 1 - 9 Month Change (n=29, n=9, n=33, n=10) | Item 7 - 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -1.14 | -1.33 | -1.30 | -1.56 |
Group A - Placebo | -1.35 | -1.73 | -0.10 | -0.42 |
Group B - Duloxetine | -0.96 | -1.14 | -2.10 | -2.24 |
Group B - Placebo | -1.16 | -1.36 | -2.36 | -2.11 |
(NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | beats per minute (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=28, n=9, n=33, n=10) | |
Group A - Duloxetine | 1.40 | 1.08 |
Group A - Placebo | -1.52 | -0.30 |
Group B - Duloxetine | 0.68 | 1.18 |
Group B - Placebo | -2.05 | -3.04 |
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Please see baseline demographics for subscale total scores. (NCT00536471)
Timeframe: Baseline, 8 weeks, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Total Score 12 Week Change (n=194,n=59,n=195,n=64) | Maier 8 Week Change (n=214,n=102,n=220,n=110) | Anxiety 12 Week Change (n=194,n=59,n=195,n=64) | Bech 12 Week Change (n=194,n=59,n=195,n=64) | Retardation 12 Week Change (n=194,n=59,n=195,n=64) | Sleep 12 Week Change (n=194,n=59,n=195,n=64) | Total Score 9 Month Change (n=29,n=9,n=33,n=10) | Anxiety 9 Month Change (n=29,n=9,n=33,n=10) | Bech 9 Month Change (n=29,n=9,n=33,n=10) | Retardation 9 Month Change (n=29,n=9,n=33,n=10) | Sleep 9 Month Change (n=29,n=9,n=33,n=10) | |
Group A - Duloxetine | -12.64 | -6.11 | -3.52 | -7.38 | -4.72 | -2.08 | -14.38 | -4.09 | -8.56 | -5.35 | -2.77 |
Group A - Placebo | -10.33 | -4.69 | -3.12 | -6.17 | -4.06 | -1.72 | -13.38 | -3.88 | -8.02 | -5.83 | -2.56 |
Group B - Duloxetine | -12.11 | -6.13 | -3.52 | -6.98 | -4.49 | -1.91 | -9.56 | -3.44 | -5.80 | -3.68 | -2.55 |
Group B - Placebo | -8.48 | -4.45 | -2.44 | -4.70 | -3.05 | -1.48 | -5.92 | -2.77 | -4.35 | -2.52 | -1.95 |
Measures depressed mood on a scale of 0 (absent) to 4 (very depressed). (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=33, n=10) | |
Group A - Duloxetine | -1.86 | -1.44 |
Group A - Placebo | -1.52 | -1.26 |
Group B - Duloxetine | -1.78 | -1.98 |
Group B - Placebo | -1.15 | -1.65 |
(NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=8, n=32, n=10) | |
Group A - Duloxetine | -16.24 | -17.05 |
Group A - Placebo | -13.24 | -15.22 |
Group B - Duloxetine | -15.60 | -13.49 |
Group B - Placebo | -10.94 | -9.12 |
A 7-item patitent-rated questionnaire pertaining to a patient's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each of the 7 questions is scored on a 6-point scale ranging fom 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42. (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=29, n=9, n=32, n=10) | |
Group A - Duloxetine | -7.60 | -7.17 |
Group A - Placebo | -6.39 | -7.13 |
Group B - Duloxetine | -7.96 | -8.19 |
Group B - Placebo | -6.85 | -6.77 |
A 21-item self-rated scale that evaluates patient social motivation and behavior in depression. Each of the 21 items is scored from 0 (minimal social adjustment) to 3 (maximal social adjustment). Total score ranges from 0 to 60. (NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=28, n=9, n=30, n=10) | |
Group A - Duloxetine | 7.18 | 8.00 |
Group A - Placebo | 3.40 | 5.30 |
Group B - Duloxetine | 7.54 | 13.81 |
Group B - Placebo | 4.52 | 9.28 |
(NCT00536471)
Timeframe: Baseline, 12 weeks, 9 months
Intervention | kilograms (Least Squares Mean) | |
---|---|---|
12 Week Change | 9 Month Change (n=28, n=9, n=33, n=10) | |
Group A - Duloxetine | -0.54 | -1.18 |
Group A - Placebo | 0.38 | -0.44 |
Group B - Duloxetine | -0.38 | -0.94 |
Group B - Placebo | -0.23 | 0.06 |
The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig). (NCT00536471)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | ||||||
---|---|---|---|---|---|---|---|
Total Score (n=192,n=54,n=185,n=61) | Tension-Anxiety (n=193,n=58,n=193,n=62) | Depression-Dejection (n=193,n=58,n=191,n=62) | Anger-Hostility (n=193,n=58,n=192,n=63) | Vigor-Activity (n=192,n=55,192,n=63) | Fatigue-Inertia (n=193,n=57,n=190,n=63) | Confusion-Bewilderment (n=192,n=58,n=189,n=62) | |
Group A - Duloxetine | -26.41 | -4.37 | -6.30 | -4.46 | 2.55 | -5.30 | -3.62 |
Group A - Placebo | -18.88 | -3.20 | -4.64 | -3.09 | 1.82 | -4.68 | -2.86 |
Group B - Duloxetine | -28.67 | -4.61 | -6.78 | -4.94 | 2.57 | -6.08 | -3.56 |
Group B - Placebo | -22.67 | -4.05 | -5.03 | -3.63 | 1.48 | -5.54 | -3.10 |
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. (NCT00536471)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Work Life (n=133,n=43,n=140,n=49) | Social Life (n=194,n=59,n=195,n=63) | Family Life (n=194,n=59,n=195,n=63) | Total Score (n=195,n=59,n=195,n=63) | |
Group A - Duloxetine | -2.47 | -2.93 | -2.81 | -8.32 |
Group A - Placebo | -2.12 | -2.50 | -2.19 | -6.84 |
Group B - Duloxetine | -1.98 | -2.67 | -2.66 | -7.70 |
Group B - Placebo | -1.22 | -1.97 | -1.56 | -4.94 |
The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig). (NCT00536471)
Timeframe: Baseline, 9 months
Intervention | units on a scale (Least Squares Mean) | ||||||
---|---|---|---|---|---|---|---|
Total Score | Tension-Anxiety | Depression-Dejection | Anger-Hostility | Vigor-Activity | Fatigue-Inertia | Confusion-Bewilderment | |
Group A - Duloxetine | -25.67 | -5.36 | -7.60 | -4.34 | 2.63 | -7.43 | -3.95 |
Group A - Placebo | -22.99 | -4.18 | -6.49 | -3.38 | 3.11 | -7.40 | -2.47 |
Group B - Duloxetine | -28.39 | -4.68 | -7.18 | -5.98 | 2.00 | -6.34 | -3.54 |
Group B - Placebo | -25.51 | -3.50 | -5.56 | -4.99 | 3.04 | -7.03 | -3.07 |
Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00552175)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | -1.61 |
Duloxetine 40 mg and 60 mg Combined | -2.47 |
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score ranges from 0 (no depression) to 63 (severe depression). (NCT00552175)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | -3.28 |
Duloxetine 40 mg | -2.94 |
Duloxetine 60 mg | -3.83 |
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score ranges from 0 (no depression) to 63 (severe depression). (NCT00552175)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | -3.27 |
Duloxetine 40 mg and 60 mg Combined | -3.37 |
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00552175)
Timeframe: Week 12
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | 3.18 |
Duloxetine 40 mg | 2.53 |
Duloxetine 60 mg | 2.52 |
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00552175)
Timeframe: Week 12
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | 3.18 |
Duloxetine 40 mg and 60 mg Combined | 2.53 |
Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00552175)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Worst Pain | Night Pain | |
Duloxetine 40 mg | -2.42 | -2.33 |
Duloxetine 60 mg | -2.59 | -2.45 |
Placebo | -1.55 | -1.56 |
Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00552175)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | -1.61 |
Duloxetine 40 mg | -2.41 |
Duloxetine 60 mg | -2.53 |
Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT00552175)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Worst Pain | Night Pain | |
Duloxetine 40 mg and 60 mg Combined | -2.51 | -2.39 |
Placebo | -1.55 | -1.56 |
The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10. (NCT00552175)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Least Squares Mean) | |||||||
---|---|---|---|---|---|---|---|---|
General Activity | Mood | Walking Ability | Normal Work | Relation to People | Sleep | Enjoyment of Life | Average of Interference Scores | |
Duloxetine 40 mg | -2.48 | -2.18 | -2.32 | -1.84 | -1.16 | -2.26 | -1.96 | -2 |
Duloxetine 60 mg | -2.1 | -2.39 | -2.31 | -1.9 | -1.49 | -2.05 | -2.35 | -2.08 |
Placebo | -1.88 | -1.91 | -1.82 | -1.49 | -0.77 | -1.69 | -1.59 | -1.56 |
The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10. (NCT00552175)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Least Squares Mean) | |||||||
---|---|---|---|---|---|---|---|---|
General Activity | Mood | Walking Ability | Normal Work | Relation to People | Sleep | Enjoyment of Life | Average of Interference Scores | |
Duloxetine 40 mg and 60 mg Combined | -2.29 | -2.28 | -2.31 | -1.86 | -1.32 | -2.15 | -2.15 | -2.04 |
Placebo | -1.88 | -1.91 | -1.82 | -1.49 | -0.77 | -1.69 | -1.59 | -1.56 |
A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10. (NCT00552175)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Worst Pain | Least Pain | Average Pain | Pain Right Now | |
Duloxetine 40 mg | -2.51 | -1.92 | -2.53 | -2.55 |
Duloxetine 60 mg | -2.68 | -2.04 | -2.56 | -2.62 |
Placebo | -1.62 | -1.13 | -1.55 | -1.67 |
A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10. (NCT00552175)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Worst Pain | Least Pain | Average Pain | Pain Right Now | |
Duloxetine 40 mg and 60 mg Combined | -2.59 | -1.98 | -2.54 | -2.59 |
Placebo | -1.62 | -1.13 | -1.54 | -1.67 |
The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment group as a main factor and baseline NPRS score as a covariate. Change from Baseline = NPRS at baseline - NPRS at Week 4; a positive number in the LS mean indicates a reduction in pain intensity from baseline. (NCT00603265)
Timeframe: Baseline, Week 4
Intervention | units on a scale (Least Squares Mean) |
---|---|
ADL5859 | 1.02 |
Duloxetine | 1.74 |
Placebo | 1.51 |
At each of the evening pain assessments, participants assessed their overall pain intensity over the preceding 24 hours using NPRS. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained at Baseline and Week 4. Change from baseline = NPRS at baseline - NPRS at Week 4. (NCT00603265)
Timeframe: Baseline, Week 4
Intervention | units on a scale (Mean) |
---|---|
ADL5859 | 1.09 |
Duloxetine | 2.15 |
Placebo | 1.51 |
"Sleep Interference was assessed on an 11-point Numeric Rating Scale where a score of 0 indicated pain did not interfere with sleep and a score of 10 indicated pain completely interfered with sleep. Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2, and 3 because a participant could have had multiple visits during Month 1, 2, and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview. LS means were calculated using ANCOVA with treatment group as a main factor and baseline SIS score as a covariate. Change from baseline = SIS score at baseline - SIS score at Week 4." (NCT00603265)
Timeframe: Baseline, Week 4
Intervention | units on a scale (Least Squares Mean) |
---|---|
ADL5859 | 1.92 |
Duloxetine | 2.27 |
Placebo | 1.56 |
A responder was defined as a participant who showed a reduction in average pain (as measured by NPRS) of at least 30% from baseline to Week 4. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The percentage of participants who qualified as responders is presented per treatment arm. (NCT00603265)
Timeframe: Baseline, Week 4
Intervention | percentage of participants (Number) |
---|---|
ADL5859 | 26.1 |
Duloxetine | 52.4 |
Placebo | 38.8 |
The mean of the daily average scores were calculated from the NPRS pain assessments obtained 1 time per week over a 4-week period. NPRS assessments were taken after the participant walked 50 feet in the clinic. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. LS means were calculated using ANCOVA with treatment group as a main factor and baseline NPRS score as a covariate. Change from baseline = NPRS at baseline - NPRS at Weeks 1, 2, 3, and 4. (NCT00603265)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Week 1 (n=67, 59, 64) | Week 2 (n=67, 61, 65) | Week 3 (n=67, 61, 63) | Week 4 (n=68, 61, 65) | |
ADL5859 | 0.88 | 0.93 | 1.24 | 1.29 |
Duloxetine | 1.42 | 1.75 | 2.25 | 2.36 |
Placebo | 1.00 | 1.23 | 1.43 | 1.79 |
The mean of the daily average scores were calculated from the NPRS pain assessments obtained 1 time per week over a 4-week period. NPRS assessments were taken while the participant was at rest. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. LS means were calculated using ANCOVA with treatment group as a main factor and baseline NPRS score as a covariate. Change from baseline = NPRS at baseline - NPRS at Weeks 1, 2, 3, and 4. (NCT00603265)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Week 1 (n=67, 59, 64) | Week 2 (n=68, 61, 65) | Week 3 (n=67, 61, 63) | Week 4 (n=68, 61, 65) | |
ADL5859 | 0.70 | 0.80 | 0.92 | 1.13 |
Duloxetine | 1.15 | 1.44 | 1.95 | 2.03 |
Placebo | 0.75 | 1.16 | 1.27 | 1.59 |
PGIC is a participant-rated instrument that measures the change in the participant's overall status for the previous 2 weeks based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The number of participants in each category is presented. (NCT00603265)
Timeframe: Week 4
Intervention | participants (Number) | |||||||
---|---|---|---|---|---|---|---|---|
Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse | Not Reported | |
ADL5859 | 7 | 20 | 20 | 19 | 0 | 3 | 0 | 0 |
Duloxetine | 11 | 15 | 17 | 14 | 2 | 1 | 1 | 2 |
Placebo | 11 | 11 | 22 | 21 | 0 | 1 | 0 | 1 |
The mean number of binge days (days when the participant had one or more binge eating episodes) per week in the interval between visits (total number of binge days in the interval divided by number of days in the interval, then multiplied by 7). (NCT00607789)
Timeframe: 12 weeks
Intervention | Mean Number of days (Mean) |
---|---|
Duloxetine Group | 4.3 |
Placebo Group | 3.8 |
The weekly frequency of binge episodes after baseline (number of binge eating days during the 12-week period divided by 7) (NCT00607789)
Timeframe: 12 weeks
Intervention | Days (Mean) |
---|---|
Duloxetine Group | 4.7 |
Placebo Group | 4.2 |
"The primary outcome measure is the visual analog scale (VAS) for pain, a 10 cm line upon which the subject marks their intensity of pain. The line is anchored on the left as No pain at all and on the right as The worst pain imaginable. The score is the number of millimeters from the left origin of the line. The primary outcome measure for each period was the average value of all assessments for that period (2 weeks of measures for baseline, 6 weeks of measures for test drug alone, 6 weeks of measures for test drug plus gabapentin, and 2 weeks of measures for gabapentin alone)." (NCT00619983)
Timeframe: Study completion (16 weeks)
Intervention | units on a scale (Median) | |||
---|---|---|---|---|
Baseilne ( weeks) | Test drug alone (6 weeks) | Drug plus gabapentin (6 weeks) | Gabapentin alone (2 weeks) | |
Donepezil | 3.3 | 4.1 | 2.9 | 2.2 |
Donepezil + Duloxetine | 5.8 | 5.2 | 3.9 | 4.3 |
Duloxetine | 6.4 | 2.9 | 2.7 | 3.0 |
Placebo | 4.9 | 3.9 | 4.1 | 4.1 |
The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe. (NCT00635219)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | -9.57 |
Vortioxetine 2.5 mg | -9.87 |
Vortioxetine 5 mg | -10.7 |
Vortioxetine 10 mg | -10.6 |
Duloxetine 60 mg | -11.0 |
"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction." (NCT00635219)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | -0.41 |
Vortioxetine 2.5 mg | -0.53 |
Vortioxetine 5 mg | -0.66 |
Vortioxetine 10 mg | -0.62 |
Duloxetine 60 mg | -0.38 |
The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. (NCT00635219)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | -1.64 |
Vortioxetine 2.5 mg | -1.83 |
Vortioxetine 5 mg | -1.81 |
Vortioxetine 10 mg | -1.83 |
Duloxetine 60 mg | -1.82 |
The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe. (NCT00635219)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | -13.3 |
Vortioxetine 2.5 mg | -14.4 |
Vortioxetine 5 mg | -15.0 |
Vortioxetine 10 mg | -14.9 |
Duloxetine 60 mg | -15.7 |
(NCT00635219)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | -14.7 |
Vortioxetine 2.5 mg | -14.3 |
Vortioxetine 5 mg | -15.8 |
Vortioxetine 10 mg | -15.8 |
Duloxetine 60 mg | -17.3 |
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. (NCT00635219)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | -14.8 |
Vortioxetine 2.5 mg | -16.2 |
Vortioxetine 5 mg | -16.5 |
Vortioxetine 10 mg | -16.3 |
Duloxetine 60 mg | -16.8 |
The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe. (NCT00635219)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | -6.11 |
Vortioxetine 2.5 mg | -7.10 |
Vortioxetine 5 mg | -6.52 |
Vortioxetine 10 mg | -7.81 |
Duloxetine 60 mg | -7.91 |
The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. (NCT00635219)
Timeframe: Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | 2.52 |
Vortioxetine 2.5 mg | 2.32 |
Vortioxetine 5 mg | 2.32 |
Vortioxetine 10 mg | 2.35 |
Duloxetine 60 mg | 2.31 |
(NCT00635219)
Timeframe: Week 8
Intervention | percentage of patients (Number) |
---|---|
Placebo | 33.8 |
Vortioxetine 2.5 mg | 32.9 |
Vortioxetine 5 mg | 36.1 |
Vortioxetine 10 mg | 35.8 |
Duloxetine 60 mg | 34.9 |
(NCT00635219)
Timeframe: Week 8
Intervention | percentage of patients (Number) |
---|---|
Placebo | 46.9 |
Vortioxetine 2.5 mg | 54.2 |
Vortioxetine 5 mg | 56.1 |
Vortioxetine 10 mg | 57.6 |
Duloxetine 60 mg | 57.1 |
See the Reported Adverse Events section for details. (NCT00641719)
Timeframe: baseline through 1 year
Intervention | participants (Number) | |
---|---|---|
Serious Adverse Events | Adverse Events | |
Duloxetine 40 mg | 11 | 126 |
Duloxetine 60 mg | 22 | 121 |
Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00641719)
Timeframe: baseline, 1 year
Intervention | units on a scale (Mean) | |||||||
---|---|---|---|---|---|---|---|---|
General Activities | Mood | Walking Ability | Normal Work | Relation to People | Sleep | Enjoyment of Life | Average Score | |
Duloxetine 40 mg | -1.1 | -1.1 | -0.8 | -1.0 | -0.6 | -1.0 | -0.8 | -0.93 |
Duloxetine 60 mg | -1.3 | -1.0 | -1.0 | -1.0 | -0.7 | -1.1 | -0.8 | -1.00 |
A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. (NCT00641719)
Timeframe: baseline, 1 year
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
Worst Pain | Least Pain | Average Pain | Pain Right Now | |
Duloxetine 40 mg | -2.2 | -1.6 | -2.1 | -1.8 |
Duloxetine 60 mg | -2.3 | -1.6 | -2.1 | -1.8 |
A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. (NCT00641719)
Timeframe: 1 year
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
Worst Pain | Least Pain | Average Pain | Pain Right Now | |
Duloxetine 40 mg | 2.4 | 1.3 | 1.8 | 1.7 |
Duloxetine 60 mg | 2.6 | 1.5 | 1.9 | 1.7 |
Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00641719)
Timeframe: 1 year
Intervention | units on a scale (Mean) | |||||||
---|---|---|---|---|---|---|---|---|
General Activities | Mood | Walking Ability | Normal Work | Relation to People | Sleep | Enjoyment of Life | Average Score | |
Duloxetine 40 mg | 1.4 | 1.2 | 1.4 | 1.2 | 1.0 | 1.2 | 1.2 | 1.21 |
Duloxetine 60 mg | 1.4 | 1.3 | 1.3 | 1.3 | 1.1 | 1.3 | 1.3 | 1.28 |
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00641719)
Timeframe: 1 year
Intervention | units on a scale (Mean) |
---|---|
Duloxetine 40 mg | 2.1 |
Duloxetine 60 mg | 2.1 |
A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. (NCT00641719)
Timeframe: baseline, 1 year
Intervention | units on a scale (Mean) |
---|---|
Duloxetine 40 mg | 0.2 |
Duloxetine 60 mg | -0.7 |
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00641719)
Timeframe: baseline, 1 year
Intervention | units on a scale (Mean) |
---|---|
Duloxetine 40 mg | -0.9 |
Duloxetine 60 mg | -1.0 |
A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. (NCT00641719)
Timeframe: 1 year
Intervention | units on a scale (Mean) |
---|---|
Duloxetine 40 mg | 6.3 |
Duloxetine 60 mg | 5.4 |
The SDS is a participant-rated anchored visual analog scale to assess disability across the three domains of work/school, social life, and family life, with each item scored from 0 (not at all) to 10 (very severely), with a summarization of the 3 items to evaluate global functioning. The Global Functional Impairment Score is a total score score that ranges from 0 (unimpaired) to 30 (highly impaired), and was used to derived the mean change from baseline to endpoint. (NCT00666757)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -13.56 |
Selective Serotonin Reuptake Inhibitor (SSRI) | -11.53 |
The SDS is completed by the participant and Item 3 is used to assess the effect of the participant's symptoms on their family life/home responsibilities. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's family life/home responsibilities. (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -4.51 |
Selective Serotonin Reuptake Inhibitor (SSRI) | -3.94 |
The SDS is completed by the participant and Item 1 is used to assess the effect of the participant's symptoms on their work/school schedule. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's work/school life. (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -4.52 |
Selective Serotonin Reuptake Inhibitor (SSRI) | -3.85 |
The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation. Scores range from 0 (none) to 27 (very severe). The QIDS-SR total score was used to derive the mean change from baseline to endpoint depression. (NCT00666757)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -13.4 |
Selective Serotonin Reuptake Inhibitor (SSRI) | -12.6 |
Mean change from baseline to endpoint in pulse rate (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | beats per minute (bpm) (Least Squares Mean) |
---|---|
Duloxetine | 2.74 |
Selective Serotonin Reuptake Inhibitor (SSRI) | 0.47 |
The HAMD-17 is a rater-administered assessment of depression severity and improvement, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -17.03 |
Selective Serotonin Reuptake Inhibitor (SSRI) | -15.3 |
The HAMD-17 Sleep Subscale consists of Items 4, 5, 6 and evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty). (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -2.77 |
Selective Serotonin Reuptake Inhibitor (SSRI) | -2.58 |
The HAMD-17 Retardation subscale consists of Items 1, 7, 8, 14 and evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe). (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -5.99 |
Selective Serotonin Reuptake Inhibitor (SSRI) | -5.49 |
"HAMD-17 Maier Subscale consists of Items 1, 2, 7, 8, 9, 10 and represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe)." (NCT00666757)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -9.01 |
Selective Serotonin Reuptake Inhibitor (SSRI) | -8.16 |
HAMD-17 Bech subscale consists of items 1, 2, 7, 8, 10, and 13 used to evaluate core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe). (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -9.21 |
Selective Serotonin Reuptake Inhibitor (SSRI) | -8.40 |
HAMD-17 subscale consists of items 10, 11, 12, 13, 15, and 17 evaluates agitation, and severity of psychic and somatic manifestations of anxiety. Total subscale scores range from 0 (normal) to 18 (severe). Mean change from baseline to endpoint. (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -4.89 |
Selective Serotonin Reuptake Inhibitor (SSRI) | -4.24 |
Mean change from baseline to endpoint in diastolic blood pressure (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | mmHg (Least Squares Mean) |
---|---|
Duloxetine | -0.14 |
Selective Serotonin Reuptake Inhibitor (SSRI) | 0.45 |
The BPI is a self-reported scale measuring pain severity and pain-specific interference on function on a scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint, in those participants who had a BPI average 24-hour pain score of 3 or greater at baseline. (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -2.95 |
Selective Serotonin Reuptake Inhibitor (SSRI) | -2.39 |
The BPI is a self-reported scale measuring pain severity and pain-specific interference on function, with scores ranging from 0 (does not interfere) to 10 (completely interferes). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint. (NCT00666757)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -1.83 |
Selective Serotonin Reuptake Inhibitor (SSRI) | -1.43 |
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -4.69 |
Selective Serotonin Reuptake Inhibitor (SSRI) | -4.04 |
"Self-administered assessment used to determine a participant's work performance (employment status, absenteeism if employed, productivity while at work, usual occupation, & annual income). Tool assesses the potential impact of change in depressive symptoms on work productivity & its associated employer costs using a 0-100 scale in which 0 meant doing no work at all on days spent at work and 100 meant performing at the level of a top worker. Absolute presenteeism: difference between score for self and score for average worker in same job. Mean change baseline to endpoint is reported." (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 24.56 |
Selective Serotonin Reuptake Inhibitor (SSRI) | 20.73 |
WP score was calculated by taking midpoint of annual before-tax income reported on HPQ. A multiplier of 1.25 produced estimated direct & indirect (i.e. benefits) income. Annual hours expected to work were calculated from expected daily work hours, multiplied by 236 days. Hourly, indirect income was total direct + indirect income, divided by # of expected annual work hours. Indirect hours lost annually for WP=hours expected to be worked annually times WP percent, times hourly rate=dollars earned, and then subtracted from total direct + indirect income=dollars lost annually due to WP. (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | dollars (Least Squares Mean) |
---|---|
Duloxetine | 7250.93 |
Selective Serotonin Reuptake Inhibitor (SSRI) | 5074.09 |
Self-administered assessment used to determine a participant's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Scale ranges from 0 to 100% of work days in past 30 days. Absenteeism and presenteeism were combined into a measure of total lost work performance by adding absenteeism to the value ([100-absenteeism] × [100-presenteeism]). Mean change baseline to endpoint. (NCT00666757)
Timeframe: Baseline, 12 weeks
Intervention | dollars (Least Squares Mean) |
---|---|
Duloxetine | -3978.98 |
Selective Serotonin Reuptake Inhibitor (SSRI) | -1932.46 |
Self-administered assessment used to determine a subject's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Defined on a 0-100 scale for the percentage of work days the respondent missed in the past 30 days. Absolute absenteeism: actual hours worked minus expected hours equals number of missed work days. Mean change baseline to endpoint is reported. (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | hours lost per week (Least Squares Mean) |
---|---|
Duloxetine | -9.56 |
Selective Serotonin Reuptake Inhibitor (SSRI) | 0.41 |
Mean change from baseline to endpoint in weight (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | kilograms (kg) (Least Squares Mean) |
---|---|
Duloxetine | -0.32 |
Selective Serotonin Reuptake Inhibitor (SSRI) | -0.17 |
Mean change from baseline to endpoint in systolic blood pressure (NCT00666757)
Timeframe: Baseline, 12 Weeks
Intervention | millimeters of mmercury (mmHg) (Least Squares Mean) |
---|---|
Duloxetine | 0.58 |
Selective Serotonin Reuptake Inhibitor (SSRI) | 0.55 |
Visitwise percentages of participants meeting response criteria (50% reduction from baseline QIDS-SR total score at 12-week endpoint) were estimated using a categorical, pseudolikelihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline QIDS-SR. The primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, and represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy. (NCT00666757)
Timeframe: Baseline, 12-Weeks
Intervention | Probability of response (Least Squares Mean) |
---|---|
Duloxetine | 0.71 |
Selective Serotonin Reuptake Inhibitor (SSRI) | 0.64 |
Visitwise percentages of participants meeting response criteria 50% reduction from baseline in HAMD-17 total score at 12-Week endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, & represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy. (NCT00666757)
Timeframe: Baseline, 12-Weeks
Intervention | Probability of response (Least Squares Mean) |
---|---|
Duloxetine | 0.73 |
Selective Serotonin Reuptake Inhibitor (SSRI) | 0.61 |
Visitwise percentages of participants meeting remission criteria HAMD-17 total score [TS] =7 at week 12 endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be contrast of remission rates at week 12 endpoint between treatment groups, & represents estimated remission rates for each treatment group had all participants completed 12 weeks of therapy. (NCT00666757)
Timeframe: 12 weeks
Intervention | Probability of remission (Least Squares Mean) |
---|---|
Duloxetine | 0.53 |
Selective Serotonin Reuptake Inhibitor (SSRI) | 0.44 |
Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score [TS]=5 at week 12 endpoint) were estimated using a pseudolikelihood-based mixed-models repeated measures analysis for a categorical outcome, model included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit & continuous, fixed covariate of baseline QIDS-SR TS, and random effect of participant. Primary analysis contrasted remission probability at week 12 endpoint between treatment groups. (NCT00666757)
Timeframe: 12 weeks
Intervention | Probability of remission (Least Squares Mean) |
---|---|
Duloxetine | 0.36 |
Selective Serotonin Reuptake Inhibitor (SSRI) | 0.32 |
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672620)
Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8.
Intervention | scores on a scale (Least Squares Mean) | ||||
---|---|---|---|---|---|
Week 1 (n=142, 143, 150, 147) | Week 2 (n=149, 146, 153, 149) | Week 4 (n=149, 146, 153, 149) | Week 6 (n=149, 146, 153, 149) | Week 8 (n=149, 146, 153, 149) | |
Duloxetine 60 mg | -0.44 | -0.75 | -1.12 | -1.39 | -1.56 |
Placebo | -0.28 | -0.63 | -0.92 | -1.11 | -1.14 |
Vortioxetine 2.5 mg | -0.40 | -0.65 | -0.92 | -1.08 | -1.21 |
Vortioxetine 5 mg | -0.37 | -0.66 | -0.90 | -1.08 | -1.17 |
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672620)
Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8.
Intervention | scores on a scale (Least Squares Mean) | ||||
---|---|---|---|---|---|
Week 1 (n=142, 143, 150, 147) | Week 2 (n=149, 146, 153, 149) | Week 4 (n=149, 146, 153, 149) | Week 6 (n=149, 146, 153, 149) | Week 8 (n=149, 146, 153, 149) | |
Duloxetine 60 mg | -2.30 | -3.94 | -4.88 | -6.15 | -6.56 |
Placebo | -2.63 | -3.82 | -5.12 | -5.84 | -5.75 |
Vortioxetine 2.5 mg | -2.98 | -4.41 | -5.10 | -5.77 | -5.91 |
Vortioxetine 5 mg | -2.55 | -3.76 | -4.25 | -4.89 | -5.29 |
A sustained response is defined as a ≥ 20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8. (NCT00672620)
Timeframe: Baseline to Week 8
Intervention | percentage of participants (Number) |
---|---|
Placebo | 12.1 |
Vortioxetine 2.5 mg | 15.8 |
Vortioxetine 5 mg | 17.0 |
Duloxetine 60 mg | 21.5 |
The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment and center as fixed factors and the CGI-S Baseline value as a covariate. (NCT00672620)
Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8.
Intervention | scores on a scale (Least Squares Mean) | ||||
---|---|---|---|---|---|
Week 1 (n=142, 143, 149, 147) | Week 2 (n=149, 146, 153, 149) | Week 4 (149, 146, 153, 149) | Week 6 (149, 146, 153, 149) | Week 8 (n=149, 146, 153, 149) | |
Duloxetine 60 mg | 3.31 | 2.99 | 2.73 | 2.50 | 2.39 |
Placebo | 3.54 | 3.21 | 2.97 | 2.83 | 2.79 |
Vortioxetine 2.5 mg | 3.42 | 3.17 | 2.93 | 2.82 | 2.73 |
Vortioxetine 5 mg | 3.46 | 3.10 | 2.87 | 2.74 | 2.63 |
The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672620)
Timeframe: Baseline and Weeks 1, 4 and 8
Intervention | scores on a scale (Least Squares Mean) | ||
---|---|---|---|
Week 1 (n=141, 142, 149, 146) | Week 4 (148, 145, 152, 149) | Week 8 (n=148, 145, 152, 149) | |
Duloxetine 60 mg | -2.88 | -4.89 | -5.70 |
Placebo | -2.51 | -4.02 | -4.25 |
Vortioxetine 2.5 mg | -2.43 | -3.65 | -3.98 |
Vortioxetine 5 mg | -2.74 | -3.69 | -4.04 |
Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks. (NCT00672620)
Timeframe: Baseline and Week 8
Intervention | participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline: Any resource use | Baseline: Any hospitalization-related services | Baseline: Hospitalization related to depression | Baseline: Any sick leave | Baseline: Sick leave related to depression | Week 8: Any resource use | Week 8: Any hospitalization-related service | Week 8: Hospitalization related to depression | Week 8: Any sick leave | Week 8: Sick leave related to depression | |
Duloxetine 60 mg | 42 | 3 | 0 | 14 | 11 | 27 | 2 | 1 | 5 | 2 |
Placebo | 40 | 4 | 2 | 18 | 13 | 21 | 1 | 0 | 5 | 2 |
Vortioxetine 2.5 mg | 51 | 1 | 1 | 11 | 9 | 19 | 0 | 0 | 5 | 4 |
Vortioxetine 5 mg | 42 | 0 | 0 | 11 | 10 | 20 | 1 | 0 | 9 | 3 |
The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with terms for treatment and center as factors and the Baseline rank value as a covariate. (NCT00672620)
Timeframe: Baseline and Weeks 1, 2, 4, and 6
Intervention | scores on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Week 1 (n=142, 143, 150, 147) | Week 2 (n=149, 146, 153, 149) | Week 4 (n=149, 146, 153, 149) | Week 6 (n=149, 146, 153, 149) | |
Duloxetine 60 mg | -5.66 | -8.42 | -10.88 | -12.78 |
Placebo | -5.12 | -7.19 | -9.39 | -10.43 |
Vortioxetine 2.5 mg | -5.44 | -7.95 | -9.94 | -11.21 |
Vortioxetine 5 mg | -5.28 | -7.99 | -8.96 | -10.97 |
The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672620)
Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8
Intervention | scores on a scale (Least Squares Mean) | ||||
---|---|---|---|---|---|
Week 1 (n=142, 143, 150, 147) | Week 2 (n=149, 146, 153, 149) | Week 4 (n=149, 146, 153, 149) | Week 6 (n=149, 146, 153, 149) | Week 8 (149, 146, 153, 149) | |
Duloxetine 60 mg | -5.49 | -8.95 | -11.34 | -13.29 | -14.10 |
Placebo | -4.90 | -7.57 | -9.66 | -11.04 | -11.22 |
Vortioxetine 2.5 mg | -5.16 | -7.71 | -9.58 | -11.25 | -11.61 |
Vortioxetine 5 mg | -5.06 | -7.81 | -9.35 | -11.27 | -11.30 |
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672620)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|---|
Placebo | -6.83 |
Vortioxetine 2.5 mg | -6.46 |
Vortioxetine 5 mg | -6.59 |
Duloxetine 60 mg | -8.91 |
A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state. (NCT00672620)
Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8.
Intervention | percentage of participants (Number) | ||||
---|---|---|---|---|---|
Week 1 (n=142, 143, 150, 147) | Week 2 (n=149, 146, 153, 149) | Week 4 (n=149, 146, 153, 149) | Week 6 (n=149, 146, 153, 149) | Week 8 (n=149, 146, 153, 149) | |
Duloxetine 60 mg | 10.2 | 22.1 | 34.9 | 47.0 | 51.0 |
Placebo | 9.2 | 15.4 | 26.2 | 32.9 | 32.2 |
Vortioxetine 2.5 mg | 8.4 | 17.1 | 30.8 | 37.7 | 41.1 |
Vortioxetine 5 mg | 8.7 | 17.6 | 24.2 | 37.3 | 37.9 |
The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with terms for treatment and center as factors and the Baseline rank value as a covariate. (NCT00672620)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|---|
Placebo | -10.50 |
Vortioxetine 2.5 mg | -12.04 |
Vortioxetine 5 mg | -11.08 |
Duloxetine 60 mg | -13.47 |
Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT00672620)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|---|
Placebo | 22.8 |
Vortioxetine 2.5 mg | 28.8 |
Vortioxetine 5 mg | 23.5 |
Duloxetine 60 mg | 37.6 |
(NCT00673452)
Timeframe: Baseline, 12 weeks
Intervention | mm Hg (Least Squares Mean) | |
---|---|---|
Systolic Blood Pressure (SBP) | Diastolic Blood Pressure (DBP) | |
Duloxetine | 1.09 | 0.83 |
Placebo | -0.72 | 0.31 |
The patient-rated SF-36 consists of 36 questions covering eight health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores: the Physical Component Summary and the Mental Component Summary are constructed based on the eight SF-36 domains. (NCT00673452)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Bodily Pain | General Health | Mental Health | Physical Functioning | Role-Emotional | Role-Physical | Social Functioning | Vitality | Physical Component Summary (PCS) | Mental Component Summary (MCS) | |
Duloxetine | 18.48 | 9.33 | 10.05 | 13.52 | 14.91 | 20.49 | 14.16 | 12.78 | 5.96 | 5.11 |
Placebo | 13.26 | 2.91 | 2.61 | 8.06 | 5.13 | 18.90 | 7.49 | 8.47 | 4.81 | 1.28 |
Response was defined as at least 50% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). (NCT00673452)
Timeframe: 12 weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 83 |
Placebo | 55 |
Response was defined as at least 30% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). (NCT00673452)
Timeframe: 12 Weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 119 |
Placebo | 88 |
(NCT00673452)
Timeframe: Baseline, 12 weeks
Intervention | kilograms (kg) (Least Squares Mean) |
---|---|
Duloxetine | -0.62 |
Placebo | 0.21 |
"The MGH-CPFQ is a self-report instrument consisting of seven questions pertaining to an individual's cognitive and physical well-being. Each question is rated 1 = greater than normal to 6 = totally absent. Total score ranges from 7 to 42." (NCT00673452)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -4.88 |
Placebo | -3.92 |
(NCT00673452)
Timeframe: Baseline, 12 weeks
Intervention | beats per minute (bpm) (Least Squares Mean) |
---|---|
Duloxetine | 1.76 |
Placebo | -0.20 |
The Clinical Global Impressions of Severity (CGI-Severity) scale evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). (NCT00673452)
Timeframe: Baseline, 12 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -1.05 |
Placebo | -0.71 |
BDI-II is a 21-item patient-completed questionnaire designed to assess characteristics of depression. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms. (NCT00673452)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -5.53 |
Placebo | -3.63 |
BAI is a 21-item patient-completed questionnaire designed to assess characteristics of anxiety. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of anxiety symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms. (NCT00673452)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -3.14 |
Placebo | -3.22 |
BPI is a self-reported form that assesses severity of pain and the interference of pain on function. There are 4 questions assessing the severity for worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Interference scores range from 0 (does not interfere) to 10 (completely interferes). (NCT00673452)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Worst Pain Severity | Least Pain Severity | Average Pain Severity | Pain Right Now Severity | General Activity Interference | Mood Interference | Walking Ability Interference | Normal Work Interference | Relations with Other People Interference | Sleep Interference | Enjoyment of Life Interference | Average Interference | |
Duloxetine | -2.32 | -1.57 | -2.14 | -2.10 | -2.38 | -2.56 | -2.16 | -2.37 | -2.17 | -2.69 | -2.84 | -2.44 |
Placebo | -1.57 | -0.96 | -1.40 | -1.34 | -1.44 | -1.61 | -1.36 | -1.60 | -1.22 | -1.81 | -1.45 | -1.52 |
MFI is a 20-item, self-reporting instrument designed to collect data on the following 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each dimension score is derived by summing the scores of the 4 individual items that pertain to each dimension. Item scores range from 1 to 5; thus, dimensional scores range from 4 to 20 with a higher score reflecting greater levels of fatigue. (NCT00673452)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | ||||
---|---|---|---|---|---|
General Fatigue | Physical Fatigue | Mental Fatigue | Reduced Activity | Reduced Motivation | |
Duloxetine | -2.21 | -2.08 | -2.01 | -1.46 | -1.66 |
Placebo | -1.38 | -1.35 | -1.09 | -0.59 | -0.72 |
Likert scales are patient-rated assessments. Mood: feeling low, sad or depressed; rated 0 = not feeling low, sad or depressed to 10 = feeling extremely low, sad or depressed. Anxious: anxious feelings; rated 0 = not feeling anxious to 10 = extremely anxious. Sleep: how much patient bothered by sleep difficulties; rated 0 = not bothered to 10 = extremely bothered. Pain: how much patient bothered by painful physical discomforts; rated 0 = not bothered to 10 = extremely bothered. Stiffness: how stiff patient felt in past 24 hours; rated 0 = not felt any stiffness to 10 = felt extremely stiff. (NCT00673452)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | ||||
---|---|---|---|---|---|
Mood | Anxiety | Pain | Sleep | Stiffness | |
Duloxetine | -1.27 | -1.22 | -2.45 | -1.96 | -2.54 |
Placebo | -0.52 | -0.58 | -1.73 | -1.47 | -1.67 |
"C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide." (NCT00673452)
Timeframe: Baseline through 12 Weeks
Intervention | participants (Number) | ||
---|---|---|---|
Suicidal Ideation | Suicidal Behavior | Suicidal Acts | |
Duloxetine | 6 | 0 | 0 |
Placebo | 7 | 0 | 0 |
"The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is very much improved, a score of 4 indicates that the patient has experienced no change, and a score of 7 indicates that the patient is very much worse." (NCT00673452)
Timeframe: 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 2.79 |
Placebo | 3.36 |
"The MADRS is a rating of depression severity with theoretical scale range 0-60, with lower values representing better outcome~Larger reduction between MADRS from baseline to 12 weeks would represent better outcome" (NCT00696293)
Timeframe: baseline and 12 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine Plus Clinical Management | -11.7 |
"The McGill Pain Questionaire, short form consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The McGill Pain Questionaire score ranged from 0 (none) to 45 (severe).~A larger reduction of the score from baseline to 12 weeks would represent a better outcome" (NCT00696293)
Timeframe: Baseline and 12 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine + Clinical Management | -6.0 |
The Sleep Subscale (Items 4,5,6) evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. (NCT00696774)
Timeframe: Baseline, 8 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine Responders | -2.27 |
Duloxetine Non-Responders | -1.31 |
The Anxiety/Somatization Subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifistations of anxiety as well as agitation. Total subscale scores range from 0 (normal) to 18 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. (NCT00696774)
Timeframe: Baseline, 8 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine Responders | -5.29 |
Duloxetine Non-Responders | -3.07 |
"The Core subscale (Items 1,2,3,7,8) evaluates core symptoms of depression. Total subscale scores range from 0 (normal) to 20 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section." (NCT00696774)
Timeframe: Baseline, 8 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine Responders | -6.87 |
Duloxetine Non-Responders | -4.40 |
"The Maier subscale (Items 1,2,7,8,9,10) represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section." (NCT00696774)
Timeframe: Baseline, 8 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine Responders | -8.58 |
Duloxetine Non-Responders | -5.29 |
The Retardation Subscale (Items 1,7,8,14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. (NCT00696774)
Timeframe: Baseline, 8 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine Responders | -5.51 |
Duloxetine Non-Responders | -3.63 |
A 14-item patient-rated scale assesses medication-related changes in sexual activity/functioning. Items rated from 1 (never, low enjoyment/pleasure) to 5 (every day, great enjoyment/pleasure). CSFQ measures 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Lower total scores are associated with diminished sexual functioning. Total scores <=47 (men) and <=41 (women) indicate global sexual dysfunction, with all phases of sexual response cycle affected. Factors used for adjustment for least squares means are in 'Other relevant information' section. (NCT00696774)
Timeframe: Baseline, 4 Weeks, 8 weeks
Intervention | Units on a scale (Least Squares Mean) | |
---|---|---|
Week 4 | Week 8 | |
Duloxetine Non-Responders | -0.78 | -0.29 |
Duloxetine Responders | 0.03 | 1.08 |
The HAMD-17 total score measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. (NCT00696774)
Timeframe: Baseline, 8 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine Responders | -15.64 |
Duloxetine Non-Responders | -9.79 |
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Factors used for adjustment for least squares means are listed in 'Other relevant information' section. (NCT00696774)
Timeframe: Baseline, 4 weeks, 8 weeks
Intervention | Units on a scale (Least Squares Mean) | |
---|---|---|
Week 4 | Week 8 | |
Duloxetine Non-Responders | -2.49 | -5.36 |
Duloxetine Responders | -8.38 | -9.95 |
The TSQM is a participant-reported measure that best describes how the study medication makes them feel since the last study visit, assessing perceived effectiveness, severity of side effects, and convenience. Convenience, Effectiveness, Side-Effects, and Global Satisfaction scale scores range from 0 (extremely dissatisfied) to 100 (extremely satisfied). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. (NCT00696774)
Timeframe: Baseline, 4 weeks, 8 weeks
Intervention | Units on a scale (Least Squares Mean) | |
---|---|---|
Week 4 | Week 8 | |
Duloxetine Non-Responders | 2.59 | 8.19 |
Duloxetine Responders | 17.64 | 18.67 |
"BPI-SF interference score asks about the degree to which pain interferes with mood, walking and other physical activity, work, social activity, relations with others, and sleep. BPI-SF interference score ranges from 0 (no interference) to 10 (interferes completely). Response is defined as a >=50% reduction in the Maier subscale score from baseline. The Maier subscale (Items 1,2,7,8,9,10) represents core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section." (NCT00696774)
Timeframe: Baseline, 4 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine Responders | -2.35 |
Duloxetine Non-Responders | -1.69 |
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. (NCT00696774)
Timeframe: 8 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine Responders | 2.12 |
Duloxetine Non-Responders | 2.61 |
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. (NCT00696774)
Timeframe: Baseline, 8 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine Responders | -2.56 |
Duloxetine Non-Responders | -2.14 |
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. (NCT00696774)
Timeframe: Baseline, 8 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine Responders | -2.52 |
Duloxetine Non-Responders | -1.40 |
The HAMA scale measures anxiety symptoms accompanying major depressive disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. Factors used for adjustment for least squares means are listed in 'Other relevant information' section. (NCT00696774)
Timeframe: Baseline, 8 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine Responders | -12.97 |
Duloxetine Non-Responders | -8.55 |
"The Maier subscale (Items 1,2,7,8,9,10) represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Response is defined as a >=50% reduction in the Maier subscale score from baseline." (NCT00696774)
Timeframe: Baseline, 4 weeks, 8 weeks
Intervention | Percentage of participants (Number) | |
---|---|---|
Week 4 (n=193) | Week 8 (n=179) | |
Duloxetine | 56.0 | 73.7 |
Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). (NCT00730691)
Timeframe: Weeks 1, 2, 4, 6 and 8
Intervention | percentage of participants (Number) | ||||
---|---|---|---|---|---|
Week 1 (n=151, 149, 142, 149, 143) | Week 2 (n=154, 154, 147, 154, 149) | Week 4 (n=154, 154, 148, 154, 149) | Week 6 (n=154, 154, 148, 154, 149) | Week 8 (n=154, 154, 148, 154, 149) | |
Duloxetine 60 mg | 4.9 | 12.1 | 17.4 | 20.8 | 28.2 |
Placebo | 4.0 | 6.5 | 10.4 | 16.2 | 22.1 |
Vortioxetine 10 mg | 2.0 | 3.9 | 13.0 | 16.9 | 20.1 |
Vortioxetine 2.5 mg | 2.0 | 8.4 | 13.6 | 14.9 | 20.1 |
Vortioxetine 5 mg | 0.7 | 7.5 | 11.5 | 14.9 | 19.6 |
The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Weeks 1 and 4
Intervention | scores on a scale (Least Squares Mean) | |
---|---|---|
Week 1 (n=150, 149, 141, 149, 141) | Week 4 (n=141, 142, 139, 141, 126) | |
Duloxetine 60 mg | -2.91 | -5.11 |
Placebo | -1.81 | -3.24 |
Vortioxetine 10 mg | -2.22 | -4.01 |
Vortioxetine 2.5 mg | -1.85 | -3.34 |
Vortioxetine 5 mg | -1.89 | -3.60 |
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Weeks 1, 2, 4, 6 and 8
Intervention | scores on a scale (Least Squares Mean) | ||||
---|---|---|---|---|---|
Week 1 (n=151, 148, 141, 149, 142) | Week 2 (n=147, 145, 142, 147, 130) | Week 4 (n=140, 135, 132, 134, 115) | Week 6 (n=127, 123, 121, 120, 112) | Week 8 (n=120, 118, 114, 111, 106) | |
Duloxetine 60 mg | -0.54 | -0.97 | -1.28 | -1.55 | -1.77 |
Placebo | -0.42 | -0.71 | -0.95 | -1.22 | -1.42 |
Vortioxetine 10 mg | -0.42 | -0.75 | -1.11 | -1.35 | -1.44 |
Vortioxetine 2.5 mg | -0.37 | -0.74 | -1.12 | -1.32 | -1.50 |
Vortioxetine 5 mg | -0.39 | -0.80 | -1.02 | -1.31 | -1.38 |
Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). (NCT00730691)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|---|
Placebo | 42.2 |
Vortioxetine 2.5 mg | 44.8 |
Vortioxetine 5 mg | 42.6 |
Vortioxetine 10 mg | 44.8 |
Duloxetine 60 mg | 51.0 |
The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|---|
Placebo | 2.47 |
Vortioxetine 2.5 mg | 2.36 |
Vortioxetine 5 mg | 2.38 |
Vortioxetine 10 mg | 2.38 |
Duloxetine 60 mg | 2.03 |
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|---|
Placebo | -11.61 |
Vortioxetine 2.5 mg | -14.12 |
Vortioxetine 5 mg | -13.87 |
Vortioxetine 10 mg | -13.22 |
Duloxetine 60 mg | -16.15 |
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|---|
Placebo | -11.27 |
Vortioxetine 2.5 mg | -12.23 |
Vortioxetine 5 mg | -11.57 |
Vortioxetine 10 mg | -11.66 |
Duloxetine 60 mg | -13.87 |
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|---|
Placebo | -6.35 |
Vortioxetine 2.5 mg | -6.15 |
Vortioxetine 5 mg | -6.68 |
Vortioxetine 10 mg | -7.95 |
Duloxetine 60 mg | -8.81 |
The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|---|
Placebo | -4.00 |
Vortioxetine 2.5 mg | -3.89 |
Vortioxetine 5 mg | -4.24 |
Vortioxetine 10 mg | -5.09 |
Duloxetine 60 mg | -5.54 |
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Weeks 1, 2, 4 and 6
Intervention | scores on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Week 1 (n= 151, 149, 142, 149, 143) | Week 2 (n=147, 145, 143, 147, 130) | Week 4 (n= 139, 135, 132, 133, 116) | Week 6 (n= 127, 123, 122, 120, 112) | |
Duloxetine 60 mg | -5.48 | -9.29 | -11.13 | -12.66 |
Placebo | -4.70 | -7.30 | -8.66 | -10.28 |
Vortioxetine 10 mg | -5.04 | -7.63 | -9.73 | -11.05 |
Vortioxetine 2.5 mg | -4.56 | -7.28 | -9.77 | -10.82 |
Vortioxetine 5 mg | -4.90 | -8.22 | -9.84 | -11.26 |
Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). (NCT00730691)
Timeframe: Baseline and Weeks 1, 2, 4 and 6
Intervention | percentage of participants (Number) | |||
---|---|---|---|---|
Week 1 (n=151, 149, 142, 149, 143) | Week 2 (n=154, 154, 147, 154, 149) | Week 4 (n=154, 154, 148, 154, 149) | Week 6 (n=154, 154, 148, 154, 149) | |
Duloxetine 60 mg | 16.8 | 28.9 | 42.3 | 47.7 |
Placebo | 11.3 | 20.8 | 26.0 | 36.4 |
Vortioxetine 10 mg | 10.1 | 21.4 | 35.1 | 40.9 |
Vortioxetine 2.5 mg | 6.7 | 20.1 | 30.5 | 37.7 |
Vortioxetine 5 mg | 8.5 | 21.1 | 32.4 | 40.5 |
The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Weeks 1, 2, 4 and 6
Intervention | scores on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Week 1 (n=151, 148, 141, 149, 141) | Week 2 (n=147, 145, 142, 147, 129) | Week 4 (n=140, 135, 132, 134, 116) | Week 6 (n=127, 123, 121, 120, 112) | |
Duloxetine 60 mg | 3.36 | 2.76 | 2.44 | 2.25 |
Placebo | 3.44 | 3.03 | 2.81 | 2.61 |
Vortioxetine 10 mg | 3.40 | 2.96 | 2.68 | 2.41 |
Vortioxetine 2.5 mg | 3.46 | 3.08 | 2.67 | 2.53 |
Vortioxetine 5 mg | 3.41 | 2.90 | 2.67 | 2.43 |
Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks. (NCT00730691)
Timeframe: Baseline and Week 8
Intervention | participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline: Any resource use | Baseline: Any hospitalization-related services | Baseline: Hospitalization related to anxiety | Baseline: Any sick leave | Baseline: Sick leave related to anxiety | Week 8: Any resource use | Week 8: Any hospitalization-related service | Week 8: Hospitalization related to anxiety | Week 8: Any sick leave | Week 8: Sick leave related to anxiety | |
Duloxetine 60 mg | 38 | 2 | 0 | 12 | 7 | 22 | 3 | 1 | 11 | 4 |
Placebo | 34 | 0 | 0 | 14 | 5 | 26 | 0 | 0 | 13 | 2 |
Vortioxetine 10 mg | 43 | 0 | 0 | 15 | 9 | 23 | 1 | 0 | 7 | 1 |
Vortioxetine 2.5 mg | 36 | 3 | 2 | 16 | 10 | 24 | 0 | 0 | 6 | 2 |
Vortioxetine 5 mg | 26 | 1 | 1 | 13 | 9 | 29 | 0 | 0 | 7 | 3 |
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to weeks 1, 2, 4 and 6
Intervention | scores on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Week 1 (n=63, 76, 70, 70, 66) | Week 2 (n=62, 73, 70, 68, 62) | Week 4 (n=60, 68, 67, 63, 54) | Week 6 (n=58, 63, 62, 54, 51) | |
Duloxetine 60 mg | -6.78 | -10.40 | -12.56 | -14.35 |
Placebo | -5.32 | -7.55 | -8.61 | -10.72 |
Vortioxetine 10 mg | -5.94 | -8.51 | -10.98 | -12.75 |
Vortioxetine 2.5 mg | -6.07 | -8.82 | -11.61 | -12.86 |
Vortioxetine 5 mg | -5.96 | -10.18 | -12.87 | -14.11 |
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Weeks 1, 2 and 4
Intervention | scores on a scale (Least Squares Mean) | ||
---|---|---|---|
Week 1 (n=116, 111, 109, 125, 112) | Week 2 (n=116, 114, 116, 123, 103) | Week 4 (n=108, 106, 106, 115, 91) | |
Duloxetine 60 mg | -4.74 | -7.09 | -7.95 |
Placebo | -3.22 | -4.53 | -4.55 |
Vortioxetine 10 mg | -4.11 | -5.46 | -6.47 |
Vortioxetine 2.5 mg | -2.74 | -4.18 | -4.98 |
Vortioxetine 5 mg | -3.28 | -5.02 | -5.92 |
The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) model with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Weeks 1, 4 and 8
Intervention | scores on a scale (Least Squares Mean) | ||
---|---|---|---|
Week 1 (n=150, 149, 141, 149, 141) | Week 4 (n=141, 142, 139, 141, 126) | Week 8 (n=123, 120, 119, 111, 108) | |
Duloxetine 60 mg | -1.19 | -2.62 | -2.77 |
Placebo | -0.81 | -1.32 | -2.21 |
Vortioxetine 10 mg | -1.25 | -1.61 | -1.94 |
Vortioxetine 2.5 mg | -0.83 | -1.83 | -1.82 |
Vortioxetine 5 mg | -0.88 | -1.70 | -1.96 |
(NCT00755807)
Timeframe: Baseline (6 weeks) through Endpoint (18 weeks)
Intervention | participants (Number) | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Due to any AE | Fatigue | Somnolence | Alanine aminotransferase increased | Constipation | Diverticulitis | Dizziness | Fall | Hypertension | Insomnia | Multiple sclerosis relapse | Nausea | Rash pruritic | |
Duloxetine | 14 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module. (NCT00755807)
Timeframe: Baseline (6 weeks) through Endpoint (18 weeks)
Intervention | participants (Number) | |
---|---|---|
Adverse Events (AEs) - Any Event | Serious Adverse Events (SAEs) - Any Event | |
Duloxetine | 130 | 7 |
Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module. (NCT00755807)
Timeframe: Baseline through 6 weeks
Intervention | participants (Number) | |
---|---|---|
Adverse Events (AEs) - Any Event | Serious Adverse Events (SAEs) - Any Event | |
Duloxetine | 70 | 4 |
Placebo | 59 | 0 |
Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. Each weekly mean change represents change relative to week 6, the baseline of the extension phase. (NCT00755807)
Timeframe: Baseline (6 weeks) through Endpoint (18 weeks)
Intervention | units on a scale (Least Squares Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 7 (n=185) | Week 8 (n=205) | Week 9 (n=184) | Week 10 (n=197) | Week 11 (n=166) | Week 12 (n=192) | Week 13 (n=166) | Week 14 (n=177) | Week 15 (n=158) | Week 16 (n=176) | Week 17 (n=156) | Week 18 (n=175) | |
Duloxetine | -0.05 | -0.31 | -0.54 | -0.62 | -0.75 | -0.89 | -1.05 | -0.98 | -0.99 | -1.04 | -1.11 | -1.04 |
(NCT00755807)
Timeframe: Baseline (6 weeks) through Endpoint (18 weeks)
Intervention | participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Discontinued Due to Any Reason | Adverse Event | Protocol Violation | Lack of Efficacy | Subject Decision | Lost to follow up | Sponsor Decision | |
Duloxetine | 34 | 14 | 7 | 6 | 4 | 2 | 1 |
"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide." (NCT00755807)
Timeframe: 6 weeks
Intervention | participants (Number) | ||
---|---|---|---|
Suicidal Ideation | Suicidal Behavior | Suicidal Acts | |
Duloxetine | 3 | 1 | 1 |
Placebo | 0 | 0 | 0 |
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity. (NCT00755807)
Timeframe: 6 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 3.27 |
Placebo | 3.48 |
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The scores range from 1 (very much better) to 7 (very much worse). (NCT00755807)
Timeframe: 18 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 2.67 |
Change from baseline to acute phase endpoint in laboratory assessment for bicarbonate, HCO3. (NCT00755807)
Timeframe: Baseline, 6 weeks
Intervention | milliEq/Liter (Mean) | |
---|---|---|
Baseline | Change to Last Observation | |
Duloxetine | 22.43 | 2.08 |
Placebo | 23.23 | 1.38 |
(NCT00755807)
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)
Intervention | mm Hg (Mean) | |
---|---|---|
Diastolic | Systolic | |
Duloxetine | -0.58 | -1.22 |
(NCT00755807)
Timeframe: Baseline, 6 weeks
Intervention | mm Hg (Least Squares Mean) | |
---|---|---|
Diastolic Blood Pressure | Systolic Blood Pressure | |
Duloxetine | 1.34 | 0.34 |
Placebo | 0.48 | -0.06 |
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. (NCT00755807)
Timeframe: Baseline (end of acute phase/Week 6), Endpoint (Week 18)
Intervention | units on a scale (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
BPI-S for Worst Pain | BPI-S for Least Pain | BPI-S for Average Pain | BPI-S for Pain Right Now | BPI-I for General Activity | BPI-I for Mood | BPI-I for Walking Ability | BPI-I for Normal Work | BPI-I for Relations With Others | BPI-I for Sleep | BPI-I for Enjoyment Of Life | BPI for Mean Interference Score | |
Duloxetine | -1.27 | -0.96 | -1.26 | -1.03 | -1.01 | -1.08 | -0.84 | -1.00 | -0.65 | -0.70 | -1.03 | -0.89 |
Change from baseline to acute phase endpoint in laboratory assessment of inorganic phosphorus. (NCT00755807)
Timeframe: Baseline, 6 weeks
Intervention | mg/dL (Mean) | |
---|---|---|
Baseline | Change to Last Observation | |
Duloxetine | 3.63 | -0.17 |
Placebo | 3.68 | 0.01 |
Change from baseline to acute phase endpoint in laboratory assessment of creatinine. (NCT00755807)
Timeframe: Baseline, 6 weeks
Intervention | milligram/deciliter (mg/dL) (Mean) | |
---|---|---|
Baseline | Change to Last Observation | |
Duloxetine | 0.79 | -0.00 |
Placebo | 0.78 | 0.01 |
(NCT00755807)
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)
Intervention | Thousand/microliter (Mean) | |
---|---|---|
Baseline | Change to Last Observation | |
Duloxetine | 0.38 | 0.02 |
A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. (NCT00755807)
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)
Intervention | units on a scale (Mean) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Physical Health Composite Section Score (N=198) | Mental Health Composite Section Score (N=201) | Physical Health Subsection Score (N=201) | Health Perceptions Subsection Score (N=201) | Energy Subsection Score (N=201) | Role Limitation Due to Physical Problems (N=201) | Pain Subsection Score (N=201) | Sexual Function Subsection Score (N=198) | Social Function Subsection Score (N=201) | Health Distress Subsection Score (N=201) | Overall Quality Of Life Subsection Score (N=201) | Emotional Well-being Subsection Score (N=201) | Role Limitation Due to Emotional Problems (N=201) | Cognitive Function Subsection Score (N=201) | Change in Health Subsection Score (N=201) | Satisfaction with Sexual Function Subsect (N=195) | |
Duloxetine | 2.70 | 1.97 | 3.16 | 2.24 | 2.93 | 0.50 | 7.45 | 0.79 | 2.53 | 1.44 | 1.47 | 2.63 | 3.15 | -0.07 | 4.35 | 1.92 |
(NCT00755807)
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)
Intervention | milliEq/Liter (Mean) | |
---|---|---|
Baseline | Change to Last Observation | |
Duloxetine | 140.08 | -0.36 |
Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst, least, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing pain interference in past 24 hours, such as general activity, mood, normal work, relations with other people, and sleep. Average interference=average of non-missing scores of individual interference items. Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity. (NCT00755807)
Timeframe: Baseline, 6 weeks
Intervention | units on a scale (Least Squares Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
BPI Severity for Worst Pain | BPI Severity for Least Pain | BPI Severity for Average Pain | BPI Severity for Pain Right Now | BPI Interference for General Activity | BPI Interference for Mood | BPI Interference for Walking Ability | BPI Interference for Normal Work | BPI Interference for Relations With Others | BPI Interference for Sleep | BPI Interference for Enjoyment Of Life | BPI Mean Interference Score | |
Duloxetine | -1.95 | -1.20 | -1.36 | -1.91 | -1.81 | -1.91 | -1.47 | -1.51 | -1.72 | -2.01 | -1.82 | -1.77 |
Placebo | -1.29 | -0.72 | -0.84 | -1.02 | -1.29 | -1.25 | -0.91 | -1.18 | -1.22 | -1.59 | -1.65 | -1.32 |
A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity. (NCT00755807)
Timeframe: Baseline, 6 weeks
Intervention | units on a scale (Least Squares Mean) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Physical Health Composite (N=106, 116) | Mental Health Composite (N=106, 116) | Physical Health (N=106, 116) | Health Perceptions (N=106, 116) | Energy Subsection Score (N=106, 116) | Role Limitation Due to Physical (N=106, 116) | Pain (N=106, 116) | Sexual Function (N=106, 116) | Social Function (N=106, 116) | Health Distress (N=106, 116) | Overall Quality Of Life (N=106, 116) | Emotional Well-being Subsection Score (N=106, 116) | Role Limitation Due to Emotional (N=106, 116) | Cognitive Function (N=106, 116) | Change in Health (N=106, 116) | Satisfaction with Sexual Function (N=102, 112) | |
Duloxetine | 6.11 | 5.81 | 3.35 | 1.41 | 6.54 | 11.73 | 12.42 | 1.30 | 5.02 | 8.96 | 3.66 | 4.59 | 6.48 | 6.38 | 8.23 | 2.66 |
Placebo | 5.12 | 4.59 | 2.65 | 1.35 | 6.51 | 8.60 | 8.84 | 1.12 | 6.97 | 9.34 | 5.43 | 3.99 | 1.58 | 5.57 | 6.25 | -1.35 |
Change from baseline to acute phase endpoint in laboratory assessment of platelet count. (NCT00755807)
Timeframe: Baseline, 6 weeks
Intervention | Thousand/microliter (Mean) | |
---|---|---|
Baseline | Change to Last Observation | |
Duloxetine | 266.92 | -2.20 |
Placebo | 281.22 | -11.00 |
This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome (≥30% or ≥50% pain reduction from baseline) was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by participants in their diaries. (NCT00755807)
Timeframe: Baseline, 6 weeks
Intervention | participants (Number) | |||
---|---|---|---|---|
≥30% Reduction (LOCF) | ≥50% Reduction (LOCF) | ≥30% Reduction (BOCF) | ≥50% Reduction (BOCF) | |
Duloxetine | 47 | 26 | 44 | 24 |
Placebo | 32 | 19 | 29 | 16 |
(NCT00755807)
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)
Intervention | gram/deciliter (g/dL) (Mean) | |
---|---|---|
Baseline | Change to Last Observation | |
Duloxetine | 7.04 | -0.06 |
"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide." (NCT00755807)
Timeframe: 18 weeks
Intervention | participants (Number) | ||
---|---|---|---|
Suicidal Ideation | Suicidal Behavior | Suicidal Acts | |
Duloxetine | 1 | 0 | 0 |
(NCT00755807)
Timeframe: Baseline through 6 weeks
Intervention | participants (Number) | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Any Adverse Event (AE) | Dizziness | Somnolence | Abdominal discomfort | Asthenia | Back pain | Balance disorder | Fear | Feeling jittery | Headache | Hypotension | Libido decreased | Mood altered | Nausea | Pain in extremity | Rash maculo-papular | Suicide attempt | Throat irritation | |
Duloxetine | 16 | 3 | 2 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 1 |
Placebo | 5 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Change from baseline to acute phase endpoint in laboratory assessment of uric acid. (NCT00755807)
Timeframe: Baseline, 6 weeks
Intervention | mg/dL (Mean) | |
---|---|---|
Baseline | Change to Last Observation | |
Duloxetine | 5.19 | -0.23 |
Placebo | 4.74 | -0.04 |
(NCT00755807)
Timeframe: Baseline through 6 weeks
Intervention | participants (Number) | |||||
---|---|---|---|---|---|---|
Discontinued Due to Any Reason | Adverse Event (AE) | Protocol Violation | Subject Decision | Lack of Efficacy | Physician Decision | |
Duloxetine | 18 | 16 | 1 | 1 | 0 | 0 |
Placebo | 12 | 5 | 3 | 2 | 1 | 1 |
(NCT00755807)
Timeframe: Baseline, 6 weeks
Intervention | kilograms (kg) (Least Squares Mean) |
---|---|
Duloxetine | -0.69 |
Placebo | 0.08 |
(NCT00755807)
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)
Intervention | kilograms (kg) (Mean) |
---|---|
Duloxetine | -0.30 |
Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity. (NCT00755807)
Timeframe: Baseline, 6 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -1.25 |
Placebo | -0.74 |
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average pain and evaluated as weekly means. Scores range from 0 (no pain) to 10 (worst possible pain). The Least Squares Mean (LS Mean) Value was adjusted for investigative site and baseline severity. (NCT00755807)
Timeframe: Baseline, 6 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -1.83 |
Placebo | -1.07 |
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). (NCT00755807)
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | -0.59 |
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity. (NCT00755807)
Timeframe: Baseline, 6 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -0.67 |
Placebo | -0.44 |
The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with a score ranging from 0 to 3. (NCT00755807)
Timeframe: Baseline, 6 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | -0.04 |
Placebo | -0.03 |
(NCT00755807)
Timeframe: Baseline, 6 weeks
Intervention | beats per minute (bpm) (Least Squares Mean) |
---|---|
Duloxetine | 1.76 |
Placebo | 0.22 |
(NCT00755807)
Timeframe: Baseline (6 weeks), endpoint (18 weeks)
Intervention | beats per minute (bpm) (Mean) |
---|---|
Duloxetine | 1.47 |
The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with the score ranging from 0 to 3. (NCT00755807)
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | -0.01 |
Response to treatment was defined as at least a 50% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint. (NCT00767806)
Timeframe: 12 weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 95 |
Placebo | 69 |
Response to treatment was defined as at least a 30% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint. (NCT00767806)
Timeframe: 12 weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 111 |
Placebo | 97 |
The Columbia Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. (NCT00767806)
Timeframe: baseline through 12 weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 0 |
Placebo | 0 |
The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety (Ten), depression-dejection (Dep), anxiety-hostility (Ang), fatigue (Fat), confusion (Con), and vigor (Vig). Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig) and ranges from 0 (least disturbed) to 80 (most disturbed). (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Tension-Anxiety - baseline; n=186,n=185 | Tension-Anxiety - change; n=186,n=185 | Depression-Dejection - baseline; n=185,n=188 | Depression-Dejection - change; n=185,n=188 | Anger-Hostility - baseline; n=186,n=185 | Anger-Hostility - change; n=186,n=185 | Vigor-Activity - baseline; n=185, n=187 | Vigor-Activity - change; n=185, n=187 | Fatigue-Inertia - baseline; n=184, n=188 | Fatigue-Inertia - change; n=184, n=188 | Confusion-Bewilderment - baseline; n=185, n=187 | Confusion-Bewilderment - change; n=185, n=187 | Total Mood Disturbance - baseline; n=181, n=180 | Total Mood Disturbance - change; n=181, n=180 | |
Duloxetine | 4.22 | -1.58 | 2.67 | -0.80 | 2.79 | -1.18 | 6.77 | 2.13 | 6.49 | -1.74 | 4.09 | -0.69 | 13.31 | -7.90 |
Placebo | 4.29 | -0.78 | 2.74 | -0.45 | 3.46 | -0.63 | 7.23 | 0.81 | 6.71 | -1.64 | 4.07 | -0.14 | 14.27 | -4.68 |
24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients completed the electronic diary at bedtime. The 11-point Likert scale was also used for assessment of night pain and worst pain each day, and evaluated as weekly means. Least Squares Mean values were controlled for investigator and baseline severity. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | ||
---|---|---|---|
Average Pain | Worst Pain | Night Pain | |
Duloxetine | -2.14 | -2.19 | -1.62 |
Placebo | -1.43 | -1.48 | -1.10 |
"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism~Presenteeism~Work productivity loss~Activity Impairment Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment." (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Mean) | |||||||
---|---|---|---|---|---|---|---|---|
Absenteeism, baseline; n=79, n=93 | Absenteeism, change; n=79, n=93 | Presenteeism, baseline; n=79, n=90 | Presenteeism, change; n=79, n=90 | Work Productivity Loss, baseline; n=77, n=89 | Work Productivity Loss, change; n=77, n=89 | Activity Impairment, baseline; n=190, n=196 | Activity Impairment, change; n=190, n=196 | |
Duloxetine | 0.08 | -0.03 | 0.49 | -0.22 | 0.50 | -0.22 | 0.56 | -0.23 |
Placebo | 0.10 | -0.03 | 0.48 | -0.18 | 0.50 | -0.18 | 0.56 | -0.17 |
Least Squares Mean values were controlled for investigator. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | Gram/Liter (Least Squares Mean) |
---|---|
Duloxetine | -0.76 |
Placebo | -0.12 |
Least Squares Mean values were controlled for investigator. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | Units/Liter (Least Squares Mean) |
---|---|
Duloxetine | 1.59 |
Placebo | -1.85 |
Least Squares Mean values were controlled for investigator. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | Units/Liter (Least Squares Mean) |
---|---|
Duloxetine | 1.90 |
Placebo | -0.54 |
Least Squares Mean values were controlled for investigator. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | Micromole/Liter (Least Squares Mean) |
---|---|
Duloxetine | -1.69 |
Placebo | 0.70 |
Least Squares Mean values were controlled for investigator. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | Gram/Liter (Least Squares Mean) |
---|---|
Duloxetine | -1.34 |
Placebo | -0.43 |
Least Squares Mean values were controlled for investigator. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | kilogram (Least Squares Mean) |
---|---|
Duloxetine | -0.31 |
Placebo | 0.05 |
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least Squares Mean values were controlled for investigator and baseline severity. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -0.95 |
Placebo | -0.79 |
Least Squares Mean values were controlled for investigator. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | Units/Liter (Least Squares Mean) |
---|---|
Duloxetine | 1.51 |
Placebo | -1.71 |
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Least Squares Mean values were controlled for investigator and baseline severity. (NCT00767806)
Timeframe: 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 2.88 |
Placebo | 3.19 |
Least Squares Mean values were controlled for investigator. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | beats per minute (Least Squares Mean) |
---|---|
Duloxetine | 0.18 |
Placebo | -0.17 |
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least Squares Mean values were controlled for investigator and baseline severity. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -2.48 |
Placebo | -1.80 |
Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Least Squares Mean values were controlled for investigator and baseline severity. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -2.69 |
Placebo | -2.22 |
Least Squares Mean values were controlled for investigator. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | Micromole/Liter (Least Squares Mean) |
---|---|
Duloxetine | -14.06 |
Placebo | 1.34 |
The results presented are the cumulative number of participants reaching each threshold of BPI average pain reduction. The thresholds are given as percent reductions in BPI average pain score from the baseline score. BPI: a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of participants under each threshold was assessed at endpoint. (NCT00767806)
Timeframe: 12 weeks
Intervention | participants (Number) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Any Increase | No Change | >0% Decrease | >=10% Decrease | >=20% Decrease | >=30% Decrease | >=40% Decrease | >=50% Decrease | >=60% Decrease | >=70% Decrease | >=80% Decrease | 100% Decrease | |
Duloxetine | 12 | 62 | 124 | 124 | 116 | 95 | 90 | 85 | 61 | 47 | 32 | 15 |
Placebo | 15 | 67 | 121 | 121 | 106 | 83 | 71 | 57 | 38 | 30 | 19 | 11 |
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Mean) | |||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
BPI severity of worst pain - baseline | BPI severity of worst pain - change | BPI severity of least pain - baseline | BPI severity of least pain - change | BPI severity of pain right now - baseline | BPI severity of pain right now - change | BPI interference with general activity - baseline | BPI interference with general activity - change | BPI interference with mood - baseline | BPI interference with mood - change | BPI interference with walking ability - baseline | BPI interference with walking ability - change | BPI interference with normal work - baseline | BPI interference with normal work - change | BPI interference relations with others - baseline | BPI interference relations with others - change | BPI interference with sleep - baseline | BPI interference with sleep - change | BPI interference with enjoyment of life - baseline | BPI interference with enjoyment of life - change | BPI average interference - baseline | BPI average interference - change | |
Duloxetine | 7.26 | -2.75 | 4.11 | -1.67 | 5.47 | -2.55 | 5.37 | -2.71 | 4.00 | -2.26 | 4.61 | -2.23 | 5.25 | -2.50 | 3.07 | -1.74 | 4.74 | -2.37 | 4.25 | -2.44 | 4.44 | -2.26 |
Placebo | 7.06 | -1.99 | 4.04 | -1.16 | 5.30 | -1.65 | 4.91 | -1.71 | 3.76 | -1.41 | 4.13 | -1.52 | 4.91 | -1.82 | 2.82 | -1.04 | 4.53 | -1.55 | 3.78 | -1.59 | 4.14 | -1.55 |
Generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1; higher scores indicate a better health state perceived by the patient. Participants were evaluated with the United Kingdom (UK) and the United States (US) population based index score. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
UK population-based Index Score-baseline | UK population-based Index Score-change | US population-based Index Score-baseline | US population-based Index Score-change | |
Duloxetine | 0.52 | 0.19 | 0.66 | 0.12 |
Placebo | 0.57 | 0.07 | 0.69 | 0.05 |
Least Squares Mean values were controlled for investigator. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | millimeter mercury (Least Squares Mean) | |
---|---|---|
Systolic Blood Pressure (millimeter mercury) | Diastolic Blood Pressure (millimeter mercury) | |
Duloxetine | 0.49 | -0.14 |
Placebo | -0.59 | -0.64 |
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). The score for each of the domain and component summary=0-100 (higher scores indicate better health status or functioning). (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | units on a scale (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Physical Component - baseline; n=147, n=153 | Physical Component - change; n=147, n=153 | Mental Component - baseline; n=147, n=153 | Mental Component - change; n=147, n=153 | Bodily Pain - baseline; n=188, n=190 | Bodily Pain -change; n=188, n=190 | Mental Health - baseline; n=165, n=166 | Mental Health - change; n=165, n=166 | General Health - baseline; n=188, n=190 | General Health - change; n=188, n=190 | Physical Functioning - baseline;n=186, n=189 | Physical Functioning - change; n=186, n=189 | Role-Emotional - baseline; n=172, n=179 | Role-Emotional - change; n=172, n=179 | Role-Physical - baseline; n=172, n=179 | Role-Physical - change; n=172, n=179 | Social Functioning -baseline; n=188, n=190 | Social Functioning - change; n=188, n=190 | Vitality - baseline; n=163, n=165 | Vitality - change; n=163, n=165 | |
Duloxetine | 34.41 | 6.15 | 49.50 | 3.34 | 33.37 | 18.31 | 69.30 | 6.65 | 53.54 | 7.81 | 50.02 | 13.18 | 73.89 | 8.19 | 46.77 | 12.97 | 67.02 | 12.70 | 50.69 | 9.33 |
Placebo | 34.29 | 5.22 | 49.59 | 0.84 | 33.93 | 13.52 | 69.72 | 1.48 | 53.11 | 5.34 | 52.13 | 9.42 | 74.21 | 5.12 | 46.42 | 11.66 | 69.67 | 7.11 | 48.64 | 6.30 |
Reasons for discontinuation are listed in the participant flow. (NCT00767806)
Timeframe: baseline, 12 weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 51 |
Placebo | 47 |
Sustained responders: participants with ≥30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and who maintain a ≥20% reduction of BPI average pain rating from baseline at every visit between last visit and earlier visit. BPI: a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of sustained responders was assessed at endpoint. (NCT00767806)
Timeframe: 12 weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 89 |
Placebo | 73 |
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. (NCT00803361)
Timeframe: Baseline, Week 15
Intervention | Units on a Scale (Mean) | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Severity of Worst Pain Baseline | Severity of Worst Pain Change | Severity of Least Pain Baseline | Severity of Least Pain Change | Severity of Average Pain Baseline | Severity of Average Pain Change | Severity of Pain Right Now Baseline | Severity of Pain Right Now Change | Interference of Pain, General Activity, Baseline | Interference of Pain, General Activity, Change | Interference of Pain, Mood, Baseline | Interference of Pain, Mood, Change | Interference of Pain,Walking Ability, Baseline | Interference of Pain,Walking Ability, Change | Int. of Pain, Normal Work, Baseline | Int. of Pain, Normal Work, Change | Int. of Pain, Relations with Others, Baseline | Int. of Pain, Relations with Others, Change | Interference of Pain, Sleep, Baseline | Interference of Pain, Sleep, Change | Interference of Pain, Enjoyment of Life, Baseline | Interference of Pain, Enjoyment of Life, Change | Mean Interference Score, Baseline | Mean Interference Score, Change | |
Duloxetine | 3.39 | -1.78 | 1.17 | -0.67 | 2.36 | -1.25 | 2.21 | -1.41 | 2.60 | -1.43 | 2.97 | -1.49 | 1.31 | -0.63 | 2.53 | -1.25 | 2.01 | -1.07 | 2.55 | -1.16 | 2.51 | -1.27 | 2.36 | -1.18 |
Placebo | 4.22 | -1.88 | 1.51 | -0.45 | 2.77 | -0.97 | 2.30 | -0.77 | 2.66 | -1.06 | 3.40 | -1.44 | 1.56 | -0.47 | 2.44 | -0.96 | 2.01 | -0.88 | 3.23 | -1.45 | 2.62 | -0.99 | 2.56 | -1.04 |
Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse). (NCT00803361)
Timeframe: Week 15
Intervention | Units on a Scale (Mean) |
---|---|
Duloxetine | 2.08 |
Placebo | 2.54 |
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain). (NCT00803361)
Timeframe: Baseline, Week 15
Intervention | Units on a Scale (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Severity of Overall Pain, Past Week, Baseline | Severity of Overall Pain, Past Week, Change | Severity of Headaches, Past Week, Baseline | Severity of Headaches, Past Week, Change | Severity of Back Pain, Past Week, Baseline | Severity of Back Pain, Past Week, Change | Severity of Shoulder Pain, Past Week, Baseline | Severity of Shoulder Pain, Past Week, Change | Pain Interference, Daily Activities, Baseline | Pain Interference, Daily Activities, Change | Pain During Waking Hours, Past Week, Baseline | Pain During Waking Hours, Past Week, Change | |
Duloxetine | 27.56 | -15.28 | 21.11 | -9.44 | 18.13 | -9.40 | 16.53 | -8.85 | 27.19 | -16.92 | 26.84 | -16.77 |
Placebo | 31.94 | -13.40 | 24.52 | -10.57 | 17.40 | -3.36 | 19.68 | -8.52 | 26.41 | -12.69 | 33.22 | -14.58 |
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' (NCT00803361)
Timeframe: Baseline, Week 15
Intervention | Units on a Scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 6.90 | -2.95 |
Placebo | 6.62 | -1.96 |
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' (NCT00803361)
Timeframe: Baseline, Week 15
Intervention | Units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 12.76 | -6.38 |
Placebo | 13.56 | -5.29 |
The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. (NCT00803361)
Timeframe: Baseline, Week 15
Intervention | Units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline | |
Duloxetine | 24.50 | -14.42 |
Placebo | 24.24 | -11.62 |
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual item scores range from 0-10, with higher numbers indicating greater disruption. Item 1 is for work/schoolwork, Item 2 is for social life/leisure activities, Item 3 is for family life/home responsibilities. (NCT00803361)
Timeframe: Baseline, Week 15
Intervention | Units on a scale (Mean) | |||||||
---|---|---|---|---|---|---|---|---|
Symptoms Disrupted Work- Baseline (N=101,N=94) | Symptoms Disrupted Work- Change(N=101,N=94) | Symptoms Disrupted Social/Leisure - Baseline | Symptoms Disrupted Social/Leisure - Change | Symptoms Disrupted Family Life - Baseline | Symptoms Disrupted Family Life - Change | Global Functional Impairment Total Score -Baseline | Global Functional Impairment Total Score -Change | |
Duloxetine | 5.94 | -3.27 | 5.84 | -3.21 | 5.50 | -3.07 | 17.24 | -9.51 |
Placebo | 5.85 | -2.59 | 5.73 | -2.60 | 5.39 | -2.45 | 17.05 | -7.71 |
Survival function is estimating the probability of participants not achieving confirmed remission. Confirmed remission is defined as a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 that is maintained for two consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). (NCT00810069)
Timeframe: Week 4 through Week 16
Intervention | estimated probability (percent) (Mean) |
---|---|
Early Intervention | 52 |
Delayed Intervention | 59 |
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 10 centimeter (cm) line between two anchors (0= no pain and 10=very severe pain). (NCT00810069)
Timeframe: Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16
Intervention | units on a scale (Mean) | |||||||
---|---|---|---|---|---|---|---|---|
Baseline (n=282, 284) | Week 4 (n=281, 283) | Week 6 (n=270, 271) | Week 8 (n=245, 241) | Week 10 (n=207, 204) | Week 12 (n=170, 181) | Week 14 (n=151, 152) | Week 16 (n=143, 152) | |
Delayed Intervention | 3.8 | 3.5 | 3.3 | 3.0 | 2.7 | 2.6 | 2.5 | 2.3 |
Early Intervention | 3.6 | 3.0 | 2.6 | 2.4 | 2.4 | 2.1 | 2.0 | 2.0 |
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. (NCT00810069)
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Baseline (n=216, 217) | Week 4 (n=215, 215) | Week 8 (n=186, 188) | Week 12 (n=140, 144) | Week 16 (n=113, 121) | |
Delayed Intervention | 19.9 | 17.5 | 14.0 | 13.2 | 10.2 |
Early Intervention | 19.9 | 16.9 | 13.5 | 12.1 | 10.3 |
Only those participants who missed at least 1 hour of work were included. (NCT00810069)
Timeframe: Week 4, Week 8, Week 12, Week 16
Intervention | Hours (Mean) | |||
---|---|---|---|---|
Week 4 (n=73, 89) | Week 8 (n=54, 67) | Week 12 (n=38, 56) | Week 16 (n=25, 39) | |
Delayed Intervention | 95.0 | 102.3 | 104.5 | 126.4 |
Early Intervention | 88.6 | 92.5 | 85.0 | 91.5 |
Only those participants who missed at least 1 hour of work due to depression were included. (NCT00810069)
Timeframe: Week 4, Week 8, Week 12, Week 16
Intervention | Hours (Mean) | |||
---|---|---|---|---|
Week 4 (n=70, 86) | Week 8 (n=47, 61) | Week 12 (n=31, 52) | Week 16 (n=24, 38) | |
Delayed Intervention | 95.1 | 109.7 | 111.4 | 126.0 |
Early Intervention | 90.6 | 98.5 | 98.7 | 91.9 |
(NCT00810069)
Timeframe: Week 4, Week 8, Week 12, Week 16
Intervention | Visits (Mean) | |||
---|---|---|---|---|
Week 4 (n=36, 55) | Week 8 (n=14, 22) | Week 12 (n=8, 12) | Week 16 (n=4, 7) | |
Delayed Intervention | 1.6 | 1.7 | 1.6 | 1.6 |
Early Intervention | 1.5 | 1.1 | 1.3 | 2.0 |
(NCT00810069)
Timeframe: Week 4, Week 8, Week 12, Week 16
Intervention | Visits (Mean) | |||
---|---|---|---|---|
Week 4 (n=25, 16) | Week 8 (n=8, 8) | Week 12 (n=3, 2) | Week 16 (n=2, 1) | |
Delayed Intervention | 1.7 | 1.9 | 1.0 | 3.0 |
Early Intervention | 2.2 | 1.6 | 1.7 | 2.0 |
(NCT00810069)
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16
Intervention | Hours (Mean) | |||
---|---|---|---|---|
Week 4 (n=153, 159) | Week 8 (n=136, 141) | Week 12 (n=119, 115) | Week 16 (n=96, 96) | |
Delayed Intervention | 38.6 | 37.7 | 38.1 | 38.0 |
Early Intervention | 37.7 | 37.9 | 37.7 | 37.2 |
(NCT00810069)
Timeframe: Week 4, Week 8, Week 12, Week 16
Intervention | participants (Number) | |||
---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | |
Delayed Intervention | 0 | 0 | 0 | 0 |
Early Intervention | 1 | 0 | 0 | 0 |
The list of AEs is located in the Reported Adverse Event module. (NCT00810069)
Timeframe: Baseline through Week 16
Intervention | participants (Number) | |
---|---|---|
Number of participants with adverse events | Number of participants with serious adverse events | |
Delayed Intervention | 101 | 4 |
Early Intervention | 112 | 8 |
The EQ-5D is a generic, multidimensional, health-related, quality of life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant. (NCT00810069)
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Baseline (n=279, 282) | Week 4 (n=279, 282) | Week 8 (n=244, 238) | Week 12 (n=168, 178) | Week 16 (n=143, 153) | |
Delayed Intervention | 0.3 | 0.5 | 0.6 | 0.6 | 0.7 |
Early Intervention | 0.4 | 0.5 | 0.7 | 0.7 | 0.7 |
The EQ-5D Health State Score is self-rated health on a vertical, visual analogue scale measured in centimeters (cm) and reported as units on a scale. Best imaginable health state = 10 cm and worst imaginable health state = 0 cm. (NCT00810069)
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Baseline (n=281, 283) | Week 4 (n=282, 280) | Week 8 (n=244, 237) | Week 12 (n=169, 177) | Week 16 (n=142, 153) | |
Delayed Intervention | 3.9 | 4.5 | 5.4 | 5.8 | 6.5 |
Early Intervention | 4.2 | 4.9 | 5.7 | 5.9 | 6.5 |
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). (NCT00810069)
Timeframe: Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16
Intervention | units on a scale (Mean) | |||||||
---|---|---|---|---|---|---|---|---|
Baseline (n=282, 284) | Week 4 (n=281, 284) | Week 6 (n=271, 277) | Week 8 (n=254, 254) | Week 10 (n=231, 236) | Week 12 (n=203, 214) | Week 14 (n=184, 194) | Week 16 (n=178, 182) | |
Delayed Intervention | 4.6 | 4.3 | 3.7 | 3.3 | 2.9 | 2.7 | 2.5 | 2.2 |
Early Intervention | 4.6 | 4.3 | 3.6 | 3.2 | 2.8 | 2.6 | 2.4 | 2.2 |
Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response defined as ≥ 50% baseline score reduction on the HAMD-17 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale, e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). (NCT00810069)
Timeframe: Week 4 through Week 16
Intervention | weeks (Median) |
---|---|
Early Intervention | 6.4 |
Delayed Intervention | 8.0 |
Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response. QIDS16SR is a 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity. (NCT00810069)
Timeframe: Week 4 through Week 16
Intervention | weeks (Median) |
---|---|
Early Intervention | 6.0 |
Delayed Intervention | 6.9 |
Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission defined as a score on the HAMD-17 of ≤ 7 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). (NCT00810069)
Timeframe: Week 4 through Week 16
Intervention | weeks (Median) |
---|---|
Early Intervention | 12.9 |
Delayed Intervention | NA |
Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission. A 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity. (NCT00810069)
Timeframe: Week 4 through Week 16
Intervention | weeks (Median) |
---|---|
Early Intervention | NA |
Delayed Intervention | NA |
Survival function is estimating the probability of participants not achieving confirmed response after 12 weeks. Confirmed response is defined as >=50% change from baseline reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17). The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). (NCT00810069)
Timeframe: Week 4 through Week 16
Intervention | estimated probability (percent) (Mean) |
---|---|
Early Intervention | 28 |
Delayed Intervention | 26 |
The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe. (NCT00811252)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | -5.74 |
Vortioxetine 5 mg | -8.09 |
Duloxetine 60 mg | -9.28 |
The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity. (NCT00811252)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | -0.65 |
Vortioxetine 5 mg | -1.08 |
Duloxetine 60 mg | -1.32 |
The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with sub-questions that assess severity. The tool was administered via an interview with the patient. (NCT00811252)
Timeframe: Up to 8 weeks
Intervention | participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
No ideation or behavior | Completed Suicide | Suicide Attempt | Preparatory Actions Toward Imminent Suicidal Behav | Suicidal Ideation: Passive | Suicidal Ideation: Active / Nonspecific | Suicidal Ideation: Active / Method, but no intent | Suicidal Ideation: Active / Method and intent, but | Suicidal Ideation: Active / Method, intent, and pl | Self-Injurious Behavior Without Suicidal Intent | |
Duloxetine 60 mg | 106 | 0 | 1 | 0 | 7 | 0 | 0 | 0 | 0 | 0 |
Placebo | 103 | 0 | 0 | 0 | 8 | 3 | 0 | 0 | 0 | 0 |
Vortioxetine 5 mg | 107 | 0 | 0 | 0 | 14 | 0 | 0 | 0 | 0 | 0 |
The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe. (NCT00811252)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | -10.3 |
Vortioxetine 5 mg | -13.7 |
Duloxetine 60 mg | -15.8 |
The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. (NCT00811252)
Timeframe: Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | 2.91 |
Vortioxetine 5 mg | 2.35 |
Duloxetine 60 mg | 2.07 |
(NCT00811252)
Timeframe: Week 8
Intervention | percentage of patients (Number) |
---|---|
Placebo | 35 |
Vortioxetine 5 mg | 53 |
Duloxetine 60 mg | 63 |
The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. (NCT00811252)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | -1.03 |
Vortioxetine 5 mg | -1.63 |
Duloxetine 60 mg | -2.05 |
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. (NCT00811252)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | -11.2 |
Vortioxetine 5 mg | -15.5 |
Duloxetine 60 mg | -18.0 |
(NCT00811252)
Timeframe: Baseline and Week 6
Intervention | units on a scale (Mean) |
---|---|
Placebo | -10.2 |
Vortioxetine 5 mg | -12.3 |
Duloxetine 60 mg | -14.4 |
(NCT00811252)
Timeframe: Baseline and Week 4
Intervention | units on a scale (Mean) |
---|---|
Placebo | -8.99 |
Vortioxetine 5 mg | -10.1 |
Duloxetine 60 mg | -12.3 |
(NCT00811252)
Timeframe: Baseline and Week 2
Intervention | units on a scale (Mean) |
---|---|
Placebo | -6.66 |
Vortioxetine 5 mg | -6.95 |
Duloxetine 60 mg | -7.91 |
(NCT00811252)
Timeframe: Baseline and Week 1
Intervention | units on a scale (Mean) |
---|---|
Placebo | -3.62 |
Vortioxetine 5 mg | -4.04 |
Duloxetine 60 mg | -3.48 |
(NCT00811252)
Timeframe: Week 8
Intervention | percentage of patients (Number) |
---|---|
Placebo | 21 |
Vortioxetine 5 mg | 34 |
Duloxetine 60 mg | 47 |
(NCT00844194)
Timeframe: Baseline and Week 12
Intervention | beats per minute (bpm) (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 2.4 |
With Major Depressive Disorder (MDD+) | 2.9 |
(NCT00844194)
Timeframe: Baseline and Week 12
Intervention | mmHg (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.4 |
With Major Depressive Disorder (MDD+) | -2.8 |
The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 2.5 |
With Major Depressive Disorder (MDD+) | 2.7 |
The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 3.0 |
With Major Depressive Disorder (MDD+) | 3.2 |
The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 2.5 |
With Major Depressive Disorder (MDD+) | 2.5 |
The change from baseline reflects the week 6 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.8 |
With Major Depressive Disorder (MDD+) | -2.2 |
The change from baseline reflects the week 12 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.7 |
With Major Depressive Disorder (MDD+) | -3.7 |
The change from baseline reflects the week 2 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.5 |
With Major Depressive Disorder (MDD+) | -1.6 |
The change from baseline reflects the week 6 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.8 |
With Major Depressive Disorder (MDD+) | -3.4 |
(NCT00844194)
Timeframe: Week 12
Intervention | Participants (Number) | |||||
---|---|---|---|---|---|---|
Absent | Feels life is not worth living | Thoughts of possible death to self | Suicidal ideas or gestures | Attempts at suicide | Missing | |
With Major Depressive Disorder (MDD+) | 26 | 1 | 0 | 0 | 0 | 0 |
Without Major Depressive Disorder (MDD-) | 66 | 0 | 0 | 0 | 0 | 0 |
(NCT00844194)
Timeframe: Week 6
Intervention | Participants (Number) | ||||
---|---|---|---|---|---|
No thoughts of killing myself | Thoughts of killing myself | Like to kill myself | Kill myself if chance | Missing | |
With Major Depressive Disorder (MDD+) | 22 | 1 | 0 | 0 | 1 |
Without Major Depressive Disorder (MDD-) | 57 | 2 | 0 | 0 | 0 |
(NCT00844194)
Timeframe: Week 2
Intervention | Participants (Number) | ||||
---|---|---|---|---|---|
No thoughts of killing myself | Thoughts of killing myself | Like to kill myself | Kill myself if chance | Missing | |
With Major Depressive Disorder (MDD+) | 27 | 1 | 0 | 0 | 0 |
Without Major Depressive Disorder (MDD-) | 67 | 3 | 0 | 0 | 0 |
(NCT00844194)
Timeframe: Week 12
Intervention | Participants (Number) | ||||
---|---|---|---|---|---|
No thoughts of killing myself | Thoughts of killing myself | Like to kill myself | Kill myself if chance | Missing | |
With Major Depressive Disorder (MDD+) | 24 | 2 | 0 | 0 | 0 |
Without Major Depressive Disorder (MDD-) | 63 | 0 | 0 | 0 | 2 |
(NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Participants (Number) | ||
---|---|---|---|
>=30% | >=50% | Missing | |
With Major Depressive Disorder (MDD+) | 17 | 12 | 6 |
Without Major Depressive Disorder (MDD-) | 42 | 30 | 14 |
(NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Participants (Number) | ||
---|---|---|---|
>=30% | >=50% | Missing | |
With Major Depressive Disorder (MDD+) | 9 | 3 | 2 |
Without Major Depressive Disorder (MDD-) | 29 | 19 | 5 |
(NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Participants (Number) | ||
---|---|---|---|
>=30% | >=50% | Missing | |
With Major Depressive Disorder (MDD+) | 17 | 11 | 4 |
Without Major Depressive Disorder (MDD-) | 42 | 30 | 6 |
Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 0.4 |
With Major Depressive Disorder (MDD+) | 0.3 |
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.8 |
With Major Depressive Disorder (MDD+) | -2.5 |
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.2 |
With Major Depressive Disorder (MDD+) | -3.0 |
(NCT00844194)
Timeframe: Week 6
Intervention | Participants (Number) | |||||
---|---|---|---|---|---|---|
Absent | Feels life is not worth living | Thoughts of possible death to self | Suicidal ideas or gestures | Attempts at suicide | Missing | |
With Major Depressive Disorder (MDD+) | 22 | 2 | 0 | 0 | 0 | 0 |
Without Major Depressive Disorder (MDD-) | 60 | 0 | 0 | 0 | 0 | 0 |
(NCT00844194)
Timeframe: Week 2
Intervention | Participants (Number) | |||||
---|---|---|---|---|---|---|
Absent | Feels life is not worth living | Thoughts of possible death to self | Suicidal ideas or gestures | Attempts at suicide | Missing | |
With Major Depressive Disorder (MDD+) | 26 | 2 | 0 | 0 | 0 | 0 |
Without Major Depressive Disorder (MDD-) | 68 | 0 | 0 | 0 | 0 | 0 |
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.1 |
With Major Depressive Disorder (MDD+) | -1.5 |
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.4 |
With Major Depressive Disorder (MDD+) | -3.1 |
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.4 |
With Major Depressive Disorder (MDD+) | -1.8 |
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.9 |
With Major Depressive Disorder (MDD+) | -0.1 |
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.1 |
With Major Depressive Disorder (MDD+) | -1.3 |
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.4 |
With Major Depressive Disorder (MDD+) | -1.7 |
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.5 |
With Major Depressive Disorder (MDD+) | -0.1 |
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.6 |
With Major Depressive Disorder (MDD+) | -1.7 |
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.5 |
With Major Depressive Disorder (MDD+) | -1.9 |
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.8 |
With Major Depressive Disorder (MDD+) | -1.0 |
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.1 |
With Major Depressive Disorder (MDD+) | -1.5 |
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.9 |
With Major Depressive Disorder (MDD+) | -2.4 |
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.9 |
With Major Depressive Disorder (MDD+) | -1.0 |
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.3 |
With Major Depressive Disorder (MDD+) | -2.1 |
The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.5 |
With Major Depressive Disorder (MDD+) | -1.1 |
The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.1 |
With Major Depressive Disorder (MDD+) | -0.2 |
The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.7 |
With Major Depressive Disorder (MDD+) | -1.3 |
Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.5 |
With Major Depressive Disorder (MDD+) | -0.8 |
Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.3 |
With Major Depressive Disorder (MDD+) | -0.5 |
Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.2 |
With Major Depressive Disorder (MDD+) | 0.0 |
Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.1 |
With Major Depressive Disorder (MDD+) | -0.1 |
Frequency with which the patient engages in general activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.3 |
With Major Depressive Disorder (MDD+) | 0.3 |
Frequency with which the patient engages in general activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.2 |
With Major Depressive Disorder (MDD+) | 0.1 |
Frequency with which the patient engages in household chores. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 0.1 |
With Major Depressive Disorder (MDD+) | -0.1 |
Frequency with which the patient engages in household chores. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 0.0 |
With Major Depressive Disorder (MDD+) | -0.1 |
Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.0 |
With Major Depressive Disorder (MDD+) | -0.9 |
Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.1 |
With Major Depressive Disorder (MDD+) | -1.0 |
Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 0.2 |
With Major Depressive Disorder (MDD+) | 0.2 |
Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 0.1 |
With Major Depressive Disorder (MDD+) | -0.3 |
Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.1 |
With Major Depressive Disorder (MDD+) | -0.7 |
Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.6 |
With Major Depressive Disorder (MDD+) | 0.6 |
Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.2 |
With Major Depressive Disorder (MDD+) | 0.3 |
The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.5 |
With Major Depressive Disorder (MDD+) | -1.2 |
The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (not at all strong) to 6 (very strong). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.2 |
With Major Depressive Disorder (MDD+) | -1.0 |
Frequency with which the patient engages in social activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 0.1 |
With Major Depressive Disorder (MDD+) | 0.3 |
Frequency with which the patient engages in social activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 0.1 |
With Major Depressive Disorder (MDD+) | 0.1 |
The change from baseline reflects the pain at week 6 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -2.0 |
With Major Depressive Disorder (MDD+) | -1.7 |
Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.2 |
With Major Depressive Disorder (MDD+) | 0.2 |
The change from baseline reflects the week 12 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.0 |
With Major Depressive Disorder (MDD+) | -3.3 |
The change from baseline reflects the week 6 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.7 |
With Major Depressive Disorder (MDD+) | -0.8 |
The change from baseline reflects the week 2 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.5 |
With Major Depressive Disorder (MDD+) | -0.4 |
The change from baseline reflects the week 12 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores of a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.8 |
With Major Depressive Disorder (MDD+) | -1.0 |
The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -2.2 |
With Major Depressive Disorder (MDD+) | -1.9 |
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.6 |
With Major Depressive Disorder (MDD+) | -1.1 |
Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.2 |
With Major Depressive Disorder (MDD+) | -0.2 |
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -2.4 |
With Major Depressive Disorder (MDD+) | -2.7 |
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.2 |
With Major Depressive Disorder (MDD+) | -2.2 |
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.7 |
With Major Depressive Disorder (MDD+) | -0.6 |
The change from baseline reflects the week 2 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.7 |
With Major Depressive Disorder (MDD+) | -1.2 |
The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52. (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores of a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.5 |
With Major Depressive Disorder (MDD+) | -9.3 |
The change from baseline reflects the week 2 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52. (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.2 |
With Major Depressive Disorder (MDD+) | -4.5 |
The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52. (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.8 |
With Major Depressive Disorder (MDD+) | -9.7 |
The change from baseline reflects the week 6 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression. (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.8 |
With Major Depressive Disorder (MDD+) | -7.3 |
The change from baseline reflects the week 2 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression. (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.9 |
With Major Depressive Disorder (MDD+) | -3.1 |
The change from baseline reflects the week 12 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression. (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.6 |
With Major Depressive Disorder (MDD+) | -7.8 |
The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -2.6 |
With Major Depressive Disorder (MDD+) | -2.6 |
The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.6 |
With Major Depressive Disorder (MDD+) | -1.1 |
The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -2.4 |
With Major Depressive Disorder (MDD+) | -2.2 |
Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.4 |
With Major Depressive Disorder (MDD+) | 0.5 |
Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.2 |
With Major Depressive Disorder (MDD+) | 0.4 |
The change from baseline reflects the pain at week 12 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.7 |
With Major Depressive Disorder (MDD+) | -1.5 |
The change from baseline reflects the pain at week 2 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.4 |
With Major Depressive Disorder (MDD+) | -1.0 |
The change from baseline reflects the week 12 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 30.2 |
With Major Depressive Disorder (MDD+) | 22.9 |
The change from baseline reflects the week 2 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief). (NCT00844194)
Timeframe: Baseline and Week 2
Intervention | scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 21.5 |
With Major Depressive Disorder (MDD+) | 18.0 |
The change from baseline reflects the week 6 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 23.5 |
With Major Depressive Disorder (MDD+) | 31.7 |
The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100. (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 0.7 |
With Major Depressive Disorder (MDD+) | 6.0 |
The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100. (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.9 |
With Major Depressive Disorder (MDD+) | 5.0 |
The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100. (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 3.5 |
With Major Depressive Disorder (MDD+) | 2.4 |
The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100. (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 4.0 |
With Major Depressive Disorder (MDD+) | -0.0 |
The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -2.8 |
With Major Depressive Disorder (MDD+) | -3.2 |
The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -2.6 |
With Major Depressive Disorder (MDD+) | -3.3 |
The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.4 |
With Major Depressive Disorder (MDD+) | -2.2 |
MDD- Responder | -1.7 |
MDD+ Responder | -2.2 |
MDD- Non-Responder | -0.9 |
MDD+ Non-Responder | -2.6 |
The change from baseline reflects the week 6 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 6
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -1.2 |
With Major Depressive Disorder (MDD+) | -2.0 |
(NCT00844194)
Timeframe: Baseline and Week 12
Intervention | mmHg (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 2.2 |
With Major Depressive Disorder (MDD+) | -0.6 |
Ancova analysis controlling for baseline and insulin intake (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | mg/dL (Least Squares Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 14.9 |
With Major Depressive Disorder (MDD+) | 13.0 |
Ancova analysis controlling for baseline and insulin intake (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | percent (Least Squares Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | 0.1 |
With Major Depressive Disorder (MDD+) | 0.1 |
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). (NCT00844194)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Mean) |
---|---|
Without Major Depressive Disorder (MDD-) | -0.9 |
With Major Depressive Disorder (MDD+) | -2.1 |
CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit. (NCT00849693)
Timeframe: Baseline, Week 10
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 60mg | -1.5 |
Duloxetine 30mg | -1.5 |
Fluoxetine 20mg | -1.4 |
Placebo | -1.4 |
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit. (NCT00849693)
Timeframe: Baseline, Week 10
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 60mg | -23.9 |
Placebo | -21.6 |
Duloxetine 30mg | -24.6 |
Fluoxetine 20mg | -22.6 |
Placebo | -21.6 |
PCS increase in systolic and diastolic BP was defined as increase of ≥5 mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value. (NCT00849693)
Timeframe: Week 10 through Week 36
Intervention | percentage of participants (Number) | ||||
---|---|---|---|---|---|
Diastolic BP Increase (N=55, 65, 64, 69) | Systolic BP Increase (N=53, 62, 57, 57) | Pulse Decrease (N=68, 75, 76, 73) | Pulse Increase (N=71, 78, 81, 79) | Weight Decrease (N=71, 78, 81, 79) | |
Duloxetine 30 mg/Duloxetine 60-120 mg | 4.6 | 6.5 | 0 | 0 | 9.0 |
Duloxetine 60 mg / Duloxetine 60-120 mg | 14.5 | 9.4 | 0 | 1.4 | 2.8 |
Fluoxetine 20 mg/Fluoxetine 20-40 mg | 20.3 | 7.0 | 0 | 0 | 3.7 |
Placebo/Duloxetine 60-120 mg | 11.6 | 10.5 | 0 | 1.3 | 13.9 |
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit. (NCT00849693)
Timeframe: Week 10, Week 36
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 60 mg / Duloxetine 60-120 mg | -7.8 |
Duloxetine 30 mg/Duloxetine 60-120 mg | -7.4 |
Fluoxetine 20 mg/Fluoxetine 20-40 mg | -10.0 |
Placebo/Duloxetine 60-120 mg | -9.0 |
"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 to 0)." (NCT00849693)
Timeframe: Baseline through Week 10
Intervention | participants (Number) | ||
---|---|---|---|
Suicidal Ideation | Suicidal Behavior | Treatment Emergent Suicidal Ideation | |
Duloxetine 30mg | 11 | 0 | 6 |
Duloxetine 60mg | 16 | 0 | 7 |
Fluoxetine 20mg | 13 | 1 | 9 |
Placebo | 15 | 1 | 11 |
CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit. (NCT00849693)
Timeframe: Week 10, Week 36
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 60 mg / Duloxetine 60-120 mg | -1.1 |
Duloxetine 30 mg/Duloxetine 60-120 mg | -0.9 |
Fluoxetine 20 mg/Fluoxetine 20-40 mg | -1.3 |
Placebo/Duloxetine 60-120 mg | -1.0 |
"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10)." (NCT00849693)
Timeframe: Week 10 through Week 36
Intervention | participants (Number) | ||
---|---|---|---|
Suicidal Ideation | Suicidal Behavior | Treatment Emergent Suicidal Ideation | |
Duloxetine 30 mg/Duloxetine 60-120 mg | 12 | 3 | 8 |
Duloxetine 60 mg / Duloxetine 60-120 mg | 6 | 2 | 5 |
Fluoxetine 20 mg/Fluoxetine 20-40 mg | 8 | 0 | 7 |
Placebo/Duloxetine 60-120 mg | 8 | 1 | 6 |
CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit. (NCT00849693)
Timeframe: Baseline, Week 10
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Mood | Somatic | Subjective | Behavior | |
Duloxetine 30mg | -7.2 | -7.9 | -4.0 | -5.6 |
Duloxetine 60mg | -7.1 | -7.6 | -3.6 | -5.8 |
Fluoxetine 20mg | -6.6 | -7.1 | -3.5 | -5.6 |
Placebo | -6.4 | -6.4 | -3.6 | -5.4 |
CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit. (NCT00849693)
Timeframe: Week 10, Week 36
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Mood | Somatic | Subjective | Behavior | |
Duloxetine 30 mg/Duloxetine 60-120 mg | -1.9 | -2.4 | -1.3 | -1.8 |
Duloxetine 60 mg / Duloxetine 60-120 mg | -1.9 | -2.8 | -1.2 | -2.1 |
Fluoxetine 20 mg/Fluoxetine 20-40 mg | -2.4 | -4.0 | -1.5 | -2.7 |
Placebo/Duloxetine 60-120 mg | -2.3 | -3.2 | -1.0 | -2.4 |
PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value. (NCT00849693)
Timeframe: Baseline through Week 10
Intervention | percentage of participants (Number) | ||||
---|---|---|---|---|---|
Diastolic BP Increase (N=93, 100, 99, 110) | Systolic BP Increase (N=88, 95, 93, 98) | Pulse Decrease (N=100, 108, 108, 112) | Pulse Increase (N=105, 114, 112, 117) | Weight Decrease (N=105, 114, 112, 117) | |
Duloxetine 30mg | 7.0 | 12.6 | 0 | 0 | 8.8 |
Duloxetine 60mg | 11.8 | 9.1 | 0 | 0 | 13.3 |
Fluoxetine 20mg | 10.1 | 12.9 | 0 | 0 | 11.6 |
Placebo | 4.5 | 10.2 | 0 | 0 | 5.1 |
Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN. (NCT00849693)
Timeframe: Baseline through Week 10
Intervention | participants (Number) | |||
---|---|---|---|---|
ALT≥3 x ULN | ALT≥5 x ULN | ALT≥10 x ULN | ALT≥3 x ULN and Total Bilirubin≥2 x ULN | |
Duloxetine 30mg | 0 | 0 | 0 | 0 |
Duloxetine 60mg | 0 | 0 | 0 | 0 |
Fluoxetine 20mg | 0 | 0 | 0 | 0 |
Placebo | 0 | 0 | 0 | 0 |
Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as ALT ≥3 x ULN, ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT≥3 x ULN and Total Bilirubin ≥2 x ULN. (NCT00849693)
Timeframe: Week 10 through Week 36
Intervention | participants (Number) | |||
---|---|---|---|---|
ALT≥3 x ULN | ALT≥5 x ULN | ALT≥10 x ULN | ALT≥3 x ULN and Total Bilirubin≥2 x ULN | |
Duloxetine 30 mg/Duloxetine 60-120 mg | 0 | 0 | 0 | 0 |
Duloxetine 60 mg / Duloxetine 60-120 mg | 0 | 0 | 0 | 0 |
Fluoxetine 20 mg/Fluoxetine 20-40 mg | 0 | 0 | 0 | 0 |
Placebo/Duloxetine 60-120 mg | 0 | 0 | 0 | 0 |
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit. (NCT00849901)
Timeframe: Baseline, Week 10
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -24.3 |
Fluoxetine | -23.7 |
Placebo | -24.3 |
CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit. (NCT00849901)
Timeframe: Baseline, Week 10
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -1.9 |
Fluoxetine | -1.8 |
Placebo | -1.9 |
"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 - 0)." (NCT00849901)
Timeframe: Baseline through Week 10
Intervention | participants (Number) | ||
---|---|---|---|
Suicidal Ideation | Suicidal Behavior | Treatment Emergent Suicidal Ideation | |
Duloxetine | 16 | 0 | 8 |
Fluoxetine | 16 | 1 | 9 |
Placebo | 15 | 0 | 7 |
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit. (NCT00849901)
Timeframe: Week 10, Week 36
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine/Duloxetine | -7.2 |
Fluoxetine/Fluoxetine | -9.9 |
Placebo/Duloxetine | -9.6 |
CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit. (NCT00849901)
Timeframe: Week 10, Week 36
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine/Duloxetine | -0.6 |
Fluoxetine/Fluoxetine | -1.0 |
Placebo/Duloxetine | -1.1 |
CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit. (NCT00849901)
Timeframe: Baseline, Week 10
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Mood (N=113, 113, 103) | Somatic (N=113, 113, 103) | Subjective (N=113, 113, 103) | Behavior (N=113, 112, 103) | |
Duloxetine | -7.0 | -7.7 | -4.0 | -5.6 |
Fluoxetine | -7.1 | -7.6 | -3.6 | -5.4 |
Placebo | -7.0 | -7.7 | -4.0 | -5.7 |
CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit. (NCT00849901)
Timeframe: Week 10, Week 36
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Mood | Somatic | Subjective | Behavior | |
Duloxetine/Duloxetine | -1.9 | -2.8 | -0.3 | -1.9 |
Fluoxetine/Fluoxetine | -2.5 | -3.6 | -1.3 | -2.8 |
Placebo/Duloxetine | -2.9 | -3.2 | -1.2 | -2.1 |
Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN. (NCT00849901)
Timeframe: Baseline through Week 10
Intervention | participants (Number) | |||
---|---|---|---|---|
ALT≥3 x ULN | ALT≥5 x ULN | ALT≥10 x ULN | ALT≥3 x ULN and Total Bilirubin≥2 x ULN | |
Duloxetine | 0 | 0 | 0 | 0 |
Fluoxetine | 0 | 0 | 0 | 0 |
Placebo | 0 | 0 | 0 | 0 |
Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN. (NCT00849901)
Timeframe: Week 10 through Week 36
Intervention | participants (Number) | |||
---|---|---|---|---|
ALT≥3 x ULN | ALT≥5 x ULN | ALT≥10 x ULN | ALT≥3 x ULN and Total Bilirubin≥2 x ULN | |
Duloxetine/Duloxetine | 0 | 0 | 0 | 0 |
Fluoxetine/Fluoxetine | 1 | 1 | 0 | 0 |
Placebo/Duloxetine | 0 | 0 | 0 | 0 |
"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10)." (NCT00849901)
Timeframe: Week 10 through Week 36
Intervention | participants (Number) | ||
---|---|---|---|
Suicidal Ideation | Suicidal Behavior | Treatment Emergent Suicidal Ideation | |
Duloxetine/Duloxetine | 13 | 1 | 9 |
Fluoxetine/Fluoxetine | 13 | 1 | 13 |
Placebo/Duloxetine | 8 | 0 | 8 |
PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value. (NCT00849901)
Timeframe: Baseline through Week 10
Intervention | percentage of participants (Number) | ||||
---|---|---|---|---|---|
Diastolic BP Increase (N=102, 106, 93) | Systolic BP Increase (N=100, 106, 90) | Pulse Decrease (N=111, 112, 102) | Pulse Increase (N=113, 114, 103) | Weight Decrease (N=113, 114, 103) | |
Duloxetine | 8.8 | 7.0 | 0.9 | 0 | 12.4 |
Fluoxetine | 7.5 | 5.7 | 0.9 | 0 | 11.4 |
Placebo | 17.2 | 6.7 | 1.0 | 1.0 | 4.9 |
PCS increase in systolic and diastolic BP was defined as increase of ≥ 5mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value. (NCT00849901)
Timeframe: Week 10 through Week 36
Intervention | percentage of participants (Number) | ||||
---|---|---|---|---|---|
Diastolic BP Increase (N=65, 76, 61) | Systolic BP Increase (N=64, 80, 69) | Pulse Decrease (N=78, 84, 82) | Pulse Increase (N=81, 91, 84) | Weight Decrease (N=81, 91, 85) | |
Duloxetine/Duloxetine | 16.9 | 12.5 | 0 | 0 | 6.2 |
Fluoxetine/Fluoxetine | 11.8 | 12.5 | 0 | 0 | 3.3 |
Placebo/Duloxetine | 4.9 | 10.1 | 0 | 0 | 9.4 |
"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=''No pain to 10=''Pain as bad as you can imagine at baseline and over the fourth treatment week of each treatment period.~The % of improvement was calculated as (x-y)/x,where x was the MPI score at baseline, and y was the MPI score at the end of each treatment stage." (NCT00863057)
Timeframe: At Baseline and over the fourth treatment week of each treatment period
Intervention | participants (Number) |
---|---|
Duloxetine and Methadone | 2 |
Duloxetine and Methadone Placebo | 2 |
Duloxetine Placebo and Methadone | 2 |
Duloxetine Placebo and Methadone Placebo | 2 |
"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=''No pain to 10=''Pain as bad as you can imagine at baseline and over the fourth treatment week of each treatment period.~The % of improvement was calculated as (x-y)/x,where x was the MPI score at baseline, and y was the MPI score at the end of each treatment stage." (NCT00863057)
Timeframe: At Baseline and over the fourth treatment week of each treatment period
Intervention | participants (Number) |
---|---|
Duloxetine and Methadone | 2 |
Duloxetine and Methadone Placebo | 2 |
Duloxetine Placebo and Methadone | 1 |
Duloxetine Placebo and Methadone Placebo | 2 |
The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 was used (see the link to the grading table in Protocol Section) (NCT00863057)
Timeframe: From study entry to end of study at week 20 or premature study discontinuation
Intervention | Participants (Count of Participants) |
---|---|
Duloxetine and Methadone | 5 |
Duloxetine and Methadone Placebo | 4 |
Duloxetine Placebo and Methadone | 6 |
Duloxetine Placebo and Methadone Placebo | 5 |
"The BPI interference scale measured level of interference with the following seven items:~General activity~Mood~Walking ability~Normal work~Relations with other people~Sleep~Enjoyment of life~Interference scales range from 0='Does not interfere' to 10='Completely interferes'. The overall BPI score is the mean of seven item with the minimum and maximal scores of 0 and 70, respectively." (NCT00863057)
Timeframe: At the fourth week of each treatment period
Intervention | Scores on a scale (Median) |
---|---|
Duloxetine and Methadone | 3.14 |
Duloxetine and Methadone Placebo | 4.14 |
Duloxetine Placebo and Methadone | 3.64 |
Duloxetine Placebo and Methadone Placebo | 3.14 |
"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=''No pain to 10=''Pain as bad as you can imagine.~Participants were given pain diaries at weeks 0, 5, 10, and 15. They started the diary 7 days prior to their clinic visits at weeks 0, 4, 9, 14, and 19. During the 7 days, each morning, they recorded their pain level due to neuropathy by circling the number that best described their neuropathy pain on average over the past 24 hours." (NCT00863057)
Timeframe: During the fourth treatment week of each treatment period
Intervention | Scores on a scale (Mean) |
---|---|
Duloxetine and Methadone | 5.20 |
Duloxetine and Methadone Placebo | 5.91 |
Duloxetine Placebo and Methadone | 6.20 |
Duloxetine Placebo and Methadone Placebo | 5.70 |
"The GIC scale is a validated instrument that consists of seven verbal descriptors on a 7-point scale:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse~Participants were carefully instructed to consider the impact of study treatments on their level of neuropathic pain intensity during the baseline phase of the study." (NCT00863057)
Timeframe: At the fourth treatment week of each treatment period
Intervention | participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
PGIC - Very much improved | PGIC - Much improved | PGIC - Minimally improved | PGIC - No change | PGIC - Much worse | CGIC - Very much improved | CGIC - Much improved | CGIC - Minimally improved | CGIC - No change | CGIC - Much worse | |
Duloxetine and Methadone | 1 | 4 | 2 | 3 | 0 | 1 | 4 | 1 | 4 | 0 |
Duloxetine and Methadone Placebo | 0 | 1 | 4 | 6 | 0 | 1 | 1 | 1 | 8 | 0 |
Duloxetine Placebo and Methadone | 1 | 2 | 4 | 2 | 1 | 1 | 3 | 3 | 3 | 0 |
Duloxetine Placebo and Methadone Placebo | 1 | 1 | 4 | 4 | 0 | 1 | 1 | 3 | 4 | 1 |
The CES-D is a 20-item self-report rating inventory measuring characteristic attitudes and symptoms of depression. Participants were asked to score each item: (0) Rarely, (1) Occasionally, (2) Sometimes, and (3) Most of time. Some items are multiplied by -1 to change direction. The overall CES-D score is simply the sum of 20 items. The highest possible total CES-D score is 48, and the lowest possible score is -12. The total CES-D score is considered missing if more than 4 items are not answered. (NCT00863057)
Timeframe: At the fourth treatment week of each treatment period
Intervention | Scores on a scale (Mean) |
---|---|
Duloxetine and Methadone | 13.8 |
Duloxetine and Methadone Placebo | 13.8 |
Duloxetine Placebo and Methadone | 13.3 |
Duloxetine Placebo and Methadone Placebo | 13.3 |
(NCT00863057)
Timeframe: During each treatment period
Intervention | mg (Number) |
---|---|
Methadone | 30 |
Duloxetine | 60 |
"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=''No pain to 10=''Pain as bad as you can imagine.~Participants were given pain diaries at weeks 0, 5, 10, and 15. They started the diary 7 days prior to their clinic visits at weeks 0, 4, 9, 14, and 19. During the 7 days, each morning, they recorded their pain level due to neuropathy by circling the number that best described their neuropathy pain on average during the night time." (NCT00863057)
Timeframe: Over the fourth treatment week of each treatment period
Intervention | Scores on a scale (Mean) |
---|---|
Duloxetine and Methadone | 5.20 |
Duloxetine and Methadone Placebo | 5.82 |
Duloxetine Placebo and Methadone | 5.90 |
Duloxetine Placebo and Methadone Placebo | 6.10 |
(NCT00863057)
Timeframe: During each treatment period and the subsequent cross-over (or final study week) period
Intervention | participants (Number) | |
---|---|---|
Treatment period (1-4, 6-9, 11-14, 16-19 weeks) | Cross-over period (5, 10, 15, 20 weeks) | |
Duloxetine and Methadone | 0 | 1 |
Duloxetine and Methadone Placebo | 0 | 0 |
Duloxetine Placebo and Methadone | 0 | 1 |
Duloxetine Placebo and Methadone Placebo | 2 | 1 |
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol. (NCT00929344)
Timeframe: Baseline and Week 12
Intervention | drinks/week (Mean) | ||
---|---|---|---|
Drinks/week Baseline | Drinks/week Week 12 | Drinks/week Change | |
Duloxetine | 42.07 | 9.16 | -32.91 |
Placebo | 41.20 | 8.06 | -33.15 |
Pregabalin | 56.67 | 7.59 | -49.08 |
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol. (NCT00929344)
Timeframe: Baseline and Week 12
Intervention | drinking days/week (Mean) | ||
---|---|---|---|
Drinking Days/Week Baseline | Drinking Days/Week Week 12 | Drinking Days/Week Change | |
Duloxetine | 5.11 | 2.17 | -2.94 |
Placebo | 4.87 | 1.85 | -3.01 |
Pregabalin | 4.54 | 1.14 | -3.40 |
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol. (NCT00929344)
Timeframe: Baseline and Week 12
Intervention | drinks/drinking day (Mean) | ||
---|---|---|---|
Drinks/Drinking Day Baseline | Drinks/Drinking Day Week 12 | Drinks/Drinking Day Change | |
Duloxetine | 8.16 | 2.21 | -5.94 |
Placebo | 8.91 | 2.90 | -6.01 |
Pregabalin | 12.98 | 2.31 | -10.67 |
"C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors and ideations are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation." (NCT00945945)
Timeframe: Baseline through 13 weeks
Intervention | participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Ideation: Wish to be dead | Ideation: Non-specific active suicidal thoughts | Ideation: Active suicidal ideation without intent | Ideation: Active suicidal ideation with intent | Ideation:Active suicidal ideation with plan to act | Behavior: Preparatory acts or behavior | Behavior: Aborted attempt | Behavior: Interrupted attempt | Acts: Non-fatal suicide attempt | Acts: Completed suicide | |
DLX30-PLA | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
PLA-DLX60 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
A self-reported measure of the severity of pain based on the average pain over 24-hours. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). BOCF endpoint was defined as the baseline value for participants discontinued during acute phase, and defined as the last non-missing observation in the treatment phase for all other randomized participants. Due to the nature of a study drug labeling error which led to a treatment crossover (see Arms), data from protocol-defined treatment groups were compromised. The results from each mixed-treatment group are presented. (NCT00945945)
Timeframe: Baseline, 13 weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Change from Baseline to Endpoint (BOCF) | |
DLX30-PLA | 6.00 | -1.93 |
PLA-DLX60 | 6.10 | -2.34 |
The PGI-I Rating Scale was a 7-point scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction and an unstructured covariance matrix. (NCT00960986)
Timeframe: 1 week, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
1-week change | 8-week change (n=28; n=37; n=39; n=37) | |
Duloxetine 30 mg With Food | 3.52 | 2.36 |
Duloxetine 30 mg Without Food | 3.47 | 2.40 |
Duloxetine 60 mg With Food | 3.72 | 2.31 |
Duloxetine 60 mg Without Food | 3.77 | 2.40 |
The HAMD-17 Sleep subscale (Items 4, 5, 6 of HAMD-17 questionnaire) evaluated initial, middle, and late insomnia. Total subscale scores ranged from 0 (no difficulty)-6 (difficulty). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. (NCT00960986)
Timeframe: Baseline, 1 week, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
1-week change | 8-week change (n=28; n=37; n=39; n=37) | |
Duloxetine 30 mg With Food | -0.66 | -2.09 |
Duloxetine 30 mg Without Food | -1.01 | -2.10 |
Duloxetine 60 mg With Food | -0.72 | -2.77 |
Duloxetine 60 mg Without Food | -0.64 | -2.32 |
The HAMD-17 Retardation/Somatization subscale (Items 1, 7, 8, 14 of HAMD-17 questionnaire) evaluated dysfunction in mood, work, sexual activity, and overall motor retardation. Total subscale scores ranged from 0 (normal)-14 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. (NCT00960986)
Timeframe: Baseline, 1 week, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
1-week change | 8-week change (n=28; n=37; n=39; n=37) | |
Duloxetine 30 mg With Food | -1.02 | -4.63 |
Duloxetine 30 mg Without Food | -1.20 | -4.55 |
Duloxetine 60 mg With Food | -0.83 | -4.92 |
Duloxetine 60 mg Without Food | -0.87 | -4.37 |
"The HAMD-17 Maier subscale (Items 1, 2, 7, 8, 9, 10 of HAMD-17 questionnaire) represented the core symptoms of depression. Total subscale scores ranged from 0 (normal)-24 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix." (NCT00960986)
Timeframe: Baseline, 1 week, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
1-week change | 8-week change (n=28; n=37; n=39; n=37) | |
Duloxetine 30 mg With Food | -2.15 | -7.55 |
Duloxetine 30 mg Without Food | -2.64 | -7.30 |
Duloxetine 60 mg With Food | -2.06 | -8.01 |
Duloxetine 60 mg Without Food | -1.90 | -7.12 |
Scores for AE scale Item 112 (nausea) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. (NCT00960986)
Timeframe: Baseline, 8 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 60 mg With Food | -0.02 |
Duloxetine 60 mg Without Food | -0.02 |
Duloxetine 30 mg With Food | -0.01 |
Duloxetine 30 mg Without Food | -1.12 |
The HAMD-17 Core Mood subscale (Items 1, 2, 3, 7, 8 of HAMD-17 questionnaire) represented the core symptoms of depression. Total subscale scores ranged from 0 (normal)-20 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. (NCT00960986)
Timeframe: Baseline, 1 week, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
1-week change | 8-week change (n=28; n=37; n=39; n=37) | |
Duloxetine 30 mg With Food | -1.52 | -5.85 |
Duloxetine 30 mg Without Food | -1.76 | -5.67 |
Duloxetine 60 mg With Food | -1.43 | -6.18 |
Duloxetine 60 mg Without Food | -1.18 | -5.39 |
Remission was defined as 17-item Hamilton Depression Rating Scale (HAMD-17) total score ≤7. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed). (NCT00960986)
Timeframe: Baseline up to 8 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine 60 mg With Food | 42.9 |
Duloxetine 60 mg Without Food | 37.3 |
Duloxetine 30 mg With Food | 35.6 |
Duloxetine 30 mg Without Food | 32.8 |
AMDP-5 common AEs score was used to create a composite measure of AEs from previous duloxetine studies (incidence >5% and 2X placebo rate). The common AEs total score was the sum of the following 8 AMDP-5 items: 1) Mean of Item 112 (nausea) + 113 (vomiting); 2) Item 111 (dry mouth); 3) Item 115 (constipation); 4) Mean of Items 101-104 (insomnia); Item 122 (increased perspiration); 8) Item 106 (decreased appetite). Score was based on a 5-point scale: 1=absent, 2=mild, 3=moderate, 4=severe, 5=extremely severe; Higher score=worse severity. (NCT00960986)
Timeframe: Baseline, 1 week, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
1-week change | 8-week change (n=28; n=37; n=39; n=37) | |
Duloxetine 30 mg With Food | -0.00 | -2.33 |
Duloxetine 30 mg Without Food | -0.37 | -3.23 |
Duloxetine 60 mg With Food | 1.25 | -3.54 |
Duloxetine 60 mg Without Food | 1.28 | -2.99 |
Response was defined as ≥50% decrease from baseline on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed). (NCT00960986)
Timeframe: Baseline up to 8 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine 60 mg With Food | 51.8 |
Duloxetine 60 mg Without Food | 49.2 |
Duloxetine 30 mg With Food | 47.5 |
Duloxetine 30 mg Without Food | 47.5 |
Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study. (NCT00960986)
Timeframe: Nausea onset up to nausea resolve (Baseline up to 8 weeks)
Intervention | days (Median) |
---|---|
Duloxetine 60 mg With Food | 6.0 |
Duloxetine 60 mg Without Food | 8.0 |
Duloxetine 30 mg With Food | 15.0 |
Duloxetine 30 mg Without Food | 6.0 |
The HAMD-17 Anxiety/Somatization subscale (Items 10, 11, 12, 13, 15, 17 of HAMD-17 questionnaire) evaluated the severity of psychic and somatic manifestations of anxiety and agitation. Total subscale scores ranged from 0 (normal)-18 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. (NCT00960986)
Timeframe: Baseline, 1 week, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
1-week change | 8-week change (n=28; n=37; n=39; n=37) | |
Duloxetine 30 mg With Food | -1.36 | -4.57 |
Duloxetine 30 mg Without Food | -1.41 | -4.26 |
Duloxetine 60 mg With Food | -0.75 | -4.93 |
Duloxetine 60 mg Without Food | -1.15 | -4.50 |
Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study. (NCT00960986)
Timeframe: Baseline to onset of nausea (Baseline up to 8 weeks)
Intervention | days (Median) |
---|---|
Duloxetine 60 mg With Food | 2.0 |
Duloxetine 60 mg Without Food | 1.0 |
Duloxetine 30 mg With Food | 7.0 |
Duloxetine 30 mg Without Food | 6.0 |
AMDP-5 AE scale Item 112 (nausea) measured nausea severity during treatment (Week 0-8). The scores ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. (NCT00960986)
Timeframe: 1 week and 8 weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Week 0-1 | Week 1-8 (n=35; n=43; n=48; n=46) | |
Duloxetine 30 mg With Food | 0.9 | 0.7 |
Duloxetine 30 mg Without Food | 0.8 | 0.4 |
Duloxetine 60 mg With Food | 1.4 | 0.5 |
Duloxetine 60 mg Without Food | 1.2 | 0.5 |
The CGI-S Rating Scale was a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix. (NCT00960986)
Timeframe: Baseline, 1 week, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
1-week change | 8-week change (n=28; n=37; n=39; n=37) | |
Duloxetine 30 mg With Food | -0.44 | -2.23 |
Duloxetine 30 mg Without Food | -0.63 | -2.27 |
Duloxetine 60 mg With Food | -0.36 | -2.43 |
Duloxetine 60 mg Without Food | -0.36 | -2.13 |
Gastric events scores (average of Item 112 [nausea] + Item 113 [vomiting]) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. (NCT00960986)
Timeframe: Baseline, 1 week and 8 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
1-week change | 8-week change (n=28; n=37; n=39; n=37) | |
Duloxetine 30 mg With Food | 0.35 | -0.04 |
Duloxetine 30 mg Without Food | 0.37 | -0.09 |
Duloxetine 60 mg With Food | 0.73 | -0.04 |
Duloxetine 60 mg Without Food | 0.72 | -0.04 |
The HAMD-17 total score ranged from 0 (not at all depressed)-52 (severely depressed). Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix. (NCT00960986)
Timeframe: Baseline, 1 week, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
1-week change | 8-week change (n=28; n=37; n=39; n=37) | |
Duloxetine 30 mg With Food | -3.84 | -13.60 |
Duloxetine 30 mg Without Food | -4.34 | -13.07 |
Duloxetine 60 mg With Food | -2.83 | -15.39 |
Duloxetine 60 mg Without Food | -2.85 | -13.45 |
"The scale consists of two parts the first part being Severity of Illness and the second part is Global Improvement. We report the Global improvement scale.~The Global Improvement is a 1-7 change scale of global improvement since inclusion in the project ranging with 1 very much improved, 4 no change, and 7 very much worse." (NCT00961298)
Timeframe: endpoint [12 weeks]
Intervention | scores on a scale (Mean) |
---|---|
Treatment Arm | 2.64 |
"The IBS-QOL consists of 34 items, each with a five-point response scale. Ratings range from 1 not at all to 5 extremely or a great deal Higher responses on the scale indicate worse outcome. A minimal total score would be 34, maximum 170." (NCT00961298)
Timeframe: endpoint [12 weeks]
Intervention | scores on a scale (Mean) |
---|---|
Treatment Arm | 81.73 |
This is a 4 item Likert scale with each assessment being 100 mm scored from measuring from 0 to 400. Higher numbers indicate worse outcome. (NCT00961298)
Timeframe: endpoint [12 weeks]
Intervention | scores on a scale (Mean) |
---|---|
Treatment Arm | 187.09 |
"The HAM-A is a 14 question scale with five responses. Responses range from 0 not present to 4 very severe. The total score ranges from 0 to 56. Higher values represent a worse outcome." (NCT00961298)
Timeframe: endpoint [12 weeks]
Intervention | scores on a scale (Mean) |
---|---|
Treatment Arm | 9.75 |
"The C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants with suicidal behaviors and ideations are provided.~Suicidal behavior: a yes answer to any of 5 suicidal behavior questions which include: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.~Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions which include wish to be dead and 4 different categories of active suicidal ideation." (NCT00965081)
Timeframe: Baseline through 12 weeks
Intervention | Participants (Number) | |||||||
---|---|---|---|---|---|---|---|---|
Wish to be dead | Non-specific active suicidal thoughts | Active suicidal ideation with no intent to act | Active suicidal ideation, some intent, no plan | Active suicidal ideation with specific plan/intent | Suicidal behavior - Preparatory acts or behavior | Suicidal behavior - Aborted attempt | Suicidal behavior - Interrupted attempt | |
Duloxetine | 3 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
Placebo | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
SF-36 has 36 items with 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, general health; each scored on 0 to 100 scale. Higher scores indicate better status. Mental component summary (MCS) and physical component summary (PCS) based on 8 SF-36 domains. Scales scored using norm-based methods; mean is 50 and standard deviation is 10 in U.S. population. Treatment group difference in Least Squares (LS) Means at endpoint from analysis of covariance. Terms for treatment group, pooled investigators, baseline in model. (NCT00965081)
Timeframe: Baseline, 12 weeks
Intervention | Units on a scale (Least Squares Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Bodily Pain Transformed (n=141, n=135) | General Health Transformed (n=140, n=134) | Mental Health Transformed (n=141, n=135) | Physical Functioning (n=141, n=135) | Role-Emotional (n=141, n=135) | Role-Physical (n=141, n=135) | Social Functioning (n=141, n=135) | Vitality (n=141, n=135) | Mental Component (n=140, n=134) | Physical Component (n=140, n=134) | |
Duloxetine | 17.06 | 7.88 | 9.36 | 9.53 | 18.88 | 18.55 | 14.05 | 11.87 | 5.56 | 4.75 |
Placebo | 14.01 | 6.12 | 5.55 | 6.34 | 10.69 | 13.13 | 6.75 | 7.59 | 2.87 | 3.91 |
The BDI-II is a 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3 (0 = not present; 3 = present in the extreme). The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline. (NCT00965081)
Timeframe: Baseline, 12 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -5.47 |
Placebo | -3.91 |
BPI Average Pain score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Treatment group difference in Least Squares (LS) Means changes from analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators, baseline. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy (DBT) due to adverse event (AE); last non-missing observation during initial DBT used to impute missing endpoint for all others. Analyses included all participants having non-missing baseline and endpoint. (NCT00965081)
Timeframe: Baseline, 12 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -2.04 |
Placebo | -1.70 |
"The BAI is a 21-item patient-completed questionnaire designed to assess the characteristics of anxiety. Each item is rated on a 4-point scale (0=not present; 3=present in the extreme). The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.~The treatment group difference in the Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline." (NCT00965081)
Timeframe: Baseline, 12 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -3.76 |
Placebo | -3.31 |
"The CGI-I measures clinician's perception of patient improvement at time of assessment compared with start of treatment. Scores range from 1 (very much improved) to 7 (very much worse).~The treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline CGI-Severity (CGI-S)." (NCT00965081)
Timeframe: 12 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 3.34 |
Placebo | 3.51 |
FIQ is a 20-item self-administered questionnaire that measures fibromyalgia (FM) patient status, progress, and outcomes over the past week. The total score ranges from 0 to 80 with higher scores reflecting a more negative impact of FM. The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline. (NCT00965081)
Timeframe: Baseline, 12 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -14.62 |
Placebo | -9.75 |
BPI-Modified Short Form mean interference score ranges from 0 (does not interfere) to 10 (completely interferes) for pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Treatment group difference in the Least Squares (LS) Means changes from baseline to endpoint is from an analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators and baseline. Last-observation-carried forward (LOCF) endpoint defined as last available post-baseline value obtained during initial double-blind therapy. (NCT00965081)
Timeframe: Baseline, 12 weeks
Intervention | Units on a scale (Least Squares Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Worst Pain | Least Pain | Pain Right Now | Pain Interference - General Activity | Pain Interference - Mood | Pain Interference - Walking ability | Pain Interference - Normal Work | Pain Interference - Relations with Other People | Pain Interference - Sleep | Pain Interference - Enjoyment of Life | Mean Interference Score | |
Duloxetine | -2.23 | -1.56 | -2.25 | -2.19 | -2.40 | -2.31 | -2.20 | -2.05 | -2.06 | -2.48 | -2.28 |
Placebo | -1.98 | -1.36 | -1.90 | -1.91 | -1.82 | -1.74 | -1.77 | -1.34 | -1.75 | -1.93 | -1.78 |
"The PGI-I scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale: score of 1 is very much better, 4 is no change, and 7 is very much worse. Treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA); model included terms for treatment group, pooled investigators and baseline PGI-Severity (PGI-S)." (NCT00965081)
Timeframe: 12 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 2.97 |
Placebo | 3.35 |
Measurements from zero to 100 with 100 being the worst pain by Visual Analog Scale (VAS). (NCT00981149)
Timeframe: 1, 3, 6 weeks
Intervention | units on a scale (Mean) | ||
---|---|---|---|
1 week | 3 weeks | 6 weeks | |
Duloxetine Study Drug | 42.9 | 30.4 | 34.8 |
Placebo | 51.4 | 44 | 36.7 |
Assessment of evoked pain using digital palpation examination at 18 predefined bodily sites. (NCT00981149)
Timeframe: 6 weeks
Intervention | Pain pressure threshold (kg/cm2) (Mean) |
---|---|
Duloxetine Study Drug | 311.9 |
Placebo | 300.8 |
Relapse is defined as achieving a Montgomery-Asberg Depression Rating Scale (MADRS) total score≥16 at any time after baseline. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). (NCT00985504)
Timeframe: Baseline through 8 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 11.9 |
Escitalopram | 11.0 |
Percentage of participants who discontinue after baseline due to lack of efficacy in the investigator's opinion. (NCT00985504)
Timeframe: Baseline through 8 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 2.0 |
Escitalopram | 1.3 |
The PGI-I is a scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, and treatment*visit. (NCT00985504)
Timeframe: 8 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 2.59 |
Escitalopram | 2.55 |
The CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit. (NCT00985504)
Timeframe: Baseline, 8 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -0.86 |
Escitalopram | -0.93 |
The AES-C is a validated 18-item instrument used to assess cognitive, behavioral, emotional and other symptoms of apathy. Clinicians rate each item based on verbal and nonverbal information provided by the participant. Item scores range from 1 (not at all characteristic) to 4 (a lot characteristic). Total scores range from 18 to 72 where higher derived scores indicate more severe apathy. The Least Squares (LS) Mean Value was calculated from a mixed model repeated measures (MMRM) model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit. (NCT00985504)
Timeframe: Baseline, 8 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -13.88 |
Escitalopram | -13.50 |
The number of days from baseline to the first relapse is defined as reaching a MADRS Total Score≥16. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Censored participants were included in the Kaplan-Meier analysis, the minimum and maximum time to relapse have been calculated and reported here. Median time to relapse and quartiles could not be computationally calculated using the Kaplan-Meier procedure due to low event rate and high completion rate (censored). (NCT00985504)
Timeframe: Baseline through 8 weeks
Intervention | days (Number) | |
---|---|---|
Minimum Number of Days from Baseline | Maximum Number of Days from Baseline | |
Duloxetine | 4.00 | 81.00 |
Escitalopram | 4.00 | 68.00 |
RSAT assesses symptoms of apathy or decreased motivation among depressed participants who have achieved symptomatic remission with antidepressant treatment and consists of 6 self-report items assessing energy level, motivation and interest, cognitive functioning, weight gain, sleep and sexual functioning, as well as affect. Each item score ranges from 0 to 4 with total scores ranging from 0 to 28. Higher scores indicate greater disease severity. LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit. (NCT00985504)
Timeframe: Baseline, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |||||||
---|---|---|---|---|---|---|---|---|
RSAT Total Score | Energy Level | Motivation and Interest | Cognitive Functioning | Weight Gain | Sleep | Sexual Functioning | Affect | |
Duloxetine | -5.50 | -1.33 | -1.41 | -0.90 | -0.25 | -0.48 | -0.62 | -0.53 |
Escitalopram | -4.98 | -1.19 | -1.29 | -0.80 | -0.11 | -0.55 | -0.60 | -0.50 |
MADRS is a rating scale for severity of depressive mood symptoms and has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Item 8 assesses the participant's inability to feel. Scores range from 0 (normal interest in surroundings and other people) to 6 (emotional paralysis, inability to feel anger/grief/pleasure). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit. (NCT00985504)
Timeframe: Baseline, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Total Score | Item 8 (Inability to Feel) | |
Duloxetine | -4.21 | -1.01 |
Escitalopram | -4.14 | -0.90 |
"The MGH-CPFQ is a 7-item participant-rated questionnaire evaluating the participant's cognitive and physical well-being during the past month. The MGH-CPFQ assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 2 (normal) to 6 (totally absent). Total scores range from 7 to 42. Higher scores indicate greater disease severity. The LS Mean Value was calculated from an analysis of covariance (ANCOVA) model with terms of treatment, pooled investigator, and baseline." (NCT00985504)
Timeframe: Baseline, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |||||||
---|---|---|---|---|---|---|---|---|
Total Score | Motivation/Interest/Enthusiasm Score | Wakefulness/Alertness Score | Energy Score | Ability to Focus/Sustain Attention Score | Ability to Remember/Recall Information Score | Ability to Find Words Score | Sharpness/Mental Acuity Score | |
Duloxetine | -6.96 | -1.34 | -0.96 | -1.28 | -0.99 | -0.91 | -0.69 | -0.79 |
Escitalopram | -6.91 | -1.35 | -1.00 | -1.21 | -1.02 | -0.85 | -0.71 | -0.85 |
AES-C subscales separately assess participants' intensity of cognitive, behavioral, emotional, and other apathy symptoms with individual item scores of 1 (not at all characteristic) to 4 (a lot characteristic). Subtotal score ranges for the subscales are: 8-32 (cognitive), 5-20 (behavioral), 2-8 (emotional), and 3-12 for other (display of personal insight, initiative and motivation). Higher subscale scores indicate greater illness severity. The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit. (NCT00985504)
Timeframe: Baseline, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Cognition Items Total Score | Behavior Items Total Score | Emotional Items Total Score | Other Items Total Score | |
Duloxetine | -6.49 | -3.35 | -1.66 | -2.43 |
Escitalopram | -6.25 | -3.25 | -1.58 | -2.44 |
The SDS is a participant-rated assessment. Total scores range from 0-30 with higher values indicating greater disruption in the participant's work/social/family life. Items 1-3 assess the effect of the participant's symptoms on work/school schedule, social life/leisure activities, and family life/home responsibilities, respectively. Item scores are 0-10; higher values indicate greater disruption. Number of unproductive days and days lost in past week (symptom related) were reported. LS Mean Value was calculated from an ANCOVA model with terms of treatment, pooled investigator, and baseline. (NCT00985504)
Timeframe: Baseline, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |||||
---|---|---|---|---|---|---|
SDS Total Score | SDS Work Score | SDS Family Score (N=212, 210) | SDS Social Score (N=212, 210) | SDS Days Lost Score (N=208, 204) | SDS Days Unproductive Score (N=209, 205) | |
Duloxetine | -7.55 | -2.42 | -2.51 | -2.56 | -0.55 | -1.78 |
Escitalopram | -7.67 | -2.29 | -2.67 | -2.72 | -0.60 | -1.89 |
Half life (NCT00989157)
Timeframe: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72
Intervention | hours (Mean) |
---|---|
Bariatric | 12.0 |
Control | 11.75 |
Area under the plasma concentration time curve (NCT00989157)
Timeframe: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72
Intervention | ng h/mL (Mean) |
---|---|
Bariatric | 646.74 |
Control | 1119.91 |
The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender. (NCT00989157)
Timeframe: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72
Intervention | ng/ml (Mean) |
---|---|
Bariatric | 51.04 |
Control | 61.41 |
Time to maximum plasma concentration (NCT00989157)
Timeframe: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72
Intervention | Hours (Mean) |
---|---|
Bariatric | 2.2 |
Control | 6 |
episodes of emesis. (NCT00989157)
Timeframe: 4 days
Intervention | number of occurences (Number) |
---|---|
Bariatric | 2 |
Control | 3 |
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction. (NCT01000805)
Timeframe: Baseline, 2 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -9.90 |
Placebo | -7.71 |
The MADRS is a rating scale for severity of depressive mood and symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction. (NCT01000805)
Timeframe: Baseline, 4 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -14.15 |
Placebo | -10.49 |
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction. (NCT01000805)
Timeframe: Day 1 through 8 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -1.93 |
Placebo | -1.31 |
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction. (NCT01000805)
Timeframe: Baseline, 8 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -16.77 |
Placebo | -12.73 |
SDS is completed by participant; used to assess effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30; higher values indicate greater disruption in the participant's work/social/family life. Each item score ranges from 0 to 10 with higher values indicating greater disruption in the participant's work/school life (item 1), social life/leisure activities (item 2), or family life/home responsibilities (item 3). The LS Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction. (NCT01000805)
Timeframe: Baseline, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Disrupt Work/School Work (N=182, 196) | Disrupt Social Life/Leisure Activities | Disrupt Family/Home Responsibilities | SDS Total Score | |
Duloxetine | -2.82 | -3.04 | -3.02 | -8.88 |
Placebo | -2.36 | -2.31 | -2.49 | -7.13 |
Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference=average of nonmissing scores of individual interference items. LS Mean Value adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction. (NCT01000805)
Timeframe: Baseline, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
BPI Severity for Worst Pain | BPI Severity for Least Pain | BPI Severity for Average Pain | BPI Severity for Pain Right Now | BPI Pain Interference with General Activity | BPI Pain Interference with Mood | BPI Pain Interference with Walking Ability | BPI Pain Interference with Normal Work | BPI Pain Interference with Relations With Others | BPI Pain Interference with Sleep | BPI Pain Interference with Enjoyment of Life | BPI Mean Pain Interference Score | |
Duloxetine | -2.25 | -1.48 | -1.93 | -2.00 | -2.01 | -2.49 | -1.52 | -2.02 | -2.01 | -1.94 | -2.44 | -2.03 |
Placebo | -1.60 | -0.86 | -1.31 | -1.27 | -1.33 | -1.76 | -1.06 | -1.46 | -1.31 | -1.56 | -1.77 | -1.46 |
"The change from baseline in SBP and DBP at week 8 is the primary analysis. For the primary analysis of SBP and DBP, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in SBP and DBP up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline." (NCT01000805)
Timeframe: Baseline, up to week 8
Intervention | mm Hg (Least Squares Mean) | |||
---|---|---|---|---|
Change from Baseline in SBP at Week 8 | Change from Baseline in DBP at Week 8 | Change from Baseline in SBP up to Week 8 | Change from Baseline in DBP up to Week 8 | |
Duloxetine | 1.38 | 0.52 | 1.41 | 0.31 |
Placebo | -0.52 | 0.05 | -0.12 | 0.01 |
"The change from baseline in pulse rate at week 8 is the primary analysis. For the primary analysis of pulse rate, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in pulse rate up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline." (NCT01000805)
Timeframe: Baseline, up to week 8
Intervention | beats per minute (bpm) (Least Squares Mean) | |
---|---|---|
Change from Baseline in Pulse Rate at Week 8 | Change from Baseline in Pulse Rate up to Week 8 | |
Duloxetine | 1.58 | 1.71 |
Placebo | -1.34 | -0.70 |
The Montgomery Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing consecutive visits (for example, visit 3 [week 1] and visit 4 [week 2], or visit 4 [week 2] and visit 5 [week 4], or visit 5 [week 4] and visit 6 [week 8]). (NCT01000805)
Timeframe: Up to 8 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 29.5 |
Placebo | 18.7 |
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment*visit interaction. (NCT01000805)
Timeframe: 8 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 2.56 |
Placebo | 3.04 |
Laboratory assessment of ALT/SGPT during the double-blind treatment phase. Normal ALT/SGPT ranges for males are 6.00 units per liter (U/L) (low) to 43.00 U/L (high). Normal ALT/SGPT ranges for females are 6.00 U/L (low) to 34.00 U/L (high). (NCT01000805)
Timeframe: Baseline through 8 weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 14 |
Placebo | 5 |
The Montgomery Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12. (NCT01000805)
Timeframe: Baseline, up to 8 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 47.0 |
Placebo | 32.8 |
"The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and completed suicide. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal acts: a yes answer to actual attempt or completed suicide." (NCT01000805)
Timeframe: Baseline through 8 weeks
Intervention | participants (Number) | ||
---|---|---|---|
Suicidal Ideation | Suicidal Behavior | Suicidal Acts | |
Duloxetine | 26 | 1 | 2 |
Placebo | 41 | 0 | 0 |
"The change from baseline in weight at week 8 is the primary analysis. For the primary analysis of weight, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in weight up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline." (NCT01000805)
Timeframe: Baseline, up to week 8
Intervention | kilograms (kg) (Least Squares Mean) | |
---|---|---|
Change from Baseline in Weight at Week 8 | Change from Baseline in Weight up to Week 8 | |
Duloxetine | -0.77 | -0.74 |
Placebo | 0.19 | 0.14 |
Measures pain severity and pain interference with function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Mean interference is the average across the 7 interference items. The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline*visit. (NCT01018680)
Timeframe: Baseline, 8 weeks (blinded endpoint)
Intervention | units on a scale (Least Squares Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
BPI-S for Worst Pain | BPI-S for Least Pain | BPI-S for Average Pain | BPI-S for Pain Right Now | BPI-I for General Activity | BPI-I for Mood | BPI-I for Walking Ability | BPI-I for Normal Work | BPI-I for Relations with Others (n=255, 258) | BPI-I for Sleep | BPI-I for Enjoyment of Life | BPI-I for Mean Interference Score | |
Duloxetine | -2.94 | -2.14 | -2.73 | -2.74 | -2.76 | -2.52 | -2.80 | -2.77 | -1.94 | -2.69 | -2.66 | -2.60 |
Placebo | -1.87 | -1.44 | -1.78 | -2.03 | -1.79 | -1.80 | -1.85 | -1.92 | -1.25 | -2.01 | -1.89 | -1.77 |
"OARSI response is composite Yes/No response assessed at 8 weeks based on decrease in 24-hour average pain ratings, range: 0 (no pain) to 10 (worst possible pain), improvement in functioning (using WOMAC physical function scores, range: 0 [no difficulty] to 68 [extreme difficulty]), and improvement in participant's impression of illness (using PGAI scores, range: 0 to 10; 10=greatest severity). OARSI responder=large response in pain or function components (50% relative and 20% absolute improvement), or moderate response (20% relative and 10% absolute improvement) in 2 of 3 components." (NCT01018680)
Timeframe: Up to 8 weeks (blinded endpoint)
Intervention | percentage of responders (Number) |
---|---|
Placebo | 48.3 |
Duloxetine | 69.6 |
Abnormal pulse rate (tachycardia) is defined as a sitting heart rate (HR) ≥ 100 beats per minute (bpm) that is also ≥ 10 bpm compared to baseline, at last visit if highest baseline HR < 100 bpm. (NCT01018680)
Timeframe: Up to 10 weeks
Intervention | percentage of participants (Number) |
---|---|
Placebo | 0.0 |
Duloxetine | 1.1 |
Abnormal high HbA1c is defined as a post-baseline HbA1c > 6.1% if baseline HbA1c ≤ 6.1% for lab samples obtained before November 17, 2010 and post-baseline HbA1c > 6.4% if baseline HbA1c ≤ 6.4% for lab samples obtained November 17, 2010 and beyond. (NCT01018680)
Timeframe: Up to 10 weeks
Intervention | percentage of participants (Number) |
---|---|
Placebo | 5.7 |
Duloxetine | 1.0 |
(NCT01018680)
Timeframe: Baseline through 10 weeks
Intervention | percentage of participants (Number) |
---|---|
Placebo | 8.8 |
Duloxetine | 15.2 |
The Least Squares (LS) Mean percentage estimates of participants using acetaminophen was determined during each week individually over the full 10-week treatment period based on participant's daily Yes/No assessments for the use of acetaminophen. The LS Mean estimates for the main effect of treatment (average weekly use) were adjusted for baseline value, treatment, investigator (pooled), week, and treatment*week. (NCT01018680)
Timeframe: Baseline through 10 weeks (blinded endpoint)
Intervention | percentage of participants (Least Squares Mean) |
---|---|
Placebo | 26 |
Duloxetine | 22 |
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares Mean estimates were adjusted for baseline value of Patient Global Impression of Severity (PGI-S), treatment, investigator (pooled), visit, and treatment*visit. The PGI-S measures participant's perception of severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (extremely ill). (NCT01018680)
Timeframe: 8 weeks (blinded endpoint)
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | 2.93 |
Duloxetine | 2.33 |
"The weekly mean 24-hour average pain score was calculated from the participant's daily 24-hour average pain ratings using an 11-point numeric rating scale, with scores from 0 (indicating no pain) to 10 (indicating the worst possible pain). The Least Squares Mean estimates were adjusted for baseline, treatment, investigator (pooled), week, treatment*week, and baseline*week." (NCT01018680)
Timeframe: Baseline, 8 weeks (blinded endpoint)
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | -1.55 |
Duloxetine | -2.46 |
The PGAI is a participant-rated measure of the severity of osteoarthritis (OA) of the knee the participant has experienced in the past week as indicated on an 11-point numeric rating scale, with scores ranging from 0 to 10, where greater numbers reflect greater severity. The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline*visit. (NCT01018680)
Timeframe: Baseline, 8 weeks (blinded endpoint)
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | -1.77 |
Duloxetine | -2.95 |
The CGI-S scale evaluates the severity of illness at the time of assessment. The scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The CGI-S must be administered by a study physician in the presence of the participant or after having been in the presence of the participant. The Least Squares Mean estimates were adjusted for baseline, treatment, investigator (pooled), visit, treatment*visit, and baseline*visit. (NCT01018680)
Timeframe: Baseline, 8 weeks (blinded endpoint)
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | -0.80 |
Duloxetine | -1.16 |
"Weekly mean 24-hour night pain and worst pain values are calculated from the participant's daily assessments of pain at night and worst pain during the previous 24 hours on an 11-point numeric rating scale, with scores from 0 (indicating no pain) to 10 (indicating the worst possible pain). The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), week, treatment*week, and baseline*week." (NCT01018680)
Timeframe: Baseline, 8 weeks (blinded endpoint)
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Night Pain Intensity | Worst Pain Intensity | |
Duloxetine | -2.26 | -2.61 |
Placebo | -1.46 | -1.58 |
30-item BPOMS measures positive and negative aspects of mood states (item score: 0=not at all to 4=extremely). 5 negative factors: tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, confusion-bewilderment; 1 positive factor: vigor-activity. Factor scores range: 0 to 20; high scores=negative mood (positive mood for vigor). Total score=sum of 5 negative factor scores minus vigor score; range: -20=least disturbed to 100=most disturbed. Least Squares Mean estimates adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline value*visit. (NCT01018680)
Timeframe: Baseline, 8 weeks (blinded endpoint)
Intervention | units on a scale (Least Squares Mean) | ||||||
---|---|---|---|---|---|---|---|
BPOMS Total Score | BPOMS Tension-Anxiety Score | BPOMS Depression-Dejection Score | BPOMS Anger-Hostility Score | BPOMS Vigor-Activity Score | BPOMS Fatigue-Inertia Score | BPOMS Confusion-Bewilderment Score | |
Duloxetine | -4.98 | -1.17 | -0.85 | -1.15 | 0.04 | -1.47 | -0.32 |
Placebo | -4.15 | -0.90 | -0.51 | -0.63 | -0.34 | -1.40 | -0.29 |
"Abnormal weight gain (potentially clinically significant [PCS] weight gain) is defined as weight gain at last visit ≥ 7% of the baseline weight.~Abnormal weight loss (PCS weight loss) is defined as weight loss at last visit ≥ 7% of the baseline weight." (NCT01018680)
Timeframe: Up to 10 weeks
Intervention | percentage of participants (Number) | |
---|---|---|
PCS Weight Gain | PCS Weight Loss | |
Duloxetine | 1.2 | 3.1 |
Placebo | 1.6 | 0.8 |
"Abnormal DPB (diastolic hypertension) is defined as sitting DBP ≥ 90 mm Hg that is also ≥ 10 mm Hg increase from baseline that is observed at last visit if highest baseline DBP < 90 mm Hg.~Abnormal SBP (systolic hypertension) is defined as sitting SBP ≥ 140 mm Hg that is also ≥ 10 mm Hg increase from baseline that is observed at last visit if highest baseline SBP < 140 mm Hg." (NCT01018680)
Timeframe: Up to 10 weeks
Intervention | percentage of participants (Number) | |
---|---|---|
Diastolic Hypertension | Systolic Hypertension (N=170, 171) | |
Duloxetine | 4.2 | 12.3 |
Placebo | 1.0 | 4.7 |
"REU captures information regarding the participant's work status and/or health care utilization. Investigators gather information from medical records, psychiatric history, and direct questioning of the participant and his or her family to complete the questionnaire. Responses to each item, comparing baseline to endpoint, are characterized as Better, Same, or Worse. Better: an increase in time spent working/volunteering/holding a job, decrease in number of health care visits; Same: no change in time spent working/volunteering/holding a job, no change in number of health care visits; Worse: decrease in time spent working/volunteering/holding a job, increase in number of health care visits." (NCT01018680)
Timeframe: Up to 10 weeks
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Outpatient Group Visits-Better | Outpatient Group Visits-Same | Outpatient Group Visits-Worse | Outpatient Individual Visits-Better | Outpatient Individual Visits-Same | Outpatient Individual Visits-Worse | ER Visits for Psychiatric Illness-Better | ER Visits for Psychiatric Illness-Same | ER Visits for Psychiatric Illness-Worse | ER Visits for Non-psychiatric Illness-Better | ER Visits for Non-psychiatric Illness-Same | ER Visits for Non-psychiatric Illness-Worse | Outpatient Visits to Other Physicians-Better | Outpatient Visits to Other Physicians-Same | Outpatient Visits to Other Physicians-Worse | Average Hours Worked for Pay per Week-Better | Average Hours Worked for Pay per Week-Same | Average Hours Worked for Pay per Week-Worse | How Long Participant Had This Job-Better | How Long Participant Had This Job-Same | How Long Participant Had This Job-Worse | Average Hours of Volunteer Work per Week-Better | Average Hours of Volunteer Work per Week-Same | Average Hours of Volunteer Work per Week-Worse | Psychiatric Visits-Better | Psychiatric Visits-Same | Psychiatric Visits-Worse | |
Duloxetine | 0.0 | 100.0 | 0.0 | 0.8 | 99.2 | 0.0 | 0.0 | 100.0 | 0.0 | 3.7 | 95.5 | 0.8 | 26.0 | 69.4 | 4.5 | 18.9 | 69.4 | 11.7 | 20.2 | 69.7 | 10.1 | 11.1 | 72.2 | 16.7 | 0.8 | 99.2 | 0.0 |
Placebo | 0.4 | 99.6 | 0.0 | 2.4 | 96.7 | 0.8 | 0.0 | 100.0 | 0.0 | 5.7 | 92.7 | 1.6 | 20.4 | 74.3 | 5.3 | 15.2 | 64.3 | 20.5 | 25.2 | 65.8 | 9.0 | 10.7 | 67.9 | 21.4 | 1.6 | 98.4 | 0.0 |
"Response is a dichotomous outcome (Yes/No) indicating at least 30% (or 50%) reduction from baseline to endpoint for the weekly mean of the 24-hour average pain ratings. The weekly mean 24-hour average pain score was calculated from the participant's daily 24-hour average pain rating assessed on an 11-point numeric rating scale, with scores from 0 (no pain) to 10 (worst possible pain)." (NCT01018680)
Timeframe: Up to 8 weeks (blinded endpoint)
Intervention | percentage of participants (Number) | |
---|---|---|
30% Response (LOCF) based on 24-Hour Average Pain | 50% Response (LOCF) based on 24-Hour Average Pain | |
Duloxetine | 53.7 | 35.5 |
Placebo | 33.7 | 16.1 |
Response is a dichotomous outcome (Yes/No) indicating at least 30% (or 50%) reduction from baseline to endpoint for BPI-S average pain rating. The BPI-S self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT01018680)
Timeframe: Up to 8 weeks (blinded endpoint)
Intervention | percentage of participants (Number) | |
---|---|---|
30% Response (LOCF) based on BPI-S Average Pain | 50% Response (LOCF) based on BPI-S Average Pain | |
Duloxetine | 58.1 | 45.7 |
Placebo | 34.0 | 21.1 |
Self-administered questionnaire captures elements of pain, stiffness, and physical disability in participants with osteoarthritis of the knee and/or hip. Index has 24 questions (5 on pain, 2 on stiffness, 17 on physical function). Each question uses a 5-point numeric rating scale ranging from 0 (none) to 4 (extreme). Pain scores range: 0 to 20. Stiffness scores range: 0 to 8. Physical function scores range: 0 to 68. Higher scores=greater impairment. Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline value*visit. (NCT01018680)
Timeframe: Baseline, 8 weeks (blinded endpoint)
Intervention | units on a scale (Least Squares Mean) | ||
---|---|---|---|
WOMAC Physical Disability Score (n=253, 251) | WOMAC Pain Score | WOMAC Stiffness Score | |
Duloxetine | -15.09 | -4.41 | -1.88 |
Placebo | -10.25 | -3.13 | -1.45 |
A secondary measure is the percentage of patients treated with duloxetine who experience a sustained 30% reduction in average pain score from baseline to 8 weeks. Sustained 30% reduction is defined as at least 30% reduction in 24-hour average pain severity at the 8 week endpoint, with a 30% reduction from baseline at a visit at least 2 weeks prior to the last visit, and at least 20% reduction from baseline at every visit in between. (NCT01028352)
Timeframe: Baseline, 2, 4 , 6 and 8 weeks
Intervention | %of participants with 30% pain reduction (Number) |
---|---|
Duloxetine | 60.9 |
Subjects were considered evaluable if they met all eligibility criteria and took at least one dose of duloxetine. Average pain was measured using Wisconsin Brief Pain Inventory Questionnaire.(BPI) The BPI is a 17-item patient self-rating scale that assessed sensory & reactive components of pain. The BPI uses 0 to 10 numeric rating scales for item rating.Since pain can be variable,the BPI asks patients to rate pain at completing questionnaire, and also at its worst, least, and average over the previous 24 hours. The primary endpoint is based on the 24-hour avg pain as reported on BPI. (NCT01028352)
Timeframe: 8 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 72.4 |
The SDS is a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Functional Impairment Score (SDS Global Score) was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated higher functional impairment in the participant's work/social/family life. (NCT01051466)
Timeframe: Baseline and up to Week 12
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Week 12 | |
Duloxetine | 19.3 | 9.4 |
Healthy Participants | 0.2 | 0.0 |
The CGI-S measures severity of illness at the time of assessment. Scores can range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). (NCT01051466)
Timeframe: Baseline and up to Week 12
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Week 12 | |
Duloxetine | 4.4 | 2.2 |
Healthy Participants | 1.0 | 1.0 |
Functional magnetic resonance imaging (fMRI) is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of sad faces in each brain region (anterior cingulate, left amygdala and right amygdala) was measured by the percentage of signal change in BOLD response. The percentage of signal change was calculated by taking the difference between BOLD response after sad faces processing and BOLD response before sad faces processing and dividing by BOLD response before sad face processing, then multiplying by 100. BOLD signals were measured using arbitrary magnetic resonance units. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value. (NCT01051466)
Timeframe: Baseline, Week 12
Intervention | percentage of signal change (Least Squares Mean) | ||
---|---|---|---|
Anterior Cingulate | Left Amygdala | Right Amygdala | |
Duloxetine | 0.13 | -0.04 | 0.03 |
Healthy Participants | 0.20 | -0.26 | -0.09 |
Gsα is a membrane-associated protein that couples receptors for neurotransmitters like serotonin to allow them to send messages between nerve cells - a process that may be altered during depression and antidepressant treatment. Gsα localization in the cholesterol-rich (lipid rafts) and cholesterol-poor regions of cell membranes of RBCs and platelets was measured with quantitative Western blots and reported as the ratio of Gsα (absorbance units) in Triton X-100 (TX-100) over Triton X-114 (TX-114), 2 detergents that discriminate between lipid raft and non-raft membrane domains. Translocation of Gsα was measured as the change from baseline in Gsα localization. Translocation of Gsα from lipid rafts in the cell membranes of WBCs was not analyzed due to technical laboratory issues. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value. (NCT01051466)
Timeframe: Baseline, Weeks 1, 8, and 12
Intervention | Ratio (Least Squares Mean) | |||||
---|---|---|---|---|---|---|
RBCs, Week 1 (n=23, 22) | RBCs, Week 8 (n=23, 22) | RBCs, Week 12 (n=23, 22) | Platelets, Week 1 (n=23, 20) | Platelets, Week 8 (n=23, 20) | Platelets, Week 12 (n=23, 20) | |
Duloxetine | 0.51 | -0.01 | 0.36 | -0.63 | -1.16 | -0.52 |
Healthy Participants | 0.09 | -0.15 | 0.10 | -0.69 | -0.92 | 7.93 |
There is evidence that stress may decrease BDNF expression, while antidepressant treatment reverses or blocks these effects. BDNF is a protein that occurs naturally and supports the survival and growth of some nerve cells in the brain. proBDNF is a precursor of BDNF. Tropomyosin receptor kinase B (trkB) is a receptor for BDNF, and pan-neurotrophin receptor p75 (p75NTR) is a receptor for proBDNF. p75NTR was not analyzed due to technical laboratory issues. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value. (NCT01051466)
Timeframe: Baseline, Week 12
Intervention | picograms per milligram (pg/mg) (Least Squares Mean) |
---|---|
Duloxetine | 52.1 |
Healthy Participants | -8.9 |
Functional MRI or fMRI is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of sad faces was measured by the percentage of signal change in BOLD response from before to after sad faces processing. The percentage of signal change was calculated by taking the difference between BOLD response after sad faces processing and BOLD response before sad faces processing and dividing by BOLD response before sad face processing, then multiplying by 100. BOLD signals were measured using arbitrary magnetic resonance units. Amygdala BOLD activation was calculated as an average between the left amygdala activation and right amygdala activation. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value. (NCT01051466)
Timeframe: Baseline, Week 12
Intervention | percentage of signal change (Least Squares Mean) |
---|---|
Duloxetine | -0.01 |
Healthy Participants | -0.16 |
HAMD17 remission is defined as a HAMD17 total score of ≤7 at Week 12 (endpoint). The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed). The percentage of participants with remission was calculated as the number of participants with a HAMD17 total score of ≤7 divided by the number of participants who had a HAMD17 observation at Week 12 then multiplied by 100. (NCT01051466)
Timeframe: Baseline, up to Week 12
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 62.1 |
HAMD17 response is defined as a >50% reduction in HAMD17 total score from baseline. The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed). The percentage of participants with a HAMD17 response was calculated as the number of participants with a >50% reduction in HAMD17 total score from baseline divided by the number of participants who had a HAMD17 observation at Week 12 then multiplied by 100. (NCT01051466)
Timeframe: Baseline, up to Week 12
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 72.4 |
The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed). (NCT01051466)
Timeframe: Baseline and up to Week 12
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Week 12 | |
Duloxetine | 22.4 | 8.5 |
Healthy Participants | 0.5 | 0.5 |
There is evidence that stress may decrease BDNF expression, while antidepressant treatment reverses or blocks these effects. BDNF is a protein that occurs naturally and supports the survival and growth of some nerve cells in the brain. proBDNF is a precursor of BDNF. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value. (NCT01051466)
Timeframe: Baseline, Week 12
Intervention | nanograms per milliliter (ng/mL) (Least Squares Mean) | |
---|---|---|
BDNF (n=23, 21) | proBDNF (n=13, 17) | |
Duloxetine | 6.61 | -5.67 |
Healthy Participants | 10.57 | -9.37 |
Cytokines are naturally produced and regulate responses to inflammation. Proinflammatory cytokines like TNFα, IL-1, and IL-6 increase inflammation in the body. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value. (NCT01051466)
Timeframe: Baseline, Week 12
Intervention | picograms per milliliter (pg/mL) (Least Squares Mean) | ||
---|---|---|---|
Cytokine TNFα | Cytokine IL-1 | Cytokine IL-6 | |
Duloxetine | -0.04 | -0.08 | -0.61 |
Healthy Participants | 0.25 | 4.01 | -0.52 |
The volume of specific brain regions is obtained using a structural magnetic resonance imaging (sMRI) procedure in which high-resolution spoiled gradient recall images are acquired in coronal brain slices. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value. (NCT01051466)
Timeframe: Baseline, Week 12
Intervention | cubic millimeters (mm^3) (Least Squares Mean) | ||||
---|---|---|---|---|---|
Subgenual Anterior Cingulate | Left Amygdalae | Right Amygdalae | Left Hippocampus | Right Hippocampus | |
Duloxetine | -188.27 | -23.68 | -33.38 | -13.56 | -14.70 |
Healthy Participants | 175.22 | 4.20 | 23.86 | 18.52 | 21.80 |
The PGI-I scale measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores can range from 1 (very much better) to 7 (very much worse). (NCT01051466)
Timeframe: Baseline, up to Week 12
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 2.6 |
The 14-item HAMA is used to assess the severity of anxiety. The investigator talked to the participant about their symptoms over the previous week. Each item was scored using a 5-point scale (0 = not present to 4 = very severe). Total HAMA scores could have ranged from 0 (normal) to 56 (severe). (NCT01051466)
Timeframe: Baseline and up to Week 12
Intervention | units on a scale (Mean) | |
---|---|---|
Baseline | Week 12 | |
Duloxetine | 21.1 | 9.6 |
Healthy Participants | 0.4 | 0.4 |
"The C-SSRS captures the occurrence, severity, and frequency of treatment-emergent suicide-related thoughts and behaviors. Suicidal ideation is defined as a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior is defined as a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Treatment-emergent outcomes were the worsening or new occurrence of suicidal behaviors or ideation during treatment compared with baseline." (NCT01051466)
Timeframe: Baseline through Week 12
Intervention | participants (Number) | |
---|---|---|
Treatment-emergent suicidal ideation | Treatment-emergent suicidal behavior | |
Duloxetine | 5 | 0 |
Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference=average of nonmissing scores of individual interference items. LS Mean Value adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction. (NCT01070329)
Timeframe: Baseline, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
BPI Severity for Worst Pain | BPI Severity for Least Pain | BPI Severity for Average Pain | BPI Severity for Pain Right Now | BPI Pain Interference with General Activity | BPI Pain Interference with Mood | BPI Pain Interference with Walking Ability | BPI Pain Interference with Normal Work | BPI Pain Interference with Relations With Others | BPI Pain Interference with Sleep | BPI Pain Interference with Enjoyment of Life | BPI Mean Pain Interference Score | |
Duloxetine | -1.88 | -1.18 | -1.66 | -1.82 | -1.87 | -2.25 | -1.62 | -1.88 | -1.90 | -2.13 | -2.32 | -2.03 |
Placebo | -1.32 | -0.80 | -1.17 | -1.25 | -1.44 | -1.77 | -1.20 | -1.47 | -1.53 | -1.74 | -1.84 | -1.58 |
"The change from baseline in SBP and DBP at week 8 is the primary analysis. For the primary analysis of SBP and DBP, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in SBP and DBP up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline." (NCT01070329)
Timeframe: Baseline, up to week 8
Intervention | mm Hg (Least Squares Mean) | |||
---|---|---|---|---|
Change from Baseline in SBP at Week 8 | Change from Baseline in DBP at Week 8 | Change from Baseline in SBP up to Week 8 | Change from Baseline in DBP up to Week 8 | |
Duloxetine | 0.82 | 1.88 | 0.56 | 1.86 |
Placebo | -1.09 | 0.08 | -1.14 | 0.05 |
"The change from baseline in pulse rate at week 8 is the primary analysis. For the primary analysis of pulse rate, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in pulse rate up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline." (NCT01070329)
Timeframe: Baseline, up to week 8
Intervention | beats per minute (bpm) (Least Squares Mean) | |
---|---|---|
Change from Baseline in Pulse Rate at Week 8 | Change from Baseline in Pulse Rate up to Week 8 | |
Duloxetine | 2.08 | 2.01 |
Placebo | 0.40 | 0.62 |
The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing visits (for example, visit 3 [week 1] and visit 4 [week 2], or visit 4 [week 2] and visit 5 [week 4], or visit 5 [week 4] and visit 6 [week 8]). (NCT01070329)
Timeframe: Up to 8 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 15.7 |
Placebo | 11.7 |
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment*visit interaction. (NCT01070329)
Timeframe: 8 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 2.48 |
Placebo | 3.17 |
Laboratory assessment of creatinine during the double-blind treatment phase. Normal creatinine ranges for males are 40.00 micromoles per liter (µmol/L) (low) to 110.00 µmol/L (high). Normal creatinine ranges for females are 31.00 µmol/L (low) to 101.00 µmol/L (high). (NCT01070329)
Timeframe: Baseline through 8 weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 1 |
Placebo | 9 |
The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12. (NCT01070329)
Timeframe: Baseline, up to 8 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 37.3 |
Placebo | 23.0 |
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction. (NCT01070329)
Timeframe: Baseline, 2 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -8.60 |
Placebo | -6.52 |
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction. (NCT01070329)
Timeframe: Baseline, 8 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -14.96 |
Placebo | -10.77 |
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction. (NCT01070329)
Timeframe: Day 1 through 8 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -1.66 |
Placebo | -1.17 |
SDS is completed by participant; used to assess effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30; higher values indicate greater disruption in the participant's work/social/family life. Each item score ranges from 0 to 10 with higher values indicating greater disruption in the participant's work/school life (item 1), social life/leisure activities (item 2), or family life/home responsibilities (item 3). The LS Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction. (NCT01070329)
Timeframe: Baseline, 8 weeks
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Disrupt Work/School Work (N=178, 188) | Disrupt Social Life/Leisure Activities | Disrupt Family/Home Responsibilities | SDS Total Score | |
Duloxetine | -3.01 | -3.14 | -3.04 | -9.16 |
Placebo | -2.06 | -2.17 | -2.09 | -6.28 |
"The change from baseline in weight at week 8 is the primary analysis. For the primary analysis of weight, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in weight up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline." (NCT01070329)
Timeframe: Baseline, up to week 8
Intervention | kilograms (kg) (Least Squares Mean) | |
---|---|---|
Change from Baseline in Weight at Week 8 | Change from Baseline in Weight up to Week 8 | |
Duloxetine | -0.69 | -0.66 |
Placebo | -0.15 | -0.09 |
"The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and completed suicide. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal acts: a yes answer to actual attempt or completed suicide." (NCT01070329)
Timeframe: Baseline through 8 weeks
Intervention | participants (Number) | ||
---|---|---|---|
Suicidal Ideation | Suicidal Behavior | Suicidal Acts | |
Duloxetine | 21 | 2 | 0 |
Placebo | 34 | 0 | 0 |
The MADRS is a rating scale for severity of depressive mood and symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction. (NCT01070329)
Timeframe: Baseline, 4 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -11.48 |
Placebo | -8.67 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II. (NCT01089556)
Timeframe: Week 8, Week 16
Intervention | units on a scale (Least Squares Mean) |
---|---|
Combination | -2.353 |
Monotherapy | -2.161 |
Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks. (NCT01089556)
Timeframe: Baseline through Week 8
Intervention | days (Mean) | |
---|---|---|
Days hospitalized | Days of sick leave (n=108, 101) | |
Duloxetine | 0 | 1.9 |
Pregabalin | 0 | 0.3 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT01089556)
Timeframe: Week 8 through Week 16
Intervention | percentage of participants (Number) |
---|---|
Combination | 61.8 |
Monotherapy | 55.8 |
Data presented are the average number of hours worked for pay per week during the last 8 weeks. (NCT01089556)
Timeframe: Week 8 through Week 16
Intervention | hours (Mean) |
---|---|
Combination | 39.8 |
Monotherapy | 34.7 |
Measures participant's perception of improvement at the time of assessment compared with the start of treatment for Study Period III. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II. (NCT01089556)
Timeframe: Week 16
Intervention | units on a scale (Least Squares Mean) |
---|---|
Combination | 2.256 |
Monotherapy | 2.350 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit. (NCT01089556)
Timeframe: Baseline, Week 8
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -2.295 |
Pregabalin | -1.682 |
Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit. (NCT01089556)
Timeframe: Week 8
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 2.508 |
Pregabalin | 2.848 |
Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment for Study Period III. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II. (NCT01089556)
Timeframe: Week 16
Intervention | units on a scale (Least Squares Mean) |
---|---|
Combination | 2.286 |
Monotherapy | 2.359 |
Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II. (NCT01089556)
Timeframe: Week 8, Week 16
Intervention | millimeter of mercury (mm Hg) (Least Squares Mean) | |
---|---|---|
Systolic BP | Diastolic BP | |
Combination | -1.206 | -0.555 |
Monotherapy | 0.124 | -0.551 |
(NCT01089556)
Timeframe: Week 8 through Week 16
Intervention | participants (Number) |
---|---|
Combination | 21 |
Monotherapy | 21 |
TEAEs in Study Period II are events that began or worsened after Week 0 compared with the period before Week 0. (NCT01089556)
Timeframe: Baseline through Week 8
Intervention | participants (Number) |
---|---|
Duloxetine | 223 |
Pregabalin | 232 |
TEAEs in Study Period III are events that began or worsened after Week 8 compared with the period before Week 8. (NCT01089556)
Timeframe: Week 8 through Week 16
Intervention | participants (Number) |
---|---|
Combination | 62 |
Monotherapy | 57 |
(NCT01089556)
Timeframe: Baseline through Week 8
Intervention | participants (Number) |
---|---|
Duloxetine | 68 |
Pregabalin | 70 |
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) mean values are controlled for treatment, site, baseline value and treatment*site. (NCT01089556)
Timeframe: Baseline, Week 8
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -4.387 |
Pregabalin | -3.367 |
Measures participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit. (NCT01089556)
Timeframe: Week 8
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 2.601 |
Pregabalin | 2.944 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT01089556)
Timeframe: Week 8 through Week 16
Intervention | percentage of participants (Number) |
---|---|
Combination | 66.7 |
Monotherapy | 64.4 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT01089556)
Timeframe: Baseline through Week 8
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 57.1 |
Pregabalin | 45.7 |
Data presented are the average number of hours worked for pay per week during the last 8 weeks. (NCT01089556)
Timeframe: Baseline through Week 8
Intervention | hours (Mean) |
---|---|
Duloxetine | 37.6 |
Pregabalin | 42.4 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT01089556)
Timeframe: Baseline through Week 8
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 52.0 |
Pregabalin | 36.9 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT01089556)
Timeframe: Week 8 through Week 16
Intervention | percentage of participants (Number) |
---|---|
Combination | 52.1 |
Monotherapy | 39.3 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT01089556)
Timeframe: Baseline through Week 8
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 40.3 |
Pregabalin | 27.8 |
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit. (NCT01089556)
Timeframe: Baseline, Week 8
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Anxiety Subscale Score (n= 398, 400) | Depression Subscale Score | |
Duloxetine | -1.991 | -1.064 |
Pregabalin | -1.433 | -0.642 |
Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks. (NCT01089556)
Timeframe: Week 8 through Week 16
Intervention | days (Mean) | |
---|---|---|
Days hospitalized (n=140, 146) | Days of sick leave (n=41, 36) | |
Combination | 0 | 0.1 |
Monotherapy | 0 | 0.4 |
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II. (NCT01089556)
Timeframe: Week 8, Week 16
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Anxiety Subscale Score (n=169, 169) | Depression Subscale Score (n=168, 170) | |
Combination | -0.860 | -0.461 |
Monotherapy | -0.245 | -0.083 |
Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site. (NCT01089556)
Timeframe: Baseline, Week 8
Intervention | millimeter of mercury (mm Hg) (Least Squares Mean) | |
---|---|---|
Systolic BP | Diastolic BP | |
Duloxetine | -3.702 | -0.816 |
Pregabalin | -1.682 | -0.951 |
The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit. (NCT01089556)
Timeframe: Baseline, Week 8
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -19.442 |
Pregabalin | -14.684 |
BPI Modified Short Form worst pain score is a self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II. (NCT01089556)
Timeframe: Week 8, Week 16
Intervention | units on a scale (Least Squares Mean) |
---|---|
Combination | -2.374 |
Monotherapy | -2.371 |
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II. (NCT01089556)
Timeframe: Week 8, Week 16
Intervention | units on a scale (Least Squares Mean) |
---|---|
Combination | -2.625 |
Monotherapy | -2.431 |
The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II. (NCT01089556)
Timeframe: Week 8, Week 16
Intervention | units on a scale (Least Squares Mean) |
---|---|
Combination | -13.734 |
Monotherapy | -11.801 |
Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site. (NCT01089556)
Timeframe: Baseline, Week 8
Intervention | beats per minute (bpm) (Least Squares Mean) |
---|---|
Duloxetine | 0.839 |
Pregabalin | -2.478 |
Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II. (NCT01089556)
Timeframe: Week 8, Week 16
Intervention | beats per minute (bpm) (Least Squares Mean) |
---|---|
Combination | 1.025 |
Monotherapy | 1.968 |
The CGI is a scale to measure the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Severity is ranked 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. A higher score indicates greater symptom severity. (NCT01117857)
Timeframe: Baseline to week 9
Intervention | units on a scale (Median) |
---|---|
Duloxetine | -2 |
The HAM-D is a 17-item well-validated and reliable measure of current depressive symptoms and their severity. Eight items are scored on a five-point scale (0-4), and nine are scored on a three-point scale (0-2) for a total score range of 0-50. A higher score indicates greater symptom severity. (NCT01117857)
Timeframe: Baseline to week 9
Intervention | units on a scale (Median) |
---|---|
Duloxetine | -7.5 |
The Greene Climacteric Scale (GCS) is a 21-item scale used to quantify the severity of perimenopausal somatic symptoms. Each item is scored 0-3 for a total range of 0-63, with a higher score indicating greater symptom severity. (NCT01117857)
Timeframe: Baseline to week 9
Intervention | units on a scale (Median) |
---|---|
Duloxetine | -7.5 |
The HFRDIS is a 10-item self-report questionnaire in which subjects rate the degree to which hot flashes interfere with daily activities and quality-of-life during the prior week. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total score range of 0-100 (higher score indicates greater symptom burden/interference). (NCT01117857)
Timeframe: Baseline to week 9
Intervention | units on a scale (Median) |
---|---|
Duloxetine | -13.5 |
The GAD-7 is a valid and efficient tool for screening anxiety and assessing its severity in clinical practice and research. Subjects rate the items for severity on a 4-point scale from 0 (not at all) to 3 (nearly every day) for a total range of 0-21. A higher score indicates greater anxiety symptom burden. (NCT01117857)
Timeframe: Baseline to week 9
Intervention | units on a scale (Median) |
---|---|
Duloxetine | -2.5 |
Response was a ≥50% improvement (reduction) in the Hamilton Anxiety Rating Scale (HAMA) Total Score at treatment period endpoint compared with baseline. Two definitions were used to determine remission: Definition 1 (HAMA Total Score ≤7 at endpoint) and Definition 2 (HAMA Total Score ≤10 at endpoint). The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity. (NCT01118780)
Timeframe: Baseline, Week 10
Intervention | percentage of participants (Number) | ||
---|---|---|---|
Response | Remission (HAMA Total Score ≤7) | Remission (HAMA Total Score ≤10) | |
Duloxetine | 71.3 | 44.8 | 62.2 |
Placebo | 45.5 | 29.5 | 40.2 |
Two definitions, using the Hamilton Anxiety Rating Scale (HAMA) Total Score at endpoint compared with baseline, were used to determine sustained improvement: Definition 1 [sustained improvement overall required a ≥30% improvement (reduction) in the HAMA Total Score at treatment period endpoint, at an earlier visit prior to endpoint, and at all visits in between] and Definition 2 (sustained improvement from Week 2 required a ≥30% reduction at treatment period endpoint, at Week 2, and at all visits in between). Both definitions required at least 2 post-baseline visits. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity. (NCT01118780)
Timeframe: (Baseline through 10 weeks) and (Baseline, Week 2 through Week 10)
Intervention | percentage of participants (Number) | |
---|---|---|
Sustained Improvement Overall (n=134, 124) | Sustained Improvement From Week 2 (n=134, 123) | |
Duloxetine | 74.6 | 26.9 |
Placebo | 55.6 | 17.9 |
The time (days) to first response, defined as a ≥50% improvement (reduction) from baseline in the Hamilton Anxiety Rating Scale (HAMA) Total Score. Participants who did not have a response were censored at the last treatment period visit. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity. (NCT01118780)
Timeframe: Baseline through 10 weeks
Intervention | days (Median) |
---|---|
Duloxetine | 50.00 |
Placebo | 70.00 |
CGI-Improvement measured the clinician's perception of the participant's improvement at the time of assessment compared with the start of treatment. Scores could have ranged from 1 (very much improved) to 7 (very much worse). Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit. (NCT01118780)
Timeframe: Week 10
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 2.10 |
Placebo | 2.63 |
The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Functional Impairment Score (SDS Global Score) was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated a higher functional impairment in the participant's work/social/family life. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit. (NCT01118780)
Timeframe: Baseline, Week 10
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -8.60 |
Placebo | -5.37 |
The Q-LES-Q-SF was a participant-rated questionnaire designed to assess the degree of enjoyment and satisfaction experienced during the past week. The questionnaire consisted of 16 items rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total raw score was the sum of Items 1 to 14 and could have ranged from 14 to 70. Total raw scores were converted to, and expressed as, the percentage of the maximum possible score. Percent=100*(total raw score - 14)/56. Higher scores indicated higher levels of enjoyment/satisfaction. Least squares (LS) mean were calculated and analyzed using analysis of covariance (ANCOVA) adjusted for treatment, pooled investigator, age category, and baseline. (NCT01118780)
Timeframe: Baseline, Week 10
Intervention | percent of maximum possible score (Least Squares Mean) |
---|---|
Duloxetine | 15.11 |
Placebo | 9.35 |
PGI-Improvement measured the participant's perception of his or her improvement at the time of assessment compared with the start of treatment. Scores could have ranged from 1 (very much better) to 7 (very much worse). Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit. (NCT01118780)
Timeframe: Week 10
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 2.35 |
Placebo | 2.97 |
The percentage of participants who reported 1 or more falls at or before Week 10. (NCT01118780)
Timeframe: Baseline through 10 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 6.2 |
Placebo | 3.5 |
Time (days) to first functional remission. Two definitions, using the Sheehan Disability Scale (SDS) Global Functional Impairment Score (SDS Global Score), were used to determine functional remission: Definition 1 (SDS Global Score ≤5 at endpoint) and Definition 2 (SDS Global Score ≤6 at endpoint). Participants, who did not have an SDS Global Score ≤5 or ≤6, were censored at the last treatment period visit. The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Score was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated a higher functional impairment in the participant's work/social/family life. (NCT01118780)
Timeframe: Baseline through 10 weeks
Intervention | days (Median) | |
---|---|---|
Functional Remission (SDS Global Score ≤5) | Functional Remission (SDS Global Score ≤6) | |
Duloxetine | 50.00 | 31.00 |
Placebo | 72.00 | 71.00 |
The time (days) to first improvement, defined as a Clinical Global Impression of Improvement (CGI-Improvement) Score ≤2. Participants who did not have a CGI-I Score ≤2 were censored at the last treatment period visit. CGI-Improvement measured the clinician's perception of the participant's improvement at the time of assessment compared with the start of treatment. Scores could have ranged from 1 (very much improved) to 7 (very much worse). A CGI-Improvement Score of ≤2 was much improved or very much improved. (NCT01118780)
Timeframe: Baseline through 10 weeks
Intervention | days (Median) |
---|---|
Duloxetine | 31.00 |
Placebo | 52.00 |
The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit. (NCT01118780)
Timeframe: Baseline, Week 10
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -15.86 |
Placebo | -11.69 |
Time (days) to the earliest visit at which the Hamilton Anxiety Rating Scale (HAMA) Total Score was a ≥30% improvement (reduction) from baseline that was sustained through the last treatment period visit. Participants who did not meet sustained improvement criteria were censored at the last treatment period visit. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity. (NCT01118780)
Timeframe: Baseline through 10 weeks
Intervention | days (Median) |
---|---|
Duloxetine | 30.00 |
Placebo | 50.00 |
HADS was a 14-item questionnaire with 2 subscales (anxiety and depression). Each item was rated on a 4-point scale (0 to 3) and higher scores indicated a greater dysfunction. The HADS Anxiety Subscale Score was the sum of the odd numbered items and scores could have ranged from 0 to 21. The HADS Depression Subscale Score was the sum of the even numbered items and scores could have ranged from 0 to 21. Higher scores indicated a greater dysfunction. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit. (NCT01118780)
Timeframe: Baseline, Week 10
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
HADS Anxiety Subscale | HADS Depression Subscale | |
Duloxetine | -7.81 | -3.29 |
Placebo | -5.62 | -1.61 |
The BPI-SF Pain Severity Subscale was a participant-rated questionnaire that measured the severity of pain. Severity scores could have ranged from 0 (no pain) to 10 (pain as bad as you can imagine) for questions assessing worst pain, least pain, and average pain in the past 24 hours, and pain right now. The BPI-SF Interference Subscale measured the interference of pain with the participant's ability to function. Interference scores could have ranged from 0 (does not interfere) to 10 (completely interferes) for questions assessing interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least squares (LS) means were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit. (NCT01118780)
Timeframe: Baseline, Week 10
Intervention | units on a scale (Least Squares Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Worst Pain (n=141, 132) | Least Pain (n=141, 132) | Average Pain (n=141, 132) | Pain Right Now (n=141, 132) | General Activity (n=140, 131) | Mood (n=140, 131) | Walking Ability (n=140, 131) | Normal Work (n=139, 131) | Relations With Other People (n=140, 131) | Sleep (n=140, 131) | Enjoyment of Life (n=140, 131) | |
Duloxetine | -1.44 | -0.92 | -1.10 | -0.81 | -1.45 | -1.59 | -0.91 | -1.21 | -0.96 | -1.58 | -1.74 |
Placebo | -0.90 | -0.50 | -0.68 | -0.59 | -0.92 | -1.19 | -0.31 | -0.83 | -0.80 | -1.07 | -1.24 |
The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Psychic Anxiety Factor Score was the sum of Items 1 to 6 and Item 14 and could have ranged from 0 to 28. The HAMA Somatic Anxiety Factor Score was the sum of Items 7 to 13 and could have ranged from 0 to 28. The HAMA Anxious Mood Item Score was the score for Item 1 and the HAMA Tension Item Score was the score for Item 2. In each case, higher scores indicated a greater degree of symptom severity. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit. (NCT01118780)
Timeframe: Baseline, Week 10
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
HAMA Psychic Anxiety Factor Score (n=143, 131) | HAMA Somatic Anxiety Factor Score (n=143, 131) | HAMA Anxious Mood Item Score (n=142, 131) | HAMA Tension Item Score (n=143, 131) | |
Duloxetine | -8.59 | -7.33 | -1.77 | -1.48 |
Placebo | -6.19 | -5.57 | -1.24 | -1.17 |
The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). Higher values indicated a higher functional impairment in the participant's work/social/family life. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit. (NCT01118780)
Timeframe: Baseline, Week 10
Intervention | units on a scale (Least Squares Mean) | ||
---|---|---|---|
Work/School (n=56, 51) | Social Life/Leisure Activities (n=140, 131) | Family/Home Management (n=140, 131) | |
Duloxetine | -2.21 | -2.84 | -2.82 |
Placebo | -1.08 | -1.94 | -1.61 |
Treatment-emergent AEs were newly occurring AEs or a worsening of AEs during the taper period. A summary of serious AEs and other AEs during the treatment period (baseline through 10 weeks) is located in the Reported Adverse Events module. (NCT01118780)
Timeframe: 2 weeks during the taper period
Intervention | participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Any Serious AE | Non-Serious AE, Dizziness | Non-Serious AE, Fatigue | Non-Serious AE, Hyperhidrosis | Non-Serious AE, Nausea | Non-Serious AE, Tinnitus | Non-Serious AE, Constipation | Non-Serious AE, Cystitis | Non-Serious AE, Headache | Non-Serious AE, Musculoskeletal Chest Pain | Non-Serious AE, Nightmare | Non-Serious AE, Oropharyngeal Pain | Non-Serious AE, Pain | Non-Serious AE, Vertigo | |
Duloxetine 30 mg Then Placebo | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Duloxetine 60 mg Then 30 mg | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 |
Placebo | 0 | 1 | 2 | 2 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 0 |
The number of participants who discontinued from the study due to an AE (serious or other AE) during the treatment period. A summary of serious and other AEs is located in the Reported Adverse Events module. (NCT01118780)
Timeframe: Baseline through 10 weeks
Intervention | participants (Number) |
---|---|
Duloxetine | 16 |
Placebo | 15 |
Two definitions, using the Sheehan Disability Scale (SDS) Global Functional Impairment Score (SDS Global Score), were used to determine functional remission: Definition 1 (SDS Global Score ≤5 at endpoint) and Definition 2 (SDS Global Score ≤6 at endpoint). The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Score was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated a higher functional impairment in the participant's work/social/family life. (NCT01118780)
Timeframe: Week 10
Intervention | percentage of participants (Number) | |
---|---|---|
Functional Remission (SDS Global Score ≤5) | Functional Remission (SDS Global Score ≤6) | |
Duloxetine | 55.0 | 60.9 |
Placebo | 32.9 | 40.7 |
"The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Treatment-emergent was the worsening or new occurrence of suicidal behavior or ideation during treatment compared with baseline (Week 0)." (NCT01118780)
Timeframe: Baseline through 10 weeks
Intervention | participants (Number) | |
---|---|---|
Treatment-Emergent Suicidal Ideation | Treatment-Emergent Suicidal Behavior | |
Duloxetine | 3 | 0 |
Placebo | 5 | 0 |
The time (days) to first remission. Two definitions, using the Hamilton Anxiety Rating Scale (HAMA) Total Score, were used to determine remission: Definition 1 (HAMA Total Score ≤7 at endpoint) and Definition 2 (HAMA Total Score ≤10 at endpoint). Participants who did not have remission were censored at the last treatment period visit. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity. (NCT01118780)
Timeframe: Baseline through 10 weeks
Intervention | days (Median) | |
---|---|---|
Remission (HAMA Total Score ≤7) | Remission (HAMA Total Score ≤10) | |
Duloxetine | 71.00 | 51.00 |
Placebo | NA | 71.00 |
The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. (NCT01140906)
Timeframe: Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | 2.86 |
Vortioxetine 15 mg | 2.18 |
Vortioxetine 20 mg | 1.92 |
Duloxetine 60 mg | 1.75 |
The Discontinuation-Emergent Signs and Symptoms Scale (DESS) was designed to evaluate possible effects of discontinuation of antidepressant therapy. It is a clinician-rated instrument that queries for signs and symptoms on a 43-item checklist (for example, agitation, insomnia, fatigue, and dizziness) to assess whether the item (event) is discontinuation-emergent. A new or worsened event reported after discontinuation of therapy scores 1 point on the checklist, and the DESS total score is the sum of all positive scores on the checklist. A higher score indicates more symptoms. (NCT01140906)
Timeframe: Change from Week 8 in DESS total score analyzed at Week 10
Intervention | units on a scale (Mean) |
---|---|
Placebo | 0.15 |
Vortioxetine 15 mg | 0.01 |
Vortioxetine 20 mg | 0.72 |
Duloxetine 60 mg | 2.28 |
(NCT01140906)
Timeframe: Week 8
Intervention | percentage of patients (Number) |
---|---|
Placebo | 19 |
Vortioxetine 15 mg | 35 |
Vortioxetine 20 mg | 38 |
Duloxetine 60 mg | 54 |
"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction." (NCT01140906)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | 0.28 |
Vortioxetine 15 mg | -0.39 |
Vortioxetine 20 mg | -0.20 |
Duloxetine 60 mg | -1.25 |
(NCT01140906)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | -12.20 |
Vortioxetine 15 mg | -17.44 |
Vortioxetine 20 mg | -18.62 |
Duloxetine 60 mg | -20.91 |
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. (NCT01140906)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | -11.70 |
Vortioxetine 15 mg | -17.23 |
Vortioxetine 20 mg | -18.79 |
Duloxetine 60 mg | -21.15 |
(NCT01140906)
Timeframe: Week 8
Intervention | percentage of patients (Number) |
---|---|
Placebo | 32 |
Vortioxetine 15 mg | 57 |
Vortioxetine 20 mg | 62 |
Duloxetine 60 mg | 74 |
The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe. (NCT01140906)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|---|
Placebo | -4.46 |
Vortioxetine 15 mg | -7.70 |
Vortioxetine 20 mg | -8.38 |
Duloxetine 60 mg | -11.39 |
A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6 (NCT01145755)
Timeframe: 6 weeks
Intervention | Participants (Number) |
---|---|
AZD2066 | 5 |
Duloxetine | 8 |
Placebo | 7 |
Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms. (NCT01145755)
Timeframe: 6 weeks
Intervention | scores on the scale (Mean) |
---|---|
AZD2066 | -13.1658 |
Duloxetine | -14.0271 |
Placebo | -14.1575 |
A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score. (NCT01145755)
Timeframe: 6 weeks
Intervention | Participants (Number) |
---|---|
AZD2066 | 9 |
Duloxetine | 9 |
Placebo | 9 |
Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT01153009)
Timeframe: Baseline and Week 8
Intervention | percentage of participants (Number) |
---|---|
Placebo | 39.2 |
Vortioxetine 15 mg | 44.1 |
Vortioxetine 20 mg | 44.2 |
Duloxetine 60 mg | 54.8 |
The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects. (NCT01153009)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|---|
Placebo | -12.83 |
Vortioxetine 15 mg | -14.30 |
Vortioxetine 20 mg | -15.57 |
Duloxetine 60 mg | -16.90 |
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects. (NCT01153009)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|---|
Placebo | -7.68 |
Vortioxetine 15 mg | -7.73 |
Vortioxetine 20 mg | -8.55 |
Duloxetine 60 mg | -9.66 |
"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.~HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity." (NCT01153009)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|---|
Placebo | -14.27 |
Vortioxetine 15 mg | -13.34 |
Vortioxetine 20 mg | -14.89 |
Duloxetine 60 mg | -18.31 |
The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects. (NCT01153009)
Timeframe: Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|---|
Placebo | 2.65 |
Vortioxetine 15 mg | 2.54 |
Vortioxetine 20 mg | 2.47 |
Duloxetine 60 mg | 2.31 |
Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT01153009)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|---|
Placebo | 26.8 |
Vortioxetine 15 mg | 26.9 |
Vortioxetine 20 mg | 29.3 |
Duloxetine 60 mg | 26.0 |
24-hour average night pain and worst pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as the baseline score and baseline score-by-visit interaction. (NCT01179672)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Night Pain | Worst Pain | |
Duloxetine | -2.65 | -2.80 |
Placebo | -2.11 | -2.25 |
SDS was self-reported and used to assess the effect of the participant's symptoms on their work (Item 1), social life (Item 2), and family life (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. SDS total score was the sum of the 3 items and ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Scores ≥5 were associated with significant functional impairment. A negative change indicated an improvement in the participant's condition. LS mean was adjusted using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction. (NCT01179672)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -6.36 |
Placebo | -5.09 |
BPI-Severity scale was a self-reported scale that measured the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). A negative change indicated an improvement in the participant's condition. Percentage of participants was calculated as: (number of participants with 30% [or 50% or 75%] reduction in BPI-Severity average pain) divided by (number of participants) multiplied by 100. (NCT01179672)
Timeframe: Baseline, 12 weeks
Intervention | percentage of participants (Number) | ||
---|---|---|---|
≥30% Reduction | ≥50% Reduction | ≥75% Reduction | |
Duloxetine | 63.0 | 46.0 | 15.0 |
Placebo | 46.7 | 29.4 | 9.6 |
24-hour self-assessment of average daily pain was recorded in the participants diary based on an 11 point Likert scale with scores ranging from 0 (no pain) to 10 (worst possible pain). Percentage of participants was calculated as: (number of participants with 30% [or 50% or 75%] reduction in average daily pain) divided by (number of participants) multiplied by 100. (NCT01179672)
Timeframe: Baseline, 12 weeks
Intervention | percentage of participants (Number) | ||
---|---|---|---|
≥30% Reduction | ≥50% Reduction | ≥75% Reduction | |
Duloxetine | 61.5 | 42.0 | 14.5 |
Placebo | 49.0 | 28.8 | 9.6 |
PGI-I was self-reported and measured a participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction. (NCT01179672)
Timeframe: 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 2.44 |
Placebo | 2.65 |
24-hour average pain severity scores were recorded daily by the participant on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The weekly mean was calculated. A negative change indicated an improvement in participant's condition. Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction. (NCT01179672)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -2.40 |
Placebo | -1.97 |
SF-MPQ was a self-reported instrument that consisted of 11 sensory descriptors describing pain. The descriptors were rated on an intensity scale from 0 (none), 1 (mild), 2 (moderate) or 3 (severe). Three (3) pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst pain). A negative change indicates an improvement. LS mean was calculated using analysis of covariance (ANCOVA) adjusted for treatment, pooled investigator and baseline. (NCT01179672)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -6.45 |
Placebo | -5.33 |
CGI-S was administered by the investigator in the presence of the participant and measured the severity of illness at the time of assessment compared with start of treatment; CGI-S scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction. (NCT01179672)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -1.40 |
Placebo | -1.17 |
BPI-Severity Scale was a self-reported scale that measured the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction. (NCT01179672)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -2.50 |
Placebo | -2.00 |
BPI-Interference Score was a self-reported scale that measured the interference of pain based on the average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average interference scores ranged from 0 (does not interfere) to 10 (completely interferes). A negative change indicates an improvement in the participant's condition. LS means was calculated using MMRM and adjusted treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction. (NCT01179672)
Timeframe: Baseline, 12 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -2.42 |
Placebo | -1.82 |
"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100." (NCT01226511)
Timeframe: 10 weeks up to 28 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine/Duloxetine (Extension Treatment) | 0 |
Placebo/Duloxetine (Extension Treatment) | 2 |
"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100." (NCT01226511)
Timeframe: Baseline up to 10 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine (Acute Treatment) | 5.9 |
Placebo (Acute Treatment) | 5.2 |
"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100." (NCT01226511)
Timeframe: Baseline up to 10 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine (Acute Treatment) | 0.0 |
Placebo (Acute Treatment) | 0.0 |
PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit. (NCT01226511)
Timeframe: Baseline, 10 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine (Acute Treatment) | -9.15 |
Placebo (Acute Treatment) | -6.36 |
PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit, and baseline*visit. (NCT01226511)
Timeframe: Baseline, 10 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine (Acute Treatment) | -9.70 |
Placebo (Acute Treatment) | -7.05 |
The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for treatment, pooled investigator, baseline, and age category. (NCT01226511)
Timeframe: Baseline, 10 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine (Acute Treatment) | 17.14 |
Placebo (Acute Treatment) | 12.16 |
Response rate was defined as the percentage of participants having a 50% improvement from baseline to endpoint on the PARS severity score for GAD. PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. (NCT01226511)
Timeframe: Baseline, 10 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine (Acute Treatment) | 51 |
Placebo (Acute Treatment) | 37 |
PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups. (NCT01226511)
Timeframe: 10 weeks, 28 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine/Duloxetine (Extension Treatment) | -3.32 |
Placebo/Duloxetine (Extension Treatment) | -5.26 |
The CGI-S scale evaluated the severity of mental illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups. (NCT01226511)
Timeframe: 10 weeks, 28 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine/Duloxetine (Extension Treatment) | -0.76 |
Placebo/Duloxetine (Extension Treatment) | -1.17 |
PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups. (NCT01226511)
Timeframe: 10 weeks, 28 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine/Duloxetine (Extension Treatment) | -3.33 |
Placebo/Duloxetine (Extension Treatment) | -5.15 |
The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for pooled investigator, baseline, and age category within reporting groups. (NCT01226511)
Timeframe: 10 weeks, 28 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine/Duloxetine (Extension Treatment) | 7.32 |
Placebo/Duloxetine (Extension Treatment) | 10.48 |
The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit. (NCT01226511)
Timeframe: Baseline, 10 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine (Acute Treatment) | -1.93 |
Placebo (Acute Treatment) | -1.38 |
Remission rate was defined as the percentage of participants having a CGI-S score ≤2 at endpoint. The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. (NCT01226511)
Timeframe: 10 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine (Acute Treatment) | 45 |
Placebo (Acute Treatment) | 30 |
"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100." (NCT01226511)
Timeframe: 10 weeks up to 28 weeks
Intervention | percentage of participants (Number) |
---|---|
Duloxetine/Duloxetine (Extension Treatment) | 3 |
Placebo/Duloxetine (Extension Treatment) | 3 |
"Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value." (NCT01237587)
Timeframe: Baseline (extension phase), 39 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine/Duloxetine - Extension Phase | -3.49 |
Placebo/Duloxetine - Extension Phase | -2.27 |
"Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value." (NCT01237587)
Timeframe: Baseline, 13 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine - Acute | -3.25 |
Placebo - Acute | -4.17 |
"Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.~Mixed Model Repeated Measure (MMRM) model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce Least Square (LS) means." (NCT01237587)
Timeframe: Baseline, 13 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine - Acute | -1.62 |
Placebo - Acute | -0.97 |
"Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function.Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.~Acute phase responders: Participants with ≥30% pain reduction from baseline on the BPI average pain severity measure at the last non-missing assessment in acute phase." (NCT01237587)
Timeframe: Baseline (Extension Phase), 39 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine/Duloxetine - Extension | -3.4 |
"Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.~Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF)." (NCT01237587)
Timeframe: 13 weeks
Intervention | Participants (Count of Participants) |
---|---|
Duloxetine - Acute | 47 |
Placebo - Acute | 33 |
"Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.~Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF)." (NCT01237587)
Timeframe: 13 weeks
Intervention | Participants (Count of Participants) |
---|---|
Duloxetine - Acute | 36 |
Placebo - Acute | 22 |
Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. (NCT01237587)
Timeframe: Baseline, 13 weeks
Intervention | units on a scale (Least Squares Mean) | ||||
---|---|---|---|---|---|
Physical Symptoms | Harm Avoidance | Social Anxiety | Separation/Panic | Total Score | |
Duloxetine - Acute | -1.39 | -1.34 | -1.86 | -1.62 | -6.21 |
Placebo - Acute | -1.44 | -0.78 | -1.42 | -1.43 | -4.99 |
Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.ANCOVA model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. (NCT01237587)
Timeframe: Baseline (extension phase), 39 weeks
Intervention | units on a scale (Least Squares Mean) | ||||
---|---|---|---|---|---|
Physical Symptoms | Harm Avoidance | Social Anxiety | Separation/Panic | Total Score | |
Duloxetine/Duloxetine - Extension Phase | -0.63 | 0.23 | -0.11 | -0.06 | -0.55 |
Placebo/Duloxetine - Extension Phase | -0.92 | 0.10 | -0.02 | 0.01 | -0.78 |
"Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for pain now, worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value." (NCT01237587)
Timeframe: Baseline (extension phase), 39 weeks
Intervention | units on a scale (Least Squares Mean) | ||
---|---|---|---|
Average Pain Score | Worst Pain Score | Score Right Now | |
Duloxetine/Duloxetine - Extension Phase | -10.65 | -4.15 | -4.74 |
Placebo/Duloxetine - Extension Phase | -6.44 | -8.06 | -6.34 |
"The Brief Pain Inventory (BPI) - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work.~MMRM model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce LS means." (NCT01237587)
Timeframe: Baseline, 13 weeks
Intervention | units on a scale (Least Squares Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Worst Pain | Least Pain | Pain Right Now | General Activity | Mood | Walking ability | Normal Work | Relations With Other People | Sleep | Enjoyment of Life | School Work | |
Duloxetine - Acute | -1.58 | -1.08 | -1.56 | -2.00 | -2.00 | -1.30 | -1.49 | -1.87 | -1.40 | -1.76 | -1.68 |
Placebo - Acute | -0.90 | -0.47 | -1.05 | -1.03 | -1.46 | -1.09 | -1.21 | -1.07 | -1.05 | -1.47 | -1.08 |
"The BPI - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value." (NCT01237587)
Timeframe: Baseline (extension phase), 39 weeks
Intervention | units on a scale (Least Squares Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Worst Pain | Least Pain | Pain Right Now | General Activity | Mood | Walking Ability | Normal Work | Relations with Other People | Sleep | Enjoyment of Life | School Work | |
Duloxetine/Duloxetine - Extension Phase | -0.65 | -0.29 | -0.38 | -0.18 | -0.15 | -0.24 | -0.62 | -0.12 | -0.63 | -0.25 | -0.59 |
Placebo/Duloxetine - Extension Phase | -0.80 | -0.45 | -0.29 | 0.20 | -0.25 | -0.21 | -0.32 | -0.41 | -0.54 | -0.26 | -0.06 |
"Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for pain now, worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value." (NCT01237587)
Timeframe: Baseline, 13 weeks
Intervention | mm (Least Squares Mean) | ||
---|---|---|---|
Average Pain Score | Worst Pain Score | Pain Score Right Now | |
Duloxetine - Acute | -11.03 | -14.36 | -8.99 |
Placebo - Acute | -9.41 | -8.46 | -7.20 |
"Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value." (NCT01237587)
Timeframe: Baseline (extension phase), 39 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine/Duloxetine - Extension Phase | -0.42 |
Placebo/Duloxetine - Extension Phase | -1.41 |
"Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value." (NCT01237587)
Timeframe: Baseline, 13 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine - Acute | -3.28 |
Placebo - Acute | -2.45 |
"Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value." (NCT01237587)
Timeframe: Baseline (extension phase), 39 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine/Duloxetine - Extension Phase | -0.20 |
Placebo/Duloxetine - Extension Phase | -0.24 |
"Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value." (NCT01237587)
Timeframe: Baseline, 13 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine - Acute | -0.16 |
Placebo - Acute | -0.15 |
"Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value." (NCT01237587)
Timeframe: Baseline (extension phase), 39 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine/Duloxetine - Extension Phase | -0.67 |
Placebo/Duloxetine - Extension Phase | -0.67 |
"Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value." (NCT01237587)
Timeframe: Baseline (extension phase), 39 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine/Duloxetine - Extension Phase | -1.71 |
Placebo/Duloxetine - Extension Phase | -1.03 |
"Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value." (NCT01237587)
Timeframe: Baseline, 13 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine - Acute | -0.88 |
Placebo - Acute | -0.66 |
"Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value." (NCT01237587)
Timeframe: Baseline, 13 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine - Acute | -3.97 |
Placebo - Acute | -5.00 |
A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (MADRS) item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms. (NCT01288079)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)
Intervention | units on a scale (Least Squares Mean) |
---|---|
1 mg BID TC-5214 | -9.1 |
4 mg BID TC-5214 | -11.2 |
60 mg QD Duloxetine | -11.4 |
Placebo | -7.6 |
"The IDS-SR was a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of MDD. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the best rating and 3 being the worst rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 (best) to 84 (worst).~Under item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. If the number of items recorded is at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place." (NCT01360866)
Timeframe: From screening to week 52/early termination
Intervention | units on a scale (Mean) |
---|---|
Prior Placebo | -5.25 |
Prior Brexpiprazole | -4.76 |
Prior ADT | -3.94 |
Prior Seroquel | -7.44 |
The efficacy of trial treatment was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at screening. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse. (NCT01360866)
Timeframe: From screening to week 52/early termination
Intervention | units on a scale (Mean) |
---|---|
Prior Placebo | 2.60 |
Prior Brexpiprazole | 2.63 |
Prior ADT | 2.63 |
Prior Seroquel | 2.40 |
"The severity of illness for each participant was rated using the CGI-S . On the basis of the investigator answer to the question: Considering your total clinical experience with this particular population, how mentally ill was the participant at that time? Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants." (NCT01360866)
Timeframe: From screening to week 52/early termination
Intervention | units on a scale (Mean) |
---|---|
Prior Placebo | -0.77 |
Prior Brexpiprazole | -0.63 |
Prior ADT | -0.48 |
Prior Seroquel | -0.93 |
"The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on regular life responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains with scores from 0 = not at all, to 10 = extremely.~Scores of 5 and above were associated with significant functional impairment." (NCT01360866)
Timeframe: From screening to week 52/early termination
Intervention | units on a scale (Mean) |
---|---|
Prior Placebo | -0.80 |
Prior Brexpiprazole | -0.70 |
Prior ADT | -0.40 |
Prior Seroquel | -1.00 |
To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole. (NCT01360866)
Timeframe: From screening to week 52/early termination
Intervention | Participants (Count of Participants) | ||||
---|---|---|---|---|---|
Participants with adverse events | Participants with treatment emergent AE (TEAE) | Participants with serious TEAE | Participants with severe TEAE | Partcipants discontinued due to AEs | |
Prior ADT | 1165 | 1163 | 33 | 99 | 134 |
Prior Brexpiprazole | 511 | 510 | 23 | 64 | 58 |
Prior Placebo | 400 | 399 | 14 | 48 | 55 |
Prior Seroquel | 51 | 51 | 1 | 4 | 6 |
The primary clinical efficacy measure is the change in spontaneous (non-evoked) pelvic pain from the baseline period to the end of treatment. This was assessed by using the 0-10 numerical pain ratings to derive the primary outcome variable of clinical pain intensity difference due to treatment. Larger values (greater changes in ratings) are better outcomes. (NCT01451606)
Timeframe: Baseline and 8 weeks
Intervention | units on a scale (Median) |
---|---|
Placebo Pill | 5 |
Duloxetine | 5 |
This is a questionnaire assessment of functional limitations due to clinical pain. The range of scores for this subscale is 0-44. The measure is the change in score from baseline to end of treatment period. A greater number (change in score) is a better outcome. (NCT01451606)
Timeframe: Baseline and 8 weeks
Intervention | units on a scale (Mean) |
---|---|
Placebo Pill | 21.58 |
Duloxetine | 12.92 |
The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups and as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied. (NCT01552057)
Timeframe: Baseline, 14 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 60 mg | -4.07 |
Placebo | -1.22 |
FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant (pt) outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a pt felt well and days a pt was unable to work due to fibromyalgia symptoms. Items 14 through 20 were 11-point scales on which a pt rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. If a pt did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied. (NCT01552057)
Timeframe: Baseline, 14 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 60 mg | -18.41 |
Placebo | -13.05 |
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied. (NCT01552057)
Timeframe: Baseline, 14 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 60 mg | -1.90 |
Placebo | -1.58 |
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied. (NCT01552057)
Timeframe: Baseline, 2 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 60 mg | -1.00 |
Placebo | -0.60 |
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied. (NCT01552057)
Timeframe: Baseline, 4 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 60 mg | -1.55 |
Placebo | -0.94 |
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied. (NCT01552057)
Timeframe: Baseline, 10 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 60 mg | -1.85 |
Placebo | -1.41 |
WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms [each rated from 0 (no problem) to 3 (severe; life-disturbing problems)] plus the severity of somatic symptoms in general [rated from 0 (no symptoms) to 3 (a great deal of symptoms)]. The total SS score ranged from 0 and 12. LS mean was calculated using an MMRM approach including administration groups, observation points, interaction between the administration groups and the observation points as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied. (NCT01552057)
Timeframe: Baseline, 14 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
WPI | SS | |
Duloxetine 60 mg | -2.34 | -1.37 |
Placebo | -1.06 | -1.00 |
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied. (NCT01552057)
Timeframe: Baseline, 14 weeks
Intervention | units on a scale (Least Squares Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Worst Pain | Least Pain | Pain Right Now | Interference With General Activity | Interference With Mood | Interference With Walking Ability | Interference With Normal Work | Interference With Relations With Other People | Interference With Sleep | Interference With Enjoyment of Life | Average Interference | |
Duloxetine 60 mg | -1.91 | -1.72 | -1.77 | -2.22 | -2.17 | -1.67 | -2.18 | -1.09 | -1.82 | -1.90 | -1.95 |
Placebo | -1.35 | -1.23 | -1.20 | -1.76 | -1.42 | -1.29 | -1.76 | -0.53 | -1.57 | -1.24 | -1.44 |
Each morning participants rated their average pain and worst pain within the past 24 hours on separate 11-point Likert scales with scores ranging from 0 (no pain) through 10 (worst possible pain). These scores were then averaged for the week and compared to baseline. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied. (NCT01552057)
Timeframe: Baseline, 14 weeks
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Average Pain | Worst Pain | |
Duloxetine 60 mg | -1.82 | -1.81 |
Placebo | -1.48 | -1.34 |
The SF-36 Health Survey is a generic, health-related survey assessing the participant's quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline as well as the presence or absence of complication by major depressive disorder as covariates. (NCT01552057)
Timeframe: Baseline, up to 14 weeks
Intervention | units on a scale (Least Squares Mean) | |||||||
---|---|---|---|---|---|---|---|---|
Physical Functioning | Role-Physical | Bodily Pain | General Health | Vitality | Social Functioning | Role-Emotional | Mental Health | |
Duloxetine 60 mg | 7.40 | 8.20 | 10.95 | 6.55 | 10.05 | 10.32 | 5.50 | 5.91 |
Placebo | 3.06 | 0.44 | 5.28 | 3.31 | 3.35 | 3.28 | -3.63 | -2.00 |
PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied. (NCT01552057)
Timeframe: 14 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 60 mg | 2.83 |
Placebo | 3.32 |
CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied. (NCT01552057)
Timeframe: 14 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 60 mg | 2.83 |
Placebo | 3.27 |
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates. (NCT01552057)
Timeframe: Baseline, up to 14 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 60 mg | -1.60 |
Placebo | -1.22 |
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied. (NCT01552057)
Timeframe: Baseline, 6 weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine 60 mg | -1.81 |
Placebo | -1.09 |
The change in gray matter volume is evaluated by subtracting the volume after the treatment (week 16) to the volume before treatment (baseline) (NCT01558700)
Timeframe: 16 weeks compared to baseline
Intervention | percentage of change (Mean) |
---|---|
Duloxetine | -0.34 |
Sugar Pill | -0.92 |
The Western Ontario and McMaster Osteoarthritis Index (WOMAC) score change was assess by subtracting WOMAC score after treatment (week 16) to the baseline WOMAC score. WOMAC score has a range from 0 up to 96, higher score meaning worse condition. The outcome is the decrease in WOMAC scores, meaning that the higher is the decrease, the most improvement in the condition. (NCT01558700)
Timeframe: 16 weeks compared to baseline
Intervention | Scores on a scale (Mean) |
---|---|
Duloxetine | 8.3 |
Sugar Pill | 8.7 |
"The IT measured choice reaction time: the participant pressed a yes button whenever an onscreen playing card turned face up and was red, or a no button if the card was not red. The IT took on average 2 minutes to complete. Lower scores equal better performance. A decrease in score over the course of the study indicates improved visual attention/vigilance. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate." (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | Log10 milliseconds (Least Squares Mean) |
---|---|
Vortioxetine (Lu AA21004) | -0.037 |
Duloxetine | -0.030 |
Placebo | -0.024 |
"The CGI-S assesses the clinician's impression of the subject's current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill). A MMRM model with baseline*week, center, week, treatment and week*treatment as factors was used for analyses." (NCT01564862)
Timeframe: Baseline, Week 1, Week 4 and Week 8
Intervention | score on a scale (Least Squares Mean) | ||
---|---|---|---|
Change from Baseline at Week 1 (n=174, 187,167) | Change from Baseline at Week 4 (n=173,184,165) | Change from Baseline at Week 8 (n=169,179,161) | |
Duloxetine | -0.353 | -1.170 | -1.698 |
Placebo | -0.243 | -0.617 | -1.225 |
Vortioxetine (Lu AA21004) | -0.289 | -0.951 | -1.546 |
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. (NCT01564862)
Timeframe: Baseline, Week 1, Week 4 and Week 8
Intervention | score on a scale (Mean) | ||
---|---|---|---|
Change at Week 1 | Change at Week 4 | Change at Week 8 | |
Duloxetine | -4.6 | -11.6 | -15.5 |
Placebo | -3.4 | -8.0 | -12.3 |
Vortioxetine (Lu AA21004) | -3.7 | -9.8 | -14.3 |
The TMT is a two-part cognitive test. TMT-B assesses executive functioning and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower score for TMT-B represents better executive function. A decrease in score over the study represents an improvement in executive function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate. (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | seconds (Least Squares Mean) |
---|---|
Vortioxetine (Lu AA21004) | -18.73 |
Duloxetine | -14.60 |
Placebo | -9.06 |
The TMT is a two-part cognitive test. TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower scores represent better speed of processing. A decrease in score over the study represents an improvement in speed in processing. An ANCOVA model was used with treatment and center as fixed factors and the baseline value as a covariate. (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | seconds (Least Squares Mean) |
---|---|
Vortioxetine (Lu AA21004) | -7.70 |
Duloxetine | -8.06 |
Placebo | -6.65 |
"The CGI-I assesses the clinician's impression of the subject's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater worsening of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. A MMRM model was used with baseline*week, center, week, treatment and week*treatment as factors in the analysis." (NCT01564862)
Timeframe: Baseline, Week 8
Intervention | score on a scale (Least Squares Mean) |
---|---|
Vortioxetine (Lu AA21004) | 2.349 |
Duloxetine | 2.235 |
Placebo | 2.639 |
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Remission was defined as a MADRS total score ≤10. (NCT01564862)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|---|
Vortioxetine (Lu AA21004) | 30.3 |
Duloxetine | 33.7 |
Placebo | 21.6 |
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Response was defined as a ≥50% decrease in MADRS Total Score from Baseline. (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | percentage of participants (Number) |
---|---|
Vortioxetine (Lu AA21004) | 50.9 |
Duloxetine | 54.5 |
Placebo | 41.3 |
The One-Back test measures the cognitive domain of attention and working memory through yes or no responses to 30 trials. The task requires participants to report when a stimulus item presented serially is the same as an item one step back from the item at hand for a total correct responses 0 to 100. It usually takes 2-3 minutes to be administered. Higher scores equal better performance. An increase in score over the course of the study indicates improved attention/working memory. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate. (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | Log 10 milliseconds (Least Squares Mean) |
---|---|
Vortioxetine (Lu AA21004) | -0.028 |
Duloxetine | -0.024 |
Placebo | -0.022 |
"The GMLT measures executive functioning and spatial problem solving. Participants learn a hidden pathway through a maze of 10 x 10 grid of tiles on a computer touch screen using step-by-step guess, with trial and error feedback after each step. Once the pathway is learned, participants repeat the same pathway four more times. It usually takes 5-6 minutes to administer this test. Lower score equals better performance. A decrease in score over the course of the study indicates improved executive function.~An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate." (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | Errors (Least Squares Mean) |
---|---|
Vortioxetine (Lu AA21004) | -5.43 |
Duloxetine | -5.16 |
Placebo | -3.49 |
The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Participants are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time for a total possible score of 0 to 133. Higher scores-correct number of symbols reflects greater objective cognitive functioning. An increase in score represents an improvement in an integrated measure of cognitive function. An Analysis of Covariance (ANCOVA) model was used with treatment and center as fixed factors and the Baseline value as a covariate. (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | Correct symbols (Least Squares Mean) |
---|---|
Vortioxetine (Lu AA21004) | 4.60 |
Duloxetine | 4.06 |
Placebo | 2.85 |
"The DT is a computerized test that measures simple reaction time and psychomotor speed. The task requires participants to respond by pressing a yes button as soon as an onscreen playing card is turned over and is red, and by pressing a no button if the card is not red. It takes 2 minutes to be administered. There is no minimum or maximum scores since it is a time-based assessment. Lower score equals better performance. A decrease in score over the course of the study indicates improved speed of processing and psychomotor function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate." (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | Log10 milliseconds (Least Squares Mean) |
---|---|
Vortioxetine (Lu AA21004) | -0.050 |
Duloxetine | -0.039 |
Placebo | -0.033 |
Improvement of Cognitive Dysfunction is determined using the change from Baseline to Week 8 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score and the Digital Symbol Substitution Test (DSST) total number of correct symbols. The MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression). The DSST assesses relative contributions of speed, memory, executive function and visual scanning. The proportion of direct effect from treatment = DSST difference / (DSST difference + coefficient*MADRS difference). (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | proportion of direct effect (Number) |
---|---|
Vortioxetine (Lu AA21004) | 75.66 |
Duloxetine | 48.69 |
PDQ is a patient-rated scale designed to subjectively assess cognitive dysfunction, comprising four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization for a total possible score of 0 to 40. The subscale Attention/Concentration is the sum of items 1, 5, 9, 13, and 17 with a range of 0-20; while the subscale Planning/Organization is the sum of items 4, 8, 12, 16, and 20 with the score range of 0 to 20. The scores of the subscales Attention/Concentration and Planning/Organization were summed. Higher scores reflect greater participant-perceived cognitive dysfunction in the domains identified. A decrease in score represents an improvement in subjective cognitive function in the domains identified. A Mixed Model Repeated Measures (MMRM) model was used with baseline*week, center, week, treatment and week*treatment as factors in the analysis. (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | score on a scale (Least Squares Mean) |
---|---|
Vortioxetine (Lu AA21004) | -8.9 |
Duloxetine | -9.3 |
Placebo | -6.3 |
The STROOP test assesses the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises of 2 sheets with 50 words each, up to 50 correct responses for each of the congruent and incongruent Stroop tests. Participants have 4 minutes to name the ink color of each word. Lower time to complete the test indicates better performance. Higher number of correct responses indicates better responses. A decrease in the time to complete the tests and an increase in the number of correct responses both indicate improvement over the course of the study. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate. (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | seconds (Mean) | |
---|---|---|
Congruent (n=174,187,167) | Incongruent (n=172,186,166) | |
Duloxetine | -4.54 | -9.83 |
Placebo | -4.37 | -8.11 |
Vortioxetine (Lu AA21004) | -3.30 | -8.17 |
"Worst joint pain according to the BPI-SF worst pain score (item #2). This item has a scale of 0 to 10 with 0 indicating No pain and 10 indicating Pain as bad as you can imagine." (NCT01598298)
Timeframe: Weeks 2, 6, 12, and 24; Week 12 reported
Intervention | units on a scale (Mean) |
---|---|
Arm I: Duloxetine | 4.0 |
Arm II: Placebo | 4.9 |
"Average joint pain according to the Brief Pain Inventory - Short Form (BPI-SF) average pain score (item #4). This item has a scale of 0 to 10 with 0 indicating No pain and 10 indicating Pain as bad as you can imagine." (NCT01598298)
Timeframe: Weeks 2, 6, 12, and 24; Week 12 reported
Intervention | units on a scale (Mean) |
---|---|
Arm I: Duloxetine | 2.9 |
Arm II: Placebo | 3.5 |
"Pain interference according to the BPI-SF: this item has a scale of 0 to 10 with 0 indicating Does not interfere and 10 indicating Completely interferes." (NCT01598298)
Timeframe: Weeks 2, 6, 12, and 24; Week 12 reported
Intervention | units on a scale (Mean) |
---|---|
Arm I: Duloxetine | 1.9 |
Arm II: Placebo | 2.6 |
The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms. (NCT01621191)
Timeframe: Baseline, 50 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine 60 mg | -0.94 |
CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse). (NCT01621191)
Timeframe: 50 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine 60 mg | 2.34 |
FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a participant felt well and days a participant was unable to work due to fibromyalgia symptoms, respectively. Items 14 through 20 were 11-point scales on which a participant rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression, respectively. If a participant did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact. (NCT01621191)
Timeframe: Baseline, 50 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine 60 mg | -6.00 |
WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms [each rated from 0 (no problem) to 3 (severe; life-disturbing problems)] plus the severity of somatic symptoms in general [rated from 0 (no symptoms) to 3 (a great deal of symptoms)]. The total SS score ranged from 0 and 12. (NCT01621191)
Timeframe: Baseline, 50 weeks
Intervention | units on a scale (Mean) | |
---|---|---|
WPI | SS | |
Duloxetine 60 mg | -1.46 | -0.37 |
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing average pain, worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items. (NCT01621191)
Timeframe: Baseline, 50 weeks
Intervention | units on a scale (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Average Pain | Worst Pain | Least Pain | Pain Right Now | Interference With General Activity | Interference With Mood | Interference With Walking Ability | Interference With Normal Work | Interference With Relations With Other People | Interference With Sleep | Interference With Enjoyment of Life | Average Interference | |
Duloxetine 60 mg | -1.31 | -1.53 | -1.26 | -1.47 | -0.72 | -0.82 | -0.73 | -0.66 | -0.38 | -1.00 | -0.68 | -0.71 |
The SF-36 Health Survey is a generic, health-related survey assessing the participant's quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. (NCT01621191)
Timeframe: Baseline, 50 weeks
Intervention | units on a scale (Mean) | |||||||
---|---|---|---|---|---|---|---|---|
Physical Functioning | Role-Physical | Bodily Pain | General Health | Vitality | Social Functioning | Role-Emotional | Mental Health | |
Duloxetine 60 mg | 4.26 | 4.02 | 6.89 | 4.14 | 0.16 | 3.26 | 3.55 | 2.13 |
PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). (NCT01621191)
Timeframe: 50 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine 60 mg | 2.48 |
A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. (NCT01621191)
Timeframe: Baseline through 53 weeks
Intervention | participants (Number) |
---|---|
Duloxetine 60 mg | 138 |
Clinician-administered 10-item scale measuring depressive symptoms (range 0-60); higher scores indicate greater severity of major depression. (NCT01754493)
Timeframe: Weeks 0, 8, 12
Intervention | units on a scale (Mean) | ||
---|---|---|---|
Week 0 | Week 8 | Week 12 | |
Treatment With Duloxetine | 31.59 | 15.67 | 11.4 |
Five self-report 11-point Likert scales measuring pain severity in the following domains (one item each): overall pain, pain interfering with daily activities, headaches, back pain, and shoulder pain. Range is 0-10; higher scores indicate higher pain severity. (NCT01754493)
Timeframe: Measured at weeks 0, 8, 12
Intervention | units on a scale (Mean) | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Overall pain, Week 0 | Pain interfering with daily activities, Week 0 | Headaches, Week 0 | Back pain, Week 0 | Shoulder pain, Week 0 | Overall pain, Week 8 | Pain interfering with daily activities, Week 8 | Headaches, Week 8 | Back pain, Week 8 | Shoulder pain, Week 8 | Overall pain, Week 12 | Pain interfering with daily activities, Week 12 | Headaches, Week 12 | Back pain, Week 12 | Shoulder pain, Week 12 | |
Treatment With Duloxetine | 5 | 4.94 | 4.24 | 5.47 | 5.29 | 6.08 | 6 | 4.5 | 5.58 | 5.17 | 4.1 | 4.8 | 3.4 | 4.9 | 4.7 |
Self-report 15-item scale measuring somatization symptoms (range 0-30); higher score indicates greater severity of somatization symptoms. (NCT01754493)
Timeframe: Measured at weeks 0, 8, 12
Intervention | units on a scale (Mean) | ||
---|---|---|---|
Week 0 | Week 8 | Week 12 | |
Treatment With Duloxetine | 16.06 | 12.87 | 11.1 |
Clinician-administered 15-item scale measuring IBS symptoms (range 15-105); higher score indicates greater IBS severity. (NCT01754493)
Timeframe: Weeks 0, 8, 12
Intervention | units on a scale (Mean) | ||
---|---|---|---|
Week 0 | Week 8 | Week 12 | |
Treatment With Duloxetine | 54.76 | 36.33 | 31.4 |
Two clinician-administered scales measuring level of change in (1) depressive symptoms and (2) IBS symptoms, assessed separately. Range is 1-7, ranging from very much improved (1) to very much worsened (7). (NCT01754493)
Timeframe: Measured at weeks 0, 8, 12
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
CGI - Major Depression, Week 0 | CGI - Major Depression, Week 8 | CGI - Major Depression, Week 12 | CGI - IBS, Week 0 | CGI - IBS, Week 8 | CGI - IBS, Week 12 | |
Treatment With Duloxetine | 4.71 | 3.58 | 3 | 4.65 | 3.58 | 3 |
Cornell Dysthymia Rating Scale scores from range 0-64. Lower or decreasing scores represent decreased severity and a better outcome, while higher or increasing scores represent more severe depression and a worse outcome. The change score was calculated by subtracting the Week 12 score from the Week 0 score. (NCT01852383)
Timeframe: Week 0 and 12
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 28.8 |
Maximum duloxetine oral dose (NCT01852383)
Timeframe: Week 0, 1, 2, 4, 6, 8, 10, 12
Intervention | mg (Mean) |
---|---|
Duloxetine | 101 |
The Treatment Emergent Symptom Scale (TESS) documents the presence of common side effects. There are 26 items and the total score range is 0-26. Low scores or decrease in scores represent less side effects and high scores or increase in scores represent more side effects. The change in side effect severity scores was calculated by subtracting the Week 12 score from the Week 0 score. (NCT01852383)
Timeframe: 0 and 12 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 5.2 |
The research rater completed the 24-item Hamilton Rating Scale for Depression (HAM-D) and documented the scores on each visit. Hamilton Rating Scale for Depression scores range from 0-50 with low scores or decreasing scores representing decreased severity and better outcome, and higher scores or increasing scores representing more severe depressive symptoms and a worse outcome. The change score was calculated by subtracting the Week 12 score from the Week 0 score. (NCT01852383)
Timeframe: Screen (0) and 12 weeks
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 8 |
Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10 (worst pain) to determine average pain in the past 24 hours (average pain). A 30% (or 50%) improvement was defined as a ≥30% (or ≥50%) reduction in BPI pain severity from baseline to endpoint. Percentage of participants = (number of participants with ≥30% or ≥50% pain reduction / total number of participants in treatment group) * 100. (NCT01855919)
Timeframe: Baseline, Week 14
Intervention | percentage of participants (Number) | |
---|---|---|
≥30% pain reduction | ≥50% pain reduction | |
Duloxetine | 68.7 | 56.5 |
Placebo | 52.2 | 39.4 |
"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation." (NCT01855919)
Timeframe: Baseline through Week 14
Intervention | percentage of participants (Number) | ||
---|---|---|---|
Wish to be dead (n=226, 220) | Nonspecific active suicidal thoughts (n=231, 223) | Suicidal behavior (n=232, 224) | |
Duloxetine | 0 | 0 | 0 |
Placebo | 0 | 0 | 0 |
WPAI is a self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities, and yields 4 types of scores: Absenteeism (work time missed)=Question (Q)2/(Q2+4))*100); Presenteeism (impairment at work/reduced on-the-job effectiveness)=(Q5/10)*100); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism)=(Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)])*100); and Activity Impairment=(Q6/10)*100. Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate. (NCT01855919)
Timeframe: Baseline, Week 14
Intervention | hours (Least Squares Mean) | |||
---|---|---|---|---|
Work time missed (n=135, 140) | Impairment at work (n=136, 140) | Work productivity loss (n=135, 140) | Work activity impairment (n=230, 226) | |
Duloxetine | -0.01 | -0.13 | -0.13 | -0.14 |
Placebo | 0.02 | -0.09 | -0.09 | -0.12 |
24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. For the analysis, weekly mean was calculated. LS means calculated using MMRM adjusted for treatment, week, interaction between treatment and week as fixed effects and baseline value as covariate. (NCT01855919)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Average Pain | Worst Pain | |
Duloxetine | -2.15 | -2.25 |
Placebo | -1.73 | -1.91 |
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores range from: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores range from: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference is defined as the average of non-missing scores of individual interference items. Higher scores indicated worsening of pain. LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate. (NCT01855919)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Worst Pain | Least Pain | Current Pain | General Activity | Mood | Walking Ability | Normal Work | Relationship People | Sleep | Enjoyment of Life | Average of 7 Interference Items | |
Duloxetine | -2.63 | -1.69 | -2.42 | -2.46 | -2.15 | -2.05 | -2.17 | -1.02 | -1.41 | -1.52 | -1.83 |
Placebo | -2.33 | -1.19 | -2.03 | -2.16 | -1.83 | -1.92 | -2.17 | -0.98 | -1.40 | -1.48 | -1.70 |
SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate. (NCT01855919)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) | |||||||
---|---|---|---|---|---|---|---|---|
Physical Functioning | Role (Physical) | Bodily Pain | General Health | Vitality | Social Functioning | Role (Emotional) | Mental Health | |
Duloxetine | 8.47 | 10.58 | 12.56 | 6.72 | 5.56 | 6.40 | 5.78 | 5.63 |
Placebo | 7.20 | 10.00 | 11.01 | 3.78 | 4.41 | 4.77 | 6.18 | 2.42 |
Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10(worst pain) to determine average pain in the past 24 hours (average pain). Participants were considered to have sustained pain reduction of ≥30% in the BPI-severity score (average pain) at the time of final evaluation and at least 1 other time point prior to the time of final evaluation compared with baseline, and a reduction of ≥20% from baseline sustained at all evaluation time points between that period. Percentage of participants = (number of participants with sustained pain reduction / total number of participants in treatment group) * 100. (NCT01855919)
Timeframe: Baseline through Week 14
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 61.3 |
Placebo | 46.0 |
Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) * 100. (NCT01855919)
Timeframe: Baseline through Week 14
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 10.3 |
Placebo | 8.0 |
PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate. (NCT01855919)
Timeframe: Week 14
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 2.46 |
Placebo | 2.76 |
BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Higher scores indicated worsening of pain. Least squares (LS) means calculated using mixed model repeating measure (MMRM) adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate. (NCT01855919)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -2.43 |
Placebo | -1.96 |
The RMDQ-24 is a health status measure completed by participants to assess physical disability due to low back pain. Participants answered 24 questions about impairment of daily living activities (standing, walking, sitting, wearing clothes, working, etc.) resulting from low back pain. The number of statements marked was summed by the clinician for a total score. The total scores range from 0 (no disability) to 24 (severe disability). LS means calculated using analysis of covariance (ANCOVA) with treatment group as a fixed effect, and baseline value as a covariate. (NCT01855919)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -3.86 |
Placebo | -3.23 |
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3 level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate. (NCT01855919)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 0.09 |
Placebo | 0.08 |
CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate. (NCT01855919)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -1.46 |
Placebo | -1.17 |
BDI-II is a 21-question multiple-choice self-reported inventory about depressive symptoms (sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping patterns, irritability, changes in appetite, concentration difficulties, tiredness or fatigue, and loss of interest in sex). The scores for each item range from 0 (best) to 3 (worst) with possible total scores of 0 to 63, where higher total scores indicate more severe depressive symptoms. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate. (NCT01855919)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -1.39 |
Placebo | -1.04 |
"Cognitive Difficulties - Attention/Concentration will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.~Baseline: Mean attention/concentration score for all individual patients in arm 1 (intervention)~5 weeks: Mean attention/concentration score for all individual patients in arm 1 (intervention)~Range of attention/concentration score 0-40 (0=no attention/concentration difficulties, 40=maximum attention/concentration difficulties)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 14.10 |
"Cognitive Difficulties - Attention/Concentration will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.~Baseline: Mean attention/concentration score for all individual patients in arm 1 (intervention)~5 weeks: Mean attention/concentration score for all individual patients in arm 1 (intervention)~Range of attention/concentration score 0-40 (0=no attention/concentration difficulties, 40=maximum attention/concentration difficulties)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) | |
---|---|---|
Baseline | week 5 timepoint | |
Arm 1 (Patients With Pain) | 17.26 | 15.83 |
"Cognitive Difficulties - Language will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.~Baseline: Mean language score for all individual patients in arm 1 (intervention)~5 weeks: Mean language score for all individual patients in arm 1 (intervention)~Range of language score 0-40 (0=no language difficulties, 40=maximum language difficulties)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 12.42 |
"Pain sensitivity will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing to assess pressure pain threshold (Pain50).~Baseline: Mean Pain50 for all individual patients in arm 1 (intervention) and arm 2 (control)~5 weeks: Mean Pain50 for all individual patients in arm 1 (intervention)~Range of Pain50 score: 0-10 kg/cm2 (higher number reflects higher pain threshold or lower pain sensitivity)" (NCT01912612)
Timeframe: 5 weeks
Intervention | kg/cm2 (Mean) | |
---|---|---|
Baseline | week 5 timepoint | |
Arm 1 (Patients With Pain) | 3.20 | 3.30 |
"Cognitive Difficulties - Verbal Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.~Baseline: Mean verbal memory score for all individual patients in arm 1 (intervention)~5 weeks: Mean verbal memory score for all individual patients in arm 1 (intervention)~Range of verbal memory score 0-40 (0=no verbal memory difficulties, 40=maximum verbal memory difficulties)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 13.97 |
"Cognitive Difficulties - Verbal Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.~Baseline: Mean verbal memory score for all individual patients in arm 1 (intervention)~5 weeks: Mean verbal memory score for all individual patients in arm 1 (intervention)~Range of verbal memory score 0-40 (0=no verbal memory difficulties, 40=maximum verbal memory difficulties)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) | |
---|---|---|
Baseline | week 5 timepoint | |
Arm 1 (Patients With Pain) | 17.15 | 16.90 |
"Cognitive Difficulties - Visual-Perceptual Ability will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.~Baseline: Mean visual-perceptual ability score for all individual patients in arm 1 (intervention)~5 weeks: Mean visual-perceptual ability score for all individual patients in arm 1 (intervention)~Range of visual-perceptual ability score 0-30 (0=no visual-perceptual difficulties, 30=maximum visual-perceptual difficulties)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 8.62 |
"Cognitive Difficulties - Visual-Perceptual Ability will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.~Baseline: Mean visual-perceptual ability score for all individual patients in arm 1 (intervention)~5 weeks: Mean visual-perceptual ability score for all individual patients in arm 1 (intervention)~Range of visual-perceptual ability score 0-30 (0=no visual-perceptual difficulties, 30=maximum visual-perceptual difficulties)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) | |
---|---|---|
Baseline | week 5 timepoint | |
Arm 1 (Patients With Pain) | 10.79 | 10.33 |
"PainDETECT score will be assessed at baseline and 5 weeks for each individual patient using the PainDETECT questionnaire.~Baseline: Mean PainDETECT score for all individual patients in arm 1 (intervention)~5 weeks: Mean PainDETECT score for all individual patients in arm 1 (intervention)~Range of PainDETECT score -1-38 (-1=no neuropathic pain; 38=most consistent with neuropathic pain)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on questionnaire (Mean) | |
---|---|---|
Baseline | week 5 timepoint | |
Arm 1 (Patients With Pain) | 11.44 | 8.54 |
"Cognitive Difficulties - Language will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.~Baseline: Mean language score for all individual patients in arm 1 (intervention)~5 weeks: Mean language score for all individual patients in arm 1 (intervention)~Range of language score 0-40 (0=no language difficulties, 40=maximum language difficulties)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) | |
---|---|---|
Baseline | week 5 timepoint | |
Arm 1 (Patients With Pain) | 15.43 | 14.83 |
"Sleep Disturbance will be assessed at baseline and 5 weeks for each individual patient using the PROMIS Sleep Disturbance Short Form 8b v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.~Baseline: Mean sleep disturbance T score for all individual patients in arm 1 (intervention)~5 weeks: Mean sleep disturbance T score for all individual patients in arm 1 (intervention)~Average sleep disturbance T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=more sleep disturbance)" (NCT01912612)
Timeframe: 5 weeks
Intervention | T score (Mean) | |
---|---|---|
Baseline | week 5 timepoint | |
Arm 1 (Patients With Pain) | 57.44 | 53.85 |
"Sleep Disturbance will be assessed at baseline and 5 weeks for each individual patient using the PROMIS Sleep Disturbance Short Form 8b v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.~Baseline: Mean sleep disturbance T score for all individual patients in arm 1 (intervention)~5 weeks: Mean sleep disturbance T score for all individual patients in arm 1 (intervention)~Average sleep disturbance T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=more sleep disturbance)" (NCT01912612)
Timeframe: 5 weeks
Intervention | T score (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 43.91 |
"Physical Function will be assessed at baseline and 5 weeks for each individual patient using the PROMIS Physical Function Short Form 10a v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.~Baseline: Mean physical function T score for all individual patients in arm 1 (intervention)~5 weeks: Mean physical function T score for all individual patients in arm 1 (intervention)~Average physical function T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=better physical function)" (NCT01912612)
Timeframe: 5 weeks
Intervention | T score (Mean) | |
---|---|---|
Baseline | week 5 timepoint | |
Arm 1 (Patients With Pain) | 41.96 | 44.03 |
"Physical Function will be assessed at baseline and 5 weeks for each individual patient using the PROMIS Physical Function Short Form 10a v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.~Baseline: Mean physical function T score for all individual patients in arm 1 (intervention)~5 weeks: Mean physical function T score for all individual patients in arm 1 (intervention)~Average physical function T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=better physical function)" (NCT01912612)
Timeframe: 5 weeks
Intervention | T score (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 56.60 |
"Worst pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.~Baseline: Mean worst pain for all individual patients in arm 1 (intervention) and arm 2 (control)~5 weeks: Mean worst pain for all individual patients in arm 1 (intervention)~Range of pain score 0-10 (0=no pain; 10=worst pain)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) | |
---|---|---|
Baseline | 5 weeks | |
Arm 1 (Patients With Pain) | 6.54 | 4.06 |
"Worst pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.~Baseline: Mean worst pain for all individual patients in arm 1 (intervention) and arm 2 (control)~5 weeks: Mean worst pain for all individual patients in arm 1 (intervention)~Range of pain score 0-10 (0=no pain; 10=worst pain)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 0.25 |
"Average pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.~Baseline: Mean average pain for all individual patients in arm 1 (intervention) and arm 2 (control)~5 weeks: Mean average pain for all individual patients in arm 1 (intervention)~Range of pain score 0-10 (0=no pain; 10=worst pain)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) | |
---|---|---|
Baseline | 5 week timepoint | |
Arm 1 (Patients With Pain) | 4.86 | 3.10 |
"Average pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.~Baseline: Mean average pain for all individual patients in arm 1 (intervention) and arm 2 (control)~5 weeks: Mean average pain for all individual patients in arm 1 (intervention)~Range of pain score 0-10 (0=no pain; 10=worst pain)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 0.15 |
"PainDETECT score will be assessed at baseline and 5 weeks for each individual patient using the PainDETECT questionnaire.~Baseline: Mean PainDETECT score for all individual patients in arm 1 (intervention)~5 weeks: Mean PainDETECT score for all individual patients in arm 1 (intervention)~Range of PainDETECT score -1-38 (-1=no neuropathic pain; 38=most consistent with neuropathic pain)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on questionnaire (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 1.13 |
"Pain interference will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.~Baseline: Mean pain interference for all individual patients in arm 1 (intervention)~5 weeks: Mean pain interference for all individual patients in arm 1 (intervention)~Range of pain interference score 0-10 (0=no interference; 10=worst interference)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) | |
---|---|---|
Baseline | 5 week timepoint | |
Arm 1 (Patients With Pain) | 4.91 | 2.30 |
"Pain interference will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.~Baseline: Mean pain interference for all individual patients in arm 1 (intervention)~5 weeks: Mean pain interference for all individual patients in arm 1 (intervention)~Range of pain interference score 0-10 (0=no interference; 10=worst interference)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 0.03 |
"Pain sensitivity will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing to assess pressure pain threshold (Pain50).~Baseline: Mean Pain50 for all individual patients in arm 1 (intervention) and arm 2 (control)~5 weeks: Mean Pain50 for all individual patients in arm 1 (intervention)~Range of Pain50 score: 0-10 kg/cm2 (higher number reflects higher pain threshold or lower pain sensitivity)" (NCT01912612)
Timeframe: 5 weeks
Intervention | kg/cm2 (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 4.06 |
"Conditioned pain modulation (CPM) will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing~Baseline: Mean CPM for all individual patients in arm 1 (intervention) and arm 2 (control)~5 weeks: Mean CPM for all individual patients in arm 1 (intervention)~Range of CPM score: -60 to +60 (more positive values reflect more impaired CPM)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) | |
---|---|---|
Baseline | week 5 timepoint | |
Arm 1 (Patients With Pain) | 9.68 | 11.93 |
"Conditioned pain modulation (CPM) will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing~Baseline: Mean CPM for all individual patients in arm 1 (intervention) and arm 2 (control)~5 weeks: Mean CPM for all individual patients in arm 1 (intervention)~Range of CPM score: -60 to +60 (more positive values reflect more impaired CPM)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 7.97 |
"Number of sites of pain will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map.~Baseline: Mean number of sites of pain for all individual patients in arm 1 (intervention)~5 weeks: Mean number of sites of pain for all individual patients in arm 1 (intervention)~Range of number of sites of pain 0-35 (0=no pain; 35=every pre-defined body site has pain)" (NCT01912612)
Timeframe: 5 weeks
Intervention | number of sites (Mean) | |
---|---|---|
Baseline | 5 week timepoint | |
Arm 1 (Patients With Pain) | 9.63 | 7.90 |
"Cognitive Difficulties - Visual-Spatial Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.~Baseline: Mean visual-spatial memory score for all individual patients in arm 1 (intervention)~5 weeks: Mean visual-spatial memory score for all individual patients in arm 1 (intervention)~Range of visual-spatial memory score 0-40 (0=no visual-spatial memory difficulties, 40=maximum visual-spatial memory difficulties)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 13.03 |
"Number of sites of pain will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map.~Baseline: Mean number of sites of pain for all individual patients in arm 1 (intervention)~5 weeks: Mean number of sites of pain for all individual patients in arm 1 (intervention)~Range of number of sites of pain 0-35 (0=no pain; 35=every pre-defined body site has pain)" (NCT01912612)
Timeframe: 5 weeks
Intervention | number of sites (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 0.52 |
"Neuropathy will be assessed at baseline and 5 weeks for each individual patient using the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) questionnaire.~Baseline: Mean neuropathy score for all individual patients in arm 1 (intervention)~5 weeks: Mean neuropathy score for all individual patients in arm 1 (intervention)~Range of neuropathy score 0-44 (0=no neuropathy; 44=most consistent with neuropathy)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on questionnaire (Mean) | |
---|---|---|
Baseline | week 5 timepoint | |
Arm 1 (Patients With Pain) | 14.09 | 9.10 |
"Neuropathy will be assessed at baseline and 5 weeks for each individual patient using the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) questionnaire.~Baseline: Mean neuropathy score for all individual patients in arm 1 (intervention)~5 weeks: Mean neuropathy score for all individual patients in arm 1 (intervention)~Range of neuropathy score 0-44 (0=no neuropathy; 44=most consistent with neuropathy)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on questionnaire (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 1.44 |
"Fibromyalgia Symptom Severity Score will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map and Symptom Severity Scale.~Baseline: Mean Fibromyalgia Symptom Severity Score for all individual patients in arm 1 (intervention)~5 weeks: Mean Fibromyalgia Symptom Severity Score for all individual patients in arm 1 (intervention)~Range of Fibromyalgia Symptom Severity Score 0-12 (0=not consistent with fibromyalgia; 12=most consistent with fibromyalgia)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) | |
---|---|---|
Baseline | week 5 timepoint | |
Arm 1 (Patients With Pain) | 5.35 | 4.90 |
"Fibromyalgia Symptom Severity Score will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map and Symptom Severity Scale.~Baseline: Mean Fibromyalgia Symptom Severity Score for all individual patients in arm 1 (intervention)~5 weeks: Mean Fibromyalgia Symptom Severity Score for all individual patients in arm 1 (intervention)~Range of Fibromyalgia Symptom Severity Score 0-12 (0=not consistent with fibromyalgia; 12=most consistent with fibromyalgia)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 1.68 |
"Fatigue will be assessed at baseline and 5 weeks for each individual patient using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.~Baseline: Mean fatigue T score for all individual patients in arm 1 (intervention)~5 weeks: Mean fatigue T score for all individual patients in arm 1 (intervention)~Average fatigue T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=more fatigue)" (NCT01912612)
Timeframe: 5 weeks
Intervention | T score (Mean) | |
---|---|---|
Baseline | week 5 timepoint | |
Arm 1 (Patients With Pain) | 56.79 | 54.51 |
"Fatigue will be assessed at baseline and 5 weeks for each individual patient using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.~Baseline: Mean fatigue T score for all individual patients in arm 1 (intervention)~5 weeks: Mean fatigue T score for all individual patients in arm 1 (intervention)~Average fatigue T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=more fatigue)" (NCT01912612)
Timeframe: 5 weeks
Intervention | T score (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 45.63 |
"Depression will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale.~Baseline: Mean depression score for all individual patients in arm 1 (intervention)~5 weeks: Mean depression score for all individual patients in arm 1 (intervention)~Range of depression score 0-21 (0=no depression, 21=maximum depression)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) | |
---|---|---|
Baseline | week 5 timepoint | |
Arm 1 (Patients With Pain) | 5.85 | 4.23 |
"Depression will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale.~Baseline: Mean depression score for all individual patients in arm 1 (intervention)~5 weeks: Mean depression score for all individual patients in arm 1 (intervention)~Range of depression score 0-21 (0=no depression, 21=maximum depression)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 1.46 |
"Cognitive Difficulties - Visual-Spatial Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.~Baseline: Mean visual-spatial memory score for all individual patients in arm 1 (intervention)~5 weeks: Mean visual-spatial memory score for all individual patients in arm 1 (intervention)~Range of visual-spatial memory score 0-40 (0=no visual-spatial memory difficulties, 40=maximum visual-spatial memory difficulties)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) | |
---|---|---|
Baseline | week 5 timepoint | |
Arm 1 (Patients With Pain) | 14.43 | 14.53 |
"Anxiety will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale.~Baseline: Mean anxiety score for all individual patients in arm 1 (intervention)~5 weeks: Mean anxiety score for all individual patients in arm 1 (intervention)~Range of anxiety score 0-21 (0=no anxiety, 21=maximum anxiety)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) |
---|---|
Baseline | |
Arm 2 (Patients Without Pain -- Control) | 3.90 |
"Anxiety will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale.~Baseline: Mean anxiety score for all individual patients in arm 1 (intervention)~5 weeks: Mean anxiety score for all individual patients in arm 1 (intervention)~Range of anxiety score 0-21 (0=no anxiety, 21=maximum anxiety)" (NCT01912612)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) | |
---|---|---|
Baseline | week 4 timepoint | |
Arm 1 (Patients With Pain) | 6.97 | 5.03 |
Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) * 100. (NCT01914666)
Timeframe: Week 53
Intervention | participants (Number) |
---|---|
Naïve | 13 |
Rollover (Pre-Placebo) | 5 |
Rollover (Pre-Duloxetine 60 mg) | 6 |
BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. (NCT01914666)
Timeframe: Baseline, Week 50
Intervention | units on a scale (Mean) |
---|---|
Naïve | -1.81 |
Rollover (Pre-Placebo) | -1.83 |
Rollover (Pre-Duloxetine 60 mg) | -0.56 |
CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). (NCT01914666)
Timeframe: Baseline, Week 50
Intervention | units on a scale (Mean) |
---|---|
Naïve | 2.09 |
Rollover (Pre-Placebo) | 2.00 |
Rollover (Pre-Duloxetine 60 mg) | 2.73 |
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life. (NCT01914666)
Timeframe: Baseline, Week 50
Intervention | units on a scale (Mean) |
---|---|
Naïve | 0.16 |
Rollover (Pre-Placebo) | 0.15 |
Rollover (Pre-Duloxetine 60 mg) | 0.11 |
PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). (NCT01914666)
Timeframe: Week 50
Intervention | units on a scale (Mean) |
---|---|
Naïve | 2.12 |
Rollover (Pre-Placebo) | 2.05 |
Rollover (Pre-Duloxetine 60 mg) | 2.61 |
RMDQ-24 is a participant completed questionnaire and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant was instructed to put a mark next to each appropriate statement. The number of statements marked was summed by the clinician for a total score. The total score ranged from 0 (no disability) to 24 (severe disability). (NCT01914666)
Timeframe: Baseline, Week 50
Intervention | units on a scale (Mean) |
---|---|
Naïve | -3.69 |
Rollover (Pre-Placebo) | -5.50 |
Rollover (Pre-Duloxetine 60 mg) | -3.29 |
A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. (NCT01914666)
Timeframe: Week 53
Intervention | participants (Number) | |
---|---|---|
Drug Related AEs | Serious AEs | |
Naïve | 42 | 4 |
Rollover (Pre-Duloxetine 60 mg) | 18 | 1 |
Rollover (Pre-Placebo) | 16 | 3 |
"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation." (NCT01914666)
Timeframe: Baseline, Week 53
Intervention | participants (Number) | ||
---|---|---|---|
Suicidal Ideation- wish to be dead (n=65,39,40) | Nonspecific suicidal thoughts (n=67,42,41) | Suicidal Behavior (n=67,42,41) | |
Naïve | 0 | 0 | 0 |
Rollover (Pre-Duloxetine 60 mg) | 0 | 0 | 0 |
Rollover (Pre-Placebo) | 0 | 0 | 0 |
SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. (NCT01914666)
Timeframe: Baseline, Week 50
Intervention | units on a scale (Mean) | |||||||
---|---|---|---|---|---|---|---|---|
Physical Functioning | Role (Physical) | Bodily Pain | General Health | Vitality | Social Functioning | Role (Emotional) | Mental Health | |
Naïve | 10.60 | 16.88 | 17.64 | 8.42 | 10.07 | 6.90 | 11.57 | 5.97 |
Rollover (Pre-Duloxetine 60 mg) | 10.12 | 7.01 | 12.62 | 5.51 | 6.10 | 3.35 | 4.47 | 4.63 |
Rollover (Pre-Placebo) | 9.52 | 11.31 | 20.26 | 8.90 | 13.24 | 8.63 | 11.51 | 8.81 |
A self-reported scale measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. (NCT01914666)
Timeframe: Baseline, Week 50
Intervention | units on a scale (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Average Pain | Worst Pain | Least Pain | Pain Right Now | General Activity | Mood | Walking Ability | Normal Work | Relationship with People | Sleep | Enjoyment of Life | Average of 7 Interference Items | |
Naïve | -3.30 | -4.16 | -1.82 | -2.70 | -3.22 | -2.52 | -2.09 | -3.22 | -1.42 | -1.73 | -2.07 | -2.33 |
Rollover (Pre-Duloxetine 60 mg) | -2.88 | -3.24 | -2.12 | -2.68 | -2.24 | -2.07 | -1.71 | -2.05 | -0.83 | -1.34 | -1.83 | -1.72 |
Rollover (Pre-Placebo) | -3.79 | -4.71 | -2.52 | -3.93 | -3.26 | -3.12 | -2.74 | -3.21 | -1.79 | -2.40 | -2.50 | -2.72 |
"Change in amount of money earned between baseline and after 6 weeks of antidepressant treatment is determined through a summary score from a variety of decision-making tasks. Participants received between $5 and $40 per visit, depending on the outcomes of the decisions made on the computerized tasks. Variable payment ensured that the decision-making tasks were approached realistically, as opposed to using hypothetical points that do not have meaning in the real world. Greater earnings indicate better financial decision-making.~The specific tasks were:~risk task~balloon analogue risk task~temporal discounting task~ultimatum game~continuous performance task" (NCT01916824)
Timeframe: Baseline, Week 6
Intervention | US Dollars (Mean) | |
---|---|---|
Baseline Visit | After 6 Weeks of Treatment | |
Healthy Controls | 25.0 | 21.9 |
Participants With Major Depressive Disorder | 23.2 | 20.5 |
WOMAC consists of 24 items divided into 3 subscales:Pain(5 items):during walking,using stairs,in bed,sitting or lying,and standing Stiffness;(2 items):after first waking and later in the day Physical Function;(17 items):stair use,rising from sitting, standing, bending,walking,getting in/out of a car,shopping,putting on/taking off socks,rising from bed,lying in bed,getting in/out of bath,sitting,getting on/off toilet,heavy household duties,light household duties.Each question is answered using a 5-point Likert scale(0 to 4).Pain subscale has a range of scores of 0(none) to 20(extreme).Stiffness subscale has a range of scores of 0(none) to 8(extreme).Physical function subscale has a range of scores of 0(none) to 68(extreme).Total score ranges from 0(none) to 96(extreme).Least squares(LS) mean was calculated using analysis of covariance(ANCOVA) and adjusted for treatment, pooled investigator,and baseline score.Last observation carried forward (LOCF) method was be used for these analyses. (NCT01931475)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Total Score | Pain | Physical Function | Stiffness | |
60 mg Duloxetine | -13.58 | -3.03 | -9.64 | -0.83 |
Placebo | -10.09 | -2.32 | -7.28 | -0.44 |
Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10 (worst pain) to determine average pain in the past 24 hours (average pain). A 30% (or 50%) improvement was defined as a ≥30% (or ≥50%) reduction in BPI pain severity from baseline to endpoint. Percentage of participants = (number of participants with ≥30% or ≥50% pain reduction / total number of participants in treatment group) * 100.The last observation carried forward (LOCF) method will be used for these analyses. (NCT01931475)
Timeframe: Week 13
Intervention | percentage of participants (Number) | |
---|---|---|
Participants with >=30% Reductions | Participants with >=50% Reductions | |
60 mg Duloxetine | 63.40 | 42.80 |
Placebo | 49.70 | 34.50 |
BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction. (NCT01931475)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) |
---|---|
60 mg Duloxetine | -2.23 |
Placebo | -1.73 |
Evaluation on whether the change in BPI average pain intensity scores is a direct analgesic effect of duloxetine and is independent of treatment effect on mood, as measured by Hospital Anxiety and Depression Scale (HADS) depression subscale (HADS-D), or anxiety as measured by HADS anxiety subscale (HADS-A). Path analysis for the direct analgesic effect was used to test the null hypothesis that the change in BPI average pain severity depends on the improvement of HADS-D or HADS-A, versus the alternative that the improvement in BPI average pain severity is due to a direct analgesic effect of the treatment and not dependent upon the improvement in depression and anxiety symptoms. (NCT01931475)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Mean) | ||
---|---|---|---|
BPI average pain score | HADS-Depression subscale score | HADS-Anxiety subscale score | |
All Participants (60 mg Duloxetine & Placebo) | -1.91 | -0.10 | 0.05 |
CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction. (NCT01931475)
Timeframe: Baseline,13 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
60 mg Duloxetine | -0.81 |
Placebo | -0.53 |
PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction. (NCT01931475)
Timeframe: 13 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
60 mg Duloxetine | 2.73 |
Placebo | 3.09 |
BPI Interference Average Score is a self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people,sleep, and enjoyment of life.The average Interference scores ranged from 0 to 10. General activity, mood,walking ability, normal work,relations with other people, sleep and enjoyment of life is each is a self-reported scale that measures the interference of pain in the past 24 hours on general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life.The Interference scores ranged from 0 (does not interfere) to 10 (completely interferes).Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction. (NCT01931475)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) | |||||||
---|---|---|---|---|---|---|---|---|
BPI Interference Average Score | General activity | Mood | Walking ability | Normal work | Relations with other people | Sleep | Enjoyment of life | |
60 mg Duloxetine | -1.63 | -2.39 | -1.43 | -2.35 | -2.06 | -0.90 | -1.21 | -1.14 |
Placebo | -1.36 | -1.83 | -1.04 | -1.88 | -1.76 | -0.84 | -0.99 | -1.07 |
BPI Severity of Worst Pain is self-reported scale that measures the severity of pain based on the worst pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). BPI Severity of Least Pain is a self-reported scale that measures the severity of pain based on the least pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). BPI Severity of Right Now Pain is a self-reported scale that measures the severity of pain based on the pain right now. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction. (NCT01931475)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Least Squares Mean) | ||
---|---|---|---|
BPI Severity of Worst Pain | BPI Severity of Least Pain | BPI Severity of Right Now Pain | |
60 mg Duloxetine | -2.71 | -1.48 | -2.21 |
Placebo | -2.00 | -1.20 | -1.74 |
HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale [0 (low level of anxiety or depression) to 3 (high level of anxiety or depression)], giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale were considered to be a 'significant' case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Mean was calculated using analysis of covariance (ANCOVA) and adjusted for treatment, pooled investigator, and baseline score. The last observation carried forward (LOCF) method will be used for these analyses. (NCT01931475)
Timeframe: Baseline, Week 13
Intervention | units on a scale (Mean) | |
---|---|---|
Depression Subscale | Anxiety Subscale | |
60 mg Duloxetine | -0.10 | 0.02 |
Placebo | -0.10 | 0.08 |
"PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). Response to treatment is defined by endpoint PGI rating of either much better or very much better.The last observation carried forward (LOCF) method will be used for these analyses." (NCT01931475)
Timeframe: Week 13
Intervention | percentage of participants (Number) | |||||||
---|---|---|---|---|---|---|---|---|
Response to Treatment | 1=Very much better | 2=Much better | 3=A little better | 4=The same | 5=A little worse | 6=Much worse | 7 = Very much worse | |
60 mg Duloxetine | 38.7 | 3.10 | 35.60 | 40.70 | 19.10 | 1.50 | 0.00 | 0.00 |
Placebo | 20.4 | 2.60 | 17.90 | 51.00 | 23.00 | 3.60 | 2.00 | 0.00 |
Our primary aim included a primary outcome measure of self-reported pain/function, which was the change in SSS total score between baseline and 8 weeks. The Swiss Spinal Stenosis Questionnaire (SSS) is a validated 12-item condition-specific instrument for patients with lumbar spinal stenosis. It provides a patient self-report measure of pain and physical function. Higher scores represent worse symptoms and less physical function. The 12-item SSS total score range is 12-55. For our analysis, we compared the change in the 12-item Total score from baseline to 8 weeks. (NCT01943435)
Timeframe: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).
Intervention | units on a scale (Mean) |
---|---|
Medical Care | -2.0 |
Group Exercise | -1.7 |
Manual Therapy and Exercise | -4.1 |
Our secondary aim was to measure the change in physical activity between baseline and 8 weeks using the Sense Wear armband (SWA). The outcome measure was the average number of minutes spent daily performing physical activities >1.5 metabolic equivalents (METs).The SWA is a small device that collects information from multiple sensors: a triaxial accelerometer, heat flux, skin temperature, and galvanic signal. The information is integrated and processed by software using proprietary algorithms utilizing subjects' demographic characteristics (gender, age, height, and weight) to provide minute-by-minute estimates of physical activity. The SWA has shown good reliability and validity. The research participants in our study will wear the SWA for a week before and after they complete the treatment interventions. (NCT01943435)
Timeframe: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).
Intervention | minutes per day (Mean) |
---|---|
Medical Care | -23.1 |
Group Exercise | 4.3 |
Manual Therapy and Exercise | -6.0 |
Our primary aim also included a performance-based outcome measure, which was the distance walked during the SPWT. The analysis was a comparison of between-group changes in SPWT between baseline and 8 weeks. The Self-Paced Walking Test (SPWT) is a validated objective measure of a patient's walking capacity, which is performed on a level walking surface. The patient is instructed to walk at their own pace and to stop when the symptoms are troublesome enough that s/he needs to sit down to rest. The total time and total distance walked are measured by the research assistant. Our unit of measure was the total distance walked, expressed in meters. (NCT01943435)
Timeframe: Primary end-point was 8 weeks ( 2 weeks after 6 week intervention is completed).
Intervention | meters (Mean) |
---|---|
Medical Care | 130.5 |
Group Exercise | 219.2 |
Manual Therapy and Exercise | 267.8 |
"Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: Week 8
Intervention | score on a scale (Mean) |
---|---|
Frail | 77.9 |
Not/Intermediate Frail | 59.4 |
"Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: Month 6
Intervention | score on a scale (Mean) |
---|---|
Frail | 77.2 |
Not/Intermediate Frail | 58.0 |
"Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: Month 12
Intervention | score on a scale (Mean) |
---|---|
Frail | 80.9 |
Not/Intermediate Frail | 56.7 |
"Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: Baseline (Week 0)
Intervention | score on a scale (Mean) |
---|---|
Medication Treatment | 71.7 |
"Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: 12 Months
Intervention | score on a scale (Mean) |
---|---|
Medication Treatment | 67.8 |
"Assesses the level of functioning of patients, a component of the frailty evaluation. Simple: the scores assigned to each of the items - none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. This method is referred to as simple scoring because the scores from each of the items are simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. This approach is practical to use as a hand-scoring approach and may be the method of choice in busy clinical settings or in paper-pencil interview situations. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: Week 8
Intervention | score on a scale (Mean) |
---|---|
Medication Treatment | 68.7 |
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01973283)
Timeframe: Week 8
Intervention | score on a scale (Mean) |
---|---|
Medication Treatment | 13.3 |
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01973283)
Timeframe: 6 Months
Intervention | score on a scale (Mean) |
---|---|
Medication Treatment | 12.5 |
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01973283)
Timeframe: Baseline (Week 0)
Intervention | score on a scale (Mean) |
---|---|
Frail | 21 |
Not/Intermediate Frail | 19.7 |
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01973283)
Timeframe: Month 12
Intervention | score on a scale (Mean) |
---|---|
Frail | 14.3 |
Not/Intermediate Frail | 13.0 |
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01973283)
Timeframe: 12 Months
Intervention | score on a scale (Mean) |
---|---|
Medication Treatment | 13.6 |
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01973283)
Timeframe: Month 6
Intervention | score on a scale (Mean) |
---|---|
Frail | 14.8 |
Not/Intermediate Frail | 10.8 |
"Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: Baseline (Week 0)
Intervention | score on a scale (Mean) |
---|---|
Frail | 82.3 |
Not/Intermediate Frail | 56.8 |
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01973283)
Timeframe: Week 8
Intervention | score on a scale (Mean) |
---|---|
Frail | 15.1 |
Not/Intermediate Frail | 11.6 |
"Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: 6 Months
Intervention | score on a scale (Mean) |
---|---|
Medication Treatment | 66.7 |
Total daily opioid use (including PO, PCEA, IV, subcutaneous, IV push) in mg oral morphine equivalents on POD 1. (NCT02005601)
Timeframe: POD 1
Intervention | mg oral morphine equivalents (Mean) |
---|---|
Duloxetine | 57.8 |
Control | 72.7 |
When considering the pain in the knee in which you are having/had surgery, on a scale of 0-10, with 0 being no pain and 10 being pain as bad as you can imagine, how would you describe your level of pain in the last 24 hours during ambulation? (NCT02005601)
Timeframe: 2 weeks after surgery
Intervention | NRS pain score (Mean) |
---|---|
Duloxetine | 3.5 |
Control | 3.8 |
Nausea severity measured using Likert scale ranging from 0 (none) to 10 (severe). (NCT02005601)
Timeframe: POD 1
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 0.9 |
Control | 2.3 |
"HAMA scale consists of 14 items to measure the severity of anxiety symptoms. Each item ranges from 0 (not present) to 4 (very severe). The total score is calculated as the sum over all items, ranging from 0 to 56, with a higher score implying a worse outcome. Change from baseline to week 4 is reported. Reduction in the score over time is interpreted as improvement in the patient´s status.~Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine)." (NCT02229825)
Timeframe: At baseline and at week 4.
Intervention | Units on a score (Mean) |
---|---|
60 mg Duloxetine | -13.0 |
120 mg Duloxetine | -13.6 |
"HAMA scale consists of 14 items to measure the severity of anxiety symptoms. Each item ranges from 0 (not present) to 4 (very severe). The total score is calculated as the sum over all items, ranging from 0 to 56, with a higher score implying a worse outcome. Change from baseline to week 8 is reported. Reduction in the score over time is interpreted as improvement in the patient´s status.~Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups." (NCT02229825)
Timeframe: At baseline and at week 8.
Intervention | Score on a scale (Mean) |
---|---|
60 mg Duloxetine - Responder | -19.6 |
60 mg Duloxetine - Non-Responder | -12.1 |
120 mg Duloxetine - Responder | -21.0 |
120 mg Duloxetine - Non-Responder | -10.8 |
"Patient Global Impression of Improvement scale is a patient-rated instrument that measures the improvement of the patient's symptoms, ranging from 1 (very much better) to 7 (much worse). A higher score indicates a worse outcome.~Number of patients per score is reported. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).~At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre." (NCT02229825)
Timeframe: At week 1, 2, 3 and week 4.
Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 172510956 | Week 172510957 | Week 272510956 | Week 272510957 | Week 372510956 | Week 372510957 | Week 472510956 | Week 472510957 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Missing | A little better | No change | A little worse | Much worse | Very much worse | Very much better | Much better | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 45 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 26 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 62 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 83 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 40 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 47 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 22 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 20 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 63 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 56 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 56 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 73 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 17 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 35 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 34 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 62 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 49 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 50 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 19 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 43 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 49 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 66 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 64 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 38 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 37 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 1 |
"Clinical Global Impression (CGI) scale was developed as an independent, simple way for clinicians to make overall evaluations of a patients disease status. The CGI-I rates the total improvement with the following question:~Compared to the patients condition as admission, how much has he or she changed?. The CGI-I score ranges from 1 (very much improved) to 7 (very much worse). A higher score indicates a worse patient outcome.~Number of patients per score is reported. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups." (NCT02229825)
Timeframe: At week 6 and week 8.
Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 672510966 | Week 672510962 | Week 672510959 | Week 672510960 | Week 872510966 | Week 872510962 | Week 872510959 | Week 872510960 | |||||||||||||||||||||||||||||||||||||||||||||||||
Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | ||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 55 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 61 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxeting - Non-Responder | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 35 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 39 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 38 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxeting - Non-Responder | 27 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxeting - Non-Responder | 15 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxeting - Non-Responder | 13 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxeting - Non-Responder | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxeting - Non-Responder | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxeting - Non-Responder | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 64 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 71 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxeting - Non-Responder | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 25 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 36 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 30 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxeting - Non-Responder | 26 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxeting - Non-Responder | 14 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 0 |
"The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) scored from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome.~Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing.~Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine)." (NCT02229825)
Timeframe: At baseline and at Week 4.
Intervention | Units on a scale (Mean) |
---|---|
60 mg Duloxetine | -20.1 |
120 mg Duloxetine | -19.9 |
"Number of patients withdrawn due to adverse events.~Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine)." (NCT02229825)
Timeframe: From start of treatment until 3 days after end of treatment, up to 120 days.
Intervention | Participants (Count of Participants) |
---|---|
60 mg Duloxetine | 11 |
120 mg Duloxetine | 9 |
"Change from baseline in weight to week 4 and week 8.~Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine)." (NCT02229825)
Timeframe: At baseline, at week 4 and week 8.
Intervention | Kilogram (kg) (Mean) | |
---|---|---|
Change from baseline to week 4 | Change from baseline to week 8 | |
120 mg Duloxetine | 0.0 | 0.1 |
60 mg Duloxetine | 0.1 | 0.5 |
"Patient Global Impression of Improvement scale is a patient-rated instrument that measures the improvement of the patient's symptoms, ranging from 1 (very much better) to 7 (much worse). A higher score indicates a worse outcome.~Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups." (NCT02229825)
Timeframe: At week 6 and week 8.
Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 672510962 | Week 672510959 | Week 672510967 | Week 672510968 | Week 872510967 | Week 872510968 | Week 872510959 | Week 872510962 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Missing | Very much better | Much better | A little worse | Very much worse | A little better | No change | Much worse | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 48 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Responder | 61 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Non-Responder | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 37 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 33 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Responder | 34 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Non-Responder | 25 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Responder | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Non-Responder | 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Non-Responder | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Non-Responder | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Non-Responder | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 62 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 17 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Responder | 72 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Non-Responder | 17 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 26 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 25 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Responder | 27 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Non-Responder | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Responder | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Non-Responder | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Responder | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Non-Responder | 15 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Responder | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Non-Responder | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120mg Duloxetine - Responder | 0 |
"The MADRS total score is used to measure the severity of depression. It is based total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome.~Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing.~Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine)." (NCT02229825)
Timeframe: At baseline and at Week 1, 2 and Week 3.
Intervention | Units on a scale (Mean) | ||
---|---|---|---|
Change from baseline to Week 1 | Change from baseline to Week 2 | Change from baseline to Week 3 | |
120 mg Duloxetine | -7.6 | -13.5 | -16.9 |
60 mg Duloxetine | -8.3 | -14.7 | -18.1 |
"The Clinical Global Impressions scales of Severity of Illness (CGI-SI) were developed as an independent, simple way for clinicians to make overall evaluations of a patient's disease status. The CGI-SI assess the severity of illness, with the following question: Considering your total clinical experience with the particular population, how mentally ill is the patient at this time?.~The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). A higher score indicates a worse patient status.~Number of patients per score is reported. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.~At week 8, within-group comparison versus week 4 was performed for each post-week 4 treatment group using Mc Nemar test." (NCT02229825)
Timeframe: At week 6 and week 8.
Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 672510962 | Week 672510965 | Week 672510960 | Week 672510961 | Week 872510962 | Week 872510965 | Week 872510960 | Week 872510961 | |||||||||||||||||||||||||||||||||||||||||||||||||
Not at all ill | Borderline ill | Mildly ill | Moderately ill | Markedly ill | Severely ill | Most extremely ill | ||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 38 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloextine - Non-Responder | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 41 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Non-Responder | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 31 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloextine - Non-Responder | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 40 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Non-Responder | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 21 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloextine - Non-Responder | 32 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 21 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Non-Responder | 16 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloextine - Non-Responder | 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Non-Responder | 19 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloextine - Non-Responder | 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Non-Responder | 14 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloextine - Non-Responder | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Non-Responder | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 51 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloextine - Non-Responder | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 54 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Non-Responder | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 30 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloextine - Non-Responder | 23 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 39 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Non-Responder | 13 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine - Responder | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloextine - Non-Responder | 19 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Non-Responder | 15 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Responder | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Non-Responder | 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloextine - Non-Responder | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Non-Responder | 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloextine - Non-Responder | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine - Non-Responder | 7 |
"Clinical Global Impression (CGI) scales were developed as an independent, simple way for clinicians to make overall evaluations of a patient's disease status. The CGI-SI assess the severity of illness, with the following question: Considering your total clinical experience with the particular population, how mentally ill is the patient at this time?. The CGI-SI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). A higher score indicates a worse patient status.~Reported is the number of patients per score by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).~At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre." (NCT02229825)
Timeframe: At baseline and at week 1, 2, 3 and week 4.
Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline72510957 | Baseline72510956 | Week 172510957 | Week 172510956 | Week 272510956 | Week 272510957 | Week 372510956 | Week 372510957 | Week 472510956 | Week 472510957 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Not at all ill | Borderline ill | Mildly ill | Moderately ill | Markedly ill | Severely ill | Most extremely ill | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 30 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 93 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 87 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 40 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 51 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 20 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 62 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 64 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 68 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 16 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 22 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 45 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 48 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 53 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 61 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 33 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 39 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 17 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 30 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 29 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 48 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 56 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 41 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 49 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 27 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 22 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 28 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 35 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 46 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 34 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 50 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 47 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 33 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 17 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 1 |
"HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status.~Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups." (NCT02229825)
Timeframe: At baseline and at Week 6 and Week 8.
Intervention | Units on a scale (Mean) | |
---|---|---|
Change from baseline to week 6 | Change from baseline to week 8 | |
120 mg Duloxetine - Non-Responder | -5.5 | -6.7 |
120 mg Duloxetine - Responder | -11.8 | -12.5 |
60 mg Duloxetine - Non-Responder | -6.4 | -7.6 |
60 mg Duloxetine - Responder | -11.6 | -12.3 |
"Change from baseline in systolic and diastolic blood pressure (BP) to week 4 and week 8.~Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine)." (NCT02229825)
Timeframe: At baseline, at week 4 and week 8.
Intervention | Millimeters of mercury (mmHg) (Mean) | |||
---|---|---|---|---|
Systolic BP: Change from baseline to week 4. | Systolic BP: Change from baseline to week 8 | Diastolic BP: Change from baseline to week 4. | Diastolic BP: Change from baseline to week 8 | |
120 mg Duloxetine | 0.5 | 2.0 | 0.7 | 2.5 |
60 mg Duloxetine | 2.0 | 2.5 | 1.9 | 2.3 |
"The Reason for Living (RFL) questionnaire is a self-report instrument, to evaluate a variety of expectations and adaptive beliefs for living, if suicide is considered.~The RFL is thought to assess 6 domains of reasons for living: 1) survival and coping beliefs, 2) responsibility to family, 3) child related concerns, 4) fear of suicide, 5) fear of social disapproval, and 6) moral objections.~The RFL uses a 6-point rating scale, with the total score ranging from 1 not at all important and to 6 extremely important. A higher score indicates more reasons to live (i.e. better outcome).~Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine)." (NCT02229825)
Timeframe: At baseline.
Intervention | Score on a scale (Mean) |
---|---|
60 mg Duloxetine | 3.8 |
120 mg Duloxetine | 3.7 |
"The MADRS total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome.~Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing.~Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups." (NCT02229825)
Timeframe: At baseline and at Week 6 and Week 8.
Intervention | Units on a scale (Mean) | |
---|---|---|
Change from baseline to week 6 | Change from baseline to week 8 | |
120 mg Duloxetine - Non-responder | -14.8 | -17.2 |
120 mg Duloxetine - Responder | -28.1 | -29.5 |
60 mg Duloxetine - Non-responder | -16.1 | -19.0 |
60 mg Duloxetine - Responder | -28.3 | -29.8 |
"Percentage of patient 'responders', i.e. patients with at least a 50% improvement in MADRS scores from baseline.~The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome.~Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups." (NCT02229825)
Timeframe: At week 6 and week 8.
Intervention | Percentage of Participants (Number) | |
---|---|---|
Week 6 | Week 8 | |
120 mg Duloxetine - Non-Responder | 39.1 | 54.7 |
120 mg Duloxetine - Responder | 98.1 | 98.1 |
60 mg Duloxetine - Non-Responder | 52.9 | 65.7 |
60 mg Duloxetine - Responder | 94.8 | 93.8 |
"Number of patients with any adverse event occuring during on-treatment phase.~Results are reported for treatment regimen (60 mg duloxetine vs. 120 mg duloxetine)." (NCT02229825)
Timeframe: From start of treatment until 3 days after end of treatment, up to 120 days.
Intervention | Participants (Count of Participants) |
---|---|
60 mg Duloxetine | 97 |
120 mg Duloxetine | 89 |
"HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status.~Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine)." (NCT02229825)
Timeframe: At baseline and at Week 1, 2, 3 and Week 4.
Intervention | Units on a scale (Mean) | |||
---|---|---|---|---|
Change from baseline to week 1 | Change from baseline to week 2 | Change from baseline to week 3 | Change from baseline to week 4 | |
120 mg Duloxetine | -2.7 | -5.2 | -6.8 | -8.1 |
60 mg Duloxetine | -3.1 | -5.8 | -7.2 | -8.0 |
"Number of patients with concomitant medication for anxiety and sleep taken at different timepoints.~V1: Screening V2: Baseline V3: Week 1 V4: Week2 V5: Week 3 V6: Week 4 V7: Week 6 V8: Week 8.~Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine)." (NCT02229825)
Timeframe: 1 week prior to baseline and at baseline, week 1, 2, 3, 4, 5, 6, 7, 8 and week 10.
Intervention | Participants (Count of Participants) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Number of patients with medication taken before V1 | Number of patients with medication taken between V1 - V2 | Number of patients with medication taken between V2 - V3 | Patients with medication taken between V3 - V4 | Number of patients with medication taken between V4 - V5 | Number of patients with medication taken between V5 - V6 | Number of patients with medication taken between V6 - V7 | Number of patients with medication taken between V7 - V8 | Number of patients with medication taken after V8 (week 10) | Number of patients with medication not taken between two consecutive visits | |
120 mg Duloxetine | 59 | 88 | 89 | 84 | 67 | 58 | 49 | 52 | 10 | 8 |
60 mg Duloxetine | 65 | 93 | 95 | 80 | 62 | 55 | 47 | 51 | 18 | 8 |
Number of patients with potentially clinically significant abnormalities. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). (NCT02229825)
Timeframe: Up to week 8.
Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Haematocrit Decrease | Haenatocrit Increase | Red blood cell ct. Decrease | Red blood cell ct. Increase | MCV Decrease | MCV Increase | MCHC Decrease | MCHC Increase | White blood cell ct. Decrease | White blood cell ct. Increase | Platelets Decrease | Platelets Increase | Eosinophils Decrease | Eosinophils Increase | Basophils Decrease | Basophils Increase | Lymphocytes Decrease | Lymphocytes Increase | Monocytes Decrease | Monocytes Increase | Neut., bands (stabs) Decrease | Neut., bands (stabs) Increase | Sodium Decrease | Sodium Increase | Potassium Decrease | Potassium Increase | Calcium Decrease | Calcium Increase | Chloride Decrease | Chloride Increase | Phosphate Decrease | Phosphate Increase | Bicarbonate Decrease | Bicarbonate Increase | AST/GOT, SGOT Decrease | AST/GOT, SGOT Increase | ALT/GPT, SGPT Decrease | ALT/GPT, SGPT Increase | Alkaline phosphatase Decrease | Alkaline phosphatase Increase | GGT Decrease | GGT Increase | Creatine kinase Decrease | Creatine kinase Increase | |
120 mg Duloxetine | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 3 |
60 mg Duloxetine | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 3 | 0 | 0 | 0 | 2 | 0 | 6 |
"Remission is defined as a total Montgomery-Asberg Depression Rating Scale (MADRS) score of ≤ 12 at week 8.~The MADRS total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each and a total MADRS score ranging from 0 to 60.~Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups." (NCT02229825)
Timeframe: At week 8.
Intervention | Percentage of participants (Number) | |
---|---|---|
No | Yes | |
120 mg Duloxetine - Non-Responder | 71.9 | 28.1 |
120 mg Duloxetine - Responder | 11.3 | 88.7 |
60 mg Duloxetine - Non-Responder | 58.6 | 41.4 |
60 mg Duloxetine - Responder | 11.5 | 88.5 |
"Percentage of patient 'responders', i.e. patients with at least a 50% improvement in HAMD-6 scores from baseline.~HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status.~Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine)." (NCT02229825)
Timeframe: At week 1, 2, 3 and week 4.
Intervention | Percentage of Participants (Number) | |||
---|---|---|---|---|
Week 1 | Week 2 | Week 3 | Week 4 | |
120 mg Duloxetine | 10.0 | 26.5 | 44.1 | 58.2 |
60 mg Duloxetine | 12.0 | 32.5 | 42.8 | 55.4 |
"Percentage of patient 'responders', i.e. patients with at least a 50% improvement in MADRS scores from baseline.~The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome.~Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine)." (NCT02229825)
Timeframe: At week 1, 2, 3 and week 4.
Intervention | Percentage of Participants (Number) | |||
---|---|---|---|---|
Week 1 | Week 2 | Week 3 | Week 4 | |
120 mg Duloxetine | 8.2 | 31.2 | 46.5 | 64.1 |
60 mg Duloxetine | 14.5 | 33.7 | 50.0 | 59.0 |
"Percentage of patient 'responders', i.e. patients with at least a 50% improvement in HAMD-6 scores from baseline.~HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status.~Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups." (NCT02229825)
Timeframe: At week 6 and week 8.
Intervention | Percentage of participants (Number) | |
---|---|---|
Week 6 | Week 8 | |
120 mg Duloxetine - Non-Responder | 31.3 | 46.9 |
120 mg Duloxetine - Responder | 90.6 | 95.3 |
60 mg Duloxetine - Non-Responder | 47.1 | 60.0 |
60 mg Duloxetine - Responder | 90.6 | 92.7 |
"The Reason for Living (RFL) questionnaire is a self-report instrument, to evaluate a variety of expectations and adaptive beliefs for living, if suicide is considered.~The RFL is thought to assess 6 domains of reasons for living: 1) survival and coping beliefs, 2) responsibility to family, 3) child related concerns, 4) fear of suicide, 5) fear of social disapproval, and 6) moral objections.~The RFL uses a 6-point rating scale, with the total score ranging from 1 not at all important and to 6 extremely important. A higher score indicates more reasons to live (i.e. better outcome).~Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups." (NCT02229825)
Timeframe: At baseline and at week 8.
Intervention | Score on a scale (Mean) |
---|---|
60 mg Duloxetine - Responder | 0.7 |
60 mg Duloxetine - Non-Responder | 0.4 |
120 mg Duloxetine - Responder | 0.8 |
120 mg Duloxetine - Non-Responder | 0.1 |
"The Clinical Global Impression of Improvement (CGI-I) scale was developed as an independent, simple way for clinicians to make overall evaluations of a patients disease status. The CGI-I rates the total improvement with the following question:~Compared to the patients condition at admission, how much has he or she changed?. The scale ranges from 1 (very much improved) to 7 (very much worse). A higher score indicates a worse patient status.~Number of patients per score is reported. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).~At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre." (NCT02229825)
Timeframe: At week 1, 2, 3 and week 4.
Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 172510956 | Week 172510957 | Week 272510956 | Week 272510957 | Week 372510956 | Week 372510957 | Week 472510956 | Week 472510957 | |||||||||||||||||||||||||||||||||||||||||||||||||
Much improved | Minimally improved | No change | Much worse | Minimally worse | Very much worse | Very much improved | ||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 29 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 25 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 75 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 84 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 52 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 55 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 22 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 16 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 64 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 60 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 61 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 76 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 13 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 17 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 31 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 76 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 78 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 46 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 53 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 38 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 44 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 67 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 45 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
120 mg Duloxetine | 34 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
60 mg Duloxetine | 2 |
The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties. Each question was answered using a 5-point Likert scale (0 to 4). Physical Function Subscale has a range of scores of 0 (none) to 68 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates. (NCT02248480)
Timeframe: Baseline, 14 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -11.77 |
Placebo | -7.07 |
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the participant.The stiffness subscale had 2 questions on stiffness associated with time of day (morning versus later in the day). Each question was answered using a 5-point Likert scale (0 to 4). The stiffness subscale has a range of scores of 0 (none) to 8 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates. (NCT02248480)
Timeframe: Baseline, 14 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -1.66 |
Placebo | -0.98 |
CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates. (NCT02248480)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -1.71 |
Placebo | -1.22 |
A responder is required to meet at least one condition: reduction of ≥50% and ≥2 score in Weekly Mean of the 24-Hour Average Pain Score, reduction of ≥50% or ≥13.6 score in WOMAC (difficulty in dairy activity) and meet ≥2 out of following 3 conditions: reduction of ≥20% and ≥1 score in Weekly Mean of the 24-Hour Average Pain, reduction of ≥20% and ≥6.8 score in WOMAC (difficulty in dairy activity), PGAI score ≥2. (NCT02248480)
Timeframe: Baseline, Week 14
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 83.6 |
Placebo | 61.9 |
Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT02248480)
Timeframe: Baseline, Week 14
Intervention | percentage of participants (Number) | |
---|---|---|
>=30% | >=50% | |
Duloxetine | 72.3 | 55.4 |
Placebo | 52.8 | 38.6 |
Participants evaluated their experience with and details of falls which were recorded. (NCT02248480)
Timeframe: Baseline through Week 14
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 10.1 |
Placebo | 9.7 |
36-item Short-Form Health Survey: SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-15); social functioning (range: 2-10); bodily pain (range: 2-12); vitality (range: 4-20); mental health (range: 5-25). Each raw scale score was converted to a scale score ranging from 0-100 points, , with higher values representing a better outcome [(Raw score) - min{raw score}] / (max {raw score} - min{raw score}) x 100]. Least squares (LS) mean was calculated using Analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and baseline data as covariate. (NCT02248480)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) | |||||||
---|---|---|---|---|---|---|---|---|
Physical Functioning | Role (Physical) | Bodily Pain | General Health | Vitality | Social Functioning | Role (Emotional) | Mental Health | |
Duloxetine | 12.62 | 11.44 | 16.32 | 5.58 | 3.99 | 5.66 | 6.32 | 3.02 |
Placebo | 6.23 | 3.66 | 9.63 | 1.82 | 3.16 | 2.54 | 0.70 | 1.48 |
Patient's Global Impressions of Improvement Scale: PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and PGI-severity at baseline as covariates. (NCT02248480)
Timeframe: Baseline, 14 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 2.23 |
Placebo | 2.84 |
24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates. (NCT02248480)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Average Pain | Worst Pain | |
Duloxetine | -2.45 | -2.73 |
Placebo | -1.79 | -1.97 |
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates. (NCT02248480)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Worse Pain | Least Pain | Pain Right Now | General Activity | Walking Ability | Mood | Normal Work | Relationship to People | Sleep | Enjoyment of Life | Average of 7 Items | |
Duloxetine | -2.92 | -1.61 | -2.29 | -2.42 | -2.58 | -1.95 | -2.48 | -1.23 | -1.65 | -1.78 | -2.01 |
Placebo | -2.13 | -1.05 | -1.52 | -1.52 | -1.74 | -1.43 | -1.67 | -0.81 | -1.19 | -1.16 | -1.34 |
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument and was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1, with the higher score indicating a better health state perceived by the participant. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm. Least squares (LS) mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline data as covariate. (NCT02248480)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | 0.12 |
Placebo | 0.07 |
24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain within 24-hours. (NCT02248480)
Timeframe: Baseline,Week 14
Intervention | percentage of participants (Number) | |
---|---|---|
>=30% | >=50% | |
Duloxetine | 72.3 | 55.4 |
Placebo | 52.8 | 38.6 |
Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. Least squares (LS) mean was calculated using a ANCOVA approach' including administration groups as fixed effects, and baseline data as covariate. (NCT02248480)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -0.78 |
Placebo | -0.51 |
Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and BPI average pain severity at baseline as covariates. (NCT02248480)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -2.57 |
Placebo | -1.80 |
The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC total score was calculated for each participant at each time point for analysis as the mean total score, range 0 (none) -96 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates. (NCT02248480)
Timeframe: Baseline, Week 14
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -17.41 |
Placebo | -10.45 |
The WOMAC index (pain, stiffness, physical function subscales) was completed by the participant.The pain subscale had 5 questions on pain associated with every day tasks. Each question was answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates. (NCT02248480)
Timeframe: Baseline, 14 Weeks
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -3.99 |
Placebo | -2.43 |
"Higher scores for fatigue represents worse outcome (more fatigue). T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.~On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population." (NCT02260388)
Timeframe: 12 Weeks
Intervention | T-Score (Mean) |
---|---|
Nortriptyline | 53.6 |
Duloxetine | 55.4 |
Pregabalin | 56.7 |
Mexiletine | 51.6 |
"Higher scores for pain interference represents worse outcome (more pain interference) T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.~On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population." (NCT02260388)
Timeframe: 12 weeks
Intervention | T-Score (Mean) |
---|---|
Nortriptyline | 56.4 |
Duloxetine | 56.5 |
Pregabalin | 60.0 |
Mexiletine | 54.5 |
"Higher scores for sleep disturbance represents worse outcome (more sleep disturbance).~T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.~On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.~Higher scores equals more of the concept being measured" (NCT02260388)
Timeframe: 12 weeks
Intervention | T-Score (Mean) |
---|---|
Nortriptyline | 58.9 |
Duloxetine | 58.9 |
Pregabalin | 58.3 |
Mexiletine | 59.1 |
"SF-12v2® Health Survey Standard The Optum™ SF-12v2® Health Survey is a shorter version of the SF-36v2® Health Survey that uses just 12 questions to measure functional health and well-being from the patient's point of view.~Survey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.~Scores are calibrated so that 50 is the average score or norm, standard deviation = 10.~Higher scores indicate better health for both mental and physical component summary scores." (NCT02260388)
Timeframe: 12 weeks
Intervention | Norm-Based Standardization Score (Mean) | |
---|---|---|
Mental Component Score | Physical Component Score | |
Duloxetine | 50.9 | 42.1 |
Mexiletine | 51.3 | 43.7 |
Nortriptyline | 51.0 | 42.8 |
Pregabalin | 47.2 | 40.0 |
Participants reported the details of their falls. Percentage equals the number of participants with fall events / total in treatment group * 100. (NCT02335346)
Timeframe: Baseline through Week 50
Intervention | Percentage of Participants (Number) |
---|---|
Duloxetine | 23.7 |
36-item Short-Form Health Survey: SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-6); social functioning (range: 2-10); bodily pain (range: 2-11); vitality (range: 4-24); mental health (range: 5-30). (NCT02335346)
Timeframe: Baseline, Week 50
Intervention | units on a scale (Mean) | |||||||
---|---|---|---|---|---|---|---|---|
Physical Functioning | Role (Physical) | Bodily Pain | General Health | Vitality | Social Functioning | Role(Emotional) | Mental Health | |
Duloxetine | 15.27 | 11.90 | 21.32 | 10.89 | 9.61 | 6.45 | 8.78 | 4.89 |
A summary of drug related (considered by the investigator) AEs and SAEs is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy. (NCT02335346)
Timeframe: Baseline through Week 53
Intervention | Percentage of participants (Number) | |
---|---|---|
Drug-Related Adverse Event | Serious Adverse Event | |
Duloxetine | 51.6 | 7.5 |
Brief Pain Inventory Severity and Interference Scores: BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. (NCT02335346)
Timeframe: Baseline, Week 50
Intervention | units on a scale (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Worst Pain | Least Pain | Average Pain | Pain Right Now | General Activity | Mood | Walking Ability | Normal Work | Relationship People | Sleep | Enjoy of Life | Average of 7 items | |
Duloxetine | -4.29 | -2.16 | -3.33 | -2.94 | -3.03 | -2.48 | -3.11 | -3.10 | -1.43 | -1.81 | -1.92 | -2.41 |
CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). (NCT02335346)
Timeframe: Baseline, Week 50
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | -2.19 |
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument.The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm with scores ranging from -0.111 to 1.0. A higher score indicates better health state. (NCT02335346)
Timeframe: Baseline, Week 50
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 0.15 |
Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. (NCT02335346)
Timeframe: Baseline, Week 50
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | -1.14 |
The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC total score was calculated for each participant at each time point for analysis as the mean total score, range 0 (none) -96 millimeter (mm)(extreme). (NCT02335346)
Timeframe: Baseline, Week 50
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | -20.23 |
Patient Global Impressions of Improvement Scale: PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). (NCT02335346)
Timeframe: Week 50
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | 2.09 |
MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. (NCT02417064)
Timeframe: Baseline up to Day 28 of Double-blind Induction Phase
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | -19.0 |
Intranasal Esketamine 84 mg Plus Oral AD | -18.8 |
Oral AD Plus Intranasal Placebo | -14.8 |
"MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using Last Observation Carried Forward (LOCF) method and last post baseline observation during double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | -18.3 |
Intranasal Esketamine 84 mg Plus Oral AD | -17.4 |
Oral AD Plus Intranasal Placebo | -14.3 |
A participant was defined as having a clinical response if there was at least 50% improvement (decrease) from baseline in the MADRS total score with onset by Day 2 and Day 8 that was maintained to Day 28. Participants were allowed one excursion (non-response) on Days 8, 15 or 22, however score must show at least 25% improvement. Participants who did not meet these criteria or discontinued during the study before Day 28 were considered as non-responders and were assigned the value of 0 (that is no). MADRS is clinician-rated scale that consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), for total possible score of 0 to 60. Higher scores represent more severe condition. (NCT02417064)
Timeframe: Day 2 up to Day 28 and Day 8 up to Day 28
Intervention | Percentage of Participants (Number) | |
---|---|---|
Day 2 up to Day 28 | Day 8 up to Day 28 | |
Intranasal Esketamine 56 mg Plus Oral Antidepressant | 10.4 | 13.0 |
Intranasal Esketamine 84 mg Plus Oral AD | 8.8 | 11.4 |
Oral AD Plus Intranasal Placebo | 1.8 | 3.5 |
"A participant was defined as a responder (yes=1 and no=0) at a given time point if the percent reduction from baseline in MADRS total score is at least 50 percent (%). The percentage of participants who achieved at least 50% reduction from baseline were reported. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: At Day 28 (Double-blind Endpoint)
Intervention | Percentage of Participants (Number) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | 53.0 |
Intranasal Esketamine 84 mg Plus Oral AD | 47.8 |
Oral AD Plus Intranasal Placebo | 37.2 |
A participant was defined as a responder (yes=1 and no=0) at a given time point if the percent reduction from baseline in MADRS total score is at least 50 percent (%). The percentage of participants who achieved at least 50% reduction from baseline were reported. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. (NCT02417064)
Timeframe: At Day 28 of Double-blind Induction phase
Intervention | Percentage of Participants (Number) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | 54.1 |
Intranasal Esketamine 84 mg Plus Oral AD | 53.1 |
Oral AD Plus Intranasal Placebo | 38.9 |
PHQ-9 is 9-item, self-reported scale assessing 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria. Each item is rated on 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half days, 3 = Nearly every day). The scores are summed for a total score ranging from 0-27. Higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). The recall period is 2 weeks. (NCT02417064)
Timeframe: Baseline up to Day 28 of Double-blind Induction phase
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | -11.0 |
Intranasal Esketamine 84 mg Plus Oral AD | -11.7 |
Oral AD Plus Intranasal Placebo | -9.1 |
"Participants who had a MADRS total score of less than or equal to (<=) 12 were considered as remitters. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: At Day 28 (Double-blind Endpoint)
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | 34.8 |
Intranasal Esketamine 84 mg Plus Oral AD | 35.4 |
Oral AD Plus Intranasal Placebo | 29.2 |
"The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1) work/school, 2) social life, and 3) family life/home responsibilities using 0 (not at all) to 10 (extremely) rating scale. Score for first 3 items are summed to create total score of 0 (unimpaired) to 30 (highly impaired) where higher score indicates greater impairment. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | -10.7 |
Intranasal Esketamine 84 mg Plus Oral AD | -10.2 |
Oral AD Plus Intranasal Placebo | -8.1 |
"PHQ-9 is 9-item, self-reported scale assessing 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria. Each item is rated on 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half days, 3 = Nearly every day). The scores are summed for a total score ranging from 0-27. Higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). The recall period is 2 weeks. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | -10.9 |
Intranasal Esketamine 84 mg Plus Oral AD | -10.9 |
Oral AD Plus Intranasal Placebo | -8.9 |
"CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients (a decrease in score indicates improvement). Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)
Intervention | Units on a scale (Median) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | -2.0 |
Intranasal Esketamine 84 mg Plus Oral AD | -2.0 |
Oral AD Plus Intranasal Placebo | -1.0 |
Participants who had a MADRS total score of less than or equal to (<=) 12 were considered as remitters. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. (NCT02417064)
Timeframe: At Day 28 of Double-blind Induction Phase
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | 36 |
Intranasal Esketamine 84 mg Plus Oral AD | 38.8 |
Oral AD Plus Intranasal Placebo | 30.6 |
The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1) work/school, 2) social life, and 3) family life/home responsibilities using 0 (not at all) to 10 (extremely) rating scale. Score for first 3 items are summed to create total score of 0 (unimpaired) to 30 (highly impaired), where higher score indicates greater impairment. (NCT02417064)
Timeframe: Baseline up to Day 28 of Double-blind Induction phase
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | -11.0 |
Intranasal Esketamine 84 mg Plus Oral AD | -11.1 |
Oral AD Plus Intranasal Placebo | -8.4 |
EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02417064)
Timeframe: Baseline up to end of Double-blind induction phase (Day 28)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | 20.9 |
Intranasal Esketamine 84 mg Plus Oral AD | 19.1 |
Oral AD Plus Intranasal Placebo | 14.9 |
EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses are used to generate Health Status Index (HSI). HSI range is -0.148 to 0.949, is anchored at 0 (dead) and 1 (full health). (NCT02417064)
Timeframe: Baseline up to End of Double-blind Induction Phase (Day 28)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | 0.224 |
Intranasal Esketamine 84 mg Plus Oral AD | 0.243 |
Oral AD Plus Intranasal Placebo | 0.181 |
EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses are used to generate Health Status Index (HSI). HSI range is -0.148 to 0.949, is anchored at 0 (dead) and 1 (full health). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state. (NCT02417064)
Timeframe: Baseline up to end of Double-blind Induction phase (Day 28)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | -19.0 |
Intranasal Esketamine 84 mg Plus Oral AD | -19.4 |
Oral AD Plus Intranasal Placebo | -14.6 |
"GAD-7 is a brief and validated 7-item self-reported assessment of overall anxiety. Participants responded to each item using a 4 point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15-21). Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | -7.4 |
Intranasal Esketamine 84 mg Plus Oral AD | -7.7 |
Oral AD Plus Intranasal Placebo | -6.0 |
"NPSI questionnaire is a 12-item self-administered questionnaire that will be completed by the participant. It assesses 5 different dimensions of neuropathic pain on a scale of 0 (no symptom) to 10 (worst imaginable symptom): burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesias/dysesthesias. The NPSI includes 12 items: 10 descriptors of the different symptoms and 2 items for assessing the duration of spontaneous ongoing and paroxysmal pain. A total score can be calculated as the sum of the scores of the 10 descriptors with scale range: 0 (no pain) -100 (worst pain imaginable).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) with baseline, treatment, and duration of DPNP as fixed effects was used to produce LS mean." (NCT02417935)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Least Squares Mean) | |||||
---|---|---|---|---|---|---|
Total Score | Burning Pain | Pressing Pain | Paroxysmal Pain | Evoked Pain | Paresthesia/Dysesthesia | |
Duloxetine | -16.1 | -1.3 | -1.4 | -1.7 | -1.2 | -2.6 |
Pregabalin | -15.4 | -1.1 | -1.4 | -1.7 | -1.0 | -2.5 |
"11-point NRS measures the severity of pain over the previous 24 hours. Participants were asked to provide 24-hour average pain scores in the daily Participant diary and among these, the weekly mean of the 24-hour average pain score was calculated. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine).~Mixed Model Repeated Measures (MMRM) model with baseline value, Duration of diabetic peripheral neuropathic pain (DPNP), treatment, week, treatment-by-week interaction as fixed effects was used to produce Least Square Mean (LS Mean)." (NCT02417935)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Least Squares Mean) |
---|---|
Pregabalin | -2.358 |
Duloxetine | -2.286 |
11-point NRS measures the severity of pain over the previous 24 hours. Patients were asked to provide 24-hour average pain scores in the daily patient diary. scores range from 0 (no pain) to 10 (pain as bad as you can imagine) and among these, the weekly mean of the 24-hour average pain score was calculated based on daily score. (NCT02417935)
Timeframe: Week 12
Intervention | Participants (Count of Participants) | |
---|---|---|
30% Reduction | 50% Reduction | |
Duloxetine | 100 | 62 |
Pregabalin | 94 | 62 |
"Brief Pain Inventory Severity and Interference Scores: BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (pain as bad as you can imagine) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.~MMRM model with baseline, duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS mean." (NCT02417935)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Least Squares Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Worst Pain | Least Pain | Average Pain | Pain Right Now | General Activity | Mood | Walking Ability | Normal Work | Relations with Other People | Sleep | Enjoyment of Life | Average Interference | |
Duloxetine | -2.7 | -1.9 | -2.4 | -2.4 | -2.1 | -2.1 | -1.9 | -1.8 | -0.9 | -1.7 | -1.8 | -1.77 |
Pregabalin | -2.8 | -1.7 | -2.5 | -2.4 | -1.9 | -1.9 | -1.8 | -1.6 | -0.7 | -1.7 | -1.6 | -1.60 |
"PGI-I assessments was completed by the participant. The participant records how he/she perceives the degree of improvement (or worsening) at the time of assessment since taking treatment. The score ranges from 1 (very much better) to 7 (very much worse).~MMRM model with duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS Mean." (NCT02417935)
Timeframe: Week 12
Intervention | units on a scale (Least Squares Mean) |
---|---|
Pregabalin | 2.6 |
Duloxetine | 2.4 |
"CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse).~MMRM model with duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS Mean." (NCT02417935)
Timeframe: Week 12
Intervention | units on a scale (Least Squares Mean) |
---|---|
Pregabalin | 2.6 |
Duloxetine | 2.5 |
"The EQ-5D is a self-reported, 5-item scale used to assess the patient's health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale.These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm (range of the Index score is -0.111 - 1).A higher score indicates better health state.~ANCOVA model with LOCF with baseline value, treatment and duration of DPNP as fixed effects was used to produce LS mean." (NCT02417935)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Least Squares Mean) |
---|---|
Pregabalin | 0.1004 |
Duloxetine | 0.1144 |
"Night pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the night pain score was calculated based on the daily pain score.~MMRM model with baseline value, treatment, week, duration of DPNP and treatment-by-week interaction as fixed effects was used to produce LS mean." (NCT02417935)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Least Squares Mean) |
---|---|
Pregabalin | -2.166 |
Duloxetine | -2.160 |
"24-hour worst pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the worst pain score was calculated based on the daily score.~MMRM model with baseline value, duration of DPNP, treatment, week, treatment-by-week interaction as fixed effects was used to produce LS mean." (NCT02417935)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Least Squares Mean) |
---|---|
Pregabalin | -2.553 |
Duloxetine | -2.416 |
"Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.~MMRM model with baseline value, duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS mean." (NCT02417935)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Least Squares Mean) |
---|---|
Pregabalin | -2.5 |
Duloxetine | -2.3 |
"CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. CGI-S permits global evaluation of participant's condition at given time. The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase [Day 28])
Intervention | Units on a scale (Median) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -2.0 |
Intranasal Placebo Plus Oral AD | -2.0 |
Response defined as SDS total score <= 12 and individual item scores each <= 4. SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0(no impairment)-10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement. It also has one item on days lost from school or work and one item on days when under productive. (NCT02418585)
Timeframe: At Day 28 [end of Double-blind Induction Phase]
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | 57.0 |
Intranasal Placebo Plus Oral AD | 39.5 |
A participant was defined as having a clinical response if there is at least 50 percent (%) improvement from baseline in the MADRS total score with onset by Day 2 and Day 8 that was maintained to Day 28. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Participants who did not meet such criterion or discontinue during the study before Day 28 for any reason were considered as non-responders. (NCT02418585)
Timeframe: Day 2 up to Day 28 and Day 8 up to Day 28
Intervention | Percentage of participants (Number) | |
---|---|---|
Onset of Clinical response on Day 2 | Onset of Clinical response on Day 8 | |
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | 7.9 | 10.5 |
Intranasal Placebo Plus Oral AD | 4.6 | 6.4 |
"MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. The percentage of participants with greater than or equal to (>=) 50 % reduction from baseline in MADRS total score was reported. The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: At Endpoint (Double-blind Induction Phase [Day 28])
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | 63.4 |
Intranasal Placebo Plus Oral AD | 49.5 |
"Remission was defined as participants who had a MADRS total score of less than or equal to (=<) 12. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: At Endpoint (Double-blind Induction Phase [Day 28])
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | 48.2 |
Intranasal Placebo Plus Oral AD | 30.3 |
"The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0(no impairment)-10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement. It also has one item on days lost from school or work and one item on days when under productive. The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase [Day 28])
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -12.5 |
Intranasal Placebo Plus Oral AD | -9.3 |
The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0(no impairment)-10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement. It also has one item on days lost from school or work and one item on days when under productive. (NCT02418585)
Timeframe: Baseline up to Day 28 of Double-blind Induction phase
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -13.6 |
Intranasal Placebo Plus Oral AD | -9.4 |
"PHQ-9 is 9-item, self-report scale assessing depressive symptoms. Each item is rated on 4-point scale (0=Not at all, 1=Several Days, 2=More than half days, 3=Nearly every day). Scale scores each of 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria and it has been used both as screening tool and measure of response to treatment for depression. The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase [Day 28])
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -12.2 |
Intranasal Placebo Plus Oral AD | -10.1 |
PHQ-9 is 9-item, self-report scale assessing depressive symptoms. Each item is rated on 4-point scale (0=Not at all, 1=Several Days, 2=More than half days, 3=Nearly every day. Scale scores each of 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria and it has been used both as screening tool and measure of response to treatment for depression. The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). (NCT02418585)
Timeframe: Baseline up to Day 28 of Double-blind Induction phase
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -13.0 |
Intranasal Placebo Plus Oral AD | -10.2 |
EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02418585)
Timeframe: Baseline up to End of Double-blind Induction Phase (Day 28)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | 29.1 |
Intranasal Placebo Plus Oral AD | 20.9 |
Remission defined as SDS total score <= 6 and individual item scores each <= 2. SDS is a participant reported outcome measure and is a 5-item questionnaire which has been widely used and accepted for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items were summed to create a total score of 0-30 where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when under productive. (NCT02418585)
Timeframe: At Day 28 (End of Double-blind Induction Phase)
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | 39.5 |
Intranasal Placebo Plus Oral AD | 20.9 |
"MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase [Day 28])
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -19.6 |
Intranasal Placebo Plus Oral AD | -16.3 |
MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. (NCT02418585)
Timeframe: Baseline up to Day 28 of Double-blind Induction Phase
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -21.4 |
Intranasal Placebo Plus Oral AD | -17.0 |
"GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase [Day 28])
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -7.9 |
Intranasal Placebo Plus Oral AD | -6.8 |
"European Quality of Life Group-5 Dimension-5-Level (EQ-5D-5L) is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). Health Status Index range is -0.148 - 0.949, is anchored at 0 (dead) and 1 (full health)." (NCT02418585)
Timeframe: Baseline up to End of Double-blind Induction Phase (Day 28)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | 0.288 |
Intranasal Placebo Plus Oral AD | 0.231 |
"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). Health Status Index range is -0.148 - 0.949, is anchored at 0 (dead) and 1 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02418585)
Timeframe: Baseline up to End of Double-blind Induction Phase (Day 28)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -23.2 |
Intranasal Placebo Plus Oral AD | -17.1 |
EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02422186)
Timeframe: Baseline and Endpoint (Double-blind Induction Phase [Day 28])
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine Plus Oral Antidepressant (AD) | 6.2 |
Oral AD Plus Intranasal Placebo | 4.4 |
"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 (health state value equal to dead) and 0.949 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02422186)
Timeframe: Baseline and Endpoint (Double-blind Induction Phase [Day 28])
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine Plus Oral Antidepressant (AD) | -6.6 |
Oral AD Plus Intranasal Placebo | -1.6 |
"The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items (to evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel [interest level], pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0-60. Higher scores represent a more severe condition. Negative change in score indicates improvement. Missing data was imputed using Last Observation Carried Forward (LOCF) method and last post baseline observation during the double-blind induction phase was carried forward as the End Point for that phase." (NCT02422186)
Timeframe: Baseline and Endpoint (Double-blind Induction Phase [Day 28])
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine Plus Oral Antidepressant (AD) | -9.3 |
Oral AD Plus Intranasal Placebo | -5.6 |
The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items (to evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel [interest level], pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0-60. Higher scores represent a more severe condition. Negative change in score indicates improvement. (NCT02422186)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase[Day 28])
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine Plus Oral Antidepressant (AD) | -10.0 |
Oral AD Plus Intranasal Placebo | -6.3 |
"Remission was defined as participants who had a MADRS total score of less than or equal to (=<) 12. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using LOCF method and last post baseline observation during the double-blind induction phase was carried forward as the End Point for that phase." (NCT02422186)
Timeframe: At Endpoint-Double-blind Induction Phase [Day 28]
Intervention | Percentage of Participants (Number) |
---|---|
Intranasal Esketamine Plus Oral Antidepressant (AD) | 15.5 |
Oral AD Plus Intranasal Placebo | 6.3 |
"Percentage of participants with greater than or equal to (>=50) percent (%) reduction from baseline are reported. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using LOCF method and last post baseline observation during the double-blind induction phase was carried forward as the End Point for that phase." (NCT02422186)
Timeframe: At Endpoint-Double-blind Induction Phase [Day 28]
Intervention | Percentage of Participants (Number) |
---|---|
Intranasal Esketamine Plus Oral Antidepressant (AD) | 23.9 |
Oral AD Plus Intranasal Placebo | 12.5 |
"EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a health status index (HSI). HSI ranges from -0.148 (health state value equal to dead) and 0.949 (full health), is anchored at 0 (dead) and 1 (full health)." (NCT02422186)
Timeframe: Baseline and Endpoint (Double-blind Induction Phase [Day 28])
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine Plus Oral Antidepressant (AD) | 0.081 |
Oral AD Plus Intranasal Placebo | 0.026 |
"CGI-S provides an overall clinician-determined summary measure of the severity of the participants illness including participants history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participants ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Missing data was imputed using LOCF method and last post baseline observation during the double-blind induction phase was carried forward as the End Point for that phase." (NCT02422186)
Timeframe: Baseline and Endpoint (Double-blind Induction Phase [Day 28])
Intervention | Units on a scale (Median) |
---|---|
Intranasal Esketamine Plus Oral Antidepressant (AD) | -1.0 |
Oral AD Plus Intranasal Placebo | 0.0 |
The SDS is a participant-reported outcome measure and is a 5-item questionnaire used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1: work/school 2: social life 3: family life/home responsibilities using a 0-10 rating scale. It also has one item on days lost from school or work and one item on days when underproductive. The score for the first 3 items are summed to create a total score of 0-30 where a higher score indicates greater impairment. The recall period is 7 days. Scores <= 4 for each item and <= 12 for the total score are considered response. Scores <= 2 for each item and <= 6 for the total score are considered remission. The change from baseline in SDS total Score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 4.7 |
Oral AD+ Intranasal Placebo | 7.2 |
PHQ-9 is a 9-item, self-report scale assessing depressive symptoms. Each item is rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). The change from baseline in PHQ-9 total score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 1.7 |
Oral AD+ Intranasal Placebo | 4.7 |
PHQ-9 is a 9-item, self-report scale assessing depressive symptoms. Each item is rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). The change from baseline in PHQ-9 total score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 3.3 |
Oral AD+ Intranasal Placebo | 5.9 |
MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal - severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. The change from baseline in MADRS total score (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 4.4 |
Oral AD+ Intranasal Placebo | 11.4 |
MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal - severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. The change from baseline in MADRS total score (last observation carried forward [LOCF] data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 7.5 |
Oral AD+ Intranasal Placebo | 12.5 |
GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety. The change from baseline in GAD-7 total score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 1.4 |
Oral AD+ Intranasal Placebo | 2.6 |
GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety. The change from baseline in GAD-7 total score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 2.2 |
Oral AD+ Intranasal Placebo | 4.0 |
"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 3.0 |
Oral AD+ Intranasal Placebo | 8.4 |
"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from 0 (dead) to 1.00 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 7.5 |
Oral AD+ Intranasal Placebo | 10.9 |
"EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health)." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | -0.023 |
Oral AD+ Intranasal Placebo | -0.073 |
"EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health)." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | -0.067 |
Oral AD+ Intranasal Placebo | -0.096 |
EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | -1.3 |
Oral AD+ Intranasal Placebo | -13.8 |
EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | -10.4 |
Oral AD+ Intranasal Placebo | -16.1 |
CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The change from baseline in CGI-S score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Median) |
---|---|
Intranasal Esketamine + Oral AD | 0.0 |
Oral AD+ Intranasal Placebo | 1.0 |
CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The change from baseline in CGI-S score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Median) |
---|---|
Intranasal Esketamine + Oral AD | 0.0 |
Oral AD+ Intranasal Placebo | 1.0 |
Relapse is defined as any of following: Montgomery-asberg depression rating scale (MADRS) total score greater than or equal to (>=) 22 for 2 consecutive assessments separated by 5-15 days and/or hospitalization for worsening depression or any other clinically relevant event to be suggestive of a relapse of depressive illness such as suicide attempt/completed suicide/hospitalization for suicide prevention; If hospitalized, start date of hospitalization will be date of relapse, if not hospitalized date of event will be used. MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal-severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. Stable remission: MADRS total score less than or equal to (<=) 12 for at least 3 of last 4 weeks of OP phase, with 1 excursion total score greater than (>) 12 or one missing assessment at OP week 13 or 14. (NCT02493868)
Timeframe: Time from randomization to the first relapse during the maintenance phase (up to 92 Weeks)
Intervention | Days (Median) |
---|---|
Intranasal Esketamine + Oral AD | NA |
Oral AD+ Intranasal Placebo | 273.0 |
Relapse is defined as any of following: MADRS total score >= 22 for 2 consecutive assessments separated by 5-15 days and/or hospitalization for worsening depression or any other clinically relevant event to be suggestive of a relapse of depressive illness such as suicide attempt/completed suicide/hospitalization for suicide prevention; If hospitalized, start date of hospitalization will be date of relapse, if not hospitalized date of event will be used. MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal-severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. Stable response is defined as >= 50 percent (%) reduction in MADRS total score from baseline (Day 1 of induction phase, prior to first intranasal dose) in each of the last 2 weeks of the OP phase, but without meeting criteria for stable remission. (NCT02493868)
Timeframe: Time from randomization to the first relapse during the maintenance phase (up to 92 Weeks)
Intervention | Days (Median) |
---|---|
Intranasal Esketamine + Oral AD | 635.0 |
Oral AD+ Intranasal Placebo | 88.0 |
The SDS is a participant-reported outcome measure and is a 5-item questionnaire used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1: work/school 2: social life 3: family life/home responsibilities using a 0-10 rating scale. It also has one item on days lost from school or work and one item on days when underproductive. The score for the first 3 items are summed to create a total score of 0-30 where a higher score indicates greater impairment. The recall period is 7 days. Scores <= 4 for each item and <= 12 for the total score are considered response. Scores <= 2 for each item and <= 6 for the total score are considered remission. The change from baseline in SDS total Score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 2.2 |
Oral AD+ Intranasal Placebo | 6.8 |
"MADRS measure depression severity, detects changes due to AD treatment. It evaluates 10 items: apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.3 |
"MADRS measures depression severity, detects changes due to AD treatment. It consists 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe condition. Negative change in score indicates improvement. Missing data was imputed using last observation carried forward (LOCF) method, last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -16.4 |
"GAD-7 is brief, validated 7-item self-reported assessment of overall anxiety. Participant's responded to each item using a 4 point scale with response categories: 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield total score ranges from 0 to 21, higher scores indicate more anxiety. Negative change in score indicates improvement. Severity of GAD-7 is categorized as: None (0-4), Mild (5-9), Moderate (10-14), Severe (15 -21). Missing data was imputed using LOCF method, last post baseline observation during the phase was carried forward as Endpoint." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -5.9 |
"GAD-7 is brief and validated 7-item self-reported assessment of overall anxiety. Participants respond to each item using a 4 point scale with response categories: 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score ranges from 0 to 21, higher scores indicate more anxiety. Negative change in score indicates improvement. Severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14), Severe (15 -21). Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.2 |
"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -0.7 |
"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -15.3 |
EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 1.6 |
EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 17.0 |
"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health)." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -0.009 |
"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health)." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.190 |
"CGI-S measures severity of participant's illness that include knowledge of participant's history, psychosocial circumstances, symptoms, behavior, impact of symptoms on participant's ability to function. CGI-S evaluates severity of psychopathology on a scale range from 0 - 7, where 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as Endpoint." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Intervention | Units on a Scale (Median) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -2.0 |
"SDS was a participant-reported outcome measure and was a 5 item questionnaire used for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0 to 10 rating scale. The score for the first three items are summed to create a total score of 0 to 30 where a higher score indicates greater impairment and a negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -1.6 |
"SDS was a 5 item questionnaire used for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, (3) family life/home responsibilities using a 0 to 10 rating scale. Score for the first three items are summed to create a total score of 0 to 30, higher score indicates greater impairment and a negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND Phase)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -9.3 |
Hopkins Verbal Learning Test (HVLT) measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Intervention | Number correct (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 2.8 |
HVLT measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Intervention | Number of words (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.5 |
"PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. A higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Intervention | Unit on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -8.9 |
HVLT measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Intervention | Number of words recalled (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.3 |
HVLT measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Intervention | Number correct (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.8 |
This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. OCL test is a measure of visual episodic memory and visual recall test scored using arcsine transformation of the percentage of correct responses (CR). The range for OCL is 0 to 100 percent (%) accuracy; presented as an arcsin transformation, the range is 0 to 1.57. Higher score indicates better performance. Higher change from baseline indicates better performance. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Intervention | Arcsine ([sqrt] of proportion of [CR]) (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.0502 |
The ONB is a measure of working memory and scored for speed of correct response (mean of the log10-transformed reaction times for correct responses). Total score ranges from 2 to 3.54 log10 msec. Lower score indicates better performance. Higher change from baseline indicates better performance. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Intervention | log10 msec (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.0177 |
This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. IDN test is a measure of visual attention (choice reaction time) and scored for speed of response (mean of the log10 transformed reaction times for correct responses). Total score ranges from 2 to 3.3 log 10 msec. Lower score indicates better performance. Higher change from baseline indicates better performance. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Intervention | log10 msec (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -0.0083 |
This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. GMLT measures executive function; maze/sequencing test, scored for total number of errors. Total score ranges from 0 to 999 number of errors. Lower score indicates better performance. Higher change from baseline indicates better performance. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Intervention | Number of Errors (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 6.9 |
"The CADSS used to measure present-state dissociative symptoms, and to assess treatment-emergent dissociative symptoms. It comprises 23 subjective items divided into 3 components: depersonalization (with score range from 0 to 28), derealization (with score range from 0 to 52), and amnesia (with score range from 0 to 8). Participants responses are coded on a 5-point scale (0 = Not at all, 1 = Mild, 2 = Moderate, 3 = 'Severe and 4 = Extreme). The total score is sum of the 23 items and range from 0 to 92, where 0 (best) and 92 (worst). A higher score indicates a more severe condition." (NCT02497287)
Timeframe: Predose, up to 1.5 hours postdose (up to end of OP/MA phase [Week 52])
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 86.1 |
"The CADSS used to measure present-state dissociative symptoms, and to assess treatment-emergent dissociative symptoms. It comprises 23 subjective items divided into 3 components: depersonalization (with score range from 0 to 28), derealization (with score range from 0 to 52), and amnesia (with score range from 0 to 8). Participants responses are coded on a 5-point scale (0 = Not at all, 1 = Mild, 2 = Moderate, 3 = 'Severe and 4 = Extreme). The total score is sum of the 23 items and range from 0 to 92, where 0 (best) and 92 (worst). A higher score indicates a more severe condition." (NCT02497287)
Timeframe: Predose, up to 1.5 hours postdose (up to end of IND phase [Week 4])
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 92.0 |
An adverse event is any untoward medical occurrence in a clinical study participants who administered a medicinal (investigational or non-investigational) product and does not necessarily have a causal relationship with the treatment. A TEAE defined as an event that was new in onset or increased in severity following treatment initiation. (NCT02497287)
Timeframe: Up to End of Follow up Phase (Week 56)
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 90.1 |
"Percentage of participants with cystitis, urinary tract infections, renal and urinary tract symptoms, renal and urinary disorders were evaluated. Cystitis and urinary tract infections are selected MedDRA preferred terms, renal and urinary tract symptoms refers to any preferred term (PT) in the group of selected PTs; and renal and urinary disorders refers to a MedDRA System Organ Class (SOC)." (NCT02497287)
Timeframe: Up to End of Follow up Phase (Week 56)
Intervention | Percentage of participants (Number) | |||
---|---|---|---|---|
Cystitis | Urinary tract infections | Renal and urinary disorders | Renal and urinary tract symptoms | |
Intranasal Esketamine + Oral Antidepressant | 0.6 | 8.1 | 10.5 | 17.0 |
"Remission is defined as MADRS total score less than or equal to (<=) 12. MADRS measures depression severity, detects changes due to AD treatment. It consists 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe condition. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Days 8, 15, 22 and Endpoint (last post-baseline assessment value during 4 weeks of IND Phase)
Intervention | Percentage of participants (Number) | |||
---|---|---|---|---|
Day 8 | Day 15 | Day 22 | End point | |
Intranasal Esketamine + Oral Antidepressant | 7.3 | 15.6 | 27.2 | 47.2 |
"Remission is defined as PHQ-9 total score <= 4. PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. The scores are summed for a total score ranging from 0-27. A higher score indicates greater severity of depression. severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Day 15 and Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Intervention | Percentage of participants (Number) | |
---|---|---|
Day 15 | Endpoint | |
Intranasal Esketamine + Oral Antidepressant | 12.7 | 26.9 |
"Response is defined as greater than or equal to (>=) 50 % reduction from baseline in the MADRS total score. MADRS measures depression severity, detects changes due to AD treatment. It consists 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe condition. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Days 8, 15, 22 and Endpoint (last post-baseline assessment during 4 weeks of IND phase)
Intervention | Percentage of participants (Number) | |||
---|---|---|---|---|
Day 8 | Day 15 | Day 22 | End point | |
Intranasal Esketamine + Oral Antidepressant | 11.6 | 25.0 | 42.8 | 78.4 |
"Response is defined as >= 50 % reduction from baseline (IND phase) in PHQ-9 total score. PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. The scores are summed for a total score ranging from 0-27. A higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Day 15 and Endpoint (last post-baseline assessment value during 4 Week IND phase)
Intervention | Percentage of participants (Number) | |
---|---|---|
Day 15 | End point | |
Intranasal Esketamine + Oral Antidepressant | 37.2 | 62.0 |
Percentage of participants with treatment-emergent acute hypertension (Systolic Blood Pressure >=180 millimeters of mercury [mm Hg] or Diastolic Blood Pressure >= 110 mm Hg) during IND and OP/MA Phases were evaluated. (NCT02497287)
Timeframe: Up to End of OP/MA phase (Week 52)
Intervention | Percentage of participants (Number) | ||
---|---|---|---|
Systolic BP >=180 | Diastolic BP >=110 | Acute hypertension | |
Intranasal Esketamine + Oral Antidepressant | 2.2 | 2.4 | 4.1 |
This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. The DET is a measure of psychomotor function and uses a well-validated simple reaction time. In this outcome measure, speed of performance of participants (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Total score ranges from 2 to 3.3 log 10 milliseconds (msec). Lower score indicates better performance. Higher change from baseline indicates better performance. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of Optimization/Maintenance [OP/MA] Phase)
Intervention | log10 msec (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -0.0028 |
"The CGI-S measures the severity of the participant's illness that include knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7, where 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Intervention | Units on a Scale (Median) |
---|---|
Intranasal Esketamine + Oral Antidepressant | 0.0 |
"PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. A higher score indicates greater severity of depression. severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant | -0.2 |
At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. Self reported pain score range from 0 (no pain) to 10 (worst possible pain) 2, 6, 12, 24, 36 and 48 hours after surgery. Higher scores mean a worse score and low scores mean a better score. (NCT02535000)
Timeframe: up to 2 days.
Intervention | Number (pain score range 0 to 10). (Mean) | |||||
---|---|---|---|---|---|---|
Pain score 2 hours after surgery. | pain score 6 hours after surgery | Pain score 12 hours after surgery. | Pain score 24 hours after surgery. | Pain score 36 hours after surgery. | Pain score 48 hours after surgery. | |
Group C (Control) | 2.27 | 2.67 | 2.10 | 1.68 | 1.48 | 1.51 |
Group D (Duloxetine) | 2.14 | 2.28 | 2.07 | 1.66 | 1.37 | 1.07 |
The main evaluation parameter was the total consumption of fentanyl (in micrograms) self-administered by the patient and accessed at 24 and 48 hours after surgery. At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. The lower the consumption of fentanyl, the better the analgesic effect of duloxetine. (NCT02535000)
Timeframe: up to 2 days.
Intervention | micrograms (Mean) | |
---|---|---|
Fentanyl consumption in between 0 and 24 hours. | Fentanyl consumption in between 24 and 48 hours. | |
Group C (Control) | 726 | 180 |
Group D (Duloxetine) | 503 | 136 |
The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD. (NCT02655354)
Timeframe: Baseline, 3-month, 6-month, 12-month
Intervention | score on a scale (Mean) | ||
---|---|---|---|
Change from Baseline at 3 Months | Change from Baseline at 6 Months | Change from Baseline at 12 Months | |
Intervention | -1.65 | -4.02 | -5.51 |
Usual Care | 0.08 | -1.44 | -4.25 |
The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome. (NCT02655354)
Timeframe: Baseline, 3-month, 6-month, 12-month
Intervention | score on a scale (Mean) | ||
---|---|---|---|
Change from Baseline at 3 Months | Change from Baseline at 6 Months | Change from Baseline at 12 Months | |
Intervention | -16.78 | -14.17 | -13.23 |
Usual Care | -15.90 | -13.83 | -11.68 |
Satisfaction with mental health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied. (NCT02655354)
Timeframe: Baseline, 3 Month, 6 Month, 12 Month
Intervention | score on a scale (Mean) | |||
---|---|---|---|---|
Baseline | 3 Month | 6 Month | 12 Month | |
Intervention | 4.1 | 3.6 | 3.6 | 3.7 |
Usual Care | 4.0 | 3.5 | 3.4 | 3.5 |
Single items that assess marijuana use. Single item self-report dichotomized as none versus at least monthly use. (NCT02655354)
Timeframe: Baseline, 3-month, 6-month, 12-month
Intervention | Participants (Count of Participants) | |||
---|---|---|---|---|
Baseline | 3 Month | 6 Month | 12 Month | |
Intervention | 125 | 60 | 60 | 51 |
Usual Care | 177 | 72 | 82 | 79 |
Single items that assess non-prescribed opioid use. Single item self-report dichotomized as none versus at least monthly use. (NCT02655354)
Timeframe: Baseline, 3-month, 6-month, 12-month
Intervention | Participants (Count of Participants) | |||
---|---|---|---|---|
Baseline | 3 Month | 6 Month | 12 Month | |
Intervention | 18 | 4 | 4 | 6 |
Usual Care | 44 | 15 | 20 | 6 |
Single items that assess non-prescribed stimulant use. Single item self-report dichotomized as none versus at least monthly use. (NCT02655354)
Timeframe: Baseline, 3-month, 6-month, 12-month
Intervention | Participants (Count of Participants) | |||
---|---|---|---|---|
Baseline | 3 Month | 6 Month | 12 Month | |
Intervention | 58 | 9 | 7 | 8 |
Usual Care | 77 | 17 | 22 | 16 |
Item 9 of the Patient Health Questionnaire 9-item (PHQ-9) scale assesses suicidal ideation. It is scored from 0 to 3, with a score of 1 or greater indicating a patient has suicidal ideation. Participants with a PHQ-9 item 9 score of greater than or equal to 1 are reported for this outcome. (NCT02655354)
Timeframe: Baseline, 3-month, 6-month, 12-month
Intervention | Participants (Count of Participants) | |||
---|---|---|---|---|
Baseline | 3 Month | 6 Month | 12 Month | |
Intervention | 67 | 69 | 63 | 51 |
Usual Care | 90 | 99 | 106 | 92 |
The SF-36 assess quality of life domains that span emotional health, overall health status, and role function; a score of 100 indicates perfect health and a score of 0 indicates extremely poor health. (NCT02655354)
Timeframe: Baseline, 3-month, 6-month, 12-month
Intervention | score on a scale (Mean) | |||
---|---|---|---|---|
Baseline | 3 Month | 6 Month | 12 Month | |
Intervention | 44.3 | 38.3 | 38.4 | 39.2 |
Usual Care | 45.1 | 39.1 | 39.5 | 41.4 |
The investigators will use the National Study on the Costs and Outcomes of Trauma (NSCOT) Cognitive Screen, a 4 - Item Traumatic Brain Injury / Post-concussive Symptom Screen. The scoring of the scale ranges from a minimum of 4 to a maximum of 20, with lower scores indicating a worse outcome. (NCT02655354)
Timeframe: Baseline, 3-month, 6-month, 12-month
Intervention | score on a scale (Mean) | |||
---|---|---|---|---|
Baseline | 3 Month | 6 Month | 12 Month | |
Intervention | 13.5 | 13.3 | 13.2 | 13.8 |
Usual Care | 13.4 | 13.2 | 13.4 | 14.2 |
A brief measure scored on a 0 to 10 scale to assess a patient's pain, with a higher score indicating more severe pain; a score of 0 indicates no pain and a score of 10 indicates very severe pain. (NCT02655354)
Timeframe: Baseline, 3-month, 6-month, 12-month
Intervention | score on a scale (Mean) | |||
---|---|---|---|---|
Baseline | 3 Month | 6 Month | 12 Month | |
Intervention | 6.8 | 4.3 | 4.1 | 3.9 |
Usual Care | 6.7 | 4.7 | 4.5 | 3.8 |
The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome. (NCT02655354)
Timeframe: Baseline, 3-month, 6-month, 12-month
Intervention | score on a scale (Mean) | ||
---|---|---|---|
Change from Baseline at 3 Months | Change from Baseline at 6 Months | Change from Baseline at 12 Months | |
Intervention | -2.04 | -1.69 | -1.81 |
Usual Care | -1.90 | -1.63 | -1.45 |
The investigators will use the Patient Health Questionnaire 9-item Depression Scale (PHQ-9). The scoring of the scale ranges from a minimum of 0 to a maximum of 27, with higher scores indicating a worse outcome. (NCT02655354)
Timeframe: Baseline, 3-month, 6-month, 12-month
Intervention | score on a scale (Mean) | ||
---|---|---|---|
Change from Baseline at 3 Months | Change from Baseline at 6 Months | Change from Baseline at 12 Months | |
Intervention | -0.79 | -1.17 | -1.84 |
Usual Care | -0.50 | -0.90 | -2.16 |
Satisfaction with health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied. (NCT02655354)
Timeframe: Baseline, 3-month, 6-month, 12-month
Intervention | score on a scale (Mean) | |||
---|---|---|---|---|
Baseline | 3 Month | 6 Month | 12 Month | |
Intervention | 4.4 | 3.9 | 4.0 | 3.9 |
Usual Care | 4.4 | 3.8 | 3.8 | 3.8 |
"Gray matter density (GMD) of the prefrontal cortex region identified as placebo biomarker. Placebo responders/non-responders were identified based on the VAS score. A minimum of 20% decrease in VAS score was needed to be qualified as responders.~GMD is a value between 0 and 1 representing the intensity of every brain voxels. The GMD of the prefrontal cortex region represent the average GMD of every voxels in this region." (NCT02903238)
Timeframe: 2 weeks
Intervention | Gray Matter Density: 0 to 1 (Mean) |
---|---|
Placebo Responders | 0.420 |
Placebo Non-responders | 0.425 |
Osteoarthritis (OA) specific pain and quality of life index (the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC). The WOMAC score is from 0 to 96 where 0 represent no pain and quality of life impairment due to OA and 96 represent the worst pain and quality of life impairment due to OA. The outcome is reported as the percent change from baseline to end of treatment (2 weeks). (NCT02903238)
Timeframe: 2 weeks
Intervention | Percent Change in WOMAC score (Mean) |
---|---|
Placebo Responders | 38.6 |
Placebo Non-responders | 4.6 |
Prolactin level (ng/mL) at 10 weeks (NCT03038867)
Timeframe: 10 Weeks
Intervention | ng/mL (Mean) |
---|---|
Duloxetine | 8.83 |
Placebo | 11.6 |
Prolactin level (ng/mL) at 2 weeks (NCT03038867)
Timeframe: 2 weeks
Intervention | ng/dL (Mean) |
---|---|
Duloxetine | 9.74 |
Placebo | 11.3 |
Prolactin level (ng/mL) at 6 weeks (NCT03038867)
Timeframe: 6 weeks
Intervention | ng/mL (Mean) |
---|---|
Duloxetine | 10.3 |
Placebo | 9.60 |
Prolactin level (ng/mL) at 8 weeks (NCT03038867)
Timeframe: 8 weeks
Intervention | ng/mL (Mean) |
---|---|
Duloxetine | 10.1 |
Placebo | 8.98 |
Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks (NCT03038867)
Timeframe: 0 weeks
Intervention | Number of sperm/mL (Mean) |
---|---|
Duloxetine | 57.4 |
Placebo | 50.2 |
Sperm concentration (number of sperm/mL) in semen analysis at 10 weeks (NCT03038867)
Timeframe: 10 Weeks
Intervention | Number of sperm/mL (Mean) |
---|---|
Duloxetine | 42.0 |
Placebo | 42.7 |
Sperm concentration (number of sperm/mL) in semen analysis at 2 weeks (NCT03038867)
Timeframe: 2 weeks
Intervention | Number of sperm/mL (Mean) |
---|---|
Duloxetine | 48.9 |
Placebo | 50.0 |
Sperm concentration (number of sperm/mL) in semen analysis at 6 weeks (NCT03038867)
Timeframe: 6 weeks
Intervention | Number of sperm/mL (Mean) |
---|---|
Duloxetine | 44.6 |
Placebo | 43.9 |
Sperm concentration (number of sperm/mL) in semen analysis at 8 weeks (NCT03038867)
Timeframe: 8 weeks
Intervention | Number of sperm/mL (Mean) |
---|---|
Duloxetine | 45.7 |
Placebo | 47.1 |
Sperm head defects (mean number) at 0 weeks (NCT03038867)
Timeframe: 0 weeks
Intervention | defects (Mean) |
---|---|
Duloxetine | 88.4 |
Placebo | 89.9 |
Sperm head defects (mean number) at 10 weeks (NCT03038867)
Timeframe: 10 Weeks
Intervention | defects (Mean) |
---|---|
Duloxetine | 90.8 |
Placebo | 88.3 |
Sperm head defects (mean number) at 2 weeks (NCT03038867)
Timeframe: 2 weeks
Intervention | defects (Mean) |
---|---|
Duloxetine | 91.5 |
Placebo | 90.7 |
Sperm head defects (mean number) at 6 weeks (NCT03038867)
Timeframe: 6 weeks
Intervention | defects (Mean) |
---|---|
Duloxetine | 91.6 |
Placebo | 91.3 |
Sperm head defects (mean number) at 8 weeks (NCT03038867)
Timeframe: 8 weeks
Intervention | defects (Mean) |
---|---|
Duloxetine | 92.3 |
Placebo | 88.7 |
Sperm motility (mean percent) at 0 weeks (NCT03038867)
Timeframe: 0 weeks
Intervention | percent motility (Mean) |
---|---|
Duloxetine | 61.7 |
Placebo | 59.7 |
Sperm motility (mean percent) at 10 weeks (NCT03038867)
Timeframe: 10 Weeks
Intervention | percent motility (Mean) |
---|---|
Duloxetine | 54.4 |
Placebo | 53.9 |
Sperm motility (mean percent) at 2 weeks (NCT03038867)
Timeframe: 2 weeks
Intervention | percent motility (Mean) |
---|---|
Duloxetine | 54.3 |
Placebo | 55.2 |
Sperm motility (mean percent) at 6 weeks (NCT03038867)
Timeframe: 6 weeks
Intervention | percent motility (Mean) |
---|---|
Duloxetine | 57.2 |
Placebo | 50.4 |
Sperm motility (mean percent) at 8 weeks (NCT03038867)
Timeframe: 8 weeks
Intervention | percent motility (Mean) |
---|---|
Duloxetine | 51.1 |
Placebo | 58.5 |
Sperm neck defects (mean number) at 0 weeks (NCT03038867)
Timeframe: 0 weeks
Intervention | defects (Mean) |
---|---|
Duloxetine | 1.36 |
Placebo | 2.55 |
Sperm neck defects (mean number) at 10 weeks (NCT03038867)
Timeframe: 10 Weeks
Intervention | defects (Mean) |
---|---|
Duloxetine | 0.91 |
Placebo | 1.55 |
Sperm neck defects (mean number) at 2 weeks (NCT03038867)
Timeframe: 2 weeks
Intervention | defects (Mean) |
---|---|
Duloxetine | 2.65 |
Placebo | 1.00 |
Sperm neck defects (mean number) at 6 weeks (NCT03038867)
Timeframe: 6 weeks
Intervention | defects (Mean) |
---|---|
Duloxetine | 1.12 |
Placebo | 0.62 |
Sperm neck defects (mean number) at 8 weeks (NCT03038867)
Timeframe: 8 weeks
Intervention | defects (Mean) |
---|---|
Duloxetine | 1.17 |
Placebo | 0.50 |
Sperm tail defects (mean number) at 0 weeks (NCT03038867)
Timeframe: 0 weeks
Intervention | defects (Mean) |
---|---|
Duloxetine | 0.13 |
Placebo | 1.89 |
Sperm tail defects (mean number) at 10 weeks (NCT03038867)
Timeframe: 10 Weeks
Intervention | defects (Mean) |
---|---|
Duloxetine | 1.09 |
Placebo | 0.96 |
Sperm tail defects (mean number) at 2 weeks (NCT03038867)
Timeframe: 2 weeks
Intervention | defects (Mean) |
---|---|
Duloxetine | 0.00 |
Placebo | 1.66 |
Sperm tail defects (mean number) at 6 weeks (NCT03038867)
Timeframe: 6 weeks
Intervention | defects (Mean) |
---|---|
Duloxetine | 0.04 |
Placebo | 2.64 |
Sperm tail defects (mean number) at 8 weeks (NCT03038867)
Timeframe: 8 weeks
Intervention | defects (Mean) |
---|---|
Duloxetine | 0.35 |
Placebo | 1.25 |
Testosterone level (ng/dL) at 0 weeks (NCT03038867)
Timeframe: 0 weeks
Intervention | ng/dL (Mean) |
---|---|
Duloxetine | 464 |
Placebo | 448 |
Testosterone level (ng/dL) at 10 weeks (NCT03038867)
Timeframe: 10 Weeks
Intervention | ng/dL (Mean) |
---|---|
Duloxetine | 445 |
Placebo | 509 |
Testosterone level (ng/dL) at 2 weeks (NCT03038867)
Timeframe: 2 weeks
Intervention | ng/dL (Mean) |
---|---|
Duloxetine | 431 |
Placebo | 482 |
Testosterone level (ng/dL) at 6 weeks (NCT03038867)
Timeframe: 6 weeks
Intervention | ng/dL (Mean) |
---|---|
Duloxetine | 485 |
Placebo | 438 |
Testosterone level (ng/dL) at 8 weeks (NCT03038867)
Timeframe: 8 weeks
Intervention | ng/dL (Mean) |
---|---|
Duloxetine | 534 |
Placebo | 460 |
Estrogen level (pg/mL) at 0 weeks (NCT03038867)
Timeframe: 0 weeks
Intervention | pg/mL (Mean) |
---|---|
Duloxetine | 51.8 |
Placebo | 58.5 |
Luteinizing hormone level (mIU/mL) at 10 weeks (NCT03038867)
Timeframe: 10 Weeks
Intervention | mIU/mL (Mean) |
---|---|
Duloxetine | 4.98 |
Placebo | 3.78 |
Estrogen level (pg/mL) at 10 weeks (NCT03038867)
Timeframe: 10 Weeks
Intervention | pg/mL (Mean) |
---|---|
Duloxetine | 31.7 |
Placebo | 133 |
Estrogen level (pg/mL) at 2 weeks (NCT03038867)
Timeframe: 2 weeks
Intervention | pg/mL (Mean) |
---|---|
Duloxetine | 53.0 |
Placebo | 44.4 |
Estrogen level (pg/mL) at 6 weeks (NCT03038867)
Timeframe: 6 weeks
Intervention | pg/mL (Mean) |
---|---|
Duloxetine | 45.8 |
Placebo | 43.5 |
Estrogen level (pg/mL) at 8 weeks (NCT03038867)
Timeframe: 8 weeks
Intervention | pg/mL (Mean) |
---|---|
Duloxetine | 49.3 |
Placebo | 39.0 |
Follicle stimulating hormone level (mIU/mL) at 0 weeks (NCT03038867)
Timeframe: 0 weeks
Intervention | mIU/mL (Mean) |
---|---|
Duloxetine | 6.56 |
Placebo | 5.26 |
Follicle stimulating hormone level (mIU/mL) at 10 weeks (NCT03038867)
Timeframe: 10 Weeks
Intervention | mIU/mL (Mean) |
---|---|
Duloxetine | 5.54 |
Placebo | 5.95 |
Follicle stimulating hormone level (mIU/mL) at 2 weeks (NCT03038867)
Timeframe: 2 weeks
Intervention | mIU/mL (Mean) |
---|---|
Duloxetine | 5.56 |
Placebo | 5.30 |
Follicle stimulating hormone level (mIU/mL) at 6 weeks (NCT03038867)
Timeframe: 6 weeks
Intervention | mIU/mL (Mean) |
---|---|
Duloxetine | 4.57 |
Placebo | 5.14 |
Follicle stimulating hormone level (mIU/mL) at 8 weeks (NCT03038867)
Timeframe: 8 weeks
Intervention | mIU/mL (Mean) |
---|---|
Duloxetine | 4.18 |
Placebo | 5.29 |
Luteinizing hormone level (mIU/mL) at 0 weeks (NCT03038867)
Timeframe: 0 weeks
Intervention | mIU/mL (Mean) |
---|---|
Duloxetine | 4.11 |
Placebo | 3.37 |
Luteinizing hormone level (mIU/mL) at 2 weeks (NCT03038867)
Timeframe: 2 weeks
Intervention | mIU/mL (Mean) |
---|---|
Duloxetine | 4.00 |
Placebo | 3.57 |
Luteinizing hormone level (mIU/mL) at 6 weeks (NCT03038867)
Timeframe: 6 weeks
Intervention | mIU/mL (Mean) |
---|---|
Duloxetine | 4.51 |
Placebo | 3.42 |
Luteinizing hormone level (mIU/mL) at 8 weeks (NCT03038867)
Timeframe: 8 weeks
Intervention | mIU/mL (Mean) |
---|---|
Duloxetine | 4.18 |
Placebo | 3.70 |
Number of participants with Tunel Values > 25% at 0 Weeks (baseline) in each treatment group (NCT03038867)
Timeframe: 0 weeks
Intervention | Participants (Count of Participants) |
---|---|
Duloxetine | 0 |
Placebo | 0 |
Number of participants with Tunel values > 25% at 10 weeks in each treatment group (NCT03038867)
Timeframe: 10 Weeks
Intervention | Participants (Count of Participants) |
---|---|
Duloxetine | 0 |
Placebo | 2 |
Number of participants with Tunel values > 25% at 2 weeks in each treatment group (NCT03038867)
Timeframe: 2 weeks
Intervention | Participants (Count of Participants) |
---|---|
Duloxetine | 1 |
Placebo | 2 |
Number of participants with TUNEL values > 25% at 6 weeks in each treatment group (NCT03038867)
Timeframe: 6 Weeks (primary time point of interest)
Intervention | Participants (Count of Participants) |
---|---|
Duloxetine | 0 |
Placebo | 2 |
Number of participants with Tunel values > 25% at 8 weeks in each treatment group (NCT03038867)
Timeframe: 8 weeks
Intervention | Participants (Count of Participants) |
---|---|
Duloxetine | 1 |
Placebo | 0 |
Prolactin level (ng/mL) at 0 weeks (NCT03038867)
Timeframe: 0 weeks
Intervention | ng/mL (Mean) |
---|---|
Duloxetine | 11.9 |
Placebo | 12.4 |
Opioid use (measured in cumulative morphine equivalents) (NCT03271151)
Timeframe: Post-operative day 14
Intervention | Oral Morphine Equivalent (mg) (Mean) |
---|---|
"Duloxetine (Cymbalta)" | 288 |
Placebo | 432.5 |
Numerical Rating Score pain with movement. Minimum value of 0, maximum value of 10. Higher scores mean more pain and worse outcome. (NCT03271151)
Timeframe: Post-operative day 14
Intervention | score on a scale (NRS) (Mean) |
---|---|
"Duloxetine (Cymbalta)" | 4.2 |
Placebo | 4.8 |
2011 Survey Criteria for Fibromyalgia. Minimum value of 0, and maximum value of 12. A higher score means a worse outcome. (NCT03271151)
Timeframe: Day of surgery
Intervention | score on a scale (Median) |
---|---|
"Duloxetine (Cymbalta)" | 2 |
Placebo | 2 |
CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Presented here are the LS mean change from baseline on CGI-S calculated using a mixed-effects model repeated measures (MMRM) approach including treatment group, observation time-points, and interaction between treatment group and observation time-points as fixed effects, and baseline CGI-S and age as covariates. (NCT03315793)
Timeframe: Baseline, Week 6
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -1.24 |
Placebo | -1.38 |
Change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) total score. CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including treatment group, observation time-points, and interaction between treatment group and observation time-points as fixed effects, and baseline CDRS-R total score and age as covariates. (NCT03315793)
Timeframe: Baseline, Week 6
Intervention | units on a scale (Least Squares Mean) |
---|---|
Duloxetine | -21.03 |
Placebo | -22.42 |
The Children's Depression Rating Scale-Revised (CDRS-R) total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning with higher numbers indicating a greater degree of depression . The total sum of scores range from 17 to 113. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression. (NCT03315793)
Timeframe: Baseline, Week 6
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 21.6 |
Placebo | 21.6 |
The Children's Depression Rating Scale-Revised (CDRS-R) Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and higher numbers indicate a greater degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression. (NCT03315793)
Timeframe: Baseline, Week 6
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 48.6 |
Placebo | 43.2 |
The Children's Depression Rating Scale-Revised (CDRS-R) total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and higher numbers indicate a greater degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression. Remission was defined for the CDRS-R total score below 28. (NCT03315793)
Timeframe: Baseline, Week 6
Intervention | percentage of participants (Number) |
---|---|
Duloxetine | 9.5 |
Placebo | 13.5 |
Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale (range 0-7) that requires the clinician to rate the severity of the patient's illness at the time of assessment: range is from 0 (=normal, not at all ill) to 7 (=extremely ill, among the most extremely ill patients worsening) (NCT03321006)
Timeframe: 12 weeks
Intervention | score on a scale (Mean) |
---|---|
Antidepressant (AD) + Low Amplification (Sham) Hearing Aids | 3.17 |
Antidepressant (AD) + Full Amplification Hearing Aids | 3.20 |
The patient is rated by a clinician among 24 dimensions (24-item HRSD) with a score on a 3 or 5 point scale. Maximum score is a 74. 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression. (NCT03321006)
Timeframe: 12 weeks
Intervention | score on a scale (Mean) |
---|---|
Antidepressant (AD) + Low Amplification (Sham) Hearing Aids | 12.04 |
Antidepressant (AD) + Full Amplification Hearing Aids | 13.86 |
"The SAS-SR contains 54 questions that measure instrumental and expressive role performance over the past 2 weeks. Each question is rated on a 5-point scale. The overall adjustment score is obtained by summing the scores of all the items and dividing by the number of items answered.~The SAS-R overall score ranges from 0-270, with higher questions indication more impairment." (NCT03321006)
Timeframe: 12 weeks
Intervention | score on a scale (Mean) |
---|---|
Antidepressant (AD) + Low Amplification (Sham) Hearing Aids | 1.96 |
Antidepressant (AD) + Full Amplification Hearing Aids | 2.10 |
Children's Depression Rating Scale-Revised (CDRS-R) Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and higher numbers indicate a higher degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression. (NCT03395353)
Timeframe: Baseline, Week 50
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | -12.8 |
CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). (NCT03395353)
Timeframe: Baseline, Week 50
Intervention | units on a scale (Mean) |
---|---|
Duloxetine | -0.9 |
Trough concentrations of duloxetine are defined as the plasma concentrations in 18 - 30 hours post the previous dose. PK samples were obtained from each subject from Week 4 to the end of treatment period (Week 50) for analysis of steady state duloxetine concentrations. If duloxetine dose changed, PK samples were taken after 2 week or more administration of the new dose. Principally 1 or 2 blood samples were drawn from each subject at pre-dose for trough concentrations. (NCT03395353)
Timeframe: Week 4 through Week 50
Intervention | ng/mL (Mean) |
---|---|
Duloxetine 40 mg (9 to 11 Years Old) | 8.51 |
Duloxetine 40 mg (12 to 17 Years Old) | 18 |
Duloxetine 60 mg (9 to 11 Years Old) | 33.4 |
Duloxetine 60 mg (12 to 17 Years Old) | 39.5 |
A summary of AEs, ADRs (considered by the investigator) and SAEs is located in the Reported Adverse Events module. An AE was included if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it is consecutive from the preceding study at the initiation of study drug administration in this study. (NCT03395353)
Timeframe: Baseline through Week 53
Intervention | percentage of participants (Number) | ||
---|---|---|---|
Serious Adverse Event | Adverse Event including Serious Adverse Event | Drug-Related Adverse Event | |
Duloxetine | 2 | 89.3 | 73.3 |
The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement. (NCT03434041)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant (AD) | 16.7 |
Intranasal Placebo + Oral AD | 11.9 |
The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. (NCT03434041)
Timeframe: Baseline up to end of the double-blind treatment phase (Day 28)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant (AD) | -10.1 |
Intranasal Placebo + Oral AD | -8.1 |
"The GAD-7 is a brief and validated 7-item self-reported assessment of overall anxiety. Participants respond to each item using a 4 point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15-21). The last post-baseline observation during the double-blind phase was carried forward as the Endpoint." (NCT03434041)
Timeframe: Baseline up to Endpoint (double-blind treatment phase [Day 28])
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant (AD) | -4.3 |
Intranasal Placebo + Oral AD | -2.9 |
The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. (NCT03434041)
Timeframe: Baseline (Day 1: predose) to 24 hours post first dose (Day 2)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant (AD) | -8.0 |
Intranasal Placebo + Oral AD | -4.4 |
Percentage of participants in remission at the end of double-blind treatment phase (Day 28) were assessed. A participant was considered as a remitter if participant had a MADRS total score of less than or equal to [<=] 12 at a visit. MADRS scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. (NCT03434041)
Timeframe: Day 28
Intervention | Percentage of Participants (Number) |
---|---|
Intranasal Esketamine + Oral Antidepressant (AD) | 12.8 |
Intranasal Placebo + Oral AD | 10.4 |
The SDS is a subject-reported outcome measure that consists of a 5-item questionnaire which has been widely used and accepted for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items are summed to create a total score of 0-30, where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when underproductive. (NCT03434041)
Timeframe: Baseline up to end of the double-blind treatment phase (Day 28)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant (AD) | -6.3 |
Intranasal Placebo + Oral AD | -5.3 |
"The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems (Level 1 indicating no problem, Level 2 indicating slight problems, Level 3 indicating moderate problems, Level 4 indicating severe problems, and Level 5 indicating extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. Health Status Index ranges from -0.148 to 0.949, and is anchored at 0 (dead) and 1 (full health), a lower score indicates worse health." (NCT03434041)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant (AD) | 0.152 |
Intranasal Placebo + Oral AD | 0.103 |
The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The CGI-S permits a global evaluation of the participant's condition at a given time. Negative change in score indicates improvement. The last post-baseline observation during the double-blind phase was carried forward as Endpoint. (NCT03434041)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)
Intervention | Units on a Scale (Median) |
---|---|
Intranasal Esketamine + Oral Antidepressant (AD) | -1.0 |
Intranasal Placebo + Oral AD | -1.0 |
"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT03434041)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine + Oral Antidepressant (AD) | -13.4 |
Intranasal Placebo + Oral AD | -9.5 |
Onset of clinical response is defined as greater than or equal to (>=) 50 percent (%) improvement from baseline in MADRS total score with onset by Day 2 that was maintained through Day 28. The MADRS scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. (NCT03434041)
Timeframe: Day 2 up to Day 28
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine + Oral Antidepressant (AD) | 6.5 |
Intranasal Placebo + Oral AD | 1.6 |
Sustained remission is defined as the first occurrence of remission (MADRS Total score <=12) that was maintained through the Day 28 assessment with one excursion prior to Day 28. The MADRS scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. (NCT03434041)
Timeframe: Up to Day 28
Intervention | Percentage of Participants (Number) |
---|---|
Intranasal Esketamine + Oral Antidepressant (AD) | 5.6 |
Intranasal Placebo + Oral AD | 6.3 |
Percentage of responders at the end of double-blind treatment phase (Day 28) were assessed. A participant was defined as a responder at a given time point if the percent improvement from baseline in MADRS total score is at least 50%. The MADRS scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. (NCT03434041)
Timeframe: Day 28
Intervention | Percentage of Responders (Number) |
---|---|
Intranasal Esketamine + Oral Antidepressant (AD) | 19.3 |
Intranasal Placebo + Oral AD | 16.0 |
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeters (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sluggish/Fatigued/Lazy | Restless | Nervous/Anxious | Nauseated/Queasy/Sick to Stomach | Talkative/Friendly | Irregular/Racing Heartbeat | Euphoric | Shaky/Jittery | Active/Alert/Energetic | Will Pay For | Will Take Again | Performance Improved | Performance Impaired | Stimulated | Like Drug | Rush | High | Good Effects | Bad Effects | Any Effect | |
Active Comparator: Duloxetine | 0.00 | 0.50 | 0.00 | 0.00 | 13.75 | 4.25 | 16.00 | 0.00 | 27.99 | 20.50 | 25.25 | 12.00 | 0.25 | 23.50 | 26.25 | 16.00 | 20.50 | 23.00 | 0.25 | 24.50 |
Placebo Comparator: Placebo | 10.33 | 0.67 | 0.67 | 0.33 | 20.00 | 1.00 | 21.67 | 0.67 | 35.67 | 36.67 | 50.00 | 26.33 | 32.67 | 38.33 | 37.67 | 31.33 | 36.67 | 30.33 | 23.67 | 38.33 |
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeters (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sluggish/Fatigued/Lazy | Restless | Nervous/Anxious | Nauseated/Queasy/Sick to Stomach | Talkative/Friendly | Irregular/Racing Heartbeat | Euphoric | Shaky/Jittery | Active/Alert/Energetic | Will Pay For | Will Take Again | Performance Improved | Performance Impaired | Stimulated | Like Drug | Rush | High | Good Effects | Bad Effects | Any Effect | |
Active Comparator: Duloxetine | 0.00 | 1.00 | 0.00 | 0.00 | 11.00 | 3.75 | 11.75 | 2.00 | 23.00 | 18.00 | 23.75 | 9.50 | 0.00 | 17.25 | 23.75 | 10.75 | 15.75 | 20.25 | 0.00 | 20.75 |
Placebo Comparator: Placebo | 0.00 | 5.00 | 0.00 | 4.67 | 29.00 | 0.00 | 28.33 | 3.67 | 25.00 | 36.00 | 33.33 | 14.67 | 5.33 | 33.00 | 32.67 | 27.33 | 27.00 | 25.33 | 4.67 | 24.67 |
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeters (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sluggish/Fatigued/Lazy | Restless | Nervous/Anxious | Nauseated/Queasy/Sick to Stomach | Talkative/Friendly | Irregular/Racing Heartbeat | Euphoric | Shaky/Jittery | Active/Alert/Energetic | Will Pay For | Will Take Again | Performance Improved | Performance Impaired | Stimulated | Like Drug | Rush | High | Good Effects | Bad Effects | Any Effect | |
Active Comparator: Duloxetine | 5.50 | 1.00 | 0.00 | 0.25 | 13.75 | 1.25 | 9.75 | 0.00 | 20.25 | 17.00 | 17.25 | 11.25 | 2.25 | 9.50 | 15.00 | 4.50 | 10.25 | 9.25 | 2.50 | 11.50 |
Placebo Comparator: Placebo | 8.67 | 5.33 | 3.00 | 2.00 | 18.67 | 2.00 | 30.00 | 6.33 | 22.33 | 33.00 | 39.33 | 20.00 | 6.00 | 31.33 | 33.67 | 30.00 | 30.33 | 31.33 | 3.67 | 30.33 |
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeters (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sluggish/Fatigued/Lazy | Restless | Nervous/Anxious | Nauseated/Queasy/Sick to Stomach | Talkative/Friendly | Irregular/Racing Heartbeat | Euphoric | Shaky/Jittery | Active/Alert/Energetic | Will Pay For | Will Take Again | Performance Improved | Performance Impaired | Stimulated | Like Drug | Rush | High | Good Effects | Bad Effects | Any Effect | |
Active Comparator: Duloxetine | 0.50 | 0.50 | 0.00 | 0.00 | 13.75 | 0.00 | 13.00 | 0.00 | 16.25 | 18.50 | 21.75 | 13.00 | 0.00 | 11.75 | 14.00 | 3.00 | 14.25 | 9.75 | 0.25 | 14.75 |
Placebo Comparator: Placebo | 10.67 | 2.00 | 2.00 | 0.33 | 14.67 | 0.00 | 22.00 | 0.67 | 17.33 | 33.33 | 40.00 | 15.00 | 5.67 | 20.33 | 35.33 | 19.00 | 21.67 | 21.00 | 6.33 | 16.00 |
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeters (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sluggish/Fatigued/Lazy | Restless | Nervous/Anxious | Nauseated/Queasy/Sick to Stomach | Talkative/Friendly | Irregular/Racing Heartbeat | Euphoric | Shaky/Jittery | Active/Alert/Energetic | Will Pay For | Will Take Again | Performance Improved | Performance Impaired | Stimulated | Like Drug | Rush | High | Good Effects | Bad Effects | Any Effect | |
Active Comparator: Duloxetine | 0.00 | 1.00 | 0.00 | 0.00 | 12.50 | 2.25 | 18.25 | 0.00 | 25.50 | 22.25 | 23.50 | 11.50 | 0.00 | 14.25 | 15.00 | 8.25 | 12.00 | 13.75 | 0.00 | 16.00 |
Placebo Comparator: Placebo | 22.33 | 1.00 | 0.67 | 3.00 | 4.33 | 0.33 | 15.67 | 1.00 | 15.33 | 23.00 | 46.33 | 7.00 | 11.33 | 21.33 | 33.67 | 10.67 | 9.33 | 12.67 | 2.67 | 12.67 |
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeters (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sluggish/Fatigued/Lazy | Restless | Nervous/Anxious | Nauseated/Queasy/Sick to Stomach | Talkative/Friendly | Irregular/Racing Heartbeat | Euphoric | Shaky/Jittery | Active/Alert/Energetic | Will Pay For | Will Take Again | Performance Improved | Performance Impaired | Stimulated | Like Drug | Rush | High | Good Effects | Bad Effects | Any Effect | |
Active Comparator: Duloxetine | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.50 | 0.00 | 0.00 | 0.25 | 0.00 | 3.00 | 0.00 | 0.00 | 0.00 | 0.50 | 0.00 | 2.00 | 0.75 | 0.00 | 3.50 |
Placebo Comparator: Placebo | 0.00 | 0.00 | 0.00 | 0.00 | 12.33 | 0.00 | 15.33 | 0.00 | 14.00 | 32.33 | 31.00 | 9.00 | 14.33 | 24.00 | 29.67 | 13.33 | 12.00 | 13.67 | 3.00 | 15.33 |
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeters (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sluggish/Fatigued/Lazy | Restless | Nervous/Anxious | Nauseated/Queasy/Sick to Stomach | Talkative/Friendly | Irregular/Racing Heartbeat | Euphoric | Shaky/Jittery | Active/Alert/Energetic | Will Pay For | Will Take Again | Performance Improved | Performance Impaired | Stimulated | Like Drug | Rush | High | Good Effects | Bad Effects | Any Effect | |
Active Comparator: Duloxetine | 0.00 | 0.50 | 0.00 | 0.00 | 0.50 | 0.00 | 0.00 | 0.00 | 0.50 | 0.75 | 1.00 | 0.00 | 0.00 | 0.50 | 1.25 | 0.00 | 1.25 | 1.25 | 0.00 | 4.25 |
Placebo Comparator: Placebo | 0.00 | 0.00 | 0.00 | 0.00 | 8.00 | 0.67 | 7.00 | 0.67 | 10.33 | 17.33 | 23.00 | 6.67 | 7.67 | 17.33 | 16.33 | 8.00 | 10.67 | 8.33 | 6.33 | 7.00 |
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeters (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sluggish/Fatigued/Lazy | Restless | Nervous/Anxious | Nauseated/Queasy/Sick to Stomach | Talkative/Friendly | Irregular/Racing Heartbeat | Euphoric | Shaky/Jittery | Active/Alert/Energetic | Will Pay For | Will Take Again | Performance Improved | Performance Impaired | Stimulated | Like Drug | Rush | High | Good Effects | Bad Effects | Any Effect | |
Active Comparator: Duloxetine | 0.00 | 1.00 | 0.00 | 0.00 | 0.75 | 0.25 | 0.00 | 0.00 | 0.75 | 1.00 | 1.50 | 0.75 | 0.25 | 0.25 | 1.50 | 0.00 | 1.50 | 1.50 | 0.00 | 1.50 |
Placebo Comparator: Placebo | 3.00 | 1.33 | 1.67 | 1.67 | 4.00 | 1.67 | 4.00 | 3.00 | 3.33 | 8.00 | 11.67 | 2.67 | 2.33 | 4.67 | 7.67 | 4.67 | 4.33 | 4.00 | 2.67 | 3.67 |
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeters (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sluggish/Fatigued/Lazy | Restless | Nervous/Anxious | Nauseated/Queasy/Sick to Stomach | Talkative/Friendly | Irregular/Racing Heartbeat | Euphoric | Shaky/Jittery | Active/Alert/Energetic | Will Pay For | Will Take Again | Performance Improved | Performance Impaired | Stimulated | Like Drug | Rush | High | Good Effects | Bad Effects | Any Effect | |
Active Comparator: Duloxetine | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 1.50 | 0.25 | 1.50 | 0.00 | 0.00 | 2.25 | 0.00 | 0.25 | 0.00 | 0.25 | 0.00 | 1.25 |
Placebo Comparator: Placebo | 1.33 | 1.00 | 1.00 | 1.00 | 1.00 | 1.33 | 0.67 | 1.33 | 1.33 | 1.33 | 1.67 | 1.33 | 1.00 | 1.00 | 1.00 | 1.00 | 0.67 | 1.33 | 1.00 | 1.00 |
A 14-item Snaith-Hamilton-Pleasure Scale covers four domains of pleasure response (interest/pastimes, social interaction, sensory experience and food/drink) with higher scores representing less anhedonia. Scores range from 0 to 56 units: lower scores representing greater anhedonia. (NCT04178993)
Timeframe: 4 times over approximately 4.5 weeks
Intervention | Units on a Scale (Mean) | |||
---|---|---|---|---|
Methylphenidate (0 mg) | Methylphenidate (20 mg) | Methylphenidate (40 mg) | Methylphenidate (60 mg) | |
Active Comparator: Duloxetine (60 mg) | 51.25 | 52.75 | 54.00 | 53.00 |
Placebo Comparator: Placebo | 44.33 | 44.00 | 44.33 | 44.67 |
"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to work for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose)." (NCT04178993)
Timeframe: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
Intervention | Trials Completed (Mean) | ||
---|---|---|---|
Methamphetamine (0mg) | Methamphetamine (10mg) | Methamphetamine (20mg) | |
Active Comparator: Duloxetine | 0 | 5.00 | 10 |
Placebo Comparator: Placebo | 1.67 | 10 | 10 |
"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to work for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose)." (NCT04178993)
Timeframe: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
Intervention | Trials Completed (Mean) | ||
---|---|---|---|
Methamphetamine (0mg) | Methamphetamine (10mg) | Methamphetamine (20mg) | |
Active Comparator: Duloxetine (60 mg) | 2.50 | 7.00 | 9.75 |
Placebo Comparator: Placebo | 0 | 6.67 | 8.00 |
"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have ten opportunities (e.g., trials) to work for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose)." (NCT04178993)
Timeframe: Following at least 4 days of maintenance on placebo during inpatient admission, up to 1 week
Intervention | Trials Completed (Mean) | ||
---|---|---|---|
Methamphetamine (0mg) | Methamphetamine (10mg) | Methamphetamine (20mg) | |
Active Comparator: Duloxetine (60 mg) | 0 | 7.25 | 9.75 |
Placebo Comparator: Placebo | 0 | 3.33 | 10 |
"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to work for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose)." (NCT04178993)
Timeframe: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
Intervention | Trials Completed (Mean) | ||
---|---|---|---|
Methamphetamine (0mg) | Methamphetamine (10mg) | Methamphetamine (20mg) | |
Active Comparator: Duloxetine (60 mg) | 0 | 7.50 | 9.75 |
Placebo Comparator: Placebo | 2.33 | 3.33 | 10 |
Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Beats Per Minute (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 88.00 | 87.50 | 88.00 |
Placebo Comparator: Placebo | 87.33 | 83.67 | 99.67 |
Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Beats Per Minute (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 91.25 | 87.75 | 87.00 |
Placebo Comparator: Placebo | 85.00 | 89.67 | 87.67 |
Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Beats Per Minute (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 76.00 | 78.50 | 89.50 |
Placebo Comparator: Placebo | 83.67 | 84.33 | 85.67 |
Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Beats Per Minute (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 78.00 | 77.25 | 83.75 |
Placebo Comparator: Placebo | 77.67 | 87.33 | 81.33 |
Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeter of Mercury (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 82.25 | 82.25 | 84.25 |
Placebo Comparator: Placebo | 82.67 | 81.67 | 88.33 |
Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeter of Mercury (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 81.00 | 82.25 | 85.00 |
Placebo Comparator: Placebo | 78.00 | 84.67 | 84.67 |
Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeter of Mercury (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 74.50 | 83.25 | 85.00 |
Placebo Comparator: Placebo | 81.67 | 85.33 | 83.00 |
Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeter of Mercury (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 128.75 | 131.00 | 144.25 |
Placebo Comparator: Placebo | 132.67 | 133.00 | 132.67 |
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeters (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sluggish/Fatigued/Lazy | Restless | Nervous/Anxious | Nauseated/Queasy/Sick to Stomach | Talkative/Friendly | Irregular/Racing Heartbeat | Euphoric | Shaky/Jittery | Active/Alert/Energetic | Will Pay For | Will Take Again | Performance Improved | Performance Impaired | Stimulated | Like Drug | Rush | High | Good Effects | Bad Effects | Any Effect | |
Active Comparator: Duloxetine | 0.00 | 1.25 | 0.00 | 0.00 | 18.25 | 1.00 | 18.00 | 0.25 | 21.50 | 18.75 | 21.50 | 18.75 | 13.50 | 20.25 | 21.50 | 2.50 | 20.25 | 20.25 | 0.00 | 19.25 |
Placebo Comparator: Placebo | 6.67 | 0.00 | 0.33 | 0.00 | 29.33 | 30.67 | 32.33 | 2.00 | 37.33 | 34.00 | 37.67 | 22.00 | 10.33 | 36.00 | 36.33 | 35.67 | 37.00 | 39.00 | 9.67 | 38.00 |
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeters (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sluggish/Fatigued/Lazy | Restless | Nervous/Anxious | Nauseated/Queasy/Sick to Stomach | Talkative/Friendly | Irregular/Racing Heartbeat | Euphoric | Shaky/Jittery | Active/Alert/Energetic | Will Pay For | Will Take Again | Performance Improved | Performance Impaired | Stimulated | Like Drug | Rush | High | Good Effects | Bad Effects | Any Effect | |
Active Comparator: Duloxetine | 0.00 | 1.25 | 0.00 | 0.00 | 15.50 | 0.75 | 14.75 | 1.25 | 24.75 | 21.25 | 23.75 | 15.00 | 0.00 | 23.25 | 24.75 | 6.75 | 20.50 | 22.75 | 0.00 | 19.50 |
Placebo Comparator: Placebo | 1.33 | 0.33 | 0.00 | 0.00 | 25.33 | 2.33 | 33.00 | 7.00 | 28.00 | 38.00 | 41.67 | 12.33 | 5.33 | 31.67 | 34.33 | 29.00 | 28.00 | 35.00 | 12.00 | 33.67 |
Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeter of Mercury (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 78.50 | 83.75 | 86.25 |
Placebo Comparator: Placebo | 80.00 | 82.33 | 87.33 |
"Subjects will complete a delay discounting task in 4 sessions following 4 days of medication maintenance. Subjects are presented a series of hypothetical choices between a smaller sum of money offered now or a larger sum of money offered a later times in the future (e.g., 4 hours, a day, 3 weeks). The discounting rate, 'k', is calculated and log10-transformed. Greater values of log-transformed 'k' correspond with greater rates of discounting (i.e., preference for smaller reinforcer provided now rather than larger, delayed reinforcers [e.g., smaller sum of money given now as opposed to a larger sum given later]). The units for discounting rates are theoretical and not linked to a physical dimension (e.g., number of button presses) and the range is theoretically not bound (i.e., negative infinity to positive infinity)." (NCT04178993)
Timeframe: 4 sessions over approximately 4.5 weeks
Intervention | log(k) (Mean) | |||
---|---|---|---|---|
Methylphenidate (0mg) | Methylphenidate (20mg) | Methylphenidate (40mg) | Methylphenidate (60mg) | |
Active Comparator: Duloxetine (60 mg) | -1.29 | -1.37 | -1.15 | -1.04 |
Placebo Comparator: Placebo | -1.40 | -1.40 | -1.45 | -1.48 |
"Subjects will complete a delay discounting task in 4 sessions following 4 days of medication maintenance. Subjects are presented a series of hypothetical choices between a smaller amount of methamphetamine offered now or a larger amount of methamphetamine offered a later times in the future (e.g., 4 hours, a day, 3 weeks). The discounting rate, 'k', is calculated and log10-transformed. Greater values of log-transformed 'k' correspond with greater rates of discounting (i.e., preference for smaller reinforcer provided now rather than larger, delayed reinforcers [e.g., smaller amount of methamphetamine given now as opposed to a larger amount given later]). The units for discounting rates are theoretical and not linked to a physical dimension (e.g., number of button presses) and the range is theoretically not bound (i.e., negative infinity to positive infinity)." (NCT04178993)
Timeframe: 4 sessions over approximately 4.5 weeks
Intervention | log(k) (Mean) | |||
---|---|---|---|---|
Methylphenidate (0mg) | Methylphenidate (20mg) | Methylphenidate (40mg) | Methylphenidate (60mg) | |
Active Comparator: Duloxetine (60 mg) | -1.31 | -1.27 | -1.15 | -1.04 |
Placebo Comparator: Placebo | -1.40 | -1.04 | -1.45 | -1.17 |
"Subjects will complete an attentional bias task. The number of inhibitory failures (i.e., commission errors) to no-go targets following methamphetamine-related stimuli will be used to evaluate attentional bias (range 0 - 1: greater values represent greater number of errors committed). Commission errors are when you response (i.e., press the corresponding key on a computer) when you were instructed not to respond." (NCT04178993)
Timeframe: 12 sessions over approximately 4.5 weeks
Intervention | Proportion of Responses (Mean) | |||
---|---|---|---|---|
Methylphenidate (0mg) | Methylphenidate (20mg) | Methylphenidate (40mg) | Methylphenidate (60mg) | |
Active Comparator: Duloxetine (60 mg) | 0.08 | 0.13 | 0.11 | 0.12 |
Placebo Comparator: Placebo | 0.07 | 0.04 | 0.08 | 0.12 |
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeters (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sluggish/Fatigued/Lazy | Restless | Nervous/Anxious | Nauseated/Queasy/Sick to Stomach | Talkative/Friendly | Irregular/Racing Heartbeat | Euphoric | Shaky/Jittery | Active/Alert/Energetic | Will Pay For | Will Take Again | Performance Improved | Performance Impaired | Stimulated | Like Drug | Rush | High | Good Effects | Bad Effects | Any Effect | |
Active Comparator: Duloxetine | 0.00 | 1.00 | 0.00 | 0.50 | 14.50 | 3.50 | 14.25 | 0.00 | 24.50 | 17.25 | 24.75 | 14.50 | 0.25 | 19.75 | 18.75 | 12.75 | 16.50 | 14.25 | 0.00 | 13.75 |
Placebo Comparator: Placebo | 4.33 | 9.33 | 3.33 | 1.67 | 22.67 | 3.00 | 33.33 | 1.33 | 30.00 | 45.67 | 48.00 | 16.67 | 11.33 | 36.67 | 47.33 | 33.33 | 33.33 | 35.67 | 6.33 | 36.33 |
Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Degrees Fahrenheit (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 98.65 | 98.65 | 98.58 |
Placebo Comparator: Placebo | 98.37 | 98.43 | 98.47 |
Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Degrees Fahrenheit (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 98.60 | 98.65 | 98.55 |
Placebo Comparator: Placebo | 98.17 | 98.13 | 98.43 |
Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Degrees Fahrenheit (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 98.50 | 98.75 | 98.35 |
Placebo Comparator: Placebo | 98.37 | 98.10 | 98.27 |
Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Degrees Fahrenheit (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 98.45 | 98.48 | 98.48 |
Placebo Comparator: Placebo | 98.10 | 98.23 | 98.40 |
Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeter of Mercury (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 127.00 | 129.75 | 135.25 |
Placebo Comparator: Placebo | 139.00 | 138.67 | 139.67 |
Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeter of Mercury (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 129.75 | 132.25 | 139.25 |
Placebo Comparator: Placebo | 133.33 | 129.00 | 130.00 |
Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.
Intervention | Millimeter of Mercury (Mean) | ||
---|---|---|---|
Methamphetamine (0 mg) | Methamphetamine (10 mg) | Methamphetamine (20 mg) | |
Active Comparator: Duloxetine | 124.25 | 128.00 | 132.75 |
Placebo Comparator: Placebo | 129.67 | 131.67 | 130.33 |
"CGI-I response was defined as having a CGI-I score of very much improved or much improved. The CGI-I employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to IP. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. By definition, all CGI-I assessments are evaluated against baseline conditions. Higher scores indicated worse condition. Percentages were rounded off to the first decimal point." (NCT04476030)
Timeframe: Days 3 and 15
Intervention | percentage of participants (Number) | |
---|---|---|
Day 3 | Day 15 | |
Placebo + Assigned ADT | 12.9 | 54.3 |
SAGE-217 + Assigned ADT | 22.9 | 56.6 |
MADRS response was defined as having a 50% or greater reduction from baseline in MADRS total score. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS total score was calculated as the sum of the 10 individual item scores. Each item yields a score of 0 (no symptoms) to 6 (symptoms of maximum severity). The total MADRS score (sum of all individual items) ranges from 0 (symptoms absent) to 60 (severe depression). Higher MADRS scores indicated more severe depression. Percentages were rounded off to the first decimal point. (NCT04476030)
Timeframe: Day 15
Intervention | percentage of participants (Number) |
---|---|
Placebo + Assigned ADT | 48.2 |
SAGE-217 + Assigned ADT | 51.6 |
MADRS remission was defined as having a MADRS total score of ≤10. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS total score was calculated as the sum of the 10 individual item scores. Each item yields a score of 0 (no symptoms) to 6 (symptoms of maximum severity). The total MADRS score (sum of all individual items) ranges from 0 (symptoms absent) to 60 (severe depression). Higher MADRS scores indicated more severe depression. Percentages were rounded off to the first decimal point. (NCT04476030)
Timeframe: Day 15
Intervention | percentage of participants (Number) |
---|---|
Placebo + Assigned ADT | 28.4 |
SAGE-217 + Assigned ADT | 30.9 |
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. A negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. The data reported is summary of data collected and analyzed during double-blind treatment period at Baseline, Day 3, Day 8, Day 12, and Day 15 using equal weights for the scheduled visits. (NCT04476030)
Timeframe: Baseline through Day 15
Intervention | score on a scale (Least Squares Mean) |
---|---|
Placebo + Assigned ADT | -10.1 |
SAGE-217 + Assigned ADT | -11.7 |
The CGI-S uses a 7-point Likert scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. Considering total clinical experience, the investigator rated the participant on severity of mental illness at the time of rating as: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = extremely ill. A higher score indicated extreme illness. A negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. (NCT04476030)
Timeframe: Baseline and Day 15
Intervention | score on a scale (Least Squares Mean) |
---|---|
Active Comparator: Placebo + Assigned ADT | -1.7 |
Experimental: SAGE-217 + Assigned ADT | -1.9 |
Each of the 14 items in the HAM-A was defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints). The HAM-A total score was calculated as sum of the 14 individual item scores, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The total score (sum of all individual items) range from 0 to 56, where <17 indicated mild severity, 18 to 24 indicated mild to moderate severity, and 25 to 30 indicated moderate to severe severity. Higher scores indicated more severe disease. Negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. (NCT04476030)
Timeframe: Baseline, Day 15
Intervention | score on a scale (Least Squares Mean) |
---|---|
Placebo + Assigned ADT | -9.0 |
SAGE-217 + Assigned ADT | -9.5 |
The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS total score was calculated as the sum of the 10 individual item scores. Each item yields a score of 0 (no symptoms) to 6 (symptoms of maximum severity). The total MADRS score (sum of all individual items) ranges from 0 (symptoms absent) to 60 (severe depression). Higher MADRS scores indicated more severe depression. A negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. (NCT04476030)
Timeframe: Baseline and Day 15
Intervention | score on a scale (Least Squares Mean) |
---|---|
Placebo + Assigned ADT | -15.9 |
SAGE-217 + Assigned ADT | -17.2 |
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. A negative change from baseline indicated improvement. End of blinded treatment was defined as the average of change from baseline values of Days 12, 15 and 18. LS mean was estimated using MMRM analysis. (NCT04476030)
Timeframe: Baseline, End of blinded treatment assessment (i.e., average of Days 12, 15 , and 18)
Intervention | score on a scale (Least Squares Mean) |
---|---|
Placebo + Assigned ADT | -12.7 |
SAGE-217 + Assigned ADT | -13.2 |
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. A negative change from baseline indicated improvement. Least Squares (LS) mean was estimated using mixed effects model for repeated measures (MMRM) analysis. (NCT04476030)
Timeframe: Baseline, Day 3
Intervention | score on a scale (Least Squares Mean) |
---|---|
Placebo + Assigned ADT | -7.0 |
SAGE-217 + Assigned ADT | -8.9 |
HAM-D remission was defined as having a HAM-D total score of ≤7. The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. Percentages were rounded off to the first decimal point. (NCT04476030)
Timeframe: Days 15 and 42
Intervention | percentage of participants (Number) | |
---|---|---|
Day 15 | Day 42 | |
Placebo + Assigned ADT | 21.8 | 39.2 |
SAGE-217 + Assigned ADT | 29.1 | 37.9 |
HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. Percentages were rounded off to the first decimal point. (NCT04476030)
Timeframe: At Days 15 and 42
Intervention | percentage of participants (Number) | |
---|---|---|
Day 15 | Day 42 | |
Placebo + Assigned ADT | 49.2 | 65.3 |
SAGE-217 + Assigned ADT | 53.4 | 59.9 |
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE was defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. The severity was graded as mild, moderate and severe. (NCT04476030)
Timeframe: Up to approximately 58 weeks
Intervention | percentage of participants (Number) | ||
---|---|---|---|
Mild | Moderate | Severe | |
Placebo + Assigned ADT | 38.1 | 25.2 | 2.3 |
SAGE-217 + Assigned ADT | 35.8 | 34.4 | 3.8 |
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE was defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. (NCT04476030)
Timeframe: Up to approximately 58 weeks
Intervention | percentage of participants (Number) |
---|---|
Placebo + Assigned ADT | 65.6 |
SAGE-217 + Assigned ADT | 74.1 |
The PHQ-9 is a participant-rated depressive symptom severity scale. The PHQ-9 total score is calculated as the sum of the 9 individual item scores. For individual items, scoring is based on responses to specific questions, as follows: 0 = not at all; 1 = several days; 2 = more than half the days; and 3 = nearly every day. The PHQ-9 possible total score range is 0 to 27, with higher scores reflecting greater depressive symptoms, and is categorized as follows: 0 to 4 = minimal depression, 5 to 9 = mild depression, 10 to 14 = moderate depression, 15 to 19 = moderately severe depression, and 20 to 27 = severe depression. Negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. (NCT04476030)
Timeframe: Baseline and Day 15
Intervention | score on a scale (Least Squares Mean) |
---|---|
Placebo + Assigned ADT | -8.7 |
SAGE-217 + Assigned ADT | -8.9 |
HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. Time (in days) from first dose of study drug to time of first HAMD response was reported in this outcome measure. (NCT04476030)
Timeframe: From first dose of study drug up to first HAMD-17 response (up to approximately 65 days)
Intervention | days (Median) |
---|---|
Placebo + Assigned ADT | 15 |
SAGE-217 + Assigned ADT | 13 |
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. A negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. The missing values were imputed for the analysis. (NCT04476030)
Timeframe: Baseline, Days 15 and 42
Intervention | score on a scale (Least Squares Mean) | |
---|---|---|
Day 15 | Day 42 | |
Placebo + Assigned ADT | -12.9 | -14.9 |
SAGE-217 + Assigned ADT | -13.7 | -14.9 |
Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. The change in Hamilton Rating Score for Depression (HRSD) from baseline to week 8 was calculated as Week 8 HRSD - Baseline HRSD. (NCT04697693)
Timeframe: Baseline and Week 8
Intervention | score on a scale (Mean) |
---|---|
Treatment With Escitalopram or Duloxetine | 3 |
Substance | Relationship Strength | Studies | Trials | Classes | Roles |
---|---|---|---|---|---|
acetylcarnitine Acetylcarnitine: An acetic acid ester of CARNITINE that facilitates movement of ACETYL COA into the matrices of mammalian MITOCHONDRIA during the oxidation of FATTY ACIDS. | 3.99 | 1 | 1 | O-acylcarnitine | human metabolite |
gamma-aminobutyric acid gamma-Aminobutyric Acid: The most common inhibitory neurotransmitter in the central nervous system.. gamma-aminobutyric acid : A gamma-amino acid that is butanoic acid with the amino substituent located at C-4. | 18 | 115 | 15 | amino acid zwitterion; gamma-amino acid; monocarboxylic acid | human metabolite; neurotransmitter; Saccharomyces cerevisiae metabolite; signalling molecule |
5-hydroxytryptophan 5-Hydroxytryptophan: The immediate precursor in the biosynthesis of SEROTONIN from tryptophan. It is used as an antiepileptic and antidepressant.. 5-hydroxytryptophan : A tryptophan derivative that is tryptophan substituted by a hydroxy group at position 5. | 3.84 | 3 | 0 | hydroxytryptophan | human metabolite; neurotransmitter |
acetic acid Acetic Acid: Product of the oxidation of ethanol and of the destructive distillation of wood. It is used locally, occasionally internally, as a counterirritant and also as a reagent. (Stedman, 26th ed). acetic acid : A simple monocarboxylic acid containing two carbons. | 3.13 | 5 | 0 | monocarboxylic acid | antimicrobial food preservative; Daphnia magna metabolite; food acidity regulator; protic solvent |
acetone methyl ketone : A ketone of formula RC(=O)CH3 (R =/= H). | 2.06 | 1 | 0 | ketone body; methyl ketone; propanones; volatile organic compound | EC 3.5.1.4 (amidase) inhibitor; human metabolite; polar aprotic solvent |
anthranilic acid anthranilic acid: RN given refers to parent cpd; structure in Negwer, 5th ed, #565. anthranilic acid : An aminobenzoic acid that is benzoic acid having a single amino substituent located at position 2. It is a metabolite produced in L-tryptophan-kynurenine pathway in the central nervous system. | 2.15 | 1 | 0 | aminobenzoic acid | human metabolite; mouse metabolite |
carbamates [no description available] | 3.13 | 1 | 0 | amino-acid anion | |
carnitine [no description available] | 3.27 | 1 | 0 | amino-acid betaine | human metabolite; mouse metabolite |
methane Methane: The simplest saturated hydrocarbon. It is a colorless, flammable gas, slightly soluble in water. It is one of the chief constituents of natural gas and is formed in the decomposition of organic matter. (Grant & Hackh's Chemical Dictionary, 5th ed). methane : A one-carbon compound in which the carbon is attached by single bonds to four hydrogen atoms. It is a colourless, odourless, non-toxic but flammable gas (b.p. -161degreeC). | 2.41 | 1 | 0 | alkane; gas molecular entity; mononuclear parent hydride; one-carbon compound | bacterial metabolite; fossil fuel; greenhouse gas |
choline [no description available] | 3.46 | 1 | 1 | cholines | allergen; Daphnia magna metabolite; Escherichia coli metabolite; human metabolite; mouse metabolite; neurotransmitter; nutrient; plant metabolite; Saccharomyces cerevisiae metabolite |
chlorine chloride : A halide anion formed when chlorine picks up an electron to form an an anion. | 2.11 | 1 | 0 | halide anion; monoatomic chlorine | cofactor; Escherichia coli metabolite; human metabolite |
hydrogen sulfide Hydrogen Sulfide: A flammable, poisonous gas with a characteristic odor of rotten eggs. It is used in the manufacture of chemicals, in metallurgy, and as an analytical reagent. (From Merck Index, 11th ed). hydrogen sulfide : A sulfur hydride consisting of a single sulfur atom bonded to two hydrogen atoms. A highly poisonous, flammable gas with a characteristic odour of rotten eggs, it is often produced by bacterial decomposition of organic matter in the absence of oxygen.. thiol : An organosulfur compound in which a thiol group, -SH, is attached to a carbon atom of any aliphatic or aromatic moiety. | 2.17 | 1 | 0 | gas molecular entity; hydracid; mononuclear parent hydride; sulfur hydride | Escherichia coli metabolite; genotoxin; metabolite; signalling molecule; toxin; vasodilator agent |
bupropion Bupropion: A propiophenone-derived antidepressant and antismoking agent that inhibits the uptake of DOPAMINE.. bupropion : An aromatic ketone that is propiophenone carrying a tert-butylamino group at position 2 and a chloro substituent at position 3 on the phenyl ring. | 8.46 | 18 | 2 | aromatic ketone; monochlorobenzenes; secondary amino compound | antidepressant; environmental contaminant; xenobiotic |
malic acid malic acid : A 2-hydroxydicarboxylic acid that is succinic acid in which one of the hydrogens attached to a carbon is replaced by a hydroxy group.. 2-hydroxydicarboxylic acid : Any dicarboxylic acid carrying a hydroxy group on the carbon atom at position alpha to the carboxy group. | 3.27 | 1 | 0 | 2-hydroxydicarboxylic acid; C4-dicarboxylic acid | food acidity regulator; fundamental metabolite |
3,4-dihydroxyphenylacetic acid 3,4-Dihydroxyphenylacetic Acid: A deaminated metabolite of LEVODOPA.. (3,4-dihydroxyphenyl)acetic acid : A dihydroxyphenylacetic acid having the two hydroxy substituents located at the 3- and 4-positions. It is a metabolite of dopamine.. dihydroxyphenylacetic acid : A dihydroxy monocarboxylic acid consisting of phenylacetic acid having two phenolic hydroxy substituents. | 2.41 | 2 | 0 | catechols; dihydroxyphenylacetic acid | human metabolite |
creatine [no description available] | 3.46 | 1 | 1 | glycine derivative; guanidines; zwitterion | geroprotector; human metabolite; mouse metabolite; neuroprotective agent; nutraceutical |
lactic acid Lactic Acid: A normal intermediate in the fermentation (oxidation, metabolism) of sugar. The concentrated form is used internally to prevent gastrointestinal fermentation. (From Stedman, 26th ed). 2-hydroxypropanoic acid : A 2-hydroxy monocarboxylic acid that is propanoic acid in which one of the alpha-hydrogens is replaced by a hydroxy group. | 2.31 | 1 | 0 | 2-hydroxy monocarboxylic acid | algal metabolite; Daphnia magna metabolite |
formaldehyde paraform: polymerized formaldehyde; RN given refers to parent cpd; used in root canal therapy | 3.31 | 6 | 0 | aldehyde; one-carbon compound | allergen; carcinogenic agent; disinfectant; EC 3.5.1.4 (amidase) inhibitor; environmental contaminant; Escherichia coli metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
kynurenine Kynurenine: A metabolite of the essential amino acid tryptophan metabolized via the tryptophan-kynurenine pathway.. kynurenine : A ketone that is alanine in which one of the methyl hydrogens is substituted by a 2-aminobenzoyl group. | 2.98 | 1 | 0 | aromatic ketone; non-proteinogenic alpha-amino acid; substituted aniline | human metabolite |
thioctic acid Thioctic Acid: An octanoic acid bridged with two sulfurs so that it is sometimes also called a pentanoic acid in some naming schemes. It is biosynthesized by cleavage of LINOLEIC ACID and is a coenzyme of oxoglutarate dehydrogenase (KETOGLUTARATE DEHYDROGENASE COMPLEX). It is used in DIETARY SUPPLEMENTS. | 5.97 | 4 | 1 | dithiolanes; heterocyclic fatty acid; thia fatty acid | fundamental metabolite; geroprotector |
methanol Methanol: A colorless, flammable liquid used in the manufacture of FORMALDEHYDE and ACETIC ACID, in chemical synthesis, antifreeze, and as a solvent. Ingestion of methanol is toxic and may cause blindness.. primary alcohol : A primary alcohol is a compound in which a hydroxy group, -OH, is attached to a saturated carbon atom which has either three hydrogen atoms attached to it or only one other carbon atom and two hydrogen atoms attached to it.. methanol : The primary alcohol that is the simplest aliphatic alcohol, comprising a methyl and an alcohol group. | 2.08 | 1 | 0 | alkyl alcohol; one-carbon compound; primary alcohol; volatile organic compound | amphiprotic solvent; Escherichia coli metabolite; fuel; human metabolite; mouse metabolite; Mycoplasma genitalium metabolite |
melatonin [no description available] | 5.27 | 3 | 1 | acetamides; tryptamines | anticonvulsant; central nervous system depressant; geroprotector; hormone; human metabolite; immunological adjuvant; mouse metabolite; radical scavenger |
phenol [no description available] | 2.03 | 1 | 0 | phenols | antiseptic drug; disinfectant; human xenobiotic metabolite; mouse metabolite |
pyrazinamide pyrazinecarboxamide : A monocarboxylic acid amide resulting from the formal condensation of the carboxy group of pyrazinoic acid (pyrazine-2-carboxylic acid) with ammonia. A prodrug for pyrazinoic acid, pyrazinecarboxamide is used as part of multidrug regimens for the treatment of tuberculosis. | 2.08 | 1 | 0 | monocarboxylic acid amide; N-acylammonia; pyrazines | antitubercular agent; prodrug |
pyridoxine 4,5-bis(hydroxymethyl)-2-methylpyridin-3-ol: structure in first source. vitamin B6 : Any member of the group of pyridines that exhibit biological activity against vitamin B6 deficiency. Vitamin B6 deficiency is associated with microcytic anemia, electroencephalographic abnormalities, dermatitis with cheilosis (scaling on the lips and cracks at the corners of the mouth) and glossitis (swollen tongue), depression and confusion, and weakened immune function. Vitamin B6 consists of the vitamers pyridoxine, pyridoxal, and pyridoxamine and their respective 5'-phosphate esters (and includes their corresponding ionized and salt forms). | 3.23 | 1 | 0 | hydroxymethylpyridine; methylpyridines; monohydroxypyridine; vitamin B6 | cofactor; Escherichia coli metabolite; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
thiamine thiamine(1+) : A primary alcohol that is 1,3-thiazol-3-ium substituted by (4-amino-2-methylpyrimidin-5-yl)methyl, methyl and 2-hydroxyethyl groups at positions 3, 4 and 5, respectively. | 5.97 | 4 | 1 | primary alcohol; vitamin B1 | Escherichia coli metabolite; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
8-hydroxy-2-(di-n-propylamino)tetralin 8-Hydroxy-2-(di-n-propylamino)tetralin: A serotonin 1A-receptor agonist that is used experimentally to test the effects of serotonin.. 8-OH-DPAT : A tetralin substituted at positions 1 and 7 by hydroxy and dipropylamino groups respectively | 2.46 | 2 | 0 | phenols; tertiary amino compound; tetralins | serotonergic antagonist |
4-iodo-2,5-dimethoxyphenylisopropylamine 4-iodo-2,5-dimethoxyphenylisopropylamine: RN given refers to unlabeled parent cpd without isomeric designation; a serotonin agonist. 2-(4-iodo-2,5-dimethoxyphenyl)-1-methylethylamine : An organoiodine compound that is amphetamine bearing two methoxy substituents at positions 2 and 5 as well as an iodo substituent at position 4. | 2.44 | 2 | 0 | amphetamines; dimethoxybenzene; organoiodine compound | |
normetanephrine Normetanephrine: A methylated metabolite of norepinephrine that is excreted in the urine and found in certain tissues. It is a marker for tumors. | 3.4 | 1 | 1 | catecholamine | |
1-(3-chlorophenyl)piperazine 1-(3-chlorophenyl)piperazine: supposed metabolite of TRAZODONE; RN given refers to parent cpd; structure. 1-(3-chlorophenyl)piperazine : A N-arylpiperazine that is piperazine carrying a 3-chlorophenyl substituent at position 1. It is a metabolite of the antidepressant drug trazodone. | 2.08 | 1 | 0 | monochlorobenzenes; N-arylpiperazine | drug metabolite; environmental contaminant; serotonergic agonist; xenobiotic |
1-anilino-8-naphthalenesulfonate 1-anilino-8-naphthalenesulfonate: RN given refers to parent cpd. 8-anilinonaphthalene-1-sulfonic acid : A naphthalenesulfonic acid that is naphthalene-1-sulfonic acid substituted by a phenylamino group at position 8. | 2.43 | 2 | 0 | aminonaphthalene; naphthalenesulfonic acid | fluorescent probe |
1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine 1-Methyl-4-phenyl-1,2,3,6-tetrahydropyridine: A dopaminergic neurotoxic compound which produces irreversible clinical, chemical, and pathological alterations that mimic those found in Parkinson disease.. 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine : A tetrahydropyridine that is 1,2,3,6-tetrahydropyridine substituted by a methyl group at position 1 and a phenyl group at position 4. | 1.98 | 1 | 0 | methylpyridines; phenylpyridine; tetrahydropyridine | neurotoxin |
3,4-methylenedioxyamphetamine 3,4-Methylenedioxyamphetamine: An amphetamine derivative that inhibits uptake of catecholamine neurotransmitters. It is a hallucinogen. It is less toxic than its methylated derivative but in sufficient doses may still destroy serotonergic neurons and has been used for that purpose experimentally. | 4.37 | 1 | 1 | benzodioxoles | |
n-methyl-3,4-methylenedioxyamphetamine N-Methyl-3,4-methylenedioxyamphetamine: An N-substituted amphetamine analog. It is a widely abused drug classified as a hallucinogen and causes marked, long-lasting changes in brain serotonergic systems. It is commonly referred to as MDMA or ecstasy.. 3,4-methylenedioxymethamphetamine : A member of the class of benzodioxoles that is 1,3-benzodioxole substituted by a 2-(methylamino)propyl group at position 5. | 10.24 | 7 | 2 | amphetamines; benzodioxoles | neurotoxin |
homovanillic acid Homovanillic Acid: A 3-O-methyl ETHER of (3,4-dihydroxyphenyl)acetic acid.. homovanillate : A hydroxy monocarboxylic acid anion which is obtained by deprotonation of the carboxy group of homovanillic acid.. homovanillic acid : A monocarboxylic acid that is the 3-O-methyl ether of (3,4-dihydroxyphenyl)acetic acid. It is a catecholamine metabolite. | 2.05 | 1 | 0 | guaiacols; monocarboxylic acid | human metabolite; mouse metabolite |
hydroxyindoleacetic acid (5-hydroxyindol-3-yl)acetic acid : A member of the class of indole-3-acetic acids that is indole-3-acetic acid substituted by a hydroxy group at C-5. | 3.81 | 2 | 1 | indole-3-acetic acids | drug metabolite; human metabolite; mouse metabolite |
tacrine Tacrine: A cholinesterase inhibitor that crosses the blood-brain barrier. Tacrine has been used to counter the effects of muscle relaxants, as a respiratory stimulant, and in the treatment of Alzheimer's disease and other central nervous system disorders.. tacrine : A member of the class of acridines that is 1,2,3,4-tetrahydroacridine substituted by an amino group at position 9. It is used in the treatment of Alzheimer's disease. | 2.55 | 2 | 0 | acridines; aromatic amine | EC 3.1.1.7 (acetylcholinesterase) inhibitor |
acetaminophen Acetaminophen: Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.. paracetamol : A member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group. | 10.74 | 13 | 5 | acetamides; phenols | antipyretic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; cyclooxygenase 3 inhibitor; environmental contaminant; ferroptosis inducer; geroprotector; hepatotoxic agent; human blood serum metabolite; non-narcotic analgesic; non-steroidal anti-inflammatory drug; xenobiotic |
acetazolamide Acetazolamide: One of the CARBONIC ANHYDRASE INHIBITORS that is sometimes effective against absence seizures. It is sometimes useful also as an adjunct in the treatment of tonic-clonic, myoclonic, and atonic seizures, particularly in women whose seizures occur or are exacerbated at specific times in the menstrual cycle. However, its usefulness is transient often because of rapid development of tolerance. Its antiepileptic effect may be due to its inhibitory effect on brain carbonic anhydrase, which leads to an increased transneuronal chloride gradient, increased chloride current, and increased inhibition. (From Smith and Reynard, Textbook of Pharmacology, 1991, p337) | 2.08 | 1 | 0 | monocarboxylic acid amide; sulfonamide; thiadiazoles | anticonvulsant; diuretic; EC 4.2.1.1 (carbonic anhydrase) inhibitor |
albendazole [no description available] | 2.08 | 1 | 0 | aryl sulfide; benzimidazoles; benzimidazolylcarbamate fungicide; carbamate ester | anthelminthic drug; microtubule-destabilising agent; tubulin modulator |
albuterol Albuterol: A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol.. albuterol : A member of the class of phenylethanolamines that is 4-(2-amino-1-hydroxyethyl)-2-(hydroxymethyl)phenol having a tert-butyl group attached to the nirogen atom. It acts as a beta-adrenergic agonist used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). | 2.08 | 1 | 0 | phenols; phenylethanolamines; secondary amino compound | beta-adrenergic agonist; bronchodilator agent; environmental contaminant; xenobiotic |
alosetron alosetron : A pyrido[4,3-b]indole compound having a 5-methyl-1H-imidazol-4-ylmethyl group at the 2-position. | 2.11 | 1 | 0 | imidazoles; pyridoindole | antiemetic; gastrointestinal drug; serotonergic antagonist |
alpha-methyl-m-tyrosine alpha-methyl-m-tyrosine: RN given refers to cpd without stereoisomeric designation; structure in Merck Index, 9th ed, #6004 | 2.02 | 1 | 0 | monocarboxylic acid | |
alprazolam Alprazolam: A triazolobenzodiazepine compound with antianxiety and sedative-hypnotic actions, that is efficacious in the treatment of PANIC DISORDERS, with or without AGORAPHOBIA, and in generalized ANXIETY DISORDERS. (From AMA Drug Evaluations Annual, 1994, p238). alprazolam : A member of the class of triazolobenzodiazepines that is 4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine carrying methyl, phenyl and chloro substituents at positions 1, 6 and 8 respectively. Alprazolam is only found in individuals that have taken this drug. | 2.78 | 3 | 0 | organochlorine compound; triazolobenzodiazepine | anticonvulsant; anxiolytic drug; GABA agonist; muscle relaxant; sedative; xenobiotic |
alprenolol Alprenolol: One of the ADRENERGIC BETA-ANTAGONISTS used as an antihypertensive, anti-anginal, and anti-arrhythmic agent.. alprenolol : A secondary alcohol that is propan-2-ol substituted by a 2-allylphenoxy group at position 1 and an isopropylamino group at position 3. It is a beta-adrenergic antagonist used as a antihypertensive, anti-arrhythmia and a sympatholytic agent. | 2.08 | 1 | 0 | secondary alcohol; secondary amino compound | anti-arrhythmia drug; antihypertensive agent; beta-adrenergic antagonist; sympatholytic agent |
amantadine amant: an antiviral compound consisting of an adamantane derivative chemically linked to a water-solube polyanioic matrix; structure in first source | 2.04 | 1 | 0 | adamantanes; primary aliphatic amine | analgesic; antiparkinson drug; antiviral drug; dopaminergic agent; NMDA receptor antagonist; non-narcotic analgesic |
diatrizoic acid Diatrizoate: A commonly used x-ray contrast medium. As DIATRIZOATE MEGLUMINE and as Diatrizoate sodium, it is used for gastrointestinal studies, angiography, and urography.. amidotrizoic acid : A member of the class of benzoic acids that is benzoic acid having iodo substituents at the 2-, 4- and 6-positions and acetamido substituents at the 3- and 5-positions. It is used, mainly as its N-methylglucamine and sodium salts, as an X-ray contrast medium in gastrointestinal studies, angiography, and urography. | 2.08 | 1 | 0 | acetamides; benzoic acids; organoiodine compound | environmental contaminant; radioopaque medium; xenobiotic |
aminoglutethimide Aminoglutethimide: An aromatase inhibitor that is used in the treatment of advanced BREAST CANCER.. aminoglutethimide : A dicarboximide that is a six-membered cyclic compound having ethyl and 4-aminophenyl substituents at the 3-position. | 2.08 | 1 | 0 | dicarboximide; piperidones; substituted aniline | adrenergic agent; anticonvulsant; antineoplastic agent; EC 1.14.14.14 (aromatase) inhibitor |
theophylline [no description available] | 4.14 | 3 | 1 | dimethylxanthine | adenosine receptor antagonist; anti-asthmatic drug; anti-inflammatory agent; bronchodilator agent; drug metabolite; EC 3.1.4.* (phosphoric diester hydrolase) inhibitor; fungal metabolite; human blood serum metabolite; immunomodulator; muscle relaxant; vasodilator agent |
amiodarone Amiodarone: An antianginal and class III antiarrhythmic drug. It increases the duration of ventricular and atrial muscle action by inhibiting POTASSIUM CHANNELS and VOLTAGE-GATED SODIUM CHANNELS. There is a resulting decrease in heart rate and in vascular resistance.. amiodarone : A member of the class of 1-benzofurans that is 1-benzofuran substituted by a butyl group at position 2 and a 4-[2-(diethylamino)ethoxy]-3,5-diiodobenzoyl group at position 3. It is a cardiovascular drug used for the treatment of cardiac dysrhythmias. | 2.52 | 2 | 0 | 1-benzofurans; aromatic ketone; organoiodine compound; tertiary amino compound | cardiovascular drug |
dan 2163 [no description available] | 3.6 | 2 | 0 | aromatic amide; aromatic amine; benzamides; pyrrolidines; sulfone | environmental contaminant; second generation antipsychotic; xenobiotic |
amitriptyline Amitriptyline: Tricyclic antidepressant with anticholinergic and sedative properties. It appears to prevent the re-uptake of norepinephrine and serotonin at nerve terminals, thus potentiating the action of these neurotransmitters. Amitriptyline also appears to antagonize cholinergic and alpha-1 adrenergic responses to bioactive amines.. amitriptyline : An organic tricyclic compound that is 10,11-dihydro-5H-dibenzo[a,d][7]annulene substituted by a 3-(dimethylamino)propylidene group at position 5. | 16.38 | 76 | 10 | carbotricyclic compound; tertiary amine | adrenergic uptake inhibitor; antidepressant; environmental contaminant; tropomyosin-related kinase B receptor agonist; xenobiotic |
amlexanox amlexanox: SRA-A antagonist;structure given in first source. amlexanox : A pyridochromene-derived monocarboxylic acid having an amino substituent at the 2-position, an oxo substituent at the 5-position and an isopropyl substituent at the 7-position. | 2.08 | 1 | 0 | monocarboxylic acid; pyridochromene | anti-allergic agent; anti-ulcer drug; non-steroidal anti-inflammatory drug |
amlodipine Amlodipine: A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.. amlodipine : A fully substituted dialkyl 1,4-dihydropyridine-3,5-dicarboxylate derivative, which is used for the treatment of hypertension, chronic stable angina and confirmed or suspected vasospastic angina. | 3.85 | 3 | 0 | dihydropyridine; ethyl ester; methyl ester; monochlorobenzenes; primary amino compound | antihypertensive agent; calcium channel blocker; vasodilator agent |
amoxapine Amoxapine: The N-demethylated derivative of the antipsychotic agent LOXAPINE that works by blocking the reuptake of norepinephrine, serotonin, or both; it also blocks dopamine receptors. Amoxapine is used for the treatment of depression.. amoxapine : A dibenzooxazepine compound having a chloro substituent at the 2-position and a piperazin-1-yl group at the 11-position. | 2.48 | 2 | 0 | dibenzooxazepine | adrenergic uptake inhibitor; antidepressant; dopaminergic antagonist; geroprotector; serotonin uptake inhibitor |
amsacrine Amsacrine: An aminoacridine derivative that intercalates into DNA and is used as an antineoplastic agent.. amsacrine : A sulfonamide that is N-phenylmethanesulfonamide substituted by a methoxy group at position 3 and an acridin-9-ylamino group at position 4. It exhibits antineoplastic activity. | 2.08 | 1 | 0 | acridines; aromatic ether; sulfonamide | antineoplastic agent; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor |
anastrozole [no description available] | 2.08 | 1 | 0 | nitrile; triazoles | antineoplastic agent; EC 1.14.14.14 (aromatase) inhibitor |
anthralin Anthralin: An anthracene derivative that disrupts MITOCHONDRIA function and structure and is used for the treatment of DERMATOSES, especially PSORIASIS. It may cause FOLLICULITIS.. anthralin : An anthracene compound derived by the substitution of -OH groups for hydrogen at C-1 and C-8, and with an oxo group at C-9. | 2.08 | 1 | 0 | anthracenes | antipsoriatic |
antipyrine Antipyrine: An analgesic and antipyretic that has been given by mouth and as ear drops. Antipyrine is often used in testing the effects of other drugs or diseases on drug-metabolizing enzymes in the liver. (From Martindale, The Extra Pharmacopoeia, 30th ed, p29). antipyrine : A pyrazolone derivative that is 1,2-dihydropyrazol-3-one substituted with methyl groups at N-1 and C-5 and with a phenyl group at N-2. | 2.08 | 1 | 0 | pyrazolone | antipyretic; cyclooxygenase 3 inhibitor; environmental contaminant; non-narcotic analgesic; non-steroidal anti-inflammatory drug; xenobiotic |
aspirin Aspirin: The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5). acetylsalicylate : A benzoate that is the conjugate base of acetylsalicylic acid, arising from deprotonation of the carboxy group.. acetylsalicylic acid : A member of the class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group. A non-steroidal anti-inflammatory drug with cyclooxygenase inhibitor activity. | 3.9 | 2 | 1 | benzoic acids; phenyl acetates; salicylates | anticoagulant; antipyretic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; drug allergen; EC 1.1.1.188 (prostaglandin-F synthase) inhibitor; geroprotector; non-narcotic analgesic; non-steroidal anti-inflammatory drug; plant activator; platelet aggregation inhibitor; prostaglandin antagonist; teratogenic agent |
astemizole Astemizole: Antihistamine drug now withdrawn from the market in many countries because of rare but potentially fatal side effects.. astemizole : A piperidine compound having a 2-(4-methoxyphenyl)ethyl group at the 1-position and an N-[(4-fluorobenzyl)benzimidazol-2-yl]amino group at the 4-position. | 2.08 | 1 | 0 | benzimidazoles; piperidines | anti-allergic agent; anticoronaviral agent; H1-receptor antagonist |
atenolol Atenolol: A cardioselective beta-1 adrenergic blocker possessing properties and potency similar to PROPRANOLOL, but without a negative inotropic effect.. atenolol : An ethanolamine compound having a (4-carbamoylmethylphenoxy)methyl group at the 1-position and an N-isopropyl substituent. | 2.5 | 2 | 0 | ethanolamines; monocarboxylic acid amide; propanolamine | anti-arrhythmia drug; antihypertensive agent; beta-adrenergic antagonist; environmental contaminant; sympatholytic agent; xenobiotic |
azasetron azasetron: a selective 5-HT3 receptor antagonist; structure given in first source; | 2.46 | 2 | 0 | benzoxazine | |
azathioprine Azathioprine: An immunosuppressive agent used in combination with cyclophosphamide and hydroxychloroquine in the treatment of rheumatoid arthritis. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), this substance has been listed as a known carcinogen. (Merck Index, 11th ed). azathioprine : A thiopurine that is 6-mercaptopurine in which the mercapto hydrogen is replaced by a 1-methyl-4-nitroimidazol-5-yl group. It is a prodrug for mercaptopurine and is used as an immunosuppressant, prescribed for the treatment of inflammatory conditions and after organ transplantation and also for treatment of Crohn's didease and MS. | 2.08 | 1 | 0 | aryl sulfide; C-nitro compound; imidazoles; thiopurine | antimetabolite; antineoplastic agent; carcinogenic agent; DNA synthesis inhibitor; hepatotoxic agent; immunosuppressive agent; prodrug |
baclofen [no description available] | 9.4 | 11 | 0 | amino acid zwitterion; gamma-amino acid; monocarboxylic acid; monochlorobenzenes; primary amino compound | central nervous system depressant; GABA agonist; muscle relaxant |
benphothiamine benfotiamine : A thioester that is a synthetic analogue of thiamine obtained by acylative cleavage of the thiazole ring and O-phospohorylation. | 5.97 | 4 | 1 | aminopyrimidine; formamides; organic phosphate; thioester | antioxidant; immunological adjuvant; nutraceutical; protective agent; provitamin B1 |
benzbromarone Benzbromarone: Uricosuric that acts by increasing uric acid clearance. It is used in the treatment of gout.. benzbromarone : 1-Benzofuran substituted at C-2 and C-3 by an ethyl group and a 3,5-dibromo-4-hydroxybenzoyl group respectively. An inhibitor of CYP2C9, it is used as an anti-gout medication. | 2.08 | 1 | 0 | 1-benzofurans; aromatic ketone | uricosuric drug |
benzethonium Benzethonium: Bactericidal cationic quaternary ammonium surfactant used as a topical anti-infective agent. It is an ingredient in medicaments, deodorants, mouthwashes, etc., and is used to disinfect apparatus, etc., in the food processing and pharmaceutical industries, in surgery, and also as a preservative. The compound is toxic orally as a result of neuromuscular blockade. | 2.31 | 1 | 0 | alkylbenzene | |
benzocaine Benzocaine: A surface anesthetic that acts by preventing transmission of impulses along NERVE FIBERS and at NERVE ENDINGS.. dextran sulfate sodium : An organic sodium salt of dextran sulfate. It induces colitis in mice.. benzocaine : A benzoate ester having 4-aminobenzoic acid as the acid component and ethanol as the alcohol component. A surface anaesthetic, it is used to suppress the gag reflex, and as a lubricant and topical anaesthetic on the larynx, mouth, nasal cavity, respiratory tract, oesophagus, rectum, urinary tract, and vagina. | 2.08 | 1 | 0 | benzoate ester; substituted aniline | allergen; antipruritic drug; sensitiser; topical anaesthetic |
bicalutamide bicalutamide: approved for treatment of advanced prostate cancer. N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanamide : A member of the class of (trifluoromethyl)benzenes that is 4-amino-2-(trifluoromethyl)benzonitrile in which one of the amino hydrogens is substituted by a 3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanoyl group.. bicalutamide : A racemate comprising of equal amounts of (R)-bicalutamide and (S)-bicalutamide. It is an oral non-steroidal antiandrogen used in the treatment of prostate cancer and hirsutism. | 2.08 | 1 | 0 | (trifluoromethyl)benzenes; monocarboxylic acid amide; monofluorobenzenes; nitrile; sulfone; tertiary alcohol | |
bay h 4502 bifonazole : A racemate comprising equimolar amounts of R- and S-bifonazole. It is a broad spectrum antifungal drug used for the treatment of fungal skin and nail infections.. 1-[biphenyl-4-yl(phenyl)methyl]imidazole : A member of the class of imidazoles carrying an alpha-(biphenyl-4-yl)benzyl substituent at position 1. | 2.08 | 1 | 0 | biphenyls; imidazoles | |
bisacodyl Bisacodyl: A diphenylmethane stimulant laxative used for the treatment of CONSTIPATION and for bowel evacuation. (From Martindale, The Extra Pharmacopoeia, 30th ed, p871) | 2.08 | 1 | 0 | diarylmethane | |
bromopride bromopride: RN given refers to parent cpd; structure | 2.08 | 1 | 0 | benzamides | |
bronopol [no description available] | 2.08 | 1 | 0 | nitro compound | |
bumetanide [no description available] | 2.08 | 1 | 0 | amino acid; benzoic acids; sulfonamide | diuretic; EC 3.6.3.49 (channel-conductance-controlling ATPase) inhibitor |
bupivacaine Bupivacaine: A widely used local anesthetic agent.. 1-butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide : A piperidinecarboxamide obtained by formal condensation of the carboxy group of N-butylpipecolic acid with the amino group of 2,6-dimethylaniline.. bupivacaine : A racemate composed of equimolar amounts of dextrobupivacaine and levobupivacaine. Used (in the form of its hydrochloride hydrate) as a local anaesthetic. | 2.11 | 1 | 0 | aromatic amide; piperidinecarboxamide; tertiary amino compound | |
buspirone Buspirone: An anxiolytic agent and serotonin receptor agonist belonging to the azaspirodecanedione class of compounds. Its structure is unrelated to those of the BENZODIAZAPINES, but it has an efficacy comparable to DIAZEPAM.. buspirone : An azaspiro compound that is 8-azaspiro[4.5]decane-7,9-dione substituted at the nitrogen atom by a 4-(piperazin-1-yl)butyl group which in turn is substituted by a pyrimidin-2-yl group at the N(4) position. | 1.99 | 1 | 0 | azaspiro compound; N-alkylpiperazine; N-arylpiperazine; organic heteropolycyclic compound; piperidones; pyrimidines | anxiolytic drug; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; sedative; serotonergic agonist |
busulfan [no description available] | 2.08 | 1 | 0 | methanesulfonate ester | alkylating agent; antineoplastic agent; carcinogenic agent; insect sterilant; teratogenic agent |
caffeine [no description available] | 2.49 | 2 | 0 | purine alkaloid; trimethylxanthine | adenosine A2A receptor antagonist; adenosine receptor antagonist; adjuvant; central nervous system stimulant; diuretic; EC 2.7.11.1 (non-specific serine/threonine protein kinase) inhibitor; EC 3.1.4.* (phosphoric diester hydrolase) inhibitor; environmental contaminant; food additive; fungal metabolite; geroprotector; human blood serum metabolite; mouse metabolite; mutagen; plant metabolite; psychotropic drug; ryanodine receptor agonist; xenobiotic |
verapamil Verapamil: A calcium channel blocker that is a class IV anti-arrhythmia agent.. verapamil : A racemate comprising equimolar amounts of dexverapamil and (S)-verapamil. An L-type calcium channel blocker of the phenylalkylamine class, it is used (particularly as the hydrochloride salt) in the treatment of hypertension, angina pectoris and cardiac arrhythmia, and as a preventive medication for migraine.. 2-(3,4-dimethoxyphenyl)-5-{[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino}-2-(propan-2-yl)pentanenitrile : A tertiary amino compound that is 3,4-dimethoxyphenylethylamine in which the hydrogens attached to the nitrogen are replaced by a methyl group and a 4-cyano-4-(3,4-dimethoxyphenyl)-5-methylhexyl group. | 2.08 | 1 | 0 | aromatic ether; nitrile; polyether; tertiary amino compound | |
carbamazepine Carbamazepine: A dibenzazepine that acts as a sodium channel blocker. It is used as an anticonvulsant for the treatment of grand mal and psychomotor or focal SEIZURES. It may also be used in the management of BIPOLAR DISORDER, and has analgesic properties.. carbamazepine : A dibenzoazepine that is 5H-dibenzo[b,f]azepine carrying a carbamoyl substituent at the azepine nitrogen, used as an anticonvulsant. | 7.84 | 8 | 1 | dibenzoazepine; ureas | analgesic; anticonvulsant; antimanic drug; drug allergen; EC 3.5.1.98 (histone deacetylase) inhibitor; environmental contaminant; glutamate transporter activator; mitogen; non-narcotic analgesic; sodium channel blocker; xenobiotic |
carisoprodol Carisoprodol: A centrally acting skeletal muscle relaxant whose mechanism of action is not completely understood but may be related to its sedative actions. It is used as an adjunct in the symptomatic treatment of musculoskeletal conditions associated with painful muscle spasm. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1202). carisoprodol : A carbamate ester that is the mono-N-isopropyl derivative of meprobamate (which is a significant metabolite). Carisoprodol interrupts neuronal communication within the reticular formation and spinal cord, resulting in sedation and alteration in pain perception. It is used as a muscle relaxant in the symptomatic treatment of musculoskeletal conditions associated with painful muscle spasm. | 3.63 | 2 | 0 | carbamate ester | muscle relaxant |
carmustine Carmustine: A cell-cycle phase nonspecific alkylating antineoplastic agent. It is used in the treatment of brain tumors and various other malignant neoplasms. (From Martindale, The Extra Pharmacopoeia, 30th ed, p462) This substance may reasonably be anticipated to be a carcinogen according to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985). (From Merck Index, 11th ed). carmustine : A member of the class of N-nitrosoureas that is 1,3-bis(2-chloroethyl)urea in which one of the nitrogens is substituted by a nitroso group. | 2.08 | 1 | 0 | N-nitrosoureas; organochlorine compound | alkylating agent; antineoplastic agent |
carprofen carprofen: RN given refers to cpd without isomeric designation. carprofen : Propanoic acid in which one of the methylene hydrogens is substituted by a 6-chloro-9H-carbazol-2-yl group. A non-steroidal anti-inflammatory drug, it is no longer used in human medicine but is still used for treatment of arthritis in elderly dogs. | 2.08 | 1 | 0 | carbazoles; organochlorine compound | EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-steroidal anti-inflammatory drug; photosensitizing agent |
carvedilol [no description available] | 7.86 | 6 | 0 | carbazoles; secondary alcohol; secondary amino compound | alpha-adrenergic antagonist; antihypertensive agent; beta-adrenergic antagonist; cardiovascular drug; vasodilator agent |
celecoxib [no description available] | 7.02 | 9 | 1 | organofluorine compound; pyrazoles; sulfonamide; toluenes | cyclooxygenase 2 inhibitor; geroprotector; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
cetirizine Cetirizine: A potent second-generation histamine H1 antagonist that is effective in the treatment of allergic rhinitis, chronic urticaria, and pollen-induced asthma. Unlike many traditional antihistamines, it does not cause drowsiness or anticholinergic side effects.. cetirizine : A member of the class of piperazines that is piperazine in which the hydrogens attached to nitrogen are replaced by a (4-chlorophenyl)(phenyl)methyl and a 2-(carboxymethoxy)ethyl group respectively. | 2.51 | 2 | 0 | ether; monocarboxylic acid; monochlorobenzenes; piperazines | anti-allergic agent; environmental contaminant; H1-receptor antagonist; xenobiotic |
chlorambucil Chlorambucil: A nitrogen mustard alkylating agent used as antineoplastic for chronic lymphocytic leukemia, Hodgkin's disease, and others. Although it is less toxic than most other nitrogen mustards, it has been listed as a known carcinogen in the Fourth Annual Report on Carcinogens (NTP 85-002, 1985). (Merck Index, 11th ed). chlorambucil : A monocarboxylic acid that is butanoic acid substituted at position 4 by a 4-[bis(2-chloroethyl)amino]phenyl group. A chemotherapy drug that can be used in combination with the antibody obinutuzumab for the treatment of chronic lymphocytic leukemia. | 2.08 | 1 | 0 | aromatic amine; monocarboxylic acid; nitrogen mustard; organochlorine compound; tertiary amino compound | alkylating agent; antineoplastic agent; carcinogenic agent; drug allergen; immunosuppressive agent |
chlordiazepoxide Chlordiazepoxide: An anxiolytic benzodiazepine derivative with anticonvulsant, sedative, and amnesic properties. It has also been used in the symptomatic treatment of alcohol withdrawal.. chlordiazepoxide : A benzodiazepine that is 3H-1,4-benzodiazepine 4-oxide substituted by a chloro group at position 7, a phenyl group at position 5 and a methylamino group at position 2. | 2.08 | 1 | 0 | benzodiazepine | |
chloroquine Chloroquine: The prototypical antimalarial agent with a mechanism that is not well understood. It has also been used to treat rheumatoid arthritis, systemic lupus erythematosus, and in the systemic therapy of amebic liver abscesses.. chloroquine : An aminoquinoline that is quinoline which is substituted at position 4 by a [5-(diethylamino)pentan-2-yl]amino group at at position 7 by chlorine. It is used for the treatment of malaria, hepatic amoebiasis, lupus erythematosus, light-sensitive skin eruptions, and rheumatoid arthritis. | 2.08 | 1 | 0 | aminoquinoline; organochlorine compound; secondary amino compound; tertiary amino compound | anticoronaviral agent; antimalarial; antirheumatic drug; autophagy inhibitor; dermatologic drug |
chlorpheniramine Chlorpheniramine: A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.. chlorphenamine : A tertiary amino compound that is propylamine which is substituted at position 3 by a pyridin-2-yl group and a p-chlorophenyl group and in which the hydrogens attached to the nitrogen are replaced by methyl groups. A histamine H1 antagonist, it is used to relieve the symptoms of hay fever, rhinitis, urticaria, and asthma. | 2.5 | 2 | 0 | monochlorobenzenes; pyridines; tertiary amino compound | anti-allergic agent; antidepressant; antipruritic drug; H1-receptor antagonist; histamine antagonist; serotonin uptake inhibitor |
chlorpromazine Chlorpromazine: The prototypical phenothiazine antipsychotic drug. Like the other drugs in this class chlorpromazine's antipsychotic actions are thought to be due to long-term adaptation by the brain to blocking DOPAMINE RECEPTORS. Chlorpromazine has several other actions and therapeutic uses, including as an antiemetic and in the treatment of intractable hiccup.. chlorpromazine : A substituted phenothiazine in which the ring nitrogen at position 10 is attached to C-3 of an N,N-dimethylpropanamine moiety. | 2.08 | 1 | 0 | organochlorine compound; phenothiazines; tertiary amine | anticoronaviral agent; antiemetic; dopaminergic antagonist; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; phenothiazine antipsychotic drug |
chlorpropamide Chlorpropamide: A sulfonylurea hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. (From Martindale, The Extra Pharmacopoeia, 30th ed, p277). chlorpropamide : An N-sulfonylurea that is urea in which a hydrogen attached to one of the nitrogens is substituted by 4-chlorobenzenesulfonyl group and a hydrogen attached to the other nitrogen is substituted by propyl group. Chlorpropamide is a hypoglycaemic agent used in the treatment of type 2 (non-insulin-dependent) diabetes mellitus not responding to dietary modification. | 2.08 | 1 | 0 | monochlorobenzenes; N-sulfonylurea | hypoglycemic agent; insulin secretagogue |
chlorthalidone Chlorthalidone: A benzenesulfonamide-phthalimidine that tautomerizes to a BENZOPHENONES form. It is considered a thiazide-like diuretic. | 2.08 | 1 | 0 | isoindoles; monochlorobenzenes; sulfonamide | |
chlorzoxazone Chlorzoxazone: A centrally acting central muscle relaxant with sedative properties. It is claimed to inhibit muscle spasm by exerting an effect primarily at the level of the spinal cord and subcortical areas of the brain. (From Martindale, The Extra Pharmacopoea, 30th ed, p1202). chlorzoxazone : A member of the class of 1,3-benzoxazoles that is 1,3-benzoxazol-2-ol in which the hydrogen atom at position 5 is substituted by chlorine. A centrally acting muscle relaxant with sedative properties, it is used for the symptomatic treatment of painful muscle spasm. | 2.08 | 1 | 0 | 1,3-benzoxazoles; heteroaryl hydroxy compound; organochlorine compound | muscle relaxant; sedative |
cifenline [no description available] | 2.08 | 1 | 0 | diarylmethane | |
ciclopirox [no description available] | 2.08 | 1 | 0 | cyclic hydroxamic acid; hydroxypyridone antifungal drug; pyridone | antibacterial agent; antiseborrheic |
ciglitazone ciglitazone: structure given in second source; PPAR agonist used for type II diabetes. ciglitazone : An aromatic ether that consists of 1,3-thiazolidine-2,4-dione with position 5 substituted by a 4-[(1-methylcyclohexyl)methoxy]benzyl group. A selective PPARgamma agonist. | 2.08 | 1 | 0 | aromatic ether; thiazolidinone | antineoplastic agent; insulin-sensitizing drug |
cilostazol [no description available] | 2.08 | 1 | 0 | lactam; tetrazoles | anticoagulant; bronchodilator agent; EC 3.1.4.17 (3',5'-cyclic-nucleotide phosphodiesterase) inhibitor; fibrin modulating drug; neuroprotective agent; platelet aggregation inhibitor; vasodilator agent |
cimetidine Cimetidine: A histamine congener, it competitively inhibits HISTAMINE binding to HISTAMINE H2 RECEPTORS. Cimetidine has a range of pharmacological actions. It inhibits GASTRIC ACID secretion, as well as PEPSIN and GASTRIN output.. cimetidine : A member of the class of guanidines that consists of guanidine carrying a methyl substituent at position 1, a cyano group at position 2 and a 2-{[(5-methyl-1H-imidazol-4-yl)methyl]sulfanyl}ethyl group at position 3. It is a H2-receptor antagonist that inhibits the production of acid in stomach. | 2.08 | 1 | 0 | aliphatic sulfide; guanidines; imidazoles; nitrile | adjuvant; analgesic; anti-ulcer drug; H2-receptor antagonist; P450 inhibitor |
ciprofibrate [no description available] | 2.08 | 1 | 0 | cyclopropanes; monocarboxylic acid; organochlorine compound | antilipemic drug |
ciprofloxacin Ciprofloxacin: A broad-spectrum antimicrobial carboxyfluoroquinoline.. ciprofloxacin : A quinolone that is quinolin-4(1H)-one bearing cyclopropyl, carboxylic acid, fluoro and piperazin-1-yl substituents at positions 1, 3, 6 and 7, respectively. | 2.57 | 2 | 0 | aminoquinoline; cyclopropanes; fluoroquinolone antibiotic; N-arylpiperazine; quinolinemonocarboxylic acid; quinolone antibiotic; quinolone; zwitterion | antibacterial drug; antiinfective agent; antimicrobial agent; DNA synthesis inhibitor; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor; environmental contaminant; topoisomerase IV inhibitor; xenobiotic |
citalopram Citalopram: A furancarbonitrile that is one of the serotonin uptake inhibitors used as an antidepressant. The drug is also effective in reducing ethanol uptake in alcoholics and is used in depressed patients who also suffer from TARDIVE DYSKINESIA in preference to tricyclic antidepressants, which aggravate dyskinesia.. citalopram : A racemate comprising equimolar amounts of (R)-citalopram and its enantiomer, escitalopram. It is used as an antidepressant, although only escitalopram is active.. 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile : A nitrile that is 1,3-dihydro-2-benzofuran-5-carbonitrile in which one of the hydrogens at position 1 is replaced by a p-fluorophenyl group, while the other is replaced by a 3-(dimethylamino)propyl group. | 18.53 | 113 | 41 | 2-benzofurans; cyclic ether; nitrile; organofluorine compound; tertiary amino compound | |
clenbuterol Clenbuterol: A substituted phenylaminoethanol that has beta-2 adrenomimetic properties at very low doses. It is used as a bronchodilator in asthma.. clenbuterol : A substituted aniline that is 2,6-dichloroaniline in which the hydrogen at position 4 has been replaced by a 2-(tert-butylamino)-1-hydroxyethyl group. | 3.21 | 1 | 0 | amino alcohol; dichlorobenzene; ethanolamines; primary arylamine; secondary amino compound; substituted aniline | beta-adrenergic agonist; bronchodilator agent; sympathomimetic agent |
clioquinol Clioquinol: A potentially neurotoxic 8-hydroxyquinoline derivative long used as a topical anti-infective, intestinal antiamebic, and vaginal trichomonacide. The oral preparation has been shown to cause subacute myelo-optic neuropathy and has been banned worldwide.. 5-chloro-7-iodoquinolin-8-ol : A monohydroxyquinoline that is quinolin-8-ol in which the hydrogens at positions 5 and 7 are replaced by chlorine and iodine, respectively. It has antibacterial and atifungal properties, and is used in creams for the treatment of skin infections. It has also been investigated as a chelator of copper and zinc ions for the possible treatment of Alzheimer's disease. | 2.08 | 1 | 0 | monohydroxyquinoline; organochlorine compound; organoiodine compound | antibacterial agent; antifungal agent; antimicrobial agent; antineoplastic agent; antiprotozoal drug; chelator; copper chelator |
clobazam Clobazam: A benzodiazepine derivative that is a long-acting GABA-A RECEPTOR agonist. It is used as an antiepileptic in the treatment of SEIZURES, including seizures associated with LENNOX-GASTAUT SYNDROME. It is also used as an anxiolytic, for the short-term treatment of acute ANXIETY.. clobazam : 7-Chloro-1H-1,5-benzodiazepine-2,4(3H,5H)-dione in which the hydrogen attached to the nitrogen at position 1 is substituted by a methyl group, whilst that attached to the other nitrogen is substituted by a phenyl group. It is used for the short-term management of acute anxiety and as an adjunct in the treatment of epilepsy in association with other antiepileptics. | 2.08 | 1 | 0 | 1,4-benzodiazepinone; organochlorine compound | anticonvulsant; anxiolytic drug; GABA modulator |
clofazimine Clofazimine: A fat-soluble riminophenazine dye used for the treatment of leprosy. It has been used investigationally in combination with other antimycobacterial drugs to treat Mycobacterium avium infections in AIDS patients. Clofazimine also has a marked anti-inflammatory effect and is given to control the leprosy reaction, erythema nodosum leprosum. (From AMA Drug Evaluations Annual, 1993, p1619). clofazimine : 3-Isopropylimino-3,5-dihydro-phenazine in which the hydrogen at position 5 is substituted substituted by a 4-chlorophenyl group, and that at position 2 is substituted by a (4-chlorophenyl)amino group. A dark red crystalline solid, clofazimine is an antimycobacterial and is one of the main drugs used for the treatment of multi-bacillary leprosy. However, it can cause red/brown discolouration of the skin, so other treatments are often preferred in light-skinned patients. | 2.08 | 1 | 0 | monochlorobenzenes; phenazines | dye; leprostatic drug; non-steroidal anti-inflammatory drug |
clofibrate angiokapsul: contains clofibrate & insoitolnicotinate | 2.08 | 1 | 0 | aromatic ether; ethyl ester; monochlorobenzenes | anticholesteremic drug; antilipemic drug; geroprotector; PPARalpha agonist |
clomiphene [no description available] | 2.08 | 1 | 0 | tertiary amine | estrogen antagonist; estrogen receptor modulator |
clomipramine Clomipramine: A tricyclic antidepressant similar to IMIPRAMINE that selectively inhibits the uptake of serotonin in the brain. It is readily absorbed from the gastrointestinal tract and demethylated in the liver to form its primary active metabolite, desmethylclomipramine.. clomipramine : A dibenzoazepine that is 10,11-dihydro-5H-dibenzo[b,f]azepine which is substituted by chlorine at position 3 and in which the hydrogen attached to the nitrogen is replaced by a 3-(dimethylamino)propyl group. One of the more sedating tricyclic antidepressants, it is used as the hydrochloride salt for the treatment of depression as well as obsessive-compulsive disorder and phobias. | 8.97 | 12 | 1 | dibenzoazepine | anticoronaviral agent; antidepressant; EC 1.8.1.12 (trypanothione-disulfide reductase) inhibitor; serotonergic antagonist; serotonergic drug; serotonin uptake inhibitor |
clonazepam Clonazepam: An anticonvulsant used for several types of seizures, including myotonic or atonic seizures, photosensitive epilepsy, and absence seizures, although tolerance may develop. It is seldom effective in generalized tonic-clonic or partial seizures. The mechanism of action appears to involve the enhancement of GAMMA-AMINOBUTYRIC ACID receptor responses.. clonazepam : 1,3-Dihydro-2H-1,4-benzodiazepin-2-one in which the hydrogens at positions 5 and 7 are substituted by 2-chlorophenyl and nitro groups, respectively. It is used in the treatment of all types of epilepsy and seizures, as well as myoclonus and associated abnormal movements, and panic disorders. However, its use can be limited by the development of tolerance and by sedation. | 3.69 | 2 | 0 | 1,4-benzodiazepinone; monochlorobenzenes | anticonvulsant; anxiolytic drug; GABA modulator |
clonidine Clonidine: An imidazoline sympatholytic agent that stimulates ALPHA-2 ADRENERGIC RECEPTORS and central IMIDAZOLINE RECEPTORS. It is commonly used in the management of HYPERTENSION.. clonidine (amino form) : A clonidine that is 4,5-dihydro-1H-imidazol-2-amine in which one of the amino hydrogens is replaced by a 2,6-dichlorophenyl group. | 8.1 | 8 | 0 | clonidine; imidazoline | |
4-chloro-N-(2,6-dimethyl-1-piperidinyl)-3-sulfamoylbenzamide [no description available] | 2.08 | 1 | 0 | sulfonamide | |
cyclobenzaprine cyclobenzaprine: RN given refers to parent cpd; Lisseril is synonymous for HCl; structure. cyclobenzaprine : 5-Methylidene-5H-dibenzo[a,d]cycloheptene in which one of the hydrogens of the methylidene group is substituted by a 2-(dimethylamino)ethyl group. A centrally acting skeletal muscle relaxant, it is used as its hydrochloride salt in the symptomatic treatment of painful muscle spasm. | 3.21 | 5 | 0 | carbotricyclic compound | antidepressant; muscle relaxant; tranquilizing drug |
dapsone [no description available] | 2.08 | 1 | 0 | substituted aniline; sulfone | anti-inflammatory drug; antiinfective agent; antimalarial; leprostatic drug |
desipramine Desipramine: A tricyclic dibenzazepine compound that potentiates neurotransmission. Desipramine selectively blocks reuptake of norepinephrine from the neural synapse, and also appears to impair serotonin transport. This compound also possesses minor anticholinergic activity, through its affinity to muscarinic receptors.. desipramine : A dibenzoazepine consisting of 10,11-dihydro-5H-dibenzo[b,f]azepine substituted on nitrogen with a 3-(methylamino)propyl group. | 10.75 | 19 | 3 | dibenzoazepine; secondary amino compound | adrenergic uptake inhibitor; alpha-adrenergic antagonist; antidepressant; cholinergic antagonist; drug allergen; EC 3.1.4.12 (sphingomyelin phosphodiesterase) inhibitor; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; H1-receptor antagonist; serotonin uptake inhibitor |
amphetamine Amphetamine: A powerful central nervous system stimulant and sympathomimetic. Amphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulation of release of monamines, and inhibiting monoamine oxidase. Amphetamine is also a drug of abuse and a psychotomimetic. The l- and the d,l-forms are included here. The l-form has less central nervous system activity but stronger cardiovascular effects. The d-form is DEXTROAMPHETAMINE.. 1-phenylpropan-2-amine : A primary amine that is isopropylamine in which a hydrogen attached to one of the methyl groups has been replaced by a phenyl group.. amphetamine : A racemate comprising equimolar amounts of (R)-amphetamine (also known as levamphetamine or levoamphetamine) and (S)-amphetamine (also known as dexamfetamine or dextroamphetamine. | 2.07 | 1 | 0 | primary amine | |
diazepam Diazepam: A benzodiazepine with anticonvulsant, anxiolytic, sedative, muscle relaxant, and amnesic properties and a long duration of action. Its actions are mediated by enhancement of GAMMA-AMINOBUTYRIC ACID activity.. diazepam : A 1,4-benzodiazepinone that is 1,3-dihydro-2H-1,4-benzodiazepin-2-one substituted by a chloro group at position 7, a methyl group at position 1 and a phenyl group at position 5. | 2.57 | 2 | 0 | 1,4-benzodiazepinone; organochlorine compound | anticonvulsant; anxiolytic drug; environmental contaminant; sedative; xenobiotic |
diazoxide Diazoxide: A benzothiadiazine derivative that is a peripheral vasodilator used for hypertensive emergencies. It lacks diuretic effect, apparently because it lacks a sulfonamide group.. diazoxide : A benzothiadiazine that is the S,S-dioxide of 2H-1,2,4-benzothiadiazine which is substituted at position 3 by a methyl group and at position 7 by chlorine. A peripheral vasodilator, it increases the concentration of glucose in the plasma and inhibits the secretion of insulin by the beta- cells of the pancreas. It is used orally in the management of intractable hypoglycaemia and intravenously in the management of hypertensive emergencies. | 2.08 | 1 | 0 | benzothiadiazine; organochlorine compound; sulfone | antihypertensive agent; beta-adrenergic agonist; bronchodilator agent; cardiotonic drug; diuretic; K-ATP channel agonist; sodium channel blocker; sympathomimetic agent; vasodilator agent |
diclofenac Diclofenac: A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.. diclofenac : A monocarboxylic acid consisting of phenylacetic acid having a (2,6-dichlorophenyl)amino group at the 2-position. | 5.19 | 10 | 1 | amino acid; aromatic amine; dichlorobenzene; monocarboxylic acid; secondary amino compound | antipyretic; drug allergen; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; environmental contaminant; non-narcotic analgesic; non-steroidal anti-inflammatory drug; xenobiotic |
diphenhydramine Diphenhydramine: A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.. diphenhydramine : An ether that is the benzhydryl ether of 2-(dimethylamino)ethanol. It is a H1-receptor antagonist used as a antipruritic and antitussive drug.. antitussive : An agent that suppresses cough. Antitussives have a central or a peripheral action on the cough reflex, or a combination of both. Compare with expectorants, which are considered to increase the volume of secretions in the respiratory tract, so facilitating their removal by ciliary action and coughing, and mucolytics, which decrease the viscosity of mucus, facilitating its removal by ciliary action and expectoration. | 2.13 | 1 | 0 | ether; tertiary amino compound | anti-allergic agent; antidyskinesia agent; antiemetic; antiparkinson drug; antipruritic drug; antitussive; H1-receptor antagonist; local anaesthetic; muscarinic antagonist; oneirogen; sedative |
dipyridamole Dipyridamole: A phosphodiesterase inhibitor that blocks uptake and metabolism of adenosine by erythrocytes and vascular endothelial cells. Dipyridamole also potentiates the antiaggregating action of prostacyclin. (From AMA Drug Evaluations Annual, 1994, p752). dipyridamole : A pyrimidopyrimidine that is 2,2',2'',2'''-(pyrimido[5,4-d]pyrimidine-2,6-diyldinitrilo)tetraethanol substituted by piperidin-1-yl groups at positions 4 and 8 respectively. A vasodilator agent, it inhibits the formation of blood clots. | 2.08 | 1 | 0 | piperidines; pyrimidopyrimidine; tertiary amino compound; tetrol | adenosine phosphodiesterase inhibitor; EC 3.5.4.4 (adenosine deaminase) inhibitor; platelet aggregation inhibitor; vasodilator agent |
disopyramide Disopyramide: A class I anti-arrhythmic agent (one that interferes directly with the depolarization of the cardiac membrane and thus serves as a membrane-stabilizing agent) with a depressant action on the heart similar to that of guanidine. It also possesses some anticholinergic and local anesthetic properties.. disopyramide : A monocarboxylic acid amide that is butanamide substituted by a diisopropylamino group at position 4, a phenyl group at position 2 and a pyridin-2-yl group at position 2. It is used as a anti-arrhythmia drug. | 2.08 | 1 | 0 | monocarboxylic acid amide; pyridines; tertiary amino compound | anti-arrhythmia drug |
disulfiram [no description available] | 2.08 | 1 | 0 | organic disulfide; organosulfur acaricide | angiogenesis inhibitor; antineoplastic agent; apoptosis inducer; EC 1.2.1.3 [aldehyde dehydrogenase (NAD(+))] inhibitor; EC 3.1.1.1 (carboxylesterase) inhibitor; EC 3.1.1.8 (cholinesterase) inhibitor; EC 5.99.1.2 (DNA topoisomerase) inhibitor; ferroptosis inducer; fungicide; NF-kappaB inhibitor |
valproic acid Valproic Acid: A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.. valproic acid : A branched-chain saturated fatty acid that comprises of a propyl substituent on a pentanoic acid stem. | 2.41 | 1 | 0 | branched-chain fatty acid; branched-chain saturated fatty acid | anticonvulsant; antimanic drug; EC 3.5.1.98 (histone deacetylase) inhibitor; GABA agent; neuroprotective agent; psychotropic drug; teratogenic agent |
racemetirosine alpha-Methyltyrosine: An inhibitor of the enzyme TYROSINE 3-MONOOXYGENASE, and consequently of the synthesis of catecholamines. It is used to control the symptoms of excessive sympathetic stimulation in patients with PHEOCHROMOCYTOMA. (Martindale, The Extra Pharmacopoeia, 30th ed) | 2.01 | 1 | 0 | ||
p-chloroamphetamine p-Chloroamphetamine: Chlorinated analog of AMPHETAMINE. Potent neurotoxin that causes release and eventually depletion of serotonin in the CNS. It is used as a research tool. | 4.49 | 5 | 0 | ||
domperidone Domperidone: A specific blocker of dopamine receptors. It speeds gastrointestinal peristalsis, causes prolactin release, and is used as antiemetic and tool in the study of dopaminergic mechanisms.. domperidone : 1-[3-(Piperidin-1-yl)propyl]-1,3-dihydro-2H-benzimidazol-2-one in which the 4-position of the piperidine ring is substituted by a 5-chloro-1,3-dihydro-2H-benzimidazol-2-on-1-yl group. A dopamine antagonist, it is used as an antiemetic for the short-term treatment of nausea and vomiting, and to control gastrointestinal effects of dopaminergic drugs given in the management of parkinsonism. The free base is used in oral suspensions, while the maleate salt is used in tablet preparations. | 2.08 | 1 | 0 | benzimidazoles; heteroarylpiperidine | antiemetic; dopaminergic antagonist |
donepezil Donepezil: An indan and piperidine derivative that acts as a selective and reversible inhibitor of ACETYLCHOLINESTERASE. Donepezil is highly selective for the central nervous system and is used in the management of mild to moderate DEMENTIA in ALZHEIMER DISEASE.. donepezil : A racemate comprising equimolar amounts of (R)- and (S)-donepezil. A centrally acting reversible acetylcholinesterase inhibitor, its main therapeutic use is in the treatment of Alzheimer's disease where it is used to increase cortical acetylcholine.. 2-[(1-benzylpiperidin-4-yl)methyl]-5,6-dimethoxyindan-1-one : A member of the class of indanones that is 5,6-dimethoxyindan-1-one which is substituted at position 2 by an (N-benzylpiperidin-4-yl)methyl group. | 2.46 | 2 | 0 | aromatic ether; indanones; piperidines; racemate | EC 3.1.1.7 (acetylcholinesterase) inhibitor; EC 3.1.1.8 (cholinesterase) inhibitor; nootropic agent |
doxazosin Doxazosin: A prazosin-related compound that is a selective alpha-1-adrenergic blocker.. doxazosin : A member of the class of quinazolines that is quinazoline substituted by an amino group at position 4, methoxy groups at positions 6 and 7 and a piperazin-1-yl group at position 2 which in turn is substituted by a 2,3-dihydro-1,4-benzodioxin-2-ylcarbonyl group at position 4. An antihypertensive agent, it is used in the treatment of high blood pressure. | 14.26 | 6 | 1 | aromatic amine; benzodioxine; monocarboxylic acid amide; N-acylpiperazine; N-arylpiperazine; quinazolines | alpha-adrenergic antagonist; antihyperplasia drug; antihypertensive agent; antineoplastic agent; vasodilator agent |
doxepin Doxepin: A dibenzoxepin tricyclic compound. It displays a range of pharmacological actions including maintaining adrenergic innervation. Its mechanism of action is not fully understood, but it appears to block reuptake of monoaminergic neurotransmitters into presynaptic terminals. It also possesses anticholinergic activity and modulates antagonism of histamine H(1)- and H(2)-receptors.. doxepin : A dibenzooxepine that is 6,11-dihydrodibenzo[b,e]oxepine substituted by a 3-(dimethylamino)propylidene group at position 11. It is used as an antidepressant drug. | 2.52 | 2 | 0 | dibenzooxepine; tertiary amino compound | antidepressant |
droperidol Droperidol: A butyrophenone with general properties similar to those of HALOPERIDOL. It is used in conjunction with an opioid analgesic such as FENTANYL to maintain the patient in a calm state of neuroleptanalgesia with indifference to surroundings but still able to cooperate with the surgeon. It is also used as a premedicant, as an antiemetic, and for the control of agitation in acute psychoses. (From Martindale, The Extra Pharmacopoeia, 29th ed, p593). droperidol : An organofluorine compound that is haloperidol in which the hydroxy group has been eliminated with the introduction of a double bond in the piperidine ring, and the 4-chlorophenyl group has been replaced by a benzimidazol-2-on-1-yl group. It is used in the management of chemotherapy-induced nausea and vomiting, and in conjunction with an opioid analgesic such as fentanyl to maintain the patient in a calm state of neuroleptanalgesia with indifference to surroundings but still able to cooperate with the surgeon. | 2.41 | 1 | 0 | aromatic ketone; benzimidazoles; organofluorine compound | anaesthesia adjuvant; antiemetic; dopaminergic antagonist; first generation antipsychotic |
ebastine [no description available] | 2.08 | 1 | 0 | organic molecular entity | |
econazole Econazole: An imidazole derivative that is commonly used as a topical antifungal agent.. econazole : A racemate composed of equimolar amounts of (R)- and (S)-econazole. Used (as its nitrate salt) to treat skin infections such as athlete's foot, jock itch, ringworm and other fungal skin infections.. 1-{2-(4-chlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl}imidazole : A member of the class of imidazoles that is 1-(2,4-dichlorophenyl)-2-(imidazol-1-yl)ethanol in which the hydroxyl hydrogen is replaced by a 4-chlorobenzyl group. | 2.61 | 2 | 0 | dichlorobenzene; ether; imidazoles; monochlorobenzenes | |
enoxacin Enoxacin: A broad-spectrum 6-fluoronaphthyridinone antibacterial agent that is structurally related to NALIDIXIC ACID.. enoxacin : A 1,8-naphthyridine derivative that is 1,4-dihydro-1,8-naphthyridine with an ethyl group at the 1 position, a carboxy group at the 3-position, an oxo sustituent at the 4-position, a fluoro substituent at the 5-position and a piperazin-1-yl group at the 7 position. An antibacterial, it is used in the treatment of urinary-tract infections and gonorrhoea. | 2.08 | 1 | 0 | 1,8-naphthyridine derivative; amino acid; fluoroquinolone antibiotic; monocarboxylic acid; N-arylpiperazine; quinolone antibiotic | antibacterial drug; DNA synthesis inhibitor |
ethacrynic acid Ethacrynic Acid: A compound that inhibits symport of sodium, potassium, and chloride primarily in the ascending limb of Henle, but also in the proximal and distal tubules. This pharmacological action results in excretion of these ions, increased urinary output, and reduction in extracellular fluid. This compound has been classified as a loop or high ceiling diuretic.. etacrynic acid : An aromatic ether that is phenoxyacetic acid in which the phenyl ring is substituted by chlorines at positions 2 and 3, and by a 2-methylidenebutanoyl group at position 4. It is a loop diuretic used to treat high blood pressure resulting from diseases such as congestive heart failure, liver failure, and kidney failure. It is also a glutathione S-transferase (EC 2.5.1.18) inhibitor. | 2.08 | 1 | 0 | aromatic ether; aromatic ketone; dichlorobenzene; monocarboxylic acid | EC 2.5.1.18 (glutathione transferase) inhibitor; ion transport inhibitor; loop diuretic |
ethosuximide Ethosuximide: An anticonvulsant especially useful in the treatment of absence seizures unaccompanied by other types of seizures.. ethosuximide : A dicarboximide that is pyrrolidine-2,5-dione in which the hydrogens at position 3 are substituted by one methyl and one ethyl group. An antiepileptic, it is used in the treatment of absence seizures and may be used for myoclonic seizures, but is ineffective against tonic-clonic seizures. | 2.08 | 1 | 0 | dicarboximide; pyrrolidinone | anticonvulsant; geroprotector; T-type calcium channel blocker |
etodolac Etodolac: A non-steroidal anti-inflammatory agent and cyclooxygenase-2 (COX-2) inhibitor with potent analgesic and anti-arthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).. etodolac : A monocarboxylic acid that is acetic acid in which one of the methyl hydrogens is substituted by a 1,8-diethyl-1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl moiety. A preferential inhibitor of cyclo-oxygenase 2 and non-steroidal anti-inflammatory, it is used for the treatment of rheumatoid arthritis and osteoarthritis, and for the alleviation of postoperative pain. Administered as the racemate, only the (S)-enantiomer is active. | 2.07 | 1 | 0 | monocarboxylic acid; organic heterotricyclic compound | antipyretic; cyclooxygenase 2 inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
brl 42810 [no description available] | 2.08 | 1 | 0 | 2-aminopurines; acetate ester | antiviral drug; prodrug |
4-biphenylylacetic acid biphenyl-4-ylacetic acid : A monocarboxylic acid in which one of the alpha-hydrogens is substituted by a biphenyl-4-yl group. An active metabolite of fenbufen, it is used as a topical medicine to treat muscle inflammation and arthritis. | 2.08 | 1 | 0 | biphenyls; monocarboxylic acid | non-steroidal anti-inflammatory drug |
felodipine Felodipine: A dihydropyridine calcium antagonist with positive inotropic effects. It lowers blood pressure by reducing peripheral vascular resistance through a highly selective action on smooth muscle in arteriolar resistance vessels.. felodipine : The mixed (methyl, ethyl) diester of 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic acid. A calcium-channel blocker, it lowers blood pressure by reducing peripheral vascular resistance through a highly selective action on smooth muscle in arteriolar resistance vessels. It is used in the management of hypertension and angina pectoris. | 2.08 | 1 | 0 | dichlorobenzene; dihydropyridine; ethyl ester; methyl ester | anti-arrhythmia drug; antihypertensive agent; calcium channel blocker; vasodilator agent |
fenofibrate Pharmavit: a polyvitamin product, comprising vitamins A, D2, B1, B2, B6, C, E, nicotinamide, & calcium pantothene; may be a promising agent for application to human populations exposed to carcinogenic and genetic hazards of ionizing radiation; RN from CHEMLINE | 2.08 | 1 | 0 | aromatic ether; chlorobenzophenone; isopropyl ester; monochlorobenzenes | antilipemic drug; environmental contaminant; geroprotector; xenobiotic |
fentanyl Fentanyl: A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078). fentanyl : A monocarboxylic acid amide resulting from the formal condensation of the aryl amino group of N-phenyl-1-(2-phenylethyl)piperidin-4-amine with propanoic acid. | 7.67 | 5 | 2 | anilide; monocarboxylic acid amide; piperidines | adjuvant; anaesthesia adjuvant; anaesthetic; intravenous anaesthetic; mu-opioid receptor agonist; opioid analgesic |
fleroxacin Fleroxacin: A broad-spectrum antimicrobial fluoroquinolone. The drug strongly inhibits the DNA-supercoiling activity of DNA GYRASE.. fleroxacin : A fluoroquinolone antibiotic that is 4-oxo-1,4-dihydroquinoline which is substituted at positions 1, 3, 6, 7 and 8 by 2-fluoroethyl, carboxy, fluoro, 4-methylpiperazin-1-yl and fluoro groups, respectively. It is active against many Gram-positive and Gram-negative bacteria. | 2.08 | 1 | 0 | difluorobenzene; fluoroquinolone antibiotic; monocarboxylic acid; N-alkylpiperazine; quinolines | antibacterial drug; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor; topoisomerase IV inhibitor |
fluconazole Fluconazole: Triazole antifungal agent that is used to treat oropharyngeal CANDIDIASIS and cryptococcal MENINGITIS in AIDS.. fluconazole : A member of the class of triazoles that is propan-2-ol substituted at position 1 and 3 by 1H-1,2,4-triazol-1-yl groups and at position 2 by a 2,4-difluorophenyl group. It is an antifungal drug used for the treatment of mucosal candidiasis and for systemic infections including systemic candidiasis, coccidioidomycosis, and cryptococcosis. | 7.57 | 2 | 0 | conazole antifungal drug; difluorobenzene; tertiary alcohol; triazole antifungal drug | environmental contaminant; P450 inhibitor; xenobiotic |
flucytosine Flucytosine: A fluorinated cytosine analog that is used as an antifungal agent.. flucytosine : An organofluorine compound that is cytosine that is substituted at position 5 by a fluorine. A prodrug for the antifungal 5-fluorouracil, it is used for the treatment of systemic fungal infections. | 2.08 | 1 | 0 | aminopyrimidine; nucleoside analogue; organofluorine compound; pyrimidine antifungal drug; pyrimidone | prodrug |
flumazenil Flumazenil: A potent benzodiazepine receptor antagonist. Since it reverses the sedative and other actions of benzodiazepines, it has been suggested as an antidote to benzodiazepine overdoses.. flumazenil : An organic heterotricyclic compound that is 5,6-dihydro-4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted at positions 3, 5, 6, and 8 by ethoxycarbonyl, methyl, oxo, and fluoro groups, respectively. It is used as an antidote to benzodiazepine overdose. | 2.08 | 1 | 0 | ethyl ester; imidazobenzodiazepine; organofluorine compound | antidote to benzodiazepine poisoning; GABA antagonist |
fluorescite fluorescein (acid form) : A xanthene dye that is highly fluorescent and commonly used as a fluorescent tracer. | 2.08 | 1 | 0 | benzoic acids; cyclic ketone; hydroxy monocarboxylic acid; organic heterotricyclic compound; phenols; xanthene dye | fluorescent dye; radioopaque medium |
fluorouracil Fluorouracil: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.. 5-fluorouracil : A nucleobase analogue that is uracil in which the hydrogen at position 5 is replaced by fluorine. It is an antineoplastic agent which acts as an antimetabolite - following conversion to the active deoxynucleotide, it inhibits DNA synthesis (by blocking the conversion of deoxyuridylic acid to thymidylic acid by the cellular enzyme thymidylate synthetase) and so slows tumour growth. | 2.52 | 2 | 0 | nucleobase analogue; organofluorine compound | antimetabolite; antineoplastic agent; environmental contaminant; immunosuppressive agent; radiosensitizing agent; xenobiotic |
fluoxetine Fluoxetine: The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.. fluoxetine : A racemate comprising equimolar amounts of (R)- and (S)-fluoxetine. A selective serotonin reuptake inhibitor (SSRI), it is used (generally as the hydrochloride salt) for the treatment of depression (and the depressive phase of bipolar disorder), bullimia nervosa, and obsessive-compulsive disorder.. N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine : An aromatic ether consisting of 4-trifluoromethylphenol in which the hydrogen of the phenolic hydroxy group is replaced by a 3-(methylamino)-1-phenylpropyl group. | 14.97 | 70 | 11 | (trifluoromethyl)benzenes; aromatic ether; secondary amino compound | |
flurbiprofen Flurbiprofen: An anti-inflammatory analgesic and antipyretic of the phenylalkynoic acid series. It has been shown to reduce bone resorption in periodontal disease by inhibiting CARBONIC ANHYDRASE.. flurbiprofen : A monocarboxylic acid that is a 2-fluoro-[1,1'-biphenyl-4-yl] moiety linked to C-2 of propionic acid. A non-steroidal anti-inflammatory, analgesic and antipyretic, it is used as a pre-operative anti-miotic as well as orally for arthritis or dental pain. | 2.41 | 1 | 0 | fluorobiphenyl; monocarboxylic acid | antipyretic; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
flutamide Flutamide: An antiandrogen with about the same potency as cyproterone in rodent and canine species. | 2.08 | 1 | 0 | (trifluoromethyl)benzenes; monocarboxylic acid amide | androgen antagonist; antineoplastic agent |
furafylline [no description available] | 2.05 | 1 | 0 | oxopurine | |
furosemide Furosemide: A benzoic-sulfonamide-furan. It is a diuretic with fast onset and short duration that is used for EDEMA and chronic RENAL INSUFFICIENCY.. furosemide : A chlorobenzoic acid that is 4-chlorobenzoic acid substituted by a (furan-2-ylmethyl)amino and a sulfamoyl group at position 2 and 5 respectively. It is a diuretic used in the treatment of congestive heart failure. | 2.08 | 1 | 0 | chlorobenzoic acid; furans; sulfonamide | environmental contaminant; loop diuretic; xenobiotic |
gabapentin Gabapentin: A cyclohexane-gamma-aminobutyric acid derivative that is used for the treatment of PARTIAL SEIZURES; NEURALGIA; and RESTLESS LEGS SYNDROME.. gabapentin : A gamma-amino acid that is cyclohexane substituted at position 1 by aminomethyl and carboxymethyl groups. Used for treatment of neuropathic pain and restless legs syndrome. | 16.61 | 79 | 9 | gamma-amino acid | anticonvulsant; calcium channel blocker; environmental contaminant; xenobiotic |
gemfibrozil [no description available] | 2.08 | 1 | 0 | aromatic ether | antilipemic drug |
gliclazide Gliclazide: An oral sulfonylurea hypoglycemic agent which stimulates insulin secretion. | 2.08 | 1 | 0 | N-sulfonylurea | hypoglycemic agent; insulin secretagogue; radical scavenger |
glimepiride glimepiride: structure given in first source | 2.08 | 1 | 0 | sulfonamide | |
glipizide Glipizide: An oral hypoglycemic agent which is rapidly absorbed and completely metabolized.. glipizide : An N-sulfonylurea that is glyburide in which the (5-chloro-2-methoxybenzoyl group is replaced by a (5-methylpyrazin-2-yl)carbonyl group. An oral hypoglycemic agent, it is used in the treatment of type 2 diabetes mellitus. | 2.08 | 1 | 0 | aromatic amide; monocarboxylic acid amide; N-sulfonylurea; pyrazines | EC 2.7.1.33 (pantothenate kinase) inhibitor; hypoglycemic agent; insulin secretagogue |
glyburide Glyburide: An antidiabetic sulfonylurea derivative with actions like those of chlorpropamide. glyburide : An N-sulfonylurea that is acetohexamide in which the acetyl group is replaced by a 2-(5-chloro-2-methoxybenzamido)ethyl group. | 2.08 | 1 | 0 | monochlorobenzenes; N-sulfonylurea | anti-arrhythmia drug; EC 2.7.1.33 (pantothenate kinase) inhibitor; EC 3.6.3.49 (channel-conductance-controlling ATPase) inhibitor; hypoglycemic agent |
guanfacine Guanfacine: A centrally acting antihypertensive agent with specificity towards ADRENERGIC ALPHA-2 RECEPTORS. | 3.61 | 2 | 0 | acetamides | |
haloperidol Haloperidol: A phenyl-piperidinyl-butyrophenone that is used primarily to treat SCHIZOPHRENIA and other PSYCHOSES. It is also used in schizoaffective disorder, DELUSIONAL DISORDERS, ballism, and TOURETTE SYNDROME (a drug of choice) and occasionally as adjunctive therapy in INTELLECTUAL DISABILITY and the chorea of HUNTINGTON DISEASE. It is a potent antiemetic and is used in the treatment of intractable HICCUPS. (From AMA Drug Evaluations Annual, 1994, p279). haloperidol : A compound composed of a central piperidine structure with hydroxy and p-chlorophenyl substituents at position 4 and an N-linked p-fluorobutyrophenone moiety. | 2.08 | 1 | 0 | aromatic ketone; hydroxypiperidine; monochlorobenzenes; organofluorine compound; tertiary alcohol | antidyskinesia agent; antiemetic; dopaminergic antagonist; first generation antipsychotic; serotonergic antagonist |
halothane [no description available] | 2.06 | 1 | 0 | haloalkane; organobromine compound; organochlorine compound; organofluorine compound | inhalation anaesthetic |
hydrochlorothiazide Hydrochlorothiazide: A thiazide diuretic often considered the prototypical member of this class. It reduces the reabsorption of electrolytes from the renal tubules. This results in increased excretion of water and electrolytes, including sodium, potassium, chloride, and magnesium. It is used in the treatment of several disorders including edema, hypertension, diabetes insipidus, and hypoparathyroidism.. hydrochlorothiazide : A benzothiadiazine that is 3,4-dihydro-2H-1,2,4-benzothiadiazine 1,1-dioxide substituted by a chloro group at position 6 and a sulfonamide at 7. It is diuretic used for the treatment of hypertension and congestive heart failure. | 2.51 | 2 | 0 | benzothiadiazine; organochlorine compound; sulfonamide | antihypertensive agent; diuretic; environmental contaminant; xenobiotic |
hydroflumethiazide Hydroflumethiazide: A thiazide diuretic with actions and uses similar to those of HYDROCHLOROTHIAZIDE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p822). hydroflumethiazide : A benzothiadiazine consisting of a 3,4-dihydro-HH-1,2,4-benzothiadiazine bicyclic system dioxygenated on sulfur and carrying trifluoromethyl and aminosulfonyl groups at positions 6 and 7 respectively. A diuretic with actions and uses similar to those of hydrochlorothiazide. | 2.08 | 1 | 0 | benzothiadiazine; thiazide | antihypertensive agent; diuretic |
hydroxyurea [no description available] | 2.08 | 1 | 0 | one-carbon compound; ureas | antimetabolite; antimitotic; antineoplastic agent; DNA synthesis inhibitor; EC 1.17.4.1 (ribonucleoside-diphosphate reductase) inhibitor; genotoxin; immunomodulator; radical scavenger; teratogenic agent |
hydroxyzine Hydroxyzine: A histamine H1 receptor antagonist that is effective in the treatment of chronic urticaria, dermatitis, and histamine-mediated pruritus. Unlike its major metabolite CETIRIZINE, it does cause drowsiness. It is also effective as an antiemetic, for relief of anxiety and tension, and as a sedative.. hydroxyzine : A N-alkylpiperazine that is piperzine in which the nitrogens atoms are substituted by 2-(2-hydroxyethoxy)ethyl and (4-chlorophenyl)(phenyl)methyl groups respectively. | 2.41 | 1 | 0 | hydroxyether; monochlorobenzenes; N-alkylpiperazine | anticoronaviral agent; antipruritic drug; anxiolytic drug; dermatologic drug; H1-receptor antagonist |
ibuprofen Midol: combination of cinnamedrine, phenacetin, aspirin & caffeine | 5.36 | 6 | 0 | monocarboxylic acid | antipyretic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; drug allergen; environmental contaminant; geroprotector; non-narcotic analgesic; non-steroidal anti-inflammatory drug; radical scavenger; xenobiotic |
phenelzine Phenelzine: One of the MONOAMINE OXIDASE INHIBITORS used to treat DEPRESSION; PHOBIC DISORDERS; and PANIC. | 2.03 | 1 | 0 | primary amine | |
lidocaine Lidocaine: A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.. lidocaine : The monocarboxylic acid amide resulting from the formal condensation of N,N-diethylglycine with 2,6-dimethylaniline. | 7.59 | 10 | 0 | benzenes; monocarboxylic acid amide; tertiary amino compound | anti-arrhythmia drug; drug allergen; environmental contaminant; local anaesthetic; xenobiotic |
ifosfamide [no description available] | 2.08 | 1 | 0 | ifosfamides | alkylating agent; antineoplastic agent; environmental contaminant; immunosuppressive agent; xenobiotic |
imipramine Imipramine: The prototypical tricyclic antidepressant. It has been used in major depression, dysthymia, bipolar depression, attention-deficit disorders, agoraphobia, and panic disorders. It has less sedative effect than some other members of this therapeutic group.. imipramine : A dibenzoazepine that is 5H-dibenzo[b,f]azepine substituted by a 3-(dimethylamino)propyl group at the nitrogen atom. | 7.64 | 9 | 0 | dibenzoazepine | adrenergic uptake inhibitor; antidepressant; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor |
amrinone Amrinone: A positive inotropic cardiotonic (CARDIOTONIC AGENTS) with vasodilator properties, phosphodiesterase 3 inhibitory activity, and the ability to stimulate calcium ion influx into the cardiac cell.. amrinone : A 3,4'-bipyridine substituted at positions 5 and 6 by an amino group and a keto function respectively. A pyridine phosphodiesterase 3 inhibitor, it is a drug that may improve the prognosis in patients with congestive heart failure. | 2.08 | 1 | 0 | bipyridines | EC 3.1.4.* (phosphoric diester hydrolase) inhibitor |
indapamide Indapamide: A benzamide-sulfonamide-indole derived DIURETIC that functions by inhibiting SODIUM CHLORIDE SYMPORTERS.. indapamide : A sulfonamide formed by condensation of the carboxylic group of 4-chloro-3-sulfamoylbenzoic acid with the amino group of 2-methyl-2,3-dihydro-1H-indol-1-amine. | 2.08 | 1 | 0 | indoles; organochlorine compound; sulfonamide | antihypertensive agent; diuretic |
indeloxazine indeloxazine: RN given refers to parent cpd without isomeric designation | 3.2 | 5 | 0 | indene | |
indomethacin Indomethacin: A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES.. indometacin : A member of the class of indole-3-acetic acids that is indole-3-acetic acid in which the indole ring is substituted at positions 1, 2 and 5 by p-chlorobenzoyl, methyl, and methoxy groups, respectively. A non-steroidal anti-inflammatory drug, it is used in the treatment of musculoskeletal and joint disorders including osteoarthritis, rheumatoid arthritis, gout, bursitis and tendinitis. | 3.35 | 6 | 0 | aromatic ether; indole-3-acetic acids; monochlorobenzenes; N-acylindole | analgesic; drug metabolite; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; environmental contaminant; gout suppressant; non-steroidal anti-inflammatory drug; xenobiotic metabolite; xenobiotic |
iohexol Iohexol: An effective non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures. Its low systemic toxicity is the combined result of low chemotoxicity and low osmolality.. iohexol : A benzenedicarboxamide compound having N-(2,3-dihydroxypropyl)carbamoyl groups at the 1- and 3-positions, iodo substituents at the 2-, 4- and 6-positions and an N-(2,3-dihydroxypropyl)acetamido group at the 5-position. | 2.08 | 1 | 0 | benzenedicarboxamide; organoiodine compound | environmental contaminant; radioopaque medium; xenobiotic |
iproniazid [no description available] | 2.08 | 1 | 0 | carbohydrazide; pyridines | |
avapro Irbesartan: A spiro compound, biphenyl and tetrazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION, and in the treatment of kidney disease.. irbesartan : A biphenylyltetrazole that is an angiotensin II receptor antagonist used mainly for the treatment of hypertension. | 2.08 | 1 | 0 | azaspiro compound; biphenylyltetrazole | angiotensin receptor antagonist; antihypertensive agent; environmental contaminant; xenobiotic |
isoflurane Isoflurane: A stable, non-explosive inhalation anesthetic, relatively free from significant side effects. | 3.8 | 1 | 1 | organofluorine compound | inhalation anaesthetic |
isoniazid Hydra: A genus of freshwater polyps in the family Hydridae, order Hydroida, class HYDROZOA. They are of special interest because of their complex organization and because their adult organization corresponds roughly to the gastrula of higher animals.. hydrazide : Compounds derived from oxoacids RkE(=O)l(OH)m (l =/= 0) by replacing -OH by -NRNR2 (R groups are commonly H). (IUPAC). | 2.08 | 1 | 0 | carbohydrazide | antitubercular agent; drug allergen |
2-propanol 2-Propanol: An isomer of 1-PROPANOL. It is a colorless liquid having disinfectant properties. It is used in the manufacture of acetone and its derivatives and as a solvent. Topically, it is used as an antiseptic.. propan-2-ol : A secondary alcohol that is propane in which one of the hydrogens attached to the central carbon is substituted by a hydroxy group. | 2.6 | 1 | 0 | secondary alcohol; secondary fatty alcohol | protic solvent |
isradipine Isradipine: A potent antagonist of CALCIUM CHANNELS that is highly selective for VASCULAR SMOOTH MUSCLE. It is effective in the treatment of chronic stable angina pectoris, hypertension, and congestive cardiac failure. | 2.08 | 1 | 0 | benzoxadiazole; dihydropyridine; isopropyl ester; methyl ester | |
itraconazole [no description available] | 2.08 | 1 | 0 | piperazines | |
ketamine Ketamine: A cyclohexanone derivative used for induction of anesthesia. Its mechanism of action is not well understood, but ketamine can block NMDA receptors (RECEPTORS, N-METHYL-D-ASPARTATE) and may interact with sigma receptors.. ketamine : A member of the class of cyclohexanones in which one of the hydrogens at position 2 is substituted by a 2-chlorophenyl group, while the other is substituted by a methylamino group. | 12.14 | 14 | 3 | cyclohexanones; monochlorobenzenes; secondary amino compound | analgesic; environmental contaminant; intravenous anaesthetic; neurotoxin; NMDA receptor antagonist; xenobiotic |
ketanserin Ketanserin: A selective serotonin receptor antagonist with weak adrenergic receptor blocking properties. The drug is effective in lowering blood pressure in essential hypertension. It also inhibits platelet aggregation. It is well tolerated and is particularly effective in older patients.. ketanserin : A member of the class of quinazolines that is quinazoline-2,4(1H,3H)-dione which is substituted at position 3 by a 2-[4-(p-fluorobenzoyl)piperidin-1-yl]ethyl group. | 2.77 | 3 | 0 | aromatic ketone; organofluorine compound; piperidines; quinazolines | alpha-adrenergic antagonist; antihypertensive agent; cardiovascular drug; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; serotonergic antagonist |
ketoconazole 1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine : A dioxolane that is 1,3-dioxolane which is substituted at positions 2, 2, and 4 by imidazol-1-ylmethyl, 2,4-dichlorophenyl, and [para-(4-acetylpiperazin-1-yl)phenoxy]methyl groups, respectively. | 2.08 | 1 | 0 | dichlorobenzene; dioxolane; ether; imidazoles; N-acylpiperazine; N-arylpiperazine | |
ketorolac Ketorolac: A pyrrolizine carboxylic acid derivative structurally related to INDOMETHACIN. It is an NSAID and is used principally for its analgesic activity. (From Martindale The Extra Pharmacopoeia, 31st ed). ketorolac : A racemate comprising equimolar amounts of (R)-(+)- and (S)-(-)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid. While only the (S)-(-) enantiomer is a COX1 and COX2 inhibitor, the (R)-(+) enantiomer exhibits potent analgesic activity. A non-steroidal anti-inflammatory drug, ketorolac is mainly used (generally as the tromethamine salt) for its potent analgesic properties in the short-term management of post-operative pain, and in eye drops to relieve the ocular itching associated with seasonal allergic conjunctivitis. It was withdrawn from the market in many countries in 1993 following association with haemorrhage and renal failure.. 5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid : A member of the class of pyrrolizines that is 2,3-dihydro-1H-pyrrolizine which is substituted at positions 1 and 5 by carboxy and benzoyl groups, respectively. | 2.03 | 1 | 0 | amino acid; aromatic ketone; monocarboxylic acid; pyrrolizines; racemate | analgesic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; non-steroidal anti-inflammatory drug |
lamotrigine [no description available] | 4.2 | 4 | 0 | 1,2,4-triazines; dichlorobenzene; primary arylamine | anticonvulsant; antidepressant; antimanic drug; calcium channel blocker; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; environmental contaminant; excitatory amino acid antagonist; geroprotector; non-narcotic analgesic; xenobiotic |
lansoprazole Lansoprazole: A 2,2,2-trifluoroethoxypyridyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. Lansoprazole is a racemic mixture of (R)- and (S)-isomers. | 2.08 | 1 | 0 | benzimidazoles; pyridines; sulfoxide | anti-ulcer drug; EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor |
leflunomide Leflunomide: An isoxazole derivative that inhibits dihydroorotate dehydrogenase, the fourth enzyme in the pyrimidine biosynthetic pathway. It is used an immunosuppressive agent in the treatment of RHEUMATOID ARTHRITIS and PSORIATIC ARTHRITIS.. leflunomide : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of 5-methyl-1,2-oxazole-4-carboxylic acid with the anilino group of 4-(trifluoromethyl)aniline. The prodrug of teriflunomide. | 2.08 | 1 | 0 | (trifluoromethyl)benzenes; isoxazoles; monocarboxylic acid amide | antineoplastic agent; antiparasitic agent; EC 1.3.98.1 [dihydroorotate oxidase (fumarate)] inhibitor; EC 3.1.3.16 (phosphoprotein phosphatase) inhibitor; hepatotoxic agent; immunosuppressive agent; non-steroidal anti-inflammatory drug; prodrug; pyrimidine synthesis inhibitor; tyrosine kinase inhibitor |
letrozole [no description available] | 2.08 | 1 | 0 | nitrile; triazoles | antineoplastic agent; EC 1.14.14.14 (aromatase) inhibitor |
lofepramine Lofepramine: A psychotropic IMIPRAMINE derivative that acts as a tricyclic antidepressant and possesses few anticholinergic properties. It is metabolized to DESIPRAMINE. | 2.08 | 1 | 0 | aromatic ketone; dibenzoazepine; monochlorobenzenes; tertiary amino compound | antidepressant |
lomustine [no description available] | 2.08 | 1 | 0 | N-nitrosoureas; organochlorine compound | alkylating agent; antineoplastic agent |
loratadine Loratadine: A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness.. loratadine : A benzocycloheptapyridine that is 6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine substituted by a chloro group at position 8 and a 1-(ethoxycarbonyl)piperidin-4-ylidene group at position 11. It is a H1-receptor antagonist commonly employed in the treatment of allergic disorders. | 2.48 | 2 | 0 | benzocycloheptapyridine; ethyl ester; N-acylpiperidine; organochlorine compound; tertiary carboxamide | anti-allergic agent; cholinergic antagonist; geroprotector; H1-receptor antagonist |
maprotiline Maprotiline: A bridged-ring tetracyclic antidepressant that is both mechanistically and functionally similar to the tricyclic antidepressants, including side effects associated with its use. | 2.7 | 3 | 0 | anthracenes | |
mebendazole Mebendazole: A benzimidazole that acts by interfering with CARBOHYDRATE METABOLISM and inhibiting polymerization of MICROTUBULES.. mebendazole : A carbamate ester that is methyl 1H-benzimidazol-2-ylcarbamate substituted by a benzoyl group at position 5. | 2.08 | 1 | 0 | aromatic ketone; benzimidazoles; carbamate ester | antinematodal drug; microtubule-destabilising agent; tubulin modulator |
mecamylamine Mecamylamine: A nicotinic antagonist that is well absorbed from the gastrointestinal tract and crosses the blood-brain barrier. Mecamylamine has been used as a ganglionic blocker in treating hypertension, but, like most ganglionic blockers, is more often used now as a research tool. | 3.59 | 2 | 0 | primary aliphatic amine | |
mefenamic acid Mefenamic Acid: A non-steroidal anti-inflammatory agent with analgesic, anti-inflammatory, and antipyretic properties. It is an inhibitor of cyclooxygenase.. mefenamic acid : An aminobenzoic acid that is anthranilic acid in which one of the hydrogens attached to the nitrogen is replaced by a 2,3-dimethylphenyl group. Although classed as a non-steroidal anti-inflammatory drug, its anti-inflammatory properties are considered to be minor. It is used to relieve mild to moderate pain, including headaches, dental pain, osteoarthritis and rheumatoid arthritis. | 2.08 | 1 | 0 | aminobenzoic acid; secondary amino compound | analgesic; antipyretic; antirheumatic drug; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; environmental contaminant; non-steroidal anti-inflammatory drug; xenobiotic |
memantine [no description available] | 4.38 | 3 | 0 | adamantanes; primary aliphatic amine | antidepressant; antiparkinson drug; dopaminergic agent; neuroprotective agent; NMDA receptor antagonist |
metformin Metformin: A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289). metformin : A member of the class of guanidines that is biguanide the carrying two methyl substituents at position 1. | 2.08 | 1 | 0 | guanidines | environmental contaminant; geroprotector; hypoglycemic agent; xenobiotic |
methadone Methadone: A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3). methadone : A racemate comprising equimolar amounts of dextromethadone and levomethadone. It is a opioid analgesic which is used as a painkiller and as a substitute for heroin in the treatment of heroin addiction.. 6-(dimethylamino)-4,4-diphenylheptan-3-one : A ketone that is heptan-3-one substituted by a dimethylamino group at position 6 and two phenyl groups at position 4. | 6.2 | 3 | 1 | benzenes; diarylmethane; ketone; tertiary amino compound | |
methiothepin Methiothepin: A serotonin receptor antagonist in the CENTRAL NERVOUS SYSTEM used as an antipsychotic.. methiothepin : A dibenzothiepine that is 10,11-dihydrodibenzo[b,f]thiepine bearing additional methylthio and 4-methylpiperazin-1-yl substituents at positions 8 and 10 respectively. Potent 5-HT2 antagonist, also active as 5-HT1 antagonist. Differentiates 5-HT1D sub-types. Also displays affinity for rodent 5-HT5B, 5-HT5A, 5-HT7 and 5-HT6 receptors (pK1 values are 6.6, 7.0, 8.4 and 8.7 respectively). | 2.93 | 4 | 0 | aryl sulfide; dibenzothiepine; N-alkylpiperazine; tertiary amino compound | antipsychotic agent; dopaminergic antagonist; geroprotector; serotonergic antagonist |
methylphenidate Methylphenidate: A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.. methylphenidate : A racemate comprising equimolar amounts of the two threo isomers of methyl phenyl(piperidin-2-yl)acetate. A central stimulant and indirect-acting sympathomimetic, is used (generally as the hydrochloride salt) in the treatment of hyperactivity disorders in children and for the treatment of narcolepsy.. methyl phenyl(piperidin-2-yl)acetate : A amino acid ester that is methyl phenylacetate in which one of the hydrogens alpha to the carbonyl group is replaced by a piperidin-2-yl group. | 2.89 | 3 | 0 | beta-amino acid ester; methyl ester; piperidines | |
metoclopramide Metoclopramide: A dopamine D2 antagonist that is used as an antiemetic.. metoclopramide : A member of the class of benzamides resulting from the formal condensation of 4-amino-5-chloro-2-methoxybenzoic acid with the primary amino group of N,N-diethylethane-1,2-diamine. | 2.08 | 1 | 0 | benzamides; monochlorobenzenes; substituted aniline; tertiary amino compound | antiemetic; dopaminergic antagonist; environmental contaminant; gastrointestinal drug; xenobiotic |
metoprolol Metoprolol: A selective adrenergic beta-1 blocking agent that is commonly used to treat ANGINA PECTORIS; HYPERTENSION; and CARDIAC ARRHYTHMIAS.. metoprolol : A propanolamine that is 1-(propan-2-ylamino)propan-2-ol substituted by a 4-(2-methoxyethyl)phenoxy group at position 1. | 4.18 | 3 | 1 | aromatic ether; propanolamine; secondary alcohol; secondary amino compound | antihypertensive agent; beta-adrenergic antagonist; environmental contaminant; geroprotector; xenobiotic |
metronidazole Metronidazole: A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS.. metronidazole : A member of the class of imidazoles substituted at C-1, -2 and -5 with 2-hydroxyethyl, nitro and methyl groups respectively. It has activity against anaerobic bacteria and protozoa, and has a radiosensitising effect on hypoxic tumour cells. It may be given by mouth in tablets, or as the benzoate in an oral suspension. The hydrochloride salt can be used in intravenous infusions. Metronidazole is a prodrug and is selective for anaerobic bacteria due to their ability to intracellularly reduce the nitro group of metronidazole to give nitroso-containing intermediates. These can covalently bind to DNA, disrupting its helical structure, inducing DNA strand breaks and inhibiting bacterial nucleic acid synthesis, ultimately resulting in bacterial cell death. | 2.08 | 1 | 0 | C-nitro compound; imidazoles; primary alcohol | antiamoebic agent; antibacterial drug; antimicrobial agent; antiparasitic agent; antitrichomonal drug; environmental contaminant; prodrug; radiosensitizing agent; xenobiotic |
mexiletine Mexiletine: Antiarrhythmic agent pharmacologically similar to LIDOCAINE. It may have some anticonvulsant properties.. mexiletine : An aromatic ether which is 2,6-dimethylphenyl ether of 2-aminopropan-1-ol. | 7.32 | 6 | 2 | aromatic ether; primary amino compound | anti-arrhythmia drug |
mianserin Mianserin: A tetracyclic compound with antidepressant effects. It may cause drowsiness and hematological problems. Its mechanism of therapeutic action is not well understood, although it apparently blocks alpha-adrenergic, histamine H1, and some types of serotonin receptors.. mianserin : A dibenzoazepine (specifically 1,2,3,4,10,14b-hexahydrodibenzo[c,f]pyrazino[1,2-a]azepine) methyl-substituted on N-2. Closely related to (and now mostly superseded by) the tetracyclic antidepressant mirtazapinean, it is an atypical antidepressant used in the treatment of depression throughout Europe and elsewhere. | 8.5 | 23 | 0 | dibenzoazepine | adrenergic uptake inhibitor; alpha-adrenergic antagonist; antidepressant; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; geroprotector; H1-receptor antagonist; histamine agonist; sedative; serotonergic antagonist |
midazolam Midazolam: A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.. midazolam : An imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively. | 2.08 | 1 | 0 | imidazobenzodiazepine; monofluorobenzenes; organochlorine compound | anticonvulsant; antineoplastic agent; anxiolytic drug; apoptosis inducer; central nervous system depressant; GABAA receptor agonist; general anaesthetic; muscle relaxant; sedative |
midodrine Midodrine: An ethanolamine derivative that is an adrenergic alpha-1 agonist. It is used as a vasoconstrictor agent in the treatment of HYPOTENSION.. midodrine : An aromatic ether that is 1,4-dimethoxybenzene which is substituted at position 2 by a 2-(glycylamino)-1-hydroxyethyl group. A direct-acting sympathomimetic with selective alpha-adrenergic agonist activity, it is used (generally as its hydrochloride salt) as a peripheral vasoconstrictor in the treatment of certain hypotensive states. The main active moiety is its major metabolite, deglymidodrine. | 3.56 | 1 | 1 | amino acid amide; aromatic ether; secondary alcohol | alpha-adrenergic agonist; prodrug; sympathomimetic agent; vasoconstrictor agent |
minoxidil Minoxidil: A potent direct-acting peripheral vasodilator (VASODILATOR AGENTS) that reduces peripheral resistance and produces a fall in BLOOD PRESSURE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p371). minoxidil : A pyrimidine N-oxide that is pyrimidine-2,4-diamine 3-oxide substituted by a piperidin-1-yl group at position 6. | 2.08 | 1 | 0 | dialkylarylamine; tertiary amino compound | |
mirtazapine Mirtazapine: A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders. | 9.44 | 29 | 0 | benzazepine; tetracyclic antidepressant | alpha-adrenergic antagonist; anxiolytic drug; H1-receptor antagonist; histamine antagonist; oneirogen; serotonergic antagonist |
moclobemide Moclobemide: A reversible inhibitor of monoamine oxidase type A; (RIMA); (see MONOAMINE OXIDASE INHIBITORS) that has antidepressive properties.. moclobemide : A member of the class of benzamides that is benzamide substituted by a chloro group at position 4 and a 2-(morpholin-4-yl)ethyl group at the nitrogen atom. It acts as a reversible monoamine oxidase inhibitor and is used in the treatment of depression. | 2.46 | 2 | 0 | benzamides; monochlorobenzenes; morpholines | antidepressant; environmental contaminant; xenobiotic |
modafinil Modafinil: A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS.. modafinil : A racemate comprising equimolar amounts of armodafinil and (S)-modafinil. A central nervous system stimulant, it is used for the treatment of sleeping disorders such as narcolepsy, obstructive sleep apnoea, and shift-work sleep disorder. The optical enantiomers of modafinil have similar pharmacological actions in animals.. 2-[(diphenylmethyl)sulfinyl]acetamide : A sulfoxide that is dimethylsulfoxide in which two hydrogens attached to one of the methyl groups are replaced by phenyl groups, while one hydrogen attached to the other methyl group is replaced by a carbamoyl (aminocarbonyl) group. | 3.23 | 1 | 0 | monocarboxylic acid amide; sulfoxide | |
acecainide Acecainide: A major metabolite of PROCAINAMIDE. Its anti-arrhythmic action may cause cardiac toxicity in kidney failure.. N-acetylprocainamide : A benzamide obtained via formal condensation of 4-acetamidobenzoic acid and 2-(diethylamino)ethylamine. | 2.08 | 1 | 0 | acetamides; benzamides | anti-arrhythmia drug |
nadolol [no description available] | 2.08 | 1 | 0 | tetralins | |
naftopidil [no description available] | 2.13 | 1 | 0 | piperazines | |
nalidixic acid [no description available] | 2.08 | 1 | 0 | 1,8-naphthyridine derivative; monocarboxylic acid; quinolone antibiotic | antibacterial drug; antimicrobial agent; DNA synthesis inhibitor |
nefazodone nefazodone: may be useful as an opiate adjunct | 6.49 | 5 | 0 | aromatic ether; monochlorobenzenes; N-alkylpiperazine; N-arylpiperazine; triazoles | alpha-adrenergic antagonist; analgesic; antidepressant; serotonergic antagonist; serotonin uptake inhibitor |
nefopam Nefopam: Non-narcotic analgesic chemically similar to ORPHENADRINE. Its mechanism of action is unclear. It is used for the relief of acute and chronic pain. (From Martindale, The Extra Pharmacopoeia, 30th ed, p26). nefopam : A racemate comprising equal amounts of (R)- and (S)-nefopam. The hydrochloride is a centrally acting non-opiate analgesic commonly used for the treatment of moderate to severe pain.. 5-methyl-1-phenyl-3,4,5,6-tetrahydro-1H-2,5-benzoxazocine : A member of the class of benzoxazocines that is 3,4,5,6-tetrahydro-1H-2,5-benzoxazocine substituted by phenyl and methyl groups at positions 1 and 5 respectively. | 2.5 | 2 | 0 | benzoxazocine; tertiary amino compound | |
neostigmine Neostigmine: A cholinesterase inhibitor used in the treatment of myasthenia gravis and to reverse the effects of muscle relaxants such as gallamine and tubocurarine. Neostigmine, unlike PHYSOSTIGMINE, does not cross the blood-brain barrier.. neostigmine : A quaternary ammonium ion comprising an anilinium ion core having three methyl substituents on the aniline nitrogen, and a 3-[(dimethylcarbamoyl)oxy] substituent at position 3. It is a parasympathomimetic which acts as a reversible acetylcholinesterase inhibitor. | 2.08 | 1 | 0 | quaternary ammonium ion | antidote to curare poisoning; EC 3.1.1.7 (acetylcholinesterase) inhibitor |
nevirapine Nevirapine: A potent, non-nucleoside reverse transcriptase inhibitor used in combination with nucleoside analogues for treatment of HIV INFECTIONS and AIDS.. nevirapine : A dipyridodiazepine that is 5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepine which is substituted by methyl, oxo, and cyclopropyl groups at positions 4, 6, and 11, respectively. A non-nucleoside reverse transcriptase inhibitor with activity against HIV-1, it is used in combination with other antiretrovirals for the treatment of HIV infection. | 2.08 | 1 | 0 | cyclopropanes; dipyridodiazepine | antiviral drug; HIV-1 reverse transcriptase inhibitor |
nicardipine Nicardipine: A potent calcium channel blockader with marked vasodilator action. It has antihypertensive properties and is effective in the treatment of angina and coronary spasms without showing cardiodepressant effects. It has also been used in the treatment of asthma and enhances the action of specific antineoplastic agents.. nicardipine : A racemate comprising equimolar amounts of (R)- and (S)-nicardipine. It is a calcium channel blocker which is used to treat hypertension.. 2-[benzyl(methyl)amino]ethyl methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate : A dihydropyridine that is 1,4-dihydropyridine substituted by a methyl, {2-[benzyl(methyl)amino]ethoxy}carbonyl, 3-nitrophenyl, methoxycarbonyl and methyl groups at positions 2, 3, 4, 5 and 6, respectively. | 2.08 | 1 | 0 | benzenes; C-nitro compound; diester; dihydropyridine; methyl ester; tertiary amino compound | |
nifedipine Nifedipine: A potent vasodilator agent with calcium antagonistic action. It is a useful anti-anginal agent that also lowers blood pressure. | 2.08 | 1 | 0 | C-nitro compound; dihydropyridine; methyl ester | calcium channel blocker; human metabolite; tocolytic agent; vasodilator agent |
nimesulide nimesulide: structure. nimesulide : An aromatic ether having phenyl and 2-methylsulfonamido-5-nitrophenyl as the two aryl groups. | 2.08 | 1 | 0 | aromatic ether; C-nitro compound; sulfonamide | cyclooxygenase 2 inhibitor; non-steroidal anti-inflammatory drug |
nimodipine Nimodipine: A calcium channel blockader with preferential cerebrovascular activity. It has marked cerebrovascular dilating effects and lowers blood pressure.. nimodipine : A dihydropyridine that is 1,4-dihydropyridine which is substituted by methyl groups at positions 2 and 6, a (2-methoxyethoxy)carbonyl group at position 3, a m-nitrophenyl group at position 4, and an isopropoxycarbonyl group at position 5. An L-type calcium channel blocker, it acts particularly on cerebral circulation, and is used both orally and intravenously for the prevention and treatment of subarachnoid hemorrhage from ruptured intracranial aneurysm. | 2.08 | 1 | 0 | 2-methoxyethyl ester; C-nitro compound; dicarboxylic acids and O-substituted derivatives; diester; dihydropyridine; isopropyl ester | antihypertensive agent; calcium channel blocker; cardiovascular drug; vasodilator agent |
nisoldipine Nisoldipine: A dihydropyridine calcium channel antagonist that acts as a potent arterial vasodilator and antihypertensive agent. It is also effective in patients with cardiac failure and angina.. nisoldipine : A racemate consisting of equimolar amounts of (R)- and (S)-nisoldipine. A calcium channel blocker, it is used in the treatment of hypertension and angina pectoris.. methyl 2-methylpropyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate : A dihydropyridine that is 1,4-dihydropyridine which is substituted by methyl groups at positions 2 and 6, a methoxycarbonyl group at position 3, an o-nitrophenyl group at position 4, and an isobutoxycarbonyl group at position 5. The racemate, a calcium channel blocker, is used in the treatment of hypertension and angina pectoris. | 2.08 | 1 | 0 | C-nitro compound; dicarboxylic acids and O-substituted derivatives; diester; dihydropyridine; methyl ester | |
nitrazepam Nitrazepam: A benzodiazepine derivative used as an anticonvulsant and hypnotic.. nitrazepam : A 1,4-benzodiazepinone that is 1,3-dihydro-2H-1,4-benzodiazepin-2-one which is substituted at positions 5 and 7 by phenyl and nitro groups, respectively. It is used as a hypnotic for the short-term management of insomnia and for the treatment of epileptic spasms in infants (West's syndrome). | 2.08 | 1 | 0 | 1,4-benzodiazepinone; C-nitro compound | anticonvulsant; antispasmodic drug; drug metabolite; GABA modulator; sedative |
nitrendipine Nitrendipine: A calcium channel blocker with marked vasodilator action. It is an effective antihypertensive agent and differs from other calcium channel blockers in that it does not reduce glomerular filtration rate and is mildly natriuretic, rather than sodium retentive.. nitrendipine : A dihydropyridine that is 1,4-dihydropyridine substituted by methyl groups at positions 2 and 6, a 3-nitrophenyl group at position 4, a ethoxycarbonyl group at position 3 and a methoxycarbonyl group at position 5. It is a calcium-channel blocker used in the treatment of hypertension. | 2.08 | 1 | 0 | C-nitro compound; dicarboxylic acids and O-substituted derivatives; diester; dihydropyridine; ethyl ester; methyl ester | antihypertensive agent; calcium channel blocker; geroprotector; vasodilator agent |
nomifensine Nomifensine: An isoquinoline derivative that prevents dopamine reuptake into synaptosomes. The maleate was formerly used in the treatment of depression. It was withdrawn worldwide in 1986 due to the risk of acute hemolytic anemia with intravascular hemolysis resulting from its use. In some cases, renal failure also developed. (From Martindale, The Extra Pharmacopoeia, 30th ed, p266). nomifensine : An N-methylated tetrahydroisoquinoline carrying phenyl and amino substituents at positions C-4 and C-8, respectively. | 3.23 | 1 | 0 | isoquinolines | dopamine uptake inhibitor |
norfloxacin Norfloxacin: A synthetic fluoroquinolone (FLUOROQUINOLONES) with broad-spectrum antibacterial activity against most gram-negative and gram-positive bacteria. Norfloxacin inhibits bacterial DNA GYRASE.. norfloxacin : A quinolinemonocarboxylic acid with broad-spectrum antibacterial activity against most gram-negative and gram-positive bacteria. Norfloxacin is bactericidal and its mode of action depends on blocking of bacterial DNA replication by binding itself to an enzyme called DNA gyrase. | 2.08 | 1 | 0 | fluoroquinolone antibiotic; N-arylpiperazine; quinolinemonocarboxylic acid; quinolone antibiotic; quinolone | antibacterial drug; DNA synthesis inhibitor; environmental contaminant; xenobiotic |
nortriptyline Nortriptyline: A metabolite of AMITRIPTYLINE that is also used as an antidepressive agent. Nortriptyline is used in major depression, dysthymia, and atypical depressions.. nortriptyline : An organic tricyclic compound that is 10,11-dihydro-5H-dibenzo[a,d][7]annulene substituted by a 3-(methylamino)propylidene group at position 5. It is an active metabolite of amitriptyline. | 9.13 | 8 | 2 | organic tricyclic compound; secondary amine | adrenergic uptake inhibitor; analgesic; antidepressant; antineoplastic agent; apoptosis inducer; drug metabolite |
ofloxacin Ofloxacin: A synthetic fluoroquinolone antibacterial agent that inhibits the supercoiling activity of bacterial DNA GYRASE, halting DNA REPLICATION.. 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid : An oxazinoquinoline that is 2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinolin-7-one substituted by methyl, carboxy, fluoro, and 4-methylpiperazin-1-yl groups at positions 3, 6, 9, and 10, respectively.. ofloxacin : A racemate comprising equimolar amounts of levofloxacin and dextrofloxacin. It is a synthetic fluoroquinolone antibacterial agent which inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication. | 2.08 | 1 | 0 | 3-oxo monocarboxylic acid; N-arylpiperazine; N-methylpiperazine; organofluorine compound; oxazinoquinoline | |
omeprazole Omeprazole: A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.. omeprazole : A racemate comprising equimolar amounts of (R)- and (S)-omeprazole.. 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole : A member of the class of benzimidazoles that is 1H-benzimidazole which is substituted by a [4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl group at position 2 and a methoxy group at position 5. | 2.08 | 1 | 0 | aromatic ether; benzimidazoles; pyridines; sulfoxide | |
ondansetron Ondansetron: A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties. | 3.21 | 5 | 0 | carbazoles | |
oxaprozin Oxaprozin: An oxazole-propionic acid derivative, cyclooxygenase inhibitor, and non-steroidal anti-inflammatory drug that is used in the treatment of pain and inflammation associated with of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; and ARTHRITIS, JUVENILE.. oxaprozin : A monocarboxylic acid that is a propionic acid derivative having a 4,5-diphenyl-1,3-oxazol-2-yl substituent at position 3. It is non-steroidal anti-inflammatory drug commonly used to relieve the pain and inflammatory responses associated with osteoarthritis and rheumatoid arthritis. | 2.08 | 1 | 0 | 1,3-oxazoles; monocarboxylic acid | analgesic; non-steroidal anti-inflammatory drug |
oxazepam Oxazepam: A benzodiazepine used in the treatment of anxiety, alcohol withdrawal, and insomnia.. oxazepam : A 1,4-benzodiazepinone that is 1,3-dihydro-2H-1,4-benzodiazepin-2-one substituted by a chloro group at position 7, a hydroxy group at position 3 and phenyl group at position 5. | 2.47 | 2 | 0 | 1,4-benzodiazepinone; organochlorine compound | anxiolytic drug; environmental contaminant; xenobiotic |
oxidopamine Oxidopamine: A neurotransmitter analogue that depletes noradrenergic stores in nerve endings and induces a reduction of dopamine levels in the brain. Its mechanism of action is related to the production of cytolytic free-radicals.. oxidopamine : A benzenetriol that is phenethylamine in which the hydrogens at positions 2, 4, and 5 on the phenyl ring are replaced by hydroxy groups. It occurs naturally in human urine, but is also produced as a metabolite of the drug DOPA (used for the treatment of Parkinson's disease). | 4.32 | 4 | 0 | benzenetriol; catecholamine; primary amino compound | drug metabolite; human metabolite; neurotoxin |
oxybutynin oxybutynin: RN given refers to parent cpd. oxybutynin : A racemate comprising equimolar amounts of (R)-oxybutynin and esoxybutynin. An antispasmodic used for the treatment of overactive bladder. | 6.13 | 8 | 0 | acetylenic compound; carboxylic ester; racemate; tertiary alcohol; tertiary amino compound | antispasmodic drug; calcium channel blocker; local anaesthetic; muscarinic antagonist; muscle relaxant; parasympatholytic |
fenclonine Fenclonine: A selective and irreversible inhibitor of tryptophan hydroxylase, a rate-limiting enzyme in the biosynthesis of serotonin (5-HYDROXYTRYPTAMINE). Fenclonine acts pharmacologically to deplete endogenous levels of serotonin. | 2.31 | 1 | 0 | phenylalanine derivative | |
palmidrol palmidrol: a cannabinoid receptor-inactive eCB-related molecule used as prophylactic in helping to prevent respiratory viral infection. palmitoyl ethanolamide : An N-(long-chain-acyl)ethanolamine that is the ethanolamide of palmitic (hexadecanoic) acid. | 3.99 | 1 | 1 | endocannabinoid; N-(long-chain-acyl)ethanolamine; N-(saturated fatty acyl)ethanolamine | anti-inflammatory drug; anticonvulsant; antihypertensive agent; neuroprotective agent |
papaverine Papaverine: An alkaloid found in opium but not closely related to the other opium alkaloids in its structure or pharmacological actions. It is a direct-acting smooth muscle relaxant used in the treatment of impotence and as a vasodilator, especially for cerebral vasodilation. The mechanism of its pharmacological actions is not clear, but it apparently can inhibit phosphodiesterases and it may have direct actions on calcium channels.. papaverine : A benzylisoquinoline alkaloid that is isoquinoline substituted by methoxy groups at positions 6 and 7 and a 3,4-dimethoxybenzyl group at position 1. It has been isolated from Papaver somniferum. | 2.08 | 1 | 0 | benzylisoquinoline alkaloid; dimethoxybenzene; isoquinolines | antispasmodic drug; vasodilator agent |
pemoline Pemoline: A central nervous system stimulant used in fatigue and depressive states and to treat hyperkinetic disorders in children.. pemoline : A member of the class of 1,3-oxazoles that is 1,3-oxazol-4(5H)-one which is substituted by an amino group at position 2 and by a phenyl group at position 5. A central nervous system stimulant, it was used to treat hyperactivity disorders in children, but withdrawn from use following reports of serious hepatotoxicity. | 2.08 | 1 | 0 | 1,3-oxazoles | central nervous system stimulant |
pentamidine Pentamidine: Antiprotozoal agent effective in trypanosomiasis, leishmaniasis, and some fungal infections; used in treatment of PNEUMOCYSTIS pneumonia in HIV-infected patients. It may cause diabetes mellitus, central nervous system damage, and other toxic effects.. pentamidine : A diether consisting of pentane-1,5-diol in which both hydroxyl hydrogens have been replaced by 4-amidinophenyl groups. A trypanocidal drug that is used for treatment of cutaneous leishmaniasis and Chagas disease. | 2.08 | 1 | 0 | aromatic ether; carboxamidine; diether | anti-inflammatory agent; antifungal agent; calmodulin antagonist; chemokine receptor 5 antagonist; EC 2.3.1.48 (histone acetyltransferase) inhibitor; NMDA receptor antagonist; S100 calcium-binding protein B inhibitor; trypanocidal drug; xenobiotic |
pentoxifylline [no description available] | 3.85 | 2 | 1 | oxopurine | |
perphenazine Perphenazine: An antipsychotic phenothiazine derivative with actions and uses similar to those of CHLORPROMAZINE.. perphenazine : A phenothiazine derivative in which the phenothiazine tricycle carries a chloro substituent at the 2-position and a 3-[4-(2-hydroxyethyl)piperazin-1-yl]propyl group at N-10. | 2.08 | 1 | 0 | N-(2-hydroxyethyl)piperazine; N-alkylpiperazine; organochlorine compound; phenothiazines | antiemetic; dopaminergic antagonist; phenothiazine antipsychotic drug |
phenacetin Saridon: contains phenacetin, caffeine, propyphenazone & pyrithyldione | 2.08 | 1 | 0 | acetamides; aromatic ether | cyclooxygenase 3 inhibitor; non-narcotic analgesic; peripheral nervous system drug |
phloretin [no description available] | 2.17 | 1 | 0 | dihydrochalcones | antineoplastic agent; plant metabolite |
pindolol Pindolol: A moderately lipophilic beta blocker (ADRENERGIC BETA-ANTAGONISTS). It is non-cardioselective and has intrinsic sympathomimetic actions, but little membrane-stabilizing activity. (From Martindale, The Extra Pharmocopoeia, 30th ed, p638). pindolol : A member of the class of indols which is the 2-hydroxy-3-(isopropylamino)propyl ether derivative of 1H-indol-4-ol. | 2.46 | 2 | 0 | indoles; secondary amine | antiglaucoma drug; antihypertensive agent; beta-adrenergic antagonist; serotonergic antagonist; vasodilator agent |
pioglitazone Pioglitazone: A thiazolidinedione and PPAR GAMMA agonist that is used in the treatment of TYPE 2 DIABETES MELLITUS.. pioglitazone : A member of the class of thiazolidenediones that is 1,3-thiazolidine-2,4-dione substituted by a benzyl group at position 5 which in turn is substituted by a 2-(5-ethylpyridin-2-yl)ethoxy group at position 4 of the phenyl ring. It exhibits hypoglycemic activity. | 2.08 | 1 | 0 | aromatic ether; pyridines; thiazolidinediones | antidepressant; cardioprotective agent; EC 2.7.1.33 (pantothenate kinase) inhibitor; EC 6.2.1.3 (long-chain-fatty-acid--CoA ligase) inhibitor; ferroptosis inhibitor; geroprotector; hypoglycemic agent; insulin-sensitizing drug; PPARgamma agonist; xenobiotic |
piracetam Piracetam: A compound suggested to be both a nootropic and a neuroprotective agent. | 2.52 | 2 | 0 | organonitrogen compound; organooxygen compound | |
piribedil Piribedil: A dopamine D2 agonist. It is used in the treatment of parkinson disease, particularly for alleviation of tremor. It has also been used for circulatory disorders and in other applications as a D2 agonist. | 2.08 | 1 | 0 | N-arylpiperazine | |
ono 1078 pranlukast: SRS-A antagonist; leukotriene D4 receptor antagonist | 2.08 | 1 | 0 | chromones | |
pyranoprofen pyranoprofen: RN given refers to unlabled parent cpd; structure given in first source | 2.08 | 1 | 0 | pyridochromene | |
praziquantel azinox: Russian drug | 3.6 | 2 | 0 | isoquinolines | |
prazosin Prazosin: A selective adrenergic alpha-1 antagonist used in the treatment of HEART FAILURE; HYPERTENSION; PHEOCHROMOCYTOMA; RAYNAUD DISEASE; PROSTATIC HYPERTROPHY; and URINARY RETENTION.. prazosin : A member of the class of piperazines that is piperazine substituted by a furan-2-ylcarbonyl group and a 4-amino-6,7-dimethoxyquinazolin-2-yl group at positions 1 and 4 respectively. | 4.26 | 6 | 0 | aromatic ether; furans; monocarboxylic acid amide; piperazines; quinazolines | alpha-adrenergic antagonist; antihypertensive agent; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor |
primaquine Primaquine: An aminoquinoline that is given by mouth to produce a radical cure and prevent relapse of vivax and ovale malarias following treatment with a blood schizontocide. It has also been used to prevent transmission of falciparum malaria by those returning to areas where there is a potential for re-introduction of malaria. Adverse effects include anemias and GI disturbances. (From Martindale, The Extra Pharmacopeia, 30th ed, p404). primaquine : An N-substituted diamine that is pentane-1,4-diamine substituted by a 6-methoxyquinolin-8-yl group at the N(4) position. It is a drug used in the treatment of malaria and Pneumocystis pneumonia. | 2.08 | 1 | 0 | aminoquinoline; aromatic ether; N-substituted diamine | antimalarial |
primidone Primidone: A barbiturate derivative that acts as a GABA modulator and anti-epileptic agent. It is partly metabolized to PHENOBARBITAL in the body and owes some of its actions to this metabolite.. primidone : A pyrimidone that is dihydropyrimidine-4,6(1H,5H)-dione substituted by an ethyl and a phenyl group at position 5. It is used as an anticonvulsant for treatment of various types of seizures. | 2.08 | 1 | 0 | pyrimidone | anticonvulsant; environmental contaminant; xenobiotic |
probenecid Probenecid: The prototypical uricosuric agent. It inhibits the renal excretion of organic anions and reduces tubular reabsorption of urate. Probenecid has also been used to treat patients with renal impairment, and, because it reduces the renal tubular excretion of other drugs, has been used as an adjunct to antibacterial therapy.. probenecid : A sulfonamide in which the nitrogen of 4-sulfamoylbenzoic acid is substituted with two propyl groups. | 2.08 | 1 | 0 | benzoic acids; sulfonamide | uricosuric drug |
procainamide Procainamide: A class Ia antiarrhythmic drug that is structurally-related to PROCAINE.. procainamide : A benzamide that is 4-aminobenzamide substituted on the amide N by a 2-(diethylamino)ethyl group. It is a pharmaceutical antiarrhythmic agent used for the medical treatment of cardiac arrhythmias. | 2.08 | 1 | 0 | benzamides | anti-arrhythmia drug; platelet aggregation inhibitor; sodium channel blocker |
prochlorperazine Prochlorperazine: A phenothiazine antipsychotic used principally in the treatment of NAUSEA; VOMITING; and VERTIGO. It is more likely than CHLORPROMAZINE to cause EXTRAPYRAMIDAL DISORDERS. (From Martindale, The Extra Pharmacopoeia, 30th ed, p612). prochlorperazine : A member of the class of phenothiazines that is 10H-phenothiazine having a chloro substituent at the 2-position and a 3-(4-methylpiperazin-1-yl)propyl group at the N-10 position. | 2.08 | 1 | 0 | N-alkylpiperazine; N-methylpiperazine; organochlorine compound; phenothiazines | alpha-adrenergic antagonist; antiemetic; cholinergic antagonist; dopamine receptor D2 antagonist; dopaminergic antagonist; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; first generation antipsychotic |
procyclidine Procyclidine: A muscarinic antagonist that crosses the blood-brain barrier and is used in the treatment of drug-induced extrapyramidal disorders and in parkinsonism.. procyclidine : A tertiary alcohol that consists of propan-1-ol substituted by a cyclohexyl and a phenyl group at position 1 and a pyrrolidin-1-yl group at position 3. | 2.55 | 2 | 0 | pyrrolidines; tertiary alcohol | antidyskinesia agent; antiparkinson drug; muscarinic antagonist |
promethazine Promethazine: A phenothiazine derivative with histamine H1-blocking, antimuscarinic, and sedative properties. It is used as an antiallergic, in pruritus, for motion sickness and sedation, and also in animals.. promethazine : A tertiary amine that is a substituted phenothiazine in which the ring nitrogen at position 10 is attached to C-3 of an N,N-dimethylpropan-2-amine moiety. | 2.48 | 2 | 0 | phenothiazines; tertiary amine | anti-allergic agent; anticoronaviral agent; antiemetic; antipruritic drug; H1-receptor antagonist; local anaesthetic; sedative |
propafenone Propafenone: An antiarrhythmia agent that is particularly effective in ventricular arrhythmias. It also has weak beta-blocking activity.. propafenone : An aromatic ketone that is 3-(propylamino)propane-1,2-diol in which the hydrogen of the primary hydroxy group is replaced by a 2-(3-phenylpropanoyl)phenyl group. It is a class 1C antiarrhythmic drug with local anesthetic effects, and is used as the hydrochloride salt in the management of supraventricular and ventricular arrhythmias. | 2.08 | 1 | 0 | aromatic ketone; secondary alcohol; secondary amino compound | anti-arrhythmia drug |
propiverine propiverine: anticholinergic used for overactive bladder syndrome | 2.13 | 1 | 0 | diarylmethane | |
propranolol Propranolol: A widely used non-cardioselective beta-adrenergic antagonist. Propranolol has been used for MYOCARDIAL INFARCTION; ARRHYTHMIA; ANGINA PECTORIS; HYPERTENSION; HYPERTHYROIDISM; MIGRAINE; PHEOCHROMOCYTOMA; and ANXIETY but adverse effects instigate replacement by newer drugs.. propranolol : A propanolamine that is propan-2-ol substituted by a propan-2-ylamino group at position 1 and a naphthalen-1-yloxy group at position 3. | 3.23 | 5 | 0 | naphthalenes; propanolamine; secondary amine | anti-arrhythmia drug; antihypertensive agent; anxiolytic drug; beta-adrenergic antagonist; environmental contaminant; human blood serum metabolite; vasodilator agent; xenobiotic |
ranitidine [no description available] | 2.08 | 1 | 0 | aralkylamine | |
riluzole Riluzole: A glutamate antagonist (RECEPTORS, GLUTAMATE) used as an anticonvulsant (ANTICONVULSANTS) and to prolong the survival of patients with AMYOTROPHIC LATERAL SCLEROSIS. | 2.08 | 1 | 0 | benzothiazoles | |
risperidone Risperidone: A selective blocker of DOPAMINE D2 RECEPTORS and SEROTONIN 5-HT2 RECEPTORS that acts as an atypical antipsychotic agent. It has been shown to improve both positive and negative symptoms in the treatment of SCHIZOPHRENIA.. risperidone : A member of the class of pyridopyrimidines that is 2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one carrying an additional 2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl group at position 2. | 4.71 | 6 | 1 | 1,2-benzoxazoles; heteroarylpiperidine; organofluorine compound; pyridopyrimidine | alpha-adrenergic antagonist; dopaminergic antagonist; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; H1-receptor antagonist; psychotropic drug; second generation antipsychotic; serotonergic antagonist |
ritanserin Ritanserin: A selective and potent serotonin-2 antagonist that is effective in the treatment of a variety of syndromes related to anxiety and depression. The drug also improves the subjective quality of sleep and decreases portal pressure.. ritanserin : A thiazolopyrimidine that is 5H-[1,3]thiazolo[3,2-a]pyrimidin-5-one which is substituted at position 7 by a methyl group and at position 6 by a 2-{4-[bis(4-fluorophenyl)methylidene]piperidin-1-yl}ethyl group. A potent and long-acting seratonin (5-hydroxytryptamine, 5-HT) antagonist of the subtype 5-HT2 (Ki = 0.39 nM), it is used in the treatment of a variety of disorders including anxiety, depression and schizophrenia. It has little sedative action. | 2.11 | 1 | 0 | organofluorine compound; piperidines; thiazolopyrimidine | antidepressant; antipsychotic agent; anxiolytic drug; dopaminergic antagonist; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; serotonergic antagonist |
rofecoxib [no description available] | 2.08 | 1 | 0 | butenolide; sulfone | analgesic; cyclooxygenase 2 inhibitor; non-steroidal anti-inflammatory drug |
ropinirole [no description available] | 2.07 | 1 | 0 | indolones; tertiary amine | antidyskinesia agent; antiparkinson drug; central nervous system drug; dopamine agonist |
saccharin Saccharin: Flavoring agent and non-nutritive sweetener.. saccharin : A 1,2-benzisothiazole having a keto-group at the 3-position and two oxo substituents at the 1-position. It is used as an artificial sweetening agent. | 2.04 | 1 | 0 | 1,2-benzisothiazole; N-sulfonylcarboxamide | environmental contaminant; sweetening agent; xenobiotic |
sibutramine sibutramine: serotonin and norepinephrine transporter inhibitor; Meridia is tradename for sibutramine hydrochloride | 2.43 | 2 | 0 | organochlorine compound; tertiary amino compound | anti-obesity agent; serotonin uptake inhibitor |
sulfadiazine Sulfadiazine: One of the short-acting SULFONAMIDES used in combination with PYRIMETHAMINE to treat toxoplasmosis in patients with acquired immunodeficiency syndrome and in newborns with congenital infections.. sulfadiazine : A sulfonamide consisting of pyrimidine with a 4-aminobenzenesulfonamido group at the 2-position.. diazine : The parent structure of the diazines. | 2.08 | 1 | 0 | pyrimidines; substituted aniline; sulfonamide antibiotic; sulfonamide | antiinfective agent; antimicrobial agent; antiprotozoal drug; coccidiostat; drug allergen; EC 1.1.1.153 [sepiapterin reductase (L-erythro-7,8-dihydrobiopterin forming)] inhibitor; EC 2.5.1.15 (dihydropteroate synthase) inhibitor; environmental contaminant; xenobiotic |
iodoacetic acid Iodoacetic Acid: A derivative of ACETIC ACID that contains one IODINE atom attached to its methyl group.. iodoacetic acid : A haloacetic acid that is acetic acid in which one of the hydrogens of the methyl group is replaced by an iodine atom. | 2.55 | 2 | 0 | haloacetic acid; organoiodine compound | alkylating agent |
sotalol Sotalol: An adrenergic beta-antagonist that is used in the treatment of life-threatening arrhythmias.. sotalol : A sulfonamide that is N-phenylmethanesulfonamide in which the phenyl group is substituted at position 4 by a 1-hydroxy-2-(isopropylamino)ethyl group. It has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. It is used (usually as the hydrochloride salt) for the management of ventricular and supraventricular arrhythmias. | 2.08 | 1 | 0 | ethanolamines; secondary alcohol; secondary amino compound; sulfonamide | anti-arrhythmia drug; beta-adrenergic antagonist; environmental contaminant; xenobiotic |
imatinib [no description available] | 2.08 | 1 | 0 | aromatic amine; benzamides; N-methylpiperazine; pyridines; pyrimidines | antineoplastic agent; apoptosis inducer; tyrosine kinase inhibitor |
vorinostat Vorinostat: A hydroxamic acid and anilide derivative that acts as a HISTONE DEACETYLASE inhibitor. It is used in the treatment of CUTANEOUS T-CELL LYMPHOMA and SEZARY SYNDROME.. vorinostat : A dicarboxylic acid diamide comprising suberic (octanedioic) acid coupled to aniline and hydroxylamine. A histone deacetylase inhibitor, it is marketed under the name Zolinza for the treatment of cutaneous T cell lymphoma (CTCL). | 2.08 | 1 | 0 | dicarboxylic acid diamide; hydroxamic acid | antineoplastic agent; apoptosis inducer; EC 3.5.1.98 (histone deacetylase) inhibitor |
succinylcholine Succinylcholine: A quaternary skeletal muscle relaxant usually used in the form of its bromide, chloride, or iodide. It is a depolarizing relaxant, acting in about 30 seconds and with a duration of effect averaging three to five minutes. Succinylcholine is used in surgical, anesthetic, and other procedures in which a brief period of muscle relaxation is called for.. succinylcholine : A quaternary ammonium ion that is the bis-choline ester of succinic acid. | 3.95 | 2 | 1 | quaternary ammonium ion; succinate ester | drug allergen; muscle relaxant; neuromuscular agent |
sulconazole sulconazole: RN given refers to cpd with unspecified isomeric designation; structure given in first source. sulconazole : A racemate comprising equimolar amounts of (R)- and (S)-sulconazole. An antifungal agent with activity against Candida species, it is used (generally as the nitrate salt) for the topical treatment of fungal skin infections.. 1-{2-[(4-chlorobenzyl)sulfanyl]-2-(2,4-dichlorophenyl)ethyl}-1H-imidazole : A member of the class of imidazoles that is 1-ethyl-1H-imidazole in which one of the hydrogens of the methyl group is replaced by a (4-chlorobenzyl)sulfanediyl group while a second is replaced by a 2,4-dichlorophenyl group. | 2.11 | 1 | 0 | dichlorobenzene; imidazoles; monochlorobenzenes; organic sulfide | |
sulfamethoxazole Sulfamethoxazole: A bacteriostatic antibacterial agent that interferes with folic acid synthesis in susceptible bacteria. Its broad spectrum of activity has been limited by the development of resistance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p208). sulfamethoxazole : An isoxazole (1,2-oxazole) compound having a methyl substituent at the 5-position and a 4-aminobenzenesulfonamido group at the 3-position. | 2.08 | 1 | 0 | isoxazoles; substituted aniline; sulfonamide antibiotic; sulfonamide | antibacterial agent; antiinfective agent; antimicrobial agent; drug allergen; EC 1.1.1.153 [sepiapterin reductase (L-erythro-7,8-dihydrobiopterin forming)] inhibitor; EC 2.5.1.15 (dihydropteroate synthase) inhibitor; environmental contaminant; epitope; P450 inhibitor; xenobiotic |
sulfanitran [no description available] | 2.08 | 1 | 0 | sulfonamide | |
sulfasalazine Sulfasalazine: A drug that is used in the management of inflammatory bowel diseases. Its activity is generally considered to lie in its metabolic breakdown product, 5-aminosalicylic acid (see MESALAMINE) released in the colon. (From Martindale, The Extra Pharmacopoeia, 30th ed, p907). sulfasalazine : An azobenzene consisting of diphenyldiazene having a carboxy substituent at the 4-position, a hydroxy substituent at the 3-position and a 2-pyridylaminosulphonyl substituent at the 4'-position. | 2.08 | 1 | 0 | ||
sulfisoxazole Sulfisoxazole: A short-acting sulfonamide antibacterial with activity against a wide range of gram- negative and gram-positive organisms.. sulfisoxazole : A sulfonamide antibacterial with an oxazole substituent. It has antibiotic activity against a wide range of gram-negative and gram-positive organisms. | 2.08 | 1 | 0 | isoxazoles; sulfonamide antibiotic; sulfonamide | antibacterial drug; drug allergen |
sulpiride Sulpiride: A dopamine D2-receptor antagonist. It has been used therapeutically as an antidepressant, antipsychotic, and as a digestive aid. (From Merck Index, 11th ed). sulpiride : A member of the class of benzamides obtained from formal condensation between the carboxy group of 2-methoxy-5-sulfamoylbenzoic acid and the primary amino group of (1-ethylpyrrolidin-2-yl)methylamine. | 3.63 | 2 | 0 | benzamides; N-alkylpyrrolidine; sulfonamide | antidepressant; antiemetic; antipsychotic agent; dopaminergic antagonist |
sumatriptan Sumatriptan: A serotonin agonist that acts selectively at 5HT1 receptors. It is used in the treatment of MIGRAINE DISORDERS.. sumatriptan : A sulfonamide that consists of N,N-dimethyltryptamine bearing an additional (N-methylsulfamoyl)methyl substituent at position 5. Selective agonist for a vascular 5-HT1 receptor subtype (probably a member of the 5-HT1D family). Used (in the form of its succinate salt) for the acute treatment of migraine with or without aura in adults. | 2.08 | 1 | 0 | sulfonamide; tryptamines | serotonergic agonist; vasoconstrictor agent |
gatifloxacin Gatifloxacin: A fluoroquinolone antibacterial agent and DNA TOPOISOMERASE II inhibitor that is used as an ophthalmic solution for the treatment of BACTERIAL CONJUNCTIVITIS.. gatifloxacin : A monocarboxylic acid that is 4-oxo-1,4-dihydroquinoline-3-carboxylic acid which is substituted on the nitrogen by a cyclopropyl group and at positions 6, 7, and 8 by fluoro, 3-methylpiperazin-1-yl, and methoxy groups, respectively. Gatifloxacin is an antibiotic of the fourth-generation fluoroquinolone family, that like other members of that family, inhibits the bacterial topoisomerase type-II enzymes. | 2.08 | 1 | 0 | N-arylpiperazine; organofluorine compound; quinolinemonocarboxylic acid; quinolone antibiotic; quinolone | antiinfective agent; antimicrobial agent; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor |
tazarotene tazarotene: a topical acetylenic retinoid; a topical kerytolytic. tazarotene : The ethyl ester of tazarotenic acid. A prodrug for tazarotenic acid, it is used for the treatment of psoriasis, acne, and sun-damaged skin. | 2.08 | 1 | 0 | acetylenic compound; ethyl ester; pyridines; retinoid; thiochromane | keratolytic drug; prodrug; teratogenic agent |
temozolomide [no description available] | 2.08 | 1 | 0 | imidazotetrazine; monocarboxylic acid amide; triazene derivative | alkylating agent; antineoplastic agent; prodrug |
terazosin Terazosin: induces decreased blood pressure; used in the treatment of benign prostatic hyperplasia | 2.46 | 2 | 0 | furans; piperazines; primary amino compound; quinazolines | alpha-adrenergic antagonist; antihypertensive agent; antineoplastic agent |
terbutaline Terbutaline: A selective beta-2 adrenergic agonist used as a bronchodilator and tocolytic.. terbutaline : A member of the class of phenylethanolamines that is catechol substituted at position 5 by a 2-(tert-butylamino)-1-hydroxyethyl group. | 2.08 | 1 | 0 | phenylethanolamines; resorcinols | anti-asthmatic drug; beta-adrenergic agonist; bronchodilator agent; EC 3.1.1.7 (acetylcholinesterase) inhibitor; hypoglycemic agent; sympathomimetic agent; tocolytic agent |
terfenadine Terfenadine: A selective histamine H1-receptor antagonist devoid of central nervous system depressant activity. The drug was used for ALLERGY but withdrawn due to causing LONG QT SYNDROME. | 2.08 | 1 | 0 | diarylmethane | |
thalidomide Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppressive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.. thalidomide : A racemate comprising equimolar amounts of R- and S-thalidomide.. 2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione : A dicarboximide that is isoindole-1,3(2H)-dione in which the hydrogen attached to the nitrogen is substituted by a 2,6-dioxopiperidin-3-yl group. | 3.21 | 1 | 0 | phthalimides; piperidones | |
thiotepa Thiotepa: A very toxic alkylating antineoplastic agent also used as an insect sterilant. It causes skin, gastrointestinal, CNS, and bone marrow damage. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), thiotepa may reasonably be anticipated to be a carcinogen (Merck Index, 11th ed). | 2.08 | 1 | 0 | aziridines | |
tiapride [no description available] | 2.08 | 1 | 0 | benzamides | |
tilorone Tilorone: An antiviral agent used as its hydrochloride. It is the first recognized synthetic, low-molecular-weight compound that is an orally active interferon inducer, and is also reported to have antineoplastic and anti-inflammatory actions.. tilorone : A member of the class of fluoren-9-ones that is 9H-fluoren-9-one which is substituted by a 2-(diethylamino)ethoxy group at positions 2 and 7. It is an interferon inducer and a selective alpha7 nicotinic acetylcholine receptor (alpha7 nAChR) agonist. Its hydrochloride salt is used as an antiviral drug. | 2.08 | 1 | 0 | aromatic ether; diether; fluoren-9-ones; tertiary amino compound | anti-inflammatory agent; antineoplastic agent; antiviral agent; interferon inducer; nicotinic acetylcholine receptor agonist |
tinidazole Tinidazole: A nitroimidazole alkylating agent that is used as an antitrichomonal agent against TRICHOMONAS VAGINALIS; ENTAMOEBA HISTOLYTICA; and GIARDIA LAMBLIA infections. It also acts as an antibacterial agent for the treatment of BACTERIAL VAGINOSIS and anaerobic bacterial infections.. tinidazole : 1H-imidazole substituted at C-1 by a (2-ethylsulfonyl)ethyl group, at C-2 by a methyl group and at C-5 by a nitro group. It is used as an antiprotozoal, antibacterial agent. | 2.08 | 1 | 0 | imidazoles | antiamoebic agent; antibacterial drug; antiparasitic agent; antiprotozoal drug |
tizanidine tizanidine: RN given refers to parent cpd; structure. tizanidine : 2,1,3-Benzothiadiazole substituted at C-4 by a Delta(1)-imidazolin-2-ylamino group and at C-4 by a chloro group. It is an agonist at alpha2-adrenergic receptor sites. | 2.52 | 2 | 0 | benzothiadiazole; imidazoles | alpha-adrenergic agonist; muscle relaxant |
nikethamide Nikethamide: A central nervous system stimulant. It was formerly used in the treatment of barbiturate overdose but is now considered to be of no value for such purposes and may be dangerous. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1229) | 2.08 | 1 | 0 | pyridinecarboxamide | |
tolbutamide Tolbutamide: A sulphonylurea hypoglycemic agent with actions and uses similar to those of CHLORPROPAMIDE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p290). tolbutamide : An N-sulfonylurea that consists of 1-butylurea having a tosyl group attached at the 3-position. | 2.08 | 1 | 0 | N-sulfonylurea | human metabolite; hypoglycemic agent; insulin secretagogue; potassium channel blocker |
tolnaftate [no description available] | 2.08 | 1 | 0 | monothiocarbamic ester | antifungal drug |
trazodone Trazodone: A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309). trazodone : An N-arylpiperazine in which one nitrogen is substituted by a 3-chlorophenyl group, while the other is substituted by a 3-(3-oxo[1,2,4]triazolo[4,3-a]pyridin-2(3H)-yl)propyl group. | 4.13 | 4 | 0 | monochlorobenzenes; N-alkylpiperazine; N-arylpiperazine; triazolopyridine | adrenergic antagonist; antidepressant; anxiolytic drug; H1-receptor antagonist; sedative; serotonin uptake inhibitor |
triamterene Triamterene: A pteridinetriamine compound that inhibits SODIUM reabsorption through SODIUM CHANNELS in renal EPITHELIAL CELLS.. triamterene : Pteridine substituted at positions 2, 4 and 7 with amino groups and at position 6 with a phenyl group. A sodium channel blocker, it is used as a diuretic in the treatment of hypertension and oedema. | 2.08 | 1 | 0 | pteridines | diuretic; sodium channel blocker |
trimebutine Trimebutine: Proposed spasmolytic with possible local anesthetic action used in gastrointestinal disorders. | 4.15 | 2 | 1 | trihydroxybenzoic acid | |
trimethoprim Trimethoprim: A pyrimidine inhibitor of dihydrofolate reductase, it is an antibacterial related to PYRIMETHAMINE. It is potentiated by SULFONAMIDES and the TRIMETHOPRIM, SULFAMETHOXAZOLE DRUG COMBINATION is the form most often used. It is sometimes used alone as an antimalarial. TRIMETHOPRIM RESISTANCE has been reported.. trimethoprim : An aminopyrimidine antibiotic whose structure consists of pyrimidine 2,4-diamine and 1,2,3-trimethoxybenzene moieties linked by a methylene bridge. | 2.08 | 1 | 0 | aminopyrimidine; methoxybenzenes | antibacterial drug; diuretic; drug allergen; EC 1.5.1.3 (dihydrofolate reductase) inhibitor; environmental contaminant; xenobiotic |
troglitazone Troglitazone: A chroman and thiazolidinedione derivative that acts as a PEROXISOME PROLIFERATOR-ACTIVATED RECEPTORS (PPAR) agonist. It was formerly used in the treatment of TYPE 2 DIABETES MELLITUS, but has been withdrawn due to hepatotoxicity. | 2.08 | 1 | 0 | chromanes; thiazolidinone | anticoagulant; anticonvulsant; antineoplastic agent; antioxidant; EC 6.2.1.3 (long-chain-fatty-acid--CoA ligase) inhibitor; ferroptosis inhibitor; hypoglycemic agent; platelet aggregation inhibitor; vasodilator agent |
thenoyltrifluoroacetone Thenoyltrifluoroacetone: Chelating agent and inhibitor of cellular respiration. | 2.08 | 1 | 0 | ||
tyramine [no description available] | 6.39 | 3 | 3 | monoamine molecular messenger; primary amino compound; tyramines | EC 3.1.1.8 (cholinesterase) inhibitor; Escherichia coli metabolite; human metabolite; mouse metabolite; neurotransmitter |
undecylenic acid undecylenic acid: a fatty acid with a terminal double bond. 10-undecenoic acid : An undecenoic acid having its double bond in the 10-position. It is derived from castor oil and is used for the treatment of skin problems.. undecenoic acid : A C11, straight-chain fatty acid carrying a C=C double bond at any position. | 2.08 | 1 | 0 | undecenoic acid | antifungal drug; plant metabolite |
urapidil [no description available] | 2.08 | 1 | 0 | piperazines | |
venlafaxine venlafaxine : A tertiary amino compound that is N,N-dimethylethanamine substituted at position 1 by a 1-hydroxycyclohexyl and 4-methoxyphenyl group. | 2.08 | 1 | 0 | cyclohexanols; monomethoxybenzene; tertiary alcohol; tertiary amino compound | adrenergic uptake inhibitor; analgesic; antidepressant; dopamine uptake inhibitor; environmental contaminant; serotonin uptake inhibitor; xenobiotic |
vigabatrin [no description available] | 2.08 | 1 | 0 | gamma-amino acid | anticonvulsant; EC 2.6.1.19 (4-aminobutyrate--2-oxoglutarate transaminase) inhibitor |
pirinixic acid pirinixic acid: structure | 2.08 | 1 | 0 | aryl sulfide; organochlorine compound; pyrimidines | |
xylometazoline xylometazoline: RN given refers to parent cpd; structure | 2.25 | 1 | 0 | alkylbenzene | |
ici 204,219 zafirlukast: a leukotriene D4 receptor antagonist | 2.08 | 1 | 0 | carbamate ester; indoles; N-sulfonylcarboxamide | anti-asthmatic agent; leukotriene antagonist |
zaleplon zaleplon: an azabicyclo(4.3.0)nonane; a nonbenzodiazepine; one of the so-called of Z drugs (zopiclone, eszopiclone, zolpidem, and zaleplon) for which there is some correlation with tumors; a hypnotic with less marked effect on psychomotor functions compared to lorazepam. zaleplon : A pyrazolo[1,5-a]pyrimidine having a nitrile group at position 3 and a 3-(N-ethylacetamido)phenyl substituent at the 7-position. | 2.08 | 1 | 0 | nitrile; pyrazolopyrimidine | anticonvulsant; anxiolytic drug; central nervous system depressant; sedative |
zinc chloride zinc chloride: RN given refers to parent cpd. zinc dichloride : A compound of zinc and chloride ions in the ratio 1:2. It exists in four crystalline forms, in each of which the Zn(2+) ions are trigonal planar coordinated to four chloride ions. | 2.11 | 1 | 0 | inorganic chloride; zinc molecular entity | astringent; disinfectant; EC 5.3.3.5 (cholestenol Delta-isomerase) inhibitor; Lewis acid |
zolpidem Zolpidem: An imidazopyridine derivative and short-acting GABA-A receptor agonist that is used for the treatment of INSOMNIA.. zolpidem : An imidazo[1,2-a]pyridine compound having a 4-tolyl group at the 2-position, an N,N-dimethylcarbamoylmethyl group at the 3-position and a methyl substituent at the 6-position. | 2.06 | 1 | 0 | imidazopyridine | central nervous system depressant; GABA agonist; sedative |
zonisamide Zonisamide: A benzisoxazole and sulfonamide derivative that acts as a CALCIUM CHANNEL blocker. It is used primarily as an adjunctive antiepileptic agent for the treatment of PARTIAL SEIZURES, with or without secondary generalization.. zonisamide : A 1,2-benzoxazole compound having a sulfamoylmethyl substituent at the 3-position. | 2.08 | 1 | 0 | 1,2-benzoxazoles; sulfonamide | anticonvulsant; antioxidant; central nervous system drug; protective agent; T-type calcium channel blocker |
zopiclone zopiclone: S(+)-enantiomer of racemic zopiclone; azabicyclo(4.3.0)nonane; a nonbenzodiazepine; one of the so-called of Z drugs (zopiclone, eszopiclone, zolpidem, and zaleplon) for which there is some correlation with tumors; was term of zopiclone 2004-2007. zopiclone : A pyrrolo[3,4-b]pyrazine compound having a 4-methylpiperazine-1-carboxyl group at the 5-position, a 5-chloropyridin-2-yl group at the 6-position and an oxo-substituent at the 7-position. | 3.55 | 2 | 0 | monochloropyridine; pyrrolopyrazine | central nervous system depressant; sedative |
corticosterone [no description available] | 2.84 | 3 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; C21-steroid; glucocorticoid; primary alpha-hydroxy ketone | human metabolite; mouse metabolite |
prednisolone Prednisolone: A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.. prednisolone : A glucocorticoid that is prednisone in which the oxo group at position 11 has been reduced to the corresponding beta-hydroxy group. It is a drug metabolite of prednisone. | 2.51 | 2 | 0 | 11beta-hydroxy steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; C21-steroid; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | adrenergic agent; anti-inflammatory drug; antineoplastic agent; drug metabolite; environmental contaminant; immunosuppressive agent; xenobiotic |
reserpine Reserpine: An alkaloid found in the roots of Rauwolfia serpentina and R. vomitoria. Reserpine inhibits the uptake of norepinephrine into storage vesicles resulting in depletion of catecholamines and serotonin from central and peripheral axon terminals. It has been used as an antihypertensive and an antipsychotic as well as a research tool, but its adverse effects limit its clinical use.. reserpine : An alkaloid found in the roots of Rauwolfia serpentina and R. vomitoria. | 3.36 | 6 | 0 | alkaloid ester; methyl ester; yohimban alkaloid | adrenergic uptake inhibitor; antihypertensive agent; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; environmental contaminant; first generation antipsychotic; plant metabolite; xenobiotic |
phentolamine Phentolamine: A nonselective alpha-adrenergic antagonist. It is used in the treatment of hypertension and hypertensive emergencies, pheochromocytoma, vasospasm of RAYNAUD DISEASE and frostbite, clonidine withdrawal syndrome, impotence, and peripheral vascular disease.. phentolamine : A substituted aniline that is 3-aminophenol in which the hydrogens of the amino group are replaced by 4-methylphenyl and 4,5-dihydro-1H-imidazol-2-ylmethyl groups respectively. An alpha-adrenergic antagonist, it is used for the treatment of hypertension. | 2.02 | 1 | 0 | imidazoles; phenols; substituted aniline; tertiary amino compound | alpha-adrenergic antagonist; vasodilator agent |
triethylenemelamine Triethylenemelamine: Toxic alkylating agent used in industry; also as antineoplastic and research tool to produce chromosome aberrations and cancers. | 3.59 | 1 | 1 | 1,3,5-triazines | alkylating agent; insect sterilant |
thyroxine Thyroxine: The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism.. thyroxine : An iodothyronine compound having iodo substituents at the 3-, 3'-, 5- and 5'-positions. | 2.11 | 1 | 0 | 2-halophenol; iodophenol; L-phenylalanine derivative; non-proteinogenic L-alpha-amino acid; thyroxine zwitterion; thyroxine | antithyroid drug; human metabolite; mouse metabolite; thyroid hormone |
spironolactone Spironolactone: A potassium sparing diuretic that acts by antagonism of aldosterone in the distal renal tubules. It is used mainly in the treatment of refractory edema in patients with congestive heart failure, nephrotic syndrome, or hepatic cirrhosis. Its effects on the endocrine system are utilized in the treatments of hirsutism and acne but they can lead to adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p827). spironolactone : A steroid lactone that is 17alpha-pregn-4-ene-21,17-carbolactone substituted by an oxo group at position 3 and an alpha-acetylsulfanyl group at position 7. | 3.12 | 1 | 0 | 3-oxo-Delta(4) steroid; oxaspiro compound; steroid lactone; thioester | aldosterone antagonist; antihypertensive agent; diuretic; environmental contaminant; xenobiotic |
penicillamine Penicillamine: 3-Mercapto-D-valine. The most characteristic degradation product of the penicillin antibiotics. It is used as an antirheumatic and as a chelating agent in Wilson's disease.. penicillamine : An alpha-amino acid having the structure of valine substituted at the beta position with a sulfanyl group. | 2.08 | 1 | 0 | non-proteinogenic alpha-amino acid; penicillamine | antirheumatic drug; chelator; copper chelator; drug allergen |
prednisone Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.. prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid. | 2.13 | 1 | 0 | 11-oxo steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; C21-steroid; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | adrenergic agent; anti-inflammatory drug; antineoplastic agent; immunosuppressive agent; prodrug |
triiodothyronine Triiodothyronine: A T3 thyroid hormone normally synthesized and secreted by the thyroid gland in much smaller quantities than thyroxine (T4). Most T3 is derived from peripheral monodeiodination of T4 at the 5' position of the outer ring of the iodothyronine nucleus. The hormone finally delivered and used by the tissues is mainly T3.. 3,3',5-triiodo-L-thyronine : An iodothyronine compound having iodo substituents at the 3-, 3'- and 5-positions. Although some is produced in the thyroid, most of the 3,3',5-triiodo-L-thyronine in the body is generated by mono-deiodination of L-thyroxine in the peripheral tissues. Its metabolic activity is about 3 to 5 times that of L-thyroxine. The sodium salt is used in the treatment of hypothyroidism. | 2.04 | 1 | 0 | 2-halophenol; amino acid zwitterion; iodophenol; iodothyronine | human metabolite; mouse metabolite; thyroid hormone |
carbon tetrachloride Carbon Tetrachloride: A solvent for oils, fats, lacquers, varnishes, rubber waxes, and resins, and a starting material in the manufacturing of organic compounds. Poisoning by inhalation, ingestion or skin absorption is possible and may be fatal. (Merck Index, 11th ed). tetrachloromethane : A chlorocarbon that is methane in which all the hydrogens have been replaced by chloro groups. | 2.08 | 1 | 0 | chlorocarbon; chloromethanes | hepatotoxic agent; refrigerant |
alanine Alanine: A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.. alanine : An alpha-amino acid that consists of propionic acid bearing an amino substituent at position 2. | 3.35 | 1 | 0 | alanine zwitterion; alanine; L-alpha-amino acid; proteinogenic amino acid; pyruvate family amino acid | EC 4.3.1.15 (diaminopropionate ammonia-lyase) inhibitor; fundamental metabolite |
chloramphenicol Amphenicol: Chloramphenicol and its derivatives. | 2.08 | 1 | 0 | C-nitro compound; carboxamide; diol; organochlorine compound | antibacterial drug; antimicrobial agent; Escherichia coli metabolite; geroprotector; Mycoplasma genitalium metabolite; protein synthesis inhibitor |
aspartic acid Aspartic Acid: One of the non-essential amino acids commonly occurring in the L-form. It is found in animals and plants, especially in sugar cane and sugar beets. It may be a neurotransmitter.. aspartic acid : An alpha-amino acid that consists of succinic acid bearing a single alpha-amino substituent. L-aspartic acid : The L-enantiomer of aspartic acid. | 5.39 | 2 | 2 | aspartate family amino acid; aspartic acid; L-alpha-amino acid; proteinogenic amino acid | Escherichia coli metabolite; mouse metabolite; neurotransmitter |
sucrose Saccharum: A plant genus of the family POACEAE widely cultivated in the tropics for the sweet cane that is processed into sugar. | 2.07 | 1 | 0 | glycosyl glycoside | algal metabolite; Escherichia coli metabolite; human metabolite; mouse metabolite; osmolyte; Saccharomyces cerevisiae metabolite; sweetening agent |
ethinyl estradiol Ethinyl Estradiol: A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.. 17alpha-ethynylestradiol : A 3-hydroxy steroid that is estradiol substituted by a ethynyl group at position 17. It is a xenoestrogen synthesized from estradiol and has been shown to exhibit high estrogenic potency on oral administration. | 2.08 | 1 | 0 | 17-hydroxy steroid; 3-hydroxy steroid; terminal acetylenic compound | xenoestrogen |
tubocurarine Tubocurarine: A neuromuscular blocker and active ingredient in CURARE; plant based alkaloid of Menispermaceae.. tubocurarine : A benzylisoquinoline alkaloid muscle relaxant which constitutes the active component of curare.. isoquinoline alkaloid : Any alkaloid that has a structure based on an isoquinoline nucleus. They are derived from the amino acids like tyrosine and phenylalanine. | 2.08 | 1 | 0 | bisbenzylisoquinoline alkaloid | drug allergen; muscle relaxant; nicotinic antagonist |
apomorphine Apomorphine: A derivative of morphine that is a dopamine D2 agonist. It is a powerful emetic and has been used for that effect in acute poisoning. It has also been used in the diagnosis and treatment of parkinsonism, but its adverse effects limit its use. | 4.39 | 3 | 0 | aporphine alkaloid | alpha-adrenergic drug; antidyskinesia agent; antiparkinson drug; dopamine agonist; emetic; serotonergic drug |
kanamycin a Kanamycin: Antibiotic complex produced by Streptomyces kanamyceticus from Japanese soil. Comprises 3 components: kanamycin A, the major component, and kanamycins B and C, the minor components.. kanamycin : Kanamycin is a naturally occurring antibiotic complex from Streptomyces kanamyceticus that consists of several components: kanamycin A, the major component (also usually designated as kanamycin), and kanamycins B, C, D and X the minor components. | 2.08 | 1 | 0 | kanamycins | bacterial metabolite |
carbostyril Quinolones: A group of derivatives of naphthyridine carboxylic acid, quinoline carboxylic acid, or NALIDIXIC ACID.. quinolin-2(1H)-one : A quinolone that is 1,2-dihydroquinoline substituted by an oxo group at position 2. | 6.47 | 9 | 1 | monohydroxyquinoline; quinolone | bacterial xenobiotic metabolite |
levodopa Levodopa: The naturally occurring form of DIHYDROXYPHENYLALANINE and the immediate precursor of DOPAMINE. Unlike dopamine itself, it can be taken orally and crosses the blood-brain barrier. It is rapidly taken up by dopaminergic neurons and converted to DOPAMINE. It is used for the treatment of PARKINSONIAN DISORDERS and is usually given with agents that inhibit its conversion to dopamine outside of the central nervous system.. L-dopa : An optically active form of dopa having L-configuration. Used to treat the stiffness, tremors, spasms, and poor muscle control of Parkinson's disease | 5.32 | 3 | 1 | amino acid zwitterion; dopa; L-tyrosine derivative; non-proteinogenic L-alpha-amino acid | allelochemical; antidyskinesia agent; antiparkinson drug; dopaminergic agent; hapten; human metabolite; mouse metabolite; neurotoxin; plant growth retardant; plant metabolite; prodrug |
phenylethyl alcohol Phenylethyl Alcohol: An antimicrobial, antiseptic, and disinfectant that is used also as an aromatic essence and preservative in pharmaceutics and perfumery.. 2-phenylethanol : A primary alcohol that is ethanol substituted by a phenyl group at position 2. | 2.11 | 1 | 0 | benzenes; primary alcohol | Aspergillus metabolite; fragrance; plant growth retardant; plant metabolite; Saccharomyces cerevisiae metabolite |
tyrosine Tyrosine: A non-essential amino acid. In animals it is synthesized from PHENYLALANINE. It is also the precursor of EPINEPHRINE; THYROID HORMONES; and melanin.. tyrosine : An alpha-amino acid that is phenylalanine bearing a hydroxy substituent at position 4 on the phenyl ring. | 2.05 | 1 | 0 | amino acid zwitterion; erythrose 4-phosphate/phosphoenolpyruvate family amino acid; L-alpha-amino acid; proteinogenic amino acid; tyrosine | EC 1.3.1.43 (arogenate dehydrogenase) inhibitor; fundamental metabolite; micronutrient; nutraceutical |
phenylalanine Phenylalanine: An essential aromatic amino acid that is a precursor of MELANIN; DOPAMINE; noradrenalin (NOREPINEPHRINE), and THYROXINE.. L-phenylalanine : The L-enantiomer of phenylalanine.. phenylalanine : An aromatic amino acid that is alanine in which one of the methyl hydrogens is substituted by a phenyl group. | 2.1 | 1 | 0 | amino acid zwitterion; erythrose 4-phosphate/phosphoenolpyruvate family amino acid; L-alpha-amino acid; phenylalanine; proteinogenic amino acid | algal metabolite; EC 3.1.3.1 (alkaline phosphatase) inhibitor; Escherichia coli metabolite; human xenobiotic metabolite; micronutrient; mouse metabolite; nutraceutical; plant metabolite; Saccharomyces cerevisiae metabolite |
colchicine (S)-colchicine : A colchicine that has (S)-configuration. It is a secondary metabolite, has anti-inflammatory properties and is used to treat gout, crystal-induced joint inflammation, familial Mediterranean fever, and many other conditions. | 2.08 | 1 | 0 | alkaloid; colchicine | anti-inflammatory agent; gout suppressant; mutagen |
triamcinolone diacetate triamcinolone diacetate: lysyl oxidase antagonist; Polcortolon may also refers to triamcinolone | 2.08 | 1 | 0 | corticosteroid hormone | |
cytarabine [no description available] | 2.08 | 1 | 0 | beta-D-arabinoside; monosaccharide derivative; pyrimidine nucleoside | antimetabolite; antineoplastic agent; antiviral agent; immunosuppressive agent |
medroxyprogesterone acetate [no description available] | 2.08 | 1 | 0 | 20-oxo steroid; 3-oxo-Delta(4) steroid; acetate ester; corticosteroid; steroid ester | adjuvant; androgen; antineoplastic agent; antioxidant; female contraceptive drug; inhibitor; progestin; synthetic oral contraceptive |
tryptophan Tryptophan: An essential amino acid that is necessary for normal growth in infants and for NITROGEN balance in adults. It is a precursor of INDOLE ALKALOIDS in plants. It is a precursor of SEROTONIN (hence its use as an antidepressant and sleep aid). It can be a precursor to NIACIN, albeit inefficiently, in mammals.. tryptophan : An alpha-amino acid that is alanine bearing an indol-3-yl substituent at position 3. | 2.98 | 1 | 0 | erythrose 4-phosphate/phosphoenolpyruvate family amino acid; L-alpha-amino acid zwitterion; L-alpha-amino acid; proteinogenic amino acid; tryptophan zwitterion; tryptophan | antidepressant; Escherichia coli metabolite; human metabolite; micronutrient; mouse metabolite; nutraceutical; plant metabolite; Saccharomyces cerevisiae metabolite |
arginine Arginine: An essential amino acid that is physiologically active in the L-form.. arginine : An alpha-amino acid that is glycine in which the alpha-is substituted by a 3-guanidinopropyl group. | 2.44 | 2 | 0 | arginine; glutamine family amino acid; L-alpha-amino acid; proteinogenic amino acid | biomarker; Escherichia coli metabolite; micronutrient; mouse metabolite; nutraceutical |
acetonitrile acetonitrile: RN given refers to unlabeled cpd. acetonitrile : A nitrile that is hydrogen cyanide in which the hydrogen has been replaced by a methyl group. | 7.05 | 1 | 0 | aliphatic nitrile; volatile organic compound | EC 3.5.1.4 (amidase) inhibitor; NMR chemical shift reference compound; polar aprotic solvent |
tetramethylammonium tetramethylammonium: RN given refers to parent cpd. tetramethylammonium : The simplest quaternary ammonium cation, comprising a central nitrogen linked to four methyl groups. | 2.41 | 1 | 0 | quaternary ammonium ion | |
triamcinolone acetonide Triamcinolone Acetonide: An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.. triamcinolone acetonide : A synthetic glucocorticoid that is the 16,17-acetonide of triamcinolone. Used to treat various skin infections. | 2.08 | 1 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; cyclic ketal; fluorinated steroid; glucocorticoid; primary alpha-hydroxy ketone | anti-allergic agent; anti-inflammatory drug |
phencyclidine Phencyclidine: A hallucinogen formerly used as a veterinary anesthetic, and briefly as a general anesthetic for humans. Phencyclidine is similar to KETAMINE in structure and in many of its effects. Like ketamine, it can produce a dissociative state. It exerts its pharmacological action through inhibition of NMDA receptors (RECEPTORS, N-METHYL-D-ASPARTATE). As a drug of abuse, it is known as PCP and Angel Dust.. phencyclidine : A member of the class of piperidines that is piperidine in which the nitrogen is substituted with a 1-phenylcyclohexyl group. Formerly used as an anaesthetic agent, it exhibits both hallucinogenic and neurotoxic effects. | 2.41 | 1 | 0 | benzenes; piperidines | anaesthetic; neurotoxin; NMDA receptor antagonist; psychotropic drug |
methylprednisolone Methylprednisolone: A PREDNISOLONE derivative with similar anti-inflammatory action.. 6alpha-methylprednisolone : The 6alpha-stereoisomer of 6-methylprednisolone. | 2.51 | 2 | 0 | 6-methylprednisolone; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | adrenergic agent; anti-inflammatory drug; antiemetic; environmental contaminant; neuroprotective agent; xenobiotic |
rotenone Derris: A plant genus of the family FABACEAE. The root is a source of rotenoids (ROTENONE) and flavonoids. Some species of Pongamia have been reclassified to this genus and some to MILLETTIA. Some species of Deguelia have been reclassified to this genus.. rotenoid : Members of the class of tetrahydrochromenochromene that consists of a cis-fused tetrahydrochromeno[3,4-b]chromene skeleton and its substituted derivatives. The term was originally restricted to natural products, but is now also used to describe semi-synthetic and fully synthetic compounds. | 2.52 | 2 | 0 | organic heteropentacyclic compound; rotenones | antineoplastic agent; metabolite; mitochondrial NADH:ubiquinone reductase inhibitor; phytogenic insecticide; piscicide; toxin |
isosorbide dinitrate Isosorbide Dinitrate: A vasodilator used in the treatment of ANGINA PECTORIS. Its actions are similar to NITROGLYCERIN but with a slower onset of action. | 5.53 | 2 | 0 | glucitol derivative; nitrate ester | nitric oxide donor; vasodilator agent |
1-naphthol 1-naphthol: RN given refers to parent cpd. 1-naphthol : A naphthol carrying a hydroxy group at position 1.. hydroxynaphthalene : Any member of the class of naphthalenes that is naphthalene carrying one or more hydroxy groups. | 2.25 | 1 | 0 | naphthol | genotoxin; human xenobiotic metabolite |
quinoxalines quinoxaline : A naphthyridine in which the nitrogens are at positions 1 and 4. | 2.43 | 2 | 0 | mancude organic heterobicyclic parent; naphthyridine; ortho-fused heteroarene | |
isatin tribulin: endogenous MONOAMINE OXIDASE inhibitory activity extractable into ethyl acetate found in brain and many mammalian tissues and fluids; ISATIN is a major component; produced in excess following alcohol withdrawal; | 2.31 | 1 | 0 | indoledione | EC 1.4.3.4 (monoamine oxidase) inhibitor; plant metabolite |
pyrrolidonecarboxylic acid Pyrrolidonecarboxylic Acid: A cyclized derivative of L-GLUTAMIC ACID. Elevated blood levels may be associated with problems of GLUTAMINE or GLUTATHIONE metabolism.. 5-oxo-L-proline : An optically active form of 5-oxoproline having L-configuration. | 3.23 | 1 | 0 | 5-oxoproline; L-proline derivative; non-proteinogenic L-alpha-amino acid | algal metabolite |
quinuclidines Quinuclidines: A class of organic compounds which contain two rings that share a pair of bridgehead carbon atoms and contains an amine group. | 4.04 | 2 | 0 | quinuclidines; saturated organic heterobicyclic parent | |
cyclohexanol Cyclohexanols: Monohydroxy derivatives of cyclohexanes that contain the general formula R-C6H11O. They have a camphorlike odor and are used in making soaps, insecticides, germicides, dry cleaning, and plasticizers.. cyclohexanols : An alcohol in which one or more hydroxy groups are attached to a cyclohexane skeleton. | 16.26 | 82 | 11 | cyclohexanols; secondary alcohol | solvent |
pyrroles 1H-pyrrole : A tautomer of pyrrole that has the double bonds at positions 2 and 4.. pyrrole : A five-membered monocyclic heteroarene comprising one NH and four CH units which forms the parent compound of the pyrrole group of compounds. Its five-membered ring structure has three tautomers. A 'closed class'.. azole : Any monocyclic heteroarene consisting of a five-membered ring containing nitrogen. Azoles can also contain one or more other non-carbon atoms, such as nitrogen, sulfur or oxygen. | 3.85 | 3 | 0 | pyrrole; secondary amine | |
thiophenes Thiophenes: A monocyclic heteroarene furan in which the oxygen atom is replaced by a sulfur.. thiophenes : Compounds containing at least one thiophene ring. | 27.3 | 1,178 | 303 | mancude organic heteromonocyclic parent; monocyclic heteroarene; thiophenes; volatile organic compound | non-polar solvent |
phenformin Phenformin: A biguanide hypoglycemic agent with actions and uses similar to those of METFORMIN. Although it is generally considered to be associated with an unacceptably high incidence of lactic acidosis, often fatal, it is still available in some countries. (From Martindale, The Extra Pharmacopoeia, 30th ed, p290). phenformin : A member of the class of biguanides that is biguanide in which one of the terminal nitrogen atoms is substituted by a 2-phenylethyl group. It was used as an anti-diabetic drug but was later withdrawn from the market due to potential risk of lactic acidosis. | 2.08 | 1 | 0 | biguanides | antineoplastic agent; geroprotector; hypoglycemic agent |
2-naphthol 2-naphthol: RN given refers to parent cpd. 2-naphthol : A naphthol carrying a hydroxy group at position 2.. naphthols : Any hydroxynaphthalene derivative that has a single hydroxy substituent. | 2.25 | 1 | 0 | naphthol | antinematodal drug; genotoxin; human urinary metabolite; human xenobiotic metabolite; mouse metabolite; radical scavenger |
shikimic acid Shikimic Acid: A tri-hydroxy cyclohexene carboxylic acid important in biosynthesis of so many compounds that the shikimate pathway is named after it.. shikimic acid : A cyclohexenecarboxylic acid that is cyclohex-1-ene-1-carboxylic acid substituted by hydroxy groups at positions 3, 4 and 5 (the 3R,4S,5R stereoisomer). It is an intermediate metabolite in plants and microorganisms. | 2.41 | 1 | 0 | alpha,beta-unsaturated monocarboxylic acid; cyclohexenecarboxylic acid; hydroxy monocarboxylic acid | Escherichia coli metabolite; plant metabolite; Saccharomyces cerevisiae metabolite |
yohimbine Yohimbine: A plant alkaloid with alpha-2-adrenergic blocking activity. Yohimbine has been used as a mydriatic and in the treatment of ERECTILE DYSFUNCTION.. yohimbine : An indole alkaloid with alpha2-adrenoceptor antagonist activity. It is produced by Corynanthe johimbe and Rauwolfia serpentina. | 3.04 | 4 | 0 | methyl 17-hydroxy-20xi-yohimban-16-carboxylate | alpha-adrenergic antagonist; dopamine receptor D2 antagonist; serotonergic antagonist |
diphenhydramine hydrochloride Antitussive Agents: Agents that suppress cough. They act centrally on the medullary cough center. EXPECTORANTS, also used in the treatment of cough, act locally.. diphenhydramine hydrochloride : The hydrochloride salt of diphenhydramine. | 2.17 | 1 | 0 | hydrochloride; organoammonium salt | anti-allergic agent; antiemetic; antiparkinson drug; antipruritic drug; H1-receptor antagonist; local anaesthetic; muscarinic antagonist; sedative |
thiazoles [no description available] | 7.3 | 8 | 3 | 1,3-thiazoles; mancude organic heteromonocyclic parent; monocyclic heteroarene | |
pyrazines Pyrazines: A heterocyclic aromatic organic compound with the chemical formula C4H4N2.. pyrazine : A diazine that is benzene in which the carbon atoms at positions 1 and 4 have been replaced by nitrogen atoms. | 3.21 | 1 | 0 | diazine; pyrazines | Daphnia magna metabolite |
ephedrine Ephedrine: A phenethylamine found in EPHEDRA SINICA. PSEUDOEPHEDRINE is an isomer. It is an alpha- and beta-adrenergic agonist that may also enhance release of norepinephrine. It has been used for asthma, heart failure, rhinitis, and urinary incontinence, and for its central nervous system stimulatory effects in the treatment of narcolepsy and depression. It has become less extensively used with the advent of more selective agonists.. (-)-ephedrine : A phenethylamine alkaloid that is 2-phenylethanamine substituted by a methyl group at the amino nitrogen and a methyl and a hydroxy group at position 2 and 1 respectively. | 3.13 | 1 | 0 | phenethylamine alkaloid; phenylethanolamines | bacterial metabolite; environmental contaminant; nasal decongestant; plant metabolite; sympathomimetic agent; vasoconstrictor agent; xenobiotic |
aminophylline Aminophylline: A drug combination that contains THEOPHYLLINE and ethylenediamine. It is more soluble in water than theophylline but has similar pharmacologic actions. It's most common use is in bronchial asthma, but it has been investigated for several other applications.. aminophylline : A mixture comprising of theophylline and ethylenediamine in a 2:1 ratio. | 2.08 | 1 | 0 | mixture | bronchodilator agent; cardiotonic drug |
galantamine Galantamine: A benzazepine derived from norbelladine. It is found in GALANTHUS and other AMARYLLIDACEAE. It is a cholinesterase inhibitor that has been used to reverse the muscular effects of GALLAMINE TRIETHIODIDE and TUBOCURARINE and has been studied as a treatment for ALZHEIMER DISEASE and other central nervous system disorders.. galanthamine : A benzazepine alkaloid isolated from certain species of daffodils. | 2.08 | 1 | 0 | benzazepine alkaloid fundamental parent; benzazepine alkaloid; organic heterotetracyclic compound; tertiary amino compound | antidote to curare poisoning; cholinergic drug; EC 3.1.1.7 (acetylcholinesterase) inhibitor; EC 3.1.1.8 (cholinesterase) inhibitor; plant metabolite |
methysergide Methysergide: An ergot derivative that is a congener of LYSERGIC ACID DIETHYLAMIDE. It antagonizes the effects of serotonin in blood vessels and gastrointestinal smooth muscle, but has few of the properties of other ergot alkaloids. Methysergide is used prophylactically in migraine and other vascular headaches and to antagonize serotonin in the carcinoid syndrome.. methysergide : A synthetic ergot alkaloid, structurally related to the oxytocic agent methylergonovine and to the potent hallucinogen LSD and used prophylactically to reduce the frequency and intensity of severe vascular headaches. | 1.99 | 1 | 0 | ergoline alkaloid | |
procarbazine hydrochloride procarbazine hydrochloride : A hydrochloride obtained by combining procarbazine with one equivalent of hydrochloric acid. An antineoplastic chemotherapy drug used for treatment of Hodgkin's lymphoma. Metabolism yields azo-procarbazine and hydrogen peroxide, which results in the breaking of DNA strands. | 2.08 | 1 | 0 | hydrochloride | antineoplastic agent |
betamethasone Betamethasone: A glucocorticoid given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Its lack of mineralocorticoid properties makes betamethasone particularly suitable for treating cerebral edema and congenital adrenal hyperplasia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p724) | 2.08 | 1 | 0 | 11beta-hydroxy steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; fluorinated steroid; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | anti-asthmatic agent; anti-inflammatory drug; immunosuppressive agent |
fluorobenzenes Fluorobenzenes: Derivatives of BENZENE that contain FLUORINE.. monofluorobenzene : The simplest member of the class of monofluorobenzenes that is benzene carrying a single fluoro substituent.. fluorobenzenes : Any fluoroarene that is a benzene or a substituted benzene carrying at least one fluoro group. | 2.08 | 1 | 0 | monofluorobenzenes | NMR chemical shift reference compound |
emetine Emetine: The principal alkaloid of ipecac, from the ground roots of Uragoga (or Cephaelis) ipecacuanha or U. acuminata, of the Rubiaceae. It is used as an amebicide in many different preparations and may cause serious cardiac, hepatic, or renal damage and violent diarrhea and vomiting. Emetine inhibits protein synthesis in EUKARYOTIC CELLS but not PROKARYOTIC CELLS.. emetine : A pyridoisoquinoline comprising emetam having methoxy substituents at the 6'-, 7'-, 10- and 11-positions. It is an antiprotozoal agent and emetic. It inhibits SARS-CoV2, Zika and Ebola virus replication and displays antimalarial, antineoplastic and antiamoebic properties. | 2.08 | 1 | 0 | isoquinoline alkaloid; pyridoisoquinoline | antiamoebic agent; anticoronaviral agent; antiinfective agent; antimalarial; antineoplastic agent; antiprotozoal drug; antiviral agent; autophagy inhibitor; emetic; expectorant; plant metabolite; protein synthesis inhibitor |
bicuculline Bicuculline: An isoquinoline alkaloid obtained from Dicentra cucullaria and other plants. It is a competitive antagonist for GABA-A receptors.. bicuculline : A benzylisoquinoline alkaloid that is 6-methyl-5,6,7,8-tetrahydro[1,3]dioxolo[4,5-g]isoquinoline which is substituted at the 5-pro-S position by a (6R)-8-oxo-6,8-dihydrofuro[3,4-e][1,3]benzodioxol-6-yl group. A light-sensitive competitive antagonist of GABAA receptors. It was originally identified in 1932 in plant alkaloid extracts and has been isolated from Dicentra cucullaria, Adlumia fungosa, Fumariaceae, and several Corydalis species. | 1.99 | 1 | 0 | benzylisoquinoline alkaloid; isoquinoline alkaloid; isoquinolines | agrochemical; central nervous system stimulant; GABA-gated chloride channel antagonist; GABAA receptor antagonist; neurotoxin |
kainic acid Kainic Acid: (2S-(2 alpha,3 beta,4 beta))-2-Carboxy-4-(1-methylethenyl)-3-pyrrolidineacetic acid. Ascaricide obtained from the red alga Digenea simplex. It is a potent excitatory amino acid agonist at some types of excitatory amino acid receptors and has been used to discriminate among receptor types. Like many excitatory amino acid agonists it can cause neurotoxicity and has been used experimentally for that purpose. | 2.11 | 1 | 0 | dicarboxylic acid; L-proline derivative; non-proteinogenic L-alpha-amino acid; pyrrolidinecarboxylic acid | antinematodal drug; excitatory amino acid agonist |
phenylpropanolamine Phenylpropanolamine: A sympathomimetic that acts mainly by causing release of NOREPINEPHRINE but also has direct agonist activity at some adrenergic receptors. It is most commonly used as a nasal vasoconstrictor and an appetite depressant.. phenylpropanolamine : An amphetamine in which the parent 1-phenylpropan-2-amine skeleton is substituted at position 1 with an hydroxy group. A decongestant and appetite suppressant, it is commonly used in prescription and over-the-counter cough and cold preparations.. (-)-norephedrine : An amphetamine that is propylbenzene substituted by a hydroxy group at position 1 and by an amino group at position 2 (the 1R,2S-stereoisomer). It is a plant alkaloid. | 7.01 | 7 | 1 | amphetamines; phenethylamine alkaloid | plant metabolite |
dimenhydrinate gravinol: has antioxidant and ant-inflammatory activities; structure in first source | 2.08 | 1 | 0 | diarylmethane | |
methoxyhydroxyphenylglycol Methoxyhydroxyphenylglycol: Synthesized from endogenous epinephrine and norepinephrine in vivo. It is found in brain, blood, CSF, and urine, where its concentrations are used to measure catecholamine turnover. | 6.64 | 5 | 4 | methoxybenzenes; phenols | |
1-naphthylisothiocyanate 1-Naphthylisothiocyanate: A tool for the study of liver damage which causes bile stasis and hyperbilirubinemia acutely and bile duct hyperplasia and biliary cirrhosis chronically, with changes in hepatocyte function. It may cause skin and kidney damage. | 2.08 | 1 | 0 | isothiocyanate | insecticide |
lithium carbonate Lithium Carbonate: A lithium salt, classified as a mood-stabilizing agent. Lithium ion alters the metabolism of BIOGENIC MONOAMINES in the CENTRAL NERVOUS SYSTEM, and affects multiple neurotransmission systems. | 2.48 | 2 | 0 | carbonate salt; lithium salt | antimanic drug |
megestrol acetate [no description available] | 2.08 | 1 | 0 | 20-oxo steroid; 3-oxo-Delta(4) steroid; acetate ester; steroid ester | antineoplastic agent; appetite enhancer; contraceptive drug; progestin; synthetic oral contraceptive |
erythromycin Erythromycin: A bacteriostatic antibiotic macrolide produced by Streptomyces erythreus. Erythromycin A is considered its major active component. In sensitive organisms, it inhibits protein synthesis by binding to 50S ribosomal subunits. This binding process inhibits peptidyl transferase activity and interferes with translocation of amino acids during translation and assembly of proteins.. erythromycin : Any of several wide-spectrum macrolide antibiotics obtained from actinomycete Saccharopolyspora erythraea (formerly known as Streptomyces erythraeus).. erythromycin A : An erythromycin that consists of erythronolide A having 2,6-dideoxy-3-C-methyl-3-O-methyl-alpha-L-ribo-hexopyranosyl and 3,4,6-trideoxy-3-(dimethylamino)-beta-D-xylo-hexopyranosyl residues attahced at positions 4 and 6 respectively. | 2.08 | 1 | 0 | cyclic ketone; erythromycin | |
hydroxychloroquine sulfate [no description available] | 2.08 | 1 | 0 | ||
levonorgestrel Levonorgestrel: A synthetic progestational hormone with actions similar to those of PROGESTERONE and about twice as potent as its racemic or (+-)-isomer (NORGESTREL). It is used for contraception, control of menstrual disorders, and treatment of endometriosis. | 2.08 | 1 | 0 | 17beta-hydroxy steroid; 3-oxo-Delta(4) steroid; terminal acetylenic compound | contraceptive drug; female contraceptive drug; progestin; synthetic oral contraceptive |
ethambutol hydrochloride ethambutol dihydrochloride : The dihydrchloride salt of ethambutol. A bacteriostatic antimycobacterial drug, it is effective against Mycobacterium tuberculosis and some other mycobacteria. It is used in combination with other antituberculous drugs in the treatment of pulmonary and extrapulmonary tuberculosis; resistant strains of M. tuberculosis are readily produced if ethambutol dihydrochloride is used alone. | 2.08 | 1 | 0 | hydrochloride | antitubercular agent |
antimycin a [no description available] | 2.08 | 1 | 0 | benzamides; formamides; macrodiolide; phenols | antifungal agent; mitochondrial respiratory-chain inhibitor; piscicide |
pregnenolone carbonitrile Pregnenolone Carbonitrile: A catatoxic steroid and microsomal enzyme inducer having significant effects on the induction of cytochrome P450. It has also demonstrated the potential for protective capability against acetaminophen-induced liver damage. | 2.08 | 1 | 0 | aliphatic nitrile | |
metylperon metylperon: RN given refers to parent cpd | 2.08 | 1 | 0 | aromatic ketone | |
laudanosine laudanosine: opium alkaloid | 2.11 | 1 | 0 | isoquinolines | |
s,n,n'-tripropylthiocarbamate Reward: An object or a situation that can serve to reinforce a response, to satisfy a motive, or to afford pleasure.. vernolate : A monounsaturated fatty acid anion that is the conjugate base of vernolic acid, obtained by deprotonation of the carboxy group; major species at pH 7.3. | 4.21 | 3 | 1 | tertiary amine | |
dronabinol Dronabinol: A psychoactive compound extracted from the resin of Cannabis sativa (marihuana, hashish). The isomer delta-9-tetrahydrocannabinol (THC) is considered the most active form, producing characteristic mood and perceptual changes associated with this compound.. Delta(9)-tetrahydrocannabinol : A diterpenoid that is 6a,7,8,10a-tetrahydro-6H-benzo[c]chromene substituted at position 1 by a hydroxy group, positions 6, 6 and 9 by methyl groups and at position 3 by a pentyl group. The principal psychoactive constituent of the cannabis plant, it is used for treatment of anorexia associated with AIDS as well as nausea and vomiting associated with cancer chemotherapy. | 3.13 | 1 | 0 | benzochromene; diterpenoid; phytocannabinoid; polyketide | cannabinoid receptor agonist; epitope; hallucinogen; metabolite; non-narcotic analgesic |
stavudine Stavudine: A dideoxynucleoside analog that inhibits reverse transcriptase and has in vitro activity against HIV.. stavudine : A nucleoside analogue obtained by formal dehydration across positions 2 and 3 of thymidine. An inhibitor of HIV-1 reverse transcriptase | 2.08 | 1 | 0 | dihydrofuran; nucleoside analogue; organic molecular entity | antimetabolite; antiviral agent; EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor |
dicloxacillin Dicloxacillin: One of the PENICILLINS which is resistant to PENICILLINASE.. dicloxacillin : A penicillin that is 6-aminopenicillanic acid in which one of the amino hydrogens is replaced by a 3-(2,6-dichlorophenyl)-5-methyl-1,2-oxazol-4-yl]formyl group. | 2.08 | 1 | 0 | dichlorobenzene; penicillin | antibacterial drug |
cladribine [no description available] | 2.08 | 1 | 0 | organochlorine compound; purine 2'-deoxyribonucleoside | antineoplastic agent; immunosuppressive agent |
metocurine metocurine: from Chinese herb Cyclea hainanensis Mrr | 2.08 | 1 | 0 | isoquinolines | |
etidronate disodium etidronate disodium : An organic sodium salt resulting from the replacement of two protons from etidronic acid (one from from each of the phosphonic acid groups) by sodium ions. | 2.08 | 1 | 0 | organic sodium salt | antineoplastic agent; bone density conservation agent; chelator |
rhodium Rhodium: A hard and rare metal of the platinum group, atomic number 45, atomic weight 102.905, symbol Rh.. rhodium atom : A cobalt group element atom of atomic number 45. | 2.11 | 1 | 0 | cobalt group element atom | |
ruthenium Ruthenium: A hard, brittle, grayish-white rare earth metal with an atomic symbol Ru, atomic number 44, and atomic weight 101.07. It is used as a catalyst and hardener for PLATINUM and PALLADIUM. | 2.06 | 1 | 0 | iron group element atom; platinum group metal atom | |
technetium Technetium: The first artificially produced element and a radioactive fission product of URANIUM. Technetium has the atomic symbol Tc, and atomic number 43. All technetium isotopes are radioactive. Technetium 99m (m=metastable) which is the decay product of Molybdenum 99, has a half-life of about 6 hours and is used diagnostically as a radioactive imaging agent. Technetium 99 which is a decay product of technetium 99m, has a half-life of 210,000 years. | 2.45 | 2 | 0 | manganese group element atom | |
titanium Titanium: A dark-gray, metallic element of widespread distribution but occurring in small amounts with atomic number, 22, atomic weight, 47.867 and symbol, Ti; specific gravity, 4.5; used for fixation of fractures. | 7.05 | 1 | 0 | titanium group element atom | |
zalcitabine Zalcitabine: A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by a hydrogen. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is a potent inhibitor of HIV replication at low concentrations, acting as a chain-terminator of viral DNA by binding to reverse transcriptase. Its principal toxic side effect is axonal degeneration resulting in peripheral neuropathy.. zalcitabine : A pyrimidine 2',3'-dideoxyribonucleoside compound having cytosine as the nucleobase. | 2.08 | 1 | 0 | pyrimidine 2',3'-dideoxyribonucleoside | antimetabolite; antiviral drug; HIV-1 reverse transcriptase inhibitor |
hypochlorous acid Hypochlorous Acid: An oxyacid of chlorine (HClO) containing monovalent chlorine that acts as an oxidizing or reducing agent.. hypochlorous acid : A chlorine oxoacid with formula HOCl; a weak, unstable acid, it is the active form of chlorine in water. | 2.17 | 1 | 0 | chlorine oxoacid; reactive oxygen species | EC 2.5.1.18 (glutathione transferase) inhibitor; EC 3.1.1.7 (acetylcholinesterase) inhibitor; human metabolite |
camptothecin NSC 100880: carboxylate (opened lactone) form of camptothecin; RN refers to (S)-isomer; structure given in first source | 2.08 | 1 | 0 | delta-lactone; pyranoindolizinoquinoline; quinoline alkaloid; tertiary alcohol | antineoplastic agent; EC 5.99.1.2 (DNA topoisomerase) inhibitor; genotoxin; plant metabolite |
phosphine phosphane : The simplest phosphine, consisting of a single phosphorus atom with three hydrogens attached.. phosphine : Phosphane (PH3) and compounds derived from it by substituting one, two or three hydrogen atoms by hydrocarbyl groups: RPH2, R2PH, R3P (R =/= H) are called primary, secondary and tertiary phosphines, respectively. A specific phosphine is preferably named as a substituted phosphane. | 2.11 | 1 | 0 | mononuclear parent hydride; phosphanes; phosphine | carcinogenic agent; fumigant insecticide |
deuterium Deuterium: The stable isotope of hydrogen. It has one neutron and one proton in the nucleus. | 2.05 | 1 | 0 | dihydrogen | |
glycerol 1-stearate glycerol 1-stearate: isolated from the young fronds of the bracken fern Pteridium aquilinum; structure in first source. rac-1-monostearoylglycerol : A rac-1-monoacylglycerol composed of equal amounts of 3-stearoyl-sn-glycerol and 1-stearoyl-sn-glycerol.. 1-monostearoylglycerol : A 1-monoglyceride that has stearoyl as the acyl group. | 2.1 | 1 | 0 | 1-acylglycerol 18:0; rac-1-monoacylglycerol | algal metabolite; Caenorhabditis elegans metabolite |
4-chloro-7-nitrobenzofurazan 4-Chloro-7-nitrobenzofurazan: A benzofuran derivative used as a protein reagent since the terminal N-NBD-protein conjugate possesses interesting fluorescence and spectral properties. It has also been used as a covalent inhibitor of both beef heart mitochondrial ATPase and bacterial ATPase.. 4-chloro-7-nitrobenzofurazan : A benzoxadiazole that is 2,1,3-benzoxadiazole which is substituted at position 4 by chlorine and at position 7 by a nitro group. | 2.1 | 1 | 0 | benzoxadiazole; C-nitro compound; organochlorine compound | EC 1.4.3.4 (monoamine oxidase) inhibitor; EC 3.6.1.3 (adenosinetriphosphatase) inhibitor; fluorescent probe; fluorochrome |
trolamine salicylate Arthritis: Acute or chronic inflammation of JOINTS. | 5.77 | 2 | 2 | ||
mafenide acetate [no description available] | 2.08 | 1 | 0 | carboxylic acid | |
titanium dioxide titanium dioxide: used medically as protectant against externally caused irritation & sunlight; high concentrations of dust may cause irritation to respiratory tract; RN given refers to titanium oxide (TiO2); structure. titanium dioxide : A titanium oxide with the formula TiO2. A naturally occurring oxide sourced from ilmenite, rutile and anatase, it has a wide range of applications. | 7.05 | 1 | 0 | titanium oxides | food colouring |
diacerein diacerein: chelates with bivalent metals; a quinone which possesses redox properties; metabolized to active rhein; proposed mechanisms include inhibiting IL1 and metalloproteinases; called a slow acting symptomatic drug in osteoarthritis; no effect of cyclooxygenase; | 2.08 | 1 | 0 | anthraquinone | |
selegiline Selegiline: A selective, irreversible inhibitor of Type B monoamine oxidase that is used for the treatment of newly diagnosed patients with PARKINSON DISEASE, and for the treatment of depressive disorders. The compound without isomeric designation is Deprenyl. | 2.11 | 1 | 0 | selegiline; terminal acetylenic compound | geroprotector |
selegiline hydrochloride, (r)-isomer [no description available] | 2.08 | 1 | 0 | hydrochloride; terminal acetylenic compound | antiparkinson drug; dopaminergic agent; EC 1.4.3.4 (monoamine oxidase) inhibitor |
thiamphenicol [no description available] | 2.08 | 1 | 0 | monocarboxylic acid amide; sulfone | antimicrobial agent; immunosuppressive agent |
pancuronium bromide pancuronium bromide : A bromide salt consisting of two bromide ions and one pancuronium dication. | 2.08 | 1 | 0 | bromide salt | cholinergic antagonist; muscle relaxant; nicotinic antagonist |
ornidazole Ornidazole: A nitroimidazole antiprotozoal agent used in ameba and trichomonas infections. It is partially plasma-bound and also has radiation-sensitizing action.. ornidazole : A C-nitro compound that is 5-nitroimidazole in which the hydrogens at positions 1 and 2 are replaced by 3-chloro-2-hydroxypropyl and methyl groups, respectively. It is used in the treatment of susceptible protozoal infections and for the treatment of anaerobic bacterial infections. | 2.08 | 1 | 0 | C-nitro compound; imidazoles; organochlorine compound; secondary alcohol | antiamoebic agent; antibacterial drug; antiinfective agent; antiprotozoal drug; antitrichomonal drug; epitope |
danazol Danazol: A synthetic steroid with antigonadotropic and anti-estrogenic activities that acts as an anterior pituitary suppressant by inhibiting the pituitary output of gonadotropins. It possesses some androgenic properties. Danazol has been used in the treatment of endometriosis and some benign breast disorders. | 2.08 | 1 | 0 | 17beta-hydroxy steroid; terminal acetylenic compound | anti-estrogen; estrogen antagonist; geroprotector |
fludarabine phosphate fludarabine phosphate: structure given in first source. fludarabine phosphate : A purine arabinonucleoside monophosphate having 2-fluoroadenine as the nucleobase. A prodrug, it is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. Once incorporated into DNA, 2-fluoro-ara-ATP functions as a DNA chain terminator. It is used for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to, or whose disease has progressed during, treatment with at least one standard alkylating-agent containing regimenas. | 2.08 | 1 | 0 | nucleoside analogue; organofluorine compound; purine arabinonucleoside monophosphate | antimetabolite; antineoplastic agent; antiviral agent; DNA synthesis inhibitor; immunosuppressive agent; prodrug |
phenyl acetate phenyl acetate: The ester formed between phenol and acetic acid. Don't confuse with phenylacetic acid derivatives listed under PHENYLACETATES.. phenyl acetate : An acetate ester obtained by the formal condensation of phenol with acetic acid. | 2.72 | 3 | 0 | benzenes; phenyl acetates | |
triamcinolone Triamcinolone: A glucocorticoid given, as the free alcohol or in esterified form, orally, intramuscularly, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. (From Martindale, The Extra Pharmacopoeia, 30th ed, p739). triamcinolone : A C21-steroid hormone that is 1,4-pregnadiene-3,20-dione carrying four hydroxy substituents at positions 11beta, 16alpha, 17alpha and 21 as well as a fluoro substituent at position 9. Used in the form of its 16,17-acetonide to treat various skin infections. | 2.1 | 1 | 0 | 11beta-hydroxy steroid; 16alpha-hydroxy steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; C21-steroid hormone; fluorinated steroid; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | anti-allergic agent; anti-inflammatory drug |
pregnanolone Pregnanolone: A pregnane found in the urine of pregnant women and sows. It has anesthetic, hypnotic, and sedative properties.. 3alpha-hydroxy-5beta-pregnan-20-one : The 3alpha-stereoisomer of 3-hydroxy-5beta-pregnan-20-one. | 2.76 | 2 | 0 | 3-hydroxy-5beta-pregnan-20-one; 3alpha-hydroxy steroid | human metabolite; intravenous anaesthetic; sedative |
benzonidazole benzonidazole: used in treatment of Chagas' disease. benznidazole : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of (2-nitroimidazol-1-yl)acetic acid with the aromatic amino group of benzylamine. Used for treatment of Chagas disease. | 2.08 | 1 | 0 | C-nitro compound; imidazoles; monocarboxylic acid amide | antiprotozoal drug |
adenosine diphosphate ribose Adenosine Diphosphate Ribose: An ester formed between the aldehydic carbon of RIBOSE and the terminal phosphate of ADENOSINE DIPHOSPHATE. It is produced by the hydrolysis of nicotinamide-adenine dinucleotide (NAD) by a variety of enzymes, some of which transfer an ADP-ribosyl group to target proteins. | 2.41 | 1 | 0 | ADP-sugar | Escherichia coli metabolite; mouse metabolite |
amoxicillin Amoxicillin: A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.. amoxicillin : A penicillin in which the substituent at position 6 of the penam ring is a 2-amino-2-(4-hydroxyphenyl)acetamido group. | 2.08 | 1 | 0 | penicillin allergen; penicillin | antibacterial drug |
timolol (S)-timolol (anhydrous) : The (S)-(-) (more active) enantiomer of timolol. A beta-adrenergic antagonist, both the hemihydrate and the maleate salt are used in the mangement of glaucoma, hypertension, angina pectoris and myocardial infarction, and for the prevention of migraine. | 2.08 | 1 | 0 | timolol | anti-arrhythmia drug; antiglaucoma drug; antihypertensive agent; beta-adrenergic antagonist |
indoramin Indoramin: An alpha-1 adrenergic antagonist that is commonly used as an antihypertensive agent. | 2.08 | 1 | 0 | tryptamines | |
tramadol Tramadol: A narcotic analgesic proposed for severe pain. It may be habituating.. tramadol : A racemate consisting of equal amounts of (R,R)- and (S,S)-tramadol. A centrally acting synthetic opioid analgesic, used (as the hydrochloride salt) to treat moderately severe pain. The (R,R)-enantiomer exhibits ten-fold higher analgesic potency than the (S,S)-enantiomer. Originally developed by Gruenenthal GmbH and launched in 1977, it was subsequently isolated from the root bark of the South African tree Nauclea latifolia.. (R,R)-tramadol : A 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol in which both stereocentres have R-configuration; the (R,R)-enantiomer of the racemic opioid analgesic tramadol, it exhibits ten-fold higher analgesic potency than the (S,S)-enantiomer. | 7.52 | 15 | 0 | 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol | adrenergic uptake inhibitor; antitussive; capsaicin receptor antagonist; delta-opioid receptor agonist; kappa-opioid receptor agonist; metabolite; mu-opioid receptor agonist; muscarinic antagonist; nicotinic antagonist; NMDA receptor antagonist; opioid analgesic; serotonergic antagonist; serotonin uptake inhibitor |
oxcarbazepine Oxcarbazepine: A carbamazepine derivative that acts as a voltage-gated sodium channel blocker. It is used for the treatment of PARTIAL SEIZURES with or without secondary generalization. It is also an inducer of CYTOCHROME P-450 CYP3A4.. oxcarbazepine : A dibenzoazepine derivative, having a carbamoyl group at the ring nitrogen, substituted with an oxo group at C-4 of the azepeine ring which is also hydrogenated at C-4 and C-5. It is a anticholinergic anticonvulsant and mood stabilizing drug, used primarily in the treatment of epilepsy. | 3.6 | 2 | 0 | cyclic ketone; dibenzoazepine | anticonvulsant; drug allergen |
carbidopa carbidopa (anhydrous) : 3-(3,4-Dihydroxyphenyl)propanoic acid in which the hydrogens alpha- to the carboxyl group are substituted by hydrazinyl and methyl groups (S-configuration). Carbidopa is a dopa decarboxylase inhibitor, so prevents conversion of levodopa to dopamine. It has no antiparkinson activity by itself, but is used (commonly as its hydrate) in the management of Parkinson's disease to reduce peripheral adverse effects of levodopa. | 2.08 | 1 | 0 | catechols; hydrazines; monocarboxylic acid | antiparkinson drug; dopaminergic agent; EC 4.1.1.28 (aromatic-L-amino-acid decarboxylase) inhibitor |
zidovudine Zidovudine: A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by an azido group. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA during reverse transcription. It improves immunologic function, partially reverses the HIV-induced neurological dysfunction, and improves certain other clinical abnormalities associated with AIDS. Its principal toxic effect is dose-dependent suppression of bone marrow, resulting in anemia and leukopenia.. zidovudine : A pyrimidine 2',3'-dideoxyribonucleoside compound having a 3'-azido substituent and thymine as the nucleobase. | 2.08 | 1 | 0 | azide; pyrimidine 2',3'-dideoxyribonucleoside | antimetabolite; antiviral drug; HIV-1 reverse transcriptase inhibitor |
feprazone Feprazone: A pyrazole that has analgesic, anti-inflammatory, and antipyretic properties. It has been used in mild to moderate pain, fever, and inflammation associated with musculoskeletal and joint disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p15) | 2.08 | 1 | 0 | organic molecular entity | |
5,7-dihydroxytryptamine 5,7-Dihydroxytryptamine: Tryptamine substituted with two hydroxyl groups in positions 5 and 7. It is a neurotoxic serotonin analog that destroys serotonergic neurons preferentially and is used in neuropharmacology as a tool. | 2.25 | 1 | 0 | ||
tobramycin Tobramycin: An aminoglycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. It is effective against gram-negative bacteria, especially the PSEUDOMONAS species. It is a 10% component of the antibiotic complex, NEBRAMYCIN, produced by the same species.. tobramycin : A amino cyclitol glycoside that is kanamycin B lacking the 3-hydroxy substituent from the 2,6-diaminoglucose ring. | 2.08 | 1 | 0 | amino cyclitol glycoside | antibacterial agent; antimicrobial agent; toxin |
paclitaxel Taxus: Genus of coniferous yew trees or shrubs, several species of which have medicinal uses. Notable is the Pacific yew, Taxus brevifolia, which is used to make the anti-neoplastic drug taxol (PACLITAXEL). | 6.74 | 15 | 1 | taxane diterpenoid; tetracyclic diterpenoid | antineoplastic agent; human metabolite; metabolite; microtubule-stabilising agent |
etoposide [no description available] | 2.08 | 1 | 0 | beta-D-glucoside; furonaphthodioxole; organic heterotetracyclic compound | antineoplastic agent; DNA synthesis inhibitor |
substance p [no description available] | 3.6 | 2 | 0 | peptide | neurokinin-1 receptor agonist; neurotransmitter; vasodilator agent |
ribavirin Rebetron: Rebetron is tradename | 2.08 | 1 | 0 | 1-ribosyltriazole; aromatic amide; monocarboxylic acid amide; primary carboxamide | anticoronaviral agent; antiinfective agent; antimetabolite; antiviral agent; EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor |
amikacin Amikacin: A broad-spectrum antibiotic derived from KANAMYCIN. It is reno- and oto-toxic like the other aminoglycoside antibiotics.. amikacin : An amino cyclitol glycoside that is kanamycin A acylated at the N-1 position by a 4-amino-2-hydroxybutyryl group. | 2.08 | 1 | 0 | alpha-D-glucoside; amino cyclitol glycoside; aminoglycoside; carboxamide | antibacterial drug; antimicrobial agent; nephrotoxin |
ticrynafen Ticrynafen: A novel diuretic with uricosuric action. It has been proposed as an antihypertensive agent.. tienilic acid : An aromatic ketone that is 2,3-dichlorophenoxyacetic acid in which the hydrogen at position 4 on the benzene ring is replaced by a thiophenecarbonyl group. A loop diuretic used to treat hypertension, it was withdrawn from the market in 1982 due to links with hepatitis. | 3.19 | 1 | 0 | aromatic ether; aromatic ketone; dichlorobenzene; monocarboxylic acid; thiophenes | antihypertensive agent; hepatotoxic agent; loop diuretic |
diltiazem Diltiazem: A benzothiazepine derivative with vasodilating action due to its antagonism of the actions of CALCIUM ion on membrane functions.. diltiazem : A 5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetate in which both stereocentres have S configuration. A calcium-channel blocker and vasodilator, it is used as the hydrochloride in the management of angina pectoris and hypertension. | 2.08 | 1 | 0 | 5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetate | antihypertensive agent; calcium channel blocker; vasodilator agent |
vecuronium bromide Vecuronium Bromide: Monoquaternary homolog of PANCURONIUM. A non-depolarizing neuromuscular blocking agent with shorter duration of action than pancuronium. Its lack of significant cardiovascular effects and lack of dependence on good kidney function for elimination as well as its short duration of action and easy reversibility provide advantages over, or alternatives to, other established neuromuscular blocking agents.. vecuronium bromide : The organic bromide salt of a 5alpha-androstane compound having 3alpha-acetoxy-, 17beta-acetoxy-, 2beta-piperidinino- and 16beta-N-methylpiperidinium substituents. | 2.08 | 1 | 0 | organic bromide salt; quaternary ammonium salt | muscle relaxant; neuromuscular agent; nicotinic antagonist |
nitazoxanide nitazoxanide: a 5-nitrothiazolyl derivative used for a broad range of intestinal parasitic infections including CRYPTOSPORIDIUM and GIARDIA; it is a redox-active nitrothiazolyl-salicylamide prodrug | 2.08 | 1 | 0 | benzamides; carboxylic ester | |
acarbose [no description available] | 2.08 | 1 | 0 | tetrasaccharide derivative | EC 3.2.1.1 (alpha-amylase) inhibitor; EC 3.2.1.20 (alpha-glucosidase) inhibitor; geroprotector; hypoglycemic agent |
epirubicin Epirubicin: An anthracycline which is the 4'-epi-isomer of doxorubicin. The compound exerts its antitumor effects by interference with the synthesis and function of DNA. | 2.25 | 1 | 0 | aminoglycoside; anthracycline antibiotic; anthracycline; deoxy hexoside; monosaccharide derivative; p-quinones; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | antimicrobial agent; antineoplastic agent; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor |
lorcainide [no description available] | 2.08 | 1 | 0 | acetamides | |
paroxetine Paroxetine: A serotonin uptake inhibitor that is effective in the treatment of depression.. paroxetine : A benzodioxole that consists of piperidine bearing 1,3-benzodioxol-5-yloxy)methyl and 4-fluorophenyl substituents at positions 3 and 4 respectively; the (3S,4R)-diastereomer. Highly potent and selective 5-HT uptake inhibitor that binds with high affinity to the serotonin transporter (Ki = 0.05 nM). Ki values are 1.1, 350 and 1100 nM for inhibition of [3H]-5-HT, [3H]-l-NA and [3H]-DA uptake respectively. Displays minimal affinity for alpha1-, alpha2- or beta-adrenoceptors, 5-HT2A, 5-HT1A, D2 or H1 receptors at concentrations below 1000 nM, however displays weak affinity for muscarinic ACh receptors (Ki = 42 nM). Antidepressant and anxiolytic in vivo. | 14.85 | 62 | 11 | aromatic ether; benzodioxoles; organofluorine compound; piperidines | antidepressant; anxiolytic drug; hepatotoxic agent; P450 inhibitor; serotonin uptake inhibitor |
captopril Captopril: A potent and specific inhibitor of PEPTIDYL-DIPEPTIDASE A. It blocks the conversion of ANGIOTENSIN I to ANGIOTENSIN II, a vasoconstrictor and important regulator of arterial blood pressure. Captopril acts to suppress the RENIN-ANGIOTENSIN SYSTEM and inhibits pressure responses to exogenous angiotensin.. captopril : A L-proline derivative in which L-proline is substituted on nitrogen with a (2S)-2-methyl-3-sulfanylpropanoyl group. It is used as an anti-hypertensive ACE inhibitor drug. | 2.08 | 1 | 0 | alkanethiol; L-proline derivative; N-acylpyrrolidine; pyrrolidinemonocarboxylic acid | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor |
staurosporine [no description available] | 2.08 | 1 | 0 | indolocarbazole alkaloid; organic heterooctacyclic compound | apoptosis inducer; bacterial metabolite; EC 2.7.11.13 (protein kinase C) inhibitor; geroprotector |
foscarnet sodium trisodium phosphonoformate : The trisodium salt of phosphonoformic acid. It is used as an antiviral agent in the treatment of cytomegalovirus retinitis (CMV retinitis, an inflamation of the retina that can lead to blindness) and as an alternative to ganciclovir for AIDS patients who require concurrent antiretroviral therapy but are unable to tolerate ganciclovir due to haematological toxicity. | 2.08 | 1 | 0 | one-carbon compound; organic sodium salt | antiviral drug |
atracurium besylate atracurium besylate : The bisbenzenesulfonate salt of atracurium. | 2.08 | 1 | 0 | organosulfonate salt; quaternary ammonium salt | muscle relaxant; nicotinic antagonist |
nicorandil Nicorandil: A derivative of the NIACINAMIDE that is structurally combined with an organic nitrate. It is a potassium-channel opener that causes vasodilatation of arterioles and large coronary arteries. Its nitrate-like properties produce venous vasodilation through stimulation of guanylate cyclase.. nicorandil : A pyrimidinecarboxamide that is nicotinamide in which one of the hydrogens attached to the carboxamide nitrogen is replaced by a 2-(nitrooxy)ethyl group. It has both nitrate-like and ATP-sensitive potassium channel activator properties, and is used for the prevention and treatment of angina pectoris. | 2.08 | 1 | 0 | nitrate ester; pyridinecarboxamide | potassium channel opener; vasodilator agent |
pergolide mesylate pergolide mesylate : A methanesulfonate salt obtained from pergolide by mixing eqimolar amount of pergolide and methanesulfonic acid. A dopamine D2 receptor agonist which also has D1 and D2 agonist properties, it is used in the management of Parkinson's disease, although it was withdrawn from the U.S. and Canadian markets in 2007 due to an increased risk of cardiac valve dysfunction. | 2.08 | 1 | 0 | methanesulfonate salt | antiparkinson drug; dopamine agonist; geroprotector |
cefadroxil anhydrous Cefadroxil: Long-acting, broad-spectrum, water-soluble, CEPHALEXIN derivative.. cefadroxil : A cephalosporin bearing methyl and (2R)-2-amino-2-(4-hydroxyphenyl)acetamido groups at positions 3 and 7, respectively, of the cephem skeleton. | 2.08 | 1 | 0 | cephalosporin | antibacterial drug |
talniflumate talniflumate: an anti-inflammatory molecule for the treatment of cystic fibrosis, chronic obstructive pulmonary disease and asthma | 2.08 | 1 | 0 | benzofurans | |
fenoldopam mesylate [no description available] | 2.08 | 1 | 0 | benzazepine | |
cefaclor anhydrous Cefaclor: Semisynthetic, broad-spectrum antibiotic derivative of CEPHALEXIN.. cefaclor : A cephalosporin bearing chloro and (R)-2-amino-2-phenylacetamido groups at positions 3 and 7, respectively, of the cephem skeleton. | 2.08 | 1 | 0 | cephalosporin | antibacterial drug; drug allergen |
pefloxacin Pefloxacin: A synthetic broad-spectrum fluoroquinolone antibacterial agent active against most gram-negative and gram-positive bacteria.. pefloxacin : A quinolone that is 4-oxo-1,4-dihydroquinoline which is substituted at positions 1, 3, 6 and 7 by ethyl, carboxy, fluorine, and 4-methylpiperazin-1-yl groups, respectively. | 2.08 | 1 | 0 | fluoroquinolone antibiotic; monocarboxylic acid; N-alkylpiperazine; N-arylpiperazine; quinolone antibiotic; quinolone | antibacterial drug; antiinfective agent; DNA synthesis inhibitor |
fomesafen fomesafen: a protoporphyrinogen oxidase-inhibiting herbicide. fomesafen : An N-sulfonylcarboxamide that is N-(methylsulfonyl)benzamide in which the phenyl ring is substituted by a nitro group at position 2 and a 2-chloro-4-(trifluoromethyl)phenoxy group at position 5. A protoporphyrinogen oxidase inhibitor, it was specially developed for use (generally as the corresponding sodium salt, fomesafen-sodium) for post-emergence control of broad-leaf weeds in soya. | 5.48 | 8 | 0 | aromatic ether; C-nitro compound; monochlorobenzenes; N-sulfonylcarboxamide; organofluorine compound; phenols | agrochemical; EC 1.3.3.4 (protoporphyrinogen oxidase) inhibitor; herbicide |
cefotetan Cefotetan: A semisynthetic cephamycin antibiotic that is administered intravenously or intramuscularly. The drug is highly resistant to a broad spectrum of beta-lactamases and is active against a wide range of both aerobic and anaerobic gram-positive and gram-negative microorganisms.. cefotetan : A semi-synthetic second-generation cephamycin antibiotic with [(1-methyl-1H-tetrazol-5-yl)sulfanyl]methyl, methoxy and {[4-(2-amino-1-carboxy-2-oxoethylidene)-1,3-dithietan-2-yl]carbonyl}amino groups at the 3, 7alpha, and 7beta positions, respectively, of the cephem skeleton. It is resistant to a wide range of beta-lactamases and is active against a broad spectrum of aerobic and anaerobic Gram-positive and Gram-negative microorganisms. | 2.08 | 1 | 0 | ||
lovastatin Lovastatin: A fungal metabolite isolated from cultures of Aspergillus terreus. The compound is a potent anticholesteremic agent. It inhibits 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It also stimulates the production of low-density lipoprotein receptors in the liver.. lovastatin : A fatty acid ester that is mevastatin carrying an additional methyl group on the carbobicyclic skeleton. It is used in as an anticholesteremic drug and has been found in fungal species such as Aspergillus terreus and Pleurotus ostreatus (oyster mushroom). | 2.08 | 1 | 0 | delta-lactone; fatty acid ester; hexahydronaphthalenes; polyketide; statin (naturally occurring) | anticholesteremic drug; antineoplastic agent; Aspergillus metabolite; prodrug |
flupirtine flupirtine: RN given refers to parent cpd without isomeric designation | 2.08 | 1 | 0 | aminopyridine | |
enoximone Enoximone: A selective phosphodiesterase inhibitor with vasodilating and positive inotropic activity that does not cause changes in myocardial oxygen consumption. It is used in patients with CONGESTIVE HEART FAILURE. | 2.08 | 1 | 0 | aromatic ketone | |
stepronin [no description available] | 2.08 | 1 | 0 | N-acyl-amino acid | |
loceryl amorolfine: RN given refers to parent cpd. amorolfine : A member of the class of morpholines that is cis-2,6-dimethylmorpholine in which the hydrogen attached to the nitrogen is replaced by a racemic 2-methyl-3-[p-(2-methylbutan-2-yl)phenyl]propyl group. An inhibitor of the action of squalene monooxygenase, Delta(14) reductase and D7-D8 isomerase and an antifungal agent, it is used (generally as its hydrochloride salt) for the topical treatment of fungal nail and skin infections. | 2.31 | 1 | 0 | morpholine antifungal drug; tertiary amino compound | EC 1.14.13.132 (squalene monooxygenase) inhibitor; EC 1.3.1.70 (Delta(14)-sterol reductase) inhibitor; EC 5.3.3.5 (cholestenol Delta-isomerase) inhibitor |
simvastatin Simvastatin: A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.. simvastatin : A member of the class of hexahydronaphthalenes that is lovastatin in which the 2-methylbutyrate ester moiety has been replaced by a 2,2-dimethylbutyrate ester group. It is used as a cholesterol-lowering and anti-cardiovascular disease drug. | 2.48 | 2 | 0 | delta-lactone; fatty acid ester; hexahydronaphthalenes; statin (semi-synthetic) | EC 1.1.1.34/EC 1.1.1.88 (hydroxymethylglutaryl-CoA reductase) inhibitor; EC 3.4.24.83 (anthrax lethal factor endopeptidase) inhibitor; ferroptosis inducer; geroprotector; prodrug |
idazoxan Idazoxan: A benzodioxane-linked imidazole that has alpha-2 adrenoceptor antagonist activity.. idazoxan : A benzodioxine that is 2,3-dihydro-1,4-benzodioxine in which one of the hydrogens at position 2 has been replaced by a 4,5-dihydro-1H-imidazol-2-yl group. | 3.45 | 7 | 0 | benzodioxine; imidazolines | alpha-adrenergic antagonist |
remoxipride Remoxipride: An antipsychotic agent that is specific for dopamine D2 receptors. It has been shown to be effective in the treatment of schizophrenia. | 2.08 | 1 | 0 | dimethoxybenzene | |
cabergoline Cabergoline: An ergoline derivative and dopamine D2-agonist that inhibits PROLACTIN secretion. It is used in the management of HYPERPROLACTINEMIA, and to suppress lactation following childbirth for medical reasons. Cabergoline is also used in the management of PARKINSON DISEASE.. cabergoline : An N-acylurea that is (8R)-ergoline-8-carboxamide in which the hydrogen attached to the piperidine nitrogen (position 6) is substituted by an allyl group and the hydrogens attached to the carboxamide nitrogen are substituted by a 3-(dimethylamino)propyl group and an N-ethylcarbamoyl group. A dopamine D2 receptor agonist, cabergoline is used in the management of Parkinson's disease and of disorders associated with hyperprolactinaemia. | 2.08 | 1 | 0 | N-acylurea | antineoplastic agent; antiparkinson drug; dopamine agonist |
atomoxetine hydrochloride Atomoxetine Hydrochloride: A propylamine derivative and selective ADRENERGIC UPTAKE INHIBITOR that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.. atomoxetine hydrochloride : The hydrochloride salt of atomoxetine. | 3.9 | 11 | 0 | hydrochloride | adrenergic uptake inhibitor; antidepressant |
quinapril Quinapril: A tetrahydroisoquinoline derivative and ANGIOTENSIN CONVERTING ENZYME inhibitor that is used in the treatment of HYPERTENSION and HEART FAILURE.. quinapril : A member of the class of isoquinolines that is (3S)-2-L-alanyl-1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid in which the alpha-amino group of the alanyl residue has been substituted by a 1-ethoxycarbonyl-4-phenylbutan-2-yl group (the all-S isomer). A prodrug for quinaprilat (by hydrolysis of the ethyl ester to the corresponding carboxylic acid), it is used as an angiotensin-converting enzyme inhibitor (ACE inhibitor) used (generally as the hydrochloride salt) for the treatment of hypertension and congestive heart failure. | 2.08 | 1 | 0 | dicarboxylic acid monoester; ethyl ester; isoquinolines; tertiary carboxamide | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; prodrug |
gepirone gepirone: RN given refers to parent cpd; structure given in first source | 4.03 | 2 | 0 | N-arylpiperazine | |
mifepristone Mifepristone: A progestational and glucocorticoid hormone antagonist. Its inhibition of progesterone induces bleeding during the luteal phase and in early pregnancy by releasing endogenous prostaglandins from the endometrium or decidua. As a glucocorticoid receptor antagonist, the drug has been used to treat hypercortisolism in patients with nonpituitary CUSHING SYNDROME. | 2.48 | 2 | 0 | 3-oxo-Delta(4) steroid; acetylenic compound; tertiary amino compound | abortifacient; contraceptive drug; hormone antagonist; synthetic oral contraceptive |
salmeterol xinafoate Salmeterol Xinafoate: A selective ADRENERGIC BETA-2 RECEPTOR agonist that functions as a BRONCHODILATOR when administered by inhalation. It is used to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE. | 2.08 | 1 | 0 | naphthoic acid | |
finasteride Finasteride: An orally active 3-OXO-5-ALPHA-STEROID 4-DEHYDROGENASE inhibitor. It is used as a surgical alternative for treatment of benign PROSTATIC HYPERPLASIA.. finasteride : An aza-steroid that is a synthetic drug for the treatment of benign prostatic hyperplasia. | 2.08 | 1 | 0 | 3-oxo steroid; aza-steroid; delta-lactam | androgen antagonist; antihyperplasia drug; EC 1.3.1.22 [3-oxo-5alpha-steroid 4-dehydrogenase (NADP(+))] inhibitor |
imiquimod Imiquimod: A topically-applied aminoquinoline immune modulator that induces interferon production. It is used in the treatment of external genital and perianal warts, superficial CARCINOMA, BASAL CELL; and ACTINIC KERATOSIS.. imiquimod : An imidazoquinoline fused [4,5-c] carrying isobutyl and amino substituents at N-1 and C-4 respectively. A prescription medication, it acts as an immune response modifier and is used to treat genital warts, superficial basal cell carcinoma, and actinic keratosis. | 2.08 | 1 | 0 | imidazoquinoline | antineoplastic agent; interferon inducer |
n 0437, (-)-isomer rotigotine: Antiparkinson Agent and dopamine receptor agonist; structure given in first source; RN given refers to cpd without isomeric designation | 3.35 | 1 | 0 | tetralins | |
sertindole sertindole : A phenylindole that is 1H-indole which is substituted on the nitrogen by a p-chlorophenyl group, at position 5 by chlorine, and at position 3 by a piperidin-4-yl group, which is itself substituted on the nitrogen by a 2-(2-oxoimidazolidin-1-yl)ethyl group. | 2.08 | 1 | 0 | heteroarylpiperidine; imidazolidinone; organochlorine compound; organofluorine compound; phenylindole | alpha-adrenergic antagonist; H1-receptor antagonist; second generation antipsychotic; serotonergic antagonist |
adapalene Adapalene: A naphthalene derivative that has specificity for RETINOIC ACID RECEPTORS. It is used as a DERMATOLOGIC AGENT for the treatment of ACNE.. adapalene : A naphthoic acid that is CD437 in which the phenolic hydroxy group has been converted to its methyl ether. | 2.08 | 1 | 0 | adamantanes; monocarboxylic acid; naphthoic acid | dermatologic drug; EC 2.7.11.22 (cyclin-dependent kinase) inhibitor; non-steroidal anti-inflammatory drug |
aromasil [no description available] | 2.08 | 1 | 0 | 17-oxo steroid; 3-oxo-Delta(1),Delta(4)-steroid | antineoplastic agent; EC 1.14.14.14 (aromatase) inhibitor; environmental contaminant; xenobiotic |
sparfloxacin [no description available] | 2.08 | 1 | 0 | fluoroquinolone antibiotic; N-arylpiperazine; quinolinemonocarboxylic acid; quinolone antibiotic; quinolone | |
zileuton [no description available] | 2.08 | 1 | 0 | 1-benzothiophenes; ureas | anti-asthmatic drug; EC 1.13.11.34 (arachidonate 5-lipoxygenase) inhibitor; ferroptosis inhibitor; leukotriene antagonist; non-steroidal anti-inflammatory drug |
cidofovir anhydrous Cidofovir: An acyclic nucleoside phosphonate that acts as a competitive inhibitor of viral DNA polymerases. It is used in the treatment of RETINITIS caused by CYTOMEGALOVIRUS INFECTIONS and may also be useful for treating HERPESVIRUS INFECTIONS.. cidofovir anhydrous : Cytosine substituted at the 1 position by a 3-hydroxy-2-(phosphonomethoxy)propyl group (S configuration). A nucleoside analogue, it is an injectable antiviral used for the treatment of cytomegalovirus (CMV) retinitis in AIDS patients. | 2.08 | 1 | 0 | phosphonic acids; pyrimidone | anti-HIV agent; antineoplastic agent; antiviral drug; photosensitizing agent |
besipirdine besipirdine: structure given in first source; a non-receptor-dependent cholinomimetic agent with noradrenergic activity with potential use for treating Alzheimer's disease | 2.06 | 1 | 0 | ||
bromfenac bromfenac: bromfenac sodium is the active cpd; structure in first source. bromfenac : Amfenac in which the the hydrogen at the 4 position of the benzoyl group is substituted by bromine. It is used for the management of ocular pain and treatment of postoperative inflammation in patients who have undergone cataract extraction. It was withdrawn from the US market in 1998, following concerns over off-label abuse and hepatic failure. | 2.08 | 1 | 0 | aromatic amino acid; benzophenones; organobromine compound; substituted aniline | non-narcotic analgesic; non-steroidal anti-inflammatory drug |
gemcitabine hydrochloride [no description available] | 2.08 | 1 | 0 | hydrochloride; organofluorine compound | anticoronaviral agent; antimetabolite; antineoplastic agent; antiviral drug; EC 1.17.4.1 (ribonucleoside-diphosphate reductase) inhibitor; immunosuppressive agent; radiosensitizing agent |
aripiprazole Aripiprazole: A piperazine and quinolone derivative that is used primarily as an antipsychotic agent. It is a partial agonist of SEROTONIN RECEPTOR, 5-HT1A and DOPAMINE D2 RECEPTORS, where it also functions as a post-synaptic antagonist, and an antagonist of SEROTONIN RECEPTOR, 5-HT2A. It is used for the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER, and as an adjunct therapy for the treatment of depression.. aripiprazole : An N-arylpiperazine that is piperazine substituted by a 4-[(2-oxo-1,2,3,4-tetrahydroquinolin-7-yl)oxy]butyl group at position 1 and by a 2,3-dichlorophenyl group at position 4. It is an antipsychotic drug used for the treatment of Schizophrenia, and other mood disorders. | 7.84 | 12 | 1 | aromatic ether; delta-lactam; dichlorobenzene; N-alkylpiperazine; N-arylpiperazine; quinolone | drug metabolite; H1-receptor antagonist; second generation antipsychotic; serotonergic agonist |
atorvastatin calcium anhydrous [no description available] | 2.08 | 1 | 0 | organic calcium salt | |
atorvastatin [no description available] | 3.59 | 2 | 0 | aromatic amide; dihydroxy monocarboxylic acid; monofluorobenzenes; pyrroles; statin (synthetic) | environmental contaminant; xenobiotic |
lamivudine [no description available] | 2.08 | 1 | 0 | monothioacetal; nucleoside analogue; oxacycle; primary alcohol | allergen; anti-HBV agent; antiviral drug; EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor; HIV-1 reverse transcriptase inhibitor; prodrug |
valsartan Valsartan: A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION.. valsartan : A monocarboxylic acid amide consisting of L-valine in which the amino hydrogens have been replaced by a pentanoyl and a [2'-(1H-tetrazol-5-yl)biphenyl]-4-yl]methyl group. It exhibits antihypertensive activity. | 2.08 | 1 | 0 | biphenylyltetrazole; monocarboxylic acid amide; monocarboxylic acid | angiotensin receptor antagonist; antihypertensive agent; environmental contaminant; xenobiotic |
ziprasidone ziprasidone: a benzisothiazoylpiperazine derivative; has combined dopamine and serotonin receptor antagonist activity; structurally related to tiospirone. ziprasidone : A piperazine compound having 1,2-benzothiazol-3-yl- and 2-(6-chloro-1,3-dihydro-2-oxindol-5-yl)ethyl substituents attached to the nitrogen atoms. | 2.46 | 2 | 0 | 1,2-benzisothiazole; indolones; organochlorine compound; piperazines | antipsychotic agent; dopaminergic antagonist; histamine antagonist; muscarinic antagonist; psychotropic drug; serotonergic antagonist |
zolmitriptan zolmitriptan: an antimigraine compound; a serotonin (5HT)-1D receptor agonist. zolmitriptan : A member of the class of tryptamines that is N,N-dimethyltryptamine in which the hydrogen at position 5 of the indole ring has been replaced by a [(4S)-2-oxo-1,3-oxazolidin-4-yl]methyl group. A serotonin 5-HT1 B and D receptor agonist, it is used for the treatment of migraine. | 2.08 | 1 | 0 | oxazolidinone; tryptamines | anti-inflammatory drug; serotonergic agonist; vasoconstrictor agent |
adefovir dipivoxil bis(pivaloyloxymethyl)-9-(2-phosphonylmethoxyethyl)adenine: structure given in first source. adefovir pivoxil : An organic phosphonate that is the dipivoxil ester of adefovir. A prodrug for adefovir, an HIV-1 reverse transcriptase inhibitor, adefovir pivoxil is used to treat chronic hepatitis B viral infection. | 2.08 | 1 | 0 | 6-aminopurines; carbonate ester; ether; organic phosphonate | antiviral drug; DNA synthesis inhibitor; HIV-1 reverse transcriptase inhibitor; nephrotoxic agent; prodrug |
emtricitabine Emtricitabine: A deoxycytidine analog and REVERSE TRANSCRIPTASE INHIBITOR with antiviral activity against HIV-1 and HEPATITIS B viruses. It is used to treat HIV INFECTIONS.. emtricitabine : An organofluorine compound that is 5-fluorocytosine substituted at the 1 position by a 2-(hydroxymethyl)-1,3-oxathiolan-5-yl group (2R,5S configuration). It is used in combination therapy for the treatment of HIV-1 infection. | 2.08 | 1 | 0 | monothioacetal; nucleoside analogue; organofluorine compound; pyrimidone | antiviral drug; HIV-1 reverse transcriptase inhibitor |
adenosine quinquefolan B: isolated from roots of Panax quinquefolium L.; RN not in Chemline 10/87; RN from Toxlit | 2.05 | 1 | 0 | adenosines; purines D-ribonucleoside | analgesic; anti-arrhythmia drug; fundamental metabolite; human metabolite; vasodilator agent |
potassium phosphate potassium phosphate: used in dental materials and to treat hypophosphatemia; RN given refers to cpd with unspecified MF. tripotassium phosphate : An inorganic potassium salt that is the tripotassium salt of phosphoric acid. | 2.07 | 1 | 0 | inorganic phosphate salt; inorganic potassium salt | |
paroxetine hydrochloride paroxetine hydrochloride : The hydrochloride salt of paroxetine. It is an antidepressant drug. | 2.08 | 1 | 0 | hydrochloride | antidepressant; anxiolytic drug; hepatotoxic agent; P450 inhibitor; serotonin uptake inhibitor |
bupropion hydrochloride [no description available] | 2.08 | 1 | 0 | aromatic ketone | |
venlafaxine hydrochloride Venlafaxine Hydrochloride: A cyclohexanol and phenylethylamine derivative that functions as a SEROTONIN AND NORADRENALINE REUPTAKE INHIBITOR (SNRI) and is used as an ANTIDEPRESSIVE AGENT. | 18.25 | 130 | 15 | hydrochloride | |
trazodone hydrochloride Triticum: A plant genus of the family POACEAE that is the source of EDIBLE GRAIN. A hybrid with rye (SECALE CEREALE) is called TRITICALE. The seed is ground into FLOUR and used to make BREAD, and is the source of WHEAT GERM AGGLUTININS.. trazodone hydrochloride : A hydrochloride salt prepared from equimolar amounts of trazodone and hydrogen chloride. | 2.08 | 1 | 0 | hydrochloride | adrenergic antagonist; antidepressant; H1-receptor antagonist; sedative; serotonin uptake inhibitor |
doxazosin mesylate Cardura: Trade name in United States. | 2.08 | 1 | 0 | methanesulfonate salt | geroprotector |
efavirenz efavirenz: HIV-1 reverse transcriptase inhibitor. efavirenz : 1,4-Dihydro-2H-3,1-benzoxazin-2-one substituted at the 4 position by cyclopropylethynyl and trifluoromethyl groups (S configuration) and at the 6 position by chlorine. A non-nucleoside reverse transcriptase inhibitor with activity against HIV, it is used with other antiretrovirals for combination therapy of HIV infection. | 2.08 | 1 | 0 | acetylenic compound; benzoxazine; cyclopropanes; organochlorine compound; organofluorine compound | antiviral drug; HIV-1 reverse transcriptase inhibitor |
nelfinavir Nelfinavir: A potent HIV protease inhibitor. It is used in combination with other antiviral drugs in the treatment of HIV in both adults and children.. nelfinavir : An aryl sulfide that is used (as its mesylate salt) for treatment of HIV and also exhibits some anticancer properties. | 2.08 | 1 | 0 | aryl sulfide; benzamides; organic heterobicyclic compound; phenols; secondary alcohol; tertiary amino compound | antineoplastic agent; HIV protease inhibitor |
glucose, (beta-d)-isomer beta-D-glucose : D-Glucopyranose with beta configuration at the anomeric centre.. (1->4)-beta-D-glucan : A beta-D-glucan in which the glucose units are connected by (1->4) linkages.. (1->3)-beta-D-glucan : A beta-D-glucan in which the glucose units are connected by (1->3) linkages. | 2.13 | 1 | 0 | D-glucopyranose | epitope; mouse metabolite |
mevastatin mevastatin: antifungal metabolite from Penicillium brevicopactum; potent inhibitory activity to sterol synthesis; structure. mevastatin : A carboxylic ester that is pravastatin that is lacking the allylic hydroxy group. A hydroxymethylglutaryl-CoA reductase inhibitor (statin) isolated from Penicillium citrinum and from Penicillium brevicompactum, its clinical use as a lipid-regulating drug ceased following reports of toxicity in animals. | 2.08 | 1 | 0 | 2-pyranones; carboxylic ester; hexahydronaphthalenes; polyketide; statin (naturally occurring) | antifungal agent; apoptosis inducer; EC 3.4.24.83 (anthrax lethal factor endopeptidase) inhibitor; fungal metabolite; Penicillium metabolite |
bupivacaine hydrochloride bupivacaine hydrochloride (anhydrous) : A racemate composed of equimolar amounts of dextrobupivacaine hydrochloride and levobupivacaine hydrochloride. The monohydrate form is commonly used as a local anaesthetic.. 1-butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide hydrochloride : A hydrochloride obtained by combining 1-butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide with one molar equivalent of hydrochloric acid. | 2.08 | 1 | 0 | hydrochloride; racemate | adrenergic antagonist; amphiphile; EC 3.1.1.8 (cholinesterase) inhibitor; EC 3.6.3.8 (Ca(2+)-transporting ATPase) inhibitor; local anaesthetic |
plerixafor plerixafor: a bicyclam derivate, highly potent & selective inhibitor of HIV-1 & HIV-2. plerixafor : An azamacrocycle consisting of two cyclam rings connected by a 1,4-phenylenebis(methylene) linker. It is a CXCR4 chemokine receptor antagonist and a hematopoietic stem cell mobilizer. It is used in combination with grulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the perpheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma. | 2.08 | 1 | 0 | azacycloalkane; azamacrocycle; benzenes; crown amine; secondary amino compound; tertiary amino compound | anti-HIV agent; antineoplastic agent; C-X-C chemokine receptor type 4 antagonist; immunological adjuvant |
amprenavir [no description available] | 2.08 | 1 | 0 | carbamate ester; sulfonamide; tetrahydrofuryl ester | antiviral drug; HIV protease inhibitor |
n-acetylaspartic acid N-acetyl-L-aspartic acid : An N-acyl-L-aspartic acid in which the acyl group is specified as acetyl. | 5.39 | 2 | 2 | N-acetyl-L-amino acid; N-acyl-L-aspartic acid | antioxidant; human metabolite; mouse metabolite; nutraceutical; rat metabolite |
6-sulfatoxymelatonin 6-sulfatoxymelatonin: metabolite of melatonin; RN given refers to parent cpd | 3.43 | 1 | 1 | acetamides | |
ticlopidine hydrochloride [no description available] | 2.08 | 1 | 0 | hydrochloride | |
epirubicin hydrochloride [no description available] | 2.08 | 1 | 0 | ||
milnacipran Milnacipran: A cyclopropanecarboxamide serotonin and norepinephrine reuptake inhibitor (SNRI) that is used in the treatment of FIBROMYALGIA. | 10.66 | 43 | 0 | acetamides | |
esreboxetine esreboxetine: a norepinephrine reuptake inhibitor | 2.08 | 1 | 0 | aromatic ether | |
dimiracetam dimiracetam: structure given in first source; an antiamnestic agent | 2.15 | 1 | 0 | ||
pazufloxacin [no description available] | 2.08 | 1 | 0 | quinolines | |
repaglinide [no description available] | 2.08 | 1 | 0 | piperidines | |
telmisartan Telmisartan: A biphenyl compound and benzimidazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION.. telmisartan : A member of the class of benzimidazoles used widely in the treatment of hypertension. | 2.08 | 1 | 0 | benzimidazoles; biphenyls; carboxybiphenyl | angiotensin receptor antagonist; antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; environmental contaminant; xenobiotic |
triazoles Triazoles: Heterocyclic compounds containing a five-membered ring with two carbon atoms and three nitrogen atoms with the molecular formula C2H3N3.. triazoles : An azole in which the five-membered heterocyclic aromatic skeleton contains three N atoms and two C atoms. | 6.31 | 4 | 0 | 1,2,3-triazole | |
miconazole nitrate miconazole nitrate : A racemate composed of equimolar amounts of (R)- and (S)-miconazole nitrate. An antifungal used for the treatment of athlete's foot, jock itch, ringworm and other fungal skin infections. It inhibits the synthesis of ergosterol, a critical component of fungal cell membranes. | 2.08 | 1 | 0 | ||
sertraline Sertraline: A selective serotonin uptake inhibitor that is used in the treatment of depression.. sertraline : A member of the class of tetralins that is tetralin which is substituted at positions 1 and 4 by a methylamino and a 3,4-dichlorophenyl group, respectively (the S,S diastereoisomer). A selective serotonin-reuptake inhibitor (SSRI), it is administered orally as the hydrochloride salt as an antidepressant for the treatment of depression, obsessive-compulsive disorder, panic disorder and post-traumatic stress disorder. | 14.06 | 38 | 9 | dichlorobenzene; secondary amino compound; tetralins | antidepressant; serotonin uptake inhibitor |
zoledronic acid Zoledronic Acid: An imidobisphosphonate inhibitor of BONE RESORPTION that is used for the treatment of malignancy-related HYPERCALCEMIA; OSTEITIS DEFORMANS; and OSTEOPOROSIS.. zoledronic acid : An imidazole compound having a 2,2-bis(phosphono)-2-hydroxyethane-1-yl substituent at the 1-position. | 2.08 | 1 | 0 | 1,1-bis(phosphonic acid); imidazoles | bone density conservation agent |
talinolol [no description available] | 2.05 | 1 | 0 | ureas | |
artemisinin (+)-artemisinin : A sesquiterpene lactone obtained from sweet wormwood, Artemisia annua, which is used as an antimalarial for the treatment of multi-drug resistant strains of falciparum malaria. | 2.08 | 1 | 0 | organic peroxide; sesquiterpene lactone | antimalarial; plant metabolite |
brinzolamide brinzolamide: an antiglaucoma agent | 2.08 | 1 | 0 | sulfonamide; thienothiazine | antiglaucoma drug; EC 4.2.1.1 (carbonic anhydrase) inhibitor |
tianeptine tianeptine: structure given in first source. tianeptine : A racemate comprising of equimolar amounts of (R)- and (S)-tianeptine. It is an atypical antidepressant used in Europe to treat patients who respond poorly to selective serotonin reuptake inhibitors (SSRIs).. 7-[(3-chloro-6-methyl-5,5-dioxido-6,11-dihydrodibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid : A member of the class of dibenzothiazepines that is 3-chloro-6-methyl-6,11-dihydrodibenzo[c,f][1,2]thiazepine 5,5-dioxide substituted by a (6-carboxyhexyl)amino group at position 11.. (S)-tianeptine : The S-enantiomer of tianeptine. | 4.38 | 3 | 0 | dibenzothiazepine; monocarboxylic acid; organochlorine compound | |
drospirenone drospirenone: a progestational compound with antimineralocorticoid and antiandrogenic activity; structure given in first source | 2.08 | 1 | 0 | 3-oxo-Delta(4) steroid; steroid lactone | aldosterone antagonist; contraceptive drug; progestin |
artemether Artemether: An artemisinin derivative that is used in the treatment of MALARIA.. artemether : An artemisinin derivative that is artemisinin in which the lactone has been converted to the corresponding lactol methyl ether. It is used in combination with lumefantrine as an antimalarial for the treatment of multi-drug resistant strains of falciparum malaria. | 2.08 | 1 | 0 | artemisinin derivative; cyclic acetal; organic peroxide; semisynthetic derivative; sesquiterpenoid | antimalarial |
uk 68798 [no description available] | 2.08 | 1 | 0 | aromatic ether; sulfonamide; tertiary amino compound | anti-arrhythmia drug; potassium channel blocker |
dapoxetine [no description available] | 2.49 | 2 | 0 | naphthalenes | |
hp 873 iloperidone: an atypical, negative symptom antipsychotic agent. iloperidone : A member of the class of piperidines that is the 4-acetyl-2-methoxyphenyl ether of 3-(piperidin-1-yl)propan-1-ol which is substituted at position 4 of the piperidine ring by a 6-fluoro-1,2-benzoxazol-3-yl group. A member of the group of second generation antipsychotics (also known as an atypical antipsychotics), it is used for the treatment of schizophrenia. | 2.08 | 1 | 0 | 1,2-benzoxazoles; aromatic ether; aromatic ketone; methyl ketone; monoamine; organofluorine compound; piperidines; tertiary amino compound | dopaminergic antagonist; second generation antipsychotic; serotonergic antagonist |
loxapine succinate [no description available] | 2.08 | 1 | 0 | succinate salt | geroprotector |
voriconazole Voriconazole: A triazole antifungal agent that specifically inhibits STEROL 14-ALPHA-DEMETHYLASE and CYTOCHROME P-450 CYP3A.. voriconazole : A triazole-based antifungal agent used for the treatment of esophageal candidiasis, invasive pulmonary aspergillosis, and serious fungal infections caused by Scedosporium apiospermum and Fusarium spp. It is an inhibitor of cytochrome P450 2C9 (CYP2C9) and CYP3A4. | 2.08 | 1 | 0 | conazole antifungal drug; difluorobenzene; pyrimidines; tertiary alcohol; triazole antifungal drug | P450 inhibitor |
betamipron [no description available] | 2.08 | 1 | 0 | organonitrogen compound; organooxygen compound | |
uroxatral [no description available] | 2.08 | 1 | 0 | hydrochloride | |
aceclofenac [no description available] | 2.08 | 1 | 0 | amino acid; carboxylic ester; dichlorobenzene; monocarboxylic acid; secondary amino compound | EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
mdl 11939 alpha-phenyl-1-(2-phenylethyl)-4-piperidinemethanol: class III antiarrythmic agent; structure given in first source | 2.02 | 1 | 0 | primary amine | |
thiocolchicoside [no description available] | 2.08 | 1 | 0 | glycoside | |
doripenem Doripenem: A carbapenem derivative antibacterial agent that is more stable to renal dehydropeptidase I than IMIPENEM, but does not need to be given with an enzyme inhibitor such as CILASTATIN. It is used in the treatment of infections such as HOSPITAL-ACQUIRED PNEUMONIA, and complicated intra-abdominal or urinary-tract infections, including PYELONEPHRITIS. | 2.08 | 1 | 0 | carbapenems | |
oxazolidin-2-one Oxazolidinones: Derivatives of oxazolidin-2-one. They represent an important class of synthetic antibiotic agents.. oxazolidin-2-one : An oxazolidinone that is 1,3-oxazolidine with an oxo substituent at position 2.. oxazolidinone : An oxazolidine containing one or more oxo groups. | 2.03 | 1 | 0 | carbamate ester; oxazolidinone | metabolite |
rosiglitazone [no description available] | 2.08 | 1 | 0 | aminopyridine; thiazolidinediones | EC 6.2.1.3 (long-chain-fatty-acid--CoA ligase) inhibitor; ferroptosis inhibitor; insulin-sensitizing drug |
tamiflu [no description available] | 2.08 | 1 | 0 | phosphate salt | |
bexarotene [no description available] | 2.08 | 1 | 0 | benzoic acids; naphthalenes; retinoid | antineoplastic agent |
s20098 [no description available] | 6.71 | 8 | 0 | acetamides | |
flunisolide flunisolide: flunisolide HFA is a formulation of flunisolide using hydrofluoroalkane (HFA) as propellant in place of chlorofluorocarbon (CFC) ones | 2.08 | 1 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; cyclic ketal; fluorinated steroid; primary alpha-hydroxy ketone | anti-asthmatic drug; anti-inflammatory drug; immunosuppressive agent |
ketorolac tromethamine Ketorolac Tromethamine: A pyrrolizine carboxylic acid derivative structurally related to INDOMETHACIN. It is a non-steroidal anti-inflammatory agent used for analgesia for postoperative pain and inhibits cyclooxygenase activity.. ketorolac tromethamine : An organoammonium salt resulting from the mixture of equimolar amounts of ketorolac and tromethamine (tris). It has potent non-sedating analgesic and moderate anti-inflammatory effects. It is used in the short-term management of post-operative pain, and in eye drops to relieve the ocular itching associated with seasonal allergic conjunctivitis. | 2.08 | 1 | 0 | organoammonium salt | analgesic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor |
clarithromycin Clarithromycin: A semisynthetic macrolide antibiotic derived from ERYTHROMYCIN that is active against a variety of microorganisms. It can inhibit PROTEIN SYNTHESIS in BACTERIA by reversibly binding to the 50S ribosomal subunits. This inhibits the translocation of aminoacyl transfer-RNA and prevents peptide chain elongation.. clarithromycin : The 6-O-methyl ether of erythromycin A, clarithromycin is a macrolide antibiotic used in the treatment of respiratory-tract, skin and soft-tissue infections. It is also used to eradicate Helicobacter pylori in the treatment of peptic ulcer disease. It prevents bacteria from growing by interfering with their protein synthesis. | 2.08 | 1 | 0 | macrolide antibiotic | antibacterial drug; environmental contaminant; protein synthesis inhibitor; xenobiotic |
nicotine (S)-nicotine : A 3-(1-methylpyrrolidin-2-yl)pyridine in which the chiral centre has S-configuration. The naturally occurring and most active enantiomer of nicotine, isolated from Nicotiana tabacum. | 2.08 | 1 | 0 | 3-(1-methylpyrrolidin-2-yl)pyridine | anxiolytic drug; biomarker; immunomodulator; mitogen; neurotoxin; nicotinic acetylcholine receptor agonist; peripheral nervous system drug; phytogenic insecticide; plant metabolite; psychotropic drug; teratogenic agent; xenobiotic |
3,4-dihydroxyphenylglycol 3,4-dihydroxyphenylglycol: noradrenaline metabolite in mouse brain; RN given refers to cpd without isomeric designation. 3,4-dihydroxyphenylethyleneglycol : A tetrol composed of ethyleneglycol having a 3,4-dihydroxyphenyl group at the 1-position. | 6.21 | 4 | 3 | catechols; tetrol | metabolite; mouse metabolite |
gliquidone gliquidone: structure; RN given refers to parent cpd | 2.08 | 1 | 0 | isoquinolines | |
lopinavir [no description available] | 2.08 | 1 | 0 | amphetamines; dicarboxylic acid diamide | anticoronaviral agent; antiviral drug; HIV protease inhibitor |
droxidopa Droxidopa: A synthetic precursor of norepinephrine that is used in the treatment of PARKINSONIAN DISORDERS and ORTHOSTATIC HYPOTENSION.. droxidopa : A serine derivative that is L-serine substituted at the beta-position by a 3,4-dihydroxyphenyl group. A prodrug for noradrenalone, it is used for treatment of neurogenic orthostatic hypotension | 3.23 | 1 | 0 | catechols; L-tyrosine derivative | antihypertensive agent; prodrug; vasoconstrictor agent |
glucuronic acid Glucuronic Acid: A sugar acid formed by the oxidation of the C-6 carbon of GLUCOSE. In addition to being a key intermediate metabolite of the uronic acid pathway, glucuronic acid also plays a role in the detoxification of certain drugs and toxins by conjugating with them to form GLUCURONIDES.. D-glucuronic acid : The D-enantiomer of glucuronic acid.. D-glucopyranuronic acid : A D-glucuronic acid in cyclic pyranose form. | 2.1 | 1 | 0 | D-glucuronic acid | algal metabolite |
moxifloxacin hydrochloride moxifloxacin hydrochloride : A hydrochloride comprising equimolar amounts of moxifloxacin and hydrogen chloride. | 2.08 | 1 | 0 | hydrochloride | antibacterial drug |
fulvestrant Fulvestrant: An estradiol derivative and estrogen receptor antagonist that is used for the treatment of estrogen receptor-positive, locally advanced or metastatic breast cancer.. fulvestrant : A 3-hydroxy steroid that is 17beta-estradiol in which the 7alpha hydrogen has been replaced by a nonyl group in which one of the hydrogens of the terminal methyl has been replaced by a (4,4,5,5,5-pentafluoropentyl)sulfinyl group. An estrogen receptor antagonist, it is used in the treatment of breast cancer. | 2.08 | 1 | 0 | 17beta-hydroxy steroid; 3-hydroxy steroid; organofluorine compound; sulfoxide | antineoplastic agent; estrogen antagonist; estrogen receptor antagonist |
mizoribine [no description available] | 2.08 | 1 | 0 | imidazoles | anticoronaviral agent |
sr141716 [no description available] | 2.08 | 1 | 0 | amidopiperidine; carbohydrazide; dichlorobenzene; monochlorobenzenes; pyrazoles | anti-obesity agent; appetite depressant; CB1 receptor antagonist |
bosentan anhydrous Bosentan: A sulfonamide and pyrimidine derivative that acts as a dual endothelin receptor antagonist used to manage PULMONARY HYPERTENSION and SYSTEMIC SCLEROSIS. | 2.08 | 1 | 0 | primary alcohol; pyrimidines; sulfonamide | antihypertensive agent; endothelin receptor antagonist |
s-ethyl glutathione [no description available] | 2.06 | 1 | 0 | oligopeptide | |
racecadotril racecadotril: parenterally active enkephalinase inhibitor | 2.08 | 1 | 0 | N-acyl-amino acid | |
fingolimod hydrochloride Fingolimod Hydrochloride: A sphingosine-derivative and IMMUNOSUPPRESSIVE AGENT that blocks the migration and homing of LYMPHOCYTES to the CENTRAL NERVOUS SYSTEM through its action on SPHINGOSINE 1-PHOSPHATE RECEPTORS. It is used in the treatment of MULTIPLE SCLEROSIS.. fingolimod hydrochloride : The hydrochloride salt of 2-amino-2-[2-(4-octylphenyl) ethyl]-1,3-propanediol (fingolimod). | 2.25 | 1 | 0 | hydrochloride | immunosuppressive agent; prodrug; sphingosine-1-phosphate receptor agonist |
tadalafil [no description available] | 2.08 | 1 | 0 | benzodioxoles; pyrazinopyridoindole | EC 3.1.4.35 (3',5'-cyclic-GMP phosphodiesterase) inhibitor; vasodilator agent |
metadoxine metadoxine: combination of above cpds | 3.23 | 1 | 0 | ||
plavix [no description available] | 2.08 | 1 | 0 | azaheterocycle sulfate salt; organoammonium sulfate salt | anticoagulant; P2Y12 receptor antagonist; platelet aggregation inhibitor |
clofarabine [no description available] | 2.08 | 1 | 0 | adenosines; organofluorine compound | antimetabolite; antineoplastic agent |
ginsenoside rh2 ginsenoside Rh2: from leaves of Panax ginseng C; structure given in first source. (20S)-ginsenoside Rh2 : A ginsenoside found in Panax species that is dammarane which is substituted by hydroxy groups at the 3beta, 12beta and 20 pro-S positions, in which the hydroxy group at position 3 has been converted to the corresponding beta-D-glucopyranoside, and in which a double bond has been introduced at the 24-25 position. | 3.21 | 1 | 0 | 12beta-hydroxy steroid; 20-hydroxy steroid; beta-D-glucoside; ginsenoside; tetracyclic triterpenoid | antineoplastic agent; apoptosis inducer; bone density conservation agent; cardioprotective agent; hepatoprotective agent; plant metabolite |
gr 113808 GR 113808: structure given in first source; a 5-HT(4) receptor antagonist: GR 125487 is the HCl salt. GR 113808 : An indolyl carboxylate ester obtained by formal condensation between the carboxy group of 1-methylindole-3-carboxylic acid with the hydroxy group of N-{2-[4-(hydroxymethyl)piperidin-1-yl]ethyl}methanesulfonamide. | 2.11 | 1 | 0 | indolyl carboxylate ester; piperidines; sulfonamide | serotonergic antagonist |
pramipexole Pramipexole: A benzothiazole derivative and dopamine agonist with antioxidant properties that is used in the treatment of PARKINSON DISEASE and RESTLESS LEGS SYNDROME.. pramipexole : A member of the class of benzothiazoles that is 4,5,6,7-tetrahydro-1,3-benzothiazole in which the hydrogens at the 2 and 6-pro-S-positions are substituted by amino and propylamino groups, respectively. | 2.49 | 2 | 0 | benzothiazoles; diamine | antidyskinesia agent; antiparkinson drug; dopamine agonist; radical scavenger |
valdecoxib [no description available] | 2.08 | 1 | 0 | isoxazoles; sulfonamide | antipyretic; antirheumatic drug; cyclooxygenase 2 inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
2-hydroxydesipramine 2-hydroxydesipramine: RN given refers to parent cpd | 3.43 | 1 | 1 | dibenzoazepine | |
hydroxypropylmethylcellulose acetate succinate hydroxypropylmethylcellulose acetate succinate: structure given in first source | 1.99 | 1 | 0 | ||
mk 0663 [no description available] | 6.2 | 3 | 1 | bipyridines; organochlorine compound; sulfone | cyclooxygenase 2 inhibitor; non-steroidal anti-inflammatory drug |
gefitinib [no description available] | 2.08 | 1 | 0 | aromatic ether; monochlorobenzenes; monofluorobenzenes; morpholines; quinazolines; secondary amino compound; tertiary amino compound | antineoplastic agent; epidermal growth factor receptor antagonist |
desloratadine desloratadine: major metabolite of loratadine. desloratadine : Loratadine in which the ethoxycarbonyl group attached to the piperidine ring is replaced by hydrogen. The major metabolite of loratidine, desloratadine is an antihistamine which is used for the symptomatic relief of allergic conditions including rhinitis and chronic urticaria. It does not readily enter the central nervous system, so does not cause drowsiness. | 2.08 | 1 | 0 | benzocycloheptapyridine | anti-allergic agent; cholinergic antagonist; drug metabolite; H1-receptor antagonist |
ly 206130 LY 206130: a serotonin 5-HT1A antagonist | 1.99 | 1 | 0 | ||
methotrexate [no description available] | 2.08 | 1 | 0 | dicarboxylic acid; monocarboxylic acid amide; pteridines | abortifacient; antimetabolite; antineoplastic agent; antirheumatic drug; dermatologic drug; DNA synthesis inhibitor; EC 1.5.1.3 (dihydrofolate reductase) inhibitor; immunosuppressive agent |
reboxetine Reboxetine: A morpholine derivative that is a selective and potent noradrenaline reuptake inhibitor; it is used in the treatment of DEPRESSIVE DISORDER. | 11.65 | 18 | 2 | aromatic ether | |
dau 6285 [no description available] | 1.99 | 1 | 0 | ||
sulbactam [no description available] | 2.08 | 1 | 0 | penicillanic acids | |
olmesartan medoxomil Olmesartan Medoxomil: An ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to manage HYPERTENSION. | 2.08 | 1 | 0 | biphenyls | |
fosamprenavir fosamprenavir: a prodrug of the protease inhibitor amprenavir. fosamprenavir : A sulfonamide with a structure based on that of sulfanilamide substituted on the sulfonamide nitrogen by a (2R,3S)-4-phenyl-2-(phosphonooxy)-3-({[(3S)-tetrahydrofuran-3-yloxy]carbonyl}amino)butyl group. It is a pro-drug of the HIV protease inhibitor and antiretroviral drug amprenavir. | 3.13 | 1 | 0 | sulfonamide | prodrug |
safinamide safinamide: short-acting inhibitor of MOA-B; FCE 26743 is (S)-isomer, FCE 28073 is (R)-isomer; structure in first source | 3.35 | 1 | 0 | amino acid amide | |
abiraterone [no description available] | 2.08 | 1 | 0 | 3beta-hydroxy-Delta(5)-steroid; 3beta-sterol; pyridines | antineoplastic agent; EC 1.14.99.9 (steroid 17alpha-monooxygenase) inhibitor |
febuxostat Febuxostat: A thiazole derivative and inhibitor of XANTHINE OXIDASE that is used for the treatment of HYPERURICEMIA in patients with chronic GOUT.. febuxostat : A 1,3-thiazolemonocarboxylic acid that is 4-methyl-1,3-thiazole-5-carboxylic acid which is substituted by a 3-cyano-4-(2-methylpropoxy)phenyl group at position 2. It is an orally-active, potent, and selective xanthine oxidase inhibitor used for the treatment of chronic hyperuricaemia in patients with gout. | 2.08 | 1 | 0 | 1,3-thiazolemonocarboxylic acid; aromatic ether; nitrile | EC 1.17.3.2 (xanthine oxidase) inhibitor |
escitalopram Escitalopram: S-enantiomer of CITALOPRAM. Belongs to a class of drugs known as SELECTIVE SEROTONIN REUPTAKE INHIBITORS, used to treat depression and generalized anxiety disorder.. escitalopram : A 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile that has S-configuration at the chiral centre. It is the active enantiomer of citalopram. | 7.65 | 6 | 2 | 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile | antidepressant; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor |
lexapro Lexapro: Trade name of escitalopram, the active S-enantiomer of the racemic citalopram. | 2.08 | 1 | 0 | ||
docetaxel anhydrous Docetaxel: A semisynthetic analog of PACLITAXEL used in the treatment of locally advanced or metastatic BREAST NEOPLASMS and NON-SMALL CELL LUNG CANCER.. docetaxel anhydrous : A tetracyclic diterpenoid that is paclitaxel with the N-benzyloxycarbonyl group replaced by N-tert-butoxycarbonyl, and the acetoxy group at position 10 replaced by a hydroxy group. | 2.83 | 3 | 0 | secondary alpha-hydroxy ketone; tetracyclic diterpenoid | antimalarial; antineoplastic agent; photosensitizing agent |
levofloxacin Levofloxacin: The L-isomer of Ofloxacin.. levofloxacin : An optically active form of ofloxacin having (S)-configuration; an inhibitor of bacterial topoisomerase IV and DNA gyrase. | 2.08 | 1 | 0 | 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid; fluoroquinolone antibiotic; quinolone antibiotic | antibacterial drug; DNA synthesis inhibitor; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor; topoisomerase IV inhibitor |
ezetimibe Ezetimibe: An azetidine derivative and ANTICHOLESTEREMIC AGENT that inhibits intestinal STEROL absorption. It is used to reduce total CHOLESTEROL; LDL CHOLESTEROL, and APOLIPOPROTEINS B in the treatment of HYPERLIPIDEMIAS.. ezetimibe : A beta-lactam that is azetidin-2-one which is substituted at 1, 3, and 4 by p-fluorophenyl, 3-(p-fluorophenyl)-3-hydroxypropyl, and 4-hydroxyphenyl groups, respectively (the 3R,3'S,4S enantiomer). | 2.08 | 1 | 0 | azetidines; beta-lactam; organofluorine compound | anticholesteremic drug; antilipemic drug; antimetabolite |
cox 189 lumiracoxib: a COX-2 inhibitor. lumiracoxib : An amino acid that is phenylacetic acid which is substituted at position 2 by the nitrogen of 2-chloro-6-fluoroaniline and at position 5 by a methyl group. A highly selective cyclooxygenase 2 inhibitor, it was briefly used for the treatment of osteoarthritis, but was withdrawn due to concersns of hepatotoxicity. | 2.08 | 1 | 0 | amino acid; monocarboxylic acid; organochlorine compound; organofluorine compound; secondary amino compound | cyclooxygenase 2 inhibitor; non-steroidal anti-inflammatory drug |
cilomilast [no description available] | 2.03 | 1 | 0 | methoxybenzenes | |
moxifloxacin Moxifloxacin: A fluoroquinolone that acts as an inhibitor of DNA TOPOISOMERASE II and is used as a broad-spectrum antibacterial agent.. moxifloxacin : A quinolone that consists of 4-oxo-1,4-dihydroquinoline-3-carboxylic acid bearing a cyclopropyl substituent at position 1, a fluoro substitiuent at position 6, a (4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl group at position 7 and a methoxy substituent at position 8. A member of the fluoroquinolone class of antibacterial agents. | 3.42 | 1 | 1 | aromatic ether; cyclopropanes; fluoroquinolone antibiotic; pyrrolidinopiperidine; quinolinemonocarboxylic acid; quinolone antibiotic; quinolone | antibacterial drug |
xamoterol Xamoterol: A phenoxypropanolamine derivative that is a selective beta-1-adrenergic agonist. | 2.08 | 1 | 0 | morpholines | |
naproxen Naproxen: An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.. naproxen : A methoxynaphthalene that is 2-methoxynaphthalene substituted by a carboxy ethyl group at position 6. Naproxen is a non-steroidal anti-inflammatory drug commonly used for the reduction of pain, fever, inflammation and stiffness caused by conditions such as osteoarthritis, kidney stones, rheumatoid arthritis, psoriatic arthritis, gout, ankylosing spondylitis, menstrual cramps, tendinitis, bursitis, and for the treatment of primary dysmenorrhea. It works by inhibiting both the COX-1 and COX-2 enzymes. | 4.32 | 5 | 0 | methoxynaphthalene; monocarboxylic acid | antipyretic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; drug allergen; environmental contaminant; gout suppressant; non-narcotic analgesic; non-steroidal anti-inflammatory drug; xenobiotic |
atazanavir sulfate Atazanavir Sulfate: An azapeptide and HIV-PROTEASE INHIBITOR that is used in the treatment of HIV INFECTIONS and AIDS in combination with other ANTI-HIV AGENTS. | 3.13 | 1 | 0 | organic sulfate salt | |
telbivudine [no description available] | 2.08 | 1 | 0 | pyrimidine 2'-deoxyribonucleoside | antiviral drug; EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor |
atropine tropan-3alpha-yl 3-hydroxy-2-phenylpropanoate : A tropane alkaloid that is (1R,5)-8-methyl-8-azabicyclo[3.2.1]octane substituted by a (3-hydroxy-2-phenylpropanoyl)oxy group at position 3. | 2.08 | 1 | 0 | ||
esketamine esketamine : The S- (more active) enantiomer of ketamine. | 6.91 | 3 | 3 | ketamine | analgesic; intravenous anaesthetic; NMDA receptor antagonist |
ru 43044 RU 43044: antagonist of adrenal cortex hormone receptors | 2.11 | 1 | 0 | ||
dronedarone Dronedarone: A non-iodinated derivative of amiodarone that is used for the treatment of ARRHYTHMIA.. dronedarone : A member of the class of 1-benzofurans used for the treatment of cardiac arrhythmias. | 2.15 | 1 | 0 | 1-benzofurans; aromatic ether; aromatic ketone; sulfonamide; tertiary amino compound | anti-arrhythmia drug; environmental contaminant; xenobiotic |
ramelteon ramelteon: melatonin MT1/MT2 receptor agonist | 3.55 | 2 | 0 | indanes | |
darunavir Darunavir: An HIV PROTEASE INHIBITOR that is used in the treatment of AIDS and HIV INFECTIONS. Due to the emergence of ANTIVIRAL DRUG RESISTANCE when used alone, it is administered in combination with other ANTI-HIV AGENTS.. darunavir : An N,N-disubstituted benzenesulfonamide bearing an unsubstituted amino group at the 4-position, used for the treatment of HIV infection. A second-generation HIV protease inhibitor, darunavir was designed to form robust interactions with the protease enzyme from many strains of HIV, including those from treatment-experienced patients with multiple resistance mutations to other protease inhibitors. | 2.05 | 1 | 0 | carbamate ester; furofuran; sulfonamide | antiviral drug; HIV protease inhibitor |
deferasirox Deferasirox: A triazole and benzoate derivative that acts as a selective iron chelator. It is used in the management of chronic IRON OVERLOAD due to blood transfusion or non-transfusion dependent THALASSEMIA.. deferasirox : A member of the class of triazoles, deferasirox is 1,2,4-triazole substituted by a 4-carboxyphenyl group at position 1 and by 2-hydroxyphenyl groups at positions 3 and 5. An orally active iron chelator, it is used to manage chronic iron overload in patients receiving long-term blood transfusions. | 2.08 | 1 | 0 | benzoic acids; monocarboxylic acid; phenols; triazoles | iron chelator |
bms204352 BMS204352: a calcium-sensitive opener of maxi-K potassium channels; structure in first source | 2.08 | 1 | 0 | ||
tbc-11251 sitaxsentan: endothelin A receptor antagonist; structure in first source | 2.08 | 1 | 0 | benzodioxoles | |
tolvaptan [no description available] | 2.08 | 1 | 0 | benzazepine; benzenedicarboxamide | aquaretic; vasopressin receptor antagonist |
lenalidomide [no description available] | 2.08 | 1 | 0 | aromatic amine; dicarboximide; isoindoles; piperidones | angiogenesis inhibitor; antineoplastic agent; immunomodulator |
solifenacin succinate Solifenacin Succinate: A quinuclidine and tetrahydroisoquinoline derivative and selective M3 MUSCARINIC ANTAGONIST. It is used as a UROLOGIC AGENT in the treatment of URINARY INCONTINENCE. | 7.43 | 5 | 1 | isoquinolines | |
lacosamide Lacosamide: An acetamide derivative that acts as a blocker of VOLTAGE-GATED SODIUM CHANNELS. It is used as an anticonvulsant, for adjunctive or monotherapy, in the treatment of PARTIAL SEIZURES. | 2.08 | 1 | 0 | N-acyl-amino acid | |
vincaleukoblastine [no description available] | 2.08 | 1 | 0 | acetate ester; indole alkaloid fundamental parent; methyl ester; organic heteropentacyclic compound; organic heterotetracyclic compound; tertiary alcohol; tertiary amino compound; vinca alkaloid | antineoplastic agent; immunosuppressive agent; microtubule-destabilising agent; plant metabolite |
vincristine sulfate [no description available] | 2.08 | 1 | 0 | organic sulfate salt | antineoplastic agent; geroprotector |
benzofurans Benzofurans: Compounds that contain a BENZENE ring fused to a furan ring. | 6.06 | 4 | 0 | ||
wortmannin [no description available] | 2.08 | 1 | 0 | acetate ester; cyclic ketone; delta-lactone; organic heteropentacyclic compound | anticoronaviral agent; antineoplastic agent; autophagy inhibitor; EC 2.7.1.137 (phosphatidylinositol 3-kinase) inhibitor; geroprotector; Penicillium metabolite; radiosensitizing agent |
bortezomib [no description available] | 4.34 | 5 | 0 | amino acid amide; L-phenylalanine derivative; pyrazines | antineoplastic agent; antiprotozoal drug; protease inhibitor; proteasome inhibitor |
ritonavir Ritonavir: An HIV protease inhibitor that works by interfering with the reproductive cycle of HIV. It also inhibits CYTOCHROME P-450 CYP3A.. ritonavir : An L-valine derivative that is L-valinamide in which alpha-amino group has been acylated by a [(2-isopropyl-1,3-thiazol-4-yl)methyl]methylcarbamoyl group and in which a hydrogen of the carboxamide amino group has been replaced by a (2R,4S,5S)-4-hydroxy-1,6-diphenyl-5-{[(1,3-thiazol-5-ylmethoxy)carbonyl]amino}hexan-2-yl group. A CYP3A inhibitor and antiretroviral drug from the protease inhibitor class used to treat HIV infection and AIDS, it is often used as a fixed-dose combination with another protease inhibitor, lopinavir. Also used in combination with dasabuvir sodium hydrate, ombitasvir and paritaprevir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver. | 2.47 | 2 | 0 | 1,3-thiazoles; carbamate ester; carboxamide; L-valine derivative; ureas | antiviral drug; environmental contaminant; HIV protease inhibitor; xenobiotic |
glycogen glycogen : A polydisperse, highly branched glucan composed of chains of D-glucopyranose residues in alpha(1->4) glycosidic linkage, joined together by alpha(1->6) glycosidic linkages. A small number of alpha(1->3) glycosidic linkages and some cumulative alpha(1->6) links also may occur. The branches in glycogen typically contain 8 to 12 glucose residues. | 2.11 | 1 | 0 | ||
bradykinin [no description available] | 2.11 | 1 | 0 | oligopeptide | human blood serum metabolite; vasodilator agent |
glucosamine D-glucosamine : An amino sugar whose structure comprises D-glucose having an amino substituent at position 2.. 2-amino-2-deoxy-D-glucopyranose : A D-glucosamine whose structure comprises D-glucopyranose having an amino substituent at position 2. | 3.19 | 1 | 0 | D-glucosamine | Escherichia coli metabolite; geroprotector; mouse metabolite |
pentostatin Pentostatin: A potent inhibitor of ADENOSINE DEAMINASE. The drug induces APOPTOSIS of LYMPHOCYTES, and is used in the treatment of many lymphoproliferative malignancies, particularly HAIRY CELL LEUKEMIA. It is also synergistic with some other antineoplastic agents and has immunosuppressive activity.. pentostatin : A member of the class of coformycins that is coformycin in which the hydroxy group at position 2' is replaced with a hydrogen. It is a drug used for the treatment of hairy cell leukaemia. | 2.08 | 1 | 0 | coformycins | antimetabolite; antineoplastic agent; Aspergillus metabolite; bacterial metabolite; EC 3.5.4.4 (adenosine deaminase) inhibitor |
quinidine Quinidine: An optical isomer of quinine, extracted from the bark of the CHINCHONA tree and similar plant species. This alkaloid dampens the excitability of cardiac and skeletal muscles by blocking sodium and potassium currents across cellular membranes. It prolongs cellular ACTION POTENTIALS, and decreases automaticity. Quinidine also blocks muscarinic and alpha-adrenergic neurotransmission.. quinidine : A cinchona alkaloid consisting of cinchonine with the hydrogen at the 6-position of the quinoline ring substituted by methoxy. | 2.47 | 2 | 0 | cinchona alkaloid | alpha-adrenergic antagonist; anti-arrhythmia drug; antimalarial; drug allergen; EC 1.14.13.181 (13-deoxydaunorubicin hydroxylase) inhibitor; EC 3.6.3.44 (xenobiotic-transporting ATPase) inhibitor; muscarinic antagonist; P450 inhibitor; potassium channel blocker; sodium channel blocker |
meropenem Meropenem: A thienamycin derivative antibacterial agent that is more stable to renal dehydropeptidase I than IMIPENEM, but does not need to be given with an enzyme inhibitor such as CILASTATIN. It is used in the treatment of bacterial infections, including infections in immunocompromised patients.. meropenem : A carbapenemcarboxylic acid in which the azetidine and pyrroline rings carry 1-hydroxymethyl and in which the azetidine and pyrroline rings carry 1-hydroxymethyl and 5-(dimethylcarbamoyl)pyrrolidin-3-ylthio substituents respectively. | 2.08 | 1 | 0 | alpha,beta-unsaturated monocarboxylic acid; carbapenemcarboxylic acid; organic sulfide; pyrrolidinecarboxamide | antibacterial agent; antibacterial drug; drug allergen |
digitoxin Digitoxin: A cardiac glycoside sometimes used in place of DIGOXIN. It has a longer half-life than digoxin; toxic effects, which are similar to those of digoxin, are longer lasting. (From Martindale, The Extra Pharmacopoeia, 30th ed, p665). digitoxin : A cardenolide glycoside in which the 3beta-hydroxy group of digitoxigenin carries a 2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1->4)-2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1->4)-2,6-dideoxy-beta-D-ribo-hexopyranosyl trisaccharide chain. | 2.08 | 1 | 0 | cardenolide glycoside | EC 3.6.3.9 (Na(+)/K(+)-transporting ATPase) inhibitor |
saquinavir Saquinavir: An HIV protease inhibitor which acts as an analog of an HIV protease cleavage site. It is a highly specific inhibitor of HIV-1 and HIV-2 proteases, and also inhibits CYTOCHROME P-450 CYP3A.. saquinavir : An aspartic acid derivative obtained by formal condensation of the primary amino group of (2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)octahydroisoquinolin-2(1H)-yl]-3-hydroxy-1-phenylbutan-2-ylamine with the carboxy group of N(2)(-quinolin-2-ylcarbonyl)-L-asparagine. An inhibitor of HIV-1 protease. | 2.08 | 1 | 0 | L-asparagine derivative; quinolines | antiviral drug; HIV protease inhibitor |
rocuronium Rocuronium: An androstanol non-depolarizing neuromuscular blocking agent. It has a mono-quaternary structure and is a weaker nicotinic antagonist than PANCURONIUM.. rocuronium : A 5alpha-androstane compound having 3alpha-hydroxy-, 17beta-acetoxy-, 2beta-morpholino- and 16beta-N-allyllyrrolidinium substituents. | 2.08 | 1 | 0 | 3alpha-hydroxy steroid; acetate ester; androstane; morpholines; quaternary ammonium ion; tertiary amino compound | drug allergen; muscle relaxant; neuromuscular agent |
perindopril erbumine [no description available] | 2.08 | 1 | 0 | addition compound | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor |
miglitol [no description available] | 2.08 | 1 | 0 | piperidines | |
rocuronium bromide rocuronium bromide : The organic bromide salt of a 5alpha androstane compound having 3alpha-hydroxy-, 17beta-acetoxy-, 2beta-morpholino- and 16beta-N-allyllyrrolidinium substituents. | 2.08 | 1 | 0 | organic bromide salt; quaternary ammonium salt | muscle relaxant; neuromuscular agent |
linezolid [no description available] | 2.46 | 2 | 0 | acetamides; morpholines; organofluorine compound; oxazolidinone | antibacterial drug; protein synthesis inhibitor |
pemirolast potassium salt [no description available] | 2.08 | 1 | 0 | ||
eplerenone Eplerenone: A spironolactone derivative and selective ALDOSTERONE RECEPTOR antagonist that is used in the management of HYPERTENSION and CONGESTIVE HEART FAILURE, post-MYOCARDIAL INFARCTION. | 3.55 | 2 | 0 | 3-oxo-Delta(4) steroid; epoxy steroid; gamma-lactone; methyl ester; organic heteropentacyclic compound; oxaspiro compound; steroid acid ester | aldosterone antagonist; antihypertensive agent |
ao 128 AO 128: alpha-glucosidase inhibitor; structure given in first source | 2.08 | 1 | 0 | organic molecular entity | |
loteprednol etabonate Loteprednol Etabonate: An androstadiene derivative corticosteroid that is used as an ANTI-ALLERGIC AGENT for the treatment of inflammatory and allergic eye conditions. | 2.08 | 1 | 0 | 11beta-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; etabonate ester; organochlorine compound; steroid acid ester; steroid ester | anti-inflammatory drug |
darifenacin darifenacin : 2-[(3S)-1-Ethylpyrrolidin-3-yl]-2,2-diphenylacetamide in which one of the hydrogens at the 2-position of the ethyl group is substituted by a 2,3-dihydro-1-benzofuran-5-yl group. It is a selective antagonist for the M3 muscarinic acetylcholine receptor, which is primarily responsible for bladder muscle contractions, and is used as the hydrobromide salt in the management of urinary incontinence. | 4.66 | 3 | 0 | 1-benzofurans; monocarboxylic acid amide; pyrrolidines | antispasmodic drug; muscarinic antagonist |
fluticasone propionate fluticasone propionate : A trifluorinated corticosteroid that consists of 6alpha,9-difluoro-11beta,17alpha-dihydroxy-17beta-{[(fluoromethyl)sulfanyl]carbonyl}-16-methyl-3-oxoandrosta-1,4-diene bearing a propionyl substituent at position 17; has anti-inflammatory, anti-asthmatic and anti-allergic activity. | 2.08 | 1 | 0 | 11beta-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; corticosteroid; fluorinated steroid; propanoate ester; steroid ester; thioester | adrenergic agent; anti-allergic agent; anti-asthmatic drug; anti-inflammatory drug; bronchodilator agent; dermatologic drug |
betadex beta-Cyclodextrins: Cyclic GLUCANS consisting of seven (7) glucopyranose units linked by 1,4-glycosidic bonds. | 2.91 | 3 | 0 | cyclodextrin | |
tretinoin Tretinoin: An important regulator of GENE EXPRESSION during growth and development, and in NEOPLASMS. Tretinoin, also known as retinoic acid and derived from maternal VITAMIN A, is essential for normal GROWTH; and EMBRYONIC DEVELOPMENT. An excess of tretinoin can be teratogenic. It is used in the treatment of PSORIASIS; ACNE VULGARIS; and several other SKIN DISEASES. It has also been approved for use in promyelocytic leukemia (LEUKEMIA, PROMYELOCYTIC, ACUTE).. retinoic acid : A retinoid consisting of 3,7-dimethylnona-2,4,6,8-tetraenoic acid substituted at position 9 by a 2,6,6-trimethylcyclohex-1-en-1-yl group (geometry of the four exocyclic double bonds is not specified).. all-trans-retinoic acid : A retinoic acid in which all four exocyclic double bonds have E- (trans-) geometry. | 2.08 | 1 | 0 | retinoic acid; vitamin A | anti-inflammatory agent; antineoplastic agent; antioxidant; AP-1 antagonist; human metabolite; keratolytic drug; retinoic acid receptor agonist; retinoid X receptor agonist; signalling molecule |
resveratrol trans-resveratrol : A resveratrol in which the double bond has E configuration. | 2.25 | 1 | 0 | resveratrol | antioxidant; phytoalexin; plant metabolite; quorum sensing inhibitor; radical scavenger |
tacrolimus Tacrolimus: A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.. tacrolimus (anhydrous) : A macrolide lactam containing a 23-membered lactone ring, originally isolated from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis. | 2.08 | 1 | 0 | macrolide lactam | bacterial metabolite; immunosuppressive agent |
mupirocin Mupirocin: A topically used antibiotic from a strain of Pseudomonas fluorescens. It has shown excellent activity against gram-positive staphylococci and streptococci. The antibiotic is used primarily for the treatment of primary and secondary skin disorders, nasal infections, and wound healing.. mupirocin : An alpha,beta-unsaturated ester resulting from the formal condensation of the alcoholic hydroxy group of 9-hydroxynonanoic acid with the carboxy group of (2E)-4-[(2S)-tetrahydro-2H-pyran-2-yl]-3-methylbut-2-enoic acid in which the tetrahydropyranyl ring is substituted at positions 3 and 4 by hydroxy groups and at position 5 by a {(2S,3S)-3-[(2S,3S)-3-hydroxybutan-2-yl]oxiran-2-yl}methyl group. Originally isolated from the Gram-negative bacterium Pseudomonas fluorescens, it is used as a topical antibiotic for the treatment of Gram-positive bacterial infections. | 2.08 | 1 | 0 | alpha,beta-unsaturated carboxylic ester; epoxide; monocarboxylic acid; oxanes; secondary alcohol; triol | antibacterial drug; bacterial metabolite; protein synthesis inhibitor |
zithromax Azithromycin: A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.. azithromycin : A macrolide antibiotic useful for the treatment of bacterial infections. | 2.08 | 1 | 0 | macrolide antibiotic | antibacterial drug; environmental contaminant; xenobiotic |
epothilone a Epothilones: A group of 16-member MACROLIDES which stabilize MICROTUBULES in a manner similar to PACLITAXEL. They were originally found in the myxobacterium Sorangium cellulosum, now renamed to Polyangium (MYXOCOCCALES). | 4.16 | 2 | 0 | epothilone; epoxide | antineoplastic agent; metabolite; microtubule-stabilising agent; tubulin modulator |
decitabine [no description available] | 2.08 | 1 | 0 | 2'-deoxyribonucleoside | |
teniposide [no description available] | 2.08 | 1 | 0 | aromatic ether; beta-D-glucoside; cyclic acetal; furonaphthodioxole; gamma-lactone; monosaccharide derivative; phenols; thiophenes | antineoplastic agent; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor |
valrubicin [no description available] | 2.08 | 1 | 0 | anthracycline; trifluoroacetamide | |
melphalan Melphalan: An alkylating nitrogen mustard that is used as an antineoplastic in the form of the levo isomer - MELPHALAN, the racemic mixture - MERPHALAN, and the dextro isomer - MEDPHALAN; toxic to bone marrow, but little vesicant action; potential carcinogen.. melphalan : A phenylalanine derivative comprising L-phenylalanine having [bis(2-chloroethyl)amino group at the 4-position on the phenyl ring. | 2.08 | 1 | 0 | L-phenylalanine derivative; nitrogen mustard; non-proteinogenic L-alpha-amino acid; organochlorine compound | alkylating agent; antineoplastic agent; carcinogenic agent; drug allergen; immunosuppressive agent |
posaconazole [no description available] | 2.08 | 1 | 0 | aromatic ether; conazole antifungal drug; N-arylpiperazine; organofluorine compound; oxolanes; triazole antifungal drug; triazoles | trypanocidal drug |
rubitecan rubitecan: RN refers to (+-)-isomer; anti-HIV agent; DNA Topoisomerases, Type I inhibitor. rubitecan : A pyranoindolizinoquinoline that is camptothecin in which the hydrogen at position 9 has been replaced by a nitro group. It is a prodrug for 9-aminocamptothecin. | 2.08 | 1 | 0 | C-nitro compound; delta-lactone; pyranoindolizinoquinoline; semisynthetic derivative; tertiary alcohol | antineoplastic agent; EC 5.99.1.2 (DNA topoisomerase) inhibitor; prodrug |
ammonium acetate ammonium acetate : An ammonium salt obtained by reaction of ammonia with acetic acid. A deliquescent white crystalline solid, it has a relatively low melting point (114degreeC) for a salt. Used as a food acidity regulator, although no longer approved for this purpose in the EU. | 2.08 | 1 | 0 | acetate salt; ammonium salt | buffer; food acidity regulator |
dipyrone Dipyrone: A drug that has analgesic, anti-inflammatory, and antipyretic properties. It is the sodium sulfonate of AMINOPYRINE.. metamizole sodium : An organic sodium salt of antipyrine substituted at C-4 by a methyl(sulfonatomethyl)amino group, commonly used as a powerful analgesic and antipyretic. | 2.41 | 1 | 0 | organic sodium salt | anti-inflammatory agent; antipyretic; antirheumatic drug; cyclooxygenase 3 inhibitor; non-narcotic analgesic; peripheral nervous system drug; prodrug |
carbenoxolone sodium Carbenoxolone: An agent derived from licorice root. It is used for the treatment of digestive tract ulcers, especially in the stomach. Antidiuretic side effects are frequent, but otherwise the drug is low in toxicity. | 2.07 | 1 | 0 | triterpenoid | |
stilbenes Stilbenes: Organic compounds that contain 1,2-diphenylethylene as a functional group.. trans-stilbene : The trans-isomer of stilbene. | 2.13 | 1 | 0 | stilbene | |
cannabidiol Cannabidiol: Compound isolated from Cannabis sativa extract.. cannabidiol : An cannabinoid that is cyclohexene which is substituted by a methyl group at position 1, a 2,6-dihydroxy-4-pentylphenyl group at position 3, and a prop-1-en-2-yl group at position 4. | 3.13 | 1 | 0 | olefinic compound; phytocannabinoid; resorcinols | antimicrobial agent; plant metabolite |
arginine vasopressin Arginine Vasopressin: The predominant form of mammalian antidiuretic hormone. It is a nonapeptide containing an ARGININE at residue 8 and two disulfide-linked cysteines at residues of 1 and 6. Arg-vasopressin is used to treat DIABETES INSIPIDUS or to improve vasomotor tone and BLOOD PRESSURE.. argipressin : The predominant form of mammalian vasopressin (antidiuretic hormone). It is a nonapeptide containing an arginine at residue 8 and two disulfide-linked cysteines at residues of 1 and 6. | 4.78 | 2 | 1 | vasopressin | cardiovascular drug; hematologic agent; mitogen |
trilostane trilostane: inhibits conversion of pregnenolone to progesterone; adrenal blocking agent used in treatment of Cushing's syndrome. trilostane : An epoxy steroid that is 3,17beta-dihydroxy-5alpha-androst-2-ene-2-carbonitrile in which the oxygen of the epoxy group is joined to the 4alpha and 5 alpha positions. | 2.08 | 1 | 0 | 17beta-hydroxy steroid; 3-hydroxy steroid; androstanoid; epoxy steroid; nitrile | abortifacient; antineoplastic agent; EC 1.1.1.210 [3beta(or 20alpha)-hydroxysteroid dehydrogenase] inhibitor |
leuprolide acetate leuprolide acetate : An acetate salt obtained by combining the nonapeptide leuprolide with acetic acid. A long lasting GnRH analog, LH-Rh agonist. It is a synthetic nonapeptide analogue of gonadotropin-releasing hormone, and is used as a subcutaneous hydrogel implant for the treatment of prostate cancer and for the suppression of gonadal sex hormone production in children with central precocious puberty. | 2.08 | 1 | 0 | acetate salt | antineoplastic agent; gonadotropin releasing hormone agonist |
propylthiouracil Propylthiouracil: A thiourea antithyroid agent. Propythiouracil inhibits the synthesis of thyroxine and inhibits the peripheral conversion of throxine to tri-iodothyronine. It is used in the treatment of hyperthyroidism. (From Martindale, The Extra Pharmacopeoia, 30th ed, p534). 6-propyl-2-thiouracil : A pyrimidinethione consisting of uracil in which the 2-oxo group is substituted by a thio group and the hydrogen at position 6 is substituted by a propyl group. | 2.08 | 1 | 0 | pyrimidinethione | antidote to paracetamol poisoning; antimetabolite; antioxidant; antithyroid drug; carcinogenic agent; EC 1.14.13.39 (nitric oxide synthase) inhibitor; hormone antagonist |
mercaptopurine Mercaptopurine: An antimetabolite antineoplastic agent with immunosuppressant properties. It interferes with nucleic acid synthesis by inhibiting purine metabolism and is used, usually in combination with other drugs, in the treatment of or in remission maintenance programs for leukemia.. purine-6-thiol : A thiol that is the tautomer of mercaptopurine.. mercaptopurine : A member of the class of purines that is 6,7-dihydro-1H-purine carrying a thione group at position 6. An adenine analogue, it is used in the treatment of acute lymphocytic leukemia (ALL), chronic myeloid leukemia (CML), Crohn's disease, and ulcerative colitis. | 2.08 | 1 | 0 | aryl thiol; purines; thiocarbonyl compound | anticoronaviral agent; antimetabolite; antineoplastic agent |
crotamiton [no description available] | 2.31 | 1 | 0 | ||
levosulpiride (S)-(-)-sulpiride : An optically active form of sulpiride having (S)-configuration. The active enantiomer of the racemic drug sulpiride. Selective D2-like dopamine antagonist (Ki values are ~ 0.015. ~ 0.013, 1, ~ 45 and ~ 77 muM at D2, D3, D4, D1 and D5 receptors respectively). | 2.08 | 1 | 0 | sulpiride | antidepressant; antiemetic; antipsychotic agent; dopaminergic antagonist |
vanilmandelic acid 3-methoxy-4-hydroxymandelic acid: used in hypertensive patients | 3.4 | 1 | 1 | ||
phenylalanine methyl ester phenylalanine methyl ester: RN given refers to (L)-isomer. methyl L-phenylalaninate : An alpha-amino acid ester that is the methyl ester of L-phenylalanine. | 2.1 | 1 | 0 | alpha-amino acid ester; L-phenylalanine derivative | |
flunarizine Flunarizine: Flunarizine is a selective calcium entry blocker with calmodulin binding properties and histamine H1 blocking activity. It is effective in the prophylaxis of migraine, occlusive peripheral vascular disease, vertigo of central and peripheral origin, and as an adjuvant in the therapy of epilepsy. | 2.41 | 1 | 0 | diarylmethane | |
eszopiclone Eszopiclone: A pyridine, pyrazine, and piperazine derivative that is used as a HYPNOTIC AND SEDATIVE in the treatment of INSOMNIA.. eszopiclone : The (5S)- (active) enantiomer of zopiclone. Unlike almost all other hypnotic sedatives, which are approved only for the relief of short-term (6-8 weeks) insomnia, eszopiclone is approved by the U.S. Food and Drug Administration for long-term use. | 2.08 | 1 | 0 | zopiclone | central nervous system depressant; sedative |
curcumin Curcumin: A yellow-orange dye obtained from tumeric, the powdered root of CURCUMA longa. It is used in the preparation of curcuma paper and the detection of boron. Curcumin appears to possess a spectrum of pharmacological properties, due primarily to its inhibitory effects on metabolic enzymes.. curcumin : A beta-diketone that is methane in which two of the hydrogens are substituted by feruloyl groups. A natural dyestuff found in the root of Curcuma longa. | 2.66 | 2 | 0 | aromatic ether; beta-diketone; diarylheptanoid; enone; polyphenol | anti-inflammatory agent; antifungal agent; antineoplastic agent; biological pigment; contraceptive drug; dye; EC 1.1.1.205 (IMP dehydrogenase) inhibitor; EC 1.1.1.21 (aldehyde reductase) inhibitor; EC 1.1.1.25 (shikimate dehydrogenase) inhibitor; EC 1.6.5.2 [NAD(P)H dehydrogenase (quinone)] inhibitor; EC 1.8.1.9 (thioredoxin reductase) inhibitor; EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor; EC 3.5.1.98 (histone deacetylase) inhibitor; flavouring agent; food colouring; geroprotector; hepatoprotective agent; immunomodulator; iron chelator; ligand; lipoxygenase inhibitor; metabolite; neuroprotective agent; nutraceutical; radical scavenger |
methimazole Methimazole: A thioureylene antithyroid agent that inhibits the formation of thyroid hormones by interfering with the incorporation of iodine into tyrosyl residues of thyroglobulin. This is done by interfering with the oxidation of iodide ion and iodotyrosyl groups through inhibition of the peroxidase enzyme.. methimazole : A member of the class of imidazoles that it imidazole-2-thione in which a methyl group replaces the hydrogen which is attached to a nitrogen. | 2.53 | 2 | 0 | 1,3-dihydroimidazole-2-thiones | antithyroid drug |
cinnarizine Cinnarizine: A piperazine derivative having histamine H1-receptor and calcium-channel blocking activity with vasodilating and antiemetic properties but it induces PARKINSONIAN DISORDERS. | 2.08 | 1 | 0 | diarylmethane; N-alkylpiperazine; olefinic compound | anti-allergic agent; antiemetic; calcium channel blocker; geroprotector; H1-receptor antagonist; histamine antagonist; muscarinic antagonist |
sulindac Sulindac: A sulfinylindene derivative prodrug whose sulfinyl moiety is converted in vivo to an active NSAID analgesic. Specifically, the prodrug is converted by liver enzymes to a sulfide which is excreted in the bile and then reabsorbed from the intestine. This helps to maintain constant blood levels with reduced gastrointestinal side effects.. sulindac : A monocarboxylic acid that is 1-benzylidene-1H-indene which is substituted at positions 2, 3, and 5 by methyl, carboxymethyl, and fluorine respectively, and in which the phenyl group of the benzylidene moiety is substituted at the para position by a methylsulfinyl group. It is a prodrug for the corresponding sulfide, a non-steroidal anti-inflammatory drug, used particularly in the treatment of acute and chronic inflammatory conditions. | 2.08 | 1 | 0 | monocarboxylic acid; organofluorine compound; sulfoxide | analgesic; antineoplastic agent; antipyretic; apoptosis inducer; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug; prodrug; tocolytic agent |
capsaicin ALGRX-4975: an injectable capsaicin (TRPV1 receptor agonist) formulation for longlasting pain relief. capsaicinoid : A family of aromatic fatty amides produced as secondary metabolites by chilli peppers. | 8.38 | 12 | 0 | capsaicinoid | non-narcotic analgesic; TRPV1 agonist; voltage-gated sodium channel blocker |
epalrestat epalrestat : A monocarboxylic acid that is 1,3-thiazolidine which is substituted on the nitrogen by a carboxymethyl group, at positions 2 and 4 by thioxo and oxo groups, respectively, and at position 5 by a 2-methyl-3-phenylprop-2-en-1-ylidene group. It is an inhibitor of aldose reductase (which catalyses the conversion of glucose to sorbitol) and is used for the treatment of some diabetic complications, including neuropathy. | 2.08 | 1 | 0 | monocarboxylic acid; thiazolidines | EC 1.1.1.21 (aldehyde reductase) inhibitor |
drotaverin drotaverin: Hungarian drug; RN given refers to parent cpd; structure | 2.08 | 1 | 0 | isoquinolines | |
capsazepine capsazepine: modified capsaicin molecule; a capsaicin receptor antagonist. capsazepine : A benzazepine that is 2,3,4,5-tetrahydro-1H-2-benzazepine which is substituted by hydroxy groups at positions 7 and 8 and on the nitrogen atom by a 2-(p-chlorophenyl)ethylaminothiocarbonyl group. A synthetic analogue of capsaicin, it was the first reported capsaicin receptor antagonist. | 2.15 | 1 | 0 | benzazepine; catechols; monochlorobenzenes; thioureas | capsaicin receptor antagonist |
tamoxifen [no description available] | 2.54 | 2 | 0 | stilbenoid; tertiary amino compound | angiogenesis inhibitor; antineoplastic agent; bone density conservation agent; EC 1.2.3.1 (aldehyde oxidase) inhibitor; EC 2.7.11.13 (protein kinase C) inhibitor; estrogen antagonist; estrogen receptor antagonist; estrogen receptor modulator |
fusidic acid Fusidic Acid: An antibiotic isolated from the fermentation broth of Fusidium coccineum. (From Merck Index, 11th ed). It acts by inhibiting translocation during protein synthesis.. fusidic acid : A steroid antibiotic that is isolated from the fermentation broth of Fusidium coccineum. | 2.08 | 1 | 0 | 11alpha-hydroxy steroid; 3alpha-hydroxy steroid; alpha,beta-unsaturated monocarboxylic acid; steroid acid; steroid antibiotic; sterol ester | EC 2.7.1.33 (pantothenate kinase) inhibitor; Escherichia coli metabolite; protein synthesis inhibitor |
valinomycin Valinomycin: A cyclododecadepsipeptide ionophore antibiotic produced by Streptomyces fulvissimus and related to the enniatins. It is composed of 3 moles each of L-valine, D-alpha-hydroxyisovaleric acid, D-valine, and L-lactic acid linked alternately to form a 36-membered ring. (From Merck Index, 11th ed) Valinomycin is a potassium selective ionophore and is commonly used as a tool in biochemical studies.. valinomycin : A twelve-membered cyclodepsipeptide composed of three repeating D-alpha-hydroxyisovaleryl-D-valyl-L-lactoyl-L-valyl units joined in sequence. An antibiotic found in several Streptomyces strains. | 2.08 | 1 | 0 | cyclodepsipeptide; macrocycle | antimicrobial agent; antiviral agent; bacterial metabolite; potassium ionophore |
hmr 3647 [no description available] | 2.08 | 1 | 0 | ||
latoconazole latoconazole: RN refers to cpd without isomeric designation; latoconazole is (E)-isomer; structure given in first source | 2.08 | 1 | 0 | conazole antifungal drug; imidazole antifungal drug | |
maraviroc [no description available] | 2.08 | 1 | 0 | tropane alkaloid | |
toremifene citrate [no description available] | 2.08 | 1 | 0 | stilbenoid | anticoronaviral agent |
nelarabine nelarabine: prodrug of ara-G. nelarabine : A purine nucleoside in which O-methylguanine is attached to arabinofuranose via a beta-N(9)-glycosidic bond. Inhibits DNA synthesis and causes cell death; a prodrug of 9-beta-D-arabinofuranosylguanine (ara-G). | 2.08 | 1 | 0 | beta-D-arabinoside; monosaccharide derivative; purine nucleoside | antineoplastic agent; DNA synthesis inhibitor; prodrug |
gestodene Gestodene: synthetic steroid with progestational activity; RN given refers to (17alpha)-isomer | 2.08 | 1 | 0 | steroid | estrogen |
orlistat Orlistat: A lactone derivative of LEUCINE that acts as a pancreatic lipase inhibitor to limit the absorption of dietary fat; it is used in the management of obesity.. orlistat : A carboxylic ester resulting from the formal condensation of the carboxy group of N-formyl-L-leucine with the hydroxy group of (3S,4S)-3-hexyl-4-[(2S)-2-hydroxytridecyl]oxetan-2-one. A pancreatic lipase inhibitor, it is used as an anti-obesity drug. | 2.08 | 1 | 0 | beta-lactone; carboxylic ester; formamides; L-leucine derivative | anti-obesity agent; bacterial metabolite; EC 2.3.1.85 (fatty acid synthase) inhibitor; EC 3.1.1.3 (triacylglycerol lipase) inhibitor |
quinine [no description available] | 2.08 | 1 | 0 | cinchona alkaloid | antimalarial; muscle relaxant; non-narcotic analgesic |
azilect [no description available] | 2.08 | 1 | 0 | ||
dasatinib N-(2-chloro-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-yl)amino)-1,3-thiazole-5-carboxamide: a dasatinib prodrug; structure in first source. dasatinib (anhydrous) : An aminopyrimidine that is 2-methylpyrimidine which is substituted at position 4 by the primary amino group of 2-amino-1,3-thiazole-5-carboxylic acid and at position 6 by a 4-(2-hydroxyethyl)piperazin-1-yl group, and in which the carboxylic acid group has been formally condensed with 2-chloro-6-methylaniline to afford the corresponding amide. A multi-targeted kinase inhibitor, it is used, particularly as the monohydrate, for the treatment of chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia. Note that the name 'dasatinib' is used to refer to the monohydrate (USAN) as well as to anhydrous dasatinib (INN). | 2.08 | 1 | 0 | 1,3-thiazoles; aminopyrimidine; monocarboxylic acid amide; N-(2-hydroxyethyl)piperazine; N-arylpiperazine; organochlorine compound; secondary amino compound; tertiary amino compound | anticoronaviral agent; antineoplastic agent; tyrosine kinase inhibitor |
ly 368975 thionisoxetine: norepinephrine inhibitor; an analog of nisoxetine; (R)-enantionmer is significantly more potent than (S)-enantiomer | 2.43 | 2 | 0 | ||
n-((2,3-dihydro-1,4-benzodioxin-2-yl)methyl)-5-methoxy-1h-indole-3-ethanamine N-((2,3-dihydro-1,4-benzodioxin-2-yl)methyl)-5-methoxy-1H-indole-3-ethanamine: structure given in first source | 3.8 | 1 | 1 | ||
ginsenosides ginsenoside : Triterpenoid saponins with a dammarane-like skeleton originally isolated from ginseng (Panax) species. Use of the term has been extended to include semi-synthetic derivatives. | 3.21 | 1 | 0 | ||
sitagliptin sitagliptin : A triazolopyrazine that exhibits hypoglycemic activity. | 2.08 | 1 | 0 | triazolopyrazine; trifluorobenzene | EC 3.4.14.5 (dipeptidyl-peptidase IV) inhibitor; environmental contaminant; hypoglycemic agent; serine proteinase inhibitor; xenobiotic |
osteoprotegerin Osteoprotegerin: A secreted member of the TNF receptor superfamily that negatively regulates osteoclastogenesis. It is a soluble decoy receptor of RANK LIGAND that inhibits both CELL DIFFERENTIATION and function of OSTEOCLASTS by inhibiting the interaction between RANK LIGAND and RECEPTOR ACTIVATOR OF NUCLEAR FACTOR-KAPPA B. | 2.31 | 1 | 0 | long-chain fatty acid | |
tolcapone Tolcapone: A benzophenone and nitrophenol compound that acts as an inhibitor of CATECHOL O-METHYLTRANSFERASE, an enzyme involved in the metabolism of DOPAMINE and LEVODOPA. It is used in the treatment of PARKINSON DISEASE in patients for whom levodopa is ineffective or contraindicated.. tolcapone : Benzophenone substituted on one of the phenyl rings at C-3 and C-4 by hydroxy groups and at C-5 by a nitro group, and on the other phenyl ring by a methyl group at C-4. It is an inhibitor of catechol O-methyltransferase. | 2.08 | 1 | 0 | 2-nitrophenols; benzophenones; catechols | antiparkinson drug; EC 2.1.1.6 (catechol O-methyltransferase) inhibitor |
quercetin [no description available] | 2.08 | 1 | 0 | 7-hydroxyflavonol; pentahydroxyflavone | antibacterial agent; antineoplastic agent; antioxidant; Aurora kinase inhibitor; chelator; EC 1.10.99.2 [ribosyldihydronicotinamide dehydrogenase (quinone)] inhibitor; geroprotector; phytoestrogen; plant metabolite; protein kinase inhibitor; radical scavenger |
bilirubin [no description available] | 3.14 | 1 | 0 | biladienes; dicarboxylic acid | antioxidant; human metabolite; mouse metabolite |
dinoprostone prostaglandin E2 : Prostaglandin F2alpha in which the hydroxy group at position 9 has been oxidised to the corresponding ketone. Prostaglandin E2 is the most common and most biologically potent of mammalian prostaglandins. | 2.08 | 1 | 0 | prostaglandins E | human metabolite; mouse metabolite; oxytocic |
calcitriol dihydroxy-vitamin D3: as a major in vitro metabolite of 1alpha,25-dihydroxyvitamin D3, produced in primary cultures of neonatal human keratinocytes | 2.08 | 1 | 0 | D3 vitamins; hydroxycalciol; triol | antineoplastic agent; antipsoriatic; bone density conservation agent; calcium channel agonist; calcium channel modulator; hormone; human metabolite; immunomodulator; metabolite; mouse metabolite; nutraceutical |
alprostadil [no description available] | 2.54 | 2 | 0 | prostaglandins E | anticoagulant; human metabolite; platelet aggregation inhibitor; vasodilator agent |
vitamin d 2 Ergocalciferols: Derivatives of ERGOSTEROL formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. They differ from CHOLECALCIFEROL in having a double bond between C22 and C23 and a methyl group at C24.. vitamin D2 : A vitamin D supplement and has been isolated from alfalfa. | 2.08 | 1 | 0 | hydroxy seco-steroid; seco-ergostane; vitamin D | bone density conservation agent; nutraceutical; plant metabolite; rodenticide |
pulmicort Budesonide: A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.. budesonide : A glucocorticoid steroid having a highly oxygenated pregna-1,4-diene structure. It is used mainly in the treatment of asthma and non-infectious rhinitis and for treatment and prevention of nasal polyposis. | 2.08 | 1 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; cyclic acetal; glucocorticoid; primary alpha-hydroxy ketone | anti-inflammatory drug; bronchodilator agent; drug allergen |
oxymetholone Oxymetholone: A synthetic hormone with anabolic and androgenic properties. It is used mainly in the treatment of anemias. According to the Fourth Annual Report on Carcinogens (NTP 85-002), this compound may reasonably be anticipated to be a carcinogen. (From Merck Index, 11th ed). oxymetholone : A 3-oxo-5alpha- steroid that is 4,5alpha-dihydrotestosterone which is substituted by a hydroxymethylidene group at position 2 and by a methyl group at the 17alpha position. A synthetic androgen, it was mainly used for the treatment of anaemias until being replaced by treatments with fewer side effects. | 2.08 | 1 | 0 | ||
eprosartan eprosartan: angiotensin II receptor antagonist. eprosartan : A member of the class of imidazoles and thiophenes that is an angiotensin II receptor antagonist used for the treatment of high blood pressure. | 2.08 | 1 | 0 | dicarboxylic acid; imidazoles; thiophenes | angiotensin receptor antagonist; antihypertensive agent; environmental contaminant; xenobiotic |
brompheniramine maleate brompheniramine maleate : The maleic acid salt of brompheniramine. A histamine H1 receptor antagonist, it is used for the symptomatic relief of allergic conditions, including rhinitis and conjunctivitis. | 2.08 | 1 | 0 | maleate salt | anti-allergic agent |
dexchlorpheniramine maleate [no description available] | 2.08 | 1 | 0 | organic molecular entity | |
mycophenolate mofetil mycophenolate mofetil : A carboxylic ester resulting from the formal condensation between the carboxylic acid group of mycophenolic acid and the hydroxy group of 2-(morpholin-4-yl)ethanol. In the liver, it is metabolised to mycophenolic acid, an immunosuppressant for which it is a prodrug. It is widely used to prevent tissue rejection following organ transplants as well as for the treatment of certain autoimmune diseases. | 2.08 | 1 | 0 | carboxylic ester; ether; gamma-lactone; phenols; tertiary amino compound | anticoronaviral agent; EC 1.1.1.205 (IMP dehydrogenase) inhibitor; immunosuppressive agent; prodrug |
entacapone entacapone: structure given in first source. entacapone : A monocarboxylic acid amide that is N,N-diethylprop-2-enamide in which the hydrogen at position 2 is substituted by a cyano group and the hydrogen at the 3E position is substituted by a 3,4-dihydroxy-5-nitrophenyl group. | 2.08 | 1 | 0 | 2-nitrophenols; catechols; monocarboxylic acid amide; nitrile | antidyskinesia agent; antiparkinson drug; central nervous system drug; EC 2.1.1.6 (catechol O-methyltransferase) inhibitor |
l 660,711 [no description available] | 2.08 | 1 | 0 | quinolines | |
travoprost Travoprost: A cloprostenol derivative that is used as an ANTIHYPERTENSIVE AGENT in the treatment of OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION.. travoprost : The isopropyl ester of prostaglandin F2alpha in which the pentyl group is replaced by a 3-(trifluoromethyl)phenoxymethyl group. A synthetic analogue of prostaglandin F2alpha, ophthalmic solutions of travoprost are used as a topical medication for controlling the progression of open-angle glaucoma and ocular hypertension, by reducing intraocular pressure. It is a pro-drug; the isopropyl ester group is hydrolysed by esterases in the cornea to the biologically active free acid, fluprostenol. | 2.08 | 1 | 0 | (trifluoromethyl)benzenes; isopropyl ester; prostaglandins Falpha | antiglaucoma drug; antihypertensive agent; ophthalmology drug; prodrug; prostaglandin receptor agonist |
tranilast tranilast: antiallergic drug; potent inhibitor of homologous passive cutaneous anaphylaxis. tranilast : An amidobenzoic acid that is anthranilic acid in which one of the anilino hydrogens is replaced by a 3,4-dimethoxycinnamoyl group. | 2.08 | 1 | 0 | amidobenzoic acid; cinnamamides; dimethoxybenzene; secondary carboxamide | anti-allergic agent; anti-asthmatic drug; antineoplastic agent; aryl hydrocarbon receptor agonist; calcium channel blocker; hepatoprotective agent; nephroprotective agent |
imipenem [no description available] | 2.08 | 1 | 0 | carbapenems | |
etretinate retinoid : Oxygenated derivatives of 3,7-dimethyl-1-(2,6,6-trimethylcyclohex-1-enyl)nona-1,3,5,7-tetraene and derivatives thereof. | 2.08 | 1 | 0 | enoate ester; ethyl ester; retinoid | keratolytic drug |
isotretinoin Isotretinoin: A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.. isotretinoin : A retinoic acid that is all-trans-retinoic acid in which the double bond which is alpha,beta- to the carboxy group is isomerised to Z configuration. A synthetic retinoid, it is used for the treatment of severe cases of acne and other skin diseases. | 2.52 | 2 | 0 | retinoic acid | antineoplastic agent; keratolytic drug; teratogenic agent |
ketotifen fumarate ketotifen fumarate : An organoammonium salt consisting of equimolar amounts of ketotifen(1+) and fumarate(1-) ions. A blocker of histamine H1 receptors with a stabilising action on mast cells, it is a non-bronchodilator anti-asthmatic drug. | 2.08 | 1 | 0 | organoammonium salt | anti-asthmatic drug; H1-receptor antagonist |
dinoprost tromethamine [no description available] | 2.08 | 1 | 0 | organic molecular entity | |
rosuvastatin calcium S 4522: structure in first source | 2.08 | 1 | 0 | N-acyl-15-methylhexadecasphinganine-1-phosphoethanolamine; organic calcium salt | anti-inflammatory agent; cardioprotective agent; CETP inhibitor |
terbinafine hydrochloride terbinafine hydrochloride : A hydrochloride obtained by reaction of terbinafine with one molar equivalent of hydrogen chloride. | 2.08 | 1 | 0 | allylamine antifungal drug; hydrochloride | EC 1.14.13.132 (squalene monooxygenase) inhibitor; P450 inhibitor |
1-monooleoyl-rac-glycerol Peceol: lipid excipient containing readily dispersible mixture of mono- & diglycerides of oleic acid. 1-oleoylglycerol : A 1-monoglyceride where the acyl group is oleoyl.. monooleoylglycerol : A monoglyceride in which the acyl group is oleoyl with the position of acylation unspecified. | 2.25 | 1 | 0 | 1-acylglycerol 18:1; monooleoylglycerol | plant metabolite |
codeine [no description available] | 2.05 | 1 | 0 | morphinane alkaloid; organic heteropentacyclic compound | antitussive; drug allergen; environmental contaminant; opioid analgesic; opioid receptor agonist; prodrug; xenobiotic |
cyclosporine ramihyphin A: one of the metabolites produced by Fusarium sp. S-435; RN given refers to cpd with unknown MF | 2.08 | 1 | 0 | homodetic cyclic peptide | anti-asthmatic drug; anticoronaviral agent; antifungal agent; antirheumatic drug; carcinogenic agent; dermatologic drug; EC 3.1.3.16 (phosphoprotein phosphatase) inhibitor; geroprotector; immunosuppressive agent; metabolite |
natamycin [no description available] | 2.08 | 1 | 0 | antibiotic antifungal drug; dicarboxylic acid monoester; epoxide; macrolide antibiotic; monosaccharide derivative; polyene antibiotic | antifungal agrochemical; antimicrobial food preservative; apoptosis inducer; bacterial metabolite; ophthalmology drug |
acitretin Acitretin: An oral retinoid effective in the treatment of psoriasis. It is the major metabolite of ETRETINATE with the advantage of a much shorter half-life when compared with etretinate.. acitretin : A retinoid that consists of 3,7-dimethylnona-2,4,6,8-tetraenoic acid having a 4-methoxy-2,3,6-trimethylphenyl group attached at position 9. | 2.08 | 1 | 0 | acitretin; alpha,beta-unsaturated monocarboxylic acid; retinoid | keratolytic drug |
hydromorphone Hydromorphone: An opioid analgesic made from MORPHINE and used mainly as an analgesic. It has a shorter duration of action than morphine.. hydromorphone : A morphinane alkaloid that is a hydrogenated ketone derivative of morphine. A semi-synthetic drug, it is a centrally acting pain medication of the opioid class. | 3.18 | 1 | 0 | morphinane alkaloid; organic heteropentacyclic compound | mu-opioid receptor agonist; opioid analgesic |
levetiracetam Levetiracetam: A pyrrolidinone and acetamide derivative that is used primarily for the treatment of SEIZURES and some movement disorders, and as a nootropic agent.. levetiracetam : A pyrrolidinone and carboxamide that is N-methylpyrrolidin-2-one in which one of the methyl hydrogens is replaced by an aminocarbonyl group, while another is replaced by an ethyl group (the S enantiomer). An anticonvulsant, it is used for the treatment of epilepsy in both human and veterinary medicine. | 2.52 | 2 | 0 | pyrrolidin-2-ones | anticonvulsant; environmental contaminant; xenobiotic |
nalmefene nalmefene: RN given refers to 5-alpha isomer | 2.08 | 1 | 0 | morphinane alkaloid | |
naloxone Naloxone: A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.. naloxone : A synthetic morphinane alkaloid that is morphinone in which the enone double bond has been reduced to a single bond, the hydrogen at position 14 has been replaced by a hydroxy group, and the methyl group attached to the nitrogen has been replaced by an allyl group. A specific opioid antagonist, it is used (commonly as its hydrochloride salt) to reverse the effects of opioids, both following their use of opioids during surgery and in cases of known or suspected opioid overdose. | 5.09 | 7 | 0 | morphinane alkaloid; organic heteropentacyclic compound; tertiary alcohol | antidote to opioid poisoning; central nervous system depressant; mu-opioid receptor antagonist |
oxycodone Oxycodone: A semisynthetic derivative of CODEINE.. oxycodone : A semisynthetic opioid of formula C18H21NO4 that is derived from thebaine. It is a moderately potent opioid analgesic, generally used for relief of moderate to severe pain. | 9.18 | 8 | 2 | organic heteropentacyclic compound; semisynthetic derivative | antitussive; mu-opioid receptor agonist; opioid analgesic |
topiramate Topiramate: A sulfamate-substituted fructose analog that was originally identified as a hypoglycemic agent. It is used for the treatment of EPILEPSY and MIGRAINE DISORDERS, and may also promote weight loss.. topiramate : A hexose derivative that is 2,3:4,5-di-O-isopropylidene-beta-D-fructopyranose in which the hydroxy group has been converted to the corresponding sulfamate ester. It blocks voltage-dependent sodium channels and is used as an antiepileptic and for the prevention of migraine. | 2.53 | 2 | 0 | cyclic ketal; ketohexose derivative; sulfamate ester | anticonvulsant; sodium channel blocker |
trospium chloride trospium chloride : An organic chloride salt of trospium. It is an antispasmodic drug used for the treatment of overactive bladder. | 4.32 | 3 | 0 | ||
lobeline Lobeline: An alkaloid that has actions similar to NICOTINE on nicotinic cholinergic receptors but is less potent. It has been proposed for a variety of therapeutic uses including in respiratory disorders, peripheral vascular disorders, insomnia, and smoking cessation. | 3.23 | 1 | 0 | ||
morphine Meconium: The thick green-to-black mucilaginous material found in the intestines of a full-term fetus. It consists of secretions of the INTESTINAL GLANDS; BILE PIGMENTS; FATTY ACIDS; AMNIOTIC FLUID; and intrauterine debris. It constitutes the first stools passed by a newborn. | 9.99 | 26 | 9 | morphinane alkaloid; organic heteropentacyclic compound; tertiary amino compound | anaesthetic; drug allergen; environmental contaminant; geroprotector; mu-opioid receptor agonist; opioid analgesic; plant metabolite; vasodilator agent; xenobiotic |
demycarosylturimycin h [no description available] | 2.08 | 1 | 0 | ||
acipimox acipimox: lipolysis inhibitor | 2.08 | 1 | 0 | pyrazinecarboxylic acid | |
atosiban [no description available] | 2.08 | 1 | 0 | oligopeptide | |
bimatoprost Bimatoprost: A cloprostenol-derived amide that is used as an ANTIHYPERTENSIVE AGENT in the treatment of OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION. | 2.08 | 1 | 0 | monocarboxylic acid amide | antiglaucoma drug; antihypertensive agent |
(endo-n-8-methyl-8-azabicyclo-(3.2.1)oct-3-yl)-2,3-dihydro-3-isopropyl-2-oxo-1h-benzimidazol-1-carboxamide (endo-N-8-methyl-8-azabicyclo-(3.2.1)oct-3-yl)-2,3-dihydro-3-isopropyl-2-oxo-1H-benzimidazol-1-carboxamide: potent agonist at the 5-HT(4) receptor positively coupled to adenylate cyclase in brain; structure given in first source | 2.11 | 1 | 0 | ||
clobetasol Clobetasol: A derivative of PREDNISOLONE with high glucocorticoid activity and low mineralocorticoid activity. Absorbed through the skin faster than FLUOCINONIDE, it is used topically in treatment of PSORIASIS but may cause marked adrenocortical suppression.. clobetasol : A 3-oxo-Delta(1),Delta(4)-steroid that is 16beta-methylpregna-1,4-diene-3,20-dione bearing hydroxy groups at the 11beta and 17alpha positions, fluorine at position 9, and a chlorine substituent at position 21. It is used as its 17alpha-propionate ester to treat various skin disorders, including exzema and psoriasis. | 2.02 | 1 | 0 | 11beta-hydroxy steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 3-oxo-Delta(1),Delta(4)-steroid; chlorinated steroid; fluorinated steroid; glucocorticoid; tertiary alpha-hydroxy ketone | anti-inflammatory drug; SMO receptor agonist |
latanoprost Latanoprost: A prostaglandin F analog used to treat OCULAR HYPERTENSION in patients with GLAUCOMA.. latanoprost : A prostaglandin Falpha that is the isopropyl ester prodrug of latanoprost free acid. Used in the treatment of open-angle glaucoma and ocular hypertension. | 2.08 | 1 | 0 | isopropyl ester; prostaglandins Falpha; triol | antiglaucoma drug; antihypertensive agent; EC 4.2.1.1 (carbonic anhydrase) inhibitor; prodrug |
mdl 100907 Serotonin 5-HT2 Receptor Antagonists: Drugs that bind to but do not activate SEROTONIN 5-HT2 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT2 RECEPTOR AGONISTS. Included under this heading are antagonists for one or more specific 5-HT2 receptor subtypes. | 2.48 | 2 | 0 | ||
nateglinide Nateglinide: A phenylalanine and cyclohexane derivative that acts as a hypoglycemic agent by stimulating the release of insulin from the pancreas. It is used in the treatment of TYPE 2 DIABETES.. nateglinide : An N-acyl-D-phenylalanine resulting from the formal condensation of the amino group of D-phenylalanine with the carboxy group of trans-4-isopropylcyclohexanecarboxylic acid. An orally-administered, rapidly-absorbed, short-acting insulinotropic agent, it is used for the treatment of type 2 diabetes mellitus. | 2.08 | 1 | 0 | phenylalanine derivative | |
fluvoxamine Fluvoxamine: A selective serotonin reuptake inhibitor that is used in the treatment of DEPRESSION and a variety of ANXIETY DISORDERS.. fluvoxamine : An oxime O-ether that is benzene substituted by a (1E)-N-(2-aminoethoxy)-5-methoxypentanimidoyl group at position 1 and a trifluoromethyl group at position 4. It is a selective serotonin reuptake inhibitor that is used for the treatment of obsessive-compulsive disorder. | 6.47 | 12 | 1 | (trifluoromethyl)benzenes; 5-methoxyvalerophenone O-(2-aminoethyl)oxime | antidepressant; anxiolytic drug; serotonin uptake inhibitor |
(6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid (6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid : A dihydroxy monocarboxylic acid that is N-isopropylindole which is substituted at position 3 by a p-fluorophenyl group and at position 2 by a 6-carboxy-3,5-dihydroxyhex-1-en-1-yl group. It has four possible diastereoisomers. | 2.08 | 1 | 0 | dihydroxy monocarboxylic acid; indoles; organofluorine compound | |
molsidomine [no description available] | 2.08 | 1 | 0 | ethyl ester; morpholines; oxadiazole; zwitterion | antioxidant; apoptosis inhibitor; cardioprotective agent; nitric oxide donor; vasodilator agent |
naltrexone Naltrexone: Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.. naltrexone : An organic heteropentacyclic compound that is naloxone substituted in which the allyl group attached to the nitrogen is replaced by a cyclopropylmethyl group. A mu-opioid receptor antagonist, it is used to treat alcohol dependence. | 2.04 | 1 | 0 | cyclopropanes; morphinane-like compound; organic heteropentacyclic compound | antidote to opioid poisoning; central nervous system depressant; environmental contaminant; mu-opioid receptor antagonist; xenobiotic |
dextromethorphan Dextromethorphan: Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.. dextromethorphan : A 6-methoxy-11-methyl-1,3,4,9,10,10a-hexahydro-2H-10,4a-(epiminoethano)phenanthrene in which the sterocenters at positions 4a, 10 and 10a have S-configuration. It is a prodrug of dextrorphan and used as an antitussive drug for suppressing cough. | 2.89 | 3 | 0 | 6-methoxy-11-methyl-1,3,4,9,10,10a-hexahydro-2H-10,4a-(epiminoethano)phenanthrene | antitussive; environmental contaminant; neurotoxin; NMDA receptor antagonist; oneirogen; prodrug; xenobiotic |
butorphanol Butorphanol: A synthetic morphinan analgesic with narcotic antagonist action. It is used in the management of severe pain.. butorphanol : Levorphanol in which a hydrogen at position 14 of the morphinan skeleton is substituted by hydroxy and one of the hydrogens of the N-methyl group is substituted by cyclopropyl. A semi-synthetic opioid agonist-antagonist analgesic, it is used as its (S,S)-tartaric acid salt for relief or moderate to severe pain. | 2.08 | 1 | 0 | morphinane alkaloid | antitussive; kappa-opioid receptor agonist; mu-opioid receptor agonist; opioid analgesic |
cefixime [no description available] | 2.08 | 1 | 0 | cephalosporin | antibacterial drug; drug allergen |
lisinopril Lisinopril: One of the ANGIOTENSIN-CONVERTING ENZYME INHIBITORS (ACE inhibitors), orally active, that has been used in the treatment of hypertension and congestive heart failure. | 2.57 | 2 | 0 | dipeptide | EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor |
ramipril Ramipril: A long-acting angiotensin-converting enzyme inhibitor. It is a prodrug that is transformed in the liver to its active metabolite ramiprilat.. ramipril : A dipeptide that is the prodrug for ramiprilat, the active metabolite obtained by hydrolysis of the ethyl ester group. An angiotensin-converting enzyme (ACE) inhibitor, used to treat high blood pressure and congestive heart failure.. quark : Quarks comprise one of two classes of the fundamental particles. Quarks possess fractional electric charges and are not observed in free state. The word "quark" first appears in James Joyce's Finnegans Wake and has been chosen by Murray Gell-Mann as a name for fundamental building blocks of particles. | 2.08 | 1 | 0 | azabicycloalkane; cyclopentapyrrole; dicarboxylic acid monoester; dipeptide; ethyl ester | bradykinin receptor B2 agonist; cardioprotective agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; matrix metalloproteinase inhibitor; prodrug |
indinavir sulfate Indinavir: A potent and specific HIV protease inhibitor that appears to have good oral bioavailability. | 2.08 | 1 | 0 | dicarboxylic acid diamide; N-(2-hydroxyethyl)piperazine; piperazinecarboxamide | HIV protease inhibitor |
enalapril maleate enalapril maleate : The maleic acid salt of enalapril. It contains one molecule of maleic acid for each molecule of enalapril. Following oral administration, the ethyl ester group of enalapril is hydrolysed to afford the corresponding carboxylic acid, enalaprilat, an angiotensin-converting enzyme (ACE) inhibitor. Enalapril is thus a prodrug for enalaprilat (which, unlike enalapril, is not absorbed by mouth), and its maleate is used in the treatment of hypertension and heart failure, for reduction of proteinuria and renal disease in patients with nephropathies, and for the prevention of stroke, myocardial infarction, and cardiac death in high-risk patients. | 2.08 | 1 | 0 | maleate salt | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; prodrug |
enalaprilat anhydrous Enalaprilat: The active metabolite of ENALAPRIL and one of the potent, intravenously administered, ANGIOTENSIN-CONVERTING ENZYME INHIBITORS. It is an effective agent for the treatment of essential hypertension and has beneficial hemodynamic effects in heart failure. The drug produces renal vasodilation with an increase in sodium excretion.. enalaprilat dihydrate : The dihydrate form of enalaprilat, an angiotensin-converting enzyme (ACE) inhibitor that is used (often in the form of its prodrug, enalapril) in the treatment of hypertension and heart failure, for reduction of proteinuria and renal disease in patients with nephropathies, and for the prevention of stroke, myocardial infarction, and cardiac death in high-risk patients. Unlike enalapril, enalaprilat is not absorbed by mouth but is administered by intravenous injection.. enalaprilat (anhydrous) : Enalapril in which the ethyl ester group has been hydrolysed to the corresponding carboxylic acid. Enalaprilat is an angiotensin-converting enzyme (ACE) inhibitor and is used (often in the form of its prodrug, enalapril) in the treatment of hypertension and heart failure, for reduction of proteinuria and renal disease in patients with nephropathies, and for the prevention of stroke, myocardial infarction, and cardiac death in high-risk patients. Unlike enalapril, enalaprilat is not absorbed by mouth but is given by intravenous injection, usually as the dihydrate. | 2.08 | 1 | 0 | dicarboxylic acid; dipeptide | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor |
trandolapril trandolapril : A heterobicylic compound that is (2S,3aR,7aS)-1-[(2S)-2-aminopropanoyl]octahydro-1H-indole-2-carboxylic acid in which the hydrogen of the amino group is substituted by a (2R)-1-ethoxy-1-oxo-4-phenylbutan-2-yl group. It is a angiotensin-converting enzyme inhibitor and a prodrug used for the treatment of hypertension. | 2.08 | 1 | 0 | dicarboxylic acid monoester; dipeptide; ethyl ester; organic heterobicyclic compound; secondary amino compound; tertiary carboxamide | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; prodrug |
pregabalin Pregabalin: A gamma-aminobutyric acid (GABA) derivative that functions as a CALCIUM CHANNEL BLOCKER and is used as an ANTICONVULSANT as well as an ANTI-ANXIETY AGENT. It is also used as an ANALGESIC in the treatment of NEUROPATHIC PAIN and FIBROMYALGIA.. pregabalin : A gamma-amino acid that is gamma-aminobutyric acid (GABA) carrying an isobutyl substitutent at the beta-position (the S-enantiomer). Binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. | 19.08 | 162 | 31 | gamma-amino acid | anticonvulsant; calcium channel blocker |
tiotropium bromide Tiotropium Bromide: A scopolamine derivative and CHOLINERGIC ANTAGONIST that functions as a BRONCHODILATOR AGENT. It is used in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.. tiotropium bromide : An organic bromide salt having (1alpha,2beta,4beta,5alpha,7beta)-7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.0(2,4)]nonane as the counterion. Used (in the form of the hydrate) for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. | 3.12 | 1 | 0 | ||
alvimopan anhydrous alvimopan: mu opioid receptor antagonist; intended to treat constipation in patients taking opiates for pain | 2.08 | 1 | 0 | peptide | |
famotidine [no description available] | 2.08 | 1 | 0 | 1,3-thiazoles; guanidines; sulfonamide | anti-ulcer drug; H2-receptor antagonist; P450 inhibitor |
cci 15641 [no description available] | 2.08 | 1 | 0 | cephalosporin | |
tenofovir disoproxil fumarate tenofovir disoproxil fumarate : A fumarate salt prepared from equimolar amounts of tenofovir disoproxil and fumaric acid. It is used in combination therapy for the treatment of HIV infection. | 2.08 | 1 | 0 | fumarate salt | antiviral drug; HIV-1 reverse transcriptase inhibitor; prodrug |
dexbrompheniramine maleate dexbrompheniramine maleate : The maleic acid salt of the (pharmacologically active) (S)-(+)-enantiomer of brompheniramine. A histamine H1 receptor antagonist, it is used for the symptomatic relief of allergic conditions, including rhinitis and conjunctivitis. | 2.08 | 1 | 0 | brompheniramine maleate | anti-allergic agent; H1-receptor antagonist |
rifaximin [no description available] | 2.08 | 1 | 0 | acetate ester; cyclic ketal; lactam; macrocycle; organic heterohexacyclic compound; rifamycins; semisynthetic derivative | antimicrobial agent; gastrointestinal drug; orphan drug |
ly 53857 LY 53857: RN given refers to maleate[1:1](8beta)-isomer | 1.98 | 1 | 0 | ||
everolimus [no description available] | 2.08 | 1 | 0 | cyclic acetal; cyclic ketone; ether; macrolide lactam; primary alcohol; secondary alcohol | anticoronaviral agent; antineoplastic agent; geroprotector; immunosuppressive agent; mTOR inhibitor |
cefpodoxime proxetil cefpodoxime proxetil: structure given in first source; prodrug for cefpodoxime. cefpodoxime proxetil : The 1-[(isopropoxycarbonyl)oxy]ethyl (proxetil) ester prodrug of cefpodoxime. After swallowing, hydrolysis of the ester group occurs in the intestinal epithelium, to release active cefpodoxime in the bloodstream. It is used to treat acute otitis media, pharyngitis, and sinusitis. | 2.08 | 1 | 0 | carboxylic acid; carboxylic ester; cephalosporin | antibacterial drug; prodrug |
fluphenazine [no description available] | 2.08 | 1 | 0 | ||
nitrofurantoin Nitrofurantoin: A urinary anti-infective agent effective against most gram-positive and gram-negative organisms. Although sulfonamides and antibiotics are usually the agents of choice for urinary tract infections, nitrofurantoin is widely used for prophylaxis and long-term suppression.. nitrofurantoin : An imidazolidine-2,4-dione that is hydantoin substituted at position 1 by a [(5-nitro-2-furyl)methylene]amino group. An antibiotic that damages bacterial DNA. | 2.48 | 2 | 0 | imidazolidine-2,4-dione; nitrofuran antibiotic; organonitrogen heterocyclic antibiotic; organooxygen heterocyclic antibiotic | antibacterial drug; antiinfective agent; hepatotoxic agent |
ergoline Ergolines: A series of structurally-related alkaloids that contain the ergoline backbone structure.. ergoline : An indole alkaloid whose structural skeleton is found in many naturally occurring and synthetic ergolines which are known to bind to neurotransmitter receptors, such as dopamine, noradrenaline and serotonin receptors and function as unselective agonists or antagonists at these receptors. | 1.98 | 1 | 0 | diamine; ergoline alkaloid; indole alkaloid fundamental parent; indole alkaloid; organic heterotetracyclic compound | |
roxithromycin (E)-roxithromycin : A major geometrical isomer of roxithromycin. | 2.08 | 1 | 0 | roxithromycin | environmental contaminant; xenobiotic |
cefdinir [no description available] | 2.08 | 1 | 0 | cephalosporin; ketoxime | antibacterial drug |
bisoprolol, fumarate (1:1) salt [no description available] | 2.08 | 1 | 0 | ||
artesunate artesunic acid: RN given for (3R-(3alpha,5abeta,6beta,8abeta,9alpha,10alpha,12beta,(2aR*))-isomer; succinic ester of artemether | 2.08 | 1 | 0 | artemisinin derivative; cyclic acetal; dicarboxylic acid monoester; hemisuccinate; semisynthetic derivative; sesquiterpenoid | antimalarial; antineoplastic agent; ferroptosis inducer |
etoposide phosphate [no description available] | 2.08 | 1 | 0 | furonaphthodioxole | |
ciclesonide ciclesonide: nasal spray approved for seasonal and perennial allergic rhinitis | 2.08 | 1 | 0 | organic molecular entity | |
temsirolimus [no description available] | 2.08 | 1 | 0 | macrolide lactam | |
dutasteride Dutasteride: A 5-ALPHA-REDUCTASE INHIBITOR that is reported to inhibit both type-1 and type2 isoforms of the enzyme and is used to treat BENIGN PROSTATIC HYPERPLASIA.. dutasteride : An aza-steroid that is inasteride in which the tert-butyl group is replaced by a 2,5-bis(trifluoromethyl)phenyl group. A synthetic 4-azasteroid, dutasteride is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5alpha-reductase, an intracellular enzyme that converts testosterone to 5alpha-dihydrotestosterone. Dutasteride is used for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate gland. | 2.08 | 1 | 0 | (trifluoromethyl)benzenes; aza-steroid; delta-lactam | antihyperplasia drug; EC 1.3.1.22 [3-oxo-5alpha-steroid 4-dehydrogenase (NADP(+))] inhibitor |
vilazodone hydrochloride [no description available] | 6.75 | 6 | 0 | hydrochloride | antidepressant; serotonergic agonist; serotonin uptake inhibitor |
tekturna [no description available] | 2.08 | 1 | 0 | fumarate salt | antihypertensive agent |
vildagliptin [no description available] | 2.08 | 1 | 0 | amino acid amide | |
sb 399885 SB 399885: 5-HT6 receptor antagonist | 2.11 | 1 | 0 | ||
chloralose Chloralose: A derivative of CHLORAL HYDRATE that was used as a sedative but has been replaced by safer and more effective drugs. Its most common use is as a general anesthetic in animal experiments. | 2.42 | 2 | 0 | ||
hypericum Hypericum: Genus of perennial plants in the family CLUSIACEAE (sometimes classified as Hypericaceae). Herbal and homeopathic preparations are used for depression, neuralgias, and a variety of other conditions. Hypericum contains flavonoids; GLYCOSIDES; mucilage, TANNINS; volatile oils (OILS, ESSENTIAL), hypericin and hyperforin.. 6-formamidopenicillanic acid : A penicillanic acid having a (6R)-formamido substituent. | 4.76 | 2 | 1 | penicillanic acids | |
taxane taxane: produced by Taxomyces andreanae | 6.03 | 2 | 1 | diterpene; terpenoid fundamental parent | |
sgd 301-76 [no description available] | 2.08 | 1 | 0 | conazole antifungal drug; imidazole antifungal drug; organic nitrate salt | antiinfective agent |
fluvoxamine maleate [no description available] | 2.08 | 1 | 0 | (trifluoromethyl)benzenes | |
thioacetazone Thioacetazone: A thiosemicarbazone that is used in association with other antimycobacterial agents in the initial and continuation phases of antituberculosis regimens. Thiacetazone containing regimens are less effective than the short-course regimen recommended by the International Union Against Tuberculosis and are used in some developing countries to reduce drug costs. (From Martindale, The Extra Pharmacopoeia, 30th ed, p217). thiosemicarbazone : A hydrazone resulting from the formal condensation of an aldehyde or ketone with the non-thioacylated nitrogen of thiosemicarbazide or its substituted derivatives. | 2.08 | 1 | 0 | ||
s 1743 Esomeprazole: The S-isomer of omeprazole.. esomeprazole : A 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole that has S configuration at the sulfur atom. An inhibitor of gastric acid secretion, it is used (generally as its sodium or magnesium salt) for the treatment of gastro-oesophageal reflux disease, dyspepsia, peptic ulcer disease, and Zollinger-Ellison syndrome. | 2.6 | 1 | 0 | magnesium salt | anti-ulcer drug; EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor |
dexlansoprazole Dexlansoprazole: The R-isomer of lansoprazole that is used to treat severe GASTROESOPHAGEAL REFLUX DISEASE. | 2.08 | 1 | 0 | benzimidazoles; sulfoxide | |
gemifloxacin mesylate gemifloxacin mesylate : The mesylate salt of gemifloxacin. | 2.08 | 1 | 0 | methanesulfonate salt | antimicrobial agent; topoisomerase IV inhibitor |
desvenlafaxine succinate Desvenlafaxine Succinate: A cyclohexanol and phenol derivative and metabolite of venlafaxine that functions as a SEROTONIN AND NORADRENALINE REUPTAKE INHIBITOR (SNRI) and is used as an ANTIDEPRESSIVE AGENT. | 12.01 | 21 | 4 | ||
ispronicline ispronicline: a neuronal nicotinic acetylcholine receptor modulator; has antidepressant, neuroprotective, and cognitive effects; structure in first source | 3.23 | 1 | 0 | ||
tapentadol Tapentadol: An opioid analgesic, MU OPIOID RECEPTOR agonist, and noradrenaline reuptake inhibitor that is used in the treatment of moderate to severe pain, and of pain associated with DIABETIC NEUROPATHIES. | 6.2 | 5 | 0 | alkylbenzene | |
paliperidone palmitate Paliperidone Palmitate: A benzisoxazole derivative and active metabolite of RISPERIDONE that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST and SEROTONIN 5-HT2 RECEPTOR ANTAGONIST. It is an ANTIPSYCHOTIC AGENT used in the treatment of SCHIZOPHRENIA.. 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-9-yl hexadecanoate : A fatty acid ester obtained by the formal condensation of the carboxy group of hexadecanoic acid with the hydroxy group of 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one.. paliperidone palmitate : A racemate comprising equimolar amounts of (R)- and (S)-paliperidone palmitate. A long-acting injectable formulation of paliperidone (the major active metabolite of risperidone) that is used for treatment of schizophrenia. | 2.41 | 1 | 0 | 1,2-benzoxazoles; fatty acid ester; heteroarylpiperidine; organofluorine compound; pyridopyrimidine | |
mocetinostat mocetinostat: undergoing phase II clinical trials for treatment of cancer. mocetinostat : A benzamide obtained by formal condensation of the carboxy group of 4-({[4-(pyridin-3-yl)pyrimidin-2-yl]amino}methyl)benzoic acid with one of the amino groups of benzene-1,2-diamine. It is an orally active and isotype-selective HDAC inhibitor which exhibits antitumour activity (IC50 = 0.15, 0.29, 1.66 and 0.59 muM for HDAC1, HDAC2, HDAC3 and HDAC11). | 2.21 | 1 | 0 | aminopyrimidine; benzamides; pyridines; secondary amino compound; secondary carboxamide; substituted aniline | antineoplastic agent; apoptosis inducer; autophagy inducer; cardioprotective agent; EC 3.5.1.98 (histone deacetylase) inhibitor; hepatotoxic agent |
mirabegron mirabegron: a beta3-adrenergic receptor agonist; structure in first source. mirabegron : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of 2-amino-1,3-thiazol-4-ylacetic acid with the anilino group of (1R)-2-{[2-(4-aminophenyl)ethyl]amino}-1-phenylethanol. Used for the treatment of overactive bladder syndrome. | 2.94 | 3 | 0 | 1,3-thiazoles; aromatic amide; ethanolamines; monocarboxylic acid amide | beta-adrenergic agonist |
rivaroxaban Rivaroxaban: A morpholine and thiophene derivative that functions as a FACTOR XA INHIBITOR and is used in the treatment and prevention of DEEP-VEIN THROMBOSIS and PULMONARY EMBOLISM. It is also used for the prevention of STROKE and systemic embolization in patients with non-valvular ATRIAL FIBRILLATION, and for the prevention of atherothrombotic events in patients after an ACUTE CORONARY SYNDROME.. rivaroxaban : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of 5-chlorothiophene-2-carboxylic acid with the amino group of 4-{4-[(5S)-5-(aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one. An anticoagulant used for prophylaxis of venous thromboembolism in patients with knee or hip replacement surgery. | 2.08 | 1 | 0 | aromatic amide; lactam; monocarboxylic acid amide; morpholines; organochlorine compound; oxazolidinone; thiophenes | anticoagulant; EC 3.4.21.6 (coagulation factor Xa) inhibitor |
piperacillin 5-(2-azetidinylmethoxy)-2-chloropyridine: affects neuronal nicotinic acetylcholine receptors; structure in first source | 2.05 | 1 | 0 | ||
hki 272 [no description available] | 2.08 | 1 | 0 | nitrile; quinolines | antineoplastic agent; tyrosine kinase inhibitor |
tofacitinib tofacitinib : A pyrrolopyrimidine that is pyrrolo[2,3-d]pyrimidine substituted at position 4 by an N-methyl,N-(1-cyanoacetyl-4-methylpiperidin-3-yl)amino moiety. Used as its citrate salt to treat moderately to severely active rheumatoid arthritis. | 2.08 | 1 | 0 | N-acylpiperidine; nitrile; pyrrolopyrimidine; tertiary amino compound | antirheumatic drug; EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor |
vortioxetine Vortioxetine: A piperazine derivative that acts as a serotonin reuptake inhibitor, as a 5-HT3 receptor antagonist, and 5-HT1A receptor agonist. It is used for the treatment of anxiety and depression.. vortioxetine : An N-arylpiperazine in which the aryl group is specified as 2-[(2,4-dimethylphenyl)sulfanyl]phenyl. Used (as its hydrobromide salt) for treatment of major depressive disorder. | 14.59 | 32 | 12 | aryl sulfide; N-arylpiperazine | antidepressant; anxiolytic drug; serotonergic agonist; serotonergic antagonist |
pazopanib pazopanib: a protein kinase inhibitor. pazopanib : A pyrimidine that is 5-(pyrimidin-2-yl}amino-2-methylbenzenesulfonamide substituted at position 4 by a (2,3-dimethylindazol-6-yl)(methyl)amino group. Used as its hydrochloride salt for treatment of kidney cancer. | 2.08 | 1 | 0 | aminopyrimidine; indazoles; sulfonamide | angiogenesis modulating agent; antineoplastic agent; tyrosine kinase inhibitor; vascular endothelial growth factor receptor antagonist |
amg 009 AMG 009: an anti-inflammatory agent; structure in first source | 2.08 | 1 | 0 | ||
cefotaxime sodium [no description available] | 2.08 | 1 | 0 | organic sodium salt | |
brimonidine tartrate Brimonidine Tartrate: A quinoxaline derivative and ADRENERGIC ALHPA-2 RECEPTOR AGONIST that is used to manage INTRAOCULAR PRESSURE associated with OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION. | 2.43 | 2 | 0 | ||
er-086526 eribulin: a halichondrin B derivative that suppresses microtubule growth and acts as an antimitotic agent; structure in first source. eribulin : A fully synthetic macrocyclic ketone analogue of marine sponge natural products. Inhibits growth phase of microtubules via tubulin-based antimitotic mechanism, which leads to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage | 2.11 | 1 | 0 | cyclic ketal; cyclic ketone; macrocycle; polycyclic ether; polyether; primary amino compound | antineoplastic agent; microtubule-destabilising agent |
a 784168 1-(3-(trifluoromethyl)pyridin-2-yl)-N-(4-(trifluoromethylsulfonyl)phenyl)-1,2,3,6-tetrahydropyridine-4-carboxamide: a TRPV1 antagonist | 2.08 | 1 | 0 | ||
sitagliptin phosphate Sitagliptin Phosphate: A pyrazine-derived DIPEPTIDYL-PEPTIDASE IV INHIBITOR and HYPOGLYCEMIC AGENT that increases the levels of the INCRETIN hormones GLUCAGON-LIKE PEPTIDE-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). It is used in the treatment of TYPE 2 DIABETES. | 2.13 | 1 | 0 | ||
lisdexamfetamine dimesylate Lisdexamfetamine Dimesylate: A dextroamphetamine drug precursor that also functions as a CENTRAL NERVOUS SYSTEM STIMULANT and DOPAMINE UPTAKE INHIBITOR and is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER. | 7.25 | 3 | 2 | ||
ru 66647 telithromycin: a ketolide; semisynthetic derivative of erythromycin with cycling of the C11-12 positions to form a carbamate ring to avoid acquired resistance to macrolides; binds 70S bacterial rRNA, specifically to the 23S part (23S RIBOSOMAL RNA), preventing protein synthesis; | 3.12 | 1 | 0 | ||
mk-0249 MK-0249: a histamine-3 receptor inverse agonist; structure in first source | 3.23 | 1 | 0 | ||
losartan potassium Erythropoietin: Glycoprotein hormone, secreted chiefly by the KIDNEY in the adult and the LIVER in the FETUS, that acts on erythroid stem cells of the BONE MARROW to stimulate proliferation and differentiation. | 2.08 | 1 | 0 | ||
scopolamine hydrobromide [no description available] | 2.05 | 1 | 0 | ||
dactolisib dactolisib: antineoplastic agent that inhibits both phosphatidylinositol 3-kinase and mTOR. dactolisib : An imidazoquinoline that is 3-methyl-2-oxo-2,3-dihydro-1H-imidazo[4,5-c]quinoline substituted at position 1 by a 4-(1-cyanoisopropyl)phenyl group and at position 8 by a quinolin-3-yl group. A dual PI3K/mTOR inhibitor used in cancer treatment. | 2.08 | 1 | 0 | imidazoquinoline; nitrile; quinolines; ring assembly; ureas | antineoplastic agent; EC 2.7.1.137 (phosphatidylinositol 3-kinase) inhibitor; mTOR inhibitor |
brexpiprazole brexpiprazole: a serotonin agent; structure in first source | 2.41 | 1 | 0 | N-arylpiperazine | |
pituitrin Pituitrin: A substance or extract from the neurohypophysis (PITUITARY GLAND, POSTERIOR). | 4.19 | 4 | 0 | ||
amlodipine, atorvastatin drug combination [no description available] | 3.12 | 1 | 0 | ||
rifamycins [no description available] | 3.12 | 1 | 0 | ||
ent-dextilidine Tilidine: An opioid analgesic used similarly to MORPHINE in the control of moderate to severe pain. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1097). ent-dextilidine : An ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate that has R configuration at the carbon bearing the phenyl group and S configuration at the carbon bearing the dimethylamino group. It is the enantiomer of dextilidine; the opioid analgesic tilidine is the racemate comprising equimolar amounts of dextilidine and ent-dextilidine.. tilidine : A racemate that is an equimolar mixture of the two trans diastereoisomers of ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate, namely dextilidine and ent-dextilidine. It is used (commonly as the hydrochloride hemihydrate) as an opioid analgesic for the management of moderate to severe pain. A prodrug, it is metabolised in the body to nortilidine, which is responsible for the analgesic activity; virtually all of the opioid activity resides in the (1S,2R) isomer. | 2.08 | 1 | 0 | ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate | |
rabeprazole sodium [no description available] | 2.08 | 1 | 0 | organic sodium salt | |
jaw [no description available] | 3.18 | 1 | 0 | indolecarboxamide | |
bivalirudin bivalirudin: designed to bind to the alpha-thrombin catalytic site and anion-binding exosite for fibrin(ogen) recognition. bivalirudin : A synthetic peptide of 20 amino acids, comprising D-Phe, Pro, Arg, Pro, Gly, Gly, Gly, Gly, Asn, Gly, Asp, Phe, Glu, Glu, Ile, Pro, Glu, Glu, Tyr, and Leu in sequence. A congener of hirudin (a naturally occurring drug found in the saliva of the medicinal leech), it a specific and reversible inhibitor of thrombin, and is used as an anticoagulant. | 2.08 | 1 | 0 | polypeptide | anticoagulant; EC 3.4.21.5 (thrombin) inhibitor |
somatostatin [no description available] | 2.08 | 1 | 0 | heterodetic cyclic peptide; peptide hormone | |
ly-146032 [no description available] | 2.08 | 1 | 0 | heterodetic cyclic peptide; lipopeptide antibiotic; lipopeptide; macrocycle; macrolide | antibacterial drug; bacterial metabolite; calcium-dependent antibiotics |
warfarin sodium warfarin sodium : A racemate comprising equal amounts of (R)- and (S)-warfarin sodium. Extensively used as both an anticoagulant drug and as a pesticide against rats and mice. | 2.08 | 1 | 0 | ||
cellulose DEAE-Cellulose: Cellulose derivative used in chromatography, as ion-exchange material, and for various industrial applications. | 2.02 | 1 | 0 | glycoside | |
chlorophyll a Chlorophyll: Porphyrin derivatives containing magnesium that act to convert light energy in photosynthetic organisms.. chlorophyll : A family of magnesium porphyrins, defined by the presence of a fifth ring beyond the four pyrrole-like rings. The rings can have various side chains which usually include a long phytol chain. | 2.21 | 1 | 0 | chlorophyll; methyl ester | cofactor |
pravastatin sodium pravastatin sodium : An organic sodium salt that is the sodium salt of pravastatin. A reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA), it is used for lowering cholesterol and preventing cardiovascular disease. It is one of the lower potency statins, but has the advantage of fewer side effects compared with lovastatin and simvastatin. | 2.08 | 1 | 0 | organic sodium salt; statin (semi-synthetic) | anticholesteremic drug |
alendronate sodium [no description available] | 2.08 | 1 | 0 | ||
sl 80.0750 [no description available] | 2.08 | 1 | 0 | ||
lucifer yellow lucifer yellow: RN given refers to di-Li salt | 2.07 | 1 | 0 | organic lithium salt | fluorochrome |
chitosan [no description available] | 2.8 | 3 | 0 | ||
mesna Mesna: A sulfhydryl compound used to prevent urothelial toxicity by inactivating metabolites from ANTINEOPLASTIC AGENTS, such as IFOSFAMIDE or CYCLOPHOSPHAMIDE. | 2.08 | 1 | 0 | organosulfonic acid | |
clavulanate potassium potassium clavulanate : A potassium salt having clavulanate as the counterion. It acts as a suicide inhibitor of bacterial beta-lactamase enzymes and has only weak anitbiotic activity when administered alone. However it can be used in combination with amoxicillin trihydrate (under the trade name Augmentin) for treatment of a variety of bacterial infections, where it prevents antibiotic inactivation by microbial lactamases. | 2.08 | 1 | 0 | potassium salt | antibacterial drug; antimicrobial agent; EC 3.5.2.6 (beta-lactamase) inhibitor |
piperacillin sodium [no description available] | 2.08 | 1 | 0 | organic sodium salt | |
oxacillin sodium [no description available] | 2.08 | 1 | 0 | organic sodium salt | |
cefazolin sodium cefazolin sodium : A cephalosporin organic sodium salt having [(5-methyl-1,3,4-thiadiazol-2-yl)sulfanyl]methyl and (1H-tetrazol-1-ylacetyl)amino side-groups. | 2.08 | 1 | 0 | organic sodium salt | |
azlocillin sodium [no description available] | 2.08 | 1 | 0 | organic sodium salt | |
quetiapine fumarate Quetiapine Fumarate: A dibenzothiazepine and ANTIPSYCHOTIC AGENT that targets the SEROTONIN 5-HT2 RECEPTOR; HISTAMINE H1 RECEPTOR, adrenergic alpha1 and alpha2 receptors, as well as the DOPAMINE D1 RECEPTOR and DOPAMINE D2 RECEPTOR. It is used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER and DEPRESSIVE DISORDER. | 8.97 | 9 | 2 | fumarate salt | |
cardiovascular agents Cardiovascular Agents: Agents that affect the rate or intensity of cardiac contraction, blood vessel diameter, or blood volume. | 3.12 | 1 | 0 | ||
tolterodine tartrate Tolterodine Tartrate: An ANTIMUSCARINIC AGENT selective for the MUSCARINIC RECEPTORS of the BLADDER that is used in the treatment of URINARY INCONTINENCE and URINARY URGE INCONTINENCE. | 7.01 | 7 | 1 | tartrate salt | |
n,n-dimethyl-2-(2-amino-4-cyanophenylthio)benzylamine N,N-dimethyl-2-(2-amino-4-cyanophenylthio)benzylamine: structure in first source | 2.06 | 1 | 0 | ||
piperidines Piperidines: A family of hexahydropyridines. | 2.44 | 2 | 0 | ||
methylcellulose Methylcellulose: Methylester of cellulose. Methylcellulose is used as an emulsifying and suspending agent in cosmetics, pharmaceutics and the chemical industry. It is used therapeutically as a bulk laxative. | 1.99 | 1 | 0 | ||
chondroitin Chondroitin: A mucopolysaccharide constituent of chondrin. (Grant & Hackh's Chemical Dictionary, 5th ed) | 3.19 | 1 | 0 | ||
ascorbic acid Ascorbic Acid: A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.. L-ascorbic acid : The L-enantiomer of ascorbic acid and conjugate acid of L-ascorbate.. L-ascorbate : The L-enantiomer of ascorbate and conjugate base of L-ascorbic acid, arising from selective deprotonation of the 3-hydroxy group. Required for a range of essential metabolic reactions in all animals and plants.. vitamin C : Any member of a group of vitamers that belong to the chemical structural class called butenolides that exhibit biological activity against vitamin C deficiency in animals. The vitamers include L-ascorbic acid and its salt, ionized and oxidized forms. | 2.04 | 1 | 0 | ascorbic acid; vitamin C | coenzyme; cofactor; flour treatment agent; food antioxidant; food colour retention agent; geroprotector; plant metabolite; skin lightening agent |
tetracycline Tetracycline: A naphthacene antibiotic that inhibits AMINO ACYL TRNA binding during protein synthesis.. tetracycline : A broad-spectrum polyketide antibiotic produced by the Streptomyces genus of actinobacteria. | 2.08 | 1 | 0 | ||
minocycline Minocycline: A TETRACYCLINE analog, having a 7-dimethylamino and lacking the 5 methyl and hydroxyl groups, which is effective against tetracycline-resistant STAPHYLOCOCCUS infections.. minocycline : A tetracycline analogue having a dimethylamino group at position 7 and lacking the methyl and hydroxy groups at position 5. | 2.31 | 1 | 0 | ||
piroxicam [no description available] | 2.08 | 1 | 0 | benzothiazine; monocarboxylic acid amide; pyridines | analgesic; antirheumatic drug; cyclooxygenase 1 inhibitor; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-steroidal anti-inflammatory drug |
roquinimex roquinimex: structure in first source | 2.08 | 1 | 0 | aromatic amide | |
acenocoumarol Acenocoumarol: A coumarin that is used as an anticoagulant. Its actions and uses are similar to those of WARFARIN. (From Martindale, The Extra Pharmacopoeia, 30th ed, p233). acenocoumarol : A hydroxycoumarin that is warfarin in which the hydrogen at position 4 of the phenyl substituent is replaced by a nitro group. | 2.03 | 1 | 0 | C-nitro compound; hydroxycoumarin; methyl ketone | anticoagulant; EC 1.6.5.2 [NAD(P)H dehydrogenase (quinone)] inhibitor |
mobic Meloxicam: A benzothiazine and thiazole derivative that acts as a NSAID and cyclooxygenase-2 (COX-2) inhibitor. It is used in the treatment of RHEUMATOID ARTHRITIS; OSTEOARTHRITIS; and ANKYLOSING SPONDYLITIS.. meloxicam : A benzothiazine that is piroxicam in which the pyridin-2-yl group is replaced by a 5-methyl-1,3-thiazol-2-yl group. A non-steroidal anti-inflammatory drug and selective inhibitor of COX-2, it is used particularly for the management of rheumatoid arthritis. | 6.69 | 4 | 3 | 1,3-thiazoles; benzothiazine; monocarboxylic acid amide | analgesic; antirheumatic drug; cyclooxygenase 2 inhibitor; non-steroidal anti-inflammatory drug |
mobiflex tenoxicam : A thienothiazine-derived monocarboxylic acid amide obtained by formal condensation of the carboxy group of 4-hydroxy-2-methylthieno[2,3-e][1,2]thiazine-3-carboxylic acid 1,1-dioxide with the amino group of 2-aminopyridine. Used for the treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis. It is also indicated for short term treatment of acute musculoskeletal disorders including strains, sprains and other soft-tissue injuries. | 2.08 | 1 | 0 | heteroaryl hydroxy compound; monocarboxylic acid amide; pyridines; thienothiazine | antipyretic; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
isoxicam isoxicam : A monocarboxylic acid amide that is piroxicam in which the pyrid-2-yl group is replaced by a 5-methyl-1,2-oxazol-3-yl group. A non-steroidal anti-inflammatory drug, it was withdrawn from the market in the 1980s following its association with cases of Stevens-Johnson syndrome. | 2.08 | 1 | 0 | benzothiazine; isoxazoles; monocarboxylic acid amide | antirheumatic drug; non-steroidal anti-inflammatory drug |
warfarin Warfarin: An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.. warfarin : A racemate comprising equal amounts of (R)- and (S)-warfarin. Extensively used as both an anticoagulant drug and as a pesticide against rats and mice.. 4-hydroxy-3-(3-oxo-1-phenylbutyl)-1-benzopyran-2-one : A member of the class of coumarins that is 4-hydroxycoumarin which is substituted at position 3 by a 1-phenyl-3-oxo-1-butyl group. | 3.83 | 2 | 1 | benzenes; hydroxycoumarin; methyl ketone | |
minocycline hydrochloride [no description available] | 2.08 | 1 | 0 | ||
tigecycline [no description available] | 2.08 | 1 | 0 | ||
lornoxicam lornoxicam : A thienothiazine-derived monocarboxylic acid amide obtained by formal condensation of the carboxy group of 6-chloro-4-hydroxy-2-methylthieno[2,3-e][1,2]thiazine-3-carboxylic acid 1,1-dioxide with the amino group of 2-aminopyridine. Used for the treatment of pain, primarily resulting from inflammatory diseases of the joints, osteoarthritis, surgery, sciatica and other inflammations. | 2.08 | 1 | 0 | heteroaryl hydroxy compound; monocarboxylic acid amide; organochlorine compound; pyridines; thienothiazine | antipyretic; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
vitamin b 12 Vitamin B 12: A cobalt-containing coordination compound produced by intestinal micro-organisms and found also in soil and water. Higher plants do not concentrate vitamin B 12 from the soil and so are a poor source of the substance as compared with animal tissues. INTRINSIC FACTOR is important for the assimilation of vitamin B 12. | 5.82 | 3 | 2 | ||
transforming growth factor alpha Transforming Growth Factor alpha: An EPIDERMAL GROWTH FACTOR related protein that is found in a variety of tissues including EPITHELIUM, and maternal DECIDUA. It is synthesized as a transmembrane protein which can be cleaved to release a soluble active form which binds to the EGF RECEPTOR. | 2.6 | 1 | 0 | ||
chondroitin sulfates Chondroitin Sulfates: Derivatives of chondroitin which have a sulfate moiety esterified to the galactosamine moiety of chondroitin. Chondroitin sulfate A, or chondroitin 4-sulfate, and chondroitin sulfate C, or chondroitin 6-sulfate, have the sulfate esterified in the 4- and 6-positions, respectively. Chondroitin sulfate B (beta heparin; DERMATAN SULFATE) is a misnomer and this compound is not a true chondroitin sulfate. | 2.11 | 1 | 0 | ||
entecavir entecavir (anhydrous) : Guanine substituted at the 9 position by a 4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl group. A synthetic analogue of 2'-deoxyguanosine, it is a nucleoside reverse transcriptase inhibitor with selective antiviral activity against hepatitis B virus. Entecavir is phosphorylated intracellularly to the active triphosphate form, which competes with deoxyguanosine triphosphate, the natural substrate of hepatitis B virus reverse transcriptase, inhibiting every stage of the enzyme's activity, although it has no activity against HIV. It is used for the treatment of chronic hepatitis B. | 2.51 | 2 | 0 | 2-aminopurines; oxopurine; primary alcohol; secondary alcohol | antiviral drug; EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor |
acyclovir Acyclovir: A GUANOSINE analog that acts as an antimetabolite. Viruses are especially susceptible. Used especially against herpes.. acyclovir : An oxopurine that is guanine substituted by a (2-hydroxyethoxy)methyl substituent at position 9. Used in the treatment of viral infections. | 2.47 | 2 | 0 | 2-aminopurines; oxopurine | antimetabolite; antiviral drug |
cyclic gmp Cyclic GMP: Guanosine cyclic 3',5'-(hydrogen phosphate). A guanine nucleotide containing one phosphate group which is esterified to the sugar moiety in both the 3'- and 5'-positions. It is a cellular regulatory agent and has been described as a second messenger. Its levels increase in response to a variety of hormones, including acetylcholine, insulin, and oxytocin and it has been found to activate specific protein kinases. (From Merck Index, 11th ed). 3',5'-cyclic GMP : A 3',5'-cyclic purine nucleotide in which the purine nucleobase is specified as guanidine. | 2.07 | 1 | 0 | 3',5'-cyclic purine nucleotide; guanyl ribonucleotide | Escherichia coli metabolite; human metabolite; mouse metabolite; plant metabolite; Saccharomyces cerevisiae metabolite |
guanosine triphosphate Guanosine Triphosphate: Guanosine 5'-(tetrahydrogen triphosphate). A guanine nucleotide containing three phosphate groups esterified to the sugar moiety. | 2.6 | 1 | 0 | guanosine 5'-phosphate; purine ribonucleoside 5'-triphosphate | Escherichia coli metabolite; mouse metabolite; uncoupling protein inhibitor |
guanine [no description available] | 2.13 | 1 | 0 | 2-aminopurines; oxopurine; purine nucleobase | algal metabolite; Escherichia coli metabolite; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
folic acid folcysteine: used to promote fertility in chickens. vitamin B9 : Any B-vitamin that exhibits biological activity against vitamin B9 deficiency. Vitamin B9 refers to the many forms of folic acid and its derivatives, including tetrahydrofolic acid (the active form), methyltetrahydrofolate (the primary form found in blood), methenyltetrahydrofolate, folinic acid amongst others. They are present in abundance in green leafy vegetables, citrus fruits, and animal products. Lack of vitamin B9 leads to anemia, a condition in which the body cannot produce sufficient number of red blood cells. Symptoms of vitamin B9 deficiency include fatigue, muscle weakness, and pale skin. | 2.02 | 1 | 0 | folic acids; N-acyl-amino acid | human metabolite; mouse metabolite; nutrient |
neopterin [no description available] | 2.98 | 1 | 0 | ||
rifampin Rifampin: A semisynthetic antibiotic produced from Streptomyces mediterranei. It has a broad antibacterial spectrum, including activity against several forms of Mycobacterium. In susceptible organisms it inhibits DNA-dependent RNA polymerase activity by forming a stable complex with the enzyme. It thus suppresses the initiation of RNA synthesis. Rifampin is bactericidal, and acts on both intracellular and extracellular organisms. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p1160) | 2.08 | 1 | 0 | cyclic ketal; hydrazone; N-iminopiperazine; N-methylpiperazine; rifamycins; semisynthetic derivative; zwitterion | angiogenesis inhibitor; antiamoebic agent; antineoplastic agent; antitubercular agent; DNA synthesis inhibitor; EC 2.7.7.6 (RNA polymerase) inhibitor; Escherichia coli metabolite; geroprotector; leprostatic drug; neuroprotective agent; pregnane X receptor agonist; protein synthesis inhibitor |
clozapine Clozapine: A tricylic dibenzodiazepine, classified as an atypical antipsychotic agent. It binds several types of central nervous system receptors, and displays a unique pharmacological profile. Clozapine is a serotonin antagonist, with strong binding to 5-HT 2A/2C receptor subtype. It also displays strong affinity to several dopaminergic receptors, but shows only weak antagonism at the dopamine D2 receptor, a receptor commonly thought to modulate neuroleptic activity. Agranulocytosis is a major adverse effect associated with administration of this agent.. clozapine : A benzodiazepine that is 5H-dibenzo[b,e][1,4]diazepine substituted by a chloro group at position 8 and a 4-methylpiperazin-1-yl group at position 11. It is a second generation antipsychotic used in the treatment of psychiatric disorders like schizophrenia. | 4.53 | 5 | 1 | benzodiazepine; N-arylpiperazine; N-methylpiperazine; organochlorine compound | adrenergic antagonist; dopaminergic antagonist; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; environmental contaminant; GABA antagonist; histamine antagonist; muscarinic antagonist; second generation antipsychotic; serotonergic antagonist; xenobiotic |
dacarbazine (E)-dacarbazine : A dacarbazine in which the N=N double bond adopts a trans-configuration. | 2.08 | 1 | 0 | dacarbazine | |
didanosine Didanosine: A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by a hydrogen. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. Didanosine is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA by binding to reverse transcriptase; ddI is then metabolized to dideoxyadenosine triphosphate, its putative active metabolite.. didanosine : A purine 2',3'-dideoxyribonucleoside that is inosine in which the hydroxy groups at both the 2' and the 3' positions on the sugar moiety have been replaced by hydrogen. An antiviral drug, it is used as a medication to treat HIV/AIDS. | 2.08 | 1 | 0 | purine 2',3'-dideoxyribonucleoside | antimetabolite; antiviral drug; EC 2.4.2.1 (purine-nucleoside phosphorylase) inhibitor; geroprotector; HIV-1 reverse transcriptase inhibitor |
ganciclovir [no description available] | 2.08 | 1 | 0 | 2-aminopurines; oxopurine | antiinfective agent; antiviral drug |
valtrex [no description available] | 2.08 | 1 | 0 | organic molecular entity | |
olanzapine Olanzapine: A benzodiazepine derivative that binds SEROTONIN RECEPTORS; MUSCARINIC RECEPTORS; HISTAMINE H1 RECEPTORS; ADRENERGIC ALPHA-1 RECEPTORS; and DOPAMINE RECEPTORS. It is an antipsychotic agent used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER; and MAJOR DEPRESSIVE DISORDER; it may also reduce nausea and vomiting in patients undergoing chemotherapy.. olanzapine : A benzodiazepine that is 10H-thieno[2,3-b][1,5]benzodiazepine substituted by a methyl group at position 2 and a 4-methylpiperazin-1-yl group at position 4. | 4.75 | 9 | 0 | benzodiazepine; N-arylpiperazine; N-methylpiperazine | antiemetic; dopaminergic antagonist; histamine antagonist; muscarinic antagonist; second generation antipsychotic; serotonergic antagonist; serotonin uptake inhibitor |
raltitrexed [no description available] | 2.08 | 1 | 0 | N-acyl-amino acid | |
allopurinol Allopurinol: A XANTHINE OXIDASE inhibitor that decreases URIC ACID production. It also acts as an antimetabolite on some simpler organisms.. allopurinol : A bicyclic structure comprising a pyrazole ring fused to a hydroxy-substituted pyrimidine ring. | 2.08 | 1 | 0 | nucleobase analogue; organic heterobicyclic compound | antimetabolite; EC 1.17.3.2 (xanthine oxidase) inhibitor; gout suppressant; radical scavenger |
citrovorum factor [no description available] | 2.08 | 1 | 0 | tetrahydrofolic acid | |
rifapentine rifapentine: cyclopentyl derivative of rifampicin | 2.08 | 1 | 0 | N-alkylpiperazine; N-iminopiperazine; rifamycins | antitubercular agent; leprostatic drug |
tegaserod tegaserod: a nonbenzamide 5-hydroxytryptamine(4) agonist; used in treatment of irritable bowel syndrome; marketing suspended 2007 in US due to higher incidence of MI, stroke, and unstable angina; structure given in first source | 2.07 | 1 | 0 | carboxamidine; guanidines; hydrazines; indoles | gastrointestinal drug; serotonergic agonist |
sildenafil citrate Sildenafil Citrate: A PHOSPHODIESTERASE TYPE-5 INHIBITOR; VASODILATOR AGENT and UROLOGICAL AGENT that is used in the treatment of ERECTILE DYSFUNCTION and PRIMARY PULMONARY HYPERTENSION.. sildenafil citrate : The citrate salt of sildenafil. | 2.08 | 1 | 0 | citrate salt | EC 3.1.4.35 (3',5'-cyclic-GMP phosphodiesterase) inhibitor; vasodilator agent |
aprepitant Aprepitant: A morpholine neurokinin-1 (NK1) receptor antagonist that is used in the management of nausea and vomiting caused by DRUG THERAPY, and for the prevention of POSTOPERATIVE NAUSEA AND VOMITING.. aprepitant : A morpholine-based antiemetic, which is or the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Aprepitant is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK1) receptors. | 2.52 | 2 | 0 | (trifluoromethyl)benzenes; cyclic acetal; morpholines; triazoles | antidepressant; antiemetic; neurokinin-1 receptor antagonist; peripheral nervous system drug; substance P receptor antagonist |
tegaserod maleate [no description available] | 2.08 | 1 | 0 | maleate salt | serotonergic agonist |
rifabutin [no description available] | 2.08 | 1 | 0 | ||
olanzapine-fluoxetine combination olanzapine-fluoxetine combination: used to treat bipolar depression | 3.48 | 1 | 1 | ||
eye [no description available] | 2.13 | 1 | 0 | ||
maltodextrin maltodextrin : A dextrin in which the D-glucose units are linked by alpha-(1->4) glycosidic bonds. | 2.41 | 1 | 0 | ||
carbidopa Carbidopa: An inhibitor of DOPA DECARBOXYLASE that prevents conversion of LEVODOPA to dopamine. It is used in PARKINSON DISEASE to reduce peripheral adverse effects of LEVODOPA. It has no anti-parkinson activity by itself.. carbidopa : The hydrate of 3-(3,4-dihydroxyphenyl)propanoic acid in which the hydrogens alpha- to the carboxyl group are substituted by hydrazinyl and methyl groups (S-configuration). Carbidopa is a dopa decarboxylase inhibitor, so prevents conversion of levodopa to dopamine. It has no antiparkinson activity by itself, but is used in the management of Parkinson's disease to reduce peripheral adverse effects of levodopa. | 2.1 | 1 | 0 |
Condition | Indicated | Relationship Strength | Studies | Trials |
---|---|---|---|---|
Innate Inflammatory Response [description not available] | 0 | 5.87 | 8 | 0 |
Inflammation A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function. | 0 | 5.87 | 8 | 0 |
Acute Liver Injury, Drug-Induced [description not available] | 0 | 5.72 | 13 | 0 |
Adverse Drug Event [description not available] | 0 | 10.89 | 18 | 7 |
Chemical and Drug Induced Liver Injury A spectrum of clinical liver diseases ranging from mild biochemical abnormalities to ACUTE LIVER FAILURE, caused by drugs, drug metabolites, herbal and dietary supplements and chemicals from the environment. | 0 | 5.72 | 13 | 0 |
Drug-Related Side Effects and Adverse Reactions Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals. | 0 | 10.89 | 18 | 7 |
Congenital Zika Syndrome [description not available] | 0 | 2.25 | 1 | 0 |
Disease Models, Animal Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases. | 0 | 7.44 | 74 | 0 |
Zika Virus Infection A viral disease transmitted by the bite of AEDES mosquitoes infected with ZIKA VIRUS. Its mild DENGUE-like symptoms include fever, rash, headaches and ARTHRALGIA. The viral infection during pregnancy, in rare cases, is associated with congenital brain and ocular abnormalities, called Congenital Zika Syndrome, including MICROCEPHALY and may also lead to GUILLAIN-BARRE SYNDROME. | 0 | 2.25 | 1 | 0 |
Osteoarthritis of Knee [description not available] | 0 | 19.9 | 100 | 55 |
Ache [description not available] | 0 | 21.43 | 216 | 75 |
Pain An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS. | 1 | 23.43 | 216 | 75 |
Osteoarthritis, Knee Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019) | 0 | 19.9 | 100 | 55 |
Antidiuretic Hormone, Inappropriate Secretion [description not available] | 0 | 5 | 13 | 0 |
Hyponatremia Deficiency of sodium in the blood; salt depletion. (Dorland, 27th ed) | 0 | 5.29 | 18 | 0 |
Inappropriate ADH Syndrome A condition of HYPONATREMIA and renal salt loss attributed to overexpansion of BODY FLUIDS resulting from sustained release of ANTIDIURETIC HORMONES which stimulates renal resorption of water. It is characterized by normal KIDNEY function, high urine OSMOLALITY, low serum osmolality, and neurological dysfunction. Etiologies include ADH-producing neoplasms, injuries or diseases involving the HYPOTHALAMUS, the PITUITARY GLAND, and the LUNG. This syndrome can also be drug-induced. | 0 | 5 | 13 | 0 |
Odontalgia [description not available] | 0 | 2.41 | 1 | 0 |
Burning Mouth Syndrome A group of painful oral symptoms associated with a burning or similar sensation. There is usually a significant organic component with a degree of functional overlay; it is not limited to the psychophysiologic group of disorders. | 0 | 4.75 | 6 | 0 |
Toothache Pain in the adjacent areas of the teeth. | 0 | 2.41 | 1 | 0 |
Peripheral Nerve Diseases [description not available] | 0 | 21.44 | 162 | 46 |
Peripheral Nervous System Diseases Diseases of the peripheral nerves external to the brain and spinal cord, which includes diseases of the nerve roots, ganglia, plexi, autonomic nerves, sensory nerves, and motor nerves. | 0 | 21.44 | 162 | 46 |
Bladder, Overactive [description not available] | 0 | 8.9 | 14 | 2 |
Urinary Incontinence Involuntary loss of URINE, such as leaking of urine. It is a symptom of various underlying pathological processes. Major types of incontinence include URINARY URGE INCONTINENCE and URINARY STRESS INCONTINENCE. | 1 | 14.17 | 39 | 5 |
Urinary Bladder, Overactive Symptom of overactive detrusor muscle of the URINARY BLADDER that contracts with abnormally high frequency and urgency. Overactive bladder is characterized by the frequent feeling of needing to urinate during the day, during the night, or both. URINARY INCONTINENCE may or may not be present. | 0 | 8.9 | 14 | 2 |
Delayed Effects, Prenatal Exposure [description not available] | 0 | 4.55 | 8 | 0 |
Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. | 0 | 6.41 | 20 | 0 |
Encephalopathy, Toxic [description not available] | 0 | 7.8 | 11 | 1 |
Autism Spectrum Disorder Wide continuum of associated cognitive and neurobehavioral disorders, including, but not limited to, three core-defining features: impairments in socialization, impairments in verbal and nonverbal communication, and restricted and repetitive patterns of behaviors. (from DSM-V) | 0 | 3.74 | 2 | 0 |
Anxiety Feelings or emotions of dread, apprehension, and impending disaster but not disabling as with ANXIETY DISORDERS. | 1 | 14.64 | 32 | 13 |
Hyperprolactinaemia [description not available] | 0 | 2.81 | 3 | 0 |
Nerve Pain [description not available] | 0 | 22.7 | 251 | 85 |
Galactorrhea Excessive or inappropriate LACTATION in females or males, and not necessarily related to PREGNANCY. Galactorrhea can occur either unilaterally or bilaterally, and be profuse or sparse. Its most common cause is HYPERPROLACTINEMIA. | 0 | 3.62 | 8 | 0 |
Hyperprolactinemia Increased levels of PROLACTIN in the BLOOD, which may be associated with AMENORRHEA and GALACTORRHEA. Relatively common etiologies include PROLACTINOMA, medication effect, KIDNEY FAILURE, granulomatous diseases of the PITUITARY GLAND, and disorders which interfere with the hypothalamic inhibition of prolactin release. Ectopic (non-pituitary) production of prolactin may also occur. (From Joynt, Clinical Neurology, 1992, Ch36, pp77-8) | 0 | 2.81 | 3 | 0 |
Neuralgia Intense or aching pain that occurs along the course or distribution of a peripheral or cranial nerve. | 1 | 24.7 | 251 | 85 |
Acute Post-operative Pain [description not available] | 0 | 16.34 | 53 | 37 |
Coxarthrosis [description not available] | 0 | 15.68 | 34 | 7 |
Pain, Postoperative Pain during the period after surgery. | 0 | 16.34 | 53 | 37 |
Osteoarthritis, Hip Noninflammatory degenerative disease of the hip joint which usually appears in late middle or old age. It is characterized by growth or maturational disturbances in the femoral neck and head, as well as acetabular dysplasia. A dominant symptom is pain on weight-bearing or motion. | 0 | 15.68 | 34 | 7 |
Benign Neoplasms [description not available] | 0 | 20.6 | 112 | 42 |
Neoplasms New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms. | 0 | 20.6 | 112 | 42 |
Depression, Involutional Form of depression in those MIDDLE AGE with feelings of ANXIETY. | 0 | 24.35 | 475 | 203 |
Depressive Disorder, Major Disorder in which five (or more) of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure. Symptoms include: depressed mood most of the day, nearly every daily; markedly diminished interest or pleasure in activities most of the day, nearly every day; significant weight loss when not dieting or weight gain; Insomnia or hypersomnia nearly every day; psychomotor agitation or retardation nearly every day; fatigue or loss of energy nearly every day; feelings of worthlessness or excessive or inappropriate guilt; diminished ability to think or concentrate, or indecisiveness, nearly every day; or recurrent thoughts of death, recurrent suicidal ideation without a specific plan, or a suicide attempt. (DSM-5) | 1 | 29.11 | 950 | 406 |
Stillbirth The event that a FETUS is born dead or stillborn. | 0 | 2.31 | 1 | 0 |
Abnormalities, Congenital [description not available] | 0 | 2.31 | 1 | 0 |
Abnormalities, Drug-Induced Congenital abnormalities caused by medicinal substances or drugs of abuse given to or taken by the mother, or to which she is inadvertently exposed during the manufacture of such substances. The concept excludes abnormalities resulting from exposure to non-medicinal chemicals in the environment. | 0 | 4.63 | 5 | 0 |
Fasting Hypoglycemia HYPOGLYCEMIA expressed in the postabsorptive state, after prolonged FASTING, or an overnight fast. | 0 | 2.41 | 1 | 0 |
Hypoglycemia A syndrome of abnormally low BLOOD GLUCOSE level. Clinical hypoglycemia has diverse etiologies. Severe hypoglycemia eventually lead to glucose deprivation of the CENTRAL NERVOUS SYSTEM resulting in HUNGER; SWEATING; PARESTHESIA; impaired mental function; SEIZURES; COMA; and even DEATH. | 0 | 2.41 | 1 | 0 |
Absent Iris [description not available] | 0 | 2.41 | 1 | 0 |
Aniridia A congenital abnormality in which there is only a rudimentary iris. This is due to the failure of the optic cup to grow. Aniridia also occurs in a hereditary form, usually autosomal dominant. | 0 | 2.41 | 1 | 0 |
Breast Cancer [description not available] | 0 | 10.21 | 18 | 10 |
Breast Neoplasms Tumors or cancer of the human BREAST. | 0 | 10.21 | 18 | 10 |
Musculoskeletal Pain Discomfort stemming from muscles, LIGAMENTS, tendons, and bones. | 1 | 11.74 | 12 | 3 |
Aging The gradual irreversible changes in structure and function of an organism that occur as a result of the passage of time. | 0 | 7.45 | 10 | 3 |
Female Genital Neoplasms [description not available] | 0 | 2.31 | 1 | 0 |
Genital Neoplasms, Female Tumor or cancer of the female reproductive tract (GENITALIA, FEMALE). | 0 | 2.31 | 1 | 0 |
Pain, Chronic [description not available] | 0 | 19.66 | 122 | 74 |
Chronic Pain Aching sensation that persists for more than a few months. It may or may not be associated with trauma or disease, and may persist after the initial injury has healed. Its localization, character, and timing are more vague than with acute pain. | 1 | 21.66 | 122 | 74 |
Depression Depressive states usually of moderate intensity in contrast with MAJOR DEPRESSIVE DISORDER present in neurotic and psychotic disorders. | 0 | 22.52 | 234 | 86 |
Cancer-Associated Pain [description not available] | 0 | 7.72 | 11 | 5 |
Cancer Pain Pain that may be caused by or related to cellular, tissue, and systemic changes that occur during NEOPLASM growth, tissue invasion, and METASTASIS. | 0 | 7.72 | 11 | 5 |
Allodynia [description not available] | 0 | 10.65 | 57 | 1 |
Diffuse Myofascial Pain Syndrome [description not available] | 0 | 18.89 | 126 | 35 |
Fibromyalgia A common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, HEADACHES, and occasionally DEPRESSION. There is significant overlap between fibromyalgia and the chronic fatigue syndrome (FATIGUE SYNDROME, CHRONIC). Fibromyalgia may arise as a primary or secondary disease process. It is most frequent in females aged 20 to 50 years. (From Adams et al., Principles of Neurology, 6th ed, p1494-95) | 1 | 20.89 | 126 | 35 |
Cancer of Pancreas [description not available] | 0 | 5.41 | 5 | 0 |
Pancreatic Neoplasms Tumors or cancer of the PANCREAS. Depending on the types of ISLET CELLS present in the tumors, various hormones can be secreted: GLUCAGON from PANCREATIC ALPHA CELLS; INSULIN from PANCREATIC BETA CELLS; and SOMATOSTATIN from the SOMATOSTATIN-SECRETING CELLS. Most are malignant except the insulin-producing tumors (INSULINOMA). | 0 | 5.41 | 5 | 0 |
Refractory Depression [description not available] | 0 | 10.31 | 10 | 8 |
Depressive Disorder, Treatment-Resistant Failure to respond to two or more trials of antidepressant monotherapy or failure to respond to four or more trials of different antidepressant therapies. (Campbell's Psychiatric Dictionary, 9th ed.) | 0 | 10.31 | 10 | 8 |
Blood Clot [description not available] | 0 | 2.41 | 1 | 0 |
Thrombosis Formation and development of a thrombus or blood clot in the blood vessel. | 0 | 2.41 | 1 | 0 |
Chronic Illness [description not available] | 0 | 15.17 | 47 | 14 |
Diabetes Mellitus, Adult-Onset [description not available] | 0 | 10.09 | 19 | 0 |
Asymmetric Diabetic Proximal Motor Neuropathy [description not available] | 0 | 20.27 | 155 | 55 |
Chronic Disease Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2). | 0 | 15.17 | 47 | 14 |
Diabetes Mellitus, Type 2 A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY. | 0 | 10.09 | 19 | 0 |
Diabetic Neuropathies Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325) | 1 | 22.27 | 155 | 55 |
Addiction, Opioid [description not available] | 0 | 3.8 | 1 | 1 |
Opioid-Related Disorders Disorders related to or resulting from abuse or misuse of OPIOIDS. | 0 | 3.8 | 1 | 1 |
2019 Novel Coronavirus Disease [description not available] | 0 | 2.82 | 2 | 0 |
Lassitude [description not available] | 0 | 11.77 | 18 | 10 |
Fatigue The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli. | 0 | 11.77 | 18 | 10 |
Emesis [description not available] | 0 | 4.96 | 4 | 2 |
Nausea An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses. | 0 | 13.09 | 27 | 18 |
Vomiting The forcible expulsion of the contents of the STOMACH through the MOUTH. | 0 | 4.96 | 4 | 2 |
Nociceptive Pain Dull or sharp aching pain caused by stimulated NOCICEPTORS due to tissue injury, inflammation or diseases. It can be divided into somatic or tissue pain and VISCERAL PAIN. | 0 | 4.17 | 5 | 0 |
Dysesthesia [description not available] | 0 | 3.23 | 5 | 0 |
Spinal Diseases Diseases involving the SPINE. | 0 | 2.41 | 1 | 0 |
Cauda Equina Syndrome Compressive lesion affecting the nerve roots of the CAUDA EQUINA (e.g., compression, herniation, inflammation, rupture, or stenosis), which controls the function of the bladder and bowel. Symptoms may include neurological dysfunction of bladder or bowels, loss of sexual sensation and altered sensation or paralysis in the lower extremities. | 0 | 2.41 | 1 | 0 |
Erythema Multiforme A skin and mucous membrane disease characterized by an eruption of macules, papules, nodules, vesicles, and/or bullae with characteristic bull's-eye lesions usually occurring on the dorsal aspect of the hands and forearms. | 0 | 2.54 | 2 | 0 |
Leucocythaemia [description not available] | 0 | 2.41 | 1 | 0 |
Leukemia A progressive, malignant disease of the blood-forming organs, characterized by distorted proliferation and development of leukocytes and their precursors in the blood and bone marrow. Leukemias were originally termed acute or chronic based on life expectancy but now are classified according to cellular maturity. Acute leukemias consist of predominately immature cells; chronic leukemias are composed of more mature cells. (From The Merck Manual, 2006) | 0 | 2.41 | 1 | 0 |
Arrhythmia [description not available] | 0 | 4.81 | 2 | 1 |
Coma A profound state of unconsciousness associated with depressed cerebral activity from which the individual cannot be aroused. Coma generally occurs when there is dysfunction or injury involving both cerebral hemispheres or the brain stem RETICULAR FORMATION. | 0 | 2.54 | 2 | 0 |
Blood Pressure, Low [description not available] | 0 | 2.41 | 1 | 0 |
Absence Seizure [description not available] | 0 | 3.59 | 8 | 0 |
Tachyarrhythmia [description not available] | 0 | 3 | 4 | 0 |
Arrhythmias, Cardiac Any disturbances of the normal rhythmic beating of the heart or MYOCARDIAL CONTRACTION. Cardiac arrhythmias can be classified by the abnormalities in HEART RATE, disorders of electrical impulse generation, or impulse conduction. | 0 | 4.81 | 2 | 1 |
Hypotension Abnormally low BLOOD PRESSURE that can result in inadequate blood flow to the brain and other vital organs. Common symptom is DIZZINESS but greater negative impacts on the body occur when there is prolonged depravation of oxygen and nutrients. | 0 | 2.41 | 1 | 0 |
Seizures Clinical or subclinical disturbances of cortical function due to a sudden, abnormal, excessive, and disorganized discharge of brain cells. Clinical manifestations include abnormal motor, sensory and psychic phenomena. Recurrent seizures are usually referred to as EPILEPSY or seizure disorder. | 0 | 3.59 | 8 | 0 |
Tachycardia Abnormally rapid heartbeat, usually with a HEART RATE above 100 beats per minute for adults. Tachycardia accompanied by disturbance in the cardiac depolarization (cardiac arrhythmia) is called tachyarrhythmia. | 0 | 3 | 4 | 0 |
Drug Overdose Accidental or deliberate use of a medication or street drug in excess of normal dosage. | 0 | 3.61 | 8 | 0 |
Anxiety Neuroses [description not available] | 0 | 19.46 | 118 | 62 |
Abdominal Migraine [description not available] | 0 | 6.91 | 9 | 3 |
Anxiety Disorders Persistent and disabling ANXIETY. | 1 | 21.46 | 118 | 62 |
Migraine Disorders A class of disabling primary headache disorders, characterized by recurrent unilateral pulsatile headaches. The two major subtypes are common migraine (without aura) and classic migraine (with aura or neurological symptoms). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1) | 0 | 6.91 | 9 | 3 |
Arthritis, Degenerative [description not available] | 0 | 16.59 | 58 | 30 |
Osteoarthritis A progressive, degenerative joint disease, the most common form of arthritis, especially in older persons. The disease is thought to result not from the aging process but from biochemical changes and biomechanical stresses affecting articular cartilage. In the foreign literature it is often called osteoarthrosis deformans. | 1 | 18.59 | 58 | 30 |
Glaucoma, Angle Closure [description not available] | 0 | 2.66 | 2 | 0 |
Intraocular Pressure The pressure of the fluids in the eye. | 0 | 2.69 | 2 | 0 |
Glaucoma, Angle-Closure A form of glaucoma in which the intraocular pressure increases because the angle of the anterior chamber is blocked and the aqueous humor cannot drain from the anterior chamber. | 0 | 2.66 | 2 | 0 |
Low Back Ache [description not available] | 0 | 16.61 | 61 | 39 |
Cardiovascular Diseases Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM. | 0 | 11.04 | 13 | 6 |
Low Back Pain Acute or chronic pain in the lumbar or sacral regions, which may be associated with musculo-ligamentous SPRAINS AND STRAINS; INTERVERTEBRAL DISK DISPLACEMENT; and other conditions. | 0 | 16.61 | 61 | 39 |
Liver Steatosis [description not available] | 0 | 2.41 | 1 | 0 |
Fatty Liver Lipid infiltration of the hepatic parenchymal cells resulting in a yellow-colored liver. The abnormal lipid accumulation is usually in the form of TRIGLYCERIDES, either as a single large droplet or multiple small droplets. Fatty liver is caused by an imbalance in the metabolism of FATTY ACIDS. | 0 | 2.41 | 1 | 0 |
Diabetes Mellitus A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE. | 0 | 8.16 | 9 | 4 |
Apnea, Obstructive Sleep [description not available] | 0 | 3.8 | 1 | 1 |
Sleep Apnea, Obstructive A disorder characterized by recurrent apneas during sleep despite persistent respiratory efforts. It is due to upper airway obstruction. The respiratory pauses may induce HYPERCAPNIA or HYPOXIA. Cardiac arrhythmias and elevation of systemic and pulmonary arterial pressures may occur. Frequent partial arousals occur throughout sleep, resulting in relative SLEEP DEPRIVATION and daytime tiredness. Associated conditions include OBESITY; ACROMEGALY; MYXEDEMA; micrognathia; MYOTONIC DYSTROPHY; adenotonsilar dystrophy; and NEUROMUSCULAR DISEASES. (From Adams et al., Principles of Neurology, 6th ed, p395) | 0 | 3.8 | 1 | 1 |
Priapism A prolonged painful erection that may lasts hours and is not associated with sexual activity. It is seen in patients with SICKLE CELL ANEMIA, advanced malignancy, spinal trauma; and certain drug treatments. | 0 | 2.6 | 1 | 0 |
Encephalopathy, Traumatic [description not available] | 0 | 2.72 | 2 | 0 |
Cerebral Concussion [description not available] | 0 | 2.41 | 1 | 0 |
Brain Injuries, Traumatic A form of acquired brain injury which occurs when a sudden trauma causes damage to the brain. | 0 | 2.72 | 2 | 0 |
Brain Concussion A nonspecific term used to describe transient alterations or loss of consciousness following closed head injuries. The duration of UNCONSCIOUSNESS generally lasts a few seconds, but may persist for several hours. Concussions may be classified as mild, intermediate, and severe. Prolonged periods of unconsciousness (often defined as greater than 6 hours in duration) may be referred to as post-traumatic coma (COMA, POST-HEAD INJURY). (From Rowland, Merritt's Textbook of Neurology, 9th ed, p418) | 0 | 2.41 | 1 | 0 |
Peripheral Nerve Injury [description not available] | 0 | 3.27 | 5 | 0 |
Constriction, Pathological [description not available] | 0 | 2.6 | 1 | 0 |
Constriction, Pathologic The condition of an anatomical structure's being constricted beyond normal dimensions. | 0 | 2.6 | 1 | 0 |
Peripheral Nerve Injuries Injuries to the PERIPHERAL NERVES. | 0 | 3.27 | 5 | 0 |
Acute Pain Intensely discomforting, distressful, or agonizing sensation associated with trauma or disease, with well-defined location, character, and timing. | 0 | 8.81 | 8 | 5 |
Apoplexy [description not available] | 0 | 9.85 | 17 | 12 |
Stroke A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810) | 0 | 9.85 | 17 | 12 |
Colitis, Mucous [description not available] | 0 | 8.11 | 9 | 6 |
Diarrhea An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight. | 0 | 9.26 | 12 | 9 |
Irritable Bowel Syndrome A disorder with chronic or recurrent colonic symptoms without a clearcut etiology. This condition is characterized by chronic or recurrent ABDOMINAL PAIN, bloating, MUCUS in FECES, and an erratic disturbance of DEFECATION. | 0 | 8.11 | 9 | 6 |
Colicky Pain [description not available] | 0 | 3.78 | 9 | 0 |
Abdominal Pain Sensation of discomfort, distress, or agony in the abdominal region. | 0 | 3.78 | 9 | 0 |
Hypesthesia Absent or reduced sensitivity to cutaneous stimulation. | 0 | 3.8 | 1 | 1 |
Gastric Ulcer [description not available] | 0 | 3.11 | 4 | 0 |
Stomach Ulcer Ulceration of the GASTRIC MUCOSA due to contact with GASTRIC JUICE. It is often associated with HELICOBACTER PYLORI infection or consumption of nonsteroidal anti-inflammatory drugs (NSAIDS). | 0 | 3.11 | 4 | 0 |
Morbid Obesity [description not available] | 0 | 2.6 | 1 | 0 |
Obesity, Morbid The condition of weighing two, three, or more times the ideal weight, so called because it is associated with many serious and life-threatening disorders. In the BODY MASS INDEX, morbid obesity is defined as having a BMI greater than 40.0 kg/m2. | 0 | 2.6 | 1 | 0 |
Sleepiness Compelling urge to sleep. | 0 | 5.02 | 2 | 1 |
Cardiovascular Stroke [description not available] | 0 | 3.78 | 3 | 0 |
Myocardial Infarction NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION). | 0 | 3.78 | 3 | 0 |
Colorectal Cancer [description not available] | 0 | 4.51 | 2 | 2 |
Colorectal Neoplasms Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI. | 1 | 6.51 | 2 | 2 |
Sex Disorders [description not available] | 0 | 8.33 | 11 | 7 |
Urinary Incontinence, Stress Involuntary discharge of URINE as a result of physical activities that increase abdominal pressure on the URINARY BLADDER without detrusor contraction or overdistended bladder. The subtypes are classified by the degree of leakage, descent and opening of the bladder neck and URETHRA without bladder contraction, and sphincter deficiency. | 0 | 24.15 | 358 | 251 |
Sexual Dysfunction, Physiological Physiological disturbances in normal sexual performance in either the male or the female. | 0 | 8.33 | 11 | 7 |
Cough A sudden, audible expulsion of air from the lungs through a partially closed glottis, preceded by inhalation. It is a protective response that serves to clear the trachea, bronchi, and/or lungs of irritants and secretions, or to prevent aspiration of foreign materials into the lungs. | 0 | 9.56 | 2 | 2 |
Apical Ballooning Syndrome [description not available] | 0 | 3.01 | 4 | 0 |
ADDH [description not available] | 0 | 9.13 | 16 | 1 |
Attention Deficit Disorder with Hyperactivity A behavior disorder originating in childhood in which the essential features are signs of developmentally inappropriate inattention, impulsivity, and hyperactivity. Although most individuals have symptoms of both inattention and hyperactivity-impulsivity, one or the other pattern may be predominant. The disorder is more frequent in males than females. Onset is in childhood. Symptoms often attenuate during late adolescence although a minority experience the full complement of symptoms into mid-adulthood. (From DSM-V) | 0 | 9.13 | 16 | 1 |
Takotsubo Cardiomyopathy A transient left ventricular apical dysfunction or ballooning accompanied by electrocardiographic (ECG) T wave inversions. This abnormality is associated with high levels of CATECHOLAMINES, either administered or endogenously secreted from a tumor or during extreme stress. | 0 | 3.01 | 4 | 0 |
Asthma, Bronchial [description not available] | 0 | 2.6 | 1 | 0 |
Asthma A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL). | 0 | 2.6 | 1 | 0 |
Allergic Reaction [description not available] | 0 | 2.6 | 1 | 0 |
Hypersensitivity Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen. | 0 | 2.6 | 1 | 0 |
Hepatocellular Carcinoma [description not available] | 0 | 2.61 | 2 | 0 |
Cancer of Liver [description not available] | 0 | 2.61 | 2 | 0 |
Carcinoma, Hepatocellular A primary malignant neoplasm of epithelial liver cells. It ranges from a well-differentiated tumor with EPITHELIAL CELLS indistinguishable from normal HEPATOCYTES to a poorly differentiated neoplasm. The cells may be uniform or markedly pleomorphic, or form GIANT CELLS. Several classification schemes have been suggested. | 0 | 2.61 | 2 | 0 |
Liver Neoplasms Tumors or cancer of the LIVER. | 0 | 2.61 | 2 | 0 |
Drug Withdrawal Symptoms [description not available] | 0 | 8.19 | 12 | 2 |
Substance Withdrawal Syndrome Physiological and psychological symptoms associated with withdrawal from the use of a drug after prolonged administration or habituation. The concept includes withdrawal from smoking or drinking, as well as withdrawal from an administered drug. | 0 | 8.19 | 12 | 2 |
Canine Diseases [description not available] | 0 | 2.21 | 1 | 0 |
Chemical Dependence [description not available] | 0 | 5.08 | 3 | 1 |
Substance-Related Disorders Disorders related to substance use or abuse. | 0 | 5.08 | 3 | 1 |
Cancer of Lung [description not available] | 0 | 4.29 | 3 | 1 |
Lung Neoplasms Tumors or cancer of the LUNG. | 0 | 4.29 | 3 | 1 |
Idiopathic Parkinson Disease [description not available] | 0 | 7.34 | 8 | 3 |
Parkinson Disease A progressive, degenerative neurologic disease characterized by a TREMOR that is maximal at rest, retropulsion (i.e. a tendency to fall backwards), rigidity, stooped posture, slowness of voluntary movements, and a masklike facial expression. Pathologic features include loss of melanin containing neurons in the substantia nigra and other pigmented nuclei of the brainstem. LEWY BODIES are present in the substantia nigra and locus coeruleus but may also be found in a related condition (LEWY BODY DISEASE, DIFFUSE) characterized by dementia in combination with varying degrees of parkinsonism. (Adams et al., Principles of Neurology, 6th ed, p1059, pp1067-75) | 0 | 7.34 | 8 | 3 |
Preterm Birth [description not available] | 0 | 2.25 | 1 | 0 |
Abnormality, Heart [description not available] | 0 | 2.25 | 1 | 0 |
Delayed Postpartum Hemorrhage [description not available] | 0 | 2.25 | 1 | 0 |
Edema-Proteinuria-Hypertension Gestosis [description not available] | 0 | 2.25 | 1 | 0 |
Complications, Pregnancy [description not available] | 0 | 4.76 | 6 | 0 |
Heart Defects, Congenital Developmental abnormalities involving structures of the heart. These defects are present at birth but may be discovered later in life. | 0 | 2.25 | 1 | 0 |
Postpartum Hemorrhage Excess blood loss from uterine bleeding associated with OBSTETRIC LABOR or CHILDBIRTH. It is defined as blood loss greater than 500 ml or of the amount that adversely affects the maternal physiology, such as BLOOD PRESSURE and HEMATOCRIT. Postpartum hemorrhage is divided into two categories, immediate (within first 24 hours after birth) or delayed (after 24 hours postpartum). | 0 | 2.25 | 1 | 0 |
Infant, Small for Gestational Age An infant having a birth weight lower than expected for its gestational age. | 0 | 2.25 | 1 | 0 |
Pre-Eclampsia A complication of PREGNANCY, characterized by a complex of symptoms including maternal HYPERTENSION and PROTEINURIA with or without pathological EDEMA. Symptoms may range between mild and severe. Pre-eclampsia usually occurs after the 20th week of gestation, but may develop before this time in the presence of trophoblastic disease. | 0 | 2.25 | 1 | 0 |
Premature Birth CHILDBIRTH before 37 weeks of PREGNANCY (259 days from the first day of the mother's last menstrual period, or 245 days after FERTILIZATION). | 0 | 2.25 | 1 | 0 |
Blood Pressure, High [description not available] | 0 | 3.93 | 4 | 0 |
Hypertension Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more. | 0 | 3.93 | 4 | 0 |
Dyskinesia, Medication-Induced [description not available] | 0 | 4.39 | 4 | 1 |
Dyskinesia, Drug-Induced Abnormal movements, including HYPERKINESIS; HYPOKINESIA; TREMOR; and DYSTONIA, associated with the use of certain medications or drugs. Muscles of the face, trunk, neck, and extremities are most commonly affected. Tardive dyskinesia refers to abnormal hyperkinetic movements of the muscles of the face, tongue, and neck associated with the use of neuroleptic agents (see ANTIPSYCHOTIC AGENTS). (Adams et al., Principles of Neurology, 6th ed, p1199) | 0 | 4.39 | 4 | 1 |
Facial Spasm, Unilateral [description not available] | 0 | 2.25 | 1 | 0 |
Psychophysiologic Disorders A group of disorders characterized by physical symptoms that are affected by emotional factors and involve a single organ system, usually under AUTONOMIC NERVOUS SYSTEM control. (American Psychiatric Glossary, 1988) | 0 | 7.87 | 6 | 2 |
Symptom Cluster [description not available] | 0 | 9.39 | 13 | 3 |
Syndrome A characteristic symptom complex. | 0 | 14.39 | 13 | 3 |
Dancing Eyes-Dancing Feet Syndrome [description not available] | 0 | 2.31 | 1 | 0 |
Opsoclonus-Myoclonus Syndrome A neurological condition that is characterized by uncontrolled rapid irregular movements of the eye (OPSOCLONUS) and the muscle (MYOCLONUS) causing unsteady, trembling gait. It is also known as dancing eyes-dancing feet syndrome and is often associated with neoplasms, viral infections, or autoimmune disorders involving the nervous system. | 0 | 2.31 | 1 | 0 |
Cancer of Prostate [description not available] | 0 | 5.07 | 3 | 1 |
Prostatic Neoplasms Tumors or cancer of the PROSTATE. | 0 | 5.07 | 3 | 1 |
Polyneuropathy, Acquired [description not available] | 0 | 6.36 | 4 | 2 |
Polyneuropathies Diseases of multiple peripheral nerves simultaneously. Polyneuropathies usually are characterized by symmetrical, bilateral distal motor and sensory impairment with a graded increase in severity distally. The pathological processes affecting peripheral nerves include degeneration of the axon, myelin or both. The various forms of polyneuropathy are categorized by the type of nerve affected (e.g., sensory, motor, or autonomic), by the distribution of nerve injury (e.g., distal vs. proximal), by nerve component primarily affected (e.g., demyelinating vs. axonal), by etiology, or by pattern of inheritance. | 0 | 6.36 | 4 | 2 |
Hospital-Acquired Condition [description not available] | 0 | 3.47 | 2 | 0 |
Microscopic Colitis [description not available] | 0 | 3.47 | 2 | 0 |
Lymphocytic Colitis [description not available] | 0 | 3.71 | 3 | 0 |
Colitis, Microscopic A condition characterized by chronic watery DIARRHEA of unknown origin, a normal COLONOSCOPY but abnormal histopathology on BIOPSY. This syndrome was first described in 1980 by Read and associates. Subtypes include COLLAGENOUS COLITIS and LYMPHOCYTIC COLITIS. Both have similar clinical symptoms and are distinguishable only by histology. | 0 | 3.47 | 2 | 0 |
Colitis, Lymphocytic A subtype of MICROSCOPIC COLITIS, characterized by chronic watery DIARRHEA of unknown origin, a normal COLONOSCOPY but abnormal histopathology on BIOPSY. Microscopic examination of biopsy samples taken from the COLON show infiltration of LYMPHOCYTES in the superficial EPITHELIUM and the underlying connective tissue (lamina propria). | 0 | 3.71 | 3 | 0 |
Recrudescence [description not available] | 0 | 9.12 | 17 | 4 |
Angiospasm, Intracranial [description not available] | 0 | 2.25 | 1 | 0 |
Alarm Clock Headache [description not available] | 0 | 2.25 | 1 | 0 |
Nasal Catarrh [description not available] | 0 | 2.25 | 1 | 0 |
Hemorrhage, Subarachnoid [description not available] | 0 | 2.25 | 1 | 0 |
Rhinitis Inflammation of the NASAL MUCOSA, the mucous membrane lining the NASAL CAVITIES. | 0 | 2.25 | 1 | 0 |
Subarachnoid Hemorrhage Bleeding into the intracranial or spinal SUBARACHNOID SPACE, most resulting from INTRACRANIAL ANEURYSM rupture. It can occur after traumatic injuries (SUBARACHNOID HEMORRHAGE, TRAUMATIC). Clinical features include HEADACHE; NAUSEA; VOMITING, nuchal rigidity, variable neurological deficits and reduced mental status. | 0 | 2.25 | 1 | 0 |
Vasospasm, Intracranial Constriction of arteries in the SKULL due to sudden, sharp, and often persistent smooth muscle contraction in blood vessels. Intracranial vasospasm results in reduced vessel lumen caliber, restricted blood flow to the brain, and BRAIN ISCHEMIA that may lead to hypoxic-ischemic brain injury (HYPOXIA-ISCHEMIA, BRAIN). | 0 | 2.25 | 1 | 0 |
Postherpetic Neuralgia [description not available] | 0 | 6.71 | 4 | 1 |
Shingles [description not available] | 0 | 4.55 | 1 | 1 |
Herpes Zoster An acute infectious, usually self-limited, disease believed to represent activation of latent varicella-zoster virus (HERPESVIRUS 3, HUMAN) in those who have been rendered partially immune after a previous attack of CHICKENPOX. It involves the SENSORY GANGLIA and their areas of innervation and is characterized by severe neuralgic pain along the distribution of the affected nerve and crops of clustered vesicles over the area. (From Dorland, 27th ed) | 0 | 4.55 | 1 | 1 |
Neuralgia, Postherpetic Pain in nerves, frequently involving facial SKIN, resulting from the activation the latent varicella-zoster virus (HERPESVIRUS 3, HUMAN). The two forms of the condition preceding the pain are HERPES ZOSTER OTICUS; and HERPES ZOSTER OPHTHALMICUS. Following the healing of the rashes and blisters, the pain sometimes persists. | 0 | 6.71 | 4 | 1 |
Postpartum Amenorrhea [description not available] | 0 | 2.86 | 3 | 0 |
Depression, Endogenous [description not available] | 0 | 19.75 | 161 | 13 |
Amenorrhea Absence of menstruation. | 0 | 2.86 | 3 | 0 |
Depressive Disorder An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities. The mood disturbance is prominent and relatively persistent. | 1 | 26.75 | 161 | 13 |
Genetic Diseases, X-Chromosome Linked [description not available] | 0 | 2.31 | 1 | 0 |
Deficiency, Mental [description not available] | 0 | 2.31 | 1 | 0 |
Autosomal Dominant Hereditary Spastic Paraplegia [description not available] | 0 | 2.31 | 1 | 0 |
Intellectual Disability Subnormal intellectual functioning which originates during the developmental period. This has multiple potential etiologies, including genetic defects and perinatal insults. Intelligence quotient (IQ) scores are commonly used to determine whether an individual has an intellectual disability. IQ scores between 70 and 79 are in the borderline range. Scores below 67 are in the disabled range. (from Joynt, Clinical Neurology, 1992, Ch55, p28) | 0 | 2.31 | 1 | 0 |
Spastic Paraplegia, Hereditary A group of inherited diseases that share similar phenotypes but are genetically diverse. Different genetic loci for autosomal recessive, autosomal dominant, and x-linked forms of hereditary spastic paraplegia have been identified. Clinically, patients present with slowly progressive distal limb weakness and lower extremity spasticity. Peripheral sensory neurons may be affected in the later stages of the disease. (J Neurol Neurosurg Psychiatry 1998 Jan;64(1):61-6; Curr Opin Neurol 1997 Aug;10(4):313-8) | 0 | 2.31 | 1 | 0 |
HbS Disease [description not available] | 0 | 2.31 | 1 | 0 |
Anemia, Sickle Cell A disease characterized by chronic hemolytic anemia, episodic painful crises, and pathologic involvement of many organs. It is the clinical expression of homozygosity for hemoglobin S. | 0 | 2.31 | 1 | 0 |
Dystonia An attitude or posture due to the co-contraction of agonists and antagonist muscles in one region of the body. It most often affects the large axial muscles of the trunk and limb girdles. Conditions which feature persistent or recurrent episodes of dystonia as a primary manifestation of disease are referred to as DYSTONIC DISORDERS. (Adams et al., Principles of Neurology, 6th ed, p77) | 0 | 2.31 | 1 | 0 |
Lock Jaw [description not available] | 0 | 2.31 | 1 | 0 |
Seasonal Affective Disorders [description not available] | 0 | 5.55 | 3 | 1 |
Seasonal Affective Disorder A syndrome characterized by depressions that recur annually at the same time each year, usually during the winter months. Other symptoms include anxiety, irritability, decreased energy, increased appetite (carbohydrate cravings), increased duration of sleep, and weight gain. SAD (seasonal affective disorder) can be treated by daily exposure to bright artificial lights (PHOTOTHERAPY), during the season of recurrence. | 0 | 5.55 | 3 | 1 |
Clinically Isolated CNS Demyelinating Syndrome [description not available] | 0 | 2.31 | 1 | 0 |
Demyelinating Diseases Diseases characterized by loss or dysfunction of myelin in the central or peripheral nervous system. | 0 | 2.31 | 1 | 0 |
Cognitive Decline [description not available] | 0 | 2.89 | 3 | 0 |
Nerve Degeneration Loss of functional activity and trophic degeneration of nerve axons and their terminal arborizations following the destruction of their cells of origin or interruption of their continuity with these cells. The pathology is characteristic of neurodegenerative diseases. Often the process of nerve degeneration is studied in research on neuroanatomical localization and correlation of the neurophysiology of neural pathways. | 0 | 2.58 | 2 | 0 |
Cognitive Dysfunction Diminished or impaired mental and/or intellectual function. | 0 | 2.89 | 3 | 0 |
Joint Pain [description not available] | 0 | 10.37 | 13 | 7 |
Arthralgia Pain in the joint. | 0 | 10.37 | 13 | 7 |
Suicidal Ideation A risk factor for suicide attempts and completions, it is the most common of all suicidal behavior, but only a minority of ideators engage in overt self-harm. | 0 | 13.76 | 26 | 22 |
Muscle Pain [description not available] | 0 | 3.98 | 2 | 1 |
Myalgia Painful sensation in the muscles. | 0 | 3.98 | 2 | 1 |
Hypertrophy General increase in bulk of a part or organ due to CELL ENLARGEMENT and accumulation of FLUIDS AND SECRETIONS, not due to tumor formation, nor to an increase in the number of cells (HYPERPLASIA). | 0 | 2.31 | 1 | 0 |
Weight Reduction [description not available] | 0 | 4.18 | 3 | 0 |
Weight Loss Decrease in existing BODY WEIGHT. | 0 | 4.18 | 3 | 0 |
Alloxan Diabetes [description not available] | 0 | 3.9 | 11 | 0 |
Behavior Disorders [description not available] | 0 | 6.67 | 8 | 1 |
Hemisensory Neglect [description not available] | 0 | 2.15 | 1 | 0 |
Mental Disorders Psychiatric illness or diseases manifested by breakdowns in the adaptational process expressed primarily as abnormalities of thought, feeling, and behavior producing either distress or impairment of function. | 0 | 6.67 | 8 | 1 |
Perceptual Disorders Cognitive disorders characterized by an impaired ability to perceive the nature of objects or concepts through use of the sense organs. These include spatial neglect syndromes, where an individual does not attend to visual, auditory, or sensory stimuli presented from one side of the body. | 0 | 2.15 | 1 | 0 |
Hemorrhage, Gingival [description not available] | 0 | 3.06 | 1 | 0 |
Gingival Hemorrhage The flowing of blood from the marginal gingival area, particularly the sulcus, seen in such conditions as GINGIVITIS, marginal PERIODONTITIS, injury, and ASCORBIC ACID DEFICIENCY. | 0 | 3.06 | 1 | 0 |
Conus Medullaris Syndrome [description not available] | 0 | 2.17 | 1 | 0 |
Neuroblastoma A common neoplasm of early childhood arising from neural crest cells in the sympathetic nervous system, and characterized by diverse clinical behavior, ranging from spontaneous remission to rapid metastatic progression and death. This tumor is the most common intraabdominal malignancy of childhood, but it may also arise from thorax, neck, or rarely occur in the central nervous system. Histologic features include uniform round cells with hyperchromatic nuclei arranged in nests and separated by fibrovascular septa. Neuroblastomas may be associated with the opsoclonus-myoclonus syndrome. (From DeVita et al., Cancer: Principles and Practice of Oncology, 5th ed, pp2099-2101; Curr Opin Oncol 1998 Jan;10(1):43-51) | 0 | 2.17 | 1 | 0 |
Behavior Disorder, Rapid Eye Movement Sleep [description not available] | 0 | 2.15 | 1 | 0 |
REM Sleep Behavior Disorder A disorder characterized by episodes of vigorous and often violent motor activity during REM sleep (SLEEP, REM). The affected individual may inflict self injury or harm others, and is difficult to awaken from this condition. Episodes are usually followed by a vivid recollection of a dream that is consistent with the aggressive behavior. This condition primarily affects adult males. (From Adams et al., Principles of Neurology, 6th ed, p393) | 0 | 2.15 | 1 | 0 |
Cacosmia [description not available] | 0 | 2.15 | 1 | 0 |
Dysgeusia A condition characterized by alterations of the sense of taste which may range from mild to severe, including gross distortions of taste quality. | 0 | 2.15 | 1 | 0 |
Serotonin Syndrome An adverse drug interaction characterized by altered mental status, autonomic dysfunction, and neuromuscular abnormalities. It is most frequently caused by use of both serotonin reuptake inhibitors and monoamine oxidase inhibitors, leading to excess serotonin availability in the CNS at the serotonin 1A receptor. | 0 | 5.71 | 18 | 0 |
Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed) | 0 | 6.62 | 10 | 2 |
Atrophic Muscular Disorders [description not available] | 0 | 2.17 | 1 | 0 |
Bewilderment [description not available] | 0 | 2.49 | 2 | 0 |
Dyskinesia Syndromes [description not available] | 0 | 2.58 | 2 | 0 |
Movement Disorders Syndromes which feature DYSKINESIAS as a cardinal manifestation of the disease process. Included in this category are degenerative, hereditary, post-infectious, medication-induced, post-inflammatory, and post-traumatic conditions. | 0 | 2.58 | 2 | 0 |
Infectious Myelitis [description not available] | 0 | 2.17 | 1 | 0 |
Basal Ganglia Diseases Diseases of the BASAL GANGLIA including the PUTAMEN; GLOBUS PALLIDUS; claustrum; AMYGDALA; and CAUDATE NUCLEUS. DYSKINESIAS (most notably involuntary movements and alterations of the rate of movement) represent the primary clinical manifestations of these disorders. Common etiologies include CEREBROVASCULAR DISORDERS; NEURODEGENERATIVE DISEASES; and CRANIOCEREBRAL TRAUMA. | 0 | 2.17 | 1 | 0 |
Disease Exacerbation [description not available] | 0 | 6.22 | 6 | 2 |
Affective Disorders [description not available] | 0 | 5.47 | 6 | 0 |
Mood Disorders Those disorders that have a disturbance in mood as their predominant feature. | 0 | 5.47 | 6 | 0 |
Disc, Herniated [description not available] | 0 | 4.85 | 2 | 1 |
Intervertebral Disc Displacement An INTERVERTEBRAL DISC in which the NUCLEUS PULPOSUS has protruded through surrounding ANNULUS FIBROSUS. This occurs most frequently in the lower lumbar region. | 0 | 4.85 | 2 | 1 |
Injuries, Spinal Cord [description not available] | 0 | 6.42 | 5 | 1 |
Autonomic Hyperreflexia [description not available] | 0 | 2.21 | 1 | 0 |
Spinal Cord Injuries Penetrating and non-penetrating injuries to the spinal cord resulting from traumatic external forces (e.g., WOUNDS, GUNSHOT; WHIPLASH INJURIES; etc.). | 0 | 6.42 | 5 | 1 |
Autonomic Dysreflexia A syndrome associated with damage to the spinal cord above the mid thoracic level (see SPINAL CORD INJURIES) characterized by a marked increase in the sympathetic response to minor stimuli such as bladder or rectal distention. Manifestations include HYPERTENSION; TACHYCARDIA (or reflex bradycardia); FEVER; FLUSHING; and HYPERHIDROSIS. Extreme hypertension may be associated with a STROKE. (From Adams et al., Principles of Neurology, 6th ed, pp538 and 1232; J Spinal Cord Med 1997;20(3):355-60) | 0 | 2.21 | 1 | 0 |
Carcinoma, Ehrlich Tumor A transplantable, poorly differentiated malignant tumor which appeared originally as a spontaneous breast carcinoma in a mouse. It grows in both solid and ascitic forms. | 0 | 2.17 | 1 | 0 |
Benign Neoplasms, Brain [description not available] | 0 | 3.71 | 3 | 0 |
Glial Cell Tumors [description not available] | 0 | 2.17 | 1 | 0 |
Brain Neoplasms Neoplasms of the intracranial components of the central nervous system, including the cerebral hemispheres, basal ganglia, hypothalamus, thalamus, brain stem, and cerebellum. Brain neoplasms are subdivided into primary (originating from brain tissue) and secondary (i.e., metastatic) forms. Primary neoplasms are subdivided into benign and malignant forms. In general, brain tumors may also be classified by age of onset, histologic type, or presenting location in the brain. | 0 | 3.71 | 3 | 0 |
Glioma Benign and malignant central nervous system neoplasms derived from glial cells (i.e., astrocytes, oligodendrocytes, and ependymocytes). Astrocytes may give rise to astrocytomas (ASTROCYTOMA) or glioblastoma multiforme (see GLIOBLASTOMA). Oligodendrocytes give rise to oligodendrogliomas (OLIGODENDROGLIOMA) and ependymocytes may undergo transformation to become EPENDYMOMA; CHOROID PLEXUS NEOPLASMS; or colloid cysts of the third ventricle. (From Escourolle et al., Manual of Basic Neuropathology, 2nd ed, p21) | 0 | 2.17 | 1 | 0 |
Pain, Intractable Persistent pain that is refractory to some or all forms of treatment. | 0 | 2.57 | 2 | 0 |
Carcinoma, Small Cell Lung [description not available] | 0 | 2.17 | 1 | 0 |
Ataxia Impairment of the ability to perform smoothly coordinated voluntary movements. This condition may affect the limbs, trunk, eyes, pharynx, larynx, and other structures. Ataxia may result from impaired sensory or motor function. Sensory ataxia may result from posterior column injury or PERIPHERAL NERVE DISEASES. Motor ataxia may be associated with CEREBELLAR DISEASES; CEREBRAL CORTEX diseases; THALAMIC DISEASES; BASAL GANGLIA DISEASES; injury to the RED NUCLEUS; and other conditions. | 0 | 2.17 | 1 | 0 |
Paraneoplastic Syndromes In patients with neoplastic diseases a wide variety of clinical pictures which are indirect and usually remote effects produced by tumor cell metabolites or other products. | 0 | 2.17 | 1 | 0 |
Neuropathy, Paraneoplastic [description not available] | 0 | 2.17 | 1 | 0 |
Small Cell Lung Carcinoma A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA). | 0 | 2.17 | 1 | 0 |
Colonic Inertia Symptom characterized by the passage of stool once a week or less. | 0 | 6.69 | 5 | 4 |
Constipation Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections. | 0 | 6.69 | 5 | 4 |
Tardive Dystonia [description not available] | 0 | 2.17 | 1 | 0 |
Tardive Dyskinesia Drug-related movement disorder characterized by uncontrollable movements in certain muscles. It is associated with a long-term exposure to certain neuroleptic medications (e.g., METOCLOPRAMIDE). | 0 | 2.17 | 1 | 0 |
Delirium of Mixed Origin [description not available] | 0 | 3.73 | 3 | 0 |
Delirium A disorder characterized by CONFUSION; inattentiveness; disorientation; ILLUSIONS; HALLUCINATIONS; agitation; and in some instances autonomic nervous system overactivity. It may result from toxic/metabolic conditions or structural brain lesions. (From Adams et al., Principles of Neurology, 6th ed, pp411-2) | 0 | 3.73 | 3 | 0 |
Bone Fractures [description not available] | 0 | 2.21 | 1 | 0 |
Fractures, Bone Breaks in bones. | 0 | 2.21 | 1 | 0 |
Pain, Procedural Pain associated with examination, treatment or procedures. | 0 | 3.59 | 1 | 1 |
Burns Injuries to tissues caused by contact with heat, steam, chemicals (BURNS, CHEMICAL), electricity (BURNS, ELECTRIC), or the like. | 0 | 3.94 | 2 | 1 |
Hiccough [description not available] | 0 | 2.17 | 1 | 0 |
Cerebral Ischemia [description not available] | 0 | 2.8 | 3 | 0 |
Injury, Ischemia-Reperfusion [description not available] | 0 | 2.57 | 2 | 0 |
Brain Ischemia Localized reduction of blood flow to brain tissue due to arterial obstruction or systemic hypoperfusion. This frequently occurs in conjunction with brain hypoxia (HYPOXIA, BRAIN). Prolonged ischemia is associated with BRAIN INFARCTION. | 0 | 2.8 | 3 | 0 |
Reperfusion Injury Adverse functional, metabolic, or structural changes in tissues that result from the restoration of blood flow to the tissue (REPERFUSION) following ISCHEMIA. | 0 | 2.57 | 2 | 0 |
Aura [description not available] | 0 | 2.21 | 1 | 0 |
Epilepsy A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313) | 0 | 2.21 | 1 | 0 |
Prurigo A name applied to several itchy skin eruptions of unknown cause. The characteristic course is the formation of a dome-shaped papule with a small transient vesicle on top, followed by crusting over or lichenification. (From Dorland, 27th ed) | 0 | 7.21 | 1 | 0 |
Sudden Unexpected Death in Epilepsy Sudden death in a patient with EPILEPSY associated with SEIZURES and seizure-related symptoms (e.g., APNEA; HYPOXEMIA) without other identifiable accidental causes (e.g., DROWNING; WOUNDS AND INJURIES). | 0 | 2.21 | 1 | 0 |
Chronic Infantile Neurologic, Cutaneous, and Articular Syndrome [description not available] | 0 | 2.21 | 1 | 0 |
Cryopyrin-Associated Periodic Syndromes A group of rare autosomal dominant diseases, commonly characterized by atypical URTICARIA (hives) with systemic symptoms that develop into end-organ damage. The atypical hives do not involve T-cell or autoantibody. Cryopyrin-associated periodic syndrome includes three previously distinct disorders: Familial cold autoinflammatory syndrome; Muckle-Wells Syndrome; and CINCA Syndrome, that are now considered to represent a disease continuum, all caused by NLRP3 PROTEIN mutations. | 0 | 2.21 | 1 | 0 |
Asialia [description not available] | 0 | 5.97 | 3 | 3 |
Xerostomia Decreased salivary flow. | 0 | 5.97 | 3 | 3 |
Hypomenorrhea [description not available] | 0 | 2.21 | 1 | 0 |
Rheumatism [description not available] | 0 | 3.45 | 2 | 0 |
Rheumatic Diseases Disorders of connective tissue, especially the joints and related structures, characterized by inflammation, degeneration, or metabolic derangement. | 0 | 3.45 | 2 | 0 |
Benign Neonatal Sleep Myoclonus [description not available] | 0 | 2.21 | 1 | 0 |
Age-Related Osteoporosis [description not available] | 0 | 2.21 | 1 | 0 |
Osteoporosis Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis. | 0 | 2.21 | 1 | 0 |
Frigidity [description not available] | 0 | 6.42 | 8 | 2 |
Sexual Dysfunctions, Psychological Disturbances in sexual desire and the psychophysiologic changes that characterize the sexual response cycle and cause marked distress and interpersonal difficulty. (APA, DSM-IV, 1994) | 0 | 6.42 | 8 | 2 |
Curling Ulcer Acute stress DUODENAL ULCER, usually observed in patients with extensive third-degree burns. | 0 | 2.21 | 1 | 0 |
Hematochezia The passage of bright red blood from the rectum. The blood may or may not be mixed with formed stool in the form of blood, blood clots, bloody stool or diarrhea. | 0 | 2.21 | 1 | 0 |
Melena The black, tarry, foul-smelling FECES that contain degraded blood. | 0 | 2.21 | 1 | 0 |
Duodenal Ulcer A PEPTIC ULCER located in the DUODENUM. | 0 | 2.21 | 1 | 0 |
Gastrointestinal Hemorrhage Bleeding in any segment of the GASTROINTESTINAL TRACT from ESOPHAGUS to RECTUM. | 0 | 2.21 | 1 | 0 |
Diabetic Retinopathy Disease of the RETINA as a complication of DIABETES MELLITUS. It is characterized by the progressive microvascular complications, such as ANEURYSM, interretinal EDEMA, and intraocular PATHOLOGIC NEOVASCULARIZATION. | 0 | 2.21 | 1 | 0 |
Late Onset Diseases [description not available] | 0 | 3.12 | 1 | 0 |
Ileitis Inflammation of any segment of the ILEUM and the ILEOCECAL VALVE. | 0 | 2.07 | 1 | 0 |
Collagenous Colitis [description not available] | 0 | 2.07 | 1 | 0 |
Colitis, Collagenous A subtype of MICROSCOPIC COLITIS, characterized by chronic watery DIARRHEA of unknown origin, a normal COLONOSCOPY but abnormal histopathology on BIOPSY. Microscopic examination of biopsy samples taken from the COLON show larger-than-normal band of subepithelial COLLAGEN. | 0 | 2.07 | 1 | 0 |
Arrhythmia, Sinoatrial [description not available] | 0 | 2.08 | 1 | 0 |
Electrocardiogram QT Prolonged [description not available] | 0 | 3.67 | 3 | 0 |
Long QT Syndrome A condition that is characterized by episodes of fainting (SYNCOPE) and varying degree of ventricular arrhythmia as indicated by the prolonged QT interval. The inherited forms are caused by mutation of genes encoding cardiac ion channel proteins. The two major forms are ROMANO-WARD SYNDROME and JERVELL-LANGE NIELSEN SYNDROME. | 0 | 3.67 | 3 | 0 |
Angioma A vascular anomaly due to proliferation of blood or lymphatic vessels that forms a tumor-like mass. Vessels in the angioma may or may not be dilated. | 0 | 3 | 1 | 0 |
Muscle Spasm [description not available] | 0 | 3 | 1 | 0 |
Hemangioma A vascular anomaly due to proliferation of BLOOD VESSELS that forms a tumor-like mass. The common types involve CAPILLARIES and VEINS. It can occur anywhere in the body but is most frequently noticed in the SKIN and SUBCUTANEOUS TISSUE. (from Stedman, 27th ed, 2000) | 0 | 3 | 1 | 0 |
Spasm An involuntary contraction of a muscle or group of muscles. Spasms may involve SKELETAL MUSCLE or SMOOTH MUSCLE. | 0 | 3 | 1 | 0 |
Abortion, Tubal [description not available] | 0 | 2.49 | 2 | 0 |
Abortion, Spontaneous Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference. | 0 | 2.49 | 2 | 0 |
Uterine Rupture A complete separation or tear in the wall of the UTERUS with or without expulsion of the FETUS. It may be due to injuries, multiple pregnancies, large fetus, previous scarring, or obstruction. | 0 | 2.08 | 1 | 0 |
HIV Coinfection [description not available] | 0 | 4.78 | 2 | 1 |
HIV Infections Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS). | 0 | 4.78 | 2 | 1 |
Urinary Retention Inability to empty the URINARY BLADDER with voiding (URINATION). | 0 | 2.48 | 2 | 0 |
Drop Attack [description not available] | 0 | 2.46 | 2 | 0 |
Syncope A transient loss of consciousness and postural tone caused by diminished blood flow to the brain (i.e., BRAIN ISCHEMIA). Presyncope refers to the sensation of lightheadedness and loss of strength that precedes a syncopal event or accompanies an incomplete syncope. (From Adams et al., Principles of Neurology, 6th ed, pp367-9) | 0 | 2.46 | 2 | 0 |
Dizzyness [description not available] | 0 | 6.07 | 6 | 5 |
Dizziness An imprecise term which may refer to a sense of spatial disorientation, motion of the environment, or lightheadedness. | 0 | 6.07 | 6 | 5 |
Menopause The last menstrual period. Permanent cessation of menses (MENSTRUATION) is usually defined after 6 to 12 months of AMENORRHEA in a woman over 45 years of age. In the United States, menopause generally occurs in women between 48 and 55 years of age. | 0 | 5.98 | 3 | 1 |
Hot Flashes A sudden, temporary sensation of heat predominantly experienced by some women during MENOPAUSE. (Random House Unabridged Dictionary, 2d ed) | 0 | 5.99 | 3 | 3 |
Hypothermia, Accidental [description not available] | 0 | 2.08 | 1 | 0 |
Hypothermia Lower than normal body temperature, especially in warm-blooded animals. | 0 | 2.08 | 1 | 0 |
Affective Psychosis, Bipolar [description not available] | 0 | 6.92 | 11 | 1 |
Agitation, Psychomotor [description not available] | 0 | 3.89 | 2 | 1 |
Atrioventricular Nodal Re-Entrant Tachycardia [description not available] | 0 | 2.08 | 1 | 0 |
Anesthesia A state characterized by loss of feeling or sensation. This depression of nerve function is usually the result of pharmacologic action and is induced to allow performance of surgery or other painful procedures. | 0 | 2.96 | 4 | 0 |
Bipolar Disorder A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence. | 0 | 6.92 | 11 | 1 |
Psychomotor Agitation A feeling of restlessness associated with increased motor activity. This may occur as a manifestation of nervous system drug toxicity or other conditions. | 0 | 3.89 | 2 | 1 |
Tachycardia, Ventricular An abnormally rapid ventricular rhythm usually in excess of 150 beats per minute. It is generated within the ventricle below the BUNDLE OF HIS, either as autonomic impulse formation or reentrant impulse conduction. Depending on the etiology, onset of ventricular tachycardia can be paroxysmal (sudden) or nonparoxysmal, its wide QRS complexes can be uniform or polymorphic, and the ventricular beating may be independent of the atrial beating (AV dissociation). | 0 | 2.08 | 1 | 0 |
Acute Disease Disease having a short and relatively severe course. | 0 | 6.2 | 7 | 1 |
Anankastic Personality [description not available] | 0 | 7.46 | 6 | 3 |
Obsessive-Compulsive Disorder An anxiety disorder characterized by recurrent, persistent obsessions or compulsions. Obsessions are the intrusive ideas, thoughts, or images that are experienced as senseless or repugnant. Compulsions are repetitive and seemingly purposeful behavior which the individual generally recognizes as senseless and from which the individual does not derive pleasure although it may provide a release from tension. | 0 | 7.46 | 6 | 3 |
Pyrexia [description not available] | 0 | 2.08 | 1 | 0 |
Complication, Postoperative [description not available] | 0 | 6.66 | 7 | 3 |
Fever An abnormal elevation of body temperature, usually as a result of a pathologic process. | 0 | 2.08 | 1 | 0 |
Postoperative Complications Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery. | 0 | 6.66 | 7 | 3 |
Ankylosing Spondylarthritis [description not available] | 0 | 3.47 | 1 | 1 |
Spondylitis, Ankylosing A chronic inflammatory condition affecting the axial joints, such as the SACROILIAC JOINT and other intervertebral or costovertebral joints. It occurs predominantly in young males and is characterized by pain and stiffness of joints (ANKYLOSIS) with inflammation at tendon insertions. | 0 | 3.47 | 1 | 1 |
Malignant Melanoma [description not available] | 0 | 3.01 | 1 | 0 |
Infection, Postoperative Wound [description not available] | 0 | 3.01 | 1 | 0 |
Melanoma A malignant neoplasm derived from cells that are capable of forming melanin, which may occur in the skin of any part of the body, in the eye, or, rarely, in the mucous membranes of the genitalia, anus, oral cavity, or other sites. It occurs mostly in adults and may originate de novo or from a pigmented nevus or malignant lentigo. Melanomas frequently metastasize widely, and the regional lymph nodes, liver, lungs, and brain are likely to be involved. The incidence of malignant skin melanomas is rising rapidly in all parts of the world. (Stedman, 25th ed; from Rook et al., Textbook of Dermatology, 4th ed, p2445) | 0 | 3.01 | 1 | 0 |
Respiratory Tract Diseases Diseases involving the RESPIRATORY SYSTEM. | 0 | 3.01 | 1 | 0 |
Bladder Diseases [description not available] | 0 | 3.36 | 2 | 0 |
Muscle Contraction A process leading to shortening and/or development of tension in muscle tissue. Muscle contraction occurs by a sliding filament mechanism whereby actin filaments slide inward among the myosin filaments. | 0 | 6.4 | 8 | 2 |
Restless Leg Syndrome [description not available] | 0 | 2.5 | 2 | 0 |
Restless Legs Syndrome A disorder characterized by aching or burning sensations in the lower and rarely the upper extremities that occur prior to sleep or may awaken the patient from sleep. | 0 | 2.5 | 2 | 0 |
Autoimmune Diabetes [description not available] | 0 | 9.52 | 15 | 0 |
Palmoplantaris Pustulosis [description not available] | 0 | 2.77 | 3 | 0 |
Diabetes Mellitus, Type 1 A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence. | 0 | 9.52 | 15 | 0 |
Psoriasis A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis. | 0 | 2.77 | 3 | 0 |
Genetic Predisposition [description not available] | 0 | 2.08 | 1 | 0 |
Dysarthosis [description not available] | 0 | 2.08 | 1 | 0 |
External Ophthalmoplegia [description not available] | 0 | 2.08 | 1 | 0 |
Charcot-Marie-Tooth Disease, Demyelinating, Type 4f [description not available] | 0 | 2.08 | 1 | 0 |
MS (Multiple Sclerosis) [description not available] | 0 | 3.48 | 1 | 1 |
Multiple Sclerosis An autoimmune disorder mainly affecting young adults and characterized by destruction of myelin in the central nervous system. Pathologic findings include multiple sharply demarcated areas of demyelination throughout the white matter of the central nervous system. Clinical manifestations include visual loss, extra-ocular movement disorders, paresthesias, loss of sensation, weakness, dysarthria, spasticity, ataxia, and bladder dysfunction. The usual pattern is one of recurrent attacks followed by partial recovery (see MULTIPLE SCLEROSIS, RELAPSING-REMITTING), but acute fulminating and chronic progressive forms (see MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE) also occur. (Adams et al., Principles of Neurology, 6th ed, p903) | 1 | 5.48 | 1 | 1 |
Weight Gain Increase in BODY WEIGHT over existing weight. | 0 | 6.21 | 4 | 3 |
Anterior Urethral Stricture [description not available] | 0 | 2.08 | 1 | 0 |
Urethral Stricture Narrowing of any part of the URETHRA. It is characterized by decreased urinary stream and often other obstructive voiding symptoms. | 0 | 2.08 | 1 | 0 |
Acute Bacterial Prostatitis [description not available] | 0 | 4.47 | 2 | 2 |
Prostatitis Infiltration of inflammatory cells into the parenchyma of PROSTATE. The subtypes are classified by their varied laboratory analysis, clinical presentation and response to treatment. | 0 | 9.47 | 2 | 2 |
Bilateral Headache [description not available] | 0 | 7.54 | 5 | 4 |
Headache The symptom of PAIN in the cranial region. It may be an isolated benign occurrence or manifestation of a wide variety of HEADACHE DISORDERS. | 0 | 7.54 | 5 | 4 |
Morphine Abuse [description not available] | 0 | 2.1 | 1 | 0 |
Morphine Dependence Strong dependence, both physiological and emotional, upon morphine. | 0 | 2.1 | 1 | 0 |
Age-Related Memory Disorders [description not available] | 0 | 2.51 | 2 | 0 |
Memory Disorders Disturbances in registering an impression, in the retention of an acquired impression, or in the recall of an impression. Memory impairments are associated with DEMENTIA; CRANIOCEREBRAL TRAUMA; ENCEPHALITIS; ALCOHOLISM (see also ALCOHOL AMNESTIC DISORDER); SCHIZOPHRENIA; and other conditions. | 0 | 2.51 | 2 | 0 |
Acne Inversa [description not available] | 0 | 3 | 1 | 0 |
Hidradenitis Suppurativa A chronic suppurative and cicatricial disease of the apocrine glands occurring chiefly in the axillae in women and in the groin and anal regions in men. It is characterized by poral occlusion with secondary bacterial infection, evolving into abscesses which eventually rupture. As the disease becomes chronic, ulcers appear, sinus tracts enlarge, fistulas develop, and fibrosis and scarring become evident. | 0 | 3 | 1 | 0 |
Arteriosclerosis, Coronary [description not available] | 0 | 2.49 | 2 | 0 |
Cardiac Hypertrophy Enlargement of the HEART due to chamber HYPERTROPHY, an increase in wall thickness without an increase in the number of cells (MYOCYTES, CARDIAC). It is the result of increase in myocyte size, mitochondrial and myofibrillar mass, as well as changes in extracellular matrix. | 0 | 2.1 | 1 | 0 |
Edema, Pulmonary [description not available] | 0 | 2.1 | 1 | 0 |
Coronary Artery Disease Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause. | 0 | 2.49 | 2 | 0 |
Cardiomegaly Enlargement of the HEART, usually indicated by a cardiothoracic ratio above 0.50. Heart enlargement may involve the right, the left, or both HEART VENTRICLES or HEART ATRIA. Cardiomegaly is a nonspecific symptom seen in patients with chronic systolic heart failure (HEART FAILURE) or several forms of CARDIOMYOPATHIES. | 0 | 2.1 | 1 | 0 |
Pulmonary Edema Excessive accumulation of extravascular fluid in the lung, an indication of a serious underlying disease or disorder. Pulmonary edema prevents efficient PULMONARY GAS EXCHANGE in the PULMONARY ALVEOLI, and can be life-threatening. | 0 | 2.1 | 1 | 0 |
Cranial Nerve V Injury [description not available] | 0 | 3.01 | 1 | 0 |
Epileptiform Neuralgia [description not available] | 0 | 3.4 | 2 | 0 |
Trigeminal Neuralgia A syndrome characterized by recurrent episodes of excruciating pain lasting several seconds or longer in the sensory distribution of the TRIGEMINAL NERVE. Pain may be initiated by stimulation of trigger points on the face, lips, or gums or by movement of facial muscles or chewing. Associated conditions include MULTIPLE SCLEROSIS, vascular anomalies, ANEURYSMS, and neoplasms. (Adams et al., Principles of Neurology, 6th ed, p187) | 0 | 3.4 | 2 | 0 |
Hyperplasia, Reactive Lymphoid [description not available] | 0 | 2.1 | 1 | 0 |
Dermatoses [description not available] | 0 | 2.1 | 1 | 0 |
Skin Diseases Diseases involving the DERMIS or EPIDERMIS. | 0 | 2.1 | 1 | 0 |
Amentia [description not available] | 0 | 2.1 | 1 | 0 |
Dementia An acquired organic mental disorder with loss of intellectual abilities of sufficient severity to interfere with social or occupational functioning. The dysfunction is multifaceted and involves memory, behavior, personality, judgment, attention, spatial relations, language, abstract thought, and other executive functions. The intellectual decline is usually progressive, and initially spares the level of consciousness. | 0 | 2.1 | 1 | 0 |
Pelvic Pain Pain in the pelvic region of genital and non-genital origin. | 0 | 8.91 | 2 | 1 |
Anorexia Nervosa An eating disorder that is characterized by the lack or loss of APPETITE, known as ANOREXIA. Other features include excess fear of becoming OVERWEIGHT; BODY IMAGE disturbance; significant WEIGHT LOSS; refusal to maintain minimal normal weight; and AMENORRHEA. This disorder occurs most frequently in adolescent females. (APA, Thesaurus of Psychological Index Terms, 1994) | 0 | 2.49 | 2 | 0 |
Psychoses [description not available] | 0 | 4.7 | 6 | 1 |
Psychotic Disorders Disorders in which there is a loss of ego boundaries or a gross impairment in reality testing with delusions or prominent hallucinations. (From DSM-IV, 1994) | 0 | 4.7 | 6 | 1 |
Hepatitis INFLAMMATION of the LIVER. | 0 | 3.01 | 1 | 0 |
Long Sleeper Syndrome [description not available] | 0 | 9.09 | 9 | 4 |
Briquet Syndrome [description not available] | 0 | 9.75 | 20 | 3 |
Sleep Wake Disorders Abnormal sleep-wake schedule or pattern associated with the CIRCADIAN RHYTHM which affect the length, timing, and/or rigidity of the sleep-wake cycle relative to the day-night cycle. | 0 | 9.09 | 9 | 4 |
Somatoform Disorders Disorders having the presence of physical symptoms that suggest a general medical condition but that are not fully explained by another medical condition, by the direct effects of a substance, or by another mental disorder. The MEDICALLY UNEXPLAINED SYMPTOMS must cause clinically significant distress or impairment in social, occupational, or other areas of functioning. In contrast to FACTITIOUS DISORDERS and MALINGERING, the physical symptoms are not under voluntary control. (APA, DSM-V) | 0 | 9.75 | 20 | 3 |
Alcohol Drinking Behaviors associated with the ingesting of ALCOHOLIC BEVERAGES, including social drinking. | 0 | 3.69 | 3 | 0 |
Complication, Intraoperative [description not available] | 0 | 2.11 | 1 | 0 |
Iris Diseases Diseases, dysfunctions, or disorders of or located in the iris. | 0 | 2.11 | 1 | 0 |
Allergic Cutaneous Angiitis [description not available] | 0 | 2.11 | 1 | 0 |
Dermatitis Medicamentosa [description not available] | 0 | 2.47 | 2 | 0 |
Central Hypothyroidism [description not available] | 0 | 2.11 | 1 | 0 |
Algodystrophic Syndrome [description not available] | 0 | 2.11 | 1 | 0 |
Hypothyroidism A syndrome that results from abnormally low secretion of THYROID HORMONES from the THYROID GLAND, leading to a decrease in BASAL METABOLIC RATE. In its most severe form, there is accumulation of MUCOPOLYSACCHARIDES in the SKIN and EDEMA, known as MYXEDEMA. It may be primary or secondary due to other pituitary disease, or hypothalamic dysfunction. | 0 | 2.11 | 1 | 0 |
Reflex Sympathetic Dystrophy A syndrome characterized by severe burning pain in an extremity accompanied by sudomotor, vasomotor, and trophic changes in bone without an associated specific nerve injury. This condition is most often precipitated by trauma to soft tissue or nerve complexes. The skin over the affected region is usually erythematous and demonstrates hypersensitivity to tactile stimuli and erythema. (Adams et al., Principles of Neurology, 6th ed, p1360; Pain 1995 Oct;63(1):127-33) | 0 | 2.11 | 1 | 0 |
Cancer of Ovary [description not available] | 0 | 2.11 | 1 | 0 |
Ovarian Neoplasms Tumors or cancer of the OVARY. These neoplasms can be benign or malignant. They are classified according to the tissue of origin, such as the surface EPITHELIUM, the stromal endocrine cells, and the totipotent GERM CELLS. | 0 | 2.11 | 1 | 0 |
Ejaculatio Praecox [description not available] | 0 | 3.5 | 1 | 1 |
Premature Ejaculation The emission of SEMEN and seminal fluid during the act of preparation for sexual intercourse, i.e. before there is penetration, or shortly after penetration. | 0 | 3.5 | 1 | 1 |
Chronic Insomnia [description not available] | 0 | 8.51 | 7 | 3 |
Sleep Initiation and Maintenance Disorders Disorders characterized by impairment of the ability to initiate or maintain sleep. This may occur as a primary disorder or in association with another medical or psychiatric condition. | 0 | 8.51 | 7 | 3 |
Hyperidrosis [description not available] | 0 | 4.31 | 2 | 0 |
Hyperhidrosis Excessive sweating. In the localized type, the most frequent sites are the palms, soles, axillae, inguinal folds, and the perineal area. Its chief cause is thought to be emotional. Generalized hyperhidrosis may be induced by a hot, humid environment, by fever, or by vigorous exercise. | 0 | 4.31 | 2 | 0 |
Adjuvant Arthritis [description not available] | 0 | 2.49 | 2 | 0 |
Cognition Disorders Disorders characterized by disturbances in mental processes related to learning, thinking, reasoning, and judgment. | 0 | 11.79 | 17 | 6 |
Anterior Choroidal Artery Infarction [description not available] | 0 | 2.11 | 1 | 0 |
Sneezing The sudden, forceful, involuntary expulsion of air from the NOSE and MOUTH caused by irritation to the MUCOUS MEMBRANES of the upper RESPIRATORY TRACT. | 0 | 2.76 | 3 | 0 |
Cerebral Infarction The formation of an area of NECROSIS in the CEREBRUM caused by an insufficiency of arterial or venous blood flow. Infarcts of the cerebrum are generally classified by hemisphere (i.e., left vs. right), lobe (e.g., frontal lobe infarction), arterial distribution (e.g., INFARCTION, ANTERIOR CEREBRAL ARTERY), and etiology (e.g., embolic infarction). | 0 | 2.11 | 1 | 0 |
Post-Dural Puncture Headache A secondary headache disorder attributed to low CEREBROSPINAL FLUID pressure caused by SPINAL PUNCTURE, usually after dural or lumbar puncture. | 0 | 2.11 | 1 | 0 |
Neuralgia, Sciatic [description not available] | 0 | 2.11 | 1 | 0 |
Sciatica A condition characterized by pain radiating from the back into the buttock and posterior/lateral aspects of the leg. Sciatica may be a manifestation of SCIATIC NEUROPATHY; RADICULOPATHY (involving the SPINAL NERVE ROOTS; L4, L5, S1, or S2, often associated with INTERVERTEBRAL DISK DISPLACEMENT); or lesions of the CAUDA EQUINA. | 0 | 2.11 | 1 | 0 |
Spinal Stenosis Narrowing of the spinal canal. | 0 | 2.11 | 1 | 0 |
Deficiency Diseases A condition produced by dietary or metabolic deficiency. The term includes all diseases caused by an insufficient supply of essential nutrients, i.e., protein (or amino acids), vitamins, and minerals. It also includes an inadequacy of calories. (From Dorland, 27th ed; Stedman, 25th ed) | 0 | 3.03 | 1 | 0 |
Mucositis, Oral [description not available] | 0 | 2.11 | 1 | 0 |
Stomatitis INFLAMMATION of the soft tissues of the MOUTH, such as MUCOSA; PALATE; GINGIVA; and LIP. | 0 | 2.11 | 1 | 0 |
Polydipsia Excessive thirst manifested by excessive fluid intake. It is characteristic of many diseases such as DIABETES MELLITUS; DIABETES INSIPIDUS; and NEPHROGENIC DIABETES INSIPIDUS. The condition may be psychogenic in origin. | 0 | 2.11 | 1 | 0 |
Acute Kidney Failure [description not available] | 0 | 3.94 | 1 | 0 |
Acute Kidney Injury Abrupt reduction in kidney function. Acute kidney injury encompasses the entire spectrum of the syndrome including acute kidney failure; ACUTE KIDNEY TUBULAR NECROSIS; and other less severe conditions. | 0 | 3.94 | 1 | 0 |
Chromosome-Defective Micronuclei [description not available] | 0 | 2.11 | 1 | 0 |
Daytime Sleepiness [description not available] | 0 | 6.46 | 3 | 3 |
Nasopharyngitis Inflammation of the NASOPHARYNX, usually including its mucosa, related lymphoid structure, and glands. | 0 | 4.41 | 1 | 1 |
Disorders of Excessive Somnolence Disorders characterized by hypersomnolence during normal waking hours that may impair cognitive functioning. Subtypes include primary hypersomnia disorders (e.g., IDIOPATHIC HYPERSOMNOLENCE; NARCOLEPSY; and KLEINE-LEVIN SYNDROME) and secondary hypersomnia disorders where excessive somnolence can be attributed to a known cause (e.g., drug affect, MENTAL DISORDERS, and SLEEP APNEA SYNDROME). (From J Neurol Sci 1998 Jan 8;153(2):192-202; Thorpy, Principles and Practice of Sleep Medicine, 2nd ed, p320) | 0 | 6.46 | 3 | 3 |
Visceral Pain Pain originating from internal organs (VISCERA) associated with autonomic phenomena (PALLOR; SWEATING; NAUSEA; and VOMITING). It often becomes a REFERRED PAIN. | 0 | 2.11 | 1 | 0 |
Anterior Optic Neuritis [description not available] | 0 | 2.13 | 1 | 0 |
Optic Neuritis Inflammation of the optic nerve. Commonly associated conditions include autoimmune disorders such as MULTIPLE SCLEROSIS, infections, and granulomatous diseases. Clinical features include retro-orbital pain that is aggravated by eye movement, loss of color vision, and contrast sensitivity that may progress to severe visual loss, an afferent pupillary defect (Marcus-Gunn pupil), and in some instances optic disc hyperemia and swelling. Inflammation may occur in the portion of the nerve within the globe (neuropapillitis or anterior optic neuritis) or the portion behind the globe (retrobulbar neuritis or posterior optic neuritis). | 0 | 2.13 | 1 | 0 |
Degenerative Disc Disease [description not available] | 0 | 2.13 | 1 | 0 |
Nerve Root Avulsion [description not available] | 0 | 2.13 | 1 | 0 |
Radiculopathy Disease involving a spinal nerve root (see SPINAL NERVE ROOTS) which may result from compression related to INTERVERTEBRAL DISK DISPLACEMENT; SPINAL CORD INJURIES; SPINAL DISEASES; and other conditions. Clinical manifestations include radicular pain, weakness, and sensory loss referable to structures innervated by the involved nerve root. | 0 | 2.13 | 1 | 0 |
Intervertebral Disc Degeneration Degenerative changes in the INTERVERTEBRAL DISC due to aging or structural damage, especially to the vertebral end-plates. | 0 | 2.13 | 1 | 0 |
Cancer of Gastrointestinal Tract [description not available] | 0 | 3.06 | 1 | 0 |
Alcohol Abuse [description not available] | 0 | 2.13 | 1 | 0 |
Alcoholism A primary, chronic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. The disease is often progressive and fatal. It is characterized by impaired control over drinking, preoccupation with the drug alcohol, use of alcohol despite adverse consequences, and distortions in thinking, most notably denial. Each of these symptoms may be continuous or periodic. (Morse & Flavin for the Joint Commission of the National Council on Alcoholism and Drug Dependence and the American Society of Addiction Medicine to Study the Definition and Criteria for the Diagnosis of Alcoholism: in JAMA 1992;268:1012-4) | 0 | 2.13 | 1 | 0 |
Dementia Praecox [description not available] | 0 | 6.48 | 5 | 2 |
Schizophrenia A severe emotional disorder of psychotic depth characteristically marked by a retreat from reality with delusion formation, HALLUCINATIONS, emotional disharmony, and regressive behavior. | 0 | 6.48 | 5 | 2 |
Convulsions, Grand Mal [description not available] | 0 | 2.13 | 1 | 0 |
Epilepsy, Tonic-Clonic A generalized seizure disorder characterized by recurrent major motor seizures. The initial brief tonic phase is marked by trunk flexion followed by diffuse extension of the trunk and extremities. The clonic phase features rhythmic flexor contractions of the trunk and limbs, pupillary dilation, elevations of blood pressure and pulse, urinary incontinence, and tongue biting. This is followed by a profound state of depressed consciousness (post-ictal state) which gradually improves over minutes to hours. The disorder may be cryptogenic, familial, or symptomatic (caused by an identified disease process). (From Adams et al., Principles of Neurology, 6th ed, p329) | 0 | 2.13 | 1 | 0 |
Chronic Hepatitis B [description not available] | 0 | 2.13 | 1 | 0 |
Hepatitis B, Chronic INFLAMMATION of the LIVER in humans caused by HEPATITIS B VIRUS lasting six months or more. It is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact. | 0 | 2.13 | 1 | 0 |
Sphincter of Oddi Dysfunction Organic or functional motility disorder involving the SPHINCTER OF ODDI and associated with biliary COLIC. Pathological changes are most often seen in the COMMON BILE DUCT sphincter, and less commonly the PANCREATIC DUCT sphincter. | 0 | 2.13 | 1 | 0 |
Leukoencephalopathy Syndrome, Posterior [description not available] | 0 | 2.13 | 1 | 0 |
Body Weight The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms. | 0 | 6.88 | 8 | 2 |
Small Fiber Neuropathy Disorder of the peripheral nerves that primarily impair small nerve fibers. The affected small nerve fibers include myelinated A-delta fibers (see A FIBERS) and unmyelinated C FIBERS. Because these small fibers innervate skin and help control autonomic function, their neuropathy presents with neuropathic pain, reduced thermal and pain sensitivity, and autonomic dysfunction (e.g. abnormal sweating or facial flushing). Small fiber neuropathy can be idiopathic or associated with underlying diseases (e.g., AMYLOIDOSIS; DIABETES MELLITUS; SARCOIDOSIS; or VASCULITIS). | 0 | 2.13 | 1 | 0 |
Itching [description not available] | 0 | 2.48 | 2 | 0 |
Erythermalgia [description not available] | 0 | 2.13 | 1 | 0 |
Erythromelalgia A peripheral arterial disease that is characterized by the triad of ERYTHEMA, burning PAIN, and increased SKIN TEMPERATURE of the extremities (or red, painful extremities). Erythromelalgia may be classified as primary or idiopathic, familial or non-familial. Secondary erythromelalgia is associated with other diseases, the most common being MYELOPROLIFERATIVE DISORDERS. | 0 | 2.13 | 1 | 0 |
Pruritus An intense itching sensation that produces the urge to rub or scratch the skin to obtain relief. | 0 | 2.48 | 2 | 0 |
Autosomal Dominant Juvenile Parkinson Disease [description not available] | 0 | 2.49 | 2 | 0 |
Parkinsonian Disorders A group of disorders which feature impaired motor control characterized by bradykinesia, MUSCLE RIGIDITY; TREMOR; and postural instability. Parkinsonian diseases are generally divided into primary parkinsonism (see PARKINSON DISEASE), secondary parkinsonism (see PARKINSON DISEASE, SECONDARY) and inherited forms. These conditions are associated with dysfunction of dopaminergic or closely related motor integration neuronal pathways in the BASAL GANGLIA. | 0 | 2.49 | 2 | 0 |
Enuresis Involuntary discharge of URINE after expected age of completed development of urinary control. This can happen during the daytime (DIURNAL ENURESIS) while one is awake or during sleep (NOCTURNAL ENURESIS). Enuresis can be in children or in adults (as persistent primary enuresis and secondary adult-onset enuresis). | 0 | 2.13 | 1 | 0 |
Complex Regional Pain Syndrome [description not available] | 0 | 2.15 | 1 | 0 |
Complex Regional Pain Syndromes Conditions characterized by pain involving an extremity or other body region, HYPERESTHESIA, and localized autonomic dysfunction following injury to soft tissue or nerve. The pain is usually associated with ERYTHEMA; SKIN TEMPERATURE changes, abnormal sudomotor activity (i.e., changes in sweating due to altered sympathetic innervation) or edema. The degree of pain and other manifestations is out of proportion to that expected from the inciting event. Two subtypes of this condition have been described: type I; (REFLEX SYMPATHETIC DYSTROPHY) and type II; (CAUSALGIA). (From Pain 1995 Oct;63(1):127-33) | 0 | 2.15 | 1 | 0 |
Dysthymia [description not available] | 0 | 7.93 | 7 | 5 |
Dysthymic Disorder Chronically depressed mood that occurs for most of the day more days than not for at least 2 years. The required minimum duration in children to make this diagnosis is 1 year. During periods of depressed mood, at least 2 of the following additional symptoms are present: poor appetite or overeating, insomnia or hypersomnia, low energy or fatigue, low self-esteem, poor concentration or difficulty making decisions, and feelings of hopelessness. (DSM-IV) | 0 | 7.93 | 7 | 5 |
Anterior Cervical Pain [description not available] | 0 | 2.48 | 2 | 0 |
Neck Pain Discomfort or more intense forms of pain that are localized to the cervical region. This term generally refers to pain in the posterior or lateral regions of the neck. | 0 | 2.48 | 2 | 0 |
Psychoses, Drug [description not available] | 0 | 3.06 | 1 | 0 |
Acathisia, Drug-Induced [description not available] | 0 | 3.42 | 2 | 0 |
Liver Dysfunction [description not available] | 0 | 4.44 | 3 | 0 |
Liver Diseases Pathological processes of the LIVER. | 0 | 4.44 | 3 | 0 |
Cardiomyopathies, Primary [description not available] | 0 | 2.04 | 1 | 0 |
Cardiomyopathies A group of diseases in which the dominant feature is the involvement of the CARDIAC MUSCLE itself. Cardiomyopathies are classified according to their predominant pathophysiological features (DILATED CARDIOMYOPATHY; HYPERTROPHIC CARDIOMYOPATHY; RESTRICTIVE CARDIOMYOPATHY) or their etiological/pathological factors (CARDIOMYOPATHY, ALCOHOLIC; ENDOCARDIAL FIBROELASTOSIS). | 0 | 2.04 | 1 | 0 |
Urinary Tract Diseases [description not available] | 0 | 2.94 | 1 | 0 |
Disorder, Borderline Personality [description not available] | 0 | 3.44 | 1 | 1 |
Borderline Personality Disorder A personality disorder marked by a pattern of instability of interpersonal relationships, self-image, and affects, and marked impulsivity beginning by early adulthood and present in a variety of contexts. (DSM-IV) | 0 | 3.44 | 1 | 1 |
Borna Disease An encephalomyelitis of horses, sheep and cattle caused by BORNA DISEASE VIRUS. | 0 | 2.04 | 1 | 0 |
Disruptive, Impulse Control, and Conduct Disorders Disorders whose essential features are the failure to resist an impulse, drive, or temptation to perform an act that is harmful to the individual or to others. Individuals experience an increased sense of tension prior to the act and pleasure, gratification or release of tension at the time of committing the act. | 0 | 2.46 | 2 | 0 |
As If Personality [description not available] | 0 | 3.85 | 2 | 1 |
Ecchymosis Extravasation of blood into the skin, resulting in a nonelevated, rounded or irregular, blue or purplish patch, larger than a petechia. | 0 | 2.04 | 1 | 0 |
Binge Eating [description not available] | 0 | 4.12 | 3 | 1 |
Bulimia Eating an excess amount of food in a short period of time, as seen in the disorder of BULIMIA NERVOSA. It is caused by an abnormal craving for food, or insatiable hunger also known as ox hunger. | 0 | 4.12 | 3 | 1 |
Inadequate Sleep [description not available] | 0 | 2.96 | 1 | 0 |
Cephalgia Syndromes [description not available] | 0 | 4.74 | 2 | 1 |
Headache Disorders Various conditions with the symptom of HEADACHE. Headache disorders are classified into major groups, such as PRIMARY HEADACHE DISORDERS (based on characteristics of their headache symptoms) and SECONDARY HEADACHE DISORDERS (based on their etiologies). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1) | 0 | 4.74 | 2 | 1 |
Panic Attacks [description not available] | 0 | 7.92 | 15 | 2 |
Panic Disorder A type of anxiety disorder characterized by unexpected panic attacks that last minutes or, rarely, hours. Panic attacks begin with intense apprehension, fear or terror and, often, a feeling of impending doom. Symptoms experienced during a panic attack include dyspnea or sensations of being smothered; dizziness, loss of balance or faintness; choking sensations; palpitations or accelerated heart rate; shakiness; sweating; nausea or other form of abdominal distress; depersonalization or derealization; paresthesias; hot flashes or chills; chest discomfort or pain; fear of dying and fear of not being in control of oneself or going crazy. Agoraphobia may also develop. Similar to other anxiety disorders, it may be inherited as an autosomal dominant trait. | 0 | 7.92 | 15 | 2 |
Dyspareunia Recurrent genital pain occurring during, before, or after SEXUAL INTERCOURSE in either the male or the female. | 0 | 2.96 | 1 | 0 |
Premenstrual Tension A term used to describe the psychological aspects of PREMENSTRUAL SYNDROME, such as the indescribable tension, depression, hostility, and increased seizure activity in women with seizure disorder. | 0 | 4.68 | 3 | 2 |
Premenstrual Syndrome A combination of distressing physical, psychologic, or behavioral changes that occur during the luteal phase of the menstrual cycle. Symptoms of PMS are diverse (such as pain, water-retention, anxiety, cravings, and depression) and they diminish markedly 2 or 3 days after the initiation of menses. | 0 | 4.68 | 3 | 2 |
Acquired Neuromyotonia [description not available] | 0 | 2.05 | 1 | 0 |
Convulsive Generalized Seizure Disorder [description not available] | 0 | 2.05 | 1 | 0 |
Obesity A status with BODY WEIGHT that is grossly above the recommended standards, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY). | 0 | 4.34 | 4 | 1 |
Fibroid [description not available] | 0 | 2.05 | 1 | 0 |
Cancer of Skin [description not available] | 0 | 2.05 | 1 | 0 |
Leiomyoma A benign tumor derived from smooth muscle tissue, also known as a fibroid tumor. They rarely occur outside of the UTERUS and the GASTROINTESTINAL TRACT but can occur in the SKIN and SUBCUTANEOUS TISSUE, probably arising from the smooth muscle of small blood vessels in these tissues. | 0 | 2.05 | 1 | 0 |
Skin Neoplasms Tumors or cancer of the SKIN. | 0 | 2.05 | 1 | 0 |
Action Tremor [description not available] | 0 | 3.33 | 2 | 0 |
Tremor Cyclical movement of a body part that can represent either a physiologic process or a manifestation of disease. Intention or action tremor, a common manifestation of CEREBELLAR DISEASES, is aggravated by movement. In contrast, resting tremor is maximal when there is no attempt at voluntary movement, and occurs as a relatively frequent manifestation of PARKINSON DISEASE. | 0 | 3.33 | 2 | 0 |
Anasarca [description not available] | 0 | 2.44 | 2 | 0 |
Edema Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE. | 0 | 2.44 | 2 | 0 |
Diabetic Glomerulosclerosis [description not available] | 0 | 2.44 | 2 | 0 |
Diabetic Nephropathies KIDNEY injuries associated with diabetes mellitus and affecting KIDNEY GLOMERULUS; ARTERIOLES; KIDNEY TUBULES; and the interstitium. Clinical signs include persistent PROTEINURIA, from microalbuminuria progressing to ALBUMINURIA of greater than 300 mg/24 h, leading to reduced GLOMERULAR FILTRATION RATE and END-STAGE RENAL DISEASE. | 0 | 2.44 | 2 | 0 |
Acute Confusional Senile Dementia [description not available] | 0 | 2.97 | 4 | 0 |
Acute Onset Vascular Dementia [description not available] | 0 | 2.05 | 1 | 0 |
Alzheimer Disease A degenerative disease of the BRAIN characterized by the insidious onset of DEMENTIA. Impairment of MEMORY, judgment, attention span, and problem solving skills are followed by severe APRAXIAS and a global loss of cognitive abilities. The condition primarily occurs after age 60, and is marked pathologically by severe cortical atrophy and the triad of SENILE PLAQUES; NEUROFIBRILLARY TANGLES; and NEUROPIL THREADS. (From Adams et al., Principles of Neurology, 6th ed, pp1049-57) | 0 | 2.97 | 4 | 0 |
Dementia, Vascular An imprecise term referring to dementia associated with CEREBROVASCULAR DISORDERS, including CEREBRAL INFARCTION (single or multiple), and conditions associated with chronic BRAIN ISCHEMIA. Diffuse, cortical, and subcortical subtypes have been described. (From Gerontol Geriatr 1998 Feb;31(1):36-44) | 0 | 2.05 | 1 | 0 |
Binge-Eating Disorder A disorder associated with three or more of the following: eating until feeling uncomfortably full; eating large amounts of food when not physically hungry; eating much more rapidly than normal; eating alone due to embarrassment; feeling of disgust, DEPRESSION, or guilt after overeating. Criteria includes occurrence on average, at least 2 days a week for 6 months. The binge eating is not associated with the regular use of inappropriate compensatory behavior (i.e. purging, excessive exercise, etc.) and does not co-occur exclusively with BULIMIA NERVOSA or ANOREXIA NERVOSA. (From DSM-IV, 1994) | 0 | 5.06 | 3 | 1 |
ALS - Amyotrophic Lateral Sclerosis [description not available] | 0 | 2.05 | 1 | 0 |
Amyotrophic Lateral Sclerosis A degenerative disorder affecting upper MOTOR NEURONS in the brain and lower motor neurons in the brain stem and SPINAL CORD. Disease onset is usually after the age of 50 and the process is usually fatal within 3 to 6 years. Clinical manifestations include progressive weakness, atrophy, FASCICULATION, hyperreflexia, DYSARTHRIA, dysphagia, and eventual paralysis of respiratory function. Pathologic features include the replacement of motor neurons with fibrous ASTROCYTES and atrophy of anterior SPINAL NERVE ROOTS and corticospinal tracts. (From Adams et al., Principles of Neurology, 6th ed, pp1089-94) | 0 | 2.05 | 1 | 0 |
Bile Duct Obstruction [description not available] | 0 | 2.05 | 1 | 0 |
Chronic Kidney Failure [description not available] | 0 | 3.85 | 2 | 1 |
Nephrosclerosis Hardening of the KIDNEY due to infiltration by fibrous connective tissue (FIBROSIS), usually caused by renovascular diseases or chronic HYPERTENSION. Nephrosclerosis leads to renal ISCHEMIA. | 0 | 2.05 | 1 | 0 |
Cholestasis Impairment of bile flow due to obstruction in small bile ducts (INTRAHEPATIC CHOLESTASIS) or obstruction in large bile ducts (EXTRAHEPATIC CHOLESTASIS). | 0 | 2.05 | 1 | 0 |
Kidney Failure, Chronic The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION. | 0 | 3.85 | 2 | 1 |
Pulsatile Tinnitus [description not available] | 0 | 2.47 | 2 | 0 |
Tinnitus A nonspecific symptom of hearing disorder characterized by the sensation of buzzing, ringing, clicking, pulsations, and other noises in the ear. Objective tinnitus refers to noises generated from within the ear or adjacent structures that can be heard by other individuals. The term subjective tinnitus is used when the sound is audible only to the affected individual. Tinnitus may occur as a manifestation of COCHLEAR DISEASES; VESTIBULOCOCHLEAR NERVE DISEASES; INTRACRANIAL HYPERTENSION; CRANIOCEREBRAL TRAUMA; and other conditions. | 0 | 2.47 | 2 | 0 |
Cold Fingers, Hereditary [description not available] | 0 | 2.05 | 1 | 0 |
Raynaud Disease An idiopathic vascular disorder characterized by bilateral Raynaud phenomenon, the abrupt onset of digital paleness or CYANOSIS in response to cold exposure or stress. | 0 | 2.05 | 1 | 0 |
Acute Post-Traumatic Stress Disorder [description not available] | 0 | 5.44 | 5 | 3 |
Combat Disorders Neurotic reactions to unusual, severe, or overwhelming military stress. | 0 | 3.83 | 2 | 1 |
Stress Disorders, Post-Traumatic A class of traumatic stress disorders with symptoms that last more than one month. | 1 | 7.44 | 5 | 3 |
Fever of Unknown Origin Fever in which the etiology cannot be ascertained. | 0 | 2.05 | 1 | 0 |
Urination Disorders Abnormalities in the process of URINE voiding, including bladder control, frequency of URINATION, as well as the volume and composition of URINE. | 0 | 4.74 | 2 | 1 |
Constitutional Liver Dysfunction [description not available] | 0 | 2.05 | 1 | 0 |
Urge Incontinence [description not available] | 0 | 8.24 | 7 | 2 |
Urinary Incontinence, Urge Involuntary discharge of URINE that is associated with an abrupt and strong desire to void. It is usually related to the involuntary contractions of the detrusor muscle of the bladder (detrusor hyperreflexia or detrusor instability). | 0 | 8.24 | 7 | 2 |
Colitis, Granulomatous [description not available] | 0 | 2.45 | 2 | 0 |
Sensation Disorders Disorders of the special senses (i.e., VISION; HEARING; TASTE; and SMELL) or somatosensory system (i.e., afferent components of the PERIPHERAL NERVOUS SYSTEM). | 0 | 2.05 | 1 | 0 |
Sicca Syndrome [description not available] | 0 | 2.05 | 1 | 0 |
Crohn Disease A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients. | 0 | 2.45 | 2 | 0 |
Sjogren's Syndrome Chronic inflammatory and autoimmune disease in which the salivary and lacrimal glands undergo progressive destruction by lymphocytes and plasma cells resulting in decreased production of saliva and tears. The primary form, often called sicca syndrome, involves both KERATOCONJUNCTIVITIS SICCA and XEROSTOMIA. The secondary form includes, in addition, the presence of a connective tissue disease, usually rheumatoid arthritis. | 0 | 2.05 | 1 | 0 |
Craniofacial Pain [description not available] | 0 | 2.05 | 1 | 0 |
Facial Pain Pain in the facial region including orofacial pain and craniofacial pain. Associated conditions include local inflammatory and neoplastic disorders and neuralgic syndromes involving the trigeminal, facial, and glossopharyngeal nerves. Conditions which feature recurrent or persistent facial pain as the primary manifestation of disease are referred to as FACIAL PAIN SYNDROMES. | 0 | 2.05 | 1 | 0 |
Lethargy A general state of sluggishness, listless, or uninterested, with being tired, and having difficulty concentrating and doing simple tasks. It may be related to DEPRESSION or DRUG ADDICTION. | 0 | 2.48 | 2 | 0 |
Hyperglycemia, Postprandial Abnormally high BLOOD GLUCOSE level after a meal. | 0 | 2.97 | 1 | 0 |
Hyperglycemia Abnormally high BLOOD GLUCOSE level. | 0 | 2.97 | 1 | 0 |
Urinary Tract Infections Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA. | 0 | 2.47 | 2 | 0 |
Bruxism A disorder characterized by grinding and clenching of the teeth. | 0 | 2.06 | 1 | 0 |
Ambulation Disorders, Neurologic [description not available] | 0 | 2.97 | 1 | 0 |
Adolescent Gynecomastia [description not available] | 0 | 2.48 | 2 | 0 |
Hypergonadotropic Hypogonadism [description not available] | 0 | 2.06 | 1 | 0 |
Gynecomastia Enlargement of the BREAST in the males, caused by an excess of ESTROGENS. Physiological gynecomastia is normally observed in NEWBORNS; ADOLESCENT; and AGING males. | 0 | 2.48 | 2 | 0 |
Hypogonadism Condition resulting from deficient gonadal functions, such as GAMETOGENESIS and the production of GONADAL STEROID HORMONES. It is characterized by delay in GROWTH, germ cell maturation, and development of secondary sex characteristics. Hypogonadism can be due to a deficiency of GONADOTROPINS (hypogonadotropic hypogonadism) or due to primary gonadal failure (hypergonadotropic hypogonadism). | 0 | 2.06 | 1 | 0 |
Bulimia Nervosa An eating disorder that is characterized by a cycle of binge eating (BULIMIA or bingeing) followed by inappropriate acts (purging) to avert weight gain. Purging methods often include self-induced VOMITING, use of LAXATIVES or DIURETICS, excessive exercise, and FASTING. | 0 | 2.06 | 1 | 0 |
Drug-Induced Stevens Johnson Syndrome [description not available] | 0 | 2.06 | 1 | 0 |
Stevens-Johnson Syndrome Rare cutaneous eruption characterized by extensive KERATINOCYTE apoptosis resulting in skin detachment with mucosal involvement. It is often provoked by the use of drugs (e.g., antibiotics and anticonvulsants) or associated with PNEUMONIA, MYCOPLASMA. It is considered a continuum of Toxic Epidermal Necrolysis. | 0 | 2.06 | 1 | 0 |
Body Dysmorphic Disorders Preoccupations with appearance or self-image causing significant distress or impairment in important areas of functioning. | 0 | 2.06 | 1 | 0 |
Orthopedic Disorders [description not available] | 0 | 7.49 | 4 | 4 |
Musculoskeletal Diseases Diseases of the muscles and their associated ligaments and other connective tissue and of the bones and cartilage viewed collectively. | 0 | 7.49 | 4 | 4 |
Herpes Simplex Virus Infection [description not available] | 0 | 2.06 | 1 | 0 |
Actinic Reticuloid Syndrome [description not available] | 0 | 2.06 | 1 | 0 |
Herpes Simplex A group of acute infections caused by herpes simplex virus type 1 or type 2 that is characterized by the development of one or more small fluid-filled vesicles with a raised erythematous base on the skin or mucous membrane. It occurs as a primary infection or recurs due to a reactivation of a latent infection. (Dorland, 27th ed.) | 0 | 2.06 | 1 | 0 |
Absence Status [description not available] | 0 | 2.47 | 2 | 0 |
Status Epilepticus A prolonged seizure or seizures repeated frequently enough to prevent recovery between episodes occurring over a period of 20-30 minutes. The most common subtype is generalized tonic-clonic status epilepticus, a potentially fatal condition associated with neuronal injury and respiratory and metabolic dysfunction. Nonconvulsive forms include petit mal status and complex partial status, which may manifest as behavioral disturbances. Simple partial status epilepticus consists of persistent motor, sensory, or autonomic seizures that do not impair cognition (see also EPILEPSIA PARTIALIS CONTINUA). Subclinical status epilepticus generally refers to seizures occurring in an unresponsive or comatose individual in the absence of overt signs of seizure activity. (From N Engl J Med 1998 Apr 2;338(14):970-6; Neurologia 1997 Dec;12 Suppl 6:25-30) | 0 | 2.47 | 2 | 0 |
Blood Loss, Postoperative [description not available] | 0 | 2.07 | 1 | 0 |
Kidney Diseases Pathological processes of the KIDNEY or its component tissues. | 0 | 2.07 | 1 | 0 |
Bladder Pain Syndrome [description not available] | 0 | 3.84 | 2 | 1 |
Cystitis, Interstitial A condition with recurring discomfort or pain in the URINARY BLADDER and the surrounding pelvic region without an identifiable disease. Severity of pain in interstitial cystitis varies greatly and often is accompanied by increased urination frequency and urgency. | 0 | 3.84 | 2 | 1 |
Neuritis A general term indicating inflammation of a peripheral or cranial nerve. Clinical manifestation may include PAIN; PARESTHESIAS; PARESIS; or HYPESTHESIA. | 0 | 5.04 | 3 | 1 |
Gait Disorders, Animal [description not available] | 0 | 2.07 | 1 | 0 |
Asystole [description not available] | 0 | 2.07 | 1 | 0 |
Embolism, Pulmonary [description not available] | 0 | 2.07 | 1 | 0 |
Heart Arrest Cessation of heart beat or MYOCARDIAL CONTRACTION. If it is treated within a few minutes, heart arrest can be reversed in most cases to normal cardiac rhythm and effective circulation. | 0 | 2.07 | 1 | 0 |
Pulmonary Embolism Blocking of the PULMONARY ARTERY or one of its branches by an EMBOLUS. | 0 | 2.07 | 1 | 0 |
Neuroma A tumor made up of nerve cells and nerve fibers. (Dorland, 27th ed) | 0 | 2.07 | 1 | 0 |
Anaplastic Astrocytoma [description not available] | 0 | 2.07 | 1 | 0 |
Astrocytoma Neoplasms of the brain and spinal cord derived from glial cells which vary from histologically benign forms to highly anaplastic and malignant tumors. Fibrillary astrocytomas are the most common type and may be classified in order of increasing malignancy (grades I through IV). In the first two decades of life, astrocytomas tend to originate in the cerebellar hemispheres; in adults, they most frequently arise in the cerebrum and frequently undergo malignant transformation. (From Devita et al., Cancer: Principles and Practice of Oncology, 5th ed, pp2013-7; Holland et al., Cancer Medicine, 3d ed, p1082) | 0 | 2.07 | 1 | 0 |
Constricted Pupil [description not available] | 0 | 11.94 | 25 | 0 |
Miosis Pupillary constriction. This may result from congenital absence of the dilatator pupillary muscle, defective sympathetic innervation, or irritation of the CONJUNCTIVA or CORNEA. | 0 | 11.94 | 25 | 0 |
Mydriasis Dilation of pupils to greater than 6 mm combined with failure of the pupils to constrict when stimulated with light. This condition may occur due to injury of the pupillary fibers in the oculomotor nerve, in acute angle-closure glaucoma, and in ADIE SYNDROME. | 0 | 11.94 | 25 | 0 |
Acute Relapsing Multiple Sclerosis [description not available] | 0 | 2.07 | 1 | 0 |
Multiple Sclerosis, Relapsing-Remitting The most common clinical variant of MULTIPLE SCLEROSIS, characterized by recurrent acute exacerbations of neurologic dysfunction followed by partial or complete recovery. Common clinical manifestations include loss of visual (see OPTIC NEURITIS), motor, sensory, or bladder function. Acute episodes of demyelination may occur at any site in the central nervous system, and commonly involve the optic nerves, spinal cord, brain stem, and cerebellum. (Adams et al., Principles of Neurology, 6th ed, pp903-914) | 0 | 2.07 | 1 | 0 |
Acute Hepatic Failure [description not available] | 0 | 7.45 | 2 | 0 |
Liver Failure, Acute A form of rapid-onset LIVER FAILURE, also known as fulminant hepatic failure, caused by severe liver injury or massive loss of HEPATOCYTES. It is characterized by sudden development of liver dysfunction and JAUNDICE. Acute liver failure may progress to exhibit cerebral dysfunction even HEPATIC COMA depending on the etiology that includes hepatic ISCHEMIA, drug toxicity, malignant infiltration, and viral hepatitis such as post-transfusion HEPATITIS B and HEPATITIS C. | 0 | 2.45 | 2 | 0 |
Muscle Disorders [description not available] | 0 | 2.07 | 1 | 0 |
Muscular Diseases Acquired, familial, and congenital disorders of SKELETAL MUSCLE and SMOOTH MUSCLE. | 0 | 2.07 | 1 | 0 |
Remission, Spontaneous A spontaneous diminution or abatement of a disease over time, without formal treatment. | 0 | 2.08 | 1 | 0 |
Leanness [description not available] | 0 | 2.07 | 1 | 0 |
Hypokalemia Abnormally low potassium concentration in the blood. It may result from potassium loss by renal secretion or by the gastrointestinal route, as by vomiting or diarrhea. It may be manifested clinically by neuromuscular disorders ranging from weakness to paralysis, by electrocardiographic abnormalities (depression of the T wave and elevation of the U wave), by renal disease, and by gastrointestinal disorders. (Dorland, 27th ed) | 0 | 2.07 | 1 | 0 |
Consciousness, Loss of [description not available] | 0 | 2.07 | 1 | 0 |
Cholera Infantum [description not available] | 0 | 6.96 | 4 | 1 |
Claustrophobia [description not available] | 0 | 3.47 | 1 | 1 |
Agoraphobia Obsessive, persistent, intense fear of open places. | 0 | 3.47 | 1 | 1 |
Phobic Disorders Anxiety disorders in which the essential feature is persistent and irrational fear of a specific object, activity, or situation that the individual feels compelled to avoid. The individual recognizes the fear as excessive or unreasonable. | 0 | 3.47 | 1 | 1 |
Bladder Disorder, Neurogenic [description not available] | 0 | 2.93 | 1 | 0 |
Urinary Bladder, Neurogenic Dysfunction of the URINARY BLADDER due to disease of the central or peripheral nervous system pathways involved in the control of URINATION. This is often associated with SPINAL CORD DISEASES, but may also be caused by BRAIN DISEASES or PERIPHERAL NERVE DISEASES. | 0 | 2.93 | 1 | 0 |
Degenerative Diseases, Central Nervous System [description not available] | 0 | 2.93 | 1 | 0 |
Neurodegenerative Diseases Hereditary and sporadic conditions which are characterized by progressive nervous system dysfunction. These disorders are often associated with atrophy of the affected central or peripheral nervous system structures. | 0 | 2.93 | 1 | 0 |
Bone Loss, Perimenopausal [description not available] | 0 | 2.94 | 1 | 0 |
Osteoporosis, Postmenopausal Metabolic disorder associated with fractures of the femoral neck, vertebrae, and distal forearm. It occurs commonly in women within 15-20 years after menopause, and is caused by factors associated with menopause including estrogen deficiency. | 0 | 2.94 | 1 | 0 |
Cirrhosis, Liver [description not available] | 0 | 3.41 | 1 | 1 |
Liver Cirrhosis Liver disease in which the normal microcirculation, the gross vascular anatomy, and the hepatic architecture have been variably destroyed and altered with fibrous septa surrounding regenerated or regenerating parenchymal nodules. | 0 | 3.41 | 1 | 1 |
Back Ache [description not available] | 0 | 5.94 | 3 | 1 |
Back Pain Acute or chronic pain located in the posterior regions of the THORAX; LUMBOSACRAL REGION; or the adjacent regions. | 0 | 5.94 | 3 | 1 |
Hypochondriacal Neuroses [description not available] | 0 | 3.35 | 2 | 0 |
Shoulder Pain Unilateral or bilateral pain of the shoulder. It is often caused by physical activities such as work or sports participation, but may also be pathologic in origin. | 0 | 2.94 | 1 | 0 |
Smoking Cessation Discontinuing the habit of SMOKING. | 0 | 2.02 | 1 | 0 |
Adipocere [description not available] | 0 | 2.02 | 1 | 0 |
Kidney Failure A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. | 0 | 2.94 | 1 | 0 |
Hepatic Failure [description not available] | 0 | 2.94 | 1 | 0 |
Liver Failure Severe inability of the LIVER to perform its normal metabolic functions, as evidenced by severe JAUNDICE and abnormal serum levels of AMMONIA; BILIRUBIN; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; LACTATE DEHYDROGENASES; and albumin/globulin ratio. (Blakiston's Gould Medical Dictionary, 4th ed) | 0 | 2.94 | 1 | 0 |
Renal Insufficiency Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE. | 0 | 2.94 | 1 | 0 |
Affective Disorders, Psychotic Disorders in which the essential feature is a severe disturbance in mood (depression, anxiety, elation, and excitement) accompanied by psychotic symptoms such as delusions, hallucinations, gross impairment in reality testing, etc. | 0 | 2.02 | 1 | 0 |
Uterine Prolapse Downward displacement of the UTERUS. It is classified in various degrees: in the first degree the UTERINE CERVIX is within the vaginal orifice; in the second degree the cervix is outside the orifice; in the third degree the entire uterus is outside the orifice. | 0 | 2.03 | 1 | 0 |
Central Nervous System Disease [description not available] | 0 | 2.94 | 1 | 0 |
Female Genitourinary Diseases [description not available] | 0 | 2.94 | 1 | 0 |
Central Nervous System Diseases Diseases of any component of the brain (including the cerebral hemispheres, diencephalon, brain stem, and cerebellum) or the spinal cord. | 0 | 2.94 | 1 | 0 |
Dissociation [description not available] | 0 | 2.03 | 1 | 0 |
Disease, Pulmonary [description not available] | 0 | 2.03 | 1 | 0 |
Lung Diseases Pathological processes involving any part of the LUNG. | 0 | 2.03 | 1 | 0 |
Prostatic Diseases Pathological processes involving the PROSTATE or its component tissues. | 0 | 2.03 | 1 | 0 |
Dehiscence, Surgical Wound [description not available] | 0 | 2.03 | 1 | 0 |
Delusional Disorder Disorder with presentation of a facade of coldness with characteristic pervasive mistrust and suspiciousness of others. | 0 | 2.03 | 1 | 0 |
Complications of Diabetes Mellitus [description not available] | 0 | 4.74 | 2 | 1 |
Impotence [description not available] | 0 | 4.34 | 1 | 1 |
Erectile Dysfunction The inability in the male to have a PENILE ERECTION due to psychological or organ dysfunction. | 0 | 4.34 | 1 | 1 |
Flushing A transient reddening of the face that may be due to fever, certain drugs, exertion, or stress. | 0 | 2.03 | 1 | 0 |
BOOP [description not available] | 0 | 2.03 | 1 | 0 |
Eosinophilia, Pulmonary [description not available] | 0 | 2.03 | 1 | 0 |
Pulmonary Eosinophilia A condition characterized by infiltration of the lung with EOSINOPHILS due to inflammation or other disease processes. Major eosinophilic lung diseases are the eosinophilic pneumonias caused by infections, allergens, or toxic agents. | 0 | 2.03 | 1 | 0 |
Cystitis Inflammation of the URINARY BLADDER, either from bacterial or non-bacterial causes. Cystitis is usually associated with painful urination (dysuria), increased frequency, urgency, and suprapubic pain. | 0 | 2.03 | 1 | 0 |
Polyarthritis [description not available] | 0 | 7.46 | 4 | 4 |
Arthritis Acute or chronic inflammation of JOINTS. | 0 | 7.46 | 4 | 4 |
Diabetic Feet [description not available] | 0 | 2.95 | 1 | 0 |
Diabetic Foot Common foot problems in persons with DIABETES MELLITUS, caused by any combination of factors such as DIABETIC NEUROPATHIES; PERIPHERAL VASCULAR DISEASES; and INFECTION. With the loss of sensation and poor circulation, injuries and infections often lead to severe foot ulceration, GANGRENE and AMPUTATION. | 0 | 2.95 | 1 | 0 |
Nicotine Addiction [description not available] | 0 | 2.04 | 1 | 0 |
Tobacco Use Disorder Tobacco used to the detriment of a person's health or social functioning. Tobacco dependence is included. | 0 | 2.04 | 1 | 0 |
Exanthem [description not available] | 0 | 2.04 | 1 | 0 |
Exanthema Diseases in which skin eruptions or rashes are a prominent manifestation. Classically, six such diseases were described with similar rashes; they were numbered in the order in which they were reported. Only the fourth (Duke's disease), fifth (ERYTHEMA INFECTIOSUM), and sixth (EXANTHEMA SUBITUM) numeric designations survive as occasional synonyms in current terminology. | 0 | 2.04 | 1 | 0 |
Chronic Fatigue and Immune Dysfunction Syndrome [description not available] | 0 | 2.04 | 1 | 0 |
Fatigue Syndrome, Chronic A syndrome characterized by persistent or recurrent fatigue, diffuse musculoskeletal pain, sleep disturbances, and subjective cognitive impairment of 6 months duration or longer. Symptoms are not caused by ongoing exertion; are not relieved by rest; and result in a substantial reduction of previous levels of occupational, educational, social, or personal activities. Minor alterations of immune, neuroendocrine, and autonomic function may be associated with this syndrome. There is also considerable overlap between this condition and FIBROMYALGIA. (From Semin Neurol 1998;18(2):237-42; Ann Intern Med 1994 Dec 15;121(12): 953-9) | 0 | 2.04 | 1 | 0 |
Gelineau Syndrome [description not available] | 0 | 2.05 | 1 | 0 |
Narcolepsy A condition characterized by recurrent episodes of daytime somnolence and lapses in consciousness (microsomnias) that may be associated with automatic behaviors and AMNESIA. CATAPLEXY; SLEEP PARALYSIS, and hypnagogic HALLUCINATIONS frequently accompany narcolepsy. The pathophysiology of this disorder includes sleep-onset rapid eye movement (REM) sleep, which normally follows stage III or IV sleep. (From Neurology 1998 Feb;50(2 Suppl 1):S2-S7) | 0 | 2.05 | 1 | 0 |
Cranial Nerve IX Diseases [description not available] | 0 | 2.04 | 1 | 0 |
Glossopharyngeal Nerve Diseases Diseases of the ninth cranial (glossopharyngeal) nerve or its nuclei in the medulla. The nerve may be injured by diseases affecting the lower brain stem, floor of the posterior fossa, jugular foramen, or the nerve's extracranial course. Clinical manifestations include loss of sensation from the pharynx, decreased salivation, and syncope. Glossopharyngeal neuralgia refers to a condition that features recurrent unilateral sharp pain in the tongue, angle of the jaw, external auditory meatus and throat that may be associated with SYNCOPE. Episodes may be triggered by cough, sneeze, swallowing, or pressure on the tragus of the ear. (Adams et al., Principles of Neurology, 6th ed, p1390) | 0 | 2.04 | 1 | 0 |
Left Ventricular Dysfunction [description not available] | 0 | 2.04 | 1 | 0 |
Cardiac Failure [description not available] | 0 | 2.04 | 1 | 0 |
Heart Failure A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION. | 0 | 2.04 | 1 | 0 |
Ventricular Dysfunction, Left A condition in which the LEFT VENTRICLE of the heart was functionally impaired. This condition usually leads to HEART FAILURE; MYOCARDIAL INFARCTION; and other cardiovascular complications. Diagnosis is made by measuring the diminished ejection fraction and a depressed level of motility of the left ventricular wall. | 0 | 2.04 | 1 | 0 |