Page last updated: 2024-12-06

sertraline

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Description

Sertraline is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It is used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder (PTSD), premenstrual dysphoric disorder, and social anxiety disorder. Sertraline works by increasing the levels of serotonin in the brain. Serotonin is a neurotransmitter that plays a role in regulating mood, sleep, appetite, and other functions. Sertraline is typically taken once daily. It can take several weeks for the full effects of sertraline to be felt. Common side effects include nausea, headache, diarrhea, dizziness, and sexual dysfunction. Sertraline is a prescription medication and should only be taken under the supervision of a doctor. It is important to talk to your doctor about any potential side effects or interactions with other medications before taking sertraline. Sertraline is one of the most widely prescribed antidepressants, and it is generally considered to be safe and effective. However, it is important to talk to your doctor about your individual needs and potential risks before taking sertraline.'

Sertraline: A selective serotonin uptake inhibitor that is used in the treatment of depression. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

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. [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]

Cross-References

ID SourceID
PubMed CID68617
CHEMBL ID809
CHEBI ID9123
SCHEMBL ID28701
MeSH IDM0029930

Synonyms (98)

Synonym
AC-15639
BIDD:GT0768
BIDD:PXR0193
BRD-K82036761-003-02-1
REGID_FOR_CID_68617
BPBIO1_001285
PRESTWICK3_001014
(1s,4s)-4-(3,4-dichlorophenyl)-n-methyl-tetralin-1-amine
CHEBI:9123 ,
(1s,4s)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-amine
cis-(+)-sertraline
cp 51974
(1s-cis)-1,2,3,4-tetrahydro-4-(3,4-dichlorophenyl)-n-methyl-1-naphthalenamine
(+)-sertraline
(1s,4s)-sertraline
sertralinum
sertralina
1-naphthalenamine, 1,2,3,4-tetrahydro-4-(3,4-dichlorophenyl)-n-methyl-, (1s-cis)-
brn 5753709
sertraline [inn:ban]
sertralina [spanish]
sertralinum [latin]
1-naphthalenamine,1,2,3,4-tetrahydro-4-(3,4-dichlorophenyl)-n-methyl-, (1s-cis)-
c17h17cl2n
hsdb 7037
BSPBIO_002698
BSPBIO_001167
AB00514002
79617-96-2
C07246
sertraline
DB01104
sertraline (inn)
D02360
NCGC00092386-04
KBIO3_001918
KBIOGR_001724
SPECTRUM4_001232
SPBIO_000385
SPECTRUM3_001079
SPECTRUM2_000493
NCGC00092386-05
NCGC00092386-07
NCGC00092386-08
NCGC00092386-06
MLS001195647
smr000596516
tba-2010_sertraline_1
SRE ,
NCGC00092386-09
CHEMBL809 ,
MLS002222308
bdbm50028094
A839725
NCGC00092386-10
HMS2098K09
1-naphthalenamine, 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-, (1s,4s)-
unii-quc7nx6wmb
quc7nx6wmb ,
HMS2231I09
FT-0630872
gtpl4798
cp-519741
sertraline [who-dd]
sertraline [mi]
sertraline [inn]
sertraline [hsdb]
sertraline [vandf]
CCG-221014
SCHEMBL28701
[(1s,4s)-4-(3,4-dichlorophenyl)tetralin-1-yl]-methyl-amine;hydrochloride
bdbm79021
ncgc00092386
cid_63009
(1s,4s)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-amine;hydrochloride
(1s-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-naphthalenamine
AB00514002_18
AB00514002_17
DTXSID6023577 ,
sr-01000759296
SR-01000759296-5
sertraline; 1-naphthalenamine, 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-, (1s-cis)-; (+)-sertraline; (1s,4s)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-1-naphthalenamine; (1s,4s)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-1-napht
SBI-0206734.P001
HMS3715K09
cp-51974
NCGC00092386-12
Q407617
219736-80-8
syn-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-amine
BRD-K82036761-003-07-0
BRD-K82036761-003-20-3
SDCCGSBI-0206734.P002
NCGC00092386-27
AKOS016842914
EN300-150167
dtxcid203577
n06ab06
sertralinum (latin)

Research Excerpts

Overview

Sertraline (SER) is an antidepressant and curcumin (CUR) is a natural compound with many properties. It is a selective serotonin reuptake inhibitor and a common first-line medication for the treatment of depression in adults. SERTraline is an environmental pollutant which received magnified scientific attention due to its global presence in waters.

ExcerptReferenceRelevance
"Sertraline is a selective serotonin reuptake inhibitor with specific indications in child and adolescent psychiatry. "( Therapeutic drug monitoring of sertraline in children and adolescents: A naturalistic study with insights into the clinical response and treatment of obsessive-compulsive disorder.
Antony, G; Banaschewski, T; Briegel, W; Correll, CU; Egberts, KM; Fekete, S; Fleischhaker, C; Gerlach, M; Hellenschmidt, T; Heuschmann, P; Imgart, H; Kaess, M; Karwautz, A; Kölch, M; Malzahn, U; Plener, PL; Reitzle, K; Renner, T; Reuter-Dang, SY; Rexroth, C; Rock, H; Romanos, M; Scherf-Clavel, M; Schulte-Körne, G; Smigielski, L; Taurines, R; Theisen, F; Tini, E; Unterecker, S; Walitza, S; Wewetzer, C, 2022
)
2.45
"Sertraline is a commonly used SSRI antidepressant drug, metabolized by CYP2C19 and CYP2B6, that exhibits a substantial interindividual variation in clinical response, of which only a part can be attributed to known genetic variants. "( Impact of the novel CYP2C:TG haplotype and CYP2B6 variants on sertraline exposure in a large patient population.
Bråten, LS; Ingelman-Sundberg, M; Jukic, MM; Kringen, MK; Molden, E, 2022
)
2.4
"Sertraline (SER) is an antidepressant and curcumin (CUR) is a natural compound with many properties."( The effects of curcumin and sertraline on stress-induced changes in the stomach tissues of rats.
Karbalay-Doust, S; Noorafshan, A; Owrang, M; Rafati, A, 2023
)
1.93
"Sertraline is a selective serotonin reuptake inhibitor and a common first-line medication for the treatment of depression in adults."( Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trial.
Al-Janabi, H; Au, P; Barnes, NM; Barnes, TRE; Birchwood, M; Drake, R; Giacco, D; Griffiths, SL; Husain, N; Katshu, MZUH; Major, B; Marriott, C; Ottridge, R; Palmer, ER; Patel, S; Sadiq, Z; Taylor, E; Tearne, S; Upthegrove, R; Walters, JTR; Watkins, B; Weetman, T; Woolley, R, 2023
)
1.63
"Sertraline is an environmental pollutant which received magnified scientific attention due to its global presence in waters. "( Aggression repeatability in stressed fish in response to an environmental concentration of sertraline and lunar cycle as evidenced by brain metabolomics.
Douda, K; Grabic, R; Grabicová, K; Horký, P; Hubená, P; Randák, T; Slavík, O, 2023
)
2.57
"Sertraline is an antidepressant medication used extensively in the therapy of depression. "( The preventive role of wheat germ oil against sertraline-induced testicular damage in male albino rats.
Hamdi, H, 2019
)
2.21
"Sertraline is an (SSRI-)antidepressant metabolized by the polymorphic CYP2C19 enzyme. "( Impact of CYP2C19 genotype on sertraline exposure in 1200 Scandinavian patients.
Bråten, LS; Haslemo, T; Ingelman-Sundberg, M; Jukic, MM; Kringen, MK; Molden, E, 2020
)
2.29
"Sertraline is an antidepressant drug that has been frequently reported in the aquatic environment and biota. "( Determination and photodegradation of sertraline residues in aqueous environment.
Gornik, T; Heath, E; Kosjek, T; Roskar, R; Trontelj, J; Vione, D; Vozic, A; Zigon, D, 2020
)
2.27
"Sertraline is an antidepressant with in vitro and in vivo antifungal properties which has been recently studied as an adjuvant in the treatment of invasive infections."( Evaluation of the expanding spectrum of sertraline against uncommon fungal pathogens.
Andrade, A; Bodden-Mendoza, BA; Espinosa-Mora, JE; González, GM; Martínez-Reséndez, MF; Treviño-Rangel, RJ; Villanueva-Lozano, H, 2020
)
1.55
"Sertraline hydrochloride is a commonly prescribed antidepressant medication that acts by amplifying serotonin signaling. "( Sertraline induces DNA damage and cellular toxicity in Drosophila that can be ameliorated by antioxidants.
Donlon, C; Jajoo, A; Levin, M; McVey, M; Shnayder, S, 2020
)
3.44
"Sertraline is a widely prescribed antidepressant and often concomitantly applied to address negative symptoms or depression."( Pharmacokinetic interactions between clozapine and sertraline in smokers and non-smokers.
Gründer, G; Haen, E; Hiemke, C; Kuzin, M; Paulzen, M; Ridders, F; Schoretsanitis, G, 2020
)
1.53
"Sertraline is an antidepressant drug with anticancer properties."( Inhibition of autophagy flux by sertraline attenuates TRAIL resistance in lung cancer via death receptor 5 upregulation.
Park, SY; Seol, JW; Zinnah, KMA, 2020
)
1.56
"Sertraline is a widely used antidepressant that becomes an aquatic pollutant through metabolic excretion and improper disposal. "( Sertraline inhibits top-down forces (predation) in microbial food web and promotes nitrification in sediment.
Li, Y; Miao, Y; Niu, L; Wang, L; Yang, N; Zhang, H; Zhang, W, 2020
)
3.44
"Sertraline is a selective serotonin reuptake inhibitor which is often used as first-line treatment for depression. "( [Sertraline-induced chronic eosinophilic pneumonia].
Brancaleone, P; Descamps, O; Detry, G; Mignon, M; Piquet, M; Weynand, B, 2021
)
2.97
"Sertraline is a safe and effective agent frequently used in the treatment of childhood depression and obsessive compulsive disorder. "( Sertraline-Induced Amotivationel Syndrome in a 12-Year-Old Girl: A Case Report.
Karayagmurlu, A; Yildiz Bayindir, B,
)
3.02
"Sertraline is a well-tolerated and effective choice for treating depression in women with polycystic ovary syndrome."( Effect of sertraline on depression severity and prolactin levels in women with polycystic ovary syndrome: a placebo-controlled randomized trial.
Akhondzadeh, S; Ansari, S; Esalatmanesh, S; Ghazizadeh-Hashemi, M; Hossein Rashidi, B; Kashani, L; Masoudi, M; Noorbala, AA; Tavolinejad, H, 2021
)
1.75
"Sertraline is a reasonable first-line choice in patients with IHD and depression, whereas the role of citalopram as the first-line agent should be reconsidered."( Efficacy and acceptability of antidepressants in patients with ischemic heart disease: systematic review and meta-analysis.
Barbui, C; Caruso, R; Gastaldon, C; Grassi, L; Hotopf, M; Ostuzzi, G; Papola, D; Rayner, L; Turrini, G, 2019
)
1.24
"Sertraline (SRT) is a modern and relatively safe selective serotonin reuptake inhibitor often used in the treatment of depression. "( Sertraline - isolation methods and quantitation in biological material.
Dziurkowska, E; Wesolowski, M, 2018
)
3.37
"Sertraline (SRT) is an antidepressant that has proven its activity in vitro against Cryptococcus, Coccidioides, Trichosporon and other fungi. "( In vitro inhibitory activity of sertraline against clinical isolates of Sporothrix schenckii.
Bonifaz, A; González, GM; Hernández-Rodríguez, PA; Rojas, OC; Téllez-Marroquín, R; Treviño-Rangel, RJ; Villanueva-Lozano, H,
)
1.86
"Sertraline is an antidepressant drug which has been reported to cause extrapyramidal symptoms."( Brain and liver oxidative stress after sertraline and haloperidol treatment in mice.
Abdel-Salam, OM; Khadrawy, YA; Sleem, AA; Youness, ER, 2013
)
1.38
"Sertraline (Zoloft) is a selective serotonin reuptake inhibitor that is a commonly prescribed drug for the treatment of depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, premenstrual dysphoric disorder and post-traumatic stress disorder. "( Analysis of sertraline in postmortem fluids and tissues in 11 aviation accident victims.
Angier, MK; Johnson, RD; Lewis, RJ; Williamson, KS, 2013
)
2.21
"Sertraline is a widely-used antidepressant that is one of the selective serotonin reuptake inhibitors. "( Persistence and dissipation pathways of the antidepressant sertraline in agricultural soils.
Li, H; Sumarah, MW; Topp, E, 2013
)
2.08
"Sertraline is an apparent non-competitive inhibitor of hPAT1-mediated transport in vitro. "( Sertraline inhibits the transport of PAT1 substrates in vivo and in vitro.
Abdulhadi, S; Brodin, B; Frølund, S; Holm, R; Kall, MA; Langthaler, L; Nielsen, CU; Nøhr, MK; Sari, H, 2013
)
3.28
"Sertraline is a selective serotonin reuptake inhibitor and curcumin is the main ingredient of turmeric with neuroprotective effects."( Curcumin and sertraline prevent the reduction of the number of neurons and glial cells and the volume of rats' medial prefrontal cortex induced by stress.
Abdollahifar, MA; Asadi-Golshan, R; Karbalay-Doust, S; Noorafshan, A; Rashidian-Rashidabadi, A, 2014
)
1.49
"Sertraline is a first-line drug for breastfeeding women due to documented low levels of exposure in breastfeeding infants and very few adverse events described in case reports."( Sertraline and breastfeeding: review and meta-analysis.
Bogen, DL; Ciolino, JD; Hoxha, D; Pinheiro, E; Wisner, KL, 2015
)
2.58
"Sertraline is a selective serotonin reuptake inhibitor. "( Hypoglycemic episodes in a case of Prementrual Dysphoric Disorder on sertraline.
Banerjee, P; Chaudhuri, PR; Munshi, S; Santra Dhali, R,
)
1.81
"Sertraline is a selective serotonin reuptake inhibitor used as an antidepressant and antipanic agent in children and adolescents. "( Asynchronicity of Organic and Psychiatric Symptoms in a Case of Sertraline Intoxication.
Baratta, A; Marciano, S; Minnei, M; Pasini, A; Pitzianti, M,
)
1.81
"Sertraline is an effective drug in reducing this complaint possibly due to its effect on reducing inflammatory cytokines."( Sertraline can reduce uremic pruritus in hemodialysis patient: A double blind randomized clinical trial from Southern Iran.
Hashemi, N; Malekmakan, L; Pakfetrat, M; Tadayon, T, 2018
)
2.64
"Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) widely prescribed to patients suffering from psychiatric disorders. "( Aquatic ecotoxicity of the selective serotonin reuptake inhibitor sertraline hydrochloride in a battery of freshwater test species.
Davoren, M; Hernan, R; Lyng, FM; Minagh, E; O'Rourke, K, 2009
)
2.03
"Sertraline is a selective serotonin reuptake inhibitor."( Sertraline-associated hair loss.
Ghanizadeh, A, 2008
)
2.51
"Sertraline is a commonly prescribed selective serotonin reuptake inhibitor drug. "( Sertraline hepatotoxicity: report of a case and review of the literature.
Gunduz, F; Ozaras, R; Tabak, F; Tabak, O; Tahan, V, 2009
)
3.24
"Sertraline is a widely used antidepressant belonging to the selective serotonin reuptake inhibitor class; its efficacy has been demonstrated not only in the treatment of major depression, obsessive compulsive and panic disorders, but also for eating, premenstrual dysphoric and post-traumatic stress disorders. "( Analytical methodologies for the determination of sertraline.
Bosch, ME; Ojeda, CB; Rojas, FS; Sánchez, AJ, 2008
)
2.04
"Sertraline is a selective serotonin reuptake inhibitor (SSRI) prescribed as an antidepressant. "( Assessment of the toxicological interaction of sertraline with cholinesterase inhibiting insecticides in aquatic insects using the black fly, Simulium vittatum IS-7.
Armbrust, KL; Kellock, KA; Kwon, JW; Overmyer, JP; Smith, PF, 2010
)
2.06
"Sertraline is a selective serotonin reuptake inhibitor with established safety for the treatment of depression. "( Sinus arrest due to sertraline.
Eksi Duran, N; Kocabay, G; Ozkan, M; Yildiz, M, 2010
)
2.13
"Sertraline is a selective serotonin reuptake inhibitor that has been used and studied extensively throughout the world and found to be safe and well tolerated in numerous patient populations, including those with either psychiatric and/or medical comorbidities. "( An evidence-based review of the clinical use of sertraline in mood and anxiety disorders.
Kamijima, K; Sheehan, DV, 2009
)
2.05
"Sertraline is a selective serotonin reuptake inhibitor, which is a commonly used drug for major depressive disorder. "( Sertraline-induced ventricular tachycardia.
Golwala, H; Patel, NH; Schechter, E; Stavrakis, S,
)
3.02
"Sertraline (SRT) is a widely used antidepressant whose poor solubility in water limits its oral applicability. "( Multi-equilibrium system based on sertraline and β-cyclodextrin supramolecular complex in aqueous solution.
Barreto, EA; De Almeida, WB; De Sousa, FB; Lopes, JF; Lula, IS; Passos, JJ; Sinisterra, RD, 2011
)
2.09
"Sertraline is a naphthalenamine derivative which has the effect of selective serotonin reuptake inhibition. "( Open label, three period, single sequence, study of 5, 25, 50 mg sertraline pharmacokinetics in healthy male Korean volunteers.
Cho, JY; Jang, IJ; Kim, KP; Kim, TE; Park, MK; Shin, KH; Shin, SG; Yoon, SH; Yu, KS, 2011
)
2.05
"Sertraline is a commonly prescribed selective inhibitor of serotonin uptake used for the treatment of mental depression and anxiety. "( Sertraline concentrations and postmortem redistribution.
Mallett, P; McIntyre, IM, 2012
)
3.26
"Sertraline is a selective serotonin reuptake inhibitor (SSRI) with well established antidepressant and anxiolytic activity. "( Spotlight on sertraline in the management of major depressive disorder in elderly patients.
Muijsers, RB; Noble, S; Plosker, GL, 2002
)
2.13
"Sertraline is an effective and well tolerated antidepressant for the treatment of major depressive disorder in patients aged > or =60 years. "( Spotlight on sertraline in the management of major depressive disorder in elderly patients.
Muijsers, RB; Noble, S; Plosker, GL, 2002
)
2.13
"Sertraline is a naphthalenamine derivative with the predominant pharmacological action of inhibiting presynaptic reuptake of serotonin from the synaptic cleft. "( Clinical pharmacokinetics of sertraline.
DeVane, CL; Liston, HL; Markowitz, JS, 2002
)
2.05
"Sertraline is a basic compound and of pharmaceutical application for antidepressant treatment. "( Analytical method for the quantitation of sertraline hydrochloride stereoisomers by electrokinetic chromatography.
Foley, JP; Zhou, MX, 2004
)
2.03
"Sertraline is a selective serotonin reuptake inhibitor (SSRI) that is chemically unrelated to other SSRIs, tricyclic antidepressants, and other currently available antidepressant medications. "( A sertraline-intoxicated driver.
Goodson, LJ; Rohrig, TP,
)
2.3
"Sertraline hydrochloride is a selective serotonin reuptake inhibitor with demonstrated efficacy and safety for the treatment of the following disorders: major depressive, obsessive-compulsive, panic, premenstrual dysphoric, social anxiety, and posttraumatic stress. "( Coadministration of sertraline with cisapride or pimozide: an open-label, nonrandomized examination of pharmacokinetics and corrected QT intervals in healthy adult volunteers.
Alderman, J, 2005
)
2.09
"Sertraline is an effective antidepressant for postmenopausal women with MDD. "( Estrogen and response to sertraline in postmenopausal women with major depressive disorder: a pilot study.
Altshuler, LL; Brunhuber, MV; Dunkin, J; Elman, S; Fairbanks, L; Rapkin, A; Rasgon, NL; Troung, C; Wroolie, TE,
)
1.88
"Sertraline hydrochloride is a highly potent and selective inhibitor of serotonin (5HT). "( Ab initio and density functional computations of the vibrational spectrum, molecular geometry and some molecular properties of the antidepressant drug sertraline (Zoloft) hydrochloride.
Bayari, SH; Kandemirli, F; Sagdinc, S, 2007
)
1.98
"Sertraline seems to be an effective, well-tolerated treatment for pruritus due to chronic liver disease. "( Sertraline as a first-line treatment for cholestatic pruritus.
Getachew, Y; Handem, I; Jacobe, H; Mayo, MJ; Rush, AJ; Saldana, S, 2007
)
3.23
"Sertraline is an effective antidepressant acting as a selective serotonin reuptake inhibitor. "( Comparative abuse liability of sertraline, alprazolam, and dextroamphetamine in humans.
Busto, U; Kaplan, HL; Sellers, EM; Zawertailo, LA, 1995
)
2.02
"Sertraline is a highly specific, potent inhibitor of serotonin reuptake. "( The role of sertraline in the management of depression.
Shelton, RC,
)
1.95
"Sertraline is a potent inhibitor of serotonin reuptake in the central nervous system and is used clinically to treat depression and obsessive-compulsive behavior. "( Distribution of sertraline in postmortem cases.
Jenkins, AJ; Levine, B; Smialek, JE, 1994
)
2.08
"Sertraline is a new antidepressant that has potent and selective inhibition of neuronal serotonin reuptake."( Sertraline intoxication in a child.
Kaminski, CA; Robbins, MS; Weibley, RE, 1994
)
2.45
"Sertraline is a serotonin reuptake inhibitor that has been approved for use in the treatment of depression. "( Sertraline: a new antidepressant.
Auster, R, 1993
)
3.17
"Sertraline is an antidepressant which selectively inhibits the neuronal uptake of serotonin in the central nervous system. "( Hemodialyzability of sertraline.
Schwenk, MH; Verga, MA; Wagner, JD, 1995
)
2.05
"Sertraline is an antidepressant for which preliminary data suggest a low inherent toxicity. "( Analysis of sertraline-only overdoses.
Anderson, B; Klein-Schwartz, W, 1996
)
2.12
"Sertraline is a member of the newest class of antidepressants, the selective serotonin reuptake inhibitors. "( Orthostatic hypotension induced by sertraline withdrawal.
Amsden, GW; Georgian, F,
)
1.85
"Sertraline is a serotonin reuptake inhibitor. "( Influence of liver cirrhosis on sertraline pharmacokinetics.
Angebaud, P; Coates, P; Démolis, JL; Funck-Brentano, C; Grangé, JD; Jaillon, P, 1996
)
2.02
"Sertraline is a relatively selective serotonin reuptake inhibitor with some dopamine reuptake inhibitor activity."( Sertraline for the treatment of depression in Parkinson's disease.
Hauser, RA; Zesiewicz, TA, 1997
)
2.46
"Sertraline (Zoloft) is a selective serotonin reuptake inhibitor that is commonly used in adults in the treatment of mood and anxiety disorders. "( Pediatric sertraline overdose.
Catalano, G; Catalano, MC; Cooper, DS; Guttman, JM,
)
1.98
"Sertraline appears to be a useful agent in the pharmacological treatment of premature ejaculation."( Treatment of premature ejaculation with sertraline hydrochloride: a single-blind placebo controlled crossover study.
McMahon, CG, 1998
)
2.01
"Sertraline is an effective and well-tolerated treatment for patients with panic disorder."( Sertraline in the treatment of panic disorder: a double-blind multicenter trial.
Clary, CM; Pohl, RB; Wolkow, RM, 1998
)
3.19
"Sertraline appears to be a useful agent in the pharmacological treatment of premature ejaculation."( Treatment of premature ejaculation with sertraline hydrochloride.
McMahon, CG, 1998
)
2.01
"Sertraline is a selective serotonin reuptake inhibitor (SSRI) for which marketing approval has been obtained recently in Germany. "( Double-blind, multicenter comparative study of sertraline and amitriptyline in hospitalized patients with major depression.
Arató, M; Bauer, H; Gallinat, J; Hegerl, U; Janka, Z; Möller, HJ; Pflug, B, 1998
)
2
"Sertraline appears to be a safe and effective short-term treatment for children and adolescents with obsessive-compulsive disorder."( Sertraline in children and adolescents with obsessive-compulsive disorder: a multicenter randomized controlled trial.
Biederman, J; Cook, EH; Cutler, NR; Dominguez, R; Ferguson, J; March, JS; Mardekian, J; Muller, B; Riesenberg, R; Rosenthal, M; Safferman, A; Sallee, FR; Steiner, H; Wagner, KD; Wolkow, R, 1998
)
3.19
"Sertraline is a selective serotonin reuptake inhibitor that is approved by the U.S. "( Sertraline-induced panic attacks.
Catalano, G; Catalano, MC; Hakala, SM,
)
3.02
"Sertraline is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. "( The effect of sertraline on routine blood chemistry values.
Catalano, G; Catalano, MC; Kanfer, SN; Stock, SL; Taylor, WD; Toner, LC,
)
1.93
"Sertraline is an effective treatment for patients with generalized social phobia."( Sertraline treatment of generalized social phobia: a 20-week, double-blind, placebo-controlled study.
Bowen, RC; Chokka, PR; Goldner, EM; Hadrava, V; Johnston, DG; Lane, RM; Lavallee, YJ; Nandy, S; Pecknold, JC; Swinson, RP; Van Ameringen , MA; Walker, JR, 2001
)
3.2
"5. Sertraline was found to be a safe, well-tolerated, and effective as an antidepressant in elderly patients suffering from hypertension and other forms of vascular comorbidity."( Clinical and treatment response characteristics of late-life depression associated with vascular disease: a pooled analysis of two multicenter trials with sertraline.
Clary, CM; Doraiswamy, PM; Krishnan, KR, 2001
)
1.02
"Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI), and is an effective antidepressant agent."( Platelet inhibition by sertraline and N-desmethylsertraline: a possible missing link between depression, coronary events, and mortality benefits of selective serotonin reuptake inhibitors.
Gurbel, PA; O'Connor, CM; Serebruany, VL, 2001
)
1.34
"Sertraline is a widely used serotonin reuptake inhibitor that has been shown to have both antidepressant and antianxiety effects."( The selective serotonin reuptake inhibitor sertraline: its profile and use in psychiatric disorders.
Born, L; MacQueen, G; Steiner, M, 2001
)
1.29
"Sertraline is an effective treatment for generalised social phobia. "( Randomised controlled general practice trial of sertraline, exposure therapy and combined treatment in generalised social phobia.
Blomhoff, S; Haug, TT; Hellström, K; Holme, I; Humble, M; Madsbu, HP; Wold, JE, 2001
)
2.01
"Sertraline is a selective serotonin reuptake inhibitor (SSRI) and an effective antidepressant."( Up-regulation of tryptophan hydroxylase expression and serotonin synthesis by sertraline.
Hwang, O; Kim, SW; Park, SY, 2002
)
1.26
"Sertraline is a selective serotonin reuptake inhibitor (SSRI) with well established antidepressant and anxiolytic activity. "( Sertraline: a review of its use in the management of major depressive disorder in elderly patients.
Muijsers, RB; Noble, S; Plosker, GL, 2002
)
3.2
"Sertraline is an effective and well tolerated antidepressant for the treatment of major depressive disorder in patients aged > or =60 years. "( Sertraline: a review of its use in the management of major depressive disorder in elderly patients.
Muijsers, RB; Noble, S; Plosker, GL, 2002
)
3.2
"Sertraline is a selective inhibitor of central serotonin reuptake. "( Sertraline. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in depression and obsessive-compulsive disorder.
McTavish, D; Murdoch, D, 1992
)
3.17
"Sertraline is a non-tricyclic, potent and selective serotonin reuptake inhibitor (SSRI) which is currently approved for the treatment of depression in several countries, including the UK and the USA. "( Sertraline in the treatment of obsessive compulsive disorder: two double-blind, placebo-controlled studies.
Chouinard, G, 1992
)
3.17
"Sertraline hydrochloride is a new naphthylamino compound that specifically blocks neuronal reuptake of serotonin. "( Sertraline: a new specific serotonin reuptake blocker.
Guthrie, SK, 1991
)
3.17
"Sertraline is a new, selective serotonin (5HT) uptake inhibitor with antidepressant activity. "( Sertraline-induced desensitization of the serotonin 5HT-2 receptor transmembrane signaling system.
Breeding, M; Knoth, K; Sanders-Bush, E; Tsutsumi, M, 1989
)
3.16
"Sertraline is a member of a new class of psychotherapeutic agents that selectively inhibit serotonin reuptake in the brain. "( Pharmacology of sertraline: a review.
Heym, J; Koe, BK, 1988
)
2.06

Effects

Sertraline has a proved efficacy in post-traumatic stress disorder (PTSD), but it is unknown which symptoms respond or in what sequence this occurs. It has a linear pharmacokinetic profile and a half-life of about 26 h.

Sertraline has shown promise in the treatment of dialysis-associated hypotension (DAH) in a limited number of end-stage renal disease patients. It has not been associated with sedating or anticholinergic effects, psychomotor impairment, or cardiovascular toxicity.

ExcerptReferenceRelevance
"Sertraline has a low potential for drug interactions at the level of the cytochrome P450 enzyme system."( Spotlight on sertraline in the management of major depressive disorder in elderly patients.
Muijsers, RB; Noble, S; Plosker, GL, 2002
)
1.41
"Sertraline has a secondary amine group; therefore, we predicted that it may react with formalin to give N-methyl derivatives."( Conversion of sertraline to N-methyl sertraline in embalming fluid: a forensic implication.
Sai Prakash, PK; Suma, R,
)
1.21
"Sertraline has a linear pharmacokinetic profile and a half-life of about 26 h."( The selective serotonin reuptake inhibitor sertraline: its profile and use in psychiatric disorders.
Born, L; MacQueen, G; Steiner, M, 2001
)
1.29
"Sertraline has a low potential for drug interactions at the level of the cytochrome P450 enzyme system."( Sertraline: a review of its use in the management of major depressive disorder in elderly patients.
Muijsers, RB; Noble, S; Plosker, GL, 2002
)
2.48
"Sertraline has a proved efficacy in post-traumatic stress disorder (PTSD), but it is unknown which symptoms respond or in what sequence this occurs. "( Characterizing the effects of sertraline in post-traumatic stress disorder.
Clary, CM; Davidson, JR; Farfel, GM; Landerman, LR, 2002
)
2.05
"Sertraline has been shown to ameliorate the effects of CMS-induced depression."( Does Sertraline Affect Hypothalamic Food Intake Peptides in the Rat Experimental Model of Chronic Mild Stress-Induced Depression?
Gormus, ZIS; Gunes, CE; Koca, RO; Kutlu, S; Solak, H, 2022
)
1.96
"Sertraline has been shown to be effective in the treatment of depression. "( Selection of the optimal dose of sertraline for depression: A dose-response meta-analysis of randomized controlled trials.
Chen, Y; Li, J; Liu, Y; Luo, X; Ren, M; Si, T; Zhu, D, 2023
)
2.63
"Sertraline has in vitro and in vivo activity against Cryptococcus and is synergistic with fluconazole in mice."( Adjunctive sertraline for asymptomatic cryptococcal antigenemia: A randomized clinical trial.
Bangdiwala, AS; Boulware, DR; Hullsiek, KH; Kirumira, P; Meya, DB; Nalintya, E; Naluyima, R; Namanda, S; Nikweri, Y; Rajasingham, R; Rutakingirwa, MK; Skipper, CP; Turya, F, 2020
)
1.67
"Sertraline hydrochloride has low solubility and undergoes first-pass metabolism resulting in low bioavailability. "( Preparation and Optimization of Sertraline Hydrochloride Tablets with Improved Dissolution Through Crystal Modification.
Al-Nimry, SS; Jaber, MA, 2017
)
2.18
"Sertraline has been studied less extensively, and there have been a few studies concerning SSRIs that report follow-up data at more than 12 weeks of follow-up."( A randomized, double-blind trial comparing sertraline and fluoxetine 6-month treatment in obese patients with Binge Eating Disorder.
Brustolin, A; Campisi, S; Fassino, S; Lavagnino, L; Leombruni, P; Pierò, A, 2008
)
1.33
"Sertraline has been used as a treatment for anxiety disorders since the mid 1990s and has proven itself an effective, well-tolerated and economically viable treatment for panic disorder (PD) when used in the range of 50 to 175 mg per day. "( Sertraline in the treatment of panic disorder.
Clayton, AH; Hobgood, CD, 2009
)
3.24
"Sertraline has a low potential for drug interactions at the level of the cytochrome P450 enzyme system."( Spotlight on sertraline in the management of major depressive disorder in elderly patients.
Muijsers, RB; Noble, S; Plosker, GL, 2002
)
1.41
"Sertraline has minimal inhibitory effects on the major cytochrome P450 enzymes, and few drug-drug interactions of clinical significance have been documented."( Clinical pharmacokinetics of sertraline.
DeVane, CL; Liston, HL; Markowitz, JS, 2002
)
1.33
"Sertraline has shown promise in the treatment of dialysis-associated hypotension (DAH) in a limited number of end-stage renal disease patients. "( Addition of sertraline to other therapies to reduce dialysis-associated hypotension.
Abu-Alfa, AK; Brewster, UC; Ciampi, MA; Perazella, MA, 2003
)
2.14
"Sertraline has a secondary amine group; therefore, we predicted that it may react with formalin to give N-methyl derivatives."( Conversion of sertraline to N-methyl sertraline in embalming fluid: a forensic implication.
Sai Prakash, PK; Suma, R,
)
1.21
"Sertraline has not been associated with sedating or anticholinergic effects, psychomotor impairment, or cardiovascular toxicity."( The role of sertraline in the management of depression.
Shelton, RC,
)
1.23
"Sertraline has dose-proportional changes in plasma concentrations, in contrast to fluoxetine and paroxetine."( Targeted pharmacotherapy in depression management: comparative pharmacokinetics of fluoxetine, paroxetine and sertraline.
Preskorn, S, 1994
)
1.22
"Sertraline treatment has negative effects on sexual function and performance in both sexes, while nefazodone has none."( Nefazodone versus sertraline in outpatients with major depression: focus on efficacy, tolerability, and effects on sexual function and satisfaction.
Feiger, A; Kiev, A; Shrivastava, RK; Wilcox, CS; Wisselink, PG, 1996
)
1.35
"Sertraline use has been increasing secondary to its efficacy and its more tolerable side effect profile than the tricyclic antidepressants."( Pediatric sertraline overdose.
Catalano, G; Catalano, MC; Cooper, DS; Guttman, JM,
)
1.26
"Sertraline has been tested extensively in the treatment of panic and obsessive-compulsive disorders."( Sertraline in the treatment of anxiety disorders.
Hirschfeld, RM, 2000
)
2.47
"Sertraline has a linear pharmacokinetic profile and a half-life of about 26 h."( The selective serotonin reuptake inhibitor sertraline: its profile and use in psychiatric disorders.
Born, L; MacQueen, G; Steiner, M, 2001
)
1.29
"Sertraline has been shown to blunt postprandial hyperglycemia in rats and to potentiate the hypoglycemic effects of sulfonylurea agents in humans. "( Sertraline-induced hypoglycemia.
Fraser, AD; Mukherjee, SD; Pollak, PT, 2001
)
3.2
"Sertraline (SRT) has been shown to be an effective antidepressant in extensive clinical trial programs but data on plasma concentrations regarding clinical outcome and tolerability are lacking. "( Clinical outcome and tolerability of sertraline in major depression: a study with plasma levels.
Boscati, L; Cerveri, G; Laini, V; Malvini, L; Manfré, S; Mauri, MC; Panza, G; Regispani, F; Scalvini, ME; Volonteri, LS, 2002
)
2.03
"Sertraline has a low potential for drug interactions at the level of the cytochrome P450 enzyme system."( Sertraline: a review of its use in the management of major depressive disorder in elderly patients.
Muijsers, RB; Noble, S; Plosker, GL, 2002
)
2.48
"Sertraline has a proved efficacy in post-traumatic stress disorder (PTSD), but it is unknown which symptoms respond or in what sequence this occurs. "( Characterizing the effects of sertraline in post-traumatic stress disorder.
Clary, CM; Davidson, JR; Farfel, GM; Landerman, LR, 2002
)
2.05
"Sertraline has minimal anticholinergic activity, is essentially devoid of cardiovascular effects, has a wide therapeutic index and may be administered to elderly patients or those with underlying cardiovascular disorders."( Sertraline. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in depression and obsessive-compulsive disorder.
McTavish, D; Murdoch, D, 1992
)
2.45
"Sertraline has been found to be superior to placebo and equivalent to amitriptyline in treatment of depression."( Paroxetine, sertraline, and fluvoxamine: new selective serotonin reuptake inhibitors.
Grimsley, SR; Jann, MW, 1992
)
1.38

Actions

Sertraline may produce dual neurotransmitter effects similar to the serotonin-norepinephrine reuptake inhibitors (SNRIs) It has been tested against an SNRI in only 1 previous study, and never at an optimal dose. Sertralines inhibit weight gain and decrease food intake without affecting locomotion in rats and genetically obese (ob/ob) mice.

ExcerptReferenceRelevance
"Sertraline led to an increase in fish aggression and more repeatable/consistent behaviour compared to control fish."( Aggression repeatability in stressed fish in response to an environmental concentration of sertraline and lunar cycle as evidenced by brain metabolomics.
Douda, K; Grabic, R; Grabicová, K; Horký, P; Hubená, P; Randák, T; Slavík, O, 2023
)
1.85
"Only sertraline was able to increase transepithelial electrical resistance in the rat colon both when used in an ex vivo (0.8 μg/mL, 180 min) or in vivo (30 mg/kg p.o., 20 days) fashion. "( Sertraline and Citalopram Actions on Gut Barrier Function.
Beltrán, CJ; Bravo, JA; Escobar-Luna, J; Eyzaguirre-Velásquez, J; González-Arancibia, C; González-Toro, MP; Julio-Pieper, M, 2021
)
2.58
"Sertraline could inhibit cell proliferation and induce apoptosis. "( [Experimental Study on Apoptosis of Kasumi-1 Cells Induced by Sertraline and Its Molecular Mechanism].
Pan, XR; Tong, JH; Xia, D; Yan, WW; Zhang, YT, 2015
)
2.1
"Sertraline had lower total costs per QALY than venlafaxine (34,788 Baht vs."( Switching to sertraline or venlafaxine after failure of SSRIs treatment in major depressive disorder: an economic evaluation of the STAR*D trial.
Leelahanaj, T, 2012
)
1.47
"Sertraline did not produce a significant decline in vigilance performance, presumably due to its concomitant effects on dopamine activity, counteracting the negative effects of serotonin on dopamine neurotransmission."( Additional dopamine reuptake inhibition attenuates vigilance impairment induced by serotonin reuptake inhibition in man.
Kruizinga, MJ; Ramaekers, JG; Riedel, WJ; Schmitt, JA; van Boxtel, MP; Vuurman, EF, 2002
)
1.04
"Sertraline may produce dual neurotransmitter effects similar to the serotonin-norepinephrine reuptake inhibitors (SNRIs); however, it has been tested against an SNRI in only 1 previous study, and never at an optimal dose. "( A randomized, double-blind, active-control study of sertraline versus venlafaxine XR in major depressive disorder.
Dunner, DL; Haman, KL; Hirschfeld, RM; Kiev, A; Lydiard, RB; Rapaport, MH; Shelton, RC; Smith, WT; Zajecka, JM, 2006
)
2.03
"Sertraline was found to inhibit weight gain and decrease food intake without affecting locomotion in rats and genetically obese (ob/ob) mice. "( Sertraline, a serotonin-uptake inhibitor, reduces food intake and body weight in lean rats and genetically obese mice.
Chapin, DS; Johnson, JL; Nielsen, JA; Torgersen, LK, 1992
)
3.17

Treatment

Sertraline treatment reduced TCTP expression in BC cell lines, significantly impacting cell viability, clonogenicity, and migration. Treatment resulted in up-regulation of brain BDNF, phospho-ERK and Bcl-2.

ExcerptReferenceRelevance
"Sertraline treatment reduced TCTP expression in BC cell lines, significantly impacting cell viability, clonogenicity, and migration."( Sertraline as a potential cancer therapeutic approach: Biological relevance of TCTP in breast cancer cell lines and tumors.
Baldissera, AB; Basílio, ABC; Boia-Ferreira, M; Castro, MAA; Chaim, OM; Gremski, LH; Resende, JSS; Senff-Ribeiro, A; Veiga, SS, 2023
)
3.07
"Sertraline in the treatment of Major Depressive Disorder (MDD) in South Korean participants."( Effects of transcranial direct current stimulation using miniaturized devices vs sertraline for depression in Korea: A 6 week, multicenter, randomized, double blind, active-controlled study.
Choi, WJ; Kim, B; Kim, S; Kim, WJ; Park, JY; Park, S; Roh, D; Son, SJ, 2020
)
1.51
"Sertraline treatments improved larval survival and health index score, especially at doses of 10 and 15 mg/kg. "( In vivo evaluation of the antifungal activity of sertraline against Aspergillus fumigatus.
Becerril-García, MA; González, GM; Méndez-Galomo, KS; Montoya, AM; Robledo-Leal, ER; Solís-Villegas, EM; Treviño-Rangel, RJ; Villanueva-Lozano, H, 2019
)
2.21
"Sertraline treatment resulted in up-regulation of brain BDNF, phospho-ERK and Bcl-2 that may be involved in the pro-cognitive effect of sertraline."( Neuroprotective and procognitive effects of sertraline: in vitro and in vivo studies.
Gil-Ad, I; Miron, O; Taler, M; Weizman, A, 2013
)
1.37
"In sertraline-treated cells, the induction of apoptosis and cell death was shown to be the result of activation of JNK, but not ERK1/2 or p38 in the mitogen-activated protein kinase (MAPK) pathway."( Sertraline, an antidepressant, induces apoptosis in hepatic cells through the mitogen-activated protein kinase pathway.
Chen, S; Couch, L; Dobrovolsky, VN; Guo, L; Lin, H; Mei, N; Wan, L; Xuan, J, 2014
)
2.36
"Sertraline treatment led to a significant increase in brain-RSA covariation for patients compared with controls, despite a lack of improvement in mean RSA."( Partial Amelioration of Medial Visceromotor Network Dysfunction in Major Depression by Sertraline.
Allen, JJ; Lane, RD; Mercado, RA; Schafer, SM; Thayer, JF; Wager, TD, 2015
)
1.36
"Sertraline treatment prevented increases in body weight, fat, insulin, and HOMA-IR (all p<0.05), without significantly altering activity levels."( Sertraline inhibits increases in body fat and carbohydrate dysregulation in adult female cynomolgus monkeys.
Appt, SE; Carr, JJ; Clarkson, TB; Jones, SR; Kritchevsky, SB; Register, TC; Shively, CA; Silverstein-Metzler, MG, 2016
)
2.6
"Sertraline might be a treatment for patients with ESRD who do not respond to other routine drugs."( Sertraline can reduce uremic pruritus in hemodialysis patient: A double blind randomized clinical trial from Southern Iran.
Hashemi, N; Malekmakan, L; Pakfetrat, M; Tadayon, T, 2018
)
2.64
"In sertraline-treated rats, E(2) decreased 5-HT(2A) receptor mRNA, and E(2)-withdrawal increased 5-HT(1A), 5-HT(2A) and 5-HT(2C) receptor mRNA."( Estradiol-sertraline synergy in ovariectomized rats.
Craft, RM; Cunningham, KA; Seitz, PK; Sell, SL; Stutz, SJ; Thomas, ML, 2008
)
1.26
"Sertraline treatment significantly reduced the BDI score as compared with both baseline and placebo."( Effects of selective serotonin reuptake inhibitor therapy on endothelial function and inflammatory markers in patients with coronary heart disease.
Angeloni, L; Costa, GM; Fontana, F; Mancini, S; Manzoli, L; Pizzi, C, 2009
)
1.07
"Sertraline treatment reduces MSNA at rest and during mental challenge in depressed patients, which may have prognostic implications in this group."( Muscle sympathetic nervous activity in depressed patients before and after treatment with sertraline.
Azul, JB; Kuniyoshi, FH; Laterza, MC; Lotufo-Neto, F; Negrão, CE; Pullenayegum, EM; Rondon, MU; Scalco, AZ; Scalco, MZ; Trombetta, IC; Wajngarten, M, 2009
)
1.3
"Sertraline treatment improved BDI score of patients with depression (P < 0.001)."( Sertraline treatment is associated with an improvement in depression and health-related quality of life in chronic peritoneal dialysis patients.
Atalay, H; Biyik, M; Biyik, Z; Guney, I; Solak, Y; Tonbul, HZ; Turk, S; Uguz, F; Yeksan, M, 2010
)
2.52
"Sertraline-treated patients experienced more adverse events, most notably gastrointestinal and respiratory, than placebo-treated patients."( Sertraline for the treatment of depression in Alzheimer disease.
Drye, LT; Frangakis, C; Lyketsos, CG; Martin, BK; Meinert, CL; Mintzer, JE; Munro, CA; Porsteinsson, AP; Rabins, PV; Rosenberg, PB; Schneider, LS; Weintraub, D, 2010
)
2.52
"Sertraline treatment is not associated with delayed improvement between 12 and 24 weeks of treatment and may not be indicated for the treatment of depression of AD."( Sertraline for the treatment of depression in Alzheimer disease: week-24 outcomes.
Drye, LT; Frangakis, C; Lyketsos, CG; Martin, BK; Meinert, CL; Mintzer, JE; Munro, CA; Porsteinsson, AP; Rabins, PV; Rosenberg, PB; Schneider, LS; Weintraub, D, 2010
)
3.25
"Sertraline treatment for depression."( Prodromal dementia with lewy bodies manifesting as sertraline-induced parkinsonism: a case report.
Kim, I; Kim, JH; Kim, YJ; Lee, BC; Ma, HI; Park, J; Yu, KH,
)
1.83
"Sertraline treatment reduced the depression-like effect in EC and SC, but not in IC."( Effects of sertraline on behavioral alterations caused by environmental enrichment and social isolation.
Erol, K; Ulupinar, E; Yildirim, E, 2012
)
1.49
"Sertraline treatment."( Cognitive improvement following treatment in late-life depression: relationship to vascular risk and age of onset.
Barch, DM; Doraiswamy, PM; DʼAngelo, G; Garcia, KS; Gersing, K; Pieper, C; Sheline, YI; Taylor, W; Welsh-Bohmer, K; Wilkins, CH, 2012
)
1.82
"sertraline-treated cells."( Accumulation of an antidepressant in vesiculogenic membranes of yeast cells triggers autophagy.
Chen, J; Korostyshevsky, D; Lee, S; Perlstein, EO, 2012
)
1.1
"The sertraline-treated rats showed a significant reduction in clinical arthritis compared to controls, at all doses given, accompanied by a significant increase in interleukin 10 and a decrease in tumor necrosis factor-α levels and cycloxygenase-2 production, without lymphotoxicity. "( Immunomodulatory effect of sertraline in a rat model of rheumatoid arthritis.
Baharav, E; Bar, M; Gil-Ad, I; Karp, L; Taler, M; Weinberger, A; Weizman, A, 2012
)
1.23
"Sertraline treatment did not modify the symptoms, which may suggest different mechanisms with regard to different antidepressant drug discontinuation syndromes."( Moclobemide discontinuation syndrome predominantly presenting with influenza-like symptoms.
Berney, P; Curtin, F; Kaufmann, C, 2002
)
1.04
"Sertraline treatment produced a lower total withdrawal symptom score and less irritability, anxiety, craving, and restlessness than placebo. "( A randomized trial of sertraline as a cessation aid for smokers with a history of major depression.
Covey, LS; Glassman, AH; Rivelli, S; Stage, K; Stetner, F, 2002
)
2.07
"Sertraline treatment of Candida spp."( Interaction of sertraline with Candida species selectively attenuates fungal virulence in vitro.
Dierich, MP; Fuchs, A; Fuchs, D; Kacani, L; Lass-Flörl, C; Ledochowski, M; Speth, C; Würzner, R, 2003
)
1.39
"Sertraline treatment decreased the symptoms of PTSD; however this was not accompanied by a significant increase in neopterin production."( Neopterin production in posttraumatic stress disorder before and after pharmacotherapy.
Atmaca, M; Kuloglu, M; Onal, S; Tezcan, E, 2003
)
1.04
"Sertraline-treated patients showed a significant improvement on the anxiety/ depression subscale of the BPRS on ITT analysis (F = 10.1, p = 0.004)."( A double-blind, placebo-controlled trial of sertraline for depressive symptoms in patients with stable, chronic schizophrenia.
Cooper, SJ; King, DJ; Lynch, G; Mulholland, C, 2003
)
1.3
"The sertraline-treated group had greater improvements in the scores for the Cornell Scale for Depression in Dementia (P =.002) and Hamilton Depression Rating Scale (P =.01), and a statistical trend toward less decline in activities of daily living on the Psychogeriatric Depression Rating Scale-activities of daily living subscale (P =.07)."( Treating depression in Alzheimer disease: efficacy and safety of sertraline therapy, and the benefits of depression reduction: the DIADS.
Baker, AS; Brandt, J; DelCampo, L; Frangakis, C; Lyketsos, CG; Miles, Q; Munro, C; Rabins, PV; Sheppard, JM; Steele, CD; Steinberg, M, 2003
)
1.04
"Sertraline-treated patients experienced statistically significantly greater improvement than placebo patients on the CDRS-R total score (mean change at week 10, -30.24 vs -25.83, respectively; P =.001; overall mean change, -22.84 vs -20.19, respectively; P =.007). "( Efficacy of sertraline in the treatment of children and adolescents with major depressive disorder: two randomized controlled trials.
Ambrosini, P; Childress, A; Deas, D; Donnelly, C; Greenbaum, MS; Rynn, M; Wagner, KD; Wohlberg, C; Yang, R, 2003
)
2.14
"Sertraline-treated patients in the comorbid group had similar adverse events and discontinuations when compared to those in the noncomorbid group."( Efficacy, safety, and tolerability of sertraline in patients with late-life depression and comorbid medical illness.
Burt, T; Cassidy, EL; Clary, CM; Doraiswamy, PM; Holland, PJ; Hornig, M; Mandel, FS; Salomon, RM; Sheikh, JI, 2004
)
1.32
"More sertraline-treated subjects reported improved functioning in the domains of family relationships, social activities, and sexual activity."( Continuous or intermittent dosing with sertraline for patients with severe premenstrual syndrome or premenstrual dysphoric disorder.
Freeman, EW; Polansky, M; Rickels, K; Sondheimer, SJ; Xiao, S, 2004
)
1.05
"Sertraline is the only treatment for major depressive disorder studied in a placebo-controlled trial of patients with ACS and found to be safe and effective."( Pharmacoeconomic analysis of sertraline treatment of depression in patients with unstable angina or a recent myocardial infarction.
Glassman, AH; Harrison, DJ; O'Connor, CM, 2005
)
1.34
"Sertraline treatment of major depressive disorder following hospitalization for a recent myocardial infarction or unstable angina appears to be a cost-effective strategy."( Pharmacoeconomic analysis of sertraline treatment of depression in patients with unstable angina or a recent myocardial infarction.
Glassman, AH; Harrison, DJ; O'Connor, CM, 2005
)
2.06
"Sertraline-treated participants with less severe alcohol dependence and early-onset PTSD had significantly fewer drinks per drinking day (p < 0.001)."( Sertraline in the treatment of co-occurring alcohol dependence and posttraumatic stress disorder.
Anton, RF; Back, SE; Brady, KT; Randall, CL; Simpson, K; Sonne, S, 2005
)
2.49
"Sertraline treatment demonstrated efficacy for both the psychic and somatic anxiety symptoms of GAD."( Sertraline in generalized anxiety disorder: efficacy in treating the psychic and somatic anxiety factors.
Allgulander, C; Austin, C; Burt, T; Dahl, AA; Kutcher, SP; Ravindran, A, 2005
)
3.21
"Both sertraline treatment and symptomatic recovery from depression were associated with increased HRV compared with placebo-treated and nonrecovered post-ACS control groups, respectively, but this results primarily from decreased HRV in the comparison groups."( Heart rate variability in acute coronary syndrome patients with major depression: influence of sertraline and mood improvement.
Bigger, JT; Gaffney, M; Glassman, AH; Van Zyl, LT, 2007
)
1.01
"Sertraline treatment improved the motor performance in R6/2 mice, but did not affect nontransgenic mice."( The antidepressant sertraline improves the phenotype, promotes neurogenesis and increases BDNF levels in the R6/2 Huntington's disease mouse model.
Duan, W; Jiang, M; Li, Q; Masuda, N; Peng, Q; Ross, CA; Zhao, M, 2008
)
1.4
"Sertraline-treated patients demonstrated a significant improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression (CGI) severity scores compared with placebo-treated patients, while dothiepin-treated patients did not show significant improvement compared with placebo."( Management of depression in real-life settings: knowledge gained from large-scale clinical trials.
Thompson, C, 1994
)
1.01
"For sertraline-treated patients with depression included on their computerized medical problem list, the mean daily dose was 57 +/- 25 mg for the first prescription and 110 +/- 65 mg for the ninth."( Selective serotonin reuptake inhibitor dose titration in the naturalistic setting.
Coons, SJ; Gregor, KJ; McDonald, RC; Overhage, JM,
)
0.61
"Sertraline treatment decreased apomorphine-induced hypothermia by almost half in FSLs, whereas slight hyperthermia was induced in FRL rats instead."( Effect of chronic antidepressant treatment on responses to apomorphine in selectively bred rat strains.
Overstreet, DH; Pucilowski, O, 1993
)
1.01
"Sertraline treatment has negative effects on sexual function and performance in both sexes, while nefazodone has none."( Nefazodone versus sertraline in outpatients with major depression: focus on efficacy, tolerability, and effects on sexual function and satisfaction.
Feiger, A; Kiev, A; Shrivastava, RK; Wilcox, CS; Wisselink, PG, 1996
)
1.35
"Sertraline treatment increases average expenditures for physician visits ($21.74; P < or = 0.05), psychiatric visits ($56.79; P < or = 0.05), laboratory tests ($1.21; P < or = 0.05), hospitalizations ($70.59; P < or = 0.05), psychiatric hospitalizations ($95.75; P < or = 0.05), and antidepressant pharmacotherapy ($69.85; P < or = 0.05), for a total per capita increase in health service use of $315.96 (P < or = 0.05), compared with treatment with fluoxetine."( Antidepressant pharmacotherapy: economic evaluation of fluoxetine, paroxetine and sertraline in a health maintenance organization.
Buesching, DP; Galin, RS; Hughes, TE; Legg, RF; Morgan, M; Nemec, NL; Robison, LM; Sclar, DA; Skaer, TL,
)
1.08
"Sertraline treatment produced significant improvements relative to placebo in time to ejaculation and number of successful attempts at intercourse, as well as overall clinical judgements of improvement."( Sertraline treatment for premature ejaculation.
Camera, A; Mendels, J; Sikes, C, 1995
)
2.46
"Sertraline treatment did not affect Kd and Bmax of [3H]CGP12177 and [3H]ketanserin bindings or cAMP, accumulation by norepinephrine, isoproternol, 5'-guanylylimidodiphosphate [Gpp(NH)p] and forskolin in the cortical membrane compared with vehicle-treated rats."( Behavioral stimulation without alteration of beta and 5-HT receptors and adenylate cyclase activity in rat brain after chronic sertraline administration.
Kamijima, K; Kiuchi, Y; Nara, K; Oguchi, K; Tadokoro, C; Yamazaki, Y, 1997
)
1.22
"Sertraline treatment led to significant reductions in mean visual analog scale (VAS) ratings, e.g., pain from 71.2 to 23.1 (t = 3.74, p < .01) and paresthesias from 53.8 to 15.0 (t = 4.15, p < .01)."( Sertraline in diabetic neuropathy: preliminary results.
Goodnick, PJ; Jimenez, I; Kumar, A, 1997
)
2.46
"Sertraline treatment was ineffective in reducing consumption during the stressful period of home-cage reunion, a period characterized by high levels of aggressive behavior."( The serotonin reuptake inhibitor sertraline reduces excessive alcohol consumption in nonhuman primates: effect of stress.
Hasert, M; Higley, J; Linnoila, M; Suomi, S, 1998
)
1.3
"Sertraline-treated patients also showed greater improvement that was statistically significant on several ratings of panic disorder symptomatology and functioning."( Methodologies and outcomes from the sertraline multicenter flexible-dose trials.
Clary, CM; Rapaport, MH; Wolkow, RM, 1998
)
1.3
"Sertraline-treated patients also had significantly more improvement than placebo-treated patients in scores on the Quality of Life Enjoyment and Satisfaction Questionnaire, patient global evaluation, and Clinical Global Impression severity of illness and global improvement scales."( Sertraline in the treatment of panic disorder: a double-blind multicenter trial.
Clary, CM; Pohl, RB; Wolkow, RM, 1998
)
2.46
"Sertraline-treated patients exhibited significantly greater improvement (P=.01) at end point than did patients treated with placebo for the primary outcome variable, panic attack frequency. "( Sertraline in the treatment of panic disorder: a flexible-dose multicenter trial.
Manfro, GG; Otto, MW; Pollack, MH; Wolkow, R; Worthington, JJ, 1998
)
3.19
"Sertraline treatment had a significantly more positive effect, when compared to nortriptyline, across almost all associated measures of cognitive function, energy, anxiety, and quality of life and was better tolerated than nortriptyline, with a lower attrition rate/side effect burden."( Comparative efficacy and safety of sertraline versus nortriptyline in major depression in patients 70 and older.
Clary, CM; Finkel, SI; Richter, EM, 1999
)
1.3
"Sertraline treatment was associated with clinical improvement and was well tolerated in >85% of the patients in this open-label treatment trial for patients with major depression after myocardial infarction. "( An open-label preliminary trial of sertraline for treatment of major depression after acute myocardial infarction (the SADHAT Trial). Sertraline Anti-Depressant Heart Attack Trial.
Baker, B; Dorian, P; Frasure-Smith, N; Glassman, AH; Harrison, W; Jiang, JW; Lespérance, F; O'Connor, CM; Shapiro, PA, 1999
)
2.02
"Sertraline treatment effectively reduces the clinical symptoms and functional impairments associated with dysthymia. "( Treatment of primary dysthymia with group cognitive therapy and pharmacotherapy: clinical symptoms and functional impairments.
Anisman, H; Bialik, RJ; Charbonneau, Y; Ellis, J; Griffiths, J; Merali, Z; Ravindran, AV; Telner, J; Wiens, A, 1999
)
1.75
"Sertraline-treated patients showed statistically greater cognitive improvement on several measures."( A double-blind comparison of sertraline and fluoxetine in depressed elderly outpatients.
Batzar, ED; Clary, CM; Doraiswamy, PM; Krishnan, KR; Newhouse, PA; Richter, EM, 2000
)
1.32
"Sertraline treatment seemed to provide an advantage in reducing drinking in alcohol-dependent patients without lifetime depression, illustrated best with a measure of drinking frequency during treatment."( Double-blind clinical trial of sertraline treatment for alcohol dependence.
Cnaan, A; Kranzler, HR; Luck, G; Pettinati, HM; Rukstalis, MR; Volpicelli, JR, 2001
)
1.32
"4. Sertraline treatment yielded comparable levels of response in all 3 groups (response criterion: CGI-much or very much improved) at treatment endpoint on both a completer analysis (HTN, 86%; VASC, 89%; NoVASC, 77%) and significantly higher response rates on a 12-week endpoint analysis (HTN, 74%; VASC, 69%; NoVASC, 58%; p < 0.05)."( Clinical and treatment response characteristics of late-life depression associated with vascular disease: a pooled analysis of two multicenter trials with sertraline.
Clary, CM; Doraiswamy, PM; Krishnan, KR, 2001
)
1.02
"Sertraline treatment was well tolerated, with a 9% discontinuation rate because of adverse events, compared with 5% for placebo."( Multicenter, double-blind comparison of sertraline and placebo in the treatment of posttraumatic stress disorder.
Davidson, JR; Farfel, GM; Rothbaum, BO; Sikes, CR; van der Kolk, BA, 2001
)
1.3
"Sertraline-treated patients were significantly more improved than non-sertraline-treated patients (chi(2)=12.53, P<0.001; odds ratio=0.534; 95% Cl 0.347-0.835). "( Randomised controlled general practice trial of sertraline, exposure therapy and combined treatment in generalised social phobia.
Blomhoff, S; Haug, TT; Hellström, K; Holme, I; Humble, M; Madsbu, HP; Wold, JE, 2001
)
2.01
"Sertraline, as drug for treatment, has been chosen since its clinical uses range from treatment of depression to that of many other psychiatric clinical conditions so that it has been thought to be a good candidate to this type of study."( A neural network approach to the outcome definition on first treatment with sertraline in a psychiatric population.
Bellodi, L; Franchini, L; Politi, E; Rossini, D; Smeraldi, E; Spagnolo, C, 2001
)
1.26
"Sertraline treatment was associated with marked improvement on all QOL/functional measurements: at the end of the acute treatment phase, 58% of responders on treatment with sertraline had achieved Q-LES-Q total scores within 10% of community norms."( Posttraumatic stress disorder and quality of life: results across 64 weeks of sertraline treatment.
Clary, CM; Endicott, J; Rapaport, MH, 2002
)
1.26
"Sertraline treatment of chronic PTSD is associated with rapid improvement in quality of life that is progressive and sustained over the course of more than 1 year of treatment."( Posttraumatic stress disorder and quality of life: results across 64 weeks of sertraline treatment.
Clary, CM; Endicott, J; Rapaport, MH, 2002
)
1.99
"Sertraline treatment also resulted in a higher proportion of remissions than fluoxetine (defined as a CGI-I ( Sertraline and fluoxetine treatment of obsessive-compulsive disorder: results of a double-blind, 6-month treatment study.
Austin, C; Bergeron, R; Chaput, Y; Goldner, E; Hadrava, V; Ravindran, AV; Swinson, R; van Ameringen, MA, 2002
)
2.48
"Sertraline treatment was well tolerated, with a 13% discontinuation rate as a result of adverse events."( Double-blind placebo-controlled pilot study of sertraline in military veterans with posttraumatic stress disorder.
Amital, D; Austin, C; Bleich, A; Kotler, M; Lane, RM; Miodownik, C; Zohar, J, 2002
)
1.29
"Treatment with sertraline with or without ketoprofen significantly reduced the baseline levels of all biomarkers to levels which were in the normal range (IDO, TGF-β1, and IL-4) or still somewhat higher than in controls (IFN-γ)."( Plasma Indoleamine-2,3-Dioxygenase (IDO) is Increased in Drug-Naï ve Major Depressed Patients and Treatment with Sertraline and Ketoprofen Normalizes IDO in Association with Pro-Inflammatory and Immune- Regulatory Cytokines.
Al-Dujaili, AH; Al-Hakeim, HK; Maes, M; Twayej, AJ, 2020
)
1.11
"Treatment with sertraline was then commenced with an objective improvement of his cognitive and behavioral status."( Efficacy of sertraline in a patient with Neuro-Beçhet's disease.
Bruno, G; Canevelli, M; Letteri, F; Tosto, G, 2013
)
1.11
"Pretreatment with sertraline, previously shown to prevent hypoglycemia-associated glucoregulatory failure, did not prevent blunting of hypoglycemia-induced CPP prevention by recurrent hypoglycemia."( Orexin signaling is necessary for hypoglycemia-induced prevention of conditioned place preference.
Dunn-Meynell, A; Levin, BE; Otlivanchik, O; Sanders, NM, 2016
)
0.76
"Treatment with sertraline (mean dose 66.0 +/- 29.8 mg) resulted in improvement in all UPDRS domains along with a significant decrease of the HADS scores. "( Motor changes during sertraline treatment in depressed patients with Parkinson's disease*.
García-Sánchez, C; Gironell, A; Kulisevsky, J; Martínez-Corral, M; Pagonabarraga, J; Pascual-Sedano, B, 2008
)
1.02
"Treatment with sertraline (5 and 10 mg/kg) significantly reversed behavioral, biochemical and mitochondrial enzyme dysfunctions in 3-nitropropionic acid treated group."( Possible role of sertraline against 3-nitropropionic acid induced behavioral, oxidative stress and mitochondrial dysfunctions in rat brain.
Kumar, A; Kumar, P, 2009
)
1.03
"Treatment with sertraline improves depressive symptoms and reduces plasma markers of oxidative stress in depressed CHF patients."( Effects of sertraline on circulating markers of oxidative stress in depressed patients with chronic heart failure: a pilot study.
Andreadou, I; Antonellos, N; Douzenis, A; Ikonomidis, I; Kremastinos, D; Lykouras, E; Markantonis-Kiroudis, S; Michalakeas, CA; Nikolaou, M; Paraskevaidis, I; Parissis, JT; Varounis, C, 2011
)
1.1
"Treatment with sertraline significantly reduced all these parameters (respectively: +19.8 ± 6.9%, -3.3 ± 2 mmHg, -13.1 ± 10.8 bpm, -9.8 ± 5.7 cpm) and serum 5-HT level dropped to 634 ± 69 ng/mL (P < 0.05)."( Sertraline inhibits formalin-induced nociception and cardiovascular responses.
Abreu, GR; Futuro Neto, HA; Gonçalves, WL; Gouvea, SA; Pires, JG; Santuzzi, CH; Tiradentes, RV, 2012
)
2.16
"Treatment with sertraline in patients with dAD is not associated with greater improvement in cognition at week 24 than treatment with placebo."( Cognitive outcomes after sertaline treatment in patients with depression of Alzheimer disease.
Drye, LT; Frangakis, CE; Longmire, CF; Lyketsos, CG; Martin, BK; Meinert, CL; Mintzer, JE; Munro, CA; Porsteinsson, AP; Rabins, PV; Rosenberg, PB; Schneider, LS; Weintraub, D, 2012
)
0.73
"Treatment with sertraline was associated with substantially less release of platelet/endothelial biomarkers than was treatment with placebo."( Platelet/endothelial biomarkers in depressed patients treated with the selective serotonin reuptake inhibitor sertraline after acute coronary events: the Sertraline AntiDepressant Heart Attack Randomized Trial (SADHART) Platelet Substudy.
Califf, RM; Finkel, MS; Gaffney, M; Glassman, AH; Harrison, W; Krishnan, KR; Malinin, AI; Musselman, DL; Nemeroff, CB; O'Connor, CM; Serebruany, VL; van Zyl, LT, 2003
)
0.87
"Treatment with sertraline in depressed post-ACS patients is associated with reductions in platelet/endothelial activation despite coadministration of widespread antiplatelet regimens including aspirin and clopidogrel. "( Platelet/endothelial biomarkers in depressed patients treated with the selective serotonin reuptake inhibitor sertraline after acute coronary events: the Sertraline AntiDepressant Heart Attack Randomized Trial (SADHART) Platelet Substudy.
Califf, RM; Finkel, MS; Gaffney, M; Glassman, AH; Harrison, W; Krishnan, KR; Malinin, AI; Musselman, DL; Nemeroff, CB; O'Connor, CM; Serebruany, VL; van Zyl, LT, 2003
)
0.88
"Treatment with sertraline was associated with less depression at the end of treatment in female subjects compared with female subjects who received placebo."( Sertraline and cognitive behavioral therapy for depressed alcoholics: results of a placebo-controlled trial.
Anton, RF; Durazo-Arvizu, R; Latham, PK; Moak, DH; Voronin, KE; Waid, RL, 2003
)
2.1
"Treatment with sertraline resulted in significantly greater last observation carried forward (LOCF)-endpoint improvement than placebo on both the HAM-A psychic and somatic anxiety factors. "( Sertraline in generalized anxiety disorder: efficacy in treating the psychic and somatic anxiety factors.
Allgulander, C; Austin, C; Burt, T; Dahl, AA; Kutcher, SP; Ravindran, A, 2005
)
2.12
"Treatment with sertraline also resulted in greater worsening of scores on the Medical Outcomes Study (MOS) Short Form 36 standardized physical component and the global Female Sexual Function Index."( Ineffectiveness of sertraline for treatment of menopausal hot flushes: a randomized controlled trial.
Cohen, B; Grady, D; Kristof, M; Olyaie, A; Sawaya, GF; Tice, J, 2007
)
1.01
"Treatment with sertraline did not improve hot flush frequency or severity in generally healthy perimenopausal and postmenopausal women, but was associated with bothersome side effects."( Ineffectiveness of sertraline for treatment of menopausal hot flushes: a randomized controlled trial.
Cohen, B; Grady, D; Kristof, M; Olyaie, A; Sawaya, GF; Tice, J, 2007
)
1.02
"Treatment with sertraline for 26 days increased the area under the mean prothrombin time vs time curve by 145 sec *h (7.9%), compared with a decrease of 17 sec *h (-1.0%) in the placebo group."( Effect of sertraline on protein binding of warfarin.
Apseloff, G; Gerber, N; Tremaine, LM; Wilner, KD, 1997
)
1.04
"Treatment with sertraline was nearly as effective and had a lower incidence of side effects."( Efficacy and safety of fluoxetine, sertraline and clomipramine in patients with premature ejaculation: a double-blind, placebo controlled study.
Kim, SC; Seo, KK, 1998
)
0.92
"Treatment with sertraline, with or without group cognitive behavior therapy, reduced the functional impairment of depression. "( Treatment of primary dysthymia with group cognitive therapy and pharmacotherapy: clinical symptoms and functional impairments.
Anisman, H; Bialik, RJ; Charbonneau, Y; Ellis, J; Griffiths, J; Merali, Z; Ravindran, AV; Telner, J; Wiens, A, 1999
)
0.66
"Treatment with sertraline was initiated in February 1998."( Fulminant chemical hepatitis possibly associated with donepezil and sertraline therapy.
Nace, DA; Towers, AL; Verrico, MM, 2000
)
0.88
"Treatment with sertraline for 4 weeks increased plasma cortisol levels, while 24 weeks of sertraline treatment increased plasma T(3) levels in depressed patients."( Effects of sertraline treatment on plasma cortisol, prolactin and thyroid hormones in female depressed patients.
Jakovljević, M; Korsić, M; Mihaljević-Peles, A; Mück-Seler, D; Pivac, N; Sagud, M, 2002
)
1.04
"Pretreatment with sertraline (1-32 mg/kg IP) did not affect the total amount of spontaneous locomotor activity during 50 min following administration of cocaine (15-40 mg/kg IP)."( Sertraline and cocaine-induced locomotion in mice. I. Acute studies.
Fischette, CT; Reith, ME; Wiener, HL, 1991
)
2.05

Toxicity

Sertraline was safe and well tolerated by patients with or without medical illness. Adverse effects were more pronounced when individuals were exposed to sertralines at pH 8. insomnia was the only adverse effect reported significantly more often than placebo (16.5%)

ExcerptReferenceRelevance
" The side-effect profile of sertraline was similar in young and old, and individual side effects did not make a notable contribution to the discontinuation rate."( Toleration and safety of sertraline: experience worldwide.
Doogan, DP, 1991
)
0.88
" In an attempt to circumvent these adverse effects, many antidepressants were prescribed at less than therapeutic doses, resulting in a high probability of inadequate treatment, relapse, or recurrence."( Striking a balance between safety and efficacy: experience with the SSRI sertraline.
Casey, DE, 1994
)
0.52
" The incidence of adverse events was similar for both treatments; 40."( Double-blind study of the efficacy and safety of sertraline versus fluoxetine in major depression.
Aguglia, E; Bolino, F; Casacchia, M; Cassano, GB; Faravelli, C; Ferrari, G; Giordano, P; Pancheri, P; Ravizza, L; Trabucchi, M, 1993
)
0.54
" The fates of SSRI-associated sexual adverse effects and clinical managements of restoring these side effects were described."( Female sexual side effects associated with selective serotonin reuptake inhibitors: a descriptive clinical study of 33 patients.
Hsu, JH; Shen, WW, 1995
)
0.29
"With some limitations in interpreting the data, the findings of this study suggest that SSRI-associated female sexual dysfunction occurs at a higher rate than we previously thought, equal potentials in implicating female sexual side effects among three SSRIs, and the absence or the low incidence of female sexual adverse effects from bupropion, and that these side effects can be managed by waiting for a spontaneous remission, dosage reduction of SSRIs, substitution with bupropion and other antidepressants, or the use of an antidote."( Female sexual side effects associated with selective serotonin reuptake inhibitors: a descriptive clinical study of 33 patients.
Hsu, JH; Shen, WW, 1995
)
0.29
"To study the adverse drug reaction (ADR) profile of selective serotonin re-uptake inhibitors (SSRI) in Belgium and the Netherlands."( [Reports of suspected side effects of selective serotonin reuptake inhibitors in Belgium and The Netherlands].
Kurz, X; Ottervanger, JP; Roisin, T; Stricker, BH; Van Ermen, AM, 1996
)
0.29
"All adverse reactions of fluoxetine, fluvoxamine, paroxetine and sertraline, reported between the moment of registration of these drugs and January 1st 1995, were assessed for causality."( [Reports of suspected side effects of selective serotonin reuptake inhibitors in Belgium and The Netherlands].
Kurz, X; Ottervanger, JP; Roisin, T; Stricker, BH; Van Ermen, AM, 1996
)
0.53
"At the national monitoring centres of Belgium and of the Netherlands adverse reactions were reported 78 and 537 times, respectively."( [Reports of suspected side effects of selective serotonin reuptake inhibitors in Belgium and The Netherlands].
Kurz, X; Ottervanger, JP; Roisin, T; Stricker, BH; Van Ermen, AM, 1996
)
0.29
" More adverse reactions were reported in the Netherlands than in Belgium."( [Reports of suspected side effects of selective serotonin reuptake inhibitors in Belgium and The Netherlands].
Kurz, X; Ottervanger, JP; Roisin, T; Stricker, BH; Van Ermen, AM, 1996
)
0.29
" We have addressed the question of whether there is a 'serotonin withdrawal syndrome' by analysis of spontaneous reports of suspected adverse drug reactions (ADRs) associated with four SSRIs."( A comparison of the post-marketing safety of four selective serotonin re-uptake inhibitors including the investigation of symptoms occurring on withdrawal.
MacKay, AV; Price, JS; Waller, PC; Wood, SM, 1996
)
0.29
" Overall, 27% of the SSRI-treated patients had no adverse sexual side effects; in contrast, 86% of patients treated with bupropion had no adverse sexual effects, and 77% of bupropion-treated patients reported at least one aspect of heightened sexual functioning."( Comparative sexual side effects of bupropion, fluoxetine, paroxetine, and sertraline.
DePalma, RL; Katholi, CR; Modell, JD; Modell, JG, 1997
)
0.53
"SSRI-induced adverse sexual effects appear to be the rule rather than the exception and may be substantially underreported unless patients are specifically asked about the effects of these medications on various aspects of sexual function."( Comparative sexual side effects of bupropion, fluoxetine, paroxetine, and sertraline.
DePalma, RL; Katholi, CR; Modell, JD; Modell, JG, 1997
)
0.53
"Blood level monitoring helps to determine the therapeutic and toxic ranges for anticonvulsants and antidepressants."( Lamotrigine toxicity secondary to sertraline.
Gerner, R; Kaufman, KR, 1998
)
0.58
" Extrapyramidal adverse effects have been reported with the selective serotonin re-uptake inhibitor (SSRI) antidepressants, particularly fluoxetine and paroxetine."( Extrapyramidal adverse effects associated with sertraline.
Lambert, MT; Petty, F; Trutia, C, 1998
)
0.56
"English-language articles identified through MEDLINE (1985 through 1997), and case reports from the American Association of Poison Control Centers (AAPCC) (1987 through 1996) and United States Food and Drug Administration (FDA) adverse event database (through 1997) that describe findings of fatal and nonfatal overdoses involving SSRIs alone or in combination with other ingestants were reviewed."( SSRI safety in overdose.
Barbey, JT; Roose, SP, 1998
)
0.3
" At very high doses (> 75 times the common daily dose), more serious adverse events, including seizures, electrocardiogram (ECG) changes, and decreased consciousness may occur."( SSRI safety in overdose.
Barbey, JT; Roose, SP, 1998
)
0.3
"There were no clinically significant cardiovascular adverse events in any of the subjects enrolled in the study."( Absence of cardiovascular adverse effects of sertraline in children and adolescents.
Biederman, J; Faraone, SV; Fine, CS; Geller, D; March, JS; Millstein, RB; Spencer, TJ; Wilens, TE; Wolkow, R, 1999
)
0.56
" Sertraline was well tolerated, with insomnia the only adverse effect reported significantly more often than placebo (16."( Efficacy and safety of sertraline treatment of posttraumatic stress disorder: a randomized controlled trial.
Asnis, GM; Baker, D; Brady, K; Farfel, GM; Pearlstein, T; Rothbaum, B; Sikes, CR, 2000
)
1.53
" There were more withdrawals due to adverse events in the clomipramine group than in the sertraline group (17% versus 12%)."( A double-blind study of the efficacy and safety of sertraline and clomipramine in outpatients with severe major depression.
Blashko, C; Goger, J; Kosolowski, J; Lane, RM; Lépine, JP; Moles, MF; Probst, C; Scharfetter, B, 2000
)
0.78
" All-cause adverse events were recorded in 35 patients (42."( An open, baseline controlled evaluation of sertraline safety and efficacy in the treatment of depression in Thai patients.
, 2001
)
0.57
" These results indicate that imipramine and sertraline are equally effective for the treatment of major depression in later life, although adverse reactions are more frequent among subjects treated with imipramine than with sertraline."( Antidepressant efficacy and safety of low-dose sertraline and standard-dose imipramine for the treatment of depression in older adults: results from a double-blind, randomized, controlled clinical trial.
Almeida, OP; Forlenza, OV; Hirata, ES; Stoppe, A, 2001
)
0.83
" This study evaluates a clinician-administered scale, the Toronto Side Effect Scale (TSES), in a natural practice clinic."( Antidepressant side effects in depression patients treated in a naturalistic setting: a study of bupropion, moclobemide, paroxetine, sertraline, and venlafaxine.
Bagby, RM; Kennedy, SH; Vanderkooy, JD, 2002
)
0.52
" A measure of side-effect intensity distinguished paroxetine from the other antidepressants on a measure of sexual dysfunction."( Antidepressant side effects in depression patients treated in a naturalistic setting: a study of bupropion, moclobemide, paroxetine, sertraline, and venlafaxine.
Bagby, RM; Kennedy, SH; Vanderkooy, JD, 2002
)
0.52
"These results confirm the clinical utility of the TSES as a simple, clinician-administered antidepressant side-effect scale."( Antidepressant side effects in depression patients treated in a naturalistic setting: a study of bupropion, moclobemide, paroxetine, sertraline, and venlafaxine.
Bagby, RM; Kennedy, SH; Vanderkooy, JD, 2002
)
0.52
" All Adverse Events (AEs) during follow-up were recorded by the psychiatrists for the duration of SSRI treatment until discontinuation or until at least 12 months."( Adverse events in users of sertraline: results from an observational study in psychiatric practice in The Netherlands.
Heerdink, ER; Leufkens, HG; Meijer, WE; van Eijk, JT, 2002
)
0.61
"In this study we found that almost three out of four patients reported an adverse event."( Adverse events in users of sertraline: results from an observational study in psychiatric practice in The Netherlands.
Heerdink, ER; Leufkens, HG; Meijer, WE; van Eijk, JT, 2002
)
0.61
"Major depression affects about 25% of the patients who have Alzheimer disease and has serious adverse consequences for patients and caregivers."( Treating depression in Alzheimer disease: efficacy and safety of sertraline therapy, and the benefits of depression reduction: the DIADS.
Baker, AS; Brandt, J; DelCampo, L; Frangakis, C; Lyketsos, CG; Miles, Q; Munro, C; Rabins, PV; Sheppard, JM; Steele, CD; Steinberg, M, 2003
)
0.56
" Safety monitoring indicated few differences in adverse effects between the 2 treatment groups."( Treating depression in Alzheimer disease: efficacy and safety of sertraline therapy, and the benefits of depression reduction: the DIADS.
Baker, AS; Brandt, J; DelCampo, L; Frangakis, C; Lyketsos, CG; Miles, Q; Munro, C; Rabins, PV; Sheppard, JM; Steele, CD; Steinberg, M, 2003
)
0.56
" Adverse events were monitored and recorded systematically during the trial."( Probing the safety of medications in the frail elderly: evidence from a randomized clinical trial of sertraline and venlafaxine in depressed nursing home residents.
Datto, CJ; DiFilippo, S; Katz, IR; Oslin, DW; Streim, JE; Ten Have, TR; Weintraub, D, 2003
)
0.53
"Twelve subjects were discontinued due to serious adverse events (SAE), 5 were discontinued due to other significant side effects, and 2 withdrew consent."( Probing the safety of medications in the frail elderly: evidence from a randomized clinical trial of sertraline and venlafaxine in depressed nursing home residents.
Datto, CJ; DiFilippo, S; Katz, IR; Oslin, DW; Streim, JE; Ten Have, TR; Weintraub, D, 2003
)
0.53
"In this frail elderly population, venlafaxine was less well tolerated and, possibly, less safe than sertraline without evidence for an increase in efficacy."( Probing the safety of medications in the frail elderly: evidence from a randomized clinical trial of sertraline and venlafaxine in depressed nursing home residents.
Datto, CJ; DiFilippo, S; Katz, IR; Oslin, DW; Streim, JE; Ten Have, TR; Weintraub, D, 2003
)
0.75
" However, subtle differences in improvements in PTSD symptom clusters, physiologic reactivity, and reported adverse events were identified."( Can physiologic assessment and side effects tease out differences in PTSD trials? A double-blind comparison of citalopram, sertraline, and placebo.
Burgin, C; Jones, DE; Masters, BK; Parker, DE; Potter-Kimball, R; Tucker, P; Wyatt, DB, 2003
)
0.53
" Sertraline-treated patients in the comorbid group had similar adverse events and discontinuations when compared to those in the noncomorbid group."( Efficacy, safety, and tolerability of sertraline in patients with late-life depression and comorbid medical illness.
Burt, T; Cassidy, EL; Clary, CM; Doraiswamy, PM; Holland, PJ; Hornig, M; Mandel, FS; Salomon, RM; Sheikh, JI, 2004
)
1.5
" Sertraline was safe and well tolerated by patients with or without medical illness."( Efficacy, safety, and tolerability of sertraline in patients with late-life depression and comorbid medical illness.
Burt, T; Cassidy, EL; Clary, CM; Doraiswamy, PM; Holland, PJ; Hornig, M; Mandel, FS; Salomon, RM; Sheikh, JI, 2004
)
1.5
" Safety was evaluated by physical and laboratory evaluations and the monitoring of adverse events (AEs)."( Concurrent administration of donepezil HCl and sertraline HCl in healthy volunteers: assessment of pharmacokinetic changes and safety following single and multiple oral doses.
Cullen, EI; Kumar, D; Nagy, CF; Perdomo, CA; Pratt, RD; Wason, S, 2004
)
0.58
"For treatment of depressive disorders in routine outpatient settings, sertraline is safe and efficacious."( Efficacy, predictors of therapy response, and safety of sertraline in routine clinical practice: prospective, open-label, non-interventional postmarketing surveillance study in 1878 patients.
Bair, MJ; Göbel, C; Löwe, B; Schenkel, I, 2005
)
0.81
" Their use is frequently associated with dose-limiting adverse effects."( Simple pharmacological test battery to assess efficacy and side effect profile of centrally acting muscle relaxant drugs.
Berzsenyi, P; Farkas, S; Kárpáti, E; Kocsis, P; Tarnawa, I,
)
0.13
" For detecting side effect liability (ataxia, sedation, impairment of voluntary motor functions), (1) the rota-rod test, (2) measurement of spontaneous motility, (3) the weight-lifting test and (4) the thiopental sleep test were used."( Simple pharmacological test battery to assess efficacy and side effect profile of centrally acting muscle relaxant drugs.
Berzsenyi, P; Farkas, S; Kárpáti, E; Kocsis, P; Tarnawa, I,
)
0.13
"Therapeutic indices calculated from the results of these in vivo experiments for the clinically used muscle relaxants are in agreement with their adverse effect profiles in humans."( Simple pharmacological test battery to assess efficacy and side effect profile of centrally acting muscle relaxant drugs.
Berzsenyi, P; Farkas, S; Kárpáti, E; Kocsis, P; Tarnawa, I,
)
0.13
" Only one patient, in the reboxetine group, dropped out due to a side effect (constipation)."( [Comparison of reboxetine and sertraline in terms of efficacy and safety in major depressive disorder].
Akgöz, S; Akkaya, C; Eker, SS; Kirli, S; Sarandöl, A, 2005
)
0.62
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
"In this sample of children and adolescents with epilepsy and depressive disorders, we observed that SSRIs are a good therapeutic option, considering their efficacy in remission of depressive symptoms, their few adverse effects, and their maintenance of satisfactory seizure control."( Sertraline and fluoxetine: safe treatments for children and adolescents with epilepsy and depression.
Kuczynski, E; Thomé-Souza, MS; Valente, KD, 2007
)
1.78
" The treatment response was assessed at baseline, week 4 and week 12, with hospital anxiety and depression scale (HADS) and Montgomery Asberg depression rating scale (MADRS), to rate depression and anxiety; mini mental adjustment to cancer scale (Mini-MAC), to assess the psychological response to the diagnosis of cancer; clinical global impression (CGI) to evaluate severity of illness; dosage record and treatment emergent symptom scale (DOTES), to assess the adverse effects of the clinical treatments and their possible relation with the drug used; and QL index to rate quality of life."( Sertraline effectiveness and safety in depressed oncological patients.
Caldera, P; Siri, I; Torta, R, 2008
)
1.79
" No severe adverse effects were observed."( Sertraline effectiveness and safety in depressed oncological patients.
Caldera, P; Siri, I; Torta, R, 2008
)
1.79
" Adverse events occurring in 10% of patients or more with adjunctive placebo or aripiprazole were akathisia (4."( The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: a second multicenter, randomized, double-blind, placebo-controlled study.
Berman, RM; Carson, WH; Fava, M; Hennicken, D; Marcus, RN; McQuade, RD; Simon, JS; Thase, ME; Trivedi, MH, 2008
)
0.35
" The presented results indicate that sertraline hydrochloride adversely affects aquatic organisms at levels several orders of magnitude higher than that reported in municipal effluent concentrations, however adverse effects may result from lower concentration exposures, further research into chronic toxicity is therefore advocated."( Aquatic ecotoxicity of the selective serotonin reuptake inhibitor sertraline hydrochloride in a battery of freshwater test species.
Davoren, M; Hernan, R; Lyng, FM; Minagh, E; O'Rourke, K, 2009
)
0.86
"Because of the high prevalence of depression and its significant adverse impact on prognosis of patients with ischemic heart disease (IHD) and HF, the Safety and Efficacy of Sertraline for Depression in Patients with Chronic Heart Failure (SADHART-CHF) trial aims to assess the effects of sertraline on response of depression as well as on the cardiac prognosis of patients with HF."( Safety and efficacy of sertraline for depression in patients with CHF (SADHART-CHF): a randomized, double-blind, placebo-controlled trial of sertraline for major depression with congestive heart failure.
Arias, RM; Callwood, DD; Cuffe, MS; Henke, E; Jiang, W; Krishnan, R; Kuchibhatla, M; O'Connor, C; Silva, SG; Zakhary, B, 2008
)
0.85
" An understanding of structure-activity relationships (SARs) of chemicals can make a significant contribution to the identification of potential toxic effects early in the drug development process and aid in avoiding such problems."( Developing structure-activity relationships for the prediction of hepatotoxicity.
Fisk, L; Greene, N; Naven, RT; Note, RR; Patel, ML; Pelletier, DJ, 2010
)
0.36
"Sertraline was safe in patients with significant HF."( Safety and efficacy of sertraline for depression in patients with heart failure: results of the SADHART-CHF (Sertraline Against Depression and Heart Disease in Chronic Heart Failure) trial.
Arias, RM; Callwood, DD; Cuffe, MS; Jiang, W; Krishnan, R; Kuchibhatla, M; O'Connor, CM; Rivelli, SK; Silva, SG; Stough, WG; Zakhary, B, 2010
)
2.11
" Also, with the aim to evaluate the antidepressant effect of its iodine product we demonstrated for this compound the toxic effect towards the male Wistar rats."( Sertraline and its iodine product: experimental and theoretical vibrational studies: potential in vitro anti-thyroid activity of sertraline and iodine product toxicity with respect to male Wistar rats.
Escudero, GE; Ferraresi Curotto, V; Ferrer, EG; Laino, CH; Pis Diez, R; Williams, PA, 2013
)
1.83
"Cisplatin is a widely used chemotherapeutic agent, but its ototoxicity side effect can occur in the majority of patients."( Possible protective effect of sertraline against cisplatin-induced ototoxicity: an experimental study.
Erdogan, S; Iseri, M; Ozturk, M; Sarı, F; Topdag, M; Ucar, S, 2013
)
0.68
"Tandospirone is safe and effective and appears non-inferior to sertraline for SAD in youths."( Clinical evaluation of the efficacy and safety of tandospirone versus sertraline monotherapy for social anxiety disorder: a randomized open-label trial.
Gan, JJ; Huang, X; Ji, JL; Li, C; Li, WH; Luo, YL; Wang, B; Zhang, W, 2013
)
0.86
" Simvastatin was the most toxic tested compound for zebrafish embryo, followed by diclofenac."( Toxicity screening of diclofenac, propranolol, sertraline and simvastatin using Danio rerio and Paracentrotus lividus embryo bioassays.
Martins, R; Ribeiro, S; Santos, MM; Torres, T, 2015
)
0.67
"To evaluate the frequency of adverse events (AEs) across 4 treatment conditions in the Child/Adolescent Anxiety Multimodal Study (CAMS), and to compare the frequency of AEs between children and adolescents."( Child/Adolescent anxiety multimodal study: evaluating safety.
Albano, AM; Birmaher, B; Chrisman, A; Compton, SN; Iyengar, S; Keeton, C; Kendall, PC; March, JS; McCracken, J; Piacentini, J; Riddle, MA; Rynn, MA; Sakolsky, DJ; Shen, S; Sherrill, JT; Walkup, JT; Waslick, B, 2015
)
0.42
" The aim of this study was to examine the features and prevalence of adverse effects of paroxetine and sertraline in breastfed infants."( Short-Term Safety of Paroxetine and Sertraline in Breastfed Infants: A Retrospective Cohort Study from a University Hospital.
Arpaci, N; Uguz, F, 2016
)
0.92
"The prevalence rate of adverse events in the infants was 12."( Short-Term Safety of Paroxetine and Sertraline in Breastfed Infants: A Retrospective Cohort Study from a University Hospital.
Arpaci, N; Uguz, F, 2016
)
0.71
"The results suggest that the prevalence rate of adverse events in the infants exposed to sertraline or paroxetine is relatively low and mostly mild."( Short-Term Safety of Paroxetine and Sertraline in Breastfed Infants: A Retrospective Cohort Study from a University Hospital.
Arpaci, N; Uguz, F, 2016
)
0.93
" Iopamidol was not toxic at concentrations up to 101 mg/L."( The effects of pharmaceuticals on a unionid mussel (Lampsilis siliquoidea): An examination of acute and chronic endpoints of toxicity across life stages.
Bendo, NA; de Solla, SR; Giacomin, M; Gillis, PL; Gilroy, ÈAM; King, LE; Salerno, J, 2017
)
0.46
" The adverse events in this chart review were consistent with the known safety profile of sertraline."( Dosage, effectiveness, and safety of sertraline treatment for posttraumatic stress disorder in a Japanese clinical setting: a retrospective study.
Hoshino, Y; Kamo, T; Kato, H; Kuribayashi, K; Maeda, M; Oe, M; Shigemura, J, 2016
)
0.93
"This study was conducted to clarify the toxic effects of sertraline (SRT) on the reproductive system of male rats and to elucidate the underlying mechanisms."( Sertraline-induced reproductive toxicity in male rats: evaluation of possible underlying mechanisms.
Atli, O; Aydogan-Kilic, G; Baysal, M; Ilgin, S; Karaduman, B; Kilic, V; Ucarcan, S,
)
1.82
" This study aimed to evaluate sertraline efficacy and adverse events in Chinese patients with PTSD over 12 weeks."( Effect and safety of sertraline for treat posttraumatic stress disorder: a multicenter randomised controlled study.
Li, BL; Li, W; Ma, YB; Meng, QG; Yang, Q; Zhang, Y, 2017
)
1.06
" Impact of Event Scale-Revised subscores constituted the primary outcome, with Clinical Global Impression Scale-Severity scores and adverse events as secondary outcomes."( Effect and safety of sertraline for treat posttraumatic stress disorder: a multicenter randomised controlled study.
Li, BL; Li, W; Ma, YB; Meng, QG; Yang, Q; Zhang, Y, 2017
)
0.77
" The most common adverse event was nausea, which occurred in 12 (33."( Effect and safety of sertraline for treat posttraumatic stress disorder: a multicenter randomised controlled study.
Li, BL; Li, W; Ma, YB; Meng, QG; Yang, Q; Zhang, Y, 2017
)
0.77
" Significantly lower adverse event rate was observed in the Shugan Jieyu group."( Clinical efficacy and safety of the Shugan Jieyu capsule in patients with acute myocardial infarction and depression.
Liu, W; Qin, J, 2016
)
0.43
"Although sertraline is widely prescribed as relatively safe antidepressant drug, hepatic toxicity was reported in some patients with sertraline treatment."( In vivo investigation on the chronic hepatotoxicity induced by sertraline.
Almansour, MI; Jarrar, BM; Jarrar, YB, 2018
)
1.14
" The most common (>20%) adverse events reported for esketamine/antidepressant were nausea, dissociation, dizziness, vertigo, and headache."( Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1).
Ameele, HVD; Blier, P; Daly, EJ; Drevets, WC; Fava, M; Fedgchin, M; Gaillard, R; Hough, D; Lane, R; Liebowitz, M; Lim, P; Manji, H; Melkote, R; Preskorn, S; Ravindran, A; Singh, JB; Trivedi, M; Vitagliano, D, 2019
)
0.51
"Our case adds to the existing literature by demonstrating that patients may experience adverse medication effects despite lamotrigine levels that are normally considered to be in the therapeutic range, highlighting the importance of clinical correlation when obtaining medication levels."( Delirium Secondary to Lamotrigine Toxicity.
Catalano, G; Catalano, MC; Fusick, AJ; Gunther, SR; Hernandez, MJ; Sanchez, DL; Sullivan, GA, 2020
)
0.56
" Therefore, BoNT/A could be a safe and effective option for the treatment of depression."( The safety and efficacy of botulinum toxin A on the treatment of depression.
Cao, C; Chen, LH; Fan, Y; Hu, H; Jiang, C; Li, Y; Liu, J; Liu, T; Luo, W; Tang, Z; Wu, W; Xu, Y; Zhang, Q, 2021
)
0.62
" These medications alleviate symptoms and restore function for many youths; however, they are associated with a distinct adverse effect profile, and their tolerability may complicate treatment or lead to discontinuation."( Adverse Effects of Antidepressant Medications and their Management in Children and Adolescents.
Croarkin, PE; Mills, JA; Poweleit, EA; Ramsey, LB; Strawn, JR, 2023
)
0.91
", weight gain) adverse effects of SSRIs and some SNRIs in pediatric patients."( Adverse Effects of Antidepressant Medications and their Management in Children and Adolescents.
Croarkin, PE; Mills, JA; Poweleit, EA; Ramsey, LB; Strawn, JR, 2023
)
0.91
"We provide a framework for discussing SSRI/SNRI tolerability with patients and their families and describe the pharmacologic basis, course, and predictors of adverse events in youth."( Adverse Effects of Antidepressant Medications and their Management in Children and Adolescents.
Croarkin, PE; Mills, JA; Poweleit, EA; Ramsey, LB; Strawn, JR, 2023
)
0.91
"SSRI/SNRIs are associated with both early-emerging (often transient) and late-emerging adverse effects in youth."( Adverse Effects of Antidepressant Medications and their Management in Children and Adolescents.
Croarkin, PE; Mills, JA; Poweleit, EA; Ramsey, LB; Strawn, JR, 2023
)
0.91

Pharmacokinetics

The pharmacokinetic interaction is likely the result of an inhibition of CYP2D6 tricyclic metabolism by sertraline. Putatively the co-administration of bupropion and sertRALine could lead to a significant drug-drug interaction.

ExcerptReferenceRelevance
"The pharmacokinetic properties of the newer specific serotonin (5-HT) reuptake inhibitors are reviewed."( Pharmacokinetics of the selective serotonin reuptake inhibitors.
DeVane, CL, 1992
)
0.28
" From a clinical point of view, it is of relevance that potency to inhibit the cytochrome P450 isozyme CYP2D6 gradually decreases from paroxetine, fluoxetine, norfluoxetine, desmethylcitalopram, fluvoxamine, and sertraline down to citalopram, explaining to a great extent differences in pharmacokinetic interactions between the SSRIs and tricyclic antidepressants, which are metabolized by this enzyme."( Comparative pharmacokinetics of selective serotonin reuptake inhibitors: a look behind the mirror.
Baumann, P; Rochat, B, 1995
)
0.48
"The pharmacokinetic interactions of sertraline and fluoxetine with the tricyclic antidepressant desipramine were studied in 18 healthy male volunteers phenotyped as extensive metabolizers of dextromethorphan."( Pharmacokinetics of desipramine coadministered with sertraline or fluoxetine.
Alderman, J; Chung, M; Harris, S; Harrison, W; Messig, M; Preskorn, SH, 1994
)
0.81
" Samples for pharmacokinetic analyses were obtained on Days 15 and 32; trough plasma concentrations of carbamazepine and its principal metabolite, carbamazepine-10, 11-epoxide (CBZ-E), were determined daily beginning on Day 13."( Absence of a sertraline-mediated effect on the pharmacokinetics and pharmacodynamics of carbamazepine.
Dewland, PM; Muirhead, DC; Rapeport, WG; Tanner, T; Wesnes, K; Williams, SA, 1996
)
0.66
"There were no significant differences between the sertraline and placebo groups in any of the pharmacokinetic parameters for carbamazepine or CBZ-E."( Absence of a sertraline-mediated effect on the pharmacokinetics and pharmacodynamics of carbamazepine.
Dewland, PM; Muirhead, DC; Rapeport, WG; Tanner, T; Wesnes, K; Williams, SA, 1996
)
0.92
"There were no significant differences between the sertraline group and the placebo group in the pharmacokinetic parameters of phenytoin."( Absence of effect of sertraline on the pharmacokinetics and pharmacodynamics of phenytoin.
Cross, M; Muirhead, DC; Rapeport, WG; Wesnes, K; Williams, SA, 1996
)
0.87
"7-fold increase in Cmax and a significant prolongation in elimination half-life in hepatically impaired patients."( Influence of liver cirrhosis on sertraline pharmacokinetics.
Angebaud, P; Coates, P; Démolis, JL; Funck-Brentano, C; Grangé, JD; Jaillon, P, 1996
)
0.58
"A nonblinded study was conducted to compare the pharmacokinetic properties of the selective serotonin reuptake inhibitor sertraline in 22 young (aged 18 to 45 years) and 22 elderly (> 65 years) volunteers, of whom half were male and half were female."( Pharmacokinetics of sertraline and its N-demethyl metabolite in elderly and young male and female volunteers.
Ronfeld, RA; Tremaine, LM; Wilner, KD, 1997
)
0.83
" The pharmacokinetic analyses were based on data from 20 individuals."( Effect of sertraline on the pharmacokinetics and protein binding of diazepam in healthy volunteers.
Baris, BA; Gardner, MJ; Preskorn, SH; Wilner, KD, 1997
)
0.7
" There were no significant treatment effects on the mean area under the plasma concentration-time curve (AUC), mean peak plasma sertraline concentration (Cmax), mean time to reach Cmax (tmax), mean terminal elimination half-life, or the mean elimination rate constant in either study."( Sertraline. Chronopharmacokinetics and the effect of coadministration with food.
Baris, BA; Ronfeld, RA; Wilner, KD, 1997
)
1.95
" An approximately 10-fold increase in the Cmax and AUC(24) of paroxetine and an approximately 2-fold increase in these parameters for sertraline occurred simultaneously with the desipramine concentration changes."( Desipramine pharmacokinetics when coadministered with paroxetine or sertraline in extensive metabolizers.
Alderman, J; Allison, J; Chung, M; Greenblatt, DJ; Harrison, W; Penenberg, D; Preskorn, SH, 1997
)
0.74
"To examine the pharmacokinetic interaction between the selective serotonin reuptake inhibitor sertraline and the tricyclic antidepressants desipramine or imipramine in 12 healthy male subjects."( The effect of sertraline on the pharmacokinetics of desipramine and imipramine.
Bergstrom, RF; Cerimele, BJ; Goldberg, MJ; Kurtz, DL, 1997
)
0.88
"Multiple-dose, but not single-dose, treatment with sertraline significantly reduced apparent plasma clearance (CL/F) and prolonged the half-life of desipramine relative to baseline."( The effect of sertraline on the pharmacokinetics of desipramine and imipramine.
Bergstrom, RF; Cerimele, BJ; Goldberg, MJ; Kurtz, DL, 1997
)
0.91
"This pharmacokinetic interaction is likely the result of an inhibition of CYP2D6 tricyclic metabolism by sertraline."( The effect of sertraline on the pharmacokinetics of desipramine and imipramine.
Bergstrom, RF; Cerimele, BJ; Goldberg, MJ; Kurtz, DL, 1997
)
0.87
"Mean area under the plasma concentration-time curve (AUC), peak plasma concentration (Cmax), and elimination half-life (t1/2) for sertraline and desmethylsertraline were similar to previously reported adult values."( Sertraline treatment of children and adolescents with obsessive-compulsive disorder or depression: pharmacokinetics, tolerability, and efficacy.
Alderman, J; Chung, M; Johnston, HF; Wolkow, R, 1998
)
1.95
" They differ, however, in their pharmacokinetic properties."( Pharmacokinetics of selective serotonin reuptake inhibitors.
Härtter, S; Hiemke, C, 2000
)
0.31
"05) and terminal elimination half-life values of sertraline (35."( Pharmacokinetics of sertraline in relation to genetic polymorphism of CYP2C19.
Chen, XP; He, N; Liu, ZQ; Shu, Y; Wang, JH; Wang, W; Zhou, HH, 2001
)
0.89
"The mean steady-state half-life of 50 mg was significantly shorter (15."( Sertraline pharmacokinetics and dynamics in adolescents.
Axelson, DA; Birmaher, B; Brent, DA; Bridge, J; Nuss, S; Perel, JM; Rudolph, GR, 2002
)
1.76
"The half-life of sertraline 50 mg becomes significantly shorter from the initial dose to steady-state, and many adolescents may benefit from twice-per-day dosing."( Sertraline pharmacokinetics and dynamics in adolescents.
Axelson, DA; Birmaher, B; Brent, DA; Bridge, J; Nuss, S; Perel, JM; Rudolph, GR, 2002
)
2.1
" The present study reports the pharmacokinetic results of up to eight serum samples per patient."( Serum disposition of sertraline, N-desmethylsertraline and paroxetine: a pharmacokinetic evaluation of repeated drug concentration measurements during 6 months of treatment for major depression.
Aberg-Wistedt, A; Agren, H; Akerblad, AC; Bengtsson, F; Höglund, P; Reis, M, 2004
)
0.64
"The co-administration of once-daily oral donepezil HCl 5 mg for 15 days and once-daily oral sertraline HCl (50 mg for 5 days increased to 100 mg for 10 days) did not result in any clinically meaningful pharmacokinetic interactions, and no unexpected AEs were observed."( Concurrent administration of donepezil HCl and sertraline HCl in healthy volunteers: assessment of pharmacokinetic changes and safety following single and multiple oral doses.
Cullen, EI; Kumar, D; Nagy, CF; Perdomo, CA; Pratt, RD; Wason, S, 2004
)
0.8
"The goal of this study was to determine whether there is a pharmacokinetic interaction, as shown by plasma concentrations and electrocardiographic evidence of QTc intervals, between sertraline 200 mg QD and cisapride 10 mg QID, and between sertraline 200 mg QD and pimozide (single 2-mg dose)."( Coadministration of sertraline with cisapride or pimozide: an open-label, nonrandomized examination of pharmacokinetics and corrected QT intervals in healthy adult volunteers.
Alderman, J, 2005
)
0.84
" Coadministration of sertraline and pimozide resulted in statistically significant increases of 35% and 37% in pimozide Cmax and AUC(0-infinity), respectively, compared with pimozide alone."( Coadministration of sertraline with cisapride or pimozide: an open-label, nonrandomized examination of pharmacokinetics and corrected QT intervals in healthy adult volunteers.
Alderman, J, 2005
)
0.97
" A pharmacokinetic analysis was performed using both traditional compartmental modeling and a population pharmacokinetic approach."( Population pharmacokinetic analysis of drug-drug interactions among risperidone, bupropion, and sertraline in CF1 mice.
DeVane, CL; Donovan, JL; Gibson, BB; Markowitz, JS; Wang, JS; Zhu, HJ, 2006
)
0.55
" It increased the plasma AUC and elimination half-life (T1/2e) of desmethyl-SERT 12."( Population pharmacokinetic analysis of drug-drug interactions among risperidone, bupropion, and sertraline in CF1 mice.
DeVane, CL; Donovan, JL; Gibson, BB; Markowitz, JS; Wang, JS; Zhu, HJ, 2006
)
0.55
"These results suggest that pharmacokinetic interactions exist among these three psychoactive drugs involving inhibition of drug metabolizing enzymes and/or P-gp and other drug transporters present in the BBB."( Population pharmacokinetic analysis of drug-drug interactions among risperidone, bupropion, and sertraline in CF1 mice.
DeVane, CL; Donovan, JL; Gibson, BB; Markowitz, JS; Wang, JS; Zhu, HJ, 2006
)
0.55
" Blood samples were collected for pharmacokinetic analysis of ADTs."( The pharmacokinetics of standard antidepressants with aripiprazole as adjunctive therapy: studies in healthy subjects and in patients with major depressive disorder.
Balch, AH; Berman, RM; Boulton, DW; Mallikaarjun, S; Patel, CG; Reeves, RA; Royzman, K, 2010
)
0.36
" For each sampling period for SER, area under the serum concentration versus time curve, maximal serum concentration (Cmax), and the time at which Cmax occurred (Tmax) were determined."( Pharmacokinetics of sertraline across pregnancy and postpartum.
Anthony, M; Davis, MF; Fankhauser, M; Freeman, MP; Fried, K; Moreno, F; Nolan, PE; Woosley, RL, 2008
)
0.67
" Putatively the co-administration of bupropion and sertraline could lead to a significant pharmacokinetic drug-drug interaction."( Effects of sertraline on the pharmacokinetics of bupropion and its major metabolite, hydroxybupropion, in mice.
Hassan, HE; Molnari, JC; Myers, AL, 2012
)
1.02
" This study was performed to evaluate the pharmacokinetic (PK) characteristics after the administration of low dose sertraline for the purpose of exploring an application of microdosing methods in PK studies."( Open label, three period, single sequence, study of 5, 25, 50 mg sertraline pharmacokinetics in healthy male Korean volunteers.
Cho, JY; Jang, IJ; Kim, KP; Kim, TE; Park, MK; Shin, KH; Shin, SG; Yoon, SH; Yu, KS, 2011
)
0.82
" In this process, particular attention is paid to the pharmacokinetic characteristics of the drug and its safety in clinical use."( Evaluation of the pharmacokinetics, safety and clinical efficacy of sertraline used to treat social anxiety.
Mandrioli, R; Mercolini, L; Raggi, MA, 2013
)
0.63
" The calculated half-life of sertraline following overdose was 28 h (IQR 19."( The pharmacokinetics of sertraline in overdose and the effect of activated charcoal.
Cooper, JM; Duffull, SB; Isbister, GK; Saiao, AS, 2015
)
1.02
" We characterized the impact of sertraline co-administration on olanzapine clearance in psychotic depression using population pharmacokinetic methods."( The Impact of Sertraline Co-Administration on the Pharmacokinetics of Olanzapine: A Population Pharmacokinetic Analysis of the STOP-PD.
Bies, RR; Davies, SJ; Flint, AJ; Kirshner, MM; Meyers, BS; Mulsant, BH; Pollock, BG; Rothschild, AJ; Sorisio, D; Whyte, EM, 2015
)
1.06
" We used NONMEM (Version VII) for population pharmacokinetic analysis, assessing effects of the covariates sex, African American origin, smoking, age, and sertraline co-administration."( The Impact of Sertraline Co-Administration on the Pharmacokinetics of Olanzapine: A Population Pharmacokinetic Analysis of the STOP-PD.
Bies, RR; Davies, SJ; Flint, AJ; Kirshner, MM; Meyers, BS; Mulsant, BH; Pollock, BG; Rothschild, AJ; Sorisio, D; Whyte, EM, 2015
)
0.98
"Population pharmacokinetic analysis comprised 336 samples from 175 individuals."( The Impact of Sertraline Co-Administration on the Pharmacokinetics of Olanzapine: A Population Pharmacokinetic Analysis of the STOP-PD.
Bies, RR; Davies, SJ; Flint, AJ; Kirshner, MM; Meyers, BS; Mulsant, BH; Pollock, BG; Rothschild, AJ; Sorisio, D; Whyte, EM, 2015
)
0.78
" This fully validated method was successfully applied to the pharmacokinetic study after an oral administration of 100 mg sertraline to 20 Chinese healthy male volunteers."( Determination of Sertraline in Human Plasma by UPLC-MS/MS and its Application to a Pharmacokinetic Study.
Tian, DD; Wang, Z; Ye, Q; Yue, XH; Zhang, JW; Zhu, K, 2016
)
0.98
" Half-life and sex effect on sertraline apparent clearance (males averaging 50% higher (p < 0."( SSRI-antipsychotic combination in psychotic depression: sertraline pharmacokinetics in the presence of olanzapine, a brief report from the STOP-PD study.
Bies, RR; Davies, SJ; Flint, AJ; Kirshner, MM; Meyers, BS; Mulsant, BH; Pollock, BG; Rothschild, AJ; Sorisio, D; Whyte, EM, 2016
)
0.97
"This subteam under the Drug Metabolism Leadership Group (Innovation and Quality Consortium) investigated the quantitative role of circulating inhibitory metabolites in drug-drug interactions using physiologically based pharmacokinetic (PBPK) modeling."( Quantitative Prediction of Drug-Drug Interactions Involving Inhibitory Metabolites in Drug Development: How Can Physiologically Based Pharmacokinetic Modeling Help?
Chen, Y; Lin, J; Mao, J; Peters, S; Shebley, M; Templeton, IE; Varma, MV; Yu, H, 2016
)
0.43
" The study objectives were to develop a physiologically-based pharmacokinetic (PBPK) model of sertraline and estimate the probability of achieving effective concentrations in various human tissues."( Physiologically-Based Pharmacokinetic Model of Sertraline in Human to Predict Clinical Relevance of Concentrations at Target Tissues.
Alhadab, AA; Brundage, RC, 2020
)
1.03
" The aim of our study was to evaluate pharmacokinetic interactions between clozapine and sertraline analysing a therapeutic drug monitoring database of 1644 clozapine-medicated patients."( Pharmacokinetic interactions between clozapine and sertraline in smokers and non-smokers.
Gründer, G; Haen, E; Hiemke, C; Kuzin, M; Paulzen, M; Ridders, F; Schoretsanitis, G, 2020
)
1.03
" The study objective was to characterize sertraline pharmacokinetics by developing and validating a sertraline population pharmacokinetic (PK) model in healthy subjects using published clinical PK data."( Population Pharmacokinetics of Sertraline in Healthy Subjects: a Model-Based Meta-analysis.
Alhadab, AA; Brundage, RC, 2020
)
1.11
" We aimed to develop a physiologically based pharmacokinetic (PBPK) model that allows gestational-age dependent prediction of sertraline dosing in pregnancy."( Application of physiologically based pharmacokinetic modeling for sertraline dosing recommendations in pregnancy.
Beitz, J; Crentsil, V; George, B; Lumen, A; Nguyen, C; Wang, J; Wesley, B, 2020
)
1
" A pharmacokinetic modeling virtual clinical trials approach was implemented to: (i) assess gestational changes in sertraline trough plasma concentrations for CYP 2C19 phenotypes, and (ii) identify appropriate dose titration strategies to stabilize sertraline levels within a defined therapeutic range throughout gestation."( The application of precision dosing in the use of sertraline throughout pregnancy for poor and ultrarapid metabolizer CYP 2C19 subjects: A virtual clinical trial pharmacokinetics study.
Almurjan, A; Badhan, RKS; Macfarlane, H, 2021
)
1.08
" These results indicate P-gp-mediated pharmacokinetic interaction increases pimozide accumulation in AC16 cells, and the subsequent elevated pimozide levels within the cells may result in an increased risk of hERG channel inhibition."( P-Glycoprotein-Mediated Pharmacokinetic Interactions Increase Pimozide hERG Channel Inhibition.
Ito, MA; Mizoi, K; Morishita, H; Ogihara, T; Perera, LMB; Yano, K; Zhang, X, 2022
)
0.72
"Sertraline is one of the most prescribed antidepressants, but its pharmacokinetic (PK) properties are still not completely characterized."( Population Pharmacokinetic Modeling to Inform Sertraline Dosing Optimization in Patients with Depression.
Ilic, N; Jankovic, SM; Milovanovic, J; Nikolic, VN; Popovic, D; Stoiljkovic, M; Vujovic, M, 2023
)
2.61

Compound-Compound Interactions

Sertraline hydrochloride combined with four-spot caress in the treatment of primary premature ejaculation (PE) Qilin Pills combined with sERTraline has a definite efficacy in thetreatment of secondary non-consolidated kidney qi PE and therefore deserves wide clinical application.

ExcerptReferenceRelevance
" Ice packs combined with a cooling blanket and dantrolene 80 mg iv were administered to control fever and rigidity, respectively."( Sertraline-phenelzine drug interaction: a serotonin syndrome reaction.
Graber, MA; Hoehns, TB; Perry, PJ, 1994
)
1.73
"Selective serotonin reuptake inhibitor antidepressants should not be combined with monoamine oxidase inhibitor antidepressants because of the risk of serotonin syndrome."( Sertraline-phenelzine drug interaction: a serotonin syndrome reaction.
Graber, MA; Hoehns, TB; Perry, PJ, 1994
)
1.73
" To minimize the potential for an adverse event, the practitioner must remember the drug-drug interactions, and possible consequences when one of these antidepressants is being prescribed."( Pharmacokinetic drug interactions of new antidepressants: a review of the effects on the metabolism of other drugs.
Richelson, E, 1997
)
0.3
" In the present study, the effect of gabapentin (GBP) on seizure score and memory is evaluated when it is given alone and in combination with some antidepressants, such as sertraline (SERTR) and alprazolam (ALP)."( Effects of gabapentin and antidepressant drug combinations on convulsions and memory in mice.
Ali, A; Dua, Y; Pal, SN; Pillai, KK; Rizwan, AN,
)
0.33
"Accumulating evidence indicates that modulation of the activity of cytochrome P450 (CYP) enzymes and the multidrug resistance transporter P-glycoprotein (P-gp) is responsible for many drug-drug interactions."( Population pharmacokinetic analysis of drug-drug interactions among risperidone, bupropion, and sertraline in CF1 mice.
DeVane, CL; Donovan, JL; Gibson, BB; Markowitz, JS; Wang, JS; Zhu, HJ, 2006
)
0.55
"The potential interaction of risperidone (RISP), which is metabolized by 2D6 and transported across the blood brain barrier (BBB) by P-gp, was studied in combination with bupropion (BUP) and also with sertraline (SERT)."( Population pharmacokinetic analysis of drug-drug interactions among risperidone, bupropion, and sertraline in CF1 mice.
DeVane, CL; Donovan, JL; Gibson, BB; Markowitz, JS; Wang, JS; Zhu, HJ, 2006
)
0.74
" Linezolid is a weak monoamine oxidase inhibitor and has been reported to interact with selective serotonin reuptake inhibitors (SSRIs)."( Drug interactions between linezolid and selective serotonin reuptake inhibitors: case report involving sertraline and review of the literature.
Andrus, MR; Byrd, DC; Clark, DB, 2006
)
0.55
"Patients taking antidepressants are more likely to also be taking multiple medications, increasing the risk of adverse drug-drug interactions (DDIs)."( The potential for clinically significant drug-drug interactions involving the CYP 2D6 system: effects with fluoxetine and paroxetine versus sertraline.
Choi, J; Golbeck, AL; Neff, M; Preskorn, SH; Shah, R, 2007
)
0.54
"Our data, showing that ziprasidone in combination with sertraline lead to a decrease of prolonged P3 latencies, are in line with previous studies showing a decrease of prolonged P3 latencies by antidepressant treatment."( The impact of ziprasidone in combination with sertraline on visually-evoked event-related potentials in depressed patients with psychotic features.
Arolt, V; Baune, BT; Dannlowski, U; Deckert, J; Evers, S; Hetzel, G; Moeller, O; Nguyen, DH, 2007
)
0.85
"The potential of metabolites to contribute to drug-drug interactions (DDIs) is not well defined."( Are circulating metabolites important in drug-drug interactions?: Quantitative analysis of risk prediction and inhibitory potency.
Fujioka, Y; Hachad, H; Isoherranen, N; Levy, RH; Yeung, CK, 2011
)
0.37
" Our aims were to prospectively assess the antiviral efficacy and safety of this drug combination in chronic hepatitis C (CHC) patients."( Open-label phase 1b pilot study to assess the antiviral efficacy of simvastatin combined with sertraline in chronic hepatitis C patients.
Altmeyer, R; Cheng, CW; Chopra, N; Lawitz, E; Lim, SG; McHutchison, JG; Patel, K; Randle, JC; Tillmann, HL, 2011
)
0.59
" Using data from a recent factorial, double-blinded, placebo-controlled trial applying tDCS-alone and combined with sertraline to treat 120 depressed outpatients over 6 wk (Brunoni et al."( Differential improvement in depressive symptoms for tDCS alone and combined with pharmacotherapy: an exploratory analysis from the Sertraline vs. Electrical Current Therapy for Treating Depression Clinical Study.
Benseñor, IM; Brunoni, AR; Fregni, F; Júnior, RF; Kemp, AH; Lotufo, PA, 2014
)
0.82
" In addition, we aimed to explore differences in drug-drug interactions across multiple GBM-derived cell cultures and predict such differences by use of transcriptional biomarkers."( Comparative drug pair screening across multiple glioblastoma cell lines reveals novel drug-drug interactions.
Baskaran, S; Forsberg Nilsson, K; Gerlee, P; Häggblad, M; Hansson, C; Karlsson-Lindahl, L; Kling, T; Lundgren, B; Martens, U; Monsefi, N; Nelander, S; Olsson, M; Schmidt, L; Uhrbom, L; Westermark, B, 2013
)
0.39
"We performed a screen in which we quantified drug-drug interactions for 465 drug pairs in each of the 5 GBM cell lines U87MG, U343MG, U373MG, A172, and T98G."( Comparative drug pair screening across multiple glioblastoma cell lines reveals novel drug-drug interactions.
Baskaran, S; Forsberg Nilsson, K; Gerlee, P; Häggblad, M; Hansson, C; Karlsson-Lindahl, L; Kling, T; Lundgren, B; Martens, U; Monsefi, N; Nelander, S; Olsson, M; Schmidt, L; Uhrbom, L; Westermark, B, 2013
)
0.39
"In this study we report on potential drug-drug interactions between drugs occurring in patient clinical data."( Using semantic predications to uncover drug-drug interactions in clinical data.
Cairelli, MJ; Fiszman, M; Kilicoglu, H; Melton, GB; Pakhomov, SV; Rindflesch, TC; Rosemblat, G; Zhang, R, 2014
)
0.4
" In addition, in an aggressive and highly resistant human ovarian xenograft mouse model the use of sertraline in combination with Doxil® generated substantial reduction in tumor progression, with extension of the median survival of tumor-bearing mice."( Modulating cancer multidrug resistance by sertraline in combination with a nanomedicine.
Bitcover, R; Drinberg, V; Peer, D; Rajchenbach, W, 2014
)
0.88
"To observe the clinical effectiveness of Qilin Pills combined with sertraline in the treatment of secondary non-consolidated kidney qi premature ejaculation (PE)."( [Efficacy of Qilin Pills combined with sertraline in the treatment of secondary non-consolidated kidney qi premature ejaculation].
Li, JX; Lu, QG, 2015
)
0.92
"Qilin Pills combined with sertraline has a definite efficacy in the treatment of secondary non-consolidated kidney qi PE and therefore deserves wide clinical application."( [Efficacy of Qilin Pills combined with sertraline in the treatment of secondary non-consolidated kidney qi premature ejaculation].
Li, JX; Lu, QG, 2015
)
0.99
"To observe the clinical effect of Shugan Yiyang Capsules combined with sertraline in the treatment of premature ejaculation (PE)."( [Efficacy of Shugan Yiyang Capsules combined with sertraline on premature ejaculation].
Wu, XW; Zeng, YY, 2015
)
0.9
"Shugan Yiyang Capsules combined with sertraline have a definite and lasting effect on premature ejaculation."( [Efficacy of Shugan Yiyang Capsules combined with sertraline on premature ejaculation].
Wu, XW; Zeng, YY, 2015
)
0.94
"To investigate the clinical effectiveness of sertraline hydrochloride combined with four-spot caress in the treatment of primary premature ejaculation (PE)."( [Sertraline hydrochloride combined with four-spot caressing for primary premature ejaculation].
Bian, TS; Huang, J; Liu, ZJ; Wang, JS; Yue, J; Zeng, QQ; Zhu, Y, 2015
)
1.59
"Sertraline hydrochloride combined with four-spot caressing, with its definite efficacy and rare adverse reactions, deserves wide clinical application in the treatment of primary PE."( [Sertraline hydrochloride combined with four-spot caressing for primary premature ejaculation].
Bian, TS; Huang, J; Liu, ZJ; Wang, JS; Yue, J; Zeng, QQ; Zhu, Y, 2015
)
2.77
" Our results show the therapeutic potential of chlorpromazine and sertraline in combination with amphotericin B against neurocryptococcosis."( In vitro synergistic effects of chlorpromazine and sertraline in combination with amphotericin B against Cryptococcus neoformans var. grubii.
Alves, SH; Chassot, F; Loreto, ÉS; Rossato, L; Santurio, JM; Zanette, RA, 2016
)
0.92
"This subteam under the Drug Metabolism Leadership Group (Innovation and Quality Consortium) investigated the quantitative role of circulating inhibitory metabolites in drug-drug interactions using physiologically based pharmacokinetic (PBPK) modeling."( Quantitative Prediction of Drug-Drug Interactions Involving Inhibitory Metabolites in Drug Development: How Can Physiologically Based Pharmacokinetic Modeling Help?
Chen, Y; Lin, J; Mao, J; Peters, S; Shebley, M; Templeton, IE; Varma, MV; Yu, H, 2016
)
0.43
"The study was a randomised pragmatic trial comparing venlafaxine and sertraline in combination with psychotherapy and social counselling."( Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study.
Bech, P; Carlsson, J; Elklit, A; Mortensen, EL; Sonne, C, 2016
)
0.91
" Limited resources and information on significant drug-drug interactions with dietary supplements and prescription medications have contributed to associated complications and unexpected events."( Dietary Supplement-Drug Interaction-Induced Serotonin Syndrome Progressing to Acute Compartment Syndrome.
Marzella, N; Patel, YA, 2017
)
0.46
"5mA; electrode 3,5×7cm) combined with 50mg/day of sertraline were performed."( Transcranial direct current stimulation of 20- and 30-minutes combined with sertraline for the treatment of depression.
Bocharnikova, EN; Druzhkova, TA; Gersamia, AG; Gotovtseva, GN; Gudkova, AA; Guekht, AB; Menshikova, AA; Pavlova, EL; Semenov, RV, 2018
)
0.96
"tDCS of 20- or 30-minutes combined with sertraline are efficient for the treatment of mild and moderate depression; the effect of 30min stimulation exceeds the one obtained from 20min."( Transcranial direct current stimulation of 20- and 30-minutes combined with sertraline for the treatment of depression.
Bocharnikova, EN; Druzhkova, TA; Gersamia, AG; Gotovtseva, GN; Gudkova, AA; Guekht, AB; Menshikova, AA; Pavlova, EL; Semenov, RV, 2018
)
0.98
"To compare the clinical effects of acupuncture combined with sertraline hydrochloride and simple sertraline hydrochloride on tumor-related depression."( [Clinical observation of acupuncture combined with sertraline hydrochloride tablets on tumor-related depression].
Deng, XY; Xu, TS, 2019
)
1.01
"The efficacy of antidepressant drugs combined with psychotherapy is controversial; hence, this meta-analysis was conducted to assess the efficacy of the combination therapy."( Efficacy of Sertraline Combined with Cognitive Behavioral Therapy for Adolescent Depression: A Systematic Review and Meta-Analysis.
Li, G; Liu, W; Wang, C; Wang, X; Yang, L, 2021
)
1
" We included the literature on the comparison of the sertraline combined with cognitive behavioral therapy (CBT) and each treatment alone for adolescent depression published in 2000-2021."( Efficacy of Sertraline Combined with Cognitive Behavioral Therapy for Adolescent Depression: A Systematic Review and Meta-Analysis.
Li, G; Liu, W; Wang, C; Wang, X; Yang, L, 2021
)
1.25
"Although the number of comparative trials is small, this study shows that sertraline is effective for adolescent depression, but sertraline combined with CBT is more effective."( Efficacy of Sertraline Combined with Cognitive Behavioral Therapy for Adolescent Depression: A Systematic Review and Meta-Analysis.
Li, G; Liu, W; Wang, C; Wang, X; Yang, L, 2021
)
1.23
" This 24-week randomized, double-blinded, controlled clinical trial randomly allocated 452 FEDN SCZ patients to receive a usual dose of ziprasidone (control group) or half the dose of ziprasidone in combination with sertraline (ZS group)."( Low-Dose Ziprasidone in Combination with Sertraline for First-Episode Drug-Naïve Patients with Schizophrenia: a Randomized Controlled Trial.
Guan, X; Kosten, TR; Liu, J; Wang, Y; Wu, F; Xiu, M; Zhang, X; Zhu, C, 2022
)
1.17
" We hypothesized that a low dose of risperidone in combination with sertraline would reduce serious adverse effects without decreasing treatment response."( Efficacy of low-dose risperidone in combination with sertraline in first-episode drug-naïve patients with schizophrenia: a randomized controlled open-label study.
Lang, X; Wu, F; Xiu, M; Xue, M; Zang, X; Zhang, X, 2023
)
1.4
"A total of 230 patients with FEMN SZ were randomly assigned to receive low-dose risperidone in combination with sertraline (RS group) or regular-dose risperidone (control group)."( Efficacy of low-dose risperidone in combination with sertraline in first-episode drug-naïve patients with schizophrenia: a randomized controlled open-label study.
Lang, X; Wu, F; Xiu, M; Xue, M; Zang, X; Zhang, X, 2023
)
1.37
"Our study suggests that low-dose risperidone in combination with sertraline was more effective for psychotic symptoms and psychosocial functioning, with significantly fewer adverse effects in patients with FEMN SZ."( Efficacy of low-dose risperidone in combination with sertraline in first-episode drug-naïve patients with schizophrenia: a randomized controlled open-label study.
Lang, X; Wu, F; Xiu, M; Xue, M; Zang, X; Zhang, X, 2023
)
1.4
" Potential drug-drug interactions (DDIs) were assessed by Lexi-Interact ver."( Potential Drug Interactions in Terminally-Ill Cancer Patients, a Report from the Middle East.
Mahzoni, H; Moghaddas, A; Momenzadeh, M; Naghsh, E; Sharifi, M, 2023
)
0.91
" Our findings highlight that rTMS in combination with antidepressants is a rapid method of symptom improvement in patients with somatic pain with MDD and is helpful for cognitive impairment and anxiety."( Rapid improvements and subsequent effects in major depressive disorder patients with somatic pain using rTMS combined with sertraline.
Lei, F; Sun, Y; Zheng, Z; Zou, K, 2023
)
1.12

Bioavailability

The study was designed to evaluate the bioavailability of two sertraline (CAS 79617-96-2) formulations. The SLN can be used as a potential carrier.

ExcerptReferenceRelevance
" They are well absorbed orally but exhibit an extensive first-pass extraction in the liver."( Pharmacokinetics of the selective serotonin reuptake inhibitors.
DeVane, CL, 1992
)
0.28
" Paroxetine is well absorbed from the gastrointestinal tract and undergoes first-pass metabolism that is partially saturable."( The pharmacologic profile of paroxetine, a new selective serotonin reuptake inhibitor.
Johnson, AM; Tulloch, IF, 1992
)
0.28
" The results of these 2 studies show that the bioavailability and elimination of sertraline tablets are not influenced by the time of administration or administration with or without food."( Sertraline. Chronopharmacokinetics and the effect of coadministration with food.
Baris, BA; Ronfeld, RA; Wilner, KD, 1997
)
1.97
"To compare the bioavailability of 2 sertraline tablets formulations (Tolrest from Laboratórios Biosintética, and Zoloft from Laboratórios Pfizer, Brazil) in 24 healthy volunteers of both sexes (12 male and 12 female) who received a single 50 mg dose of each sertraline formulation."( Comparative bioavailability of two sertraline tablet formulations in healthy human volunteers after a single dose administration.
Corso, G; De Nucci, G; Frota Bezerra, FA; Lerner, FE; Moraes, ME; Moraes, MO; Perozin, M; Sucupira, M, 1998
)
0.85
"Since the 90% CI for both Cmax and AUC(0-96h) mean ratio were within the 80-125% interval proposed by the Food and Drug Administration, it was concluded that Tolrest was bioequivalent to Zolof for both extent and rate of absorption in a single dose administration."( Comparative bioavailability of two sertraline tablet formulations in healthy human volunteers after a single dose administration.
Corso, G; De Nucci, G; Frota Bezerra, FA; Lerner, FE; Moraes, ME; Moraes, MO; Perozin, M; Sucupira, M, 1998
)
0.58
"The study was designed to evaluate the bioavailability of two sertraline (CAS 79617-96-2) formulations."( Serotonin reuptake inhibitors: bioequivalence of sertraline capsules.
Alpan, RS; Erenmemisoglu, A; Koytchev, R; Ozalp, Y; van der Meer, MJ, 2004
)
0.82
"An open-label, randomised, crossover single dose study, using 2 periods x 2 sequences, with a minimum washout period of 4 weeks, was conducted in order to assess the comparative bioavailability of two formulations of sertraline hydrochloride (CAS 79617-96-2) 100 mg tablets."( Comparative bioavailability/ bioequivalence of two different sertraline formulations: a randomised, 2-period x 2-sequence, crossover clinical trial in healthy volunteers.
Almeida, S; Caturla, MC; Cea, E; Filipe, A; Portolés, A; Terleira, A, 2005
)
0.76
"To compare the bioavailability of two sertraline tablet (50 mg) formulations (Serlift from Ranbaxy Laboratories Ltd."( Comparative bioavailability of two sertraline tablet formulations after single-dose administration in healthy Thai volunteers.
Gaysonsiri, D; Kanchanawat, S; Khuroo, A; Kittiwattanagul, K; Monif, T; Panigrahy, BK; Paupairoj, P; Reyar, S; Tassaneeyakul, W; Tippabhotla, SK; Vannaprasath, S, 2008
)
0.89
"The following recommendations are made regarding intubation studies: (i) no intubation study is recommended for compounds with high permeability, since these compounds are likely to be well absorbed from the colon; (ii) compounds with moderate permeability may require an intubation study if the dog colon and in silico models predict a marginally acceptable CR concentration-time profile; (iii) use a dose that approximates 1 h of the intended CR delivery rate; (iv) use the smallest volume possible; (v) define and record tubing placement; (vi) use a thermodynamically stable solution or/and suspension."( The use of gastrointestinal intubation studies for controlled release development.
Sutton, SC, 2009
)
0.35
"To determine the bioavailability of 50 mg sertraline tablets between the test product (Zotaline, M&H Manufacturing Co."( Bioequivalence study of 50 mg sertraline tablets in healthy Thai volunteers.
Chatsiricharoenkul, S; Kongpatanakul, S; Niyomnaitham, S; Pongnarin, P; Sathirakul, K, 2009
)
0.91
" Self-report indices of mood and personality, and genotype (5-HTTLPR) and sertraline bioavailability were assessed."( Mood and personality effects in healthy participants after chronic administration of sertraline.
Allen, NB; Simmons, JG, 2011
)
0.82
" Genotype and bioavailability of sertraline did not moderate these findings, however gender did."( Mood and personality effects in healthy participants after chronic administration of sertraline.
Allen, NB; Simmons, JG, 2011
)
0.87
" Hence, sertraline could alter the bioavailability of drugs absorbed via PAT1."( Sertraline inhibits the transport of PAT1 substrates in vivo and in vitro.
Abdulhadi, S; Brodin, B; Frølund, S; Holm, R; Kall, MA; Langthaler, L; Nielsen, CU; Nøhr, MK; Sari, H, 2013
)
2.27
"Human serum albumin (HSA)-drug binding is an important factor to determine half life and bioavailability of drugs."( Exploring binding properties of sertraline with human serum albumin: Combination of spectroscopic and molecular modeling studies.
Ashrafi-Kooshk, MR; Khodarahmi, R; Nowroozi, A; Rahimi, B; Sadrjavadi, K; Shahlaei, M, 2015
)
0.7
" Poor bioavailability (around 44%) of hydrochloride salt is considered to be conversion of salts to free base in the gastrointestinal tract which retard it's absorption."( Systematic Development of Sertraline Loaded Solid Lipid Nanoparticle (SLN) by Emulsification-Ultrasonication Method and Pharmacokinetic Study in Sprague-Dawley Rats.
Harwansh, RK; Iqbal, Z; Rahman, MA, 2019
)
0.81
" Hence, the SLN can be used as a potential carrier for successful delivery of poorly water-soluble drugs associated with poor oral bioavailability like sertraline."( Systematic Development of Sertraline Loaded Solid Lipid Nanoparticle (SLN) by Emulsification-Ultrasonication Method and Pharmacokinetic Study in Sprague-Dawley Rats.
Harwansh, RK; Iqbal, Z; Rahman, MA, 2019
)
1.01
" plasma concentration data then absorption and bioavailability were optimized from oral data."( Physiologically-Based Pharmacokinetic Model of Sertraline in Human to Predict Clinical Relevance of Concentrations at Target Tissues.
Alhadab, AA; Brundage, RC, 2020
)
0.82
" The steroid structure was chemically altered to improve bioavailability and create an oral dosage form."( Neuroactive steroids - new possibilities in the treatment of postpartum depression.
Adamičková, A; Gažová, A; Hrubá, O; Massarová, P; Vranecová, K; Žigová, L, 2022
)
0.72

Dosage Studied

Two weeks after the increase of the dosage of sertraline, the patient developed a full-blown SS, which resolved completely after the discontinuation of the drug. Outpatients at a Veterans Affairs mental health clinic who were being treated with fluoxetine were randomly assigned to receive either 50 or 75 mg of sERTraline hydrochloride for every 20 mg of fluoxettine.

ExcerptRelevanceReference
"The pharmacology and pharmacokinetics, adverse effects, drug interactions, efficacy, and dosage and administration of the new selective serotonin reuptake inhibitors paroxetine, sertraline, and fluvoxamine are reviewed."( Paroxetine, sertraline, and fluvoxamine: new selective serotonin reuptake inhibitors.
Grimsley, SR; Jann, MW, 1992
)
0.86
" Furthermore, the SSRIs generally do not require dosage escalation for most patients and evidence indicates that they are effective in the treatment of depression associated with anxiety and insomnia."( Bridging the gap between psychiatric practice and primary care.
Thompson, C, 1992
)
0.28
" The first of these studies of a flexible dosing design showed that sertraline, given for eight weeks in daily dosages of 50-200 mg, was a safe and effective treatment for OCD, and superior to placebo."( Sertraline in the treatment of obsessive compulsive disorder: two double-blind, placebo-controlled studies.
Chouinard, G, 1992
)
1.96
" There was no evidence for tolerance to the hypophagic and weight-loss effects of sertraline during either of the chronic dosing studies."( Sertraline, a serotonin-uptake inhibitor, reduces food intake and body weight in lean rats and genetically obese mice.
Chapin, DS; Johnson, JL; Nielsen, JA; Torgersen, LK, 1992
)
1.95
" Once-daily dosing is recommended, with steady state being reached after about 7 days."( Clinical implications of the pharmacology of sertraline.
Warrington, SJ, 1991
)
0.54
" The incidence of side effects was related to both dosage and dosage regimen."( Toleration and safety of sertraline: experience worldwide.
Doogan, DP, 1991
)
0.58
" The primary adverse events associated with serotonin reuptake inhibitors involve the gastrointestinal system, although side effects may be less frequent at lower dosage levels."( Clinical overview of serotonin reuptake inhibitors.
Rickels, K; Schweizer, E, 1990
)
0.28
" After a 2-week titration period in which the once-daily sertraline dose was increased from 50 mg/day to a maximum of 200 mg/day, dosage was maintained until the end of the eighth week, then patients were titrated off medication over the next 2 weeks."( Results of a double-blind placebo controlled trial of a new serotonin uptake inhibitor, sertraline, in the treatment of obsessive-compulsive disorder.
Bick, PA; Chouinard, G; Gaffney, M; Goodman, W; Greist, J; Hackett, E; Jenike, M; Rasmussen, S; White, K, 1990
)
0.75
" Chronic dosing produces down-regulation of beta-adrenergic receptors."( Sertraline: a new antidepressant.
Caillard, V; Doogan, DP, 1988
)
1.72
" Acute and repeated dosing of sertraline decreased serotonin content of whole blood."( Sertraline, 1S,4S-N-methyl-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-naphthylamine, a new uptake inhibitor with selectivity for serotonin.
Browne, RG; Koe, BK; Weissman, A; Welch, WM, 1983
)
2
" Outpatients at a Veterans Affairs mental health clinic who were being treated with fluoxetine were randomly assigned to receive either 50 or 75 mg of sertraline hydrochloride for every 20 mg of fluoxetine (as the hydrochloride salt) or to continue to receive their current dosage of fluoxetine."( Clinical effect of converting antidepressant therapy from fluoxetine to sertraline.
Christenson, JL; Cushing, AG; Haider, A; Miller, DR; Station, RD, 1995
)
0.72
" The current study examined the efficacy, safety, and optimal dosing strategy of sertraline in patients with OCD."( Double-blind parallel comparison of three dosages of sertraline and placebo in outpatients with obsessive-compulsive disorder.
Chouinard, G; DuBoff, E; Greist, J; Halaris, A; Kim, SW; Koran, L; Liebowitz, M; Lydiard, RB; Rasmussen, S; White, K, 1995
)
0.77
" The starting dosage (sertraline 50 mg/day, fluoxetine 20 mg/day) was the final dosage in 76% of patients in both treatment groups."( A double-blind multicenter trial comparing sertraline and fluoxetine in outpatients with major depression.
Bennie, EH; Martindale, JJ; Mullin, JM, 1995
)
0.87
" Its pharmacologic profile permits once-daily dosing while allowing plasma drug levels to equilibrate within 1 week."( The role of sertraline in the management of depression.
Shelton, RC,
)
0.51
" At t1/2 of 24 h makes once-daily dosing feasible and allows for new steady-state concentrations and wash-out within a reasonable time after dose adjustment."( Targeted pharmacotherapy in depression management: comparative pharmacokinetics of fluoxetine, paroxetine and sertraline.
Preskorn, S, 1994
)
0.5
" Case study reports suggest that elderly persons are responsive to selective serotonin uptake inhibitors, although medication selection and dosage may need to be adjusted as a result of the medical conditions sometimes present in the elderly."( Treatment of obsessive compulsive disorder in the elderly: a review and case example.
Calamari, JE; Faber, SD; Hitsman, BL; Poppe, CJ, 1994
)
0.29
" The Regenstrief Medical Record System was used to analyze the dosing of SSRIs in the outpatient population of an urban teaching hospital."( Selective serotonin reuptake inhibitor dose titration in the naturalistic setting.
Coons, SJ; Gregor, KJ; McDonald, RC; Overhage, JM,
)
0.13
"Eleven patients meeting DSM-III-R criteria for at least one personality disorder were treated with sertraline in an open clinical trial with a flexible dosing schedule."( An open trial of sertraline in personality disordered patients with impulsive aggression.
Coccaro, EF; Kavoussi, RJ; Liu, J, 1994
)
0.84
" Concentrations in plasma were determined after 7 days of desipramine (50 mg/day) dosing alone, during the 21 days of desipramine and selective serotonin reuptake inhibitor (SSRI) coadministration (fluoxetine, 20 mg/day; sertraline, 50 mg/day), and for 21 days of continued desipramine administration after SSRI discontinuation."( Pharmacokinetics of desipramine coadministered with sertraline or fluoxetine.
Alderman, J; Chung, M; Harris, S; Harrison, W; Messig, M; Preskorn, SH, 1994
)
0.72
" In keeping with previous data obtained with other sigma receptor ligands, low doses of sertraline and of clorgyline potentiated selectively with a bell-shaped dose-response curve the effect of N-methyl-D-aspartate (NMDA) on pyramidal neurons in the CA3 region of the rat dorsal hippocampus."( Modification of the N-methyl-D-aspartate response by antidepressant sigma receptor ligands.
Bergeron, R; De Montigny, C; Debonnel, G, 1993
)
0.51
" Bruxism remitted in all patients after a decrease in antidepressant dosage (N = 1) or addition of buspirone (N = 3)."( SSRI-associated nocturnal bruxism in four patients.
Ellison, JM; Stanziani, P, 1993
)
0.29
" In addition, they suggest that a decrease in SSRI dosage or the addition of buspirone may relieve SSRI-associated nocturnal bruxism."( SSRI-associated nocturnal bruxism in four patients.
Ellison, JM; Stanziani, P, 1993
)
0.29
"With some limitations in interpreting the data, the findings of this study suggest that SSRI-associated female sexual dysfunction occurs at a higher rate than we previously thought, equal potentials in implicating female sexual side effects among three SSRIs, and the absence or the low incidence of female sexual adverse effects from bupropion, and that these side effects can be managed by waiting for a spontaneous remission, dosage reduction of SSRIs, substitution with bupropion and other antidepressants, or the use of an antidote."( Female sexual side effects associated with selective serotonin reuptake inhibitors: a descriptive clinical study of 33 patients.
Hsu, JH; Shen, WW, 1995
)
0.29
" Side effects increased with increasing dosage but were usually mild and well tolerated."( Sertraline safety and efficacy in major depression: a double-blind fixed-dose comparison with placebo.
Abuzzahab, FS; Amin, M; Claghorn, JL; Dubé, S; Fabre, LF; Mendels, J; Petrie, WM; Small, JG, 1995
)
1.73
"The results of this study suggest that dosing adjustments of digoxin may not be necessary in patients receiving concomitant sertraline administration."( Absence of a sertraline-mediated effect on digoxin pharmacokinetics and electrocardiographic findings.
Coates, PE; Dewland, PM; Forster, PL; Rapeport, WG, 1996
)
0.87
" Cognitive function testing was performed on Day 1 before carbamazepine dosing (baseline), Day 15 (carbamazepine alone), and Day 32 (carbamazepine plus sertraline or placebo)."( Absence of a sertraline-mediated effect on the pharmacokinetics and pharmacodynamics of carbamazepine.
Dewland, PM; Muirhead, DC; Rapeport, WG; Tanner, T; Wesnes, K; Williams, SA, 1996
)
0.86
" The plasma phenytoin concentration-time profile was determined on Day 7 before the start of sertraline or placebo dosing and at the end of dosing on Day 24."( Absence of effect of sertraline on the pharmacokinetics and pharmacodynamics of phenytoin.
Cross, M; Muirhead, DC; Rapeport, WG; Wesnes, K; Williams, SA, 1996
)
0.83
" Cognitive function testing was performed before dosing and over a 24-hour period after dosing on Days 1, 2, and 25."( Absence of effect of sertraline on time-based sensitization of cognitive impairment with haloperidol.
Oliver, SD; Rapeport, WG; Wesnes, K; Williams, SA, 1996
)
0.61
" Indeed, planned pharmacokinetic drug interactions at the level of P450s have been proposed to reduce cyclosporine dosage requirements, to reduce variability of TCA levels, and to manipulate the contribution of alternative metabolic pathways to minimize toxic effects."( Cytochrome P450 enzymes: interpretation of their interactions with selective serotonin reuptake inhibitors. Part II.
Harvey, AT; Preskorn, SH, 1996
)
0.29
"1 for protocols 1 and 2, respectively) in stimulating the 5-HTP-induced HTR and produced a bell-shaped dose-response curve."( The stimulatory and inhibitory components of cocaine's actions on the 5-HTP-induced 5-HT2A receptor response.
Darmani, NA; Reeves, SL, 1996
)
0.29
" The tramadol dosage had recently been increased, resulting in what was believed to be serotonergic syndrome."( Possible serotonin syndrome associated with tramadol and sertraline coadministration.
Blackburn, KH; Mason, BJ, 1997
)
0.54
"Serotonin syndrome is a toxic hyperserotonergic state that develops soon after initiation or dosage increments of the offending agent."( Possible serotonin syndrome associated with tramadol and sertraline coadministration.
Blackburn, KH; Mason, BJ, 1997
)
0.54
" In this study, sertraline was administered at a dosage of 200mg once daily (the maximum recommended daily dosage) for 21 days after upward dosage titration from 50 mg/day over a 9-day period."( Pharmacokinetics of sertraline and its N-demethyl metabolite in elderly and young male and female volunteers.
Ronfeld, RA; Tremaine, LM; Wilner, KD, 1997
)
0.97
" There was a small but statistically significant decrease (16%) in the clearance of tolbutamide in patients receiving the maximum recommended dosage of sertraline."( A study of the potential effect of sertraline on the pharmacokinetics and protein binding of tolbutamide.
Preskorn, SH; Tremaine, LM; Wilner, KD, 1997
)
0.77
" These results suggest that sertraline at the maximum recommended dosage under steady-state conditions, and demethylsertraline, the principal metabolite of sertraline, are unlikely to exert significant inhibitory effects on the CYP2C19 and CYP3A3/4 hepatic isoenzymes responsible for the metabolism of diazepam."( Effect of sertraline on the pharmacokinetics and protein binding of diazepam in healthy volunteers.
Baris, BA; Gardner, MJ; Preskorn, SH; Wilner, KD, 1997
)
0.99
" The dose-response curve was biphasic for citalopram with a maximum of 64% inhibition."( Behavioral profiles of SSRIs in animal models of depression, anxiety and aggression. Are they all alike?
Meier, E; Sánchez, C, 1997
)
0.3
"With conservative dosing and close monitoring, combinations of SRIs with bupropion in this uncontrolled clinical series appeared to be safe and often more effective than monotherapy."( Combining serotonin reuptake inhibitors and bupropion in partial responders to antidepressant monotherapy.
Baldessarini, RJ; Bodkin, JA; Gardner, DM; Lasser, RA; Wines, JD, 1997
)
0.3
"A sustained-release formulation of bupropion (bupropion SR), developed with an improved pharmacokinetic profile to permit less frequent dosing than the immediate-release form, has not been evaluated in active comparator trials."( Double-blind comparison of bupropion sustained release and sertraline in depressed outpatients.
Ascher, JA; Hughes, AR; Johnston, JA; Kavoussi, RJ; Segraves, RT, 1997
)
0.54
" The dosage of sertraline ranged from 25 to 150 mg/day (93."( The extent and determinants of changes in CYP2D6 and CYP1A2 activities with therapeutic doses of sertraline.
Herrmann, N; Kalow, W; Naranjo, CA; Ozdemir, V; Reed, K; Sellers, EM; Shulman, RW, 1998
)
0.87
" In case 2, a 25 mg reduction in the total daily dose of sertraline resulted in halving of the lamotrigine blood level even though the lamotrigine dosage was increased by 33%."( Lamotrigine toxicity secondary to sertraline.
Gerner, R; Kaufman, KR, 1998
)
0.82
" The purpose of this study was to assess whether there was a difference in expenditures during the first 90 days of SSRI therapy with paroxetine or sertraline versus fluoxetine in patients who were also receiving a stable dosage of a nonpsychiatric drug also metabolized by the CYP-450 2D6 or 3A4 isoenzyme systems."( Economic consequences of selective serotonin reuptake inhibitor use with drugs also metabolized by the cytochrome P-450 system.
Croghan, TW; Crown, WH; Hylan, TR; Melfi, CA; Meneades, LM; Ozminkowski, RJ; Robinson, RL,
)
0.33
"Sertraline hydrochloride was titrated to a maximum of 200 mg/d during the first 4 weeks of double-blind therapy, after which patients continued to receive this dosage of medication for 8 more weeks."( Sertraline in children and adolescents with obsessive-compulsive disorder: a multicenter randomized controlled trial.
Biederman, J; Cook, EH; Cutler, NR; Dominguez, R; Ferguson, J; March, JS; Mardekian, J; Muller, B; Riesenberg, R; Rosenthal, M; Safferman, A; Sallee, FR; Steiner, H; Wagner, KD; Wolkow, R, 1998
)
3.19
" Sixteen patients who did not respond to the traditional antipsychotics after 2 weeks of treatment with a certain dosage of haloperidol were administered with 50 mg of sertraline for a period of 2 weeks."( Co-administration of sertraline and haloperidol.
Han, CS; Kim, SH; Lee, MS; You, YW, 1998
)
0.81
"Evidence that serotonergic antidepressants are effective for treating premenstrual syndrome (PMS) raises the question of whether dosing only in the symptomatic premenstrual phase is effective for this disorder."( Full- or half-cycle treatment of severe premenstrual syndrome with a serotonergic antidepressant.
Arredondo, F; Freeman, EW; Kao, LC; Pollack, SE; Rickels, K; Sondheimer, SJ, 1999
)
0.3
" Cost, number of prescriptions, and dosage strength data is also presented."( Trends in the use of selective serotonin reuptake inhibitors in nine Department of Veterans Affairs outpatient facilities.
Voris, JC, 1999
)
0.3
" administration, sertraline is slowly absorbed with peak plasma concentrations at 6 - 8 h, and has a terminal elimination half-life of approximately 26 h, indicating once-daily dosing is available."( Bioequivalence evaluation of two sertraline tablet formulations in healthy male volunteers after a single dose administration.
Chen, LM; Qu, ZW; Wu, JF; Zhang, JT; Zhu, CJ, 1999
)
0.92
"To test the efficacy of late-luteal phase dosing of sertraline hydrochloride in women with moderate-to-severe premenstrual dysphoric disorder."( Luteal phase sertraline treatment for premenstrual dysphoric disorder. Results of a double-blind, placebo-controlled, crossover study.
Jermain, DM; Kuehl, TJ; Preece, CK; Sulak, PJ; Sykes, RL,
)
0.75
" The flexible dosage range was 50 to 150 mg/d."( Differential response to antidepressants in women with premenstrual syndrome/premenstrual dysphoric disorder: a randomized controlled trial.
Freeman, EW; Polansky, M; Rickels, K; Sondheimer, SJ, 1999
)
0.3
" If there was an insufficient response, the dose was titrated upwards to a maximum of 200 mg/day, with 2 weeks at each dosage level."( An open study of sertraline in patients with major depression who failed to respond to moclobemide.
Chiu, E; George, T; Hokin, A; Krapivensky, N; Theodoros, MT; Tiller, JW, 1999
)
0.64
" The proposed methods were applied successfully to the determination of the cited drugs either in pure or dosage forms with good accuracy and precision."( Spectrophotometric determination of fluoxetine and sertraline using chloranil, 2, 3 dichloro-5, 6 dicyano benzoquinone and iodine.
Bebawy, LI; El-Kousy, N; Shokry, M; Suddik, JK, 1999
)
0.56
" However, there is no data on the dosage of selective serotonin uptake inhibitors (SSRIs) required to maintain symptom resolution in women treated for major depression during pregnancy."( Dose of selective serotonin uptake inhibitors across pregnancy: clinical implications.
Hostetter, A; Llewellyn, A; McLaughlin, E; Stowe, ZN; Strader, JR, 2000
)
0.31
"6 kg, and their mean sertraline dosage was 55 mg/d."( The effects of grapefruit juice on sertraline metabolism: an in vitro and in vivo study.
Buffum, J; Bui, BC; Chan, WK; Harralson, AF; Lee, AJ, 1999
)
0.9
"Fifty-seven highly recurrent unipolar patients, excluded from previous long-term studies with selective serotonin reuptake inhibitors (SSRIs) after they experienced a new recurrence, were acutely treated with the full dosage of the SSRIs they were on."( Will a second prophylactic treatment with a higher dosage of the same antidepressant either prevent or delay new depressive episodes?
Bongiorno, F; Franchini, L; Rossini, D; Smeraldi, E; Spagnolo, C; Zanardi, R, 2000
)
0.31
" All three sertraline doses produced significant efficacy compared to placebo, with no consistent evidence of a dose-response effect."( The efficacy of sertraline in panic disorder: combined results from two fixed-dose studies.
Clary, CM; Fayyad, R; Londborg, P; Sheikh, JI, 2000
)
1.04
" Clinical effects from the medications were measured in relation to and shown to be a function of dosage level."( Therapeutic effects and long-term efficacy of antidepressant medication for persons with developmental disabilities. Behavioral assessment in two cases of treatment-resistant aggression and self-injury.
Blew, P; Luiselli, JK; Thibadeau, S, 2001
)
0.31
" A 34 year-old male patient experienced visual hallucinations and severe tremor after dramatically increasing his dosage of oxycodone while on stable amounts of sertraline and cyclosporin."( Visual hallucination and tremor induced by sertraline and oxycodone in a bone marrow transplant patient.
Flockhart, DA; Rosebraugh, CJ; Woosley, RL; Yasuda, SU, 2001
)
0.77
"2 per cent of patients the final sertraline dosage was 50 mg."( An open, baseline controlled evaluation of sertraline safety and efficacy in the treatment of depression in Thai patients.
, 2001
)
0.85
" While some patients clearly benefit from higher doses, the results of the current study are consistent with the lack of any evidence for a dose-response curve with sertraline in the treatment of depression."( The antidepressant effect of sertraline is not enhanced by dose titration: results from an outpatient clinical trial.
Demartinis, N; García-España, F; Mandos, LA; Rickels, K; Rynn, M; Schweizer, E, 2001
)
0.8
" To determine whether selective serotonin reuptake inhibitors (SSRI) induced hypomania is secondary to medication effects, we examined the dose-response relationship of SSRI-induced hypomania in two patients with depressive disorder."( Dose-response relationship of selective serotonin reuptake inhibitors treatment-emergent hypomania in depressive disorders.
Ramasubbu, R, 2001
)
0.31
" However, the time course for maximum inhibition to occur or for inhibition to dissipate when dosing is discontinued, requires clarification."( Differential time course of cytochrome P450 2D6 enzyme inhibition by fluoxetine, sertraline, and paroxetine in healthy volunteers.
Boulton, DW; DeVane, CL; Goldman, J; Liston, HL; Markowitz, JS; Risch, SC, 2002
)
0.54
" This raises the important question of whether once-weekly enteric-coated fluoxetine, 90 mg, is effective for maintenance of response in patients whose depressive symptoms have responded to daily dosing with selective serotonin reuptake inhibitors (SSRIs) such as citalopram, paroxetine, or sertraline."( Switching patients from daily citalopram, paroxetine, or sertraline to once-weekly fluoxetine in the maintenance of response for depression.
Brown, EB; Gonzales, JS; Miner, CM; Munir, R, 2002
)
0.74
" Patients with a DSM-IV diagnosis of OCD and a Y-BOCS greater or equal to 16 were randomly assigned to receive one of the two dosing regimens; an upper target dose of 150 mg/day was selected on the basis of a review of mean dosages used in flexible-dose sertraline studies."( Sertraline treatment of obsessive-compulsive disorder: efficacy and tolerability of a rapid titration regimen.
Albert, U; Bogetto, F; Maina, G, 2002
)
1.94
" In addition, no dosage adjustments are warranted for elderly patients solely based on age."( Sertraline: a review of its use in the management of major depressive disorder in elderly patients.
Muijsers, RB; Noble, S; Plosker, GL, 2002
)
1.76
"For paroxetine and fluoxetine, plasma concentrations and dosage strongly influence the magnitude of enzyme inhibition."( CYP2D6 inhibition by selective serotonin reuptake inhibitors: analysis of achievable steady-state plasma concentrations and the effect of ultrarapid metabolism at CYP2D6.
Alfaro, CL; Ereshefsky, L; Gaedigk, A; Lam, YW; Simpson, J, 2002
)
0.31
" In addition, no dosage adjustments are warranted for elderly patients solely based on age."( Spotlight on sertraline in the management of major depressive disorder in elderly patients.
Muijsers, RB; Noble, S; Plosker, GL, 2002
)
0.68
"Cognitive and psychomotor performance are not altered in healthy humans receiving multiple dosing with sertraline."( Effects of sertraline on autonomic and cognitive functions in healthy volunteers.
Grossmann, J; Kirch, W; Mück-Weymann, M; Siepmann, M, 2003
)
0.92
" We review the pharmacology, the adverse effects, the dosing guidelines, as well as the indications of sertraline."( The antidepressant sertraline: a review of its uses in a range of psychiatric and medical conditions.
Emes, R; Gill, T; Khouzam, HR; Raroque, R, 2003
)
0.86
" Drug dosage was maintained at levels that achieved remission."( Older community residents with depression: long-term treatment with sertraline. Randomised, double-blind, placebo-controlled study.
Abou-Saleh, MT; Ashworth, L; Mottram, PG; Wilson, KC, 2003
)
0.55
"Sertraline at therapeutic dosage does not provide significant protection against recurrence."( Older community residents with depression: long-term treatment with sertraline. Randomised, double-blind, placebo-controlled study.
Abou-Saleh, MT; Ashworth, L; Mottram, PG; Wilson, KC, 2003
)
2
" The heterocyclic agent trazodone significantly inhibited paw oedema by 46 and 41% at 1 and 2h after dosing at the highest dose (40 mg kg(-1)) examined."( Evaluation of the anti-inflammatory and anti-nociceptive effects of different antidepressants in the rat.
Abdel-Salam, OM; El-Shenawy, SM; Nofal, SM, 2003
)
0.32
" The authors report the outcome of extended, high-dosage sertraline treatment in a sample of nursing home residents experiencing residual significant depressive symptoms after 10 weeks of treatment with sertraline at a final dosage of 100 mg/day."( Effect of increasing the dose and duration of sertraline trial in the treatment of depressed nursing home residents.
Datto, CJ; DiFilippo, SD; Katz, IR; Oslin, DW; Streim, JE; Weintraub, D, 2003
)
0.82
"Sertraline hydrochloride, mean dosage of 95 mg/d, or identical placebo, randomly assigned."( Treating depression in Alzheimer disease: efficacy and safety of sertraline therapy, and the benefits of depression reduction: the DIADS.
Baker, AS; Brandt, J; DelCampo, L; Frangakis, C; Lyketsos, CG; Miles, Q; Munro, C; Rabins, PV; Sheppard, JM; Steele, CD; Steinberg, M, 2003
)
2
" Medication dosage was started at 50 mg/day, increased to 100 mg/day after 1 week, and then increased up to 200 mg/day if subjects had not remitted."( Sertraline as monotherapy in the treatment of psychotic and nonpsychotic depression.
El Sheshai, A; Fayek, M; Kingsbury, SJ; Rady, A; Simpson, GM, 2003
)
1.76
"Patients were randomly assigned to receive a flexible dosage (50-200 mg/d) of sertraline (n = 189) or matching placebo tablets (n = 187) for 10 weeks."( Efficacy of sertraline in the treatment of children and adolescents with major depressive disorder: two randomized controlled trials.
Ambrosini, P; Childress, A; Deas, D; Donnelly, C; Greenbaum, MS; Rynn, M; Wagner, KD; Wohlberg, C; Yang, R, 2003
)
0.93
" Due to the cyclic luteal occurrence of PMDD, luteal phase dosing of SSRIs has been suggested and proven effective for sertraline as well as several other SSRIs."( Treatment of premenstrual dysphoric disorder with luteal phase dosing of sertraline.
Halbreich, U; Kahn, LS, 2003
)
0.76
" Subjects with higher postmenstrual symptoms before treatment remained more symptomatic regardless of the dosing regimen."( Continuous or intermittent dosing with sertraline for patients with severe premenstrual syndrome or premenstrual dysphoric disorder.
Freeman, EW; Polansky, M; Rickels, K; Sondheimer, SJ; Xiao, S, 2004
)
0.59
"Premenstrual dosing does not differ from continuous dosing with sertraline in premenstrual syndrome treatment."( Continuous or intermittent dosing with sertraline for patients with severe premenstrual syndrome or premenstrual dysphoric disorder.
Freeman, EW; Polansky, M; Rickels, K; Sondheimer, SJ; Xiao, S, 2004
)
0.83
" The mean levodopa equivalent dosage (LED) was 1010+/-318 mg before surgery and 116+/-93 mg 3 months after surgery."( Effects of deep brain stimulation of the subthalamic nucleus on sleep architecture in parkinsonian patients.
Bergamasco, B; Cicolin, A; Fattori, E; Guastamacchia, G; Lanotte, MM; Lopiano, L; Makrydakis, G; Mutani, R; Tavella, A; Terreni, A; Torre, E; Zibetti, M, 2004
)
0.32
" Multiple SSRI dosing ranges were evaluated in autistic patients of different ages with various functional impairments."( Treating functional impairment of autism with selective serotonin-reuptake inhibitors.
Eichner, SF; Jones, JR; Moore, ML, 2004
)
0.32
" Two weeks after the increase of the dosage of sertraline, the patient developed a full-blown SS, which resolved completely after the discontinuation of the drug."( Repetition of serotonin syndrome after reexposure to SSRI--a case report.
Modestin, J; Tomaselli, G, 2004
)
0.58
" The mean daily dosage was 34."( Efficacy and tolerability of mirtazapine and sertraline in Korean veterans with posttraumatic stress disorder: a randomized open label trial.
Chung, MY; Jun, EM; Jun, YJ; Kim, SS; Kim, WC; Min, KH, 2004
)
0.58
" In consecutive dosing periods separated by washout periods of > or = 3 weeks, healthy volunteers received either oral donepezil HCI 5 mg once daily for 15 days, oral sertraline HCl 50 mg once daily for 5 days followed by 10 days of once-daily sertraline HCl 100 mg, or the simultaneous administration of oral donepezil HCl and sertraline HCl."( Concurrent administration of donepezil HCl and sertraline HCl in healthy volunteers: assessment of pharmacokinetic changes and safety following single and multiple oral doses.
Cullen, EI; Kumar, D; Nagy, CF; Perdomo, CA; Pratt, RD; Wason, S, 2004
)
0.78
" After 4 weeks of treatment with sertraline at a standard dosage of 50 mg/day, both the single TRH test and the combined T3/TRH test were repeated in the depressed patients."( The influence of 4-week treatment with sertraline on the combined T3/TRH test in depressed patients.
Alajbegovic, L; Baghai, TC; Eser, D; Möller, HJ; Rupprecht, R; Schaaf, L; Schüle, C; Schwarz, M; Zwanzger, P, 2005
)
0.88
"Three simple and sensitive spectrophotometric methods were developed and validated for determination of the hydrochloride salts of fluoxetine, sertraline, and paroxetine in their pharmaceutical dosage forms."( Development and validation of spectrophotometric methods for determination of fluoxetine, sertraline, and paroxetine in pharmaceutical dosage forms.
Darwish, IA,
)
0.55
"Use of intermittent dosing strategies for the treatment of premenstrual dysphoric disorder (PMDD) highlights the need for detailed empirical data on the onset, duration and pattern of symptom expression in women suffering from PMDD."( Pretreatment pattern of symptom expression in premenstrual dysphoric disorder.
Fayyad, R; Gillespie, JA; Pearlstein, T; Yonkers, KA, 2005
)
0.33
"Despite the proven efficacy of luteal phase medication dosing for women with premenstrual dysphoric disorder (PMDD), it is not known whether this approach adequately treats symptoms that linger into the first 2-3 days of the follicular phase, a time when up to one-third of women diagnosed with PMDD report residual symptoms."( Luteal phase treatment of premenstrual dysphoric disorder improves symptoms that continue into the postmenstrual phase.
Fayyad, R; Gillespie, JA; Pearlstein, T; Yonkers, KA, 2005
)
0.33
" The first study used continuous dosing of sertraline, 50-150 mg/day, throughout the menstrual cycle, while the second study used intermittent dosing with sertraline, 50-100 mg/day in the 14-16 days prior to onset of menses."( Luteal phase treatment of premenstrual dysphoric disorder improves symptoms that continue into the postmenstrual phase.
Fayyad, R; Gillespie, JA; Pearlstein, T; Yonkers, KA, 2005
)
0.59
" luteal phase dosing on the first day of menses (0."( Luteal phase treatment of premenstrual dysphoric disorder improves symptoms that continue into the postmenstrual phase.
Fayyad, R; Gillespie, JA; Pearlstein, T; Yonkers, KA, 2005
)
0.33
" All patients received sertraline in a dosage of 50 mg daily."( Adjunctive bright light in non-seasonal major depression: results from patient-reported symptom and well-being scales.
Bech, P; Dam, H; Lunde, M; Martiny, K; Undén, M, 2005
)
0.64
"This prospective 6-week study examined the differences in dosage and steady state plasma concentrations of sertraline in Chinese versus Caucasian depressed patients."( A comparative study of sertraline dosages, plasma concentrations, efficacy and adverse reactions in Chinese versus Caucasian patients.
Fan, A; Hong Ng, C; Klimidis, S; Kong Wai Ho, B; Naing, KO; Norman, TR; Schweitzer, I, 2006
)
0.86
" Antidepressant medication costs, however, are significantly higher when fluoxetine is the initial SSRI rather than sertraline or paroxetine, reflecting the larger proportion of fluoxetine patients prescribed a daily dosage of two or more capsules."( Comparing SSRI treatment costs for depression using retrospective claims data: the role of nonrandom selection and skewed data.
Berndt, ER; Colucci, SV; Grudzinski, AN; Miceli, R; Russell, JM; Xu, Y,
)
0.34
"Eighty-four patients 60 years of age and over with a principal diagnosis of generalized anxiety disorder, panic disorder, agoraphobia, or social phobia were randomly assigned to one of three conditions: 15 sessions of CBT, pharmacologic treatment with an SSRI (sertraline; maximum dosage 150 mg), or a waitlist control group."( A randomized, controlled trial of the effectiveness of cognitive-behavioral therapy and sertraline versus a waitlist control group for anxiety disorders in older adults.
Comijs, H; Emmelkamp, PM; Gundy, CM; Schuurmans, J; van den Hout, M; van Dyck, R; Weijnen, I, 2006
)
0.74
" Dosing strategies for the SSRIs sertraline and paroxetine are provided, and an algorithm for PTSD pharmacotherapy is discussed."( Pharmacologic treatment of acute and chronic stress following trauma: 2006.
Davidson, JR, 2006
)
0.62
" Outpatients with DSM-IV GAD (N = 326) who satisfied inclusion/exclusion criteria and completed a 1-week screening phase were randomly assigned to 10-week double-blind treatment with flexible dosing of sertraline (50-200 mg/day) or placebo."( Sertraline treatment for generalized anxiety disorder: a randomized, double-blind, placebo-controlled study.
Brawman-Mintzer, O; Carter, RE; Knapp, RG; Rickels, K; Rynn, M, 2006
)
1.96
"To determine if voluntary prescription change forms for antidepressant drugs could induce dosing changes and reduce the cost of antidepressant therapy in a Medicaid population."( Initial results of the use of prescription order change forms to achieve dose form optimization (consolidation and tablet splitting) of SSRI antidepressants in a state Medicaid program.
Hamer, AM; Hartung, DM; Haxby, DG; Ketchum, KL; Pollack, DA,
)
0.13
" The objective of this study was to evaluate the safety and efficacy of sertraline in the treatment of moderate-to-severe PMS using 3 different dosing strategies: luteal phase (2 cycles), followed by continuous dosing throughout the month (1 cycle), followed by dosing begun at the first onset of PMS symptoms, or "symptom-onset" dosing (1 cycle)."( Low-dose sertraline in the treatment of moderate-to-severe premenstrual syndrome: efficacy of 3 dosing strategies.
Farfel, GM; Fayyad, R; Gillespie, JA; Kornstein, SG; Pearlstein, TB, 2006
)
0.98
"Intermittent luteal-phase dosing with low doses of sertraline (25 and 50 mg/day) produced significant improvement across 2 menstrual cycles, based on total DSR scores, compared with placebo."( Low-dose sertraline in the treatment of moderate-to-severe premenstrual syndrome: efficacy of 3 dosing strategies.
Farfel, GM; Fayyad, R; Gillespie, JA; Kornstein, SG; Pearlstein, TB, 2006
)
1
"This trial was conducted to compare the efficacy and tolerability of a fixed dose of escitalopram 10 mg/day with sertraline optimally dosed within its recommended dose range (50-200 mg/day) for the treatment of major depressive disorder."( Escitalopram versus sertraline in the treatment of major depressive disorder: a randomized clinical trial.
Armstrong, EP; Haim Erder, M; Skrepnek, GH; Ventura, D, 2007
)
0.87
" At week 8, the mean sertraline dosage was 144 mg/day (median = 150 mg/day)."( Escitalopram versus sertraline in the treatment of major depressive disorder: a randomized clinical trial.
Armstrong, EP; Haim Erder, M; Skrepnek, GH; Ventura, D, 2007
)
0.98
"No differences in efficacy were observed for fixed-dose escitalopram 10 mg/day and sertraline flexibly dosed from 50-200 mg/day."( Escitalopram versus sertraline in the treatment of major depressive disorder: a randomized clinical trial.
Armstrong, EP; Haim Erder, M; Skrepnek, GH; Ventura, D, 2007
)
0.89
" Patients recruited from 10 VA medical centers were randomly assigned to 12 weeks of flexibly dosed sertraline (25-200 mg/day) (N = 86; 70% with combat-related PTSD; 79% male) or placebo (N = 83; 72% combat-related PTSD; 81% male) between May 1994 and September 1996."( Randomized, double-blind comparison of sertraline and placebo for posttraumatic stress disorder in a Department of Veterans Affairs setting.
Baker, DG; Farfel, GM; Friedman, MJ; Marmar, CR; Sikes, CR, 2007
)
0.83
" The treatment response was assessed at baseline, week 4 and week 12, with hospital anxiety and depression scale (HADS) and Montgomery Asberg depression rating scale (MADRS), to rate depression and anxiety; mini mental adjustment to cancer scale (Mini-MAC), to assess the psychological response to the diagnosis of cancer; clinical global impression (CGI) to evaluate severity of illness; dosage record and treatment emergent symptom scale (DOTES), to assess the adverse effects of the clinical treatments and their possible relation with the drug used; and QL index to rate quality of life."( Sertraline effectiveness and safety in depressed oncological patients.
Caldera, P; Siri, I; Torta, R, 2008
)
1.79
"Selective serotonin reuptake inhibitors were found to be effective in treating premenstrual symptoms, with continuous dosing regimens favored for effectiveness."( Selective serotonin reuptake inhibitors for premenstrual syndrome and premenstrual dysphoric disorder: a meta-analysis.
Aperi, J; Borenstein, J; Jones, JB; Karne, A; Shah, NR; Shemtov, R, 2008
)
0.35
" This pilot study is designed to evaluate the effectiveness of variable dosing in PMED using the antidepressant sertraline."( Variable dosing of sertraline for premenstrual exacerbation of depression: a pilot study.
Ferslew, KE; Frizzell, PG; Kayser, RA; Miller, BE; Miller, MN; Newell, CL,
)
0.67
"The use of variable dosing in PMED increases the effectiveness of treatment."( Variable dosing of sertraline for premenstrual exacerbation of depression: a pilot study.
Ferslew, KE; Frizzell, PG; Kayser, RA; Miller, BE; Miller, MN; Newell, CL,
)
0.46
" Adverse effects were evaluated using the Dosage Record and Treatment Emergent Symptom Scale (DOTES)."( Efficacy and tolerability of aripiprazole augmentation in sertraline-resistant patients with borderline personality disorder.
Bellino, S; Bogetto, F; Paradiso, E, 2008
)
0.59
"Insufficient data inform dosing of antidepressants and clinical monitoring for major depressive disorder (MDD) during the perinatal period."( Pharmacokinetics of sertraline across pregnancy and postpartum.
Anthony, M; Davis, MF; Fankhauser, M; Freeman, MP; Fried, K; Moreno, F; Nolan, PE; Woosley, RL, 2008
)
0.67
"The objective of the current study was to develop a validated stability-indicating high-performance liquid chromatographic method for alprazolam and sertraline in combined dosage forms."( Development of a stability-indicating high-performance liquid chromatographic method for the simultaneous determination of alprazolam and sertraline in combined dosage forms.
Pathak, A; Rajput, SJ,
)
0.53
" Greater clinical severity and low initial dosing may increase the risk of switching antidepressants."( Antidepressant switching among adherent patients treated for depression.
Hassan, M; Marcus, SC; Olfson, M, 2009
)
0.35
" Also included are human pharmacokinetic studies with prototype CR dosage forms for CJ-13,610 and CP-424,391."( The use of gastrointestinal intubation studies for controlled release development.
Sutton, SC, 2009
)
0.35
" Blood samples were collected before dosing and at frequent intervals for up to 96 h post dose."( Bioequivalence study of 50 mg sertraline tablets in healthy Thai volunteers.
Chatsiricharoenkul, S; Kongpatanakul, S; Niyomnaitham, S; Pongnarin, P; Sathirakul, K, 2009
)
0.64
" Phase 1 was a 6-week lead-in with open-label sertraline flexibly dosed to 100 mg (or escitalopram equivalent) to prospectively define treatment refractoriness (lack of remission)."( Next-step strategies for panic disorder refractory to initial pharmacotherapy: a 3-phase randomized clinical trial.
Hoge, EA; Lebeau, RT; Moshier, SJ; Otto, MW; Pollack, MH; Simon, NM; Thompson, EH; Worthington, JJ; Zalta, AK, 2009
)
0.61
"It is important that variations in drug metabolism during pregnancy be considered as these changes may necessitate a dosage adjustment to ensure that therapeutic failure does not occur during pregnancy."( Changes in antidepressant metabolism in pregnancy evidenced by metabolic ratios in hair: a novel approach.
Baumer, C; Koren, G; O'Brien, L; Sachs, H; Thieme, D, 2010
)
0.36
" medical centers with mild-to-moderate AD (Mini-Mental State Examination scores 10-26) and depression of AD were randomized to double-blinded treatment with sertraline (N = 67) or placebo (N = 64), with a target dosage of 100 mg daily."( Sertraline for the treatment of depression in Alzheimer disease.
Drye, LT; Frangakis, C; Lyketsos, CG; Martin, BK; Meinert, CL; Mintzer, JE; Munro, CA; Porsteinsson, AP; Rabins, PV; Rosenberg, PB; Schneider, LS; Weintraub, D, 2010
)
2
" When managing a patient with nonpsychotic depression and inadequate response to the maximum dose of a single antidepressant, the physician should first identify factors that may contribute to the poor response, such as suboptimal dosage resulting from nonadherence, inadequate duration of therapy, and comorbid medical and psychiatric conditions."( Clinical inquiries. What's best when a patient doesn't respond to the maximum dose of an antidepressant?
Lo, V; Maggio, L, 2010
)
0.36
" The applicability of the proposed method was shown by the successful analysis of sertraline in tablet dosage forms."( Electrochemical behaviour of sertraline hydrochloride at a glassy carbon electrode and its determination in pharmaceutical products using osteryoung square wave voltammetry.
Cay, HY; Dermiş, S, 2010
)
0.88
" Patients were treated with torin (sertraline) in dosage 25-50 mg daily during 4 weeks."( [Torin (sertraline) in the treatment of depressive and obsessive-compulsive disorders in children].
Malinina, EV; Zabozlaeva, IV, 2010
)
1.07
"we related medication choice and dosage range to outcomes of treatment as reflected by discharge rates and suicidality."( Was Cipriani right? Audits to compare discharge rates and suicidality between antidepressant monotherapies used in a British community mental health team.
Agius, M; Gardner, J; Liu, K; Zaman, R, 2010
)
0.36
" Regarding Dose Ranges, we note that wheras many patients had their dosage titrated upwards from the starting dose, most did not have the dosage titrated to the highest dose of the relevant medication."( Was Cipriani right? Audits to compare discharge rates and suicidality between antidepressant monotherapies used in a British community mental health team.
Agius, M; Gardner, J; Liu, K; Zaman, R, 2010
)
0.36
" Important issues related to adherence included parental and child attitudes, complex dosing schedules, and barriers to communication between parents and providers."( Promoting adherence to psychotropic medication for youth-part 2.
McGuinness, TM; Worley, J, 2010
)
0.36
"Seventy Iranian veterans of the Iran-Iraq war who met the DSM-IV criteria for diagnosis of PTSD were randomized to receive either flexibly dosed sertraline (50-200 mg/day) (n=35, completers=32) or placebo (n=35, completers=30) for 10 weeks."( A randomized, double-blind, placebo-controlled trial on the efficacy and tolerability of sertraline in Iranian veterans with post-traumatic stress disorder.
Beiraghdar, F; Karami, G; Moghaddam, BR; Nazari, MA; Panahi, Y; Saadat, AR; Sahebkar, A, 2011
)
0.79
" Second we do not know which dosage we should be aiming at with that antidepressant."( Strategic use of new generation antidepressants for depression: SUN(^_^)D study protocol.
Akechi, T; Furukawa, TA; Inagaki, M; Miki, K; Shimodera, S; Watanabe, N; Yamada, M; Yonemoto, N, 2011
)
0.37
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."( FDA-approved drug labeling for the study of drug-induced liver injury.
Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011
)
0.37
" Each child received either flexibly dosed sertraline between 25-150 mg/day or placebo."( A randomized controlled trial of sertraline to prevent posttraumatic stress disorder in burned children.
Chang, Y; Chedekel, DS; Drake, J; Levine, JB; Luthra, R; Saxe, GN; Sheridan, RL; Sorrentino, EA; Stoddard, FJ, 2011
)
0.91
" No subject discontinued dosing due to adverse events."( Open-label phase 1b pilot study to assess the antiviral efficacy of simvastatin combined with sertraline in chronic hepatitis C patients.
Altmeyer, R; Cheng, CW; Chopra, N; Lawitz, E; Lim, SG; McHutchison, JG; Patel, K; Randle, JC; Tillmann, HL, 2011
)
0.59
" We undertook parallel studies in endothelial cells derived from brain microvessels to determine the dose-response and time-course of effects."( Effects of sertraline and fluoxetine on p-glycoprotein at barrier sites: in vivo and in vitro approaches.
Gibb, W; Ho, HL; Iqbal, M; Kapoor, A; Matthews, SG; Petropoulos, S, 2013
)
0.78
" A dose-response relationship between active-sham differences with the long allele was also suggested."( Impact of 5-HTTLPR and BDNF polymorphisms on response to sertraline versus transcranial direct current stimulation: implications for the serotonergic system.
Benseñor, IM; Brunoni, AR; Brunoni, D; Coprerski, B; Cordeiro, Q; Fregni, F; Goulart, AC; Kemp, AH; Lotufo, PA; Perez, AB; Shiozawa, P; Valiengo, LC, 2013
)
0.64
" Cox regression models, adjusted for demographic and clinical characteristics, were used to examine associations of antidepressant dosing with ventricular arrhythmia and cardiac, noncardiac, and all-cause mortality."( Evaluation of the FDA warning against prescribing citalopram at doses exceeding 40 mg.
Blow, FC; Bohnert, AS; Ganoczy, D; Kales, HC; Nallamothu, BK; Pfeiffer, PN; Zivin, K, 2013
)
0.39
" Sertraline was initiated at 25 mg daily orally for the first month, with dosage increment of 25 mg monthly according to clinical response up to a maximum of 200 mg daily as necessary."( Use of sertraline for antihistamine-refractory uremic pruritus in renal palliative care patients.
Chan, KY; Chan, ML; Cheng, HW; Li, CW; Sham, MK; Wong, H; Yip, T, 2013
)
1.76
"Twenty-one adult female cynomolgus monkeys were housed in small, stable social groups, trained to participate in oral dosing, and began a 5-week cumulative dose-response study."( Sertraline effects on cerebrospinal fluid monoamines and species-typical socioemotional behavior of female cynomolgus monkeys.
Higley, JD; Register, TC; Shively, CA; Willard, SL, 2014
)
1.85
" Depressed patients were administered sertraline 50mg at 8:00am on the first day, and the dosage was subsequently titrated up to a maximum of 200mg daily during the 8-week trial."( Sertraline and periodic limb movements during sleep: an 8-week open-label study in depressed patients with insomnia.
Hao, Y; Jia, F; Li, X; Liu, W; Ren, Y; Wing, YK; Zhang, B; Zhou, P, 2013
)
2.1
" This effect of sertraline on PLMS might be dosage dependent."( Sertraline and periodic limb movements during sleep: an 8-week open-label study in depressed patients with insomnia.
Hao, Y; Jia, F; Li, X; Liu, W; Ren, Y; Wing, YK; Zhang, B; Zhou, P, 2013
)
2.18
"This study aimed at evaluating the safety and efficacy of an improved dosage regimen of sertraline in patients with premature ejaculation (PE) and to examine whether the premature ejaculation diagnostic tool (PEDT) can be used as a measure of treatment response in these patients."( An improved dosage regimen of sertraline hydrochloride in the treatment for premature ejaculation: an 8-week, single-blind, randomized controlled study followed by a 4-week, open-label extension study.
Ding, Q; Fang, J; Gu, B; Jiang, HW; Liu, J; Wen, H; Xu, G; Zhang, LM; Zhang, YF, 2014
)
0.91
"Oxidation of active pharmaceutical ingredients is a common chemical degradation process occurring in solid dosage forms."( Impact of sertraline salt form on the oxidative stability in powder blends.
Hsieh, YL; Pan, W; Shalaev, EY; Shamblin, SL; Taylor, LS; Waterman, KC; Xiang, Y; Yu, W, 2014
)
0.8
" However, therapeutic efficacy and treatment success is often variable, requiring changes in dosing regimens or drug selection."( The development and validation of a turbulent flow-liquid chromatography-tandem mass spectrometric method for the simultaneous quantification of citalopram, sertraline, bupropion and hydroxybupropion in serum.
Clarke, W; Jannetto, PJ; Johnson-Davis, KL; Langman, LJ; Marzinke, MA; Moskowitz, J; Petrides, AK, 2014
)
0.6
" However, both single and multiple dosing treatments of SC alcoholic extract remarkably decreased the in vivo metabolism of tacrolimus indicated by the enhanced AUC (7-12 fold) and elevated Cmax (10 fold)."( Multifaceted interaction of the traditional Chinese medicinal herb Schisandra chinensis with cytochrome P450-mediated drug metabolism in rats.
Hu, J; Li, Y; Wang, B; Yang, S, 2014
)
0.4
" The patient was known to suffer from depression and was treated with sertraline (Zoloft®) for 6 months at the dosage of 100 mg/day."( [Thrombopathy induced by selective serotonin reuptake inhibitors: a case report].
Amar, L; Ben Said, M; Bertil, S; Fischer, AM; Gaussem, P; Helley, D; Rivet, N; Smadja, D,
)
0.37
" We calculated the ratio of the mean doses for each study and weighted it by the total sample size to find the weighted mean ratio for each drug, which was then used to define the drug׳s dosage equivalent to fluoxetine 40mg/d."( Dose equivalents of antidepressants: Evidence-based recommendations from randomized controlled trials.
Barbui, C; Cipriani, A; Furukawa, TA; Hayasaka, Y; Leucht, S; Magni, LR; Ogawa, Y; Purgato, M; Takeshima, N, 2015
)
0.42
" In the primary analysis, fluoxetine 40mg/day was equivalent to paroxetine dosage of 34."( Dose equivalents of antidepressants: Evidence-based recommendations from randomized controlled trials.
Barbui, C; Cipriani, A; Furukawa, TA; Hayasaka, Y; Leucht, S; Magni, LR; Ogawa, Y; Purgato, M; Takeshima, N, 2015
)
0.42
"To determine the efficacy of symptom-onset dosing with the SRI sertraline hydrochloride for treatment of PMDD."( Symptom-Onset Dosing of Sertraline for the Treatment of Premenstrual Dysphoric Disorder: A Randomized Clinical Trial.
Altemus, M; Gueorguieva, R; Kornstein, SG; Merry, B; Van Steenburgh, K; Yonkers, KA, 2015
)
0.96
" Step I randomization compares the minimum and the maximum dosing strategy for the first-line antidepressant."( Strategic use of new generation antidepressants for depression: SUN(^_^) D protocol update and statistical analysis plan.
Akechi, T; Furukawa, TA; Guyatt, GH; Hayasaka, Y; Inagaki, M; Kato, T; Mantani, A; Miki, K; Ogawa, Y; Shimodera, S; Shinohara, K; Tajika, A; Takeshima, N; Tanaka, S; Watanabe, N; Yamada, M; Yonemoto, N, 2015
)
0.42
" The observed results were unchanged with the addition of SSRI dosage as a covariate."( Side-effects of SSRIs disrupt multimodal treatment for pediatric OCD in a randomized-controlled trial.
Bussing, R; Geffken, GR; Goodman, WK; Guzick, AG; McNamara, JP; Murphy, TK; Reid, AM; Storch, EA, 2015
)
0.42
" These findings suggest that dosage changes due to AS do not explain why those with higher AS had worse multimodal outcome."( Side-effects of SSRIs disrupt multimodal treatment for pediatric OCD in a randomized-controlled trial.
Bussing, R; Geffken, GR; Goodman, WK; Guzick, AG; McNamara, JP; Murphy, TK; Reid, AM; Storch, EA, 2015
)
0.42
" The present study was designed to clarify the relationship between dosage and treatment response in major depressive disorder."( Systematic Review and Meta-Analysis: Dose-Response Relationship of Selective Serotonin Reuptake Inhibitors in Major Depressive Disorder.
Bloch, MH; Freemantle, N; Jakubovski, E; Taylor, MJ; Varigonda, AL, 2016
)
0.43
" Endpoint and tolerability analyses were analyzed using meta-regression and stratified subgroup analysis by predefined SSRI dose categories in order to assess the effect of SSRI dosing on the efficacy and tolerability of SSRIs for major depressive disorder."( Systematic Review and Meta-Analysis: Dose-Response Relationship of Selective Serotonin Reuptake Inhibitors in Major Depressive Disorder.
Bloch, MH; Freemantle, N; Jakubovski, E; Taylor, MJ; Varigonda, AL, 2016
)
0.43
" Food and Drug Administration (FDA) on the risk of suicidality among children associated with use of antidepressants, but the warning's effect on dosing of antidepressants has not been evaluated."( Dosing of Selective Serotonin Reuptake Inhibitors Among Children and Adults Before and After the FDA Black-Box Warning.
Azrael, D; Bushnell, GA; Miller, M; Pate, V; Stürmer, T; Swanson, SA; White, A, 2016
)
0.43
"The proportion of commercially insured children initiating an SSRI with a low dose was higher after the 2004 FDA warning on the risk of suicidality among children, suggesting improved prescribing practices surrounding SSRI dosing among children."( Dosing of Selective Serotonin Reuptake Inhibitors Among Children and Adults Before and After the FDA Black-Box Warning.
Azrael, D; Bushnell, GA; Miller, M; Pate, V; Stürmer, T; Swanson, SA; White, A, 2016
)
0.43
"We observed a 60-year-old man who experienced resting tremors, dyskinesia and dysgraphia 2 months after a stepwise increase in sertraline dosing from 50 to 200 mg/day."( A case of dysgraphia induced by sertraline and a review of official spontaneous adverse reaction databases.
Antoniazzi, S; Carnovale, C; Clementi, E; Galimberti, C; Gentili, M; Marinaccio, PM; Pozzi, M; Radice, S; Viganò, C, 2016
)
0.92
" Grade 4 or 5 adverse event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200 mg/day and higher doses of 300-400 mg/day (hazard ratio 1·27, 95% CI 0·69-2·32; p=0·45)."( Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study.
Abassi, M; Akampurira, A; Alhadab, A; Bahr, NC; Boulware, DR; Fisher, J; Hullsiek, KH; Kiggundu, R; Meya, DB; Morawski, BM; Musubire, A; Nabeta, HW; Nielsen, K; Rhein, J; Smith, KD; Tugume, L; Velamakanni, SS; Williams, DA, 2016
)
0.74
" 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
)
0.96
" All drugs showed maximum occupancy at 4h after dosing and then decreasing occupancies with time."( Time-course of serotonin transporter occupancy by single dose of three SSRIs in human brain: A positron emission tomography study with [(11)C]DASB.
Arakawa, R; Kim, W; Ogawa, K; Okubo, Y; Sakayori, T; Tateno, A, 2016
)
0.43
" In contrast, among doses above these, there was no indication of a dose-response relationship."( A mega-analysis of fixed-dose trials reveals dose-dependency and a rapid onset of action for the antidepressant effect of three selective serotonin reuptake inhibitors.
Eriksson, E; Hieronymus, F; Nilsson, S, 2016
)
0.43
" 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
" In addition there is no need to adjust sertraline dosage in patients with ESRD."( Sertraline can reduce uremic pruritus in hemodialysis patient: A double blind randomized clinical trial from Southern Iran.
Hashemi, N; Malekmakan, L; Pakfetrat, M; Tadayon, T, 2018
)
2.19
" Using a blinded dosing strategy, we demonstrated that high dose sertraline monotherapy provided no benefit for the prevention of Ebola virus disease in rhesus macaques with regards to reduction of viral load, morbidity, or survival highlighting the challenges of translating results between in vitro and in vivo models."( High dose sertraline monotherapy fails to protect rhesus macaques from lethal challenge with Ebola virus Makona.
Adams, RD; Bennett, RS; Hensley, LE; Honko, AN; Huzella, L; Jahrling, PB; Johnson, JC; Marchand, JS; Oberlander, N; Olinger, GG; Torzewski, LM, 2017
)
1.1
"Regression analyses indicated a dose-response relationship between therapist-reported quantity of exposure and independent evaluations of treatment outcome, with more time devoted to exposure linked to better outcomes."( Therapist-Reported Features of Exposure Tasks That Predict Differential Treatment Outcomes for Youth With Anxiety.
Albano, AM; Bergman, RL; Birmaher, B; Caporino, NE; Compton, SN; Ginsburg, GS; Kendall, PC; McCracken, JT; O'Rourke, S; Peris, TS; Piacentini, J; Sakolsky, D; Walkup, JT, 2017
)
0.46
" All subjects began open-label sertraline treatment and were followed over 12 weeks with clinically indicated flexible dosing and an option to switch antidepressants."( Presence of neuroticism and antidepressant remission rates in late-life depression: results from the Neurobiology of Late-Life Depression (NBOLD) study.
Grady, JJ; Manning, KJ; Steffens, DC; Wu, R, 2018
)
0.77
" Serum concentration of citalopram and daily dosage correlated positively while daily dosage and mother milk concentration did not (rho = 0."( Antidepressants in breast milk; comparative analysis of excretion ratios.
Augustin, M; Franz, C; Gründer, G; Paulzen, M; Saßmannshausen, H; Schoretsanitis, G, 2019
)
0.51
"The present study involved segmental testing of hair in two clinical cases with known dosage histories."( Segmental Hair Analysis-Interpretation of the Time of Drug Intake in Two Patients Undergoing Drug Treatment.
Johansen, SS; Linnet, K; Nielsen, MKK; Wang, X, 2019
)
0.51
" Sertraline dosage was titrated during a 10-week period and continued until week 24; medication management was manualized."( Efficacy of Prolonged Exposure Therapy, Sertraline Hydrochloride, and Their Combination Among Combat Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial.
Acierno, R; Allard, CB; Hoge, CW; Kim, HM; King, AP; Liberzon, I; Martis, B; Norman, SB; Phan, KL; Porter, K; Powell, C; Rauch, SAM; Rothbaum, BO; Simon, NM; Stein, MB; Tuerk, PW; Venners, MR, 2019
)
1.69
" Subjects were evaluated every 2 weeks up to 12 weeks by the study psychiatrist, who followed a flexible, clinically based medication dosing schedule."( Functional connectivity predictors of acute depression treatment outcome.
Pearlson, GD; Steffens, DC; Wang, L, 2019
)
0.51
" Monitoring the body levels of this drug and its active metabolite, N-desmethylsertraline (DSRT), permits optimizing the dosage and personalizing the treatment, especially in the case of severe adverse reactions or lack of response to the applied therapy."( Sertraline - isolation methods and quantitation in biological material.
Dziurkowska, E; Wesolowski, M, 2018
)
2.15
"Using patient-derived glioblastoma stem cell (GSC) cultures from 15 GBM patients, we described stem cell properties of individual cultures, determined the dose-response relationships of the drugs in the CUSP9, and assessed the efficacy the CUSP9 combination with TMZ in concentrations clinically achievable."( The efficacy of a coordinated pharmacological blockade in glioblastoma stem cells with nine repurposed drugs using the CUSP9 strategy.
Grieg, Z; Langmoen, IA; Sandberg, CJ; Skaga, E; Skaga, IØ; Vik-Mo, EO, 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
" At the time of randomization, the median dosage of sertraline was 150 mg/d (interquartile range [IQR], 150-200 mg/d) and the median dosage of olanzapine was 15 mg/d (IQR, 10-20 mg/d)."( Effect of Continuing Olanzapine vs Placebo on Relapse Among Patients With Psychotic Depression in Remission: The STOP-PD II Randomized Clinical Trial.
Alexopoulos, GS; Banerjee, S; Flint, AJ; Marino, P; Meyers, BS; Mulsant, BH; Pollari, CD; Rothschild, AJ; Rudorfer, MV; Voineskos, AN; Whyte, EM; Wu, Y, 2019
)
0.76
" A 12-lead electrocardiogram was recorded in triplicate before dosing and at selected time points up to 72 hours after dosing."( A Thorough QT Study to Evaluate the Effects of a Supratherapeutic Dose of Sertraline on Cardiac Repolarization in Healthy Subjects.
Abbas, R; Bachinsky, M; Chappell, PB; Crownover, PH; Damle, B; LaBadie, RR; Riley, S, 2020
)
0.79
" Uncertainty in drug dosing in pregnancy can lead to suboptimal therapy, which can contribute to disease exacerbation."( Application of physiologically based pharmacokinetic modeling for sertraline dosing recommendations in pregnancy.
Beitz, J; Crentsil, V; George, B; Lumen, A; Nguyen, C; Wang, J; Wesley, B, 2020
)
0.8
" Donepezil (3 mg/kg; po) and sertraline (10 mg/kg; po) dosing was started from D-8 and continued up to D-32."( Development and treatment of cognitive inflexibility in sub-chronic stress-re-stress (SRS) model of PTSD.
Krishnamurthy, S; Prajapati, SK, 2021
)
0.91
"Since several recent meta-analyses report a dose-response relationship for the antidepressant effect of the selective serotonin reuptake inhibitors (SSRIs), we investigated how these drugs are dosed in clinical practice."( Low SSRI dosing in clinical practice-a register-based longitudinal study.
Eriksson, E; Hieronymus, F; Lisinski, A; Wallerstedt, SM, 2021
)
0.62
" The lack of consensus regarding effective dosing of SSRIs may have contributed to this state of affairs."( Low SSRI dosing in clinical practice-a register-based longitudinal study.
Eriksson, E; Hieronymus, F; Lisinski, A; Wallerstedt, SM, 2021
)
0.62
" In addition, since each antidepressant possesses a different dosage range from the other, overdoses of these antidepressants might also be the causes of these differences."( Antidepressant Screening Demonstrated Non-Monotonic Responses to Amitriptyline, Amoxapine and Sertraline in Locomotor Activity Assay in Larval Zebrafish.
Audira, G; Chen, KH; Hsiao, CD; Hussain, A; Saputra, F; Siregar, P; Suryanto, ME; Uapipatanakul, B, 2021
)
0.84
" After experiencing a major Covid-19-related personal trauma, patients showed clinical worsening which required dosage adjustment (20 mg/day vortioxetine; 600 mg/day trazodone, and 200 mg/day sertraline) and, for some of them, hospitalisation."( Differential Response to Three Antidepressants in Patients with Major Depressive Episode Who Suffered Covid-19-Related Trauma.
Amici, E; De Filippis, S; Di Giovanni, A; Giovanetti, V; Kotzalidis, GD; Lombardozzi, G; Matrone, M; Perrini, F; Trovini, G, 2022
)
0.91
" Knowing the CYP2B6 and CYP2C19 genotype, including the CYP2C:TG haplotype status, can prospectively be useful to clinicians in making more appropriate sertraline dosing decisions."( Impact of the novel CYP2C:TG haplotype and CYP2B6 variants on sertraline exposure in a large patient population.
Bråten, LS; Ingelman-Sundberg, M; Jukic, MM; Kringen, MK; Molden, E, 2022
)
1.16
" Sixty-one patients suffering from OCD who were resistant to sertraline monotherapy were randomly allocated to receive mirtazapine (mean dosage = 39."( Is mirtazapine augmentation effective for patients with obsessive-compulsive disorder who failed to respond to sertraline monotherapy? A placebo-controlled, double-blind, clinical trial.
Baniasadipour, H; Mowla, A, 2023
)
1.36
" This case report is novel is several aspects: the tics emergence was immediate whereas previous cases were delayed; the tics symptoms were measured and quantified by a validated scale; a dose-response relationship was observed; to our knowledge, our case was the first adolescent female reported; and finally, paroxetine was well-tolerated as a substitute, although it is unclear whether the observed tics-sparing effect is co-incidental, ideocratic or can be replicated."( Sertraline-Induced Tics: A Case Report and Narrative Review.
Arasu, R; Badeshae, S; Chen, W; Furlong, Y, 2023
)
2.35
" The steroid structure was chemically altered to improve bioavailability and create an oral dosage form."( Neuroactive steroids - new possibilities in the treatment of postpartum depression.
Adamičková, A; Gažová, A; Hrubá, O; Massarová, P; Vranecová, K; Žigová, L, 2022
)
0.72
" Another interesting aspect of antidepressants is that they have shown to induce non-monotonic dose-response (NMDR) curves."( Contrasting dose response relationships of neuroactive antidepressants on the behavior of C. elegans.
Estruch, IM; van den Brink, NW; van der Most, MA, 2023
)
0.91
" Scatter plots revealed a complex relationship between the dosage of clozapine and dose-adjusted sertraline concentrations composed of an initial decrease at clozapine doses below 300 mg, an increase between 300 and 600 mg and a final decrease at 800 mg which was best modeled by a third order polynomial term."( Lower sertraline plasma concentration in patients co-medicated with clozapine-Implications for pharmacological augmentation strategies in schizophrenia.
Endres, K; Gaebler, AJ; Haen, E; Hiemke, C; Omar, NB; Paulzen, M; Schoretsanitis, G, 2023
)
1.61
" This finding can serve to inform sertraline dosing optimization, especially when changes in kidney function occur in treated individuals, to prevent adverse drug reactions and maximize therapeutic benefits."( Population Pharmacokinetic Modeling to Inform Sertraline Dosing Optimization in Patients with Depression.
Ilic, N; Jankovic, SM; Milovanovic, J; Nikolic, VN; Popovic, D; Stoiljkovic, M; Vujovic, M, 2023
)
1.45
" However, the relationship between the dosage of sertraline and its efficacy and safety are unclear."( Selection of the optimal dose of sertraline for depression: A dose-response meta-analysis of randomized controlled trials.
Chen, Y; Li, J; Liu, Y; Luo, X; Ren, M; Si, T; Zhu, D, 2023
)
1.45
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
antidepressantAntidepressants are mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions.
serotonin uptake inhibitorA compound that specifically inhibits the reuptake of serotonin in the brain. This increases the serotonin concentration in the synaptic cleft which then activates serotonin receptors to a greater extent.
[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]

Drug Classes (3)

ClassDescription
tetralinsCompounds containing a tetralin skeleton.
secondary amino compoundA compound formally derived from ammonia by replacing two hydrogen atoms by organyl groups.
dichlorobenzeneAny member of the class of chlorobenzenes carrying two chloro groups at unspecified positions.
[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 Targets (73)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, Beta-lactamaseEscherichia coli K-12Potency28.18380.044717.8581100.0000AID485294
glp-1 receptor, partialHomo sapiens (human)Potency2.81840.01846.806014.1254AID624417
phosphopantetheinyl transferaseBacillus subtilisPotency25.11890.141337.9142100.0000AID1490
ATAD5 protein, partialHomo sapiens (human)Potency30.85520.004110.890331.5287AID493106; AID493107
Fumarate hydrataseHomo sapiens (human)Potency35.48130.00308.794948.0869AID1347053
USP1 protein, partialHomo sapiens (human)Potency56.23410.031637.5844354.8130AID504865
PPM1D proteinHomo sapiens (human)Potency26.21230.00529.466132.9993AID1347411
TDP1 proteinHomo sapiens (human)Potency26.10110.000811.382244.6684AID686978; AID686979
Smad3Homo sapiens (human)Potency35.48130.00527.809829.0929AID588855
regulator of G-protein signaling 4Homo sapiens (human)Potency29.93490.531815.435837.6858AID504845
nonstructural protein 1Influenza A virus (A/WSN/1933(H1N1))Potency11.22020.28189.721235.4813AID2326
polyproteinZika virusPotency35.48130.00308.794948.0869AID1347053
67.9K proteinVaccinia virusPotency10.61010.00018.4406100.0000AID720579; AID720580
IDH1Homo sapiens (human)Potency10.32250.005210.865235.4813AID686970
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency26.67950.035520.977089.1251AID504332
heat shock 70kDa protein 5 (glucose-regulated protein, 78kDa)Homo sapiens (human)Potency46.45150.016525.307841.3999AID602332
NPC intracellular cholesterol transporter 1 precursorHomo sapiens (human)Potency58.04790.01262.451825.0177AID485313
D(1A) dopamine receptorHomo sapiens (human)Potency8.29420.02245.944922.3872AID488981; AID488982; AID488983
vitamin D3 receptor isoform VDRAHomo sapiens (human)Potency89.12510.354828.065989.1251AID504847
chromobox protein homolog 1Homo sapiens (human)Potency5.01190.006026.168889.1251AID488953
atrial natriuretic peptide receptor 2 precursorHomo sapiens (human)Potency14.68920.00669.809418.4927AID1347050
ras-related protein Rab-9AHomo sapiens (human)Potency58.04790.00022.621531.4954AID485297
serine/threonine-protein kinase mTOR isoform 1Homo sapiens (human)Potency24.21440.00378.618923.2809AID2660; AID2666; AID2667; AID2668
histone-lysine N-methyltransferase 2A isoform 2 precursorHomo sapiens (human)Potency7.94330.010323.856763.0957AID2662
urokinase-type plasminogen activator precursorMus musculus (house mouse)Potency10.00000.15855.287912.5893AID540303
plasminogen precursorMus musculus (house mouse)Potency10.00000.15855.287912.5893AID540303
urokinase plasminogen activator surface receptor precursorMus musculus (house mouse)Potency10.00000.15855.287912.5893AID540303
gemininHomo sapiens (human)Potency16.35080.004611.374133.4983AID624296; AID624297
peripheral myelin protein 22Rattus norvegicus (Norway rat)Potency36.12540.005612.367736.1254AID624032
Rap guanine nucleotide exchange factor 3Homo sapiens (human)Potency35.48136.309660.2008112.2020AID720709
Interferon betaHomo sapiens (human)Potency26.21230.00339.158239.8107AID1347411
D(1A) dopamine receptorSus scrofa (pig)Potency26.12160.00378.108123.2809AID2667
Ataxin-2Homo sapiens (human)Potency14.12540.011912.222168.7989AID588378
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
5-hydroxytryptamine receptor 4Cavia porcellus (domestic guinea pig)IC50 (µMol)1.08300.00011.00768.7800AID625218
5-hydroxytryptamine receptor 4Cavia porcellus (domestic guinea pig)Ki0.56730.00000.887110.0000AID625218
Bile salt export pumpHomo sapiens (human)IC50 (µMol)29.34000.11007.190310.0000AID1449628
Aldo-keto reductase family 1 member B1Rattus norvegicus (Norway rat)IC50 (µMol)0.98480.00041.877310.0000AID625207
Aldo-keto reductase family 1 member B1Rattus norvegicus (Norway rat)Ki0.97660.00322.28879.3160AID625207
Muscarinic acetylcholine receptor M2Homo sapiens (human)IC50 (µMol)2.76750.00001.23267.7930AID625152
Muscarinic acetylcholine receptor M2Homo sapiens (human)Ki0.98400.00000.690210.0000AID625152
Muscarinic acetylcholine receptor M4Homo sapiens (human)IC50 (µMol)2.63090.00001.15467.5858AID625154
Muscarinic acetylcholine receptor M4Homo sapiens (human)Ki0.36690.00000.79519.1201AID625154
ATP-dependent translocase ABCB1Homo sapiens (human)IC50 (µMol)31.80000.00022.318510.0000AID681144
Cytochrome P450 3A4Homo sapiens (human)IC50 (µMol)0.80000.00011.753610.0000AID550788
Muscarinic acetylcholine receptor M5Homo sapiens (human)IC50 (µMol)0.50730.00010.99178.0000AID625155
Muscarinic acetylcholine receptor M5Homo sapiens (human)Ki0.36450.00000.72926.9183AID625155
Alpha-2A adrenergic receptorHomo sapiens (human)IC50 (µMol)0.28880.00001.44217.3470AID625201
Alpha-2A adrenergic receptorHomo sapiens (human)Ki0.10830.00010.807410.0000AID625201
Cytochrome P450 2D6Homo sapiens (human)IC50 (µMol)1.40000.00002.015110.0000AID550787
Muscarinic acetylcholine receptor M1Homo sapiens (human)IC50 (µMol)1.28820.00001.403910.0000AID625151
Muscarinic acetylcholine receptor M1Homo sapiens (human)Ki0.31020.00000.59729.1201AID625151
Cytochrome P450 2C9 Homo sapiens (human)IC50 (µMol)14.25000.00002.800510.0000AID1210069; AID550785
Transcriptional activator protein LuxRAliivibrio fischeriIC50 (µMol)27.00001.36003.25337.0000AID493958
Angiotensin-converting enzymeOryctolagus cuniculus (rabbit)IC50 (µMol)8.31730.00001.612910.0000AID625171
Angiotensin-converting enzymeOryctolagus cuniculus (rabbit)Ki6.81410.00042.03378.6606AID625171
Alpha-2B adrenergic receptorHomo sapiens (human)IC50 (µMol)0.18140.00001.23808.1590AID625202
Alpha-2B adrenergic receptorHomo sapiens (human)Ki0.08280.00020.725710.0000AID625202
Alpha-2C adrenergic receptorHomo sapiens (human)IC50 (µMol)4.47700.00001.47257.8980AID625203
Alpha-2C adrenergic receptorHomo sapiens (human)Ki0.65050.00030.483410.0000AID625203
DRattus norvegicus (Norway rat)IC50 (µMol)0.26000.00030.50267.7625AID179927
D(3) dopamine receptorRattus norvegicus (Norway rat)IC50 (µMol)0.26000.00030.39075.4000AID179927
Sodium-dependent noradrenaline transporter Homo sapiens (human)IC50 (µMol)0.87830.00081.541620.0000AID262048; AID550777; AID625207
Sodium-dependent noradrenaline transporter Homo sapiens (human)Ki0.97660.00031.465610.0000AID625207
Sodium-dependent dopamine transporterRattus norvegicus (Norway rat)IC50 (µMol)0.82500.00070.97749.7000AID550777
D(1B) dopamine receptorRattus norvegicus (Norway rat)IC50 (µMol)0.26000.00030.35635.4000AID179927
5-hydroxytryptamine receptor 2AHomo sapiens (human)IC50 (µMol)2.74090.00010.88018.8500AID625192
5-hydroxytryptamine receptor 2AHomo sapiens (human)Ki0.78310.00000.385510.0000AID625192
5-hydroxytryptamine receptor 2CHomo sapiens (human)IC50 (µMol)1.08300.00011.03029.0000AID625218
5-hydroxytryptamine receptor 2CHomo sapiens (human)Ki0.56730.00010.954910.0000AID625218
D(4) dopamine receptorRattus norvegicus (Norway rat)IC50 (µMol)0.26000.00030.38715.4000AID179927
3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)IC50 (µMol)0.80000.00010.526710.0000AID550788
Sodium-dependent serotonin transporterHomo sapiens (human)IC50 (µMol)0.00160.00010.86458.7096AID1718178; AID262046; AID550776; AID625222
Sodium-dependent serotonin transporterHomo sapiens (human)Ki0.00010.00000.70488.1930AID625222
Sodium-dependent serotonin transporterRattus norvegicus (Norway rat)IC50 (µMol)0.17430.00030.81978.4900AID179927; AID550776
Melanocortin receptor 5Homo sapiens (human)IC50 (µMol)4.59800.00091.25669.5180AID625149
Melanocortin receptor 5Homo sapiens (human)Ki4.31320.00053.52658.9290AID625149
Cytochrome P450 2C19Homo sapiens (human)IC50 (µMol)0.65500.00002.398310.0000AID550786; AID625247
5-hydroxytryptamine receptor 2BHomo sapiens (human)IC50 (µMol)3.39350.00011.18738.9125AID625217
5-hydroxytryptamine receptor 2BHomo sapiens (human)Ki2.15950.00030.769310.0000AID625217
Cytochrome P450 2J2Homo sapiens (human)IC50 (µMol)18.50000.01202.53129.4700AID1210069
D(2) dopamine receptorRattus norvegicus (Norway rat)IC50 (µMol)0.26000.00010.54948.4000AID179927
Sodium-dependent dopamine transporter Homo sapiens (human)IC50 (µMol)0.21750.00071.841946.0000AID262047; AID550778; AID625256
Sodium-dependent dopamine transporter Homo sapiens (human)Ki0.02580.00021.11158.0280AID625256
Potassium voltage-gated channel subfamily H member 2Homo sapiens (human)IC50 (µMol)8.31730.00091.901410.0000AID625171
Potassium voltage-gated channel subfamily H member 2Homo sapiens (human)Ki6.81410.00211.840710.0000AID625171
Sigma intracellular receptor 2Rattus norvegicus (Norway rat)Ki5.29700.00241.10509.3000AID1718151
Nuclear receptor subfamily 3 group C member 3 Bos taurus (cattle)IC50 (µMol)8.31730.10482.83988.3173AID625171
Nuclear receptor subfamily 3 group C member 3 Bos taurus (cattle)Ki6.81410.08582.95428.6606AID625171
Sigma non-opioid intracellular receptor 1Homo sapiens (human)IC50 (µMol)0.06970.00030.70285.3660AID625223
Sigma non-opioid intracellular receptor 1Homo sapiens (human)Ki0.04320.00000.490110.0000AID625223; AID712773
Sigma non-opioid intracellular receptor 1Rattus norvegicus (Norway rat)Ki0.05700.00030.26715.0700AID1718165
TransporterRattus norvegicus (Norway rat)IC50 (µMol)0.26000.00081.95628.8000AID179927
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Sodium-dependent noradrenaline transporter Homo sapiens (human)Kd0.42000.00080.25331.0600AID145563
Sodium-dependent serotonin transporterHomo sapiens (human)Kd0.00030.00010.03170.2000AID204080
Sodium-dependent dopamine transporter Homo sapiens (human)Kd0.02500.02502.14439.3000AID64372
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (348)

Processvia Protein(s)Taxonomy
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
angiogenesisRap guanine nucleotide exchange factor 3Homo sapiens (human)
adaptive immune responseRap guanine nucleotide exchange factor 3Homo sapiens (human)
signal transductionRap guanine nucleotide exchange factor 3Homo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayRap guanine nucleotide exchange factor 3Homo sapiens (human)
associative learningRap guanine nucleotide exchange factor 3Homo sapiens (human)
Rap protein signal transductionRap guanine nucleotide exchange factor 3Homo sapiens (human)
regulation of actin cytoskeleton organizationRap guanine nucleotide exchange factor 3Homo sapiens (human)
negative regulation of syncytium formation by plasma membrane fusionRap guanine nucleotide exchange factor 3Homo sapiens (human)
intracellular signal transductionRap guanine nucleotide exchange factor 3Homo sapiens (human)
positive regulation of GTPase activityRap guanine nucleotide exchange factor 3Homo sapiens (human)
regulation of angiogenesisRap guanine nucleotide exchange factor 3Homo sapiens (human)
positive regulation of angiogenesisRap guanine nucleotide exchange factor 3Homo sapiens (human)
positive regulation of protein export from nucleusRap guanine nucleotide exchange factor 3Homo sapiens (human)
positive regulation of stress fiber assemblyRap guanine nucleotide exchange factor 3Homo sapiens (human)
regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionRap guanine nucleotide exchange factor 3Homo sapiens (human)
positive regulation of syncytium formation by plasma membrane fusionRap guanine nucleotide exchange factor 3Homo sapiens (human)
establishment of endothelial barrierRap guanine nucleotide exchange factor 3Homo sapiens (human)
cellular response to cAMPRap guanine nucleotide exchange factor 3Homo sapiens (human)
Ras protein signal transductionRap guanine nucleotide exchange factor 3Homo sapiens (human)
regulation of insulin secretionRap guanine nucleotide exchange factor 3Homo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M2Homo sapiens (human)
regulation of heart contractionMuscarinic acetylcholine receptor M2Homo sapiens (human)
response to virusMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
presynaptic modulation of chemical synaptic transmissionMuscarinic acetylcholine receptor M2Homo sapiens (human)
regulation of smooth muscle contractionMuscarinic acetylcholine receptor M2Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M2Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M2Homo sapiens (human)
signal transductionMuscarinic acetylcholine receptor M4Homo sapiens (human)
cell surface receptor signaling pathwayMuscarinic acetylcholine receptor M4Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M4Homo sapiens (human)
regulation of locomotionMuscarinic acetylcholine receptor M4Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M4Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M4Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M4Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M4Homo sapiens (human)
G2/M transition of mitotic cell cycleATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic metabolic processATP-dependent translocase ABCB1Homo sapiens (human)
response to xenobiotic stimulusATP-dependent translocase ABCB1Homo sapiens (human)
phospholipid translocationATP-dependent translocase ABCB1Homo sapiens (human)
terpenoid transportATP-dependent translocase ABCB1Homo sapiens (human)
regulation of response to osmotic stressATP-dependent translocase ABCB1Homo sapiens (human)
transmembrane transportATP-dependent translocase ABCB1Homo sapiens (human)
transepithelial transportATP-dependent translocase ABCB1Homo sapiens (human)
stem cell proliferationATP-dependent translocase ABCB1Homo sapiens (human)
ceramide translocationATP-dependent translocase ABCB1Homo sapiens (human)
export across plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
transport across blood-brain barrierATP-dependent translocase ABCB1Homo sapiens (human)
positive regulation of anion channel activityATP-dependent translocase ABCB1Homo sapiens (human)
carboxylic acid transmembrane transportATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic detoxification by transmembrane export across the plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic transport across blood-brain barrierATP-dependent translocase ABCB1Homo sapiens (human)
regulation of chloride transportATP-dependent translocase ABCB1Homo sapiens (human)
lipid hydroxylationCytochrome P450 3A4Homo sapiens (human)
lipid metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid catabolic processCytochrome P450 3A4Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid metabolic processCytochrome P450 3A4Homo sapiens (human)
cholesterol metabolic processCytochrome P450 3A4Homo sapiens (human)
androgen metabolic processCytochrome P450 3A4Homo sapiens (human)
estrogen metabolic processCytochrome P450 3A4Homo sapiens (human)
alkaloid catabolic processCytochrome P450 3A4Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 3A4Homo sapiens (human)
calcitriol biosynthetic process from calciolCytochrome P450 3A4Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D metabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D catabolic processCytochrome P450 3A4Homo sapiens (human)
retinol metabolic processCytochrome P450 3A4Homo sapiens (human)
retinoic acid metabolic processCytochrome P450 3A4Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 3A4Homo sapiens (human)
aflatoxin metabolic processCytochrome P450 3A4Homo sapiens (human)
oxidative demethylationCytochrome P450 3A4Homo sapiens (human)
gastric acid secretionMuscarinic acetylcholine receptor M5Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M5Homo sapiens (human)
dopamine transportMuscarinic acetylcholine receptor M5Homo sapiens (human)
transmission of nerve impulseMuscarinic acetylcholine receptor M5Homo sapiens (human)
regulation of phosphatidylinositol dephosphorylationMuscarinic acetylcholine receptor M5Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M5Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M5Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M5Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M5Homo sapiens (human)
positive regulation of cytokine productionAlpha-2A adrenergic receptorHomo sapiens (human)
DNA replicationAlpha-2A adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
Ras protein signal transductionAlpha-2A adrenergic receptorHomo sapiens (human)
Rho protein signal transductionAlpha-2A adrenergic receptorHomo sapiens (human)
female pregnancyAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of cell population proliferationAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2A adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-2A adrenergic receptorHomo sapiens (human)
actin cytoskeleton organizationAlpha-2A adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of cell migrationAlpha-2A adrenergic receptorHomo sapiens (human)
activation of protein kinase activityAlpha-2A adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2A adrenergic receptorHomo sapiens (human)
cellular response to hormone stimulusAlpha-2A adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2A adrenergic receptorHomo sapiens (human)
vasodilationAlpha-2A adrenergic receptorHomo sapiens (human)
glucose homeostasisAlpha-2A adrenergic receptorHomo sapiens (human)
fear responseAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of potassium ion transportAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of MAP kinase activityAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of epidermal growth factor receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion-dependent exocytosisAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretionAlpha-2A adrenergic receptorHomo sapiens (human)
intestinal absorptionAlpha-2A adrenergic receptorHomo sapiens (human)
thermoceptionAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of lipid catabolic processAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of membrane protein ectodomain proteolysisAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion transportAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretion involved in cellular response to glucose stimulusAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of uterine smooth muscle contractionAlpha-2A adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-inhibiting adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
phospholipase C-activating adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of wound healingAlpha-2A adrenergic receptorHomo sapiens (human)
presynaptic modulation of chemical synaptic transmissionAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion transmembrane transporter activityAlpha-2A adrenergic receptorHomo sapiens (human)
xenobiotic metabolic processCytochrome P450 2D6Homo sapiens (human)
steroid metabolic processCytochrome P450 2D6Homo sapiens (human)
cholesterol metabolic processCytochrome P450 2D6Homo sapiens (human)
estrogen metabolic processCytochrome P450 2D6Homo sapiens (human)
coumarin metabolic processCytochrome P450 2D6Homo sapiens (human)
alkaloid metabolic processCytochrome P450 2D6Homo sapiens (human)
alkaloid catabolic processCytochrome P450 2D6Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2D6Homo sapiens (human)
isoquinoline alkaloid metabolic processCytochrome P450 2D6Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2D6Homo sapiens (human)
retinol metabolic processCytochrome P450 2D6Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 2D6Homo sapiens (human)
negative regulation of bindingCytochrome P450 2D6Homo sapiens (human)
oxidative demethylationCytochrome P450 2D6Homo sapiens (human)
negative regulation of cellular organofluorine metabolic processCytochrome P450 2D6Homo sapiens (human)
arachidonic acid metabolic processCytochrome P450 2D6Homo sapiens (human)
positive regulation of monoatomic ion transportMuscarinic acetylcholine receptor M1Homo sapiens (human)
signal transductionMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
protein kinase C-activating G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
neuromuscular synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of locomotionMuscarinic acetylcholine receptor M1Homo sapiens (human)
saliva secretionMuscarinic acetylcholine receptor M1Homo sapiens (human)
cognitionMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of postsynaptic membrane potentialMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of glial cell proliferationMuscarinic acetylcholine receptor M1Homo sapiens (human)
positive regulation of intracellular protein transportMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
postsynaptic modulation of chemical synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M1Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2C9 Homo sapiens (human)
steroid metabolic processCytochrome P450 2C9 Homo sapiens (human)
cholesterol metabolic processCytochrome P450 2C9 Homo sapiens (human)
estrogen metabolic processCytochrome P450 2C9 Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2C9 Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2C9 Homo sapiens (human)
urea metabolic processCytochrome P450 2C9 Homo sapiens (human)
monocarboxylic acid metabolic processCytochrome P450 2C9 Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2C9 Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 2C9 Homo sapiens (human)
amide metabolic processCytochrome P450 2C9 Homo sapiens (human)
icosanoid biosynthetic processCytochrome P450 2C9 Homo sapiens (human)
oxidative demethylationCytochrome P450 2C9 Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 2C9 Homo sapiens (human)
MAPK cascadeAlpha-2B adrenergic receptorHomo sapiens (human)
angiogenesisAlpha-2B adrenergic receptorHomo sapiens (human)
regulation of vascular associated smooth muscle contractionAlpha-2B adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2B adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-2B adrenergic receptorHomo sapiens (human)
female pregnancyAlpha-2B adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2B adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2B adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2B adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2B adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of neuron differentiationAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of blood pressureAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of uterine smooth muscle contractionAlpha-2B adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2B adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2B adrenergic receptorHomo sapiens (human)
regulation of smooth muscle contractionAlpha-2C adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2C adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-2C adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2C adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2C adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2C adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2C adrenergic receptorHomo sapiens (human)
positive regulation of neuron differentiationAlpha-2C adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretionAlpha-2C adrenergic receptorHomo sapiens (human)
monoamine transportSodium-dependent noradrenaline transporter Homo sapiens (human)
neurotransmitter transportSodium-dependent noradrenaline transporter Homo sapiens (human)
chemical synaptic transmissionSodium-dependent noradrenaline transporter Homo sapiens (human)
response to xenobiotic stimulusSodium-dependent noradrenaline transporter Homo sapiens (human)
response to painSodium-dependent noradrenaline transporter Homo sapiens (human)
norepinephrine uptakeSodium-dependent noradrenaline transporter Homo sapiens (human)
neuron cellular homeostasisSodium-dependent noradrenaline transporter Homo sapiens (human)
amino acid transportSodium-dependent noradrenaline transporter Homo sapiens (human)
norepinephrine transportSodium-dependent noradrenaline transporter Homo sapiens (human)
dopamine uptake involved in synaptic transmissionSodium-dependent noradrenaline transporter Homo sapiens (human)
sodium ion transmembrane transportSodium-dependent noradrenaline transporter Homo sapiens (human)
temperature homeostasis5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of cytokine production involved in immune response5-hydroxytryptamine receptor 2AHomo sapiens (human)
glycolytic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
intracellular calcium ion homeostasis5-hydroxytryptamine receptor 2AHomo sapiens (human)
activation of phospholipase C activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of cytosolic calcium ion concentration5-hydroxytryptamine receptor 2AHomo sapiens (human)
memory5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of cell population proliferation5-hydroxytryptamine receptor 2AHomo sapiens (human)
response to xenobiotic stimulus5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of phosphatidylinositol biosynthetic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
regulation of dopamine secretion5-hydroxytryptamine receptor 2AHomo sapiens (human)
artery smooth muscle contraction5-hydroxytryptamine receptor 2AHomo sapiens (human)
urinary bladder smooth muscle contraction5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of heat generation5-hydroxytryptamine receptor 2AHomo sapiens (human)
negative regulation of potassium ion transport5-hydroxytryptamine receptor 2AHomo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transduction5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of neuron apoptotic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein localization to cytoskeleton5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of fat cell differentiation5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of glycolytic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of vasoconstriction5-hydroxytryptamine receptor 2AHomo sapiens (human)
symbiont entry into host cell5-hydroxytryptamine receptor 2AHomo sapiens (human)
sensitization5-hydroxytryptamine receptor 2AHomo sapiens (human)
behavioral response to cocaine5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of inflammatory response5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylation5-hydroxytryptamine receptor 2AHomo sapiens (human)
detection of temperature stimulus involved in sensory perception of pain5-hydroxytryptamine receptor 2AHomo sapiens (human)
detection of mechanical stimulus involved in sensory perception of pain5-hydroxytryptamine receptor 2AHomo sapiens (human)
release of sequestered calcium ion into cytosol5-hydroxytryptamine receptor 2AHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergic5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 2AHomo sapiens (human)
presynaptic modulation of chemical synaptic transmission5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of execution phase of apoptosis5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of platelet aggregation5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of DNA biosynthetic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 2AHomo sapiens (human)
phospholipase C-activating serotonin receptor signaling pathway5-hydroxytryptamine receptor 2AHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 2AHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 2AHomo sapiens (human)
behavioral fear response5-hydroxytryptamine receptor 2CHomo sapiens (human)
intracellular calcium ion homeostasis5-hydroxytryptamine receptor 2CHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
phospholipase C-activating serotonin receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
locomotory behavior5-hydroxytryptamine receptor 2CHomo sapiens (human)
feeding behavior5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of phosphatidylinositol biosynthetic process5-hydroxytryptamine receptor 2CHomo sapiens (human)
cGMP-mediated signaling5-hydroxytryptamine receptor 2CHomo sapiens (human)
regulation of nervous system process5-hydroxytryptamine receptor 2CHomo sapiens (human)
regulation of appetite5-hydroxytryptamine receptor 2CHomo sapiens (human)
regulation of corticotropin-releasing hormone secretion5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of fat cell differentiation5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of calcium-mediated signaling5-hydroxytryptamine receptor 2CHomo sapiens (human)
release of sequestered calcium ion into cytosol5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 2CHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 2CHomo sapiens (human)
androgen biosynthetic process3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
steroid catabolic process3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
cell-cell signaling3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
androgen metabolic process3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
male gonad development3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
response to xenobiotic stimulus3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
biphenyl metabolic process3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
dibenzo-p-dioxin metabolic process3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
phthalate metabolic process3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
hippocampus development3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
hypothalamus development3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
cell differentiation3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
male genitalia development3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
female genitalia development3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
response to nutrient levels3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
response to follicle-stimulating hormone3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
response to testosterone3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
response to peptide hormone3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
response to steroid hormone3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
bone development3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
testosterone biosynthetic process3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
steroid biosynthetic process3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
monoamine transportSodium-dependent serotonin transporterHomo sapiens (human)
response to hypoxiaSodium-dependent serotonin transporterHomo sapiens (human)
neurotransmitter transportSodium-dependent serotonin transporterHomo sapiens (human)
response to nutrientSodium-dependent serotonin transporterHomo sapiens (human)
memorySodium-dependent serotonin transporterHomo sapiens (human)
circadian rhythmSodium-dependent serotonin transporterHomo sapiens (human)
response to xenobiotic stimulusSodium-dependent serotonin transporterHomo sapiens (human)
response to toxic substanceSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of gene expressionSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of serotonin secretionSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of cerebellar granule cell precursor proliferationSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of synaptic transmission, dopaminergicSodium-dependent serotonin transporterHomo sapiens (human)
response to estradiolSodium-dependent serotonin transporterHomo sapiens (human)
social behaviorSodium-dependent serotonin transporterHomo sapiens (human)
vasoconstrictionSodium-dependent serotonin transporterHomo sapiens (human)
sperm ejaculationSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of neuron differentiationSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of cell cycleSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of organ growthSodium-dependent serotonin transporterHomo sapiens (human)
behavioral response to cocaineSodium-dependent serotonin transporterHomo sapiens (human)
enteric nervous system developmentSodium-dependent serotonin transporterHomo sapiens (human)
brain morphogenesisSodium-dependent serotonin transporterHomo sapiens (human)
serotonin uptakeSodium-dependent serotonin transporterHomo sapiens (human)
membrane depolarizationSodium-dependent serotonin transporterHomo sapiens (human)
platelet aggregationSodium-dependent serotonin transporterHomo sapiens (human)
cellular response to retinoic acidSodium-dependent serotonin transporterHomo sapiens (human)
cellular response to cGMPSodium-dependent serotonin transporterHomo sapiens (human)
regulation of thalamus sizeSodium-dependent serotonin transporterHomo sapiens (human)
conditioned place preferenceSodium-dependent serotonin transporterHomo sapiens (human)
sodium ion transmembrane transportSodium-dependent serotonin transporterHomo sapiens (human)
amino acid transportSodium-dependent serotonin transporterHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMelanocortin receptor 5Homo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayMelanocortin receptor 5Homo sapiens (human)
regulation of metabolic processMelanocortin receptor 5Homo sapiens (human)
long-chain fatty acid metabolic processCytochrome P450 2C19Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2C19Homo sapiens (human)
steroid metabolic processCytochrome P450 2C19Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2C19Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2C19Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2C19Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 2C19Homo sapiens (human)
neural crest cell migration5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of cytokine production5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of endothelial cell proliferation5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled receptor internalization5-hydroxytryptamine receptor 2BHomo sapiens (human)
heart morphogenesis5-hydroxytryptamine receptor 2BHomo sapiens (human)
cardiac muscle hypertrophy5-hydroxytryptamine receptor 2BHomo sapiens (human)
intracellular calcium ion homeostasis5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
activation of phospholipase C activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein kinase C-activating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
phospholipase C-activating serotonin receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of cell population proliferation5-hydroxytryptamine receptor 2BHomo sapiens (human)
response to xenobiotic stimulus5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of phosphatidylinositol biosynthetic process5-hydroxytryptamine receptor 2BHomo sapiens (human)
neural crest cell differentiation5-hydroxytryptamine receptor 2BHomo sapiens (human)
intestine smooth muscle contraction5-hydroxytryptamine receptor 2BHomo sapiens (human)
phosphorylation5-hydroxytryptamine receptor 2BHomo sapiens (human)
calcium-mediated signaling5-hydroxytryptamine receptor 2BHomo sapiens (human)
cGMP-mediated signaling5-hydroxytryptamine receptor 2BHomo sapiens (human)
vasoconstriction5-hydroxytryptamine receptor 2BHomo sapiens (human)
negative regulation of apoptotic process5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of canonical NF-kappaB signal transduction5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of MAP kinase activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transduction5-hydroxytryptamine receptor 2BHomo sapiens (human)
embryonic morphogenesis5-hydroxytryptamine receptor 2BHomo sapiens (human)
regulation of behavior5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of nitric-oxide synthase activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
release of sequestered calcium ion into cytosol5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of cell division5-hydroxytryptamine receptor 2BHomo sapiens (human)
ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein kinase C signaling5-hydroxytryptamine receptor 2BHomo sapiens (human)
cellular response to temperature stimulus5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 2BHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 2BHomo sapiens (human)
fatty acid metabolic processCytochrome P450 2J2Homo sapiens (human)
icosanoid metabolic processCytochrome P450 2J2Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2J2Homo sapiens (human)
regulation of heart contractionCytochrome P450 2J2Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2J2Homo sapiens (human)
linoleic acid metabolic processCytochrome P450 2J2Homo sapiens (human)
organic acid metabolic processCytochrome P450 2J2Homo sapiens (human)
monoamine transportSodium-dependent dopamine transporter Homo sapiens (human)
neurotransmitter transportSodium-dependent dopamine transporter Homo sapiens (human)
lactationSodium-dependent dopamine transporter Homo sapiens (human)
sensory perception of smellSodium-dependent dopamine transporter Homo sapiens (human)
locomotory behaviorSodium-dependent dopamine transporter Homo sapiens (human)
response to xenobiotic stimulusSodium-dependent dopamine transporter Homo sapiens (human)
response to iron ionSodium-dependent dopamine transporter Homo sapiens (human)
dopamine transportSodium-dependent dopamine transporter Homo sapiens (human)
adenohypophysis developmentSodium-dependent dopamine transporter Homo sapiens (human)
response to nicotineSodium-dependent dopamine transporter Homo sapiens (human)
positive regulation of multicellular organism growthSodium-dependent dopamine transporter Homo sapiens (human)
regulation of dopamine metabolic processSodium-dependent dopamine transporter Homo sapiens (human)
response to cocaineSodium-dependent dopamine transporter Homo sapiens (human)
dopamine biosynthetic processSodium-dependent dopamine transporter Homo sapiens (human)
dopamine catabolic processSodium-dependent dopamine transporter Homo sapiens (human)
response to ethanolSodium-dependent dopamine transporter Homo sapiens (human)
cognitionSodium-dependent dopamine transporter Homo sapiens (human)
dopamine uptake involved in synaptic transmissionSodium-dependent dopamine transporter Homo sapiens (human)
response to cAMPSodium-dependent dopamine transporter Homo sapiens (human)
norepinephrine uptakeSodium-dependent dopamine transporter Homo sapiens (human)
prepulse inhibitionSodium-dependent dopamine transporter Homo sapiens (human)
dopamine uptakeSodium-dependent dopamine transporter Homo sapiens (human)
hyaloid vascular plexus regressionSodium-dependent dopamine transporter Homo sapiens (human)
amino acid transportSodium-dependent dopamine transporter Homo sapiens (human)
norepinephrine transportSodium-dependent dopamine transporter Homo sapiens (human)
sodium ion transmembrane transportSodium-dependent dopamine transporter Homo sapiens (human)
regulation of heart rate by cardiac conductionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of heart rate by hormonePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of membrane potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
positive regulation of DNA-templated transcriptionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion homeostasisPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cardiac muscle contractionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of membrane repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of ventricular cardiac muscle cell membrane repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cellular response to xenobiotic stimulusPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
ventricular cardiac muscle cell action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane depolarization during action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarization during action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarization during cardiac muscle cell action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of heart rate by cardiac conductionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion export across plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarization during ventricular cardiac muscle cell action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
negative regulation of potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
positive regulation of potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
negative regulation of potassium ion export across plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion import across plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
negative regulation of receptor internalizationAtaxin-2Homo sapiens (human)
regulation of translationAtaxin-2Homo sapiens (human)
RNA metabolic processAtaxin-2Homo sapiens (human)
P-body assemblyAtaxin-2Homo sapiens (human)
stress granule assemblyAtaxin-2Homo sapiens (human)
RNA transportAtaxin-2Homo sapiens (human)
lipid transportSigma non-opioid intracellular receptor 1Homo sapiens (human)
nervous system developmentSigma non-opioid intracellular receptor 1Homo sapiens (human)
G protein-coupled opioid receptor signaling pathwaySigma non-opioid intracellular receptor 1Homo sapiens (human)
regulation of neuron apoptotic processSigma non-opioid intracellular receptor 1Homo sapiens (human)
protein homotrimerizationSigma non-opioid intracellular receptor 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (126)

Processvia Protein(s)Taxonomy
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
guanyl-nucleotide exchange factor activityRap guanine nucleotide exchange factor 3Homo sapiens (human)
protein bindingRap guanine nucleotide exchange factor 3Homo sapiens (human)
protein domain specific bindingRap guanine nucleotide exchange factor 3Homo sapiens (human)
cAMP bindingRap guanine nucleotide exchange factor 3Homo sapiens (human)
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M2Homo sapiens (human)
arrestin family protein bindingMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M4Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M4Homo sapiens (human)
protein bindingATP-dependent translocase ABCB1Homo sapiens (human)
ATP bindingATP-dependent translocase ABCB1Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
efflux transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
ATP hydrolysis activityATP-dependent translocase ABCB1Homo sapiens (human)
transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
ubiquitin protein ligase bindingATP-dependent translocase ABCB1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
carboxylic acid transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
phosphatidylcholine floppase activityATP-dependent translocase ABCB1Homo sapiens (human)
phosphatidylethanolamine flippase activityATP-dependent translocase ABCB1Homo sapiens (human)
ceramide floppase activityATP-dependent translocase ABCB1Homo sapiens (human)
floppase activityATP-dependent translocase ABCB1Homo sapiens (human)
monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
steroid bindingCytochrome P450 3A4Homo sapiens (human)
iron ion bindingCytochrome P450 3A4Homo sapiens (human)
protein bindingCytochrome P450 3A4Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
retinoic acid 4-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
oxidoreductase activityCytochrome P450 3A4Homo sapiens (human)
oxygen bindingCytochrome P450 3A4Homo sapiens (human)
enzyme bindingCytochrome P450 3A4Homo sapiens (human)
heme bindingCytochrome P450 3A4Homo sapiens (human)
vitamin D3 25-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
caffeine oxidase activityCytochrome P450 3A4Homo sapiens (human)
quinine 3-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
testosterone 6-beta-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1-alpha,25-dihydroxyvitamin D3 23-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
aromatase activityCytochrome P450 3A4Homo sapiens (human)
vitamin D 24-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1,8-cineole 2-exo-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
phosphatidylinositol phospholipase C activityMuscarinic acetylcholine receptor M5Homo sapiens (human)
protein bindingMuscarinic acetylcholine receptor M5Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M5Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M5Homo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2A adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2A adrenergic receptorHomo sapiens (human)
protein kinase bindingAlpha-2A adrenergic receptorHomo sapiens (human)
alpha-1B adrenergic receptor bindingAlpha-2A adrenergic receptorHomo sapiens (human)
alpha-2C adrenergic receptor bindingAlpha-2A adrenergic receptorHomo sapiens (human)
thioesterase bindingAlpha-2A adrenergic receptorHomo sapiens (human)
heterotrimeric G-protein bindingAlpha-2A adrenergic receptorHomo sapiens (human)
protein homodimerization activityAlpha-2A adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-2A adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2A adrenergic receptorHomo sapiens (human)
norepinephrine bindingAlpha-2A adrenergic receptorHomo sapiens (human)
guanyl-nucleotide exchange factor activityAlpha-2A adrenergic receptorHomo sapiens (human)
monooxygenase activityCytochrome P450 2D6Homo sapiens (human)
iron ion bindingCytochrome P450 2D6Homo sapiens (human)
oxidoreductase activityCytochrome P450 2D6Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2D6Homo sapiens (human)
heme bindingCytochrome P450 2D6Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
phosphatidylinositol phospholipase C activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
protein bindingMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
iron ion bindingCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid 14,15-epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid 11,12-epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
oxidoreductase activityCytochrome P450 2C9 Homo sapiens (human)
(S)-limonene 6-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
(S)-limonene 7-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
caffeine oxidase activityCytochrome P450 2C9 Homo sapiens (human)
(R)-limonene 6-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
aromatase activityCytochrome P450 2C9 Homo sapiens (human)
heme bindingCytochrome P450 2C9 Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2C9 Homo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2B adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2B adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2B adrenergic receptorHomo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2C adrenergic receptorHomo sapiens (human)
alpha-2A adrenergic receptor bindingAlpha-2C adrenergic receptorHomo sapiens (human)
protein homodimerization activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-2C adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2C adrenergic receptorHomo sapiens (human)
guanyl-nucleotide exchange factor activityAlpha-2C adrenergic receptorHomo sapiens (human)
actin bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
neurotransmitter:sodium symporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
dopamine:sodium symporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
norepinephrine:sodium symporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
protein bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
alpha-tubulin bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
metal ion bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
beta-tubulin bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
Gq/11-coupled serotonin receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
virus receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein tyrosine kinase activator activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
identical protein binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein-containing complex binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
1-(4-iodo-2,5-dimethoxyphenyl)propan-2-amine binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
Gq/11-coupled serotonin receptor activity5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 2CHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
identical protein binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
1-(4-iodo-2,5-dimethoxyphenyl)propan-2-amine binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 2CHomo sapiens (human)
3-oxo-5-alpha-steroid 4-dehydrogenase activity3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
protein binding3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
testosterone dehydrogenase [NAD(P)] activity3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
amide binding3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
3-oxo-5alpha-steroid 4-dehydrogenase (NADP+) activity3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
integrin bindingSodium-dependent serotonin transporterHomo sapiens (human)
monoatomic cation channel activitySodium-dependent serotonin transporterHomo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent serotonin transporterHomo sapiens (human)
serotonin:sodium:chloride symporter activitySodium-dependent serotonin transporterHomo sapiens (human)
protein bindingSodium-dependent serotonin transporterHomo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent serotonin transporterHomo sapiens (human)
antiporter activitySodium-dependent serotonin transporterHomo sapiens (human)
syntaxin-1 bindingSodium-dependent serotonin transporterHomo sapiens (human)
cocaine bindingSodium-dependent serotonin transporterHomo sapiens (human)
sodium ion bindingSodium-dependent serotonin transporterHomo sapiens (human)
identical protein bindingSodium-dependent serotonin transporterHomo sapiens (human)
nitric-oxide synthase bindingSodium-dependent serotonin transporterHomo sapiens (human)
actin filament bindingSodium-dependent serotonin transporterHomo sapiens (human)
serotonin bindingSodium-dependent serotonin transporterHomo sapiens (human)
protein bindingMelanocortin receptor 5Homo sapiens (human)
hormone bindingMelanocortin receptor 5Homo sapiens (human)
melanocortin receptor activityMelanocortin receptor 5Homo sapiens (human)
monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
iron ion bindingCytochrome P450 2C19Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 2C19Homo sapiens (human)
oxidoreductase activityCytochrome P450 2C19Homo sapiens (human)
(S)-limonene 6-monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
(S)-limonene 7-monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
oxygen bindingCytochrome P450 2C19Homo sapiens (human)
enzyme bindingCytochrome P450 2C19Homo sapiens (human)
heme bindingCytochrome P450 2C19Homo sapiens (human)
(R)-limonene 6-monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
aromatase activityCytochrome P450 2C19Homo sapiens (human)
long-chain fatty acid omega-1 hydroxylase activityCytochrome P450 2C19Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2C19Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2C19Homo sapiens (human)
Gq/11-coupled serotonin receptor activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
G-protein alpha-subunit binding5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
GTPase activator activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 2BHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 2BHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
monooxygenase activityCytochrome P450 2J2Homo sapiens (human)
iron ion bindingCytochrome P450 2J2Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
arachidonic acid 14,15-epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
arachidonic acid 11,12-epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
isomerase activityCytochrome P450 2J2Homo sapiens (human)
linoleic acid epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
hydroperoxy icosatetraenoate isomerase activityCytochrome P450 2J2Homo sapiens (human)
arachidonic acid 5,6-epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
heme bindingCytochrome P450 2J2Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2J2Homo sapiens (human)
protease bindingSodium-dependent dopamine transporter Homo sapiens (human)
signaling receptor bindingSodium-dependent dopamine transporter Homo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent dopamine transporter Homo sapiens (human)
dopamine:sodium symporter activitySodium-dependent dopamine transporter Homo sapiens (human)
protein bindingSodium-dependent dopamine transporter Homo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent dopamine transporter Homo sapiens (human)
dopamine bindingSodium-dependent dopamine transporter Homo sapiens (human)
amine bindingSodium-dependent dopamine transporter Homo sapiens (human)
protein-containing complex bindingSodium-dependent dopamine transporter Homo sapiens (human)
metal ion bindingSodium-dependent dopamine transporter Homo sapiens (human)
protein phosphatase 2A bindingSodium-dependent dopamine transporter Homo sapiens (human)
heterocyclic compound bindingSodium-dependent dopamine transporter Homo sapiens (human)
norepinephrine:sodium symporter activitySodium-dependent dopamine transporter Homo sapiens (human)
transcription cis-regulatory region bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
inward rectifier potassium channel activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
delayed rectifier potassium channel activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
protein bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
ubiquitin protein ligase bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
identical protein bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
protein homodimerization activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
C3HC4-type RING finger domain bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel activity involved in cardiac muscle cell action potential repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
scaffold protein bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel activity involved in ventricular cardiac muscle cell action potential repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
RNA bindingAtaxin-2Homo sapiens (human)
epidermal growth factor receptor bindingAtaxin-2Homo sapiens (human)
protein bindingAtaxin-2Homo sapiens (human)
mRNA bindingAtaxin-2Homo sapiens (human)
G protein-coupled opioid receptor activitySigma non-opioid intracellular receptor 1Homo sapiens (human)
protein bindingSigma non-opioid intracellular receptor 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (72)

Processvia Protein(s)Taxonomy
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
plasma membraneRap guanine nucleotide exchange factor 3Homo sapiens (human)
cortical actin cytoskeletonRap guanine nucleotide exchange factor 3Homo sapiens (human)
plasma membraneRap guanine nucleotide exchange factor 3Homo sapiens (human)
microvillusRap guanine nucleotide exchange factor 3Homo sapiens (human)
endomembrane systemRap guanine nucleotide exchange factor 3Homo sapiens (human)
membraneRap guanine nucleotide exchange factor 3Homo sapiens (human)
lamellipodiumRap guanine nucleotide exchange factor 3Homo sapiens (human)
filopodiumRap guanine nucleotide exchange factor 3Homo sapiens (human)
extracellular exosomeRap guanine nucleotide exchange factor 3Homo sapiens (human)
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
clathrin-coated endocytic vesicle membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
asymmetric synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
symmetric synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
presynaptic membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
neuronal cell bodyMuscarinic acetylcholine receptor M2Homo sapiens (human)
axon terminusMuscarinic acetylcholine receptor M2Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
glutamatergic synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
cholinergic synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M2Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M4Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M4Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M4Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M4Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M4Homo sapiens (human)
cytoplasmATP-dependent translocase ABCB1Homo sapiens (human)
plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
cell surfaceATP-dependent translocase ABCB1Homo sapiens (human)
membraneATP-dependent translocase ABCB1Homo sapiens (human)
apical plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
extracellular exosomeATP-dependent translocase ABCB1Homo sapiens (human)
external side of apical plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
cytoplasmCytochrome P450 3A4Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 3A4Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 3A4Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M5Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M5Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M5Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M5Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M5Homo sapiens (human)
cytoplasmAlpha-2A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
basolateral plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
neuronal cell bodyAlpha-2A adrenergic receptorHomo sapiens (human)
axon terminusAlpha-2A adrenergic receptorHomo sapiens (human)
presynaptic active zone membraneAlpha-2A adrenergic receptorHomo sapiens (human)
dopaminergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
postsynaptic density membraneAlpha-2A adrenergic receptorHomo sapiens (human)
glutamatergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
GABA-ergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
receptor complexAlpha-2A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
mitochondrionCytochrome P450 2D6Homo sapiens (human)
endoplasmic reticulumCytochrome P450 2D6Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2D6Homo sapiens (human)
cytoplasmCytochrome P450 2D6Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2D6Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
presynaptic membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
axon terminusMuscarinic acetylcholine receptor M1Homo sapiens (human)
Schaffer collateral - CA1 synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
postsynaptic density membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
glutamatergic synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
cholinergic synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M1Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2C9 Homo sapiens (human)
plasma membraneCytochrome P450 2C9 Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C9 Homo sapiens (human)
cytoplasmCytochrome P450 2C9 Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C9 Homo sapiens (human)
cytosolAlpha-2B adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2B adrenergic receptorHomo sapiens (human)
cell surfaceAlpha-2B adrenergic receptorHomo sapiens (human)
intracellular membrane-bounded organelleAlpha-2B adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2B adrenergic receptorHomo sapiens (human)
cytoplasmAlpha-2C adrenergic receptorHomo sapiens (human)
endosomeAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
cell surfaceSodium-dependent noradrenaline transporter Homo sapiens (human)
membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
neuronal cell body membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
presynaptic membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
plasma membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
axonSodium-dependent noradrenaline transporter Homo sapiens (human)
neurofilament5-hydroxytryptamine receptor 2AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
caveola5-hydroxytryptamine receptor 2AHomo sapiens (human)
axon5-hydroxytryptamine receptor 2AHomo sapiens (human)
cytoplasmic vesicle5-hydroxytryptamine receptor 2AHomo sapiens (human)
presynaptic membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
neuronal cell body5-hydroxytryptamine receptor 2AHomo sapiens (human)
dendritic shaft5-hydroxytryptamine receptor 2AHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
cell body fiber5-hydroxytryptamine receptor 2AHomo sapiens (human)
glutamatergic synapse5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled serotonin receptor complex5-hydroxytryptamine receptor 2AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 2AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2CHomo sapiens (human)
synapse5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled serotonin receptor complex5-hydroxytryptamine receptor 2CHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2CHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 2CHomo sapiens (human)
endoplasmic reticulum membrane3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
neuronal cell body3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
cell body fiber3-oxo-5-alpha-steroid 4-dehydrogenase 2Homo sapiens (human)
plasma membraneSodium-dependent serotonin transporterHomo sapiens (human)
focal adhesionSodium-dependent serotonin transporterHomo sapiens (human)
endosome membraneSodium-dependent serotonin transporterHomo sapiens (human)
endomembrane systemSodium-dependent serotonin transporterHomo sapiens (human)
presynaptic membraneSodium-dependent serotonin transporterHomo sapiens (human)
membrane raftSodium-dependent serotonin transporterHomo sapiens (human)
synapseSodium-dependent serotonin transporterHomo sapiens (human)
postsynaptic membraneSodium-dependent serotonin transporterHomo sapiens (human)
serotonergic synapseSodium-dependent serotonin transporterHomo sapiens (human)
synapseSodium-dependent serotonin transporterHomo sapiens (human)
plasma membraneSodium-dependent serotonin transporterHomo sapiens (human)
neuron projectionSodium-dependent serotonin transporterHomo sapiens (human)
plasma membraneMelanocortin receptor 5Homo sapiens (human)
plasma membraneMelanocortin receptor 5Homo sapiens (human)
cytoplasmMelanocortin receptor 5Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2C19Homo sapiens (human)
plasma membraneCytochrome P450 2C19Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C19Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C19Homo sapiens (human)
cytoplasmCytochrome P450 2C19Homo sapiens (human)
nucleoplasm5-hydroxytryptamine receptor 2BHomo sapiens (human)
cytoplasm5-hydroxytryptamine receptor 2BHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2BHomo sapiens (human)
synapse5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled serotonin receptor complex5-hydroxytryptamine receptor 2BHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 2BHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2BHomo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2J2Homo sapiens (human)
extracellular exosomeCytochrome P450 2J2Homo sapiens (human)
cytoplasmCytochrome P450 2J2Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2J2Homo sapiens (human)
cytoplasmSodium-dependent dopamine transporter Homo sapiens (human)
plasma membraneSodium-dependent dopamine transporter Homo sapiens (human)
cell surfaceSodium-dependent dopamine transporter Homo sapiens (human)
membraneSodium-dependent dopamine transporter Homo sapiens (human)
axonSodium-dependent dopamine transporter Homo sapiens (human)
neuron projectionSodium-dependent dopamine transporter Homo sapiens (human)
neuronal cell bodySodium-dependent dopamine transporter Homo sapiens (human)
axon terminusSodium-dependent dopamine transporter Homo sapiens (human)
membrane raftSodium-dependent dopamine transporter Homo sapiens (human)
postsynaptic membraneSodium-dependent dopamine transporter Homo sapiens (human)
dopaminergic synapseSodium-dependent dopamine transporter Homo sapiens (human)
flotillin complexSodium-dependent dopamine transporter Homo sapiens (human)
axonSodium-dependent dopamine transporter Homo sapiens (human)
presynaptic membraneSodium-dependent dopamine transporter Homo sapiens (human)
plasma membraneSodium-dependent dopamine transporter Homo sapiens (human)
neuronal cell body membraneSodium-dependent dopamine transporter Homo sapiens (human)
plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cell surfacePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
perinuclear region of cytoplasmPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel complexPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
inward rectifier potassium channel complexPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cytoplasmAtaxin-2Homo sapiens (human)
Golgi apparatusAtaxin-2Homo sapiens (human)
trans-Golgi networkAtaxin-2Homo sapiens (human)
cytosolAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
membraneAtaxin-2Homo sapiens (human)
perinuclear region of cytoplasmAtaxin-2Homo sapiens (human)
ribonucleoprotein complexAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
nuclear envelopeSigma non-opioid intracellular receptor 1Homo sapiens (human)
nuclear inner membraneSigma non-opioid intracellular receptor 1Homo sapiens (human)
nuclear outer membraneSigma non-opioid intracellular receptor 1Homo sapiens (human)
endoplasmic reticulumSigma non-opioid intracellular receptor 1Homo sapiens (human)
endoplasmic reticulum membraneSigma non-opioid intracellular receptor 1Homo sapiens (human)
lipid dropletSigma non-opioid intracellular receptor 1Homo sapiens (human)
cytosolSigma non-opioid intracellular receptor 1Homo sapiens (human)
postsynaptic densitySigma non-opioid intracellular receptor 1Homo sapiens (human)
membraneSigma non-opioid intracellular receptor 1Homo sapiens (human)
growth coneSigma non-opioid intracellular receptor 1Homo sapiens (human)
cytoplasmic vesicleSigma non-opioid intracellular receptor 1Homo sapiens (human)
anchoring junctionSigma non-opioid intracellular receptor 1Homo sapiens (human)
postsynaptic density membraneSigma non-opioid intracellular receptor 1Homo sapiens (human)
endoplasmic reticulumSigma non-opioid intracellular receptor 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (248)

Assay IDTitleYearJournalArticle
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID503332Effect on Cdc2 expressed in HEK293 cells assessed as effect on Cdc2:Cdc25C interaction complexes in presence of camptothecin by EYFP and/or YFP Venus fragment based reporter gene assay2006Nature chemical biology, Jun, Volume: 2, Issue:6
Identifying off-target effects and hidden phenotypes of drugs in human cells.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1904255Anti-cryptococcal activity against Cryptococcus neoformans H99 assessed as inhibition of fungal growth incubated for 72 hrs by microdilution method2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID1210073Inhibition of CYP2C19 in human liver microsomes using omeprazole substrate by LC-MS/MS method2013Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1
Discovery and characterization of novel, potent, and selective cytochrome P450 2J2 inhibitors.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1904260Antifungal activity against Candida glabrata 9073 assessed as inhibition of fungal growth incubated for 48 hrs by microdilution method2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID1759282Effect on PI3K/AKT/mTOR signaling pathway in human SGC-7901 cells assessed as reduction in phosphorylated mTOR expression at 3 to 6 uM by Western blotting analysis2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID262068Tmax in rat at 1 mg/kg, iv or 1 mg/kg, po2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID503339Inhibition of HSP90 expressed in HEK293 cells assessed as effect on HSP90-Cdc37 by EYFP and/or YFP Venus fragment based reporter gene assay2006Nature chemical biology, Jun, Volume: 2, Issue:6
Identifying off-target effects and hidden phenotypes of drugs in human cells.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID144700Noncompetitive inhibition of N-methyl-D-aspartate (NMDA) Receptor, by the displacement of [3H]MK-801 in rat brain membranes; nd means not determined1998Bioorganic & medicinal chemistry letters, Mar-03, Volume: 8, Issue:5
Synthesis of a potent wide-spectrum serotonin-, norepinephrine-, dopamine-reuptake inhibitor (SNDRI) and a species-selective dopamine-reuptake inhibitor based on the gamma-amino alcohol functional group.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1220556Fraction unbound in CD-1 mouse brain homogenates at 1 uM after 6 hrs by equilibrium dialysis method2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Species independence in brain tissue binding using brain homogenates.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID700107Antidepressant activity in BALB/cJ mouse assessed as reduction in immobility at 20 mg/kg, po measured after 30 mins post drug administration by forced swim test2012Journal of medicinal chemistry, Jan-26, Volume: 55, Issue:2
Identification of novel α4β2-nicotinic acetylcholine receptor (nAChR) agonists based on an isoxazole ether scaffold that demonstrate antidepressant-like activity.
AID262066Oral bioavailability in rat at 1 mg/kg, po2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID712773Binding affinity to sigma 1 receptor2012ACS medicinal chemistry letters, Dec-13, Volume: 3, Issue:12
From α4β2 Nicotinic Ligands to the Discovery of σ1 Receptor Ligands: Pharmacophore Analysis and Rational Design.
AID1705389Cytotoxicity against human HEK293T cells incubated for 48 hrs by MTT assay2020European journal of medicinal chemistry, Dec-01, Volume: 207Monoterpenoid-based inhibitors of filoviruses targeting the glycoprotein-mediated entry process.
AID1759262Induction of apoptosis in human SGC-7901 cells assessed as upregulation of cleaved caspase 3 expression level by Western blotting analysis2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID179747In vitro inhibition of serotonin (5-HT) uptake in crude rat brain synaptosomes1988Journal of medicinal chemistry, Jan, Volume: 31, Issue:1
Molecular structure of fluoxetine hydrochloride, a highly selective serotonin-uptake inhibitor.
AID186980Inhibition of [3H]- NE reuptake into rat hippocampal synaptosomes1998Bioorganic & medicinal chemistry letters, Mar-03, Volume: 8, Issue:5
Synthesis of a potent wide-spectrum serotonin-, norepinephrine-, dopamine-reuptake inhibitor (SNDRI) and a species-selective dopamine-reuptake inhibitor based on the gamma-amino alcohol functional group.
AID1904256Antifungal activity against Candida albicans SC5314 assessed as inhibition of fungal growth incubated for 48 hrs by microdilution method2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID1210074Inhibition of CYP1A2 in human liver microsomes using phenacetin substrate by LC-MS/MS method2013Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1
Discovery and characterization of novel, potent, and selective cytochrome P450 2J2 inhibitors.
AID1904258Antifungal activity against Candida albicans 0304103 assessed as inhibition of fungal growth incubated for 48 hrs by microdilution method2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID196062Inhibition of uptake of tritiated norepinephrine (NE) in rat synaptosomes1987Journal of medicinal chemistry, Aug, Volume: 30, Issue:8
Pyrroloisoquinoline antidepressants. 2. In-depth exploration of structure-activity relationships.
AID550788Inhibition of CYP3A42011Bioorganic & medicinal chemistry, Jan-01, Volume: 19, Issue:1
Synthesis and pharmacological evaluation of 4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalenyl amines as triple reuptake inhibitors.
AID1533457Antiviral activity against Ebolavirus infected in mouse assessed as protection against viral infection at 20 mg/kg/day relative to control2019European journal of medicinal chemistry, Jan-15, Volume: 162Second generation of diazachrysenes: Protection of Ebola virus infected mice and mechanism of action.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID262047Inhibition of dopamine re-uptake at human dopamine transporter expressed in HEK293 cells2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID1904280Inhibition of Cryptococcus neoformans H99 delta5,6-desaturase assessed as accumulation of ergosta-7,22-dien-3-ol at 16 ug/ml incubated for 24 hrs by GC-MS analysis2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID262058Blood clearance in rat in CNS penetration assay at 1 mg/kg, iv or 1 mg/kg, po2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID262051Distribution coefficient of the compound, log D2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID330665Effect on life span of Caenorhabditis elegans at 250 uM2007Nature, Nov-22, Volume: 450, Issue:7169
An antidepressant that extends lifespan in adult Caenorhabditis elegans.
AID710152Antidepressant activity in BALB/cJ mouse assessed as reduction of immobility time at 20 mg/kg, ip administered 30 mins before test measured over 6 mins trial by forced swim test2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Discovery of highly potent and selective α4β2-nicotinic acetylcholine receptor (nAChR) partial agonists containing an isoxazolylpyridine ether scaffold that demonstrate antidepressant-like activity. Part II.
AID700132Antidepressant activity in BALB/cJ mouse assessed as reduction in immobility at 10 mg/kg, ip measured after 30 mins post drug administration by forced swim test2012Journal of medicinal chemistry, Jan-26, Volume: 55, Issue:2
Identification of novel α4β2-nicotinic acetylcholine receptor (nAChR) agonists based on an isoxazole ether scaffold that demonstrate antidepressant-like activity.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID588208Literature-mined public compounds from Lowe et al phospholipidosis modelling dataset2010Molecular pharmaceutics, Oct-04, Volume: 7, Issue:5
Predicting phospholipidosis using machine learning.
AID1863562Antiviral activity against pseudotyped Ebola virus assessed as inhibition of viral entry2022European journal of medicinal chemistry, Oct-05, Volume: 240Discovery of potent ebola entry inhibitors with (3S,4aS,8aS)-2-(3-amino-2-hydroxypropyl) decahydroisoquinoline-3-carboxamide scaffold.
AID1759266Induction of apoptosis in human SGC-7901 cells assessed as early apoptotic cells at 8 uM by FITC/PI staining based flow cytometry analysis (Rvb = 3.06 %)2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID50341Maximal activatory effect against human carbonic anhydrase I (hCA I)2003Bioorganic & medicinal chemistry letters, Aug-18, Volume: 13, Issue:16
Carbonic anhydrase activators. The selective serotonin reuptake inhibitors fluoxetine, sertraline and citalopram are strong activators of isozymes I and II.
AID1472910Binding affinity to Ebola virus Zaire Mayinga-76 recombinant GP protein by SYPRO orange dye-based fluorescence assay2018Journal of medicinal chemistry, 02-08, Volume: 61, Issue:3
Target Identification and Mode of Action of Four Chemically Divergent Drugs against Ebolavirus Infection.
AID1759285Effect on PI3K/AKT/mTOR signaling pathway in human SGC-7901 cells assessed as change in total AKT expression at 8 to 16 uM by Western blotting analysis2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID1759264Antiproliferative activity against cisplatin resistant human SGC-7901 cells assessed as sensitizing activity in presence of cisplatin2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID196063Inhibition the uptake of tritiated serotonin (5-HT) by the serotonin transporter SERT in rat synaptosomes1987Journal of medicinal chemistry, Aug, Volume: 30, Issue:8
Pyrroloisoquinoline antidepressants. 2. In-depth exploration of structure-activity relationships.
AID1759275Induction of cell cycle arrest in human SGC-7901 cells assessed as accumulation at G0/G1 phase at 8 to 16 uM by flow cytometry analysis2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID1220559Fraction unbound in cynomolgus monkey brain homogenates at 1 uM after 6 hrs by equilibrium dialysis method2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Species independence in brain tissue binding using brain homogenates.
AID1904259Antifungal activity against Candida tropicalis 10186 assessed as inhibition of fungal growth incubated for 48 hrs by microdilution method2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID262062Unbound volume of distribution in rat at 1 mg/kg, iv or 1 mg/kg, po2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID1904242Inhibition of Cryptococcus neoformans H99 delta5,6-desaturase assessed as change in sterol content at < 8 ug/ml incubated for 24 hrs by GC-MS analysis2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1759268Induction of apoptosis in human SGC-7901 cells assessed as necrotic cells at 8 uM by FITC/PI staining based flow cytometry analysis (Rvb = 0.068 %)2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID262050Selectivity for inhibition of serotonin re-uptake at human serotonin transporter over inhibition of noradrenaline re-uptake at human noradrenaline transporter2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID262056Half life in human liver microsome2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID1759273Induction of apoptosis in human SGC-7901 cells assessed as total caspase 3 expression level at 8 to 16 uM by Western blotting analysis2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID503338Inhibition of HSP90 expressed in HEK293 cells assessed as reduction of HSP90-eEF2K signaling complex by EYFP and/or YFP Venus fragment based reporter gene assay2006Nature chemical biology, Jun, Volume: 2, Issue:6
Identifying off-target effects and hidden phenotypes of drugs in human cells.
AID678714Inhibition of human CYP2C19 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 3-butyryl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1904243Anti-cryptococcal activity against Cryptococcus neoformans H99 assessed as fungal growth inhibition2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID1472913Binding affinity to Ebola virus Zaire Mayinga-76 recombinant GP protein assessed as change in melting temperature at 500 uM by SYPRO orange dye-based fluorescence assay2018Journal of medicinal chemistry, 02-08, Volume: 61, Issue:3
Target Identification and Mode of Action of Four Chemically Divergent Drugs against Ebolavirus Infection.
AID179744In vitro inhibition of norepinephrine (NE) uptake in crude rat brain synaptosomes1988Journal of medicinal chemistry, Jan, Volume: 31, Issue:1
Molecular structure of fluoxetine hydrochloride, a highly selective serotonin-uptake inhibitor.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1207702Inhibition of L-type calcium channel measured using whole-cell patch clamp in rat ventricular myocytes2012Journal of applied toxicology : JAT, Oct, Volume: 32, Issue:10
Predictive model for L-type channel inhibition: multichannel block in QT prolongation risk assessment.
AID1904266Antifungal activity against Aspergillus fumigatus 023-2 assessed as inhibition of fungal growth incubated for 48 hrs by microdilution method2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID311933Inhibition of ASM in rat PC12 cells assessed as residual activity at 10 uM2008Journal of medicinal chemistry, Jan-24, Volume: 51, Issue:2
Identification of new functional inhibitors of acid sphingomyelinase using a structure-property-activity relation model.
AID550776Inhibition of [3H]serotonin reuptake at human SERT expressed in HEK293 cells by scintillation counting2011Bioorganic & medicinal chemistry, Jan-01, Volume: 19, Issue:1
Synthesis and pharmacological evaluation of 4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalenyl amines as triple reuptake inhibitors.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1705387Inhibition of glycoprotein in VSV-G pseudotyped EBOV Mayinga infected in human HEK293T cells assessed as reduction in virus entry preincubated with pseudotyped virus for 1 hr followed by cell infection and measured after 48 hrs by luciferase reporter gene2020European journal of medicinal chemistry, Dec-01, Volume: 207Monoterpenoid-based inhibitors of filoviruses targeting the glycoprotein-mediated entry process.
AID678717Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-benzyloxyquinoline as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID493958Inhibition of LuxR-dependent quorum sensing in Vibrio fischeri assessed as reduction of 3-oxo-C6-HSL-induced bioluminescence intensity2010Bioorganic & medicinal chemistry letters, Aug-01, Volume: 20, Issue:15
LuxR-dependent quorum sensing: computer aided discovery of new inhibitors structurally unrelated to N-acylhomoserine lactones.
AID588209Literature-mined public compounds from Greene et al multi-species hepatotoxicity modelling dataset2010Chemical research in toxicology, Jul-19, Volume: 23, Issue:7
Developing structure-activity relationships for the prediction of hepatotoxicity.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID503335Inhibition of of c-Jun expressed in HEK293 cells assessed as induction of protein interaction in presence of camptothecin with Pin1 by EYFP based reporter gene assay2006Nature chemical biology, Jun, Volume: 2, Issue:6
Identifying off-target effects and hidden phenotypes of drugs in human cells.
AID539464Solubility of the compound in 0.1 M phosphate buffer at 600 uM at pH 7.4 after 24 hrs by LC/MS/MS analysis2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID761146Antidepressant-like activity in BALB/cJ mouse assessed as decrease in immobility time at 20 mg/kg, ip administered 30 mins before test measured for 6 mins by forced swimming test2013Journal of medicinal chemistry, Jul-11, Volume: 56, Issue:13
Chemistry, pharmacology, and behavioral studies identify chiral cyclopropanes as selective α4β2-nicotinic acetylcholine receptor partial agonists exhibiting an antidepressant profile. Part II.
AID1904257Antifungal activity against Candida albicans 904 assessed as inhibition of fungal growth incubated for 48 hrs by microdilution method2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID616837Anti-depressant activity in mouse assessed as immobility effect at 10 mg/kg, po after 60 mins by forced swimming test2011Journal of medicinal chemistry, Sep-22, Volume: 54, Issue:18
Design and synthesis of novel arylpiperazine derivatives containing the imidazole core targeting 5-HT(2A) receptor and 5-HT transporter.
AID196059Inhibition of the uptake of tritiated dopamine (DA) in rat synaptosomes1987Journal of medicinal chemistry, Aug, Volume: 30, Issue:8
Pyrroloisoquinoline antidepressants. 2. In-depth exploration of structure-activity relationships.
AID64372Equilibrium dissociation constant (KD) for Competitive binding between [3H]WIN-35428 and the compound at human transporter-hDAT1998Bioorganic & medicinal chemistry letters, Mar-03, Volume: 8, Issue:5
Synthesis of a potent wide-spectrum serotonin-, norepinephrine-, dopamine-reuptake inhibitor (SNDRI) and a species-selective dopamine-reuptake inhibitor based on the gamma-amino alcohol functional group.
AID250135Inhibition of compound against MES-SA/DX5 cell line was determined using P-glycoprotein assay2005Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8
A pharmacophore hypothesis for P-glycoprotein substrate recognition using GRIND-based 3D-QSAR.
AID1759279Effect on PI3K/AKT/mTOR signaling pathway in human SGC-7901 cells assessed as reduction in phosphorylated AKT expression at 8 to 16 uM by Western blotting analysis2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID503337Inhibition of cofilin1 expressed in HEK293 cells assessed as effect on cofilin1; Limk2 interaction complexes by EYFP and/or YFP Venus fragment based reporter gene assay2006Nature chemical biology, Jun, Volume: 2, Issue:6
Identifying off-target effects and hidden phenotypes of drugs in human cells.
AID1904279Inhibition of Cryptococcus neoformans H99 delta5,6-desaturase assessed as accumulation of ergosta-7,22-dien-3-ol at < 8 ug/ml incubated for 24 hrs by GC-MS analysis2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID179927Inhibition of 5-HT uptake in synaptosomal preparation from rat corpus striatum, using [3H]5-HT1984Journal of medicinal chemistry, Nov, Volume: 27, Issue:11
Nontricyclic antidepressant agents derived from cis- and trans-1-amino-4-aryltetralins.
AID262046Inhibition of serotonin re-uptake at human serotonin transporter expressed in HEK293 cells2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID1904263Antifungal activity against Candida auris 0029 assessed as inhibition of fungal growth incubated for 48 hrs by microdilution method2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1220560Fraction unbound in human occipital cortex at 1 uM after 6 hrs by equilibrium dialysis method2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Species independence in brain tissue binding using brain homogenates.
AID1904269Cytotoxicity against HUVEC cells2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1210070Inhibition of CYP2D6 in human liver microsomes using bufuralol substrate by LC-MS/MS method2013Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1
Discovery and characterization of novel, potent, and selective cytochrome P450 2J2 inhibitors.
AID262053Permeability from apical to basolateral in Caco-2 cell membrane2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID311935Partition coefficient, log P of the compound2008Journal of medicinal chemistry, Jan-24, Volume: 51, Issue:2
Identification of new functional inhibitors of acid sphingomyelinase using a structure-property-activity relation model.
AID550786Inhibition of CYP2C192011Bioorganic & medicinal chemistry, Jan-01, Volume: 19, Issue:1
Synthesis and pharmacological evaluation of 4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalenyl amines as triple reuptake inhibitors.
AID1705409Antiviral activity against eGFP-EBOV infected in African green monkey Vero E6 cells2020European journal of medicinal chemistry, Dec-01, Volume: 207Monoterpenoid-based inhibitors of filoviruses targeting the glycoprotein-mediated entry process.
AID262054Permeability from basolateral to apical in Caco-2 cell membrane2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID262048Inhibition of noradrenaline re-uptake at human noradrenaline transporter expressed in HEK293 cells2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID1759267Induction of apoptosis in human SGC-7901 cells assessed as late apoptotic cells at 8 uM by FITC/PI staining based flow cytometry analysis (Rvb = 2.56 %)2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID262052Dissociation constant, pKa of the compound2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID1220554Fraction unbound in Wistar Han rat brain homogenates at 1 uM after 6 hrs by equilibrium dialysis method2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Species independence in brain tissue binding using brain homogenates.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID179973Inhibition of norepinephrine uptake in synaptosomal preparation fro rat hypothalamus, using [3H]norepinephrine1984Journal of medicinal chemistry, Nov, Volume: 27, Issue:11
Nontricyclic antidepressant agents derived from cis- and trans-1-amino-4-aryltetralins.
AID550778Inhibition of [3H]dopamine reuptake at human DAT expressed in CHOK1 cells by scintillation counting2011Bioorganic & medicinal chemistry, Jan-01, Volume: 19, Issue:1
Synthesis and pharmacological evaluation of 4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalenyl amines as triple reuptake inhibitors.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID503333Effect on Cdc2 expressed in HEK293 cells assessed as effect on Cdc2:Cdc25A interaction complexes in presence of camptothecin by EYFP and/or YFP Venus fragment based reporter gene assay2006Nature chemical biology, Jun, Volume: 2, Issue:6
Identifying off-target effects and hidden phenotypes of drugs in human cells.
AID1759265Induction of apoptosis in human SGC-7901 cells assessed as viable cells at 8 uM by FITC/PI staining based flow cytometry analysis (Rvb = 94.3 %)2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID550785Inhibition of CYP2C92011Bioorganic & medicinal chemistry, Jan-01, Volume: 19, Issue:1
Synthesis and pharmacological evaluation of 4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalenyl amines as triple reuptake inhibitors.
AID1718151Displacement of [3H]DTG from sigma 2 receptor in Sprague-Dawley rat brain membranes in presence of (+)-pentazocine by scintillation counting method2020Journal of medicinal chemistry, 12-24, Volume: 63, Issue:24
Small Molecules Selectively Targeting Sigma-1 Receptor for the Treatment of Neurological Diseases.
AID1904271Anti-cryptococcal activity against Cryptococcus neoformans H99 infected Cryptococcal meningitis ICR mouse model of assessed as reduction in fungal burden in brain at 15 mg/kg, IG administered daily measured after 5 days2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID681144TP_TRANSPORTER: cell accumulation of calcein in L-MDR1 cells2003The Journal of pharmacology and experimental therapeutics, Apr, Volume: 305, Issue:1
Inhibition of P-glycoprotein by newer antidepressants.
AID1220557Fraction unbound in Hartley guinea pig brain homogenates at 1 uM after 6 hrs by equilibrium dialysis method2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Species independence in brain tissue binding using brain homogenates.
AID678713Inhibition of human CYP2C9 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-methoxy-4-trifluoromethylcoumarin-3-acetic acid as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1904252Inhibition of biofilm formation in Cryptococcus neoformans H99 at 8 ug/ml incubated for 24 hrs by XTT reduction assay2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID1186830Fraction unbound in mouse brain2014Journal of medicinal chemistry, Oct-23, Volume: 57, Issue:20
Rational use of plasma protein and tissue binding data in drug design.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID262064Half life in rat at 1 mg/kg, iv or 1 mg/kg, po2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID1718178Inhibition of SERT (unknown origin)2020Journal of medicinal chemistry, 12-24, Volume: 63, Issue:24
Small Molecules Selectively Targeting Sigma-1 Receptor for the Treatment of Neurological Diseases.
AID1904297Anti-cryptococcal activity against Cryptococcus assessed as inhibition of fungal growth incubated for 72 hrs by microdilution method2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1759278Effect on PI3K/AKT/mTOR signaling pathway in human SGC-7901 cells assessed as reduction in phosphorylated PI3K expression at 3 to 6 uM by Western blotting analysis2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1904267Metabolic stability in mouse liver microsomes assessed as half life2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID1904254Antifungal activity against Candida auris 0030 assessed as inhibition of fungal growth incubated for 48 hrs by microdilution method2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID186979Inhibition of [3H]- DA reuptake into rat striatal synaptosomes1998Bioorganic & medicinal chemistry letters, Mar-03, Volume: 8, Issue:5
Synthesis of a potent wide-spectrum serotonin-, norepinephrine-, dopamine-reuptake inhibitor (SNDRI) and a species-selective dopamine-reuptake inhibitor based on the gamma-amino alcohol functional group.
AID1904262Antifungal activity against Candida krusei 10153 assessed as inhibition of fungal growth incubated for 48 hrs by microdilution method2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1904261Antifungal activity against Candida glabrata 9025 assessed as inhibition of fungal growth incubated for 48 hrs by microdilution method2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID1472912Antiviral activity against Ebolavirus infected in human HepG2 cells assessed as reduction in virus entry after 48 hrs by Celltiter-Glo luminescent assay2018Journal of medicinal chemistry, 02-08, Volume: 61, Issue:3
Target Identification and Mode of Action of Four Chemically Divergent Drugs against Ebolavirus Infection.
AID1220558Fraction unbound in Beagle dog brain homogenates at 1 uM after 6 hrs by equilibrium dialysis method2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Species independence in brain tissue binding using brain homogenates.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID678716Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using diethoxyfluorescein as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1759281Effect on PI3K/AKT/mTOR signaling pathway in human SGC-7901 cells assessed as reduction in phosphorylated mTOR expression at 8 to 16 uM by Western blotting analysis2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID493961Induction of of LuxR-dependent quorum sensing in Vibrio fischeri assessed as induction of bioluminescence intensity up to 200 uM2010Bioorganic & medicinal chemistry letters, Aug-01, Volume: 20, Issue:15
LuxR-dependent quorum sensing: computer aided discovery of new inhibitors structurally unrelated to N-acylhomoserine lactones.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1759277Effect on PI3K/AKT/mTOR signaling pathway in human SGC-7901 cells assessed as reduction in phosphorylated PI3K expression at 8 to 16 uM by Western blotting analysis2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID1705388Inhibition of glycoprotein in VSV-G infected in human HEK293T cells assessed as reduction in virus entry preincubated with virus for 1 hr followed by cell infection and measured after 48 hrs by luciferase reporter gene assay2020European journal of medicinal chemistry, Dec-01, Volume: 207Monoterpenoid-based inhibitors of filoviruses targeting the glycoprotein-mediated entry process.
AID515780Intrinsic solubility of the compound in water2010Bioorganic & medicinal chemistry, Oct-01, Volume: 18, Issue:19
QSAR-based solubility model for drug-like compounds.
AID712772Binding affinity to sigma 2 receptor2012ACS medicinal chemistry letters, Dec-13, Volume: 3, Issue:12
From α4β2 Nicotinic Ligands to the Discovery of σ1 Receptor Ligands: Pharmacophore Analysis and Rational Design.
AID550787Inhibition of CYP2D62011Bioorganic & medicinal chemistry, Jan-01, Volume: 19, Issue:1
Synthesis and pharmacological evaluation of 4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalenyl amines as triple reuptake inhibitors.
AID418843Antidepressant activity in C57BL/6J mouse assessed as decrease in immobility time at 10 mg/kg, ip administered 30 mins prior to testing measured every 1 min for 6 mins by forced swim test relative to control2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Selective 5-hydroxytryptamine 2C receptor agonists derived from the lead compound tranylcypromine: identification of drugs with antidepressant-like action.
AID1210071Inhibition of CYP3A4 in human liver microsomes using testosterone substrate by LC-MS/MS method2013Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1
Discovery and characterization of novel, potent, and selective cytochrome P450 2J2 inhibitors.
AID1904273Anti-cryptococcal activity against Cryptococcus neoformans H99 assessed as cell membrane damage at 4 ug/ml incubated for 8 hrs by transmission electron microscopy2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID503336Effect on cofilin1 expressed in HEK293 cells assessed as effect on cofilin1; Limk2 interaction complexes in presence of camptothecin by EYFP and/or YFP Venus fragment based reporter gene assay2006Nature chemical biology, Jun, Volume: 2, Issue:6
Identifying off-target effects and hidden phenotypes of drugs in human cells.
AID1220555Fraction unbound in Sprague-Dawley rat brain homogenates at 1 uM after 6 hrs by equilibrium dialysis method2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Species independence in brain tissue binding using brain homogenates.
AID1847246Antiviral activity against Ebola virus infected in African green monkey assessed as reduction in viral infection incubated for 48 hrs by CellTiter-Glo Luminescent Cell Viability Assay2021European journal of medicinal chemistry, Nov-05, Volume: 223Potential pharmacological strategies targeting the Niemann-Pick C1 receptor and Ebola virus glycoprotein interaction.
AID50343Maximal activatory effect against human carbonic anhydrase I (hCA I) at a concentration of 1 uM2003Bioorganic & medicinal chemistry letters, Aug-18, Volume: 13, Issue:16
Carbonic anhydrase activators. The selective serotonin reuptake inhibitors fluoxetine, sertraline and citalopram are strong activators of isozymes I and II.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID186981Inhibition of [3H]5-HT reuptake into rat frontal cortex synaptosomes1998Bioorganic & medicinal chemistry letters, Mar-03, Volume: 8, Issue:5
Synthesis of a potent wide-spectrum serotonin-, norepinephrine-, dopamine-reuptake inhibitor (SNDRI) and a species-selective dopamine-reuptake inhibitor based on the gamma-amino alcohol functional group.
AID330659Effect on life span of Caenorhabditis elegans at 50 uM2007Nature, Nov-22, Volume: 450, Issue:7169
An antidepressant that extends lifespan in adult Caenorhabditis elegans.
AID1904245Anti-cryptococcal activity against Cryptococcus neoformans H99 assessed as inhibition of fungal growth at 8 ug/ml incubated upto 72 hrs by time-growth curve assay2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID1210072Inhibition of CYP2C9 in human liver microsomes using tolbutamide substrate by LC-MS/MS method2013Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1
Discovery and characterization of novel, potent, and selective cytochrome P450 2J2 inhibitors.
AID204080Equilibrium dissociation constant (KD) for Competitive binding between [3H]- imipramine and the compound at human transporter-hSERT1998Bioorganic & medicinal chemistry letters, Mar-03, Volume: 8, Issue:5
Synthesis of a potent wide-spectrum serotonin-, norepinephrine-, dopamine-reuptake inhibitor (SNDRI) and a species-selective dopamine-reuptake inhibitor based on the gamma-amino alcohol functional group.
AID678715Inhibition of human CYP2D6 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 4-methylaminoethyl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1904272Toxicity in ICR mouse model of Cryptococcal meningitis infected with Cryptococcus neoformans H99 assessed as median survival time at 15 mg/kg, IG administered daily (Rvb = 11 day)2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID625277FDA Liver Toxicity Knowledge Base Benchmark Dataset (LTKB-BD) drugs of less concern for DILI2011Drug discovery today, Aug, Volume: 16, Issue:15-16
FDA-approved drug labeling for the study of drug-induced liver injury.
AID1904264Antifungal activity against Candida auris 15448 assessed as inhibition of fungal growth incubated for 48 hrs by microdilution method2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID550789Inhibition of human ERG2011Bioorganic & medicinal chemistry, Jan-01, Volume: 19, Issue:1
Synthesis and pharmacological evaluation of 4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalenyl amines as triple reuptake inhibitors.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID179960Inhibition of dopamine uptake in synaptosomal preparation in rat corpus striatum, using [3H]dopamine1984Journal of medicinal chemistry, Nov, Volume: 27, Issue:11
Nontricyclic antidepressant agents derived from cis- and trans-1-amino-4-aryltetralins.
AID678712Inhibition of human CYP1A2 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using ethoxyresorufin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1904268Metabolic stability in mouse liver microsomes assessed as clearance2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID1759287Effect on PI3K/AKT/mTOR signaling pathway in human SGC-7901 cells assessed as change in total mTOR expression at 8 to 16 uM by Western blotting analysis2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID1210069Inhibition of human recombinant CYP2J2 assessed as reduction in astemizole O-demethylation by LC-MS/MS method2013Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1
Discovery and characterization of novel, potent, and selective cytochrome P450 2J2 inhibitors.
AID1759280Effect on PI3K/AKT/mTOR signaling pathway in human SGC-7901 cells assessed as reduction in phosphorylated AKT expression at 3 to 6 uM by Western blotting analysis2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID229635Selectivity ratio measured as the ratio of IC50 of NE/IC50 of 5-HT1988Journal of medicinal chemistry, Jan, Volume: 31, Issue:1
Molecular structure of fluoxetine hydrochloride, a highly selective serotonin-uptake inhibitor.
AID1904251Fungicidal activity against Cryptococcus neoformans H99 assessed as fungal growth inhibition incubated upto 72 hrs by time-fungicidal curve assay2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID550784Inhibition of CYP1A2011Bioorganic & medicinal chemistry, Jan-01, Volume: 19, Issue:1
Synthesis and pharmacological evaluation of 4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalenyl amines as triple reuptake inhibitors.
AID1759283Effect on PI3K/AKT/mTOR signaling pathway in human SGC-7901 cells assessed as change in total PI3K expression at 8 to 16 uM by Western blotting analysis2021Bioorganic & medicinal chemistry letters, 06-01, Volume: 41Discovery of sertraline and its derivatives able to combat drug-resistant gastric cancer cell via inducing apoptosis.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID262060Volume of distribution in rat at 1 mg/kg, iv or 1 mg/kg, po2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID678722Covalent binding affinity to human liver microsomes assessed per mg of protein at 10 uM after 60 mins presence of NADPH2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID503334Effect on p53 expressed in HEK293 cells assessed as effect on p53-p53 interaction complexes in presence of camptothecin by EYFP and/or YFP Venus fragment based reporter gene assay2006Nature chemical biology, Jun, Volume: 2, Issue:6
Identifying off-target effects and hidden phenotypes of drugs in human cells.
AID588210Human drug-induced liver injury (DILI) modelling dataset from Ekins et al2010Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 38, Issue:12
A predictive ligand-based Bayesian model for human drug-induced liver injury.
AID1705408Antiviral activity against eGFP-MARV infected in African green monkey Vero E6 cells2020European journal of medicinal chemistry, Dec-01, Volume: 207Monoterpenoid-based inhibitors of filoviruses targeting the glycoprotein-mediated entry process.
AID1472911Antiviral activity against Ebolavirus infected in african green monkey Vero E6 cells assessed as reduction in virus entry after 48 hrs by by Celltiter-Glo luminescent assay2018Journal of medicinal chemistry, 02-08, Volume: 61, Issue:3
Target Identification and Mode of Action of Four Chemically Divergent Drugs against Ebolavirus Infection.
AID1705390Selectivity index, ratio of CC50 for human HEK293T cells to IC50 for glycoprotein in VSV-G pseudotyped EBOV Mayinga infected in human HEK293T cells2020European journal of medicinal chemistry, Dec-01, Volume: 207Monoterpenoid-based inhibitors of filoviruses targeting the glycoprotein-mediated entry process.
AID1718165Displacement of [3H]-(+)-pentazocine from sigma 1 receptor in Sprague-Dawley rat brain membranes by scintillation counting method2020Journal of medicinal chemistry, 12-24, Volume: 63, Issue:24
Small Molecules Selectively Targeting Sigma-1 Receptor for the Treatment of Neurological Diseases.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1449628Inhibition of human BSEP expressed in baculovirus transfected fall armyworm Sf21 cell membranes vesicles assessed as reduction in ATP-dependent [3H]-taurocholate transport into vesicles incubated for 5 mins by Topcount based rapid filtration method2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Mitigating the inhibition of human bile salt export pump by drugs: opportunities provided by physicochemical property modulation, in silico modeling, and structural modification.
AID311934Dissociation constant, pKa of the compound2008Journal of medicinal chemistry, Jan-24, Volume: 51, Issue:2
Identification of new functional inhibitors of acid sphingomyelinase using a structure-property-activity relation model.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID262049Selectivity for inhibition of serotonin re-uptake at human serotonin transporter over inhibition of dopamine re-uptake at human dopamine transporter2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID262055Ratio of permeability from apical to basolateral over basolateral to apical in Caco-2 cell membrane2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID550783Half life in mouse liver microsome2011Bioorganic & medicinal chemistry, Jan-01, Volume: 19, Issue:1
Synthesis and pharmacological evaluation of 4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalenyl amines as triple reuptake inhibitors.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID688847Octanol-phosphate buffered saline partition coefficient, log K of the compound2011Bioorganic & medicinal chemistry letters, Dec-15, Volume: 21, Issue:24
Fluorescent reporters of monoamine transporter distribution and function.
AID1904265Antifungal activity against Aspergillus fumigatus 7544 assessed as inhibition of fungal growth incubated for 48 hrs by microdilution method2022Journal of medicinal chemistry, 05-12, Volume: 65, Issue:9
Discovery of Novel Sertraline Derivatives as Potent Anti-
AID503311Antiproliferative activity against human PC3 cells at 10 uM after 120 hrs by MTT assay relative to DMSO2006Nature chemical biology, Jun, Volume: 2, Issue:6
Identifying off-target effects and hidden phenotypes of drugs in human cells.
AID550777Inhibition of [3H]norepinephrine reuptake at human NET expressed in MDCK cells by scintillation counting2011Bioorganic & medicinal chemistry, Jan-01, Volume: 19, Issue:1
Synthesis and pharmacological evaluation of 4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalenyl amines as triple reuptake inhibitors.
AID145563Equilibrium dissociation constant (KD) for Competitive binding between [3H]- nisoxatine and the compound at human Norepinephrine transporter1998Bioorganic & medicinal chemistry letters, Mar-03, Volume: 8, Issue:5
Synthesis of a potent wide-spectrum serotonin-, norepinephrine-, dopamine-reuptake inhibitor (SNDRI) and a species-selective dopamine-reuptake inhibitor based on the gamma-amino alcohol functional group.
AID262057Half life in rat liver microsome2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Designing rapid onset selective serotonin re-uptake inhibitors. Part 1: Structure-activity relationships of substituted (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthaleneamine.
AID550782Half life in human liver microsome2011Bioorganic & medicinal chemistry, Jan-01, Volume: 19, Issue:1
Synthesis and pharmacological evaluation of 4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalenyl amines as triple reuptake inhibitors.
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. 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.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. 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.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. 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.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS 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.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347405qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS LOPAC collection2020ACS 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.
AID1347045Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot counterscreen GloSensor control cell line2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347059CD47-SIRPalpha protein protein interaction - Alpha assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID588349qHTS for Inhibitors of ATXN expression: Validation of Cytotoxic Assay
AID504836Inducers of the Endoplasmic Reticulum Stress Response (ERSR) in human glioma: Validation2002The Journal of biological chemistry, Apr-19, Volume: 277, Issue:16
Sustained ER Ca2+ depletion suppresses protein synthesis and induces activation-enhanced cell death in mast cells.
AID1347049Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot screen2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID588378qHTS for Inhibitors of ATXN expression: Validation
AID1347057CD47-SIRPalpha protein protein interaction - LANCE assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347410qHTS for inhibitors of adenylyl cyclases using a fission yeast platform: a pilot screen against the NCATS LOPAC library2019Cellular signalling, 08, Volume: 60A fission yeast platform for heterologous expression of mammalian adenylyl cyclases and high throughput screening.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347050Natriuretic polypeptide receptor (hNpr2) antagonism - Pilot subtype selectivity assay2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347058CD47-SIRPalpha protein protein interaction - HTRF assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347151Optimization of GU AMC qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings 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.
AID1347149Furin counterscreen qHTS for Zika virus inhibitors2020Proceedings 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.
AID1347168HepG2 cells viability qHTS for Zika virus inhibitors2020Proceedings 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.
AID1347167Vero cells viability qHTS for Zika virus inhibitors2020Proceedings 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.
AID1347155Optimization screen NINDS Rhodamine qHTS for Zika virus inhibitors: Linked NS2B-NS3 protease assay2020Proceedings 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.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings 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.
AID1347169Tertiary RLuc qRT-PCR qHTS assay for Zika virus inhibitors2020Proceedings 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.
AID1347150Optimization screen NINDS AMC qHTS for Zika virus inhibitors: Linked NS2B-NS3 protease assay2020Proceedings 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.
AID1801851LoxA HTP Assay from Article 10.1021/acs.biochem.6b00338: \\Biochemical and Cellular Characterization and Inhibitor Discovery of Pseudomonas aeruginosa 15-Lipoxygenase.\\2016Biochemistry, 06-14, Volume: 55, Issue:23
Biochemical and Cellular Characterization and Inhibitor Discovery of Pseudomonas aeruginosa 15-Lipoxygenase.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (3,207)

TimeframeStudies, This Drug (%)All Drugs %
pre-199029 (0.90)18.7374
1990's647 (20.17)18.2507
2000's1074 (33.49)29.6817
2010's1082 (33.74)24.3611
2020's375 (11.69)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 133.13

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.

MetricThis Compound (vs All)
Research Demand Index133.13 (24.57)
Research Supply Index8.41 (2.92)
Research Growth Index6.21 (4.65)
Search Engine Demand Index250.71 (26.88)
Search Engine Supply Index2.01 (0.95)

This Compound (133.13)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials1,028 (29.54%)5.53%
Reviews293 (8.42%)6.00%
Case Studies686 (19.71%)4.05%
Observational12 (0.34%)0.25%
Other1,461 (41.98%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (300)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Study of the Effect of Antidepressant Drugs on Neurotrophic Factors in Patients With Depression [NCT03126188]105 participants (Actual)Observational2017-04-05Completed
Cognitive Processing Therapy Versus Sertraline for the Treatment of Post-traumatic Stress Disorder & Substance Use Disorder Egyptian Patients [NCT03469128]Phase 1150 participants (Actual)Interventional2016-01-01Completed
Efficacy of Dynamic Therapy Versus Selective Serotonin Reuptake Inhibitor for Depression [NCT00043550]Phase 3156 participants (Actual)Interventional2001-11-30Completed
Matching Genotypes and Serotonergic Medications for Alcoholism [NCT01113164]Phase 179 participants (Actual)Interventional2008-09-30Completed
The Effects of Treatment With Sertraline for Panic Disorder and/or Depression Driven Chest Pain and/or Palpitations in a Double Blind, Care as Usual and Placebo Controlled Study [NCT01114100]Phase 4210 participants (Actual)Interventional2000-01-31Completed
Brain Markers of Anxiety Disorders and SSRI/CBT Treatment in Children and Adolescents [NCT01160588]156 participants (Actual)Observational2010-07-31Completed
Collaborative Care for Depressed Elders in China [NCT01287494]Phase 4320 participants (Anticipated)Interventional2010-08-31Recruiting
Combined Treatment for Alcohol-Dependent Individuals With PTSD [NCT00262223]Phase 269 participants (Actual)Interventional2006-05-31Completed
Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients [NCT01352572]300 participants (Anticipated)Interventional2002-01-31Active, not recruiting
A Prospective, Longitudinal Comparison of the Pharmacokinetic Properties of Sertraline Before and After Roux-en-Y Gastric Bypass [NCT01214382]Phase 331 participants (Actual)Interventional2010-10-31Completed
Z 31801 - A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women [NCT04094870]Phase 480 participants (Actual)Interventional2019-10-30Completed
Continuation Electroconvulsive Therapy Associated With Pharmacotherapy Versus Pharmacotherapy Alone for Relapse Prevention in Major Depression. A Clinical, Controlled, Prospective and Randomized Trial [NCT01305707]Phase 4104 participants (Actual)Interventional2009-07-31Terminated(stopped due to Difficulties in recruiting)
An Investigation of the Role of Inflammatory Processes in the Development and Treatment of Idiopathic Unipolar and Bipolar Depression in Patients With Moderate to Severe Depressive Symptoms. [NCT03920475]104 participants (Actual)Observational2015-08-05Completed
Development of A Technique to Predict Antidepressant Responsiveness in Depressive Patients [NCT01237275]300 participants (Anticipated)Interventional1999-10-31Active, not recruiting
SS1: Pilot Study of Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome (MDS) [NCT02452983]Phase 114 participants (Actual)Interventional2015-05-31Terminated(stopped due to This protocol is closed to further enrollment due to lack of study progress.)
Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Single-dose, Crossover Oral Bioequivalence Study of Sertraline Hydrochloride 100 mg Tablets (Dr. Reddy's Laboratories Limited, India) With the Reference Formulation ZOLOFT® 100 mg [NCT01267383]Phase 132 participants (Actual)Interventional2006-09-30Completed
Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety [NCT05683223]240 participants (Anticipated)Interventional2023-06-01Recruiting
Prediction of Antidepressant Response Using Pharmacogenetics of Bioamine Transporter and Peripheral Lymphocytic Phenotype [NCT01352559]1,000 participants (Anticipated)Interventional2001-11-30Active, not recruiting
Effects of Sertraline on Brain Connectivity in Adolescents With OCD (Obsessive-Compulsive Disorder) [NCT02797808]Phase 1/Phase 241 participants (Actual)Interventional2013-08-31Completed
Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of Selective Serotonin Reuptake Inhibitors in Healthy Subjects [NCT02175602]Phase 141 participants (Actual)Interventional2014-06-30Completed
International Committee of Medical Journal Editors [NCT02179268]Phase 3203 participants (Actual)Interventional2012-03-31Completed
Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Single-dose, Crossover Oral Bioequivalence Study of Sertraline Hydrochloride 100 mg Tablets (Dr. Reddy's Laboratories Limited, India) With the Reference Formulation ZOLOFT® 100 mg [NCT01267396]Phase 132 participants (Actual)Interventional2006-09-30Completed
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 30 participants (Actual)Interventional2019-12-01Withdrawn(stopped due to New design was developed to better fit company strategy, a new study has replaced 5413541TRD3011 study)
The Changes in Functional Recovery and Brain Neurotrophic Factor Six Months After Percutaneous Coronary Intervention in Cardiovascular Patients With Depression [NCT03841474]150 participants (Anticipated)Interventional2021-03-01Recruiting
Phenotype Predictors of Cognitive Outcomes in Geriatric Depression [NCT05273996]Phase 475 participants (Anticipated)Interventional2021-09-28Recruiting
Psychiatric Orders in Psychoanalytic Treatment of ASD [NCT05930912]1 participants (Actual)Observational2023-06-01Active, not recruiting
Acute Myocardial Necrosis and Depression: Antiplatelet Effect of Reuptake Inhibition of Serotonin: The ANDROS Study [NCT02463110]Phase 42 participants (Actual)Interventional2015-07-31Terminated(stopped due to Investigator's decision)
A Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial of Brexpiprazole (1 - 3 mg/Day) as Monotherapy or as Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder [NCT03033069]Phase 2336 participants (Actual)Interventional2017-01-26Completed
A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression [NCT02493868]Phase 3719 participants (Actual)Interventional2015-10-01Completed
Efficacy and Safety of Aripiprazole 2.5mg Combine Sertraline 50mg in Major Depression [NCT00873795]41 participants (Actual)Interventional2007-04-30Completed
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants [NCT03511118]1,600 participants (Anticipated)Observational2018-10-04Recruiting
Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene [NCT02237937]Phase 480 participants (Anticipated)Interventional2011-09-30Recruiting
A Randomized Controlled Study of Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder [NCT04977544]200 participants (Anticipated)Interventional2019-09-01Recruiting
Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder [NCT03279471]Phase 268 participants (Actual)Interventional2017-10-01Completed
The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients [NCT00581009]Phase 1/Phase 296 participants (Actual)Interventional2001-05-30Completed
SMART Trial to Predict Anhedonia Response to Antidepressant Treatment [NCT05537584]Phase 4183 participants (Anticipated)Interventional2022-09-30Recruiting
A New Biomarker-Based Approach Towards Developing Improved Treatment for Major Depressive Disorder (MDD) Based Upon Targeting Monoamine Oxidase A (MAO-A) [NCT02269540]Early Phase 110 participants (Actual)Interventional2014-10-31Completed
Pharmacologic Treatment of PTSD in Sexually Abused Children [NCT00078767]Phase 324 participants (Actual)Interventional2001-04-30Completed
A Randomized Placebo-Controlled Trial of Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders [NCT06081348]Phase 2130 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Predict Antidepressant Responsiveness Using Pharmacogenomics [NCT01228357]1,000 participants (Anticipated)Interventional2003-02-28Recruiting
Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder [NCT03514810]Phase 128 participants (Actual)Interventional2017-01-10Completed
Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury [NCT02320240]3,255,526 participants (Actual)Observational2013-06-30Completed
A PHASE IV, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO DETERMINE THE RELATIVE BIOAVAILABILITY OF ZOLOFT (REGISTERED) ORAL SOLUTION (20 MG/ML; FARMASIERRA MANUFACTURING, S.L.) COMPARED TO ZOLOFT (REGISTERED) TABLETS (50 MG; WYETH INDÚSTR [NCT03711708]Phase 436 participants (Actual)Interventional2018-11-06Completed
Strategic Use of New Generation Antidepressants for Depression [NCT01109693]Phase 42,011 participants (Actual)Interventional2010-12-31Completed
A Single-center, Open-label, Randomized, Two-treatment, Two-period Crossover Trial to Investigate Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and S [NCT03342963]Phase 174 participants (Actual)Interventional2017-11-21Completed
Utility of Plasma Drug Level Monitoring and CYP2C19 Genotyping in Dose Personalization of Sertraline [NCT05210153]148 participants (Anticipated)Observational2020-07-16Recruiting
Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT. [NCT00594269]Phase 4149 participants (Actual)Interventional2008-08-31Completed
SPRITES: SERTRALINE PEDIATRIC REGISTRY FOR THE EVALUATION OF SAFETY A NON-INTERVENTIONAL, LONGITUDINAL, COHORT STUDY TO EVALUATE THE EFFECTS OF LONG-TERM SERTRALINE TREATMENT IN CHILDREN AND ADOLESCENTS [NCT01302080]941 participants (Actual)Observational2012-04-04Completed
Single-Dose Fasting In Vivo Bioequivalence Study of Sertraline Hydrochloride Tablets (100 mg; Mylan) and Zoloft® Tablets (100 mg; Pfizer) in Healthy Volunteers [NCT00650325]Phase 149 participants (Actual)Interventional2002-11-30Completed
Postpartum Depression: Transdermal Estradiol Versus Sertraline [NCT00744328]Phase 485 participants (Actual)Interventional2008-08-31Terminated(stopped due to Recruitment Issues)
TRY FIRST: A 12-Week, Randomized, Open-Label Trial of Duloxetine Versus Generic SSRIs in the Treatment of a Severe Depressive Episode [NCT00666757]Phase 4750 participants (Actual)Interventional2008-05-31Completed
Imaging Antidepressant vs. Cognitive Behavior Therapy Effects on Unipolar Depression [NCT00787501]Phase 198 participants (Actual)Interventional2008-06-30Completed
Assessment of the Inter-patient Variability in Clinical Response and Correlated Genetic Variations in Substance Use Disorders [NCT05833399]200 participants (Anticipated)Observational2022-11-28Recruiting
Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients [NCT00817375]1,000 participants (Anticipated)Interventional2003-02-28Recruiting
Medication and Psychotherapy Treatment Trial for Psychogenic Nonepileptic Seizures [NCT00835627]Phase 438 participants (Actual)Interventional2008-09-30Completed
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Sertraline 100 mg Tablets Under Fed Conditions [NCT00864019]Phase 130 participants (Actual)Interventional2004-08-31Completed
Neuro-Genetic Markers of SSRI Treatment Response in Social Anxiety Disorder [NCT00872131]200 participants (Actual)Observational2008-03-31Completed
The Effect of a Selective Serotonin Reuptake Inhibitor on Gait, Balance, and Bone Metabolism in Older Adults [NCT02228005]Phase 425 participants (Actual)Interventional2014-07-31Completed
THE AIUNI - Integral Assessment in Unipolar Depression [NCT02268487]Phase 4100 participants (Anticipated)Interventional2014-01-31Recruiting
Effects and Consequences for Mother and Child From Treatment for Depression, A Prospective Randomized, Placebo- Controlled, Trial With Internet-based Cognitive Behavior Therapy and Sertraline or Placebo for Moderate Depression in Pregnancy [NCT02185547]Phase 417 participants (Actual)Interventional2016-02-21Terminated(stopped due to Difficulties in recruiting participants.)
A Randomised, Controlled Evaluation of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression [NCT02122393]Phase 345 participants (Actual)Interventional2002-04-30Completed
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 3139 participants (Actual)Interventional2015-08-20Completed
Serum Concentrations of Antidepressant Drugs in Pregnant Women - a Naturalistic Study [NCT04806230]81 participants (Actual)Observational2011-04-01Completed
Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline [NCT01028482]42 participants (Actual)Interventional2008-03-31Completed
Assessment of PACAP-BDNF Signaling System Involvement in Etiology and Treatment of Major Depression [NCT00944996]100 participants (Actual)Interventional2009-06-30Completed
Treatment Refractory Panic Disorder [NCT00118417]Phase 2/Phase 346 participants (Actual)Interventional1999-03-31Completed
[11C] Sertraline PET Imaging Study That Investigates Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration [NCT00969852]Phase 410 participants (Anticipated)Interventional2009-07-31Completed
A Factorial, Double-blinded, Randomized Clinical Trial on Major Depressive Disorder Using Transcranial Direct Current Stimulation [NCT01033084]Phase 2/Phase 3120 participants (Actual)Interventional2009-12-31Completed
Symptom Onset Antidepressant Treatment for PMDD [NCT00536198]Phase 4252 participants (Actual)Interventional2007-11-06Completed
A Study to Compare the Relative Bioavailability of Ranbaxy and Pfizer Formulation of Sertraline 100 mg Tablets in Healthy Adult Volunteers Under Fed Conditions. [NCT00778973]36 participants (Actual)Interventional2005-08-31Completed
A Study of Sertraline to Prevent PTSD [NCT00182078]Phase 426 participants (Actual)Interventional2002-11-30Completed
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Sertraline Tablets 100 mg Under Fasting Conditions [NCT00602849]38 participants (Actual)Interventional2003-06-30Completed
Special Investigation Of J Zoloft For Panic Disorder Patients [NCT00605917]997 participants (Actual)Observational2007-04-30Completed
Sertraline/[S,S]-Reboxetine Combination Versus Sertraline And [S,S]-Reboxetine Monotherapy In Major Depressive Disorder (MDD) In A Double-Blind, Placebo-Controlled, Eight Week Study. [NCT00636246]Phase 2510 participants (Actual)Interventional2004-06-30Completed
The Outcome of Treatment of Traumatised Refugees With Trauma-Focused Cognitive Behavioural Therapy and / or Antidepressants - a Randomised Controlled Trial [NCT00917397]Phase 4280 participants (Actual)Interventional2009-06-30Completed
A Multicenter Randomized, Double-Blind, Parallel-Group Study of Sertraline Versus Venlafaxine XR in the Acute Treatment of Outpatients With Major Depressive Disorder [NCT00644982]Phase 4163 participants (Actual)Interventional2002-10-31Completed
International Study to Predict Optimised Treatment - in Depression [NCT00693849]Phase 42,688 participants (Anticipated)Interventional2008-09-30Active, not recruiting
Randomized, 2-Way Crossover, Bioequivalence Study of Sertraline Hydrochloride 100 mg Tablets and Zoloft® 100 mg Tablets Administered as 1 x 100 mg Tablet in Healthy Subjects Under Fasting Conditions [NCT00836849]Phase 124 participants (Actual)Interventional2002-03-31Completed
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 3440 participants (Actual)Interventional2020-11-09Completed
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs [NCT04278404]5,000 participants (Anticipated)Observational2020-03-05Recruiting
Treatment of Orthostatic Intolerance [NCT00262470]Phase 1/Phase 2150 participants (Anticipated)Interventional1997-04-30Active, not recruiting
Special Investigation Of Long Term Use Of J ZOLOFT. [NCT00605813]542 participants (Actual)Observational2007-09-30Completed
Vortioxetine Versus Sertraline in Control Metabolic, Distress and Depression in Mexican Patients With Type 2 Diabetes [NCT03978286]Phase 421 participants (Actual)Interventional2016-06-30Completed
Efficacy of Nepeta Menthoides Boiss & Bohse Freeze Dried Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial [NCT02565316]Phase 2/Phase 370 participants (Actual)Interventional2014-11-30Completed
Optimizing PTSD Treatment: PE Versus PE Plus Sertraline [NCT01600456]Phase 3150 participants (Actual)Interventional2011-03-31Completed
Efficacy of Deep Anaesthesia With Isoflurane as a Fast-response Antidepressant Agent in Treatment Resistant Depression Patients : Proof of Concept [NCT04171193]Phase 230 participants (Anticipated)Interventional2019-12-31Not yet recruiting
Patient Dimensions as Predictors of Response, Relapse and Recurrence Following Cognitive-Behavioral Therapy, Interpersonal Psychotherapy and Pharmacotherapy Treatment of Patients With Major Depression. [NCT00744406]Phase 272 participants (Actual)Interventional2003-07-31Completed
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder [NCT00797966]Phase 2850 participants (Actual)Interventional2009-05-31Completed
A Study to Compare the Relative Bioavailability of Ranbaxy and Pfizer Formulations of Sertraline 100 mg Tablets in Healthy Adult Volunteers Under Fasting Conditions. [NCT00779350]36 participants (Actual)Interventional2005-08-31Completed
Non-randomized Control Clinical Trial to Evaluate the Efficacy and Safety of Symptomatic Drug Therapy for Mild to Moderate Huntington's Disease Patients [NCT04071639]Phase 160 participants (Anticipated)Interventional2020-03-12Recruiting
Shanghai Mental Health Center in China [NCT02739061]142 participants (Actual)Interventional2014-06-12Completed
A Phase 1, Single Center Randomized, Three-way Crossover, Double-blinded, Placebo- And Moxifloxacin-controlled Thorough Qt (Tqt) Study To Determine The Effects Of Sertraline (Zoloft (Registered)) On The Cardiac Repolarization In Healthy Subjects [NCT02651623]Phase 154 participants (Actual)Interventional2016-01-31Completed
The Clinical Application of Tumor Reversion: A Phase I Study of Sertraline (Zoloft) in Combination With Timed-sequential Cytosine Arabinoside (Ara-C) in Adults With Relapsed and Refractory Acute Myeloid Leukemia (AML) [NCT02891278]Phase 16 participants (Actual)Interventional2016-08-11Completed
Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness [NCT00817011]1,000 participants (Anticipated)Interventional2006-04-30Recruiting
Randomized, 2-Way Crossover, Bioequivalence Study of Sertraline Hydrochloride 100 mg Tablets and Zoloft® 100 mg Tablets Administered as 1 x 100 mg Tablet in Healthy Subjects Under Fed Conditions. [NCT00836667]Phase 118 participants (Actual)Interventional2002-03-31Completed
[NCT00946036]Phase 10 participants InterventionalCompleted
[NCT00944242]Phase 10 participants InterventionalCompleted
A Randomized, Double-Blind, Multicenter Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder [NCT00677352]Phase 4321 participants (Actual)Interventional2008-05-31Completed
Adapting Marital Therapy in Older Adults With Depression [NCT00612807]Phase 1/Phase 242 participants (Actual)Interventional2006-07-31Completed
A Double-Blind Augmentation Study of LEvetiracetam in Obsessive Compulsive Disorder [NCT00299611]Phase 2/Phase 312 participants (Actual)Interventional2005-11-30Terminated(stopped due to Sponsor decided to terminate the study due to budget consideration)
Drug Use Investigation of Jzoloft. [NCT00605865]2,272 participants (Actual)Observational2007-04-30Completed
Effect of Combined Antioxidant Therapy on Oxidative Stress Markers and Inflammatory in Patients With Chronic Subjective Endotic Tinnitus [NCT05646693]Phase 258 participants (Anticipated)Interventional2022-12-01Recruiting
A Phase 3, Multicenter, Randomized, Double-blind Trial of Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder [NCT04124614]Phase 3450 participants (Actual)Interventional2019-10-17Completed
Rhodiola Rosea Therapy of Major Depressive Disorder [NCT01098318]Phase 358 participants (Actual)Interventional2010-06-30Completed
Antidepressant Treatment of Melancholia in Late :Ife [NCT00000378]Phase 4110 participants (Actual)Interventional1997-07-31Completed
The Use of Quantitative EEG (QEEG) as a Predictor of Treatment Outcome in Major Depressive Disorder [NCT00157547]Phase 495 participants (Actual)Interventional2003-04-30Completed
An 8-week, Open-label Study to Evaluate the Effect of Sertraline on Polysomnogram in Depressive Patients With Insomnia [NCT01032434]31 participants (Actual)Interventional2009-12-31Completed
Sertraline Pharmacotherapy for Alcoholism Subtypes [NCT00368550]Phase 4134 participants (Actual)Interventional2004-02-29Completed
Cognitive Behavioral Therapy vs. Sertraline in the Treatment of Post Traumatic Stress Disorder [NCT00391430]Phase 439 participants (Actual)Interventional2005-05-31Terminated(stopped due to Difficulty enrolling subjects)
An Integrated Pharmacological and Psychological Approach to Young People With Comorbid Depression and Substance Abuse [NCT00232284]Phase 260 participants (Actual)Interventional2004-09-30Completed
Establishing Multimodal Brain Biomarkers Using Data-driven Analytics for Treatment Selection in Depression [NCT05892744]Phase 450 participants (Anticipated)Interventional2023-09-30Recruiting
Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Tolerability Of Indiplon Therapy Initiated With Sertraline Versus Sertraline Monotherapy In Subjects With Insomnia And Co-Existing Major Depressive Disorder [NCT00232167]Phase 3380 participants Interventional2005-11-30Terminated(stopped due to Please see Detailed Description below for termination reason.)
[NCT00229476]Phase 460 participants Interventional2003-12-31Completed
Escitalopram vs. Sertraline in the Treatment of Dysthymic Disorder and Double Depression [NCT00234312]Phase 440 participants Interventional2005-09-30Completed
A Phase I, Single Center, Open Label, Intra Subject, Dose Escalation Study to Evaluate Safety and Tolerability of Sertraline Plus Telenzepine in Overweight Healthy Subjects [NCT01155531]Phase 140 participants (Actual)Interventional2010-05-31Completed
Nuclear Magnetic Resonance Imaging Study of Treatment With Sertraline in Geriatric Depression [NCT00245557]43 participants (Actual)Interventional2004-11-30Completed
TMSFOS: Preliminary Study to Investigate the Effect of rTMS and SSRI Antidepressants on Leukocyte Expression of the C-FOS and DUSP1 Genes in Patients Treated for Depression [NCT02042573]Phase 460 participants (Anticipated)Interventional2013-11-30Recruiting
An Eight-Week, Double-Blind, Group-Sequential Design, Placebo Controlled Trial To Evaluate The Safety And Efficacy Of The Co- Administration Of Sertraline And Elzasonan (CP-448,187) In Outpatients With Major Depressive Disorder [NCT00275197]Phase 2262 participants (Actual)Interventional2005-12-31Completed
A Controlled, Randomized, Double-Blind Trial of Sertraline in Patients With Frontal Lobe Dementia (FLD) [NCT00001777]Phase 130 participants Interventional1997-12-31Completed
Effects of Chronic Sertraline Hydrochloride Administration on Vascular Endothelial and Autonomic Function in Patients With Chronic Heart Failure [NCT00585455]4 participants (Actual)Observational2006-01-31Terminated(stopped due to PI change in institution)
Combined Mirtazapine and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment of Post-traumatic Stress Disorder (PTSD) [NCT01178671]Phase 438 participants (Actual)Interventional2010-07-31Completed
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies [NCT02893371]1,037,352 participants (Actual)Observational2016-09-30Completed
A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension (ATRAX Trial) [NCT02641652]Phase 4136 participants (Anticipated)Interventional2017-11-30Not yet recruiting
A Proof-of-concept Clinical Trial Assessing the Safety of the Coordinated Undermining of Survival Paths by 9 Repurposed Drugs Combined With Metronomic Temozolomide (CUSP9v3 Treatment Protocol) for Recurrent Glioblastoma [NCT02770378]Phase 1/Phase 210 participants (Actual)Interventional2016-11-30Completed
Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS) [NCT01032018]Phase 1/Phase 2150 participants (Actual)Interventional2010-01-31Completed
Single-Dose Food In Vivo Bioequivalence Study of Sertraline Hydrochloride Tablets (100 mg; Mylan) and Zoloft® Tablets (100 mg; Pfizer) in Healthy Volunteers [NCT00648856]Phase 121 participants (Actual)Interventional2002-12-31Completed
A Double-Blind Placebo-Controlled Randomized Clinical Trial of Fluvoxamine and Sertraline in Childhood Autism - Does SSRI Therapy Improve Behaviour and/or Mood? [NCT00655174]Phase 3108 participants (Actual)Interventional1999-06-30Completed
LY2216684 and Sertraline Pharmacokinetic Interaction Study in Healthy Subjects [NCT01250873]Phase 120 participants (Actual)Interventional2010-11-30Completed
Group Cognitive Behavioral Therapy Versus Fluoxetine for Obsessive-Compulsive Disorder: a Randomized Open Trial for Any Patient. [NCT00680602]Phase 4158 participants (Actual)Interventional2006-01-31Completed
Randomized Trial of Sertraline Treatment of Depression in Chronic Kidney Disease [NCT00946998]Phase 3201 participants (Actual)Interventional2010-02-08Completed
The Efficacy and Tolerability of Seroquel XR Combined With a Selective Serotonin Re-Uptake Inhibitor Versus Seroquel XR Monotherapy in the Acute Treatment of Major Depressive Disorder With Psychotic Features [NCT00955474]Phase 432 participants (Actual)Interventional2008-09-30Terminated(stopped due to AstraZeneca halted funding; patent expired for Seroquel (Quetiapine) in 2012)
Determining the Impact of Dementia and Executive Impairment on Antidepressant Treatment Response in Older Persons [NCT01477268]Phase 430 participants (Actual)Interventional2007-06-30Completed
A Randomized Controlled Study on the Treatment of Moderate Depressive Disorder With Cheek Acupuncture [NCT05923021]126 participants (Anticipated)Interventional2023-07-01Not yet recruiting
Clinical Protocol of Self-Controlled Study on the Effects of Sertraline on Depression in Parkinson's Disease [NCT01437189]35 participants (Anticipated)Interventional2011-08-31Recruiting
SSRI Treatment of Dual Diagnosis PTSD and Alcohol Dependence: A Test of the Serotonergic Hypothesis [NCT02504931]Phase 449 participants (Actual)Interventional2011-04-30Completed
Pharmacotherapy in Depression With Panic Spectrum [NCT00177996]Phase 430 participants (Actual)Interventional2001-10-31Completed
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Sertraline 100 mg Tablets Under Fasting Conditions [NCT00864344]Phase 130 participants (Actual)Interventional2004-08-31Completed
Effectiveness of Quetiapine XR Versus Sertraline in Acute Depression as add-on Therapy to Previous Mood Stabilizer Treatment: a Pilot Study [NCT00857584]Phase 327 participants (Actual)Interventional2009-05-31Completed
The Treatment Efficacy of Combination Atypical Antipsychotics With Sertraline in Patients With Schizophrenia [NCT04076371]1,640 participants (Actual)Interventional2012-01-31Completed
A Multicenter, 10-Week, Randomized, Double-Blind Study Of Sertraline And Placebo In Children And Adolescents With Posttraumatic Stress Disorder (PTSD) [NCT00150306]Phase 3160 participants Interventional2002-11-30Terminated(stopped due to Please see Detailed Description below for termination reason.)
A Randomized, Double-Blind, Active Controlled Clinical Trial of Switching to Vilazodone for Antidepressant-Associated Sexual Dysfunction [NCT01856127]Phase 44 participants (Actual)Interventional2013-01-31Terminated(stopped due to PI left institution)
Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD [NCT00215241]Phase 2/Phase 380 participants Interventional2004-04-30Completed
A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder [NCT04174170]Phase 3591 participants (Actual)Interventional2019-10-30Completed
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)Interventional2011-11-30Active, not recruiting
Treatment of Pediatric Obsessive-Compulsive Disorder [NCT00000384]Phase 30 participants Interventional1997-05-31Completed
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Sertraline Tablets 100 mg Under Fed Conditions [NCT00601588]43 participants (Actual)Interventional2003-06-30Completed
Noradrenergic Augmentation of SSRI Therapy in Patients With Depression Unresponsive or Incompletely Responsive to SSRI Monotherapy [NCT00485862]Phase 4214 participants (Actual)Interventional2003-06-30Completed
Prospective 24-week Study, Comparing Clinical Outcomes Between Switching Antidepressants and Maintaining the Same Antidepressant in Patients With Major Depressive Disorder Who do Not Show a 20% Reduction in Symptoms at Week 2 [NCT00519012]Phase 4200 participants (Anticipated)Interventional2007-08-31Recruiting
Effectiveness of Selective Serotonin Reuptake Inhibitors Combined With Antipsychotic Medication for the Treatment of Psychotic Depression [NCT00056472]Phase 3259 participants (Actual)Interventional2003-01-31Completed
[NCT00508859]Phase 493 participants (Actual)Interventional1997-07-31Completed
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 3203 participants (Anticipated)Interventional2023-01-01Recruiting
Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Assessing Bioequivalence Of Zoloft ODT 50 Mg Under Fasting Condition With And Without Water To Jzoloft Tablet 50 Mg Under Fasting Condition With Water In Healthy Japanese Subjects [NCT01699724]Phase 130 participants (Actual)Interventional2012-09-30Completed
fMRI Studies of Emotional Circuitry in Major Depression: Treatment Changes [NCT01027559]97 participants (Actual)Interventional2009-02-28Completed
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 32,944 participants (Actual)Interventional2011-10-31Completed
The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease [NCT02917122]Phase 1/Phase 215 participants (Actual)Interventional2015-08-31Terminated(stopped due to Funding is insufficient.)
Sertraline for Alcohol Dependence and Depression [NCT00004554]Phase 4171 participants (Actual)Interventional2000-01-31Completed
Safety and Efficacy of Sertraline for Depression CHF [NCT00078286]Phase 2/Phase 3469 participants (Actual)Interventional2003-11-30Completed
Omega-3 for Depression and Other Cardiac Risk Factors [NCT00116857]Phase 3122 participants (Actual)Interventional2005-02-28Completed
A Randomized, Double-Blinded, Placebo Controlled, Trial of the Effect of Sertraline Vs. Placebo in Reducing the Incidence and Severity of Hot Flashes in Healthy Women [NCT00283192]100 participants Interventional2003-07-31Completed
Lamotrigine Use in Treatment Refractory Depression in Adolescents [NCT00284791]50 participants Interventional2006-01-31Terminated
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)Observational2022-10-01Completed
An Intensive Treatment Program of Interpersonal Psychotherapy Plus Pharmacotherapy for Severely Depressed Inpatients [NCT00325000]0 participants Interventional2000-11-30Terminated
A Six-Week, Fixed Dose, Double-Blind, Double-Dummy, Placebo and Sertraline Controlled, Multicentre Trial to Evaluate the Safety and Efficacy of CP-316,311 in Outpatients With Major Depressive Disorder [NCT00143091]Phase 2200 participants Interventional2005-04-30Terminated(stopped due to See Detailed Description for termination reason.)
Augmentation of the Antidepressant Action of Sertraline With Triiodothyronine (T3)and Reboxetine: Clinical Efficacy, Adverse Effects and Predictors of Response. [NCT00421369]35 participants (Actual)Interventional2007-09-30Completed
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 3494 participants (Actual)Interventional2006-05-31Completed
Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania [NCT00118014]Phase 475 participants (Actual)Interventional2000-01-31Completed
Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram (LEAP-SE): A Multicenter, Randomized, Blinded Outcome Study of EEG-guided Treatment With Sertraline Versus Escitalopram in Adults With Major Depressive Disorder [NCT04388202]Phase 40 participants (Actual)Interventional2020-10-15Withdrawn(stopped due to No participants enrolled)
Treatment Response Study of Sertraline to Treat Japanese Major Depressive Disorder [NCT01454635]96 participants (Actual)Interventional2008-06-30Completed
A Phase 4 Randomized, Double-Blind, Placebo Controlled Methodology Study to Evaluate the Time of Onset of AntiDepressant Response in Subjects With Major Depressive Disorder [NCT00406952]165 participants (Actual)Interventional2006-11-30Completed
Triiodothyronine (T3) Supplementation in Bipolar and Unipolar Depression: A Random Assignment, Double Blind, Placebo-Controlled Study. [NCT00158990]Phase 3220 participants Interventional2002-10-31Completed
Sertraline Alone vs. in Combination With Risperidone in the Treatment of Attenuated Positive and Negative Symptoms [NCT00169988]8 participants (Actual)Interventional2004-03-31Completed
A Multi-center, Randomized, Double-blind, Parallel-group Study of Sertraline vs. Venlafaxine XR in the Acute Treatment of Outpatients With Major Depressive Disorder [NCT00179283]Phase 320 participants Interventional2002-04-30Completed
Cognitive and Physical Impairment in Frail Older Adults [NCT04962841]485 participants (Anticipated)Observational2020-04-01Recruiting
Acute Efficacy of Bupropion, Sertraline, and Venlafaxine as Adjuvant Treatment to Mood Stabilizers in Bipolar Depression: A Randomized, Double-Blind, Comparative Study [NCT00001483]Phase 275 participants Interventional1995-06-30Completed
A Double-blind, Randomized, Placebo- and Active-Controlled Study of F2695 SR in Adult Patients With Fatigue Associated With Major Depressive Disorder [NCT01254305]Phase 2262 participants (Actual)Interventional2011-04-30Completed
Stereotypies and Mental Retardation: Neurobiological Basis [NCT00491478]Phase 30 participants Interventional1992-09-30Recruiting
CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia: Depression, Anxiety, and Mild Cognitive Impairment [NCT02955719]145 participants (Actual)Interventional2016-03-30Completed
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 4418 participants (Anticipated)Interventional2023-11-01Not yet recruiting
The Effect of Antidepressants and Gabapentin on Tamoxifen Pharmacokinetics: A Prospective Study [NCT00667121]85 participants (Anticipated)Observational2011-03-16Active, not recruiting
Sertraline and Cognitive Therapy in Depressed Alcoholics [NCT00000458]Phase 2100 participants InterventionalCompleted
CREST-II: Tiagabine, Sertraline, or Donepezil vs. Unmatched Placebo [NCT00015132]Phase 20 participants Interventional1999-03-31Completed
Treatment of Cholestatic Pruritus With Sertraline [NCT00058903]Phase 240 participants (Anticipated)Interventional2003-04-30Completed
A Phase III Double-Blind Randomized Trial Comparing Sertraline (Zoloft) And Hypericum Perforatum (St. John's Wort) In Cancer Patients With Mild To Moderate Depression [NCT00066859]Phase 32 participants (Actual)Interventional2004-03-01Completed
[NCT00080158]Phase 2/Phase 3120 participants Interventional2004-03-31Completed
[NCT00009191]Phase 40 participants Interventional2005-11-30Completed
Prevention of Recurrent Postpartum Depression [NCT00276900]Phase 3300 participants Interventional2003-12-31Completed
Sequenced Treatment Alternatives to Relieve Depression [NCT00021528]Phase 44,000 participants Interventional2001-07-31Completed
Depression and Health Outcomes in Refractory Epilepsy [NCT00026637]Phase 3140 participants (Actual)Interventional2001-08-31Completed
Comparing the Safety and Effectiveness of a Mood Stabilizing Medication, an Antidepressant Medication, and a Combination of Both Medications to Treat Symptoms of Bipolar Type II Depression [NCT00276965]Phase 3139 participants (Actual)Interventional2006-09-30Completed
Improving Hispanic Retention in Antidepressant Therapy [NCT00057642]50 participants (Actual)Interventional2002-09-30Completed
A Randomized Controlled Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease [NCT00208117]Phase 17 participants (Actual)Interventional2005-04-30Terminated(stopped due to Unable to enroll subjects)
A Randomized Placebo-Controlled Trial of Sertraline for the Neurobehavioral Sequelae of Traumatic Brain Injury [NCT00208585]100 participants (Anticipated)Interventional2000-02-29Recruiting
Thyroid Axis in Major Depression [NCT00208702]Phase 4153 participants (Actual)Interventional1996-09-30Completed
Treatment Outcome of Vascular Depression [NCT00045773]208 participants (Actual)Observational2001-04-30Completed
Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD [NCT00133822]Phase 1/Phase 265 participants Interventional2004-04-30Completed
Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder [NCT00048854]Phase 1/Phase 266 participants (Actual)Interventional2001-09-30Completed
Efficacy of an SSRI in Acute Stress Disorder and PTSD [NCT00050804]Phase 480 participants Interventional2002-12-31Completed
Intervention to Prevent Post-Stroke Major Depression. [NCT00177424]Phase 4154 participants (Anticipated)Interventional2004-07-31Terminated(stopped due to Recruitment goals could not be met.)
Dynamic Measures of Neurochemistry in Mood Disorders [NCT00178828]Phase 442 participants (Actual)Interventional2002-10-31Completed
The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to [NCT00179257]Phase 320 participants Interventional2004-06-30Completed
Sertraline in the Treatment of Generalized Social Phobia With Comorbidity [NCT00182533]Phase 4170 participants (Anticipated)Interventional2002-07-31Terminated(stopped due to Study drug could not be re-supplied)
A Randomized Double-Blind Comparison of Sertraline With Early Alprazolam XR Co-Administration vs Sertraline/Placebo for Primary Care Panic Disorder Patients [NCT00198094]Phase 4150 participants (Anticipated)Interventional2003-12-31Completed
An Electrophysiological Predictor of SSRI Response in Veterans With PTSD [NCT04183205]Phase 494 participants (Anticipated)Interventional2019-09-11Recruiting
A Comparison of Two Different Treatments for Major Depression With Psychotic Features: Ziprasidone vs. Combined Sertraline and Haloperidol [NCT00340379]Phase 2/Phase 372 participants (Actual)Interventional2003-04-30Completed
Ziprasidone for the Treatment of Refractory Social Anxiety Disorder [NCT00215150]Phase 251 participants (Actual)Interventional2004-11-30Completed
Effect of Pharmacological Treatment of Depression on A1C and Quality of Life in Underserved Hispanics and African Americans With Diabetes: A Randomized, Placebo Controlled Trial. [NCT00624013]Phase 489 participants (Actual)Interventional2006-09-30Completed
The Effect of Problem Solving Therapy and Antidepressant Therapy on Cerebral Perfusion and Brain Derived Neurotropic Factor in Depressed Elders [NCT01305889]19 participants (Actual)Interventional2011-03-31Completed
Sertraline Augmented With GABA Agents for Cocaine Dependence [NCT00654953]Phase 2102 participants (Actual)Interventional2006-01-31Completed
Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury [NCT00704379]Phase 2/Phase 394 participants (Actual)Interventional2008-06-30Completed
Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline [NCT01309074]Phase 40 participants (Actual)Interventional2009-11-30Withdrawn(stopped due to No subjects could be enrolled and therefore we decided to withdraw/stop the study.)
[NCT02655354]635 participants (Actual)Interventional2015-10-31Completed
A Randomized, Double-blind, Placebo-controlled Pilot Study of Sertraline for the Prevention of PTSD in Burn Victims [NCT02520726]Phase 45 participants (Actual)Interventional2013-09-30Terminated(stopped due to Insufficient enrollment)
Child/Adolescent Anxiety Multimodal Treatment Study [NCT00052078]Phase 3488 participants (Actual)Interventional2003-01-31Completed
NMDA Modulation in Major Depressive Disorder in Late- Life [NCT03414931]Phase 2136 participants (Actual)Interventional2016-01-31Completed
Modulation of Visually Evoked Potentials by an Antidepressant [NCT00263133]12 participants Interventional2005-12-31Completed
Effects of Ziprasidone vs. Placebo During the First Four Weeks of Eight Weeks Sertraline Treatment in Patients With Post-traumatic Stress Disorder (PTSD) [NCT00248261]7 participants (Actual)Observational2005-11-30Terminated(stopped due to High rate of early drop-outs)
A Pilot Study of Sertraline Plus Relapse Prevention Therapy (RP) for the Treatment of Pathological Gambling With Comorbid Abuse or Dependence [NCT00249431]Phase 29 participants (Actual)Interventional2001-12-31Terminated(stopped due to Inability to recruit patients.)
Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly [NCT00701675]Phase 442 participants (Actual)Interventional2005-10-31Completed
A Comparison of Non-Surgical Treatment Methods for Patients With Lumbar Spinal Stenosis [NCT01943435]259 participants (Actual)Interventional2013-11-20Completed
Treatment Outcomes of Vascular Depression [NCT00339066]131 participants (Actual)Interventional2001-08-31Completed
Pharmacologic Dissection of Vestibular Migraine and Chronic Subjective Dizziness: A Double-Blind Parallel Group Trial Comparing Response to Verapamil Versus Sertraline [NCT01669304]Phase 132 participants (Actual)Interventional2012-08-31Completed
Early Detection and Intervention for the Prevention of Psychosis Project [NCT00531518]292 participants (Actual)Interventional2007-10-31Completed
Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis [NCT02908334]Phase 20 participants (Actual)Interventional2016-11-30Withdrawn(stopped due to failure to enroll)
Late-life Depression and Cerebral Perfusion [NCT01751828]0 participants (Actual)Interventional2012-12-31Withdrawn(stopped due to This was an initial unfunded pilot project stopped after similar studies were funded.)
Algorithm Guided Treatment Strategies for Major Depressive Disorder [NCT01764867]Phase 41,080 participants (Anticipated)Interventional2012-06-30Recruiting
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 4500 participants (Anticipated)Interventional2012-08-31Recruiting
The Efficacy and Safety of Sertraline in Maintenance Hemodialysis Patients With Depression: a Randomized Controlled Study [NCT06124417]Phase 4125 participants (Actual)Interventional2022-01-10Completed
Effects of Cerebral Hypoperfusion and Its Reversal on Late-Life Depression [NCT01794455]Phase 41 participants (Actual)Interventional2013-05-31Terminated(stopped due to Enrollment difficulties)
Assessment of Cost- Effectiveness Interventions and the Quality of Life in Patients With Major Depression Through Resources Available in Brazilian Public Health [NCT02901249]Phase 468 participants (Actual)Interventional2010-05-31Completed
Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode [NCT02918097]Phase 478 participants (Actual)Interventional2010-05-31Completed
"Response Variability in Treatment Resistant Depression - an Ancillary Study to Sequenced Treatment Alternatives to Relieve Depression (STAR*D)" [NCT00375843]Phase 4118 participants (Actual)Interventional2005-01-31Completed
Antibiotic Treatment and Intravenous Immunoglobulin Double-blind, Randomized, Placebo-controlled Trial for PANDAS [NCT01769027]Phase 20 participants (Actual)Interventional2013-06-30Withdrawn(stopped due to No participants enrolled)
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 31,254 participants (Anticipated)Interventional2023-08-01Not yet recruiting
Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder [NCT01460212]Phase 480 participants (Anticipated)Interventional2011-12-31Recruiting
"Randomized Double Blinding Controlled Study on Jia Wei Xiao Yao Jiaonang Treating Mild to Moderate Major Depressive Disorder" [NCT01467804]180 participants (Anticipated)Interventional2011-11-30Not yet recruiting
Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease [NCT02813447]15 participants (Actual)Interventional2016-08-31Terminated(stopped due to COVID-19 hold)
Depression in Alzheimer's Disease (DIADS-2) [NCT00086138]Phase 2/Phase 3131 participants (Actual)Interventional2004-07-31Completed
Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis [NCT00004300]Phase 240 participants InterventionalSuspended
Study on the Brain Hippocampal Volume, Cortisol and C-reactive Protein Levels Relationship With Anxious Symptoms in Major Depressive Patients [NCT04430556]30 participants (Anticipated)Interventional2018-07-01Active, not recruiting
Efficacy of Exposure and Response Prevention(ERP) and SSRIs, and Its Predictors in Obsessive-Compulsive Disorder [NCT02022709]Phase 478 participants (Actual)Interventional2014-01-31Completed
Efficacy of Interpersonal Psychotherapy in Treatment Resistant Depression [NCT01896349]74 participants (Anticipated)Interventional2013-04-30Recruiting
Treatment of Pediatric OCD for SRI Partial Responders [NCT00074815]Phase 3124 participants (Actual)Interventional2003-09-30Completed
NMDA Modulation in Major Depressive Disorder [NCT04637620]Phase 290 participants (Anticipated)Interventional2017-06-01Recruiting
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 3236 participants (Actual)Interventional2015-08-07Completed
Treatment for Psychogenic Nonepileptic Seizures: A Pilot, 12 Week, Prospective, Randomized, Placebo-controlled, Double-blind, Clinical Trial of Sertraline in the Treatment of Comorbid Psychiatric Disorders in NES [NCT00159965]Phase 438 participants (Actual)Interventional2003-12-31Completed
Sertraline Versus Escitalopram in South Asian Participants With Moderate to Severe Major Depressive Disorder: A Double-blind, Parallel, Randomized Controlled Trial [NCT05950061]Phase 3744 participants (Actual)Interventional2022-06-01Completed
Assessing Tolerability and Efficacy of Vortioxetine Versus SSRIs in Elderly Patients With Depression: a Pragmatic, Multicenter, Open-label, Parallel-group, Superiority, Randomized Trial [NCT03779789]Phase 4362 participants (Actual)Interventional2019-02-01Completed
The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy - a Randomised Clinical Study [NCT01569685]Phase 4207 participants (Actual)Interventional2012-04-30Completed
Improving Outcomes in Pharmacotherapy of Social Phobia [NCT00282828]Phase 4397 participants (Actual)Interventional2006-03-31Completed
Short-Term Versus Long-Term Treatment for Severe PMS [NCT00318773]Phase 4174 participants (Actual)Interventional2002-02-28Completed
Exercise Training and Depression in Older Adults II [NCT00331305]Phase 3457 participants (Actual)Interventional1999-08-31Completed
Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care (EMBARC) for Depression [NCT01407094]Phase 2296 participants (Actual)Interventional2011-07-29Completed
Sertraline and Naltrexone for Alcohol Dependents [NCT00000440]Phase 2124 participants InterventionalCompleted
Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism [NCT00000446]Phase 20 participants InterventionalCompleted
Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives [NCT00000451]Phase 2198 participants (Actual)Interventional2003-01-31Completed
Comparison of Antidepressants in the Real-World: Retrospective Cohort Study Using Big Data [NCT04446039]405,349 participants (Actual)Observational2022-07-04Completed
ASCEND: A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression [NCT02358343]Phase 3184 participants (Actual)Interventional2015-03-23Completed
Effectiveness of Sertraline in Alleviating Uremic Pruritis in Hemodialysis Patients [NCT05341843]Phase 260 participants (Actual)Interventional2022-05-01Completed
Sequencing CBT for Child Anxiety: CBT Plus Sertraline Versus Switch to Sertraline [NCT01977729]Phase 21 participants (Actual)Interventional2013-10-31Terminated(stopped due to funding)
Extracellular Vesicles as Predictors of Antidepressant Outcomes in Pediatric Anxiety (EV-SOPRANO) [NCT04221997]Phase 4150 participants (Anticipated)Interventional2019-11-01Recruiting
Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) a Multicentre Open-label Randomized Controlled Trial Protocol [NCT05814640]Phase 1/Phase 2520 participants (Anticipated)Interventional2023-02-20Recruiting
A Placebo Controlled Clinical Trial of a Standardized Extract of Hypericum Perforatum in Major Depressive Disorder [NCT00005013]0 participants Interventional1998-12-31Completed
An I-123-ADAM SPECT Imaging Study to Evaluate the Serotonin Transporter (SERT) Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Assisting in Detecting MDD [NCT02473783]Phase 237 participants (Actual)Interventional2011-10-31Completed
Research on Standardized Electronic Cognitive Training Technique in Early Stage of Senile Depression With Cognitive Impairment [NCT05588102]128 participants (Anticipated)Interventional2021-05-18Recruiting
Cryptococcal Antigen Screening Plus Sertraline [NCT03002012]Phase 322 participants (Actual)Interventional2017-11-15Terminated(stopped due to SAEs with n=1 serotonin syndrome, n=2 SAEs after sertraline interruption.)
Preventing Depression Recurrence in Diabetes [NCT00374426]Phase 4262 participants Interventional1998-03-31Completed
A Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients [NCT01607593]123 participants (Actual)Observational2012-08-31Completed
Randomized Trial of Sertraline, Prolonged Exposure, and Their Combination for Post-traumatic Stress Disorder (PTSD) in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF). [NCT01524133]Phase 4223 participants (Actual)Interventional2011-11-30Completed
Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment [NCT02469545]Phase 260 participants (Actual)Interventional2014-06-30Completed
A Randomized Controlled Trial of Sertraline Combined With Fluvoxamine in the Treatment of Refractory Obsessive-compulsive Disorder [NCT04963257]Phase 4400 participants (Anticipated)Interventional2020-01-01Recruiting
Efficacy of Hydroxyzine Versus Treatment as Usual for Panic Disorder: An Eight-Week, Open Label, Pilot, Randomized Controlled Trial. [NCT05737511]Phase 480 participants (Anticipated)Interventional2023-12-30Not yet recruiting
The Study of Mindfulness Based Cognitive Therapy and Obsessive-Compulsive Disorder [NCT03179839]123 participants (Actual)Interventional2017-01-20Completed
Effectiveness of PTSD Treatment: CBT Versus Sertraline [NCT00127673]Phase 3200 participants (Actual)Interventional2004-09-30Completed
Pharmacovigilance in Gerontopsychiatric Patients [NCT02374567]Phase 3407 participants (Actual)Interventional2015-01-31Terminated
RCT of Sertraline Versus Cognitive Behavioural Therapy for Anxiety Symptoms in People With Generalised Anxiety Disorder Who Have Failed to Respond to Low Intensity Psychological Interventions as Defined by the NICE GAD Guidelines [NCT02347033]Phase 45 participants (Actual)Interventional2014-08-31Terminated(stopped due to Difficulties with recruitment during the internal pilot phase)
A Controlled Trial of Sertraline in Young Children With Fragile X Syndrome [NCT01474746]Phase 257 participants (Actual)Interventional2012-01-31Completed
Fear Conditioning, Extinction and Recall in Healthy Subjects and in Obsessive-compulsive Disorder Patients Pre and Post Treatment With Sertraline. [NCT03068429]Phase 469 participants (Actual)Interventional2016-12-01Completed
Placebo Controlled Trial of Sertraline and Interpersonal Psycho-Therapy for Postpartum Depression [NCT00602355]Phase 2162 participants (Actual)Interventional2008-02-29Completed
Treatment of Pediatric Anxiety Disorders by Predicting Treatment Response Through Biocellular Markers and Sleep [NCT02189213]14 participants (Actual)Interventional2014-07-31Terminated(stopped due to Insufficient funding)
An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression [NCT02497287]Phase 3802 participants (Actual)Interventional2015-09-30Completed
Riluzole Augmentation Pilot in Depression (RAPID) Trial [NCT01703039]Phase 221 participants (Actual)Interventional2013-01-31Terminated(stopped due to PI departure, slow recruitment)
Psychophysiology, Neurosteroids, and Stress in Premenstrual Dysphoric Disorder [NCT02777372]Phase 484 participants (Actual)Interventional2016-04-01Completed
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 3346 participants (Actual)Interventional2015-08-10Completed
Understanding the Prognostic Benefits of Exercise and Anti-depressant Therapy (UPBEAT) [NCT00302068]Phase 3101 participants (Actual)Interventional2006-07-31Completed
Improving Depression Treatment Outcomes With an Insulin-Sensitizing Agent [NCT00834652]Phase 4206 participants (Actual)Interventional2007-09-30Completed
Effects of Treatment on Decision-making in Major Depression [NCT01916824]Phase 453 participants (Actual)Interventional2013-08-31Completed
Phase 1, Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Period Crossover Bioequivalence Study Comparing Sertraline Hydrochloride 50 mg Film-Coated Tablets To Sertraline Hydrochloride 50 mg Hard Capsules Under Fasted Conditions [NCT01235195]Phase 130 participants (Actual)Interventional2010-11-30Completed
Sustaining Remission of Psychotic Depression [NCT01427608]Phase 4269 participants (Actual)Interventional2011-10-31Completed
Prophylactic Use of Immediate Postpartum Sertraline to Prevent Postpartum Depression: A Double Blind Randomized Placebo Controlled Trial [NCT02235064]2 participants (Actual)Interventional2014-07-31Terminated(stopped due to Low recruitment, completion of funding cycle)
Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain [NCT04747314]Phase 2/Phase 3300 participants (Anticipated)Interventional2021-03-31Recruiting
A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of Precise Repetitive Transcranial Magnetic Stimulation (rTMS) Therapy Based on Neuroimaging in Depressed Adolescents With Anhedonia. [NCT05544071]88 participants (Anticipated)Interventional2023-02-12Recruiting
A Pilot Study Examining the Gut Microbiota in Patients With Obsessive-Compulsive Disorder vs. Healthy Controls and Following 12-weeks of Open-label Selective Serotonin Reuptake Inhibitors Treatment [NCT02285699]43 participants (Anticipated)Interventional2014-11-01Completed
A Pragmatic Trial of Pharmacotherapy Options Following Unsatisfactory Initial Treatment in OCD [NCT04539951]Phase 21,600 participants (Anticipated)Interventional2020-09-22Recruiting
Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis [NCT01802385]Phase 3460 participants (Actual)Interventional2015-03-09Completed
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 3252 participants (Actual)Interventional2018-05-25Completed
Depression Screening RCT in ACS Patients: Quality of Life and Cost Outcomes [NCT01993017]1,501 participants (Actual)Interventional2013-11-30Completed
Treatment of Post-TBI Depression [NCT00233103]Phase 252 participants (Actual)Interventional2003-06-30Completed
A Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder [NCT02385799]Phase 258 participants (Actual)Interventional2015-04-30Completed
Frontal Hypoperfusion Effects on Antidepressant Outcomes in Late-Life Depression (R21) [NCT01896934]Phase 431 participants (Actual)Interventional2013-07-31Completed
Testing an Imaging Biomarker for Treatment Stratification in Major Depression [NCT02137369]Phase 477 participants (Actual)Interventional2014-09-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00000378 (1) [back to overview]HAMILTON Rating Scale for DEPRESSION Range
NCT00043550 (1) [back to overview]Hamilton Rating Scale for Depression-17 Item
NCT00052078 (1) [back to overview]Clinical Global Impression - Improvement Scale
NCT00056472 (3) [back to overview]Remission of Depression Hamilton Depression Scale (Ham-D) and Psychosis Schedule for Affective Disorders in Schizophrenia - Delusional Item (SADS) During the Course of the Trial
NCT00056472 (3) [back to overview]Scores on CGI-S Compared to Baseline Over the Course of the Trial
NCT00056472 (3) [back to overview]Mean Score Hamilton Depression Rating Scale (Ham-D) Over the Course of the Trial From Week to Week.
NCT00074815 (1) [back to overview]Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
NCT00078286 (2) [back to overview]Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo
NCT00078286 (2) [back to overview]Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo.
NCT00086138 (2) [back to overview]Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC)
NCT00086138 (2) [back to overview]Remission According to Cornell Scale for Depression in Dementia Scale
NCT00116857 (1) [back to overview]Beck Depression Inventory-II
NCT00118417 (3) [back to overview]Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6)
NCT00118417 (3) [back to overview]Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24)
NCT00118417 (3) [back to overview]Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12)
NCT00127673 (4) [back to overview]Depression Symptoms
NCT00127673 (4) [back to overview]PTSD Symptoms
NCT00127673 (4) [back to overview]Quality of Life Functioning
NCT00127673 (4) [back to overview]State Anxiety
NCT00159965 (14) [back to overview]Davidson Trauma Scale (DTS)
NCT00159965 (14) [back to overview]Dissociative Experiences Scale (DES)
NCT00159965 (14) [back to overview]Global Assessment of Functioning (GAF)
NCT00159965 (14) [back to overview]Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)
NCT00159965 (14) [back to overview]Modified Hamilton Depression Scale (MHRS)
NCT00159965 (14) [back to overview]Number of Nonepileptic Seizures (NES)
NCT00159965 (14) [back to overview]Oxford Handicap Scale (OHS)
NCT00159965 (14) [back to overview]Symptom Checklist 90 (SCL-90)
NCT00159965 (14) [back to overview]Clinical Global Impressions - Improvement (CGI-I)
NCT00159965 (14) [back to overview]Family Assessment Device (FAD)
NCT00159965 (14) [back to overview]Barratt Impulsivity Scale (BIS)
NCT00159965 (14) [back to overview]Beck Depression Inventory-II (BDI-II)
NCT00159965 (14) [back to overview]Quality of Life in Epilepsy-31 (QOLIE-31)
NCT00159965 (14) [back to overview]Clinical Global Impressions - Severity (CGI-S)
NCT00182078 (3) [back to overview]Diagnostic Interview for Children and Adolescents (DICA) - Child
NCT00182078 (3) [back to overview]The Child Depression Inventory (CDI)
NCT00182078 (3) [back to overview]Diagnostic Interview Schedule for Children and Adolescents (DICA) - Parent
NCT00215150 (1) [back to overview]Brief Social Phobia Scale(BSPS)
NCT00233103 (4) [back to overview]BAI
NCT00233103 (4) [back to overview]Life-3
NCT00233103 (4) [back to overview]Depression at End of Treatment
NCT00233103 (4) [back to overview]Depression at Baseline
NCT00245557 (3) [back to overview]Geriatric Depression Scale
NCT00245557 (3) [back to overview]Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)
NCT00245557 (3) [back to overview]HAM-D 17 (Hamilton Depression Rating Scale)
NCT00262223 (2) [back to overview]Heavy Drinking Days/Week
NCT00262223 (2) [back to overview]PTSD Symptom Severity / Clinician Administered PTSD Scale
NCT00282828 (2) [back to overview]Post-treatment Social Phobia Severity as Defined by Endpoint LSAS Scores
NCT00282828 (2) [back to overview]Rates of Remission (LSAS≤30) After 12 Weeks of Randomized Treatment During Phase II, Among Phase I Non-responders
NCT00302068 (7) [back to overview]Interleuken 6 (IL-6)
NCT00302068 (7) [back to overview]Heart Rate Variability (HRV)
NCT00302068 (7) [back to overview]C-reactive Protein (CRP)
NCT00302068 (7) [back to overview]Percent Change in Flow Mediated Dilation (FMD)
NCT00302068 (7) [back to overview]Hamilton Depression Rating Scale
NCT00302068 (7) [back to overview]Baroreflex Sensitivity (BRS)
NCT00302068 (7) [back to overview]Platelet Factor 4
NCT00340379 (3) [back to overview]21 Item Hamilton Depression Rating Scale
NCT00340379 (3) [back to overview]Clinical Global Impression Improvement Scale
NCT00340379 (3) [back to overview]Brief Psychiatric Rating Scale at 12 Weeks
NCT00368550 (3) [back to overview]Change in the Level of Alcohol-related Problems
NCT00368550 (3) [back to overview]Number of Days of Heavy Drinking (Defined as Days on Which Women Drank >= 4 Drinks and Men Drank >= 5 Drinks)
NCT00368550 (3) [back to overview]Number of Days on Which Subjects Drank
NCT00531518 (1) [back to overview]Psychotic Symptoms
NCT00536198 (12) [back to overview]Adverse Events
NCT00536198 (12) [back to overview]Clinical Global Impressions-Improvement (CGI-I)
NCT00536198 (12) [back to overview]Clinical Global Severity (CGI-S)
NCT00536198 (12) [back to overview]DRSP
NCT00536198 (12) [back to overview]DRSP Anger/Irritability Subscale
NCT00536198 (12) [back to overview]DRSP Depression Subscale
NCT00536198 (12) [back to overview]DRSP Physical Subscale
NCT00536198 (12) [back to overview]Inventory of Depression Symptoms (IDS-C)
NCT00536198 (12) [back to overview]Michelson SSRI Withdrawal Checklist
NCT00536198 (12) [back to overview]Number of Days Pills Were Taken
NCT00536198 (12) [back to overview]Premenstrual Tension Scale (PMTS)
NCT00536198 (12) [back to overview]Number of Symptomatic Days Before Pills Were Taken
NCT00602355 (5) [back to overview]Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)
NCT00602355 (5) [back to overview]Depression Illness Severity Based on Beck Depression Inventory (BDI)
NCT00602355 (5) [back to overview]Global Illness Severity Based on Clinical Global Impression (CGI) Scale
NCT00602355 (5) [back to overview]Hamilton Anxiety Rating Scale (HARS)
NCT00602355 (5) [back to overview]Hamilton Depression Rating Scale (HAM-D)
NCT00605813 (6) [back to overview]Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
NCT00605813 (6) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction
NCT00605813 (6) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness
NCT00605813 (6) [back to overview]Number of Participants of Treatment Related Adverse Events (TRAEs)
NCT00605813 (6) [back to overview]Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt)
NCT00605813 (6) [back to overview]Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies
NCT00605865 (16) [back to overview]Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not
NCT00605865 (16) [back to overview]Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments.
NCT00605865 (16) [back to overview]Factors Considered to Affect the Efficacy of Sertraline: Age
NCT00605865 (16) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt)
NCT00605865 (16) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction
NCT00605865 (16) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness
NCT00605865 (16) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug
NCT00605865 (16) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications
NCT00605865 (16) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose
NCT00605865 (16) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not
NCT00605865 (16) [back to overview]Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
NCT00605865 (16) [back to overview]Number of Participants of Treatment Related Adverse Events (TRAEs)
NCT00605865 (16) [back to overview]Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity
NCT00605865 (16) [back to overview]Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient
NCT00605865 (16) [back to overview]Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride
NCT00605865 (16) [back to overview]Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt)
NCT00605917 (14) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications
NCT00605917 (14) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status
NCT00605917 (14) [back to overview]Factors Considered to Affect the Efficacy of Sertraline: Complication
NCT00605917 (14) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness
NCT00605917 (14) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose
NCT00605917 (14) [back to overview]Number of Participants of Treatment Related Adverse Events (TRAEs)
NCT00605917 (14) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies
NCT00605917 (14) [back to overview]Factors Considered to Affect the Efficacy of Sertraline: Drinking Status
NCT00605917 (14) [back to overview]Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug
NCT00605917 (14) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug
NCT00605917 (14) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder
NCT00605917 (14) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline
NCT00605917 (14) [back to overview]Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
NCT00605917 (14) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose
NCT00612807 (2) [back to overview]Dyadic Adjustment Scale (DAS)
NCT00612807 (2) [back to overview]Hamilton Depression Rating Scale (HDRS)
NCT00624013 (2) [back to overview]HbA1C (%)
NCT00624013 (2) [back to overview]Quality of Life
NCT00654953 (1) [back to overview]Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites
NCT00666757 (25) [back to overview]Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure)
NCT00666757 (25) [back to overview]Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure)
NCT00666757 (25) [back to overview]Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure)
NCT00666757 (25) [back to overview]Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint
NCT00666757 (25) [back to overview]Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]
NCT00666757 (25) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure)
NCT00666757 (25) [back to overview]Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure)
NCT00666757 (25) [back to overview]Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure)
NCT00666757 (25) [back to overview]Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint
NCT00666757 (25) [back to overview]Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure)
NCT00666757 (25) [back to overview]Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]
NCT00666757 (25) [back to overview]Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]
NCT00666757 (25) [back to overview]Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint
NCT00666757 (25) [back to overview]Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure)
NCT00666757 (25) [back to overview]Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint
NCT00666757 (25) [back to overview]Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint
NCT00666757 (25) [back to overview]Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint
NCT00666757 (25) [back to overview]Change From Baseline in Weight at Week-12 Endpoint
NCT00666757 (25) [back to overview]Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)
NCT00666757 (25) [back to overview]Change From Baseline in Pulse Rate at Week-12 Endpoint
NCT00666757 (25) [back to overview]Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure)
NCT00666757 (25) [back to overview]Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint]
NCT00666757 (25) [back to overview]Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure)
NCT00666757 (25) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure)
NCT00666757 (25) [back to overview]Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)
NCT00677352 (7) [back to overview]Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase
NCT00677352 (7) [back to overview]Mean Change From Baseline in Panic Attack at the End of Treatment Phase
NCT00677352 (7) [back to overview]Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement
NCT00677352 (7) [back to overview]Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase
NCT00677352 (7) [back to overview]Number of Participants With Summary of Adverse Events in Treatment Phase
NCT00677352 (7) [back to overview]Summary of Adverse Events in Tapering Phase
NCT00677352 (7) [back to overview]Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase
NCT00701675 (1) [back to overview]Comparisons of End of Study HAM-A Score Means for Sertraline 50 mg vs Placebo, Sertraline 100 mg vs Placebo, and Sertraline 50 mg vs. Sertraline 100 mg
NCT00704379 (6) [back to overview]Iowa Gambling Task Score
NCT00704379 (6) [back to overview]Neuroimaging Variables (i.e., Fractional Anisotropy [FA] of Frontal White Matter Such as the Cingulate Gyrus)
NCT00704379 (6) [back to overview]Social Functioning Examination Total Score
NCT00704379 (6) [back to overview]Time to Onset of Diagnostic and Statistical Manual (DSM) IV Defined Mood and Anxiety Disorders Associated With Traumatic Brain Injury (TBI)
NCT00704379 (6) [back to overview]Total Community Integration Questionnaire Scores
NCT00704379 (6) [back to overview]Memory Function Composite
NCT00744328 (2) [back to overview]To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29
NCT00744328 (2) [back to overview]Infant Serum Concentrations of Estradiol in 3 Treatment Arms
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 15 Score (Satisfaction With Medication).
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 16 Score (Overall Life Satisfaction).
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Score (the Mean of 3 Individual Item Scores).
NCT00797966 (14) [back to overview]Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
NCT00797966 (14) [back to overview]Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.
NCT00797966 (14) [back to overview]Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).
NCT00797966 (14) [back to overview]Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (QLES-Q-SF) Subscale Score - the Overall General Subscore (Sum of First 14 Items).
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Depression Rating Scale (HAM-D17) Score.
NCT00797966 (14) [back to overview]Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).
NCT00834652 (1) [back to overview]Change of Beck Depression Inventory-II Scores Over 16 Weeks
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
NCT00857584 (18) [back to overview]Number of Patients With Response at Week 4.
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
NCT00857584 (18) [back to overview]Number of Patients With Response at Week 8.
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
NCT00857584 (18) [back to overview]Number of Patients With Response at Week 2
NCT00857584 (18) [back to overview]Number of Patients With Remission at Week 8.
NCT00857584 (18) [back to overview]Number of Patients Response at Week 1
NCT00857584 (18) [back to overview]Number of Patients With Remission at Week 2.
NCT00857584 (18) [back to overview]Number of Patients With Remission at Week 4.
NCT00857584 (18) [back to overview]Number of Patients With Remission at Week 1.
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
NCT00946998 (5) [back to overview]Change in Quality of Life From Baseline to Exit in the Kidney Disease Quality of Life -Short Form, Version 1.3, Patient-reported Overall Health.
NCT00946998 (5) [back to overview]Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale
NCT00946998 (5) [back to overview]Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.
NCT00946998 (5) [back to overview]Serious Adverse Events During the 12 Week Study Duration.
NCT00946998 (5) [back to overview]Response to Treatment Defined as a Decline of 50% in the Baseline QIDS-C-16 Score and Remission of Depression Defined as a QIDS-C-16 Score of 5
NCT00955474 (15) [back to overview]Blood Hemoglobin A1C at Baseline and Week 8.
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale.
NCT00955474 (15) [back to overview]Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8.
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score.
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score
NCT00955474 (15) [back to overview]Depression
NCT00955474 (15) [back to overview]Blood Level of Triglycerides at Baseline and Week 8.
NCT00955474 (15) [back to overview]CPFQ (Cognitive and Psychological Functioning Questionnaire)
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8.
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8.
NCT00955474 (15) [back to overview]Psychosis
NCT00955474 (15) [back to overview]LDL Blood Levels at Baseline and Week 8.
NCT00955474 (15) [back to overview]HDL Blood Levels at Baseline and Week 8.
NCT00955474 (15) [back to overview]Fasting Blood Glucose
NCT01027559 (2) [back to overview]Blood Oxygen-level Dependent Activations During an Emotional Distractor Task Between fMRI Scans of Depressed Participants in the CBT Group and Control Participants.
NCT01027559 (2) [back to overview]Hamilton Depression Rating Scale Score at Baseline and 12 Weeks
NCT01032018 (2) [back to overview]Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)
NCT01032018 (2) [back to overview]Depressive Symptom Reduction
NCT01098318 (6) [back to overview]Number of Participants With Treatment Emergent Side Effects
NCT01098318 (6) [back to overview]Change in Sexual Function
NCT01098318 (6) [back to overview]Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (17-items) at Week 8 and Week 12.
NCT01098318 (6) [back to overview]Number of Participants With Suicide Ideation as Determined by the Columbia Suicide Form
NCT01098318 (6) [back to overview]The Clinical Global Impression (CGI) Severity and Change
NCT01098318 (6) [back to overview]Change in Depressive Symptoms as Measured by the Beck Depression Inventory
NCT01155531 (3) [back to overview]Changes in the Meal Calories Consumed
NCT01155531 (3) [back to overview]Safety of Sertraline and Telenzepine Combination
NCT01155531 (3) [back to overview]Changes in the VAS Score From Baseline.
NCT01178671 (10) [back to overview]Time to Discontinuation of Study Treatment
NCT01178671 (10) [back to overview]Sexual Functioning
NCT01178671 (10) [back to overview]Sleep Quality
NCT01178671 (10) [back to overview]Adverse Effects
NCT01178671 (10) [back to overview]Alternative Measure of PTSD Severity
NCT01178671 (10) [back to overview]Depression Severity
NCT01178671 (10) [back to overview]PTSD Self-rated Severity
NCT01178671 (10) [back to overview]PTSD Severity
NCT01178671 (10) [back to overview]Remission Status
NCT01178671 (10) [back to overview]Response Status
NCT01235195 (5) [back to overview]Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)]
NCT01235195 (5) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
NCT01235195 (5) [back to overview]Maximum Observed Plasma Concentration (Cmax)
NCT01235195 (5) [back to overview]Plasma Decay Half-Life (t1/2)
NCT01235195 (5) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax)
NCT01250873 (6) [back to overview]Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of LY2216684
NCT01250873 (6) [back to overview]Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of LY2216684
NCT01250873 (6) [back to overview]Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Sertraline
NCT01250873 (6) [back to overview]Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of LY2216684
NCT01250873 (6) [back to overview]Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of Sertraline
NCT01250873 (6) [back to overview]Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of Sertraline
NCT01254305 (3) [back to overview]Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score
NCT01254305 (3) [back to overview]Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward
NCT01254305 (3) [back to overview]Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score
NCT01302080 (48) [back to overview]Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36
NCT01302080 (48) [back to overview]Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3
NCT01302080 (48) [back to overview]Change From Baseline in Cognitive Function Using Trails B at Month 3
NCT01302080 (48) [back to overview]Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36
NCT01302080 (48) [back to overview]Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36
NCT01302080 (48) [back to overview]Change From Baseline in Height at Month 3
NCT01302080 (48) [back to overview]Change From Baseline in Weight at Month 3
NCT01302080 (48) [back to overview]Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36
NCT01302080 (48) [back to overview]Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36
NCT01302080 (48) [back to overview]Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36
NCT01302080 (48) [back to overview]Change From Baseline in Weight at Month 30
NCT01302080 (48) [back to overview]Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12
NCT01302080 (48) [back to overview]Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18
NCT01302080 (48) [back to overview]Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24
NCT01302080 (48) [back to overview]Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30
NCT01302080 (48) [back to overview]Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36
NCT01302080 (48) [back to overview]Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6
NCT01302080 (48) [back to overview]Change From Baseline in Body Mass Index (BMI) at Month 12
NCT01302080 (48) [back to overview]Change From Baseline in Body Mass Index (BMI) at Month 18
NCT01302080 (48) [back to overview]Change From Baseline in Body Mass Index (BMI) at Month 24
NCT01302080 (48) [back to overview]Change From Baseline in Body Mass Index (BMI) at Month 30
NCT01302080 (48) [back to overview]Change From Baseline in Body Mass Index (BMI) at Month 36
NCT01302080 (48) [back to overview]Change From Baseline in Body Mass Index (BMI) at Month 6
NCT01302080 (48) [back to overview]Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12
NCT01302080 (48) [back to overview]Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18
NCT01302080 (48) [back to overview]Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24
NCT01302080 (48) [back to overview]Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30
NCT01302080 (48) [back to overview]Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36
NCT01302080 (48) [back to overview]Change From Baseline in Cognitive Function Using Trails B at Month 12
NCT01302080 (48) [back to overview]Change From Baseline in Cognitive Function Using Trails B at Month 18
NCT01302080 (48) [back to overview]Change From Baseline in Cognitive Function Using Trails B at Month 24
NCT01302080 (48) [back to overview]Change From Baseline in Cognitive Function Using Trails B at Month 30
NCT01302080 (48) [back to overview]Change From Baseline in Cognitive Function Using Trails B at Month 36
NCT01302080 (48) [back to overview]Change From Baseline in Cognitive Function Using Trails B at Month 6
NCT01302080 (48) [back to overview]Change From Baseline in Height at Month 12
NCT01302080 (48) [back to overview]Change From Baseline in Height at Month 18
NCT01302080 (48) [back to overview]Change From Baseline in Height at Month 24
NCT01302080 (48) [back to overview]Change From Baseline in Height at Month 30
NCT01302080 (48) [back to overview]Change From Baseline in Height at Month 36
NCT01302080 (48) [back to overview]Change From Baseline in Height at Month 6
NCT01302080 (48) [back to overview]Change From Baseline in Weight at Month 12
NCT01302080 (48) [back to overview]Change From Baseline in Weight at Month 18
NCT01302080 (48) [back to overview]Change From Baseline in Weight at Month 24
NCT01302080 (48) [back to overview]Change From Baseline in Weight at Month 36
NCT01302080 (48) [back to overview]Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6
NCT01302080 (48) [back to overview]Change From Baseline in Weight at Month 6
NCT01302080 (48) [back to overview]Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3
NCT01302080 (48) [back to overview]Change From Baseline in Body Mass Index (BMI) at Month 3
NCT01360866 (5) [back to overview]Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score
NCT01360866 (5) [back to overview]Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score
NCT01360866 (5) [back to overview]Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score
NCT01360866 (5) [back to overview]Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score
NCT01360866 (5) [back to overview]Adverse Events (AEs) - All Participants
NCT01407094 (1) [back to overview]Hamilton Rating Scale for Depression
NCT01427608 (4) [back to overview]Changes in Metabolic Measure: Cholesterol
NCT01427608 (4) [back to overview]Changes in Metabolic Measures: Triglycerides
NCT01427608 (4) [back to overview]Changes in Metabolic Measures: Weight
NCT01427608 (4) [back to overview]Number of Subjects at Risk of Relapse During the Randomized Phase.
NCT01474746 (28) [back to overview]Mullen Scales of Early Learning - Fine Motor Age-equivalent Score
NCT01474746 (28) [back to overview]Clinical Global Impression - Improvement
NCT01474746 (28) [back to overview]Eye Tracking
NCT01474746 (28) [back to overview]Eye Tracking
NCT01474746 (28) [back to overview]Mullen Scales of Early Learning - Cognitive T Score Sum
NCT01474746 (28) [back to overview]Mullen Scales of Early Learning - Cognitive T Score Sum
NCT01474746 (28) [back to overview]Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score
NCT01474746 (28) [back to overview]Mullen Scales of Early Learning - Fine Motor Age-equivalent Score
NCT01474746 (28) [back to overview]Mullen Scales of Early Learning - Fine Motor Raw Score
NCT01474746 (28) [back to overview]Mullen Scales of Early Learning - Fine Motor Raw Score
NCT01474746 (28) [back to overview]Mullen Scales of Early Learning - Summary Age-equivalent Score
NCT01474746 (28) [back to overview]Mullen Scales of Early Learning - Summary Age-equivalent Score
NCT01474746 (28) [back to overview]Mullen Scales of Early Learning - Visual Reception Age-equivalent Score
NCT01474746 (28) [back to overview]Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) - Adaptive Behavior Composite Standard Score
NCT01474746 (28) [back to overview]Sensory Processing Measure-Preschool (SPM-P) Social Participation: Raw Score
NCT01474746 (28) [back to overview]Sensory Processing Measure - Preschool (SPM-P) Social Participation: Raw Score
NCT01474746 (28) [back to overview]Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score
NCT01474746 (28) [back to overview]Change in Mullen Scales of Early Learning - Expressive Language Standard T Score
NCT01474746 (28) [back to overview]Change in Mullen Scales of Early Learning - Expressive Language Raw Score
NCT01474746 (28) [back to overview]Visual Analog Scale
NCT01474746 (28) [back to overview]Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score
NCT01474746 (28) [back to overview]Mullen Scales of Early Learning - Visual Reception Raw Score
NCT01474746 (28) [back to overview]Mullen Scales of Early Learning - Visual Reception Raw Score
NCT01474746 (28) [back to overview]Mullen Scales of Early Learning - Visual Reception Age-equivalent Score
NCT01474746 (28) [back to overview]Sensory Profile - Sensation Seeking Subscale Raw Score
NCT01474746 (28) [back to overview]The Autism Diagnostic Observation Schedule (ADOS-2)
NCT01474746 (28) [back to overview]The Visual Analog Scale
NCT01474746 (28) [back to overview]Autism Diagnostic Observation Schedule
NCT01524133 (2) [back to overview]Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
NCT01524133 (2) [back to overview]Patient Health Questionnaire-15
NCT01607593 (3) [back to overview]Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation
NCT01607593 (3) [back to overview]Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation
NCT01607593 (3) [back to overview]Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation
NCT01703039 (5) [back to overview]Number of Patients Experiencing an Antidepressant Response (>50% Reduction in HDRS) at Endpoint of 8 Weeks
NCT01703039 (5) [back to overview]Number of Patients Experiencing Remission From Depression (HDRS<7) at Endpoint of 8 Weeks
NCT01703039 (5) [back to overview]Mean Change in Clinical Global Impression (CGI) Scale From Baseline (0 Weeks) to Endpoint at 8 Weeks
NCT01703039 (5) [back to overview]Mean Change in Hamilton Anxiety Rating Scale (HARS) Score From Baseline (0 Weeks) to Endpoint at 8 Weeks
NCT01703039 (5) [back to overview]Mean Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline (0 Weeks) to Endpoint at 8 Weeks
NCT01794455 (2) [back to overview]Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16)
NCT01794455 (2) [back to overview]Montgomery-Asberg Depression Rating Scale
NCT01802385 (8) [back to overview]Center for Epidemiologic Studies in Depression (CES-D) Scale
NCT01802385 (8) [back to overview]Event Free Survival
NCT01802385 (8) [back to overview]Safety (Occurence of Adverse Events)
NCT01802385 (8) [back to overview]Survival
NCT01802385 (8) [back to overview]Fungal Clearance as Determined by Early Fungicidal Activity of CDF
NCT01802385 (8) [back to overview]Number of Participants Experiencing IRIS OR Relapse
NCT01802385 (8) [back to overview]Count of Participants With Cerebrospinal Fluid Sterility
NCT01802385 (8) [back to overview]Quantitative Neurocognitive Performance Score (QNPZ-8)
NCT01896934 (3) [back to overview]Change in Clinician-rated Depression Severity
NCT01896934 (3) [back to overview]Remission of Depression
NCT01896934 (3) [back to overview]Change in Patient-rated Depression Severity
NCT01916824 (1) [back to overview]Money Earned
NCT01943435 (3) [back to overview]Self Paced Walking Test (SPWT)
NCT01943435 (3) [back to overview]Sense Wear Armband
NCT01943435 (3) [back to overview]Swiss Spinal Stenosis (SSS) Questionnaire Score
NCT01993017 (3) [back to overview]Cost of Health Care Utilization
NCT01993017 (3) [back to overview]Depression-free Days
NCT01993017 (3) [back to overview]Quality-Adjusted Life Years (QALYs)
NCT02137369 (2) [back to overview]Number of Remission From Major Depressive Episode Events
NCT02137369 (2) [back to overview]Number of Response to Treatment Events
NCT02189213 (1) [back to overview]Clinical Global Impression-Improvement (CGI-I) Score
NCT02235064 (11) [back to overview]Reported Infant Weight at 12 Weeks Following Delivery
NCT02235064 (11) [back to overview]Number of Participants With Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital
NCT02235064 (11) [back to overview]Number of Participants With Perceived Infant Feeding Difficulties 12 Weeks Postpartum
NCT02235064 (11) [back to overview]Number of Participants With Perceived Infant Feeding Difficulties 4 Weeks Postpartum
NCT02235064 (11) [back to overview]Number of Participants With Perceived Infant Feeding Difficulties 8 Weeks Postpartum
NCT02235064 (11) [back to overview]Number of Participants With Perceived Infant Sleeping Difficulty at 12 Weeks Postpartum
NCT02235064 (11) [back to overview]Number of Participants With Development of Postpartum Depression up to 12 Weeks Following Discharge From Hospital
NCT02235064 (11) [back to overview]Reported Infant Weight at 4 Weeks Following Delivery
NCT02235064 (11) [back to overview]Reported Infant Weight at 8 Weeks Following Delivery
NCT02235064 (11) [back to overview]Number of Participants With Perceived Infant Sleeping Difficulty at 4 Weeks Postpartum
NCT02235064 (11) [back to overview]Number of Participants With Perceived Infant Sleeping Difficulty at 8 Weeks Postpartum
NCT02358343 (15) [back to overview]Serum Phosphorus Level
NCT02358343 (15) [back to overview]Satisfaction With Life Scale
NCT02358343 (15) [back to overview]GAD-7
NCT02358343 (15) [back to overview]SF-36 Energy/Vitality
NCT02358343 (15) [back to overview]Sheehan Disability Scale
NCT02358343 (15) [back to overview]BDI-II
NCT02358343 (15) [back to overview]Exercise
NCT02358343 (15) [back to overview]Global Quality of Life Scale
NCT02358343 (15) [back to overview]Number of Participants Who Accepted Depression Treatment
NCT02358343 (15) [back to overview]Number of Participants Who Initiated Depression Treatment
NCT02358343 (15) [back to overview]Perceived Social Support
NCT02358343 (15) [back to overview]Percent Inter-dialytic Weight Gain
NCT02358343 (15) [back to overview]Percentage of Dialysis Treatment Sessions Skipped and/or Shortened
NCT02358343 (15) [back to overview]PSQI
NCT02358343 (15) [back to overview]QIDS-C Score
NCT02385799 (15) [back to overview]Change in Mullen Scales of Early Learning - Combined Age Equivalent Score
NCT02385799 (15) [back to overview]Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score
NCT02385799 (15) [back to overview]Change in Mullen Scales of Early Learning - Expressive Language Raw Score
NCT02385799 (15) [back to overview]Visual Analog Scale - Language/Communication Score
NCT02385799 (15) [back to overview]Visual Analog Scale - Language/Communication Score
NCT02385799 (15) [back to overview]Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score
NCT02385799 (15) [back to overview]Sensory Processing Measure-Preschool - Social Participation Raw Score
NCT02385799 (15) [back to overview]Sensory Processing Measure-Preschool - Social Participation Raw Score
NCT02385799 (15) [back to overview]Preschool Language Scale-Fifth Edition - Total Language Raw Score
NCT02385799 (15) [back to overview]Preschool Language Scale-Fifth Edition - Total Language Raw Score
NCT02385799 (15) [back to overview]Preschool Anxiety Scale-Revised - Total Score
NCT02385799 (15) [back to overview]Preschool Anxiety Scale-Revised - Total Score
NCT02385799 (15) [back to overview]Clinical Global Impression Scale-Severity (CGI-S)
NCT02385799 (15) [back to overview]Clinical Global Impression Scale-Improvement (CGI-I)
NCT02385799 (15) [back to overview]Clinical Global Impression Scale-Improvement (CGI-I)
NCT02417064 (16) [back to overview]Change From Baseline in Generalized Anxiety Disorder-7 Item (GAD-7) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])
NCT02417064 (16) [back to overview]Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 of Double- Blind Induction Phase- Mixed- Effects Model Using Repeated Measures (MMRM) Analysis
NCT02417064 (16) [back to overview]Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis
NCT02417064 (16) [back to overview]Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis
NCT02417064 (16) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis
NCT02417064 (16) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis
NCT02417064 (16) [back to overview]Percentage of Participants With Onset of Clinical Response by Day 2 and Day 8
NCT02417064 (16) [back to overview]Percentage of Participants Who Achieved at Least 50% Reduction From Baseline in MADRS Total Score at the Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)
NCT02417064 (16) [back to overview]Percentage of Participants Who Achieved at Least 50% Reduction From Baseline in MADRS Total Score at Day 28 of Double-blind Induction Phase (Observed Data)
NCT02417064 (16) [back to overview]Percentage of Participants in Remission (MADRS<=12) at the Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis (LOCF Data)
NCT02417064 (16) [back to overview]Percentage of Participants in Remission (MADRS<=12) at Day 28 of Double-blind Induction Phase (Observed Data)
NCT02417064 (16) [back to overview]Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score up to Endpoint (Double-blind Induction Phase [Day 28])
NCT02417064 (16) [back to overview]Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis
NCT02417064 (16) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): EQ-VAS
NCT02417064 (16) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): Health Status Index
NCT02417064 (16) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): Sum Score
NCT02418585 (16) [back to overview]Change From Baseline in Generalized Anxiety Disorder (GAD-7) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])
NCT02418585 (16) [back to overview]Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 in the Double-blind Induction Phase- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis
NCT02418585 (16) [back to overview]Percentage of Participants Who Achieved >=50% Reduction From Baseline in MADRS Total Score at the Endpoint (Double-blind Induction Phase [Day 28])
NCT02418585 (16) [back to overview]Change From Baseline in EQ 5D-5L-Health Status Index to End of Double-blind Induction Phase (Day 28)
NCT02418585 (16) [back to overview]Percentage of Participants in Response (SDS Total Score <=12 and Individual Item Scores Each <=4) at the End of 4-Week Double-blind Induction Phase (Day 28)
NCT02418585 (16) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis
NCT02418585 (16) [back to overview]Percentage of Participants in Remission (SDS Total Score <=6 and Individual Item Scores Each <=2) at the End of 4-Week Double-blind Induction Phase (Day 28)
NCT02418585 (16) [back to overview]Percentage of Participants in Remission (MADRS<=12) at the Endpoint (Double-blind Induction Phase [Day 28])
NCT02418585 (16) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis
NCT02418585 (16) [back to overview]Change From Baseline in Patient Health Questionnaire - 9-Item Depression Module (PHQ-9) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis
NCT02418585 (16) [back to overview]Percentage of Participants With Onset of Clinical Response on Day 2 and Day 8
NCT02418585 (16) [back to overview]Change From Baseline in Patient Health Questionnaire - 9-Item Depression Module (PHQ-9) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis
NCT02418585 (16) [back to overview]Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])
NCT02418585 (16) [back to overview]Change From Baseline in EQ 5D-5L- European Quality of Life - Visual Analogue Scale (EQ-VAS) to End of Double-blind Induction Phase (Day 28)
NCT02418585 (16) [back to overview]Change From Baseline in EQ 5D-5L- Sum Score to End of Double-blind Induction Phase (Day 28)
NCT02418585 (16) [back to overview]Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis
NCT02422186 (8) [back to overview]Percentage of Participants Who Achieved >=50% Reduction From Baseline in MADRS Total Score at Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)
NCT02422186 (8) [back to overview]Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis
NCT02422186 (8) [back to overview]Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis
NCT02422186 (8) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): Sum Score
NCT02422186 (8) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): EQ-VAS
NCT02422186 (8) [back to overview]Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis on Ranks
NCT02422186 (8) [back to overview]Percentage of Participants in Remission (MADRS<=12) at Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)
NCT02422186 (8) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): Health Status Index
NCT02473783 (3) [back to overview]The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed)
NCT02473783 (3) [back to overview]Hamilton Depression Rating Scale (HAM-D) Total Scores
NCT02473783 (3) [back to overview]Safety Assessments - the Tolerability of Injection of I-123-ADAM Solution
NCT02493868 (18) [back to overview]Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in Sheehan Disability Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Time to Relapse in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Time to Relapse in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in PHQ-9 Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in Clinical Global Impression-Severity Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in EQ-5D-5L EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Sum Score at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level Sum Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in Generalized Anxiety Disorder-7 Items (GAD-7) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in Generalized Anxiety Disorder-7 Items Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02497287 (34) [back to overview]Percentage of Participants With Response as Assessed by PHQ-9 Total Score During IND Phase
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in Clinical Global Impression of Severity (CGI-S) Scale Score During IND Phase
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in CGI-S Scale Score During OP/MA Phase
NCT02497287 (34) [back to overview]Change From Baseline in Sheehan Disability Scale Total Score During OP/MA Phase
NCT02497287 (34) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Total Score During IND Phase
NCT02497287 (34) [back to overview]Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Total Recall
NCT02497287 (34) [back to overview]Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Recognition Discrimination Index
NCT02497287 (34) [back to overview]Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Number of Words Recalled
NCT02497287 (34) [back to overview]Percentage of Participants With an Increase Score From Predose at Any Time in Clinician-Administered Dissociative States Scale (CADSS) Total Score During IND Phase
NCT02497287 (34) [back to overview]Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT02497287 (34) [back to overview]Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders
NCT02497287 (34) [back to overview]Percentage of Participants With Remission as Assessed by MADRS Total Score During IND Phase
NCT02497287 (34) [back to overview]Percentage of Participants With Remission as Assessed by PHQ-9 Total Score During IND Phase
NCT02497287 (34) [back to overview]Percentage of Participants With Response as Assessed by MADRS Total Score During IND Phase
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in GAD-7 Total Score During OP/MA Phase
NCT02497287 (34) [back to overview]Percentage of Participants With Treatment-Emergent Acute Hypertension (Systolic and Diastolic) During IND and OP/MA Phases
NCT02497287 (34) [back to overview]Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Delayed Recall
NCT02497287 (34) [back to overview]Change From Baseline in Cognitive Test Battery: One Card Learning Test (OCL) Score
NCT02497287 (34) [back to overview]Change From Baseline in Cognitive Test Battery: One Back Test (ONB) Score
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in PHQ-9 Total Score During OP/MA Phase
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in Patient Health Questionnaire - 9 (PHQ-9) Total Score During IND Phase
NCT02497287 (34) [back to overview]Change From Baseline in Cognitive Test Battery: Identification Test (IDN) Score
NCT02497287 (34) [back to overview]Change From Baseline in Cognitive Test Battery: Groton Maze Learning Test (GMLT) Score
NCT02497287 (34) [back to overview]Change From Baseline in Cognitive Test Battery: Detection Test (DET) Score
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in Montgomery Asberg Depression Rating Scale (MADRS) Total Score During Induction (IND) Phase
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in MADRS Total Score During Optimization/Maintenance (OP/MA) Phase
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in Generalized Anxiety Disorder (GAD-7) Total Score During IND Phase
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During OP/MA Phase: Sum Score
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During IND Phase: Sum Score
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in EQ-5D-5L Score During OP/MA Phase: EQ-VAS
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in EQ-5D-5L Score During IND Phase: EQ-VAS
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in EQ-5D-5L Scale Score During OP/MA Phase: Health Status Index
NCT02497287 (34) [back to overview]Percentage of Participants With an Increase Score From Predose at Any Time in CADSS Total Score During OP/MA Phase
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in EQ-5D-5L Scale Score During IND Phase: Health Status Index
NCT02504931 (2) [back to overview]Percent Heavy Drinking Days
NCT02504931 (2) [back to overview]PTSD (Post Traumatic Stress Disorder) Symptom Score From PCL (Patient Monitoring Checklist)
NCT02655354 (13) [back to overview]Number of Participants Endorsing a Single Item That Assesses Stimulant Use
NCT02655354 (13) [back to overview]Number of Participants Endorsing a Single Item That Assesses Opioid Use
NCT02655354 (13) [back to overview]Number of Participants Endorsing a Single Item That Assesses Marijuana Use
NCT02655354 (13) [back to overview]Cognitive Impairment Scale
NCT02655354 (13) [back to overview]Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury
NCT02655354 (13) [back to overview]Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury
NCT02655354 (13) [back to overview]Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury
NCT02655354 (13) [back to overview]Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury
NCT02655354 (13) [back to overview]Brief Pain Inventory
NCT02655354 (13) [back to overview]TSOS Patient Satisfaction: Overall Health Care
NCT02655354 (13) [back to overview]TSOS Patient Satisfaction: Mental Health Care
NCT02655354 (13) [back to overview]SF-36 Quality of Life
NCT02655354 (13) [back to overview]Number of Participants With Suicidal Ideation
NCT02777372 (4) [back to overview]Acoustic Startle Response (ASR) Magnitude Based on Menstrual Cycle Phase
NCT02777372 (4) [back to overview]Impact of Sertraline on ASR Magnitude
NCT02777372 (4) [back to overview]Interleukin 6 (IL-6) Level
NCT02777372 (4) [back to overview]Tumor Necrosis Factor Alpha (TNF-alpha) Level
NCT02797808 (2) [back to overview]CY-BOCS Total Score at 12-weeks
NCT02797808 (2) [back to overview]Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses
NCT02901249 (3) [back to overview]Number of Participants With Response to Treatment
NCT02901249 (3) [back to overview]Quality of Life -WHOQOL Intrument Scores
NCT02901249 (3) [back to overview]Number of Participants With Remission to Treatment
NCT02917122 (3) [back to overview]Change of Hamilton Rating Scale for Depression Among Different Weeks
NCT02917122 (3) [back to overview]Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks
NCT02917122 (3) [back to overview]Change of Taiwanese Depression Questionnaire Among Different Weeks
NCT02918097 (3) [back to overview]Number of Participants With Remission to Treatment
NCT02918097 (3) [back to overview]"Number of Participants With Response to Treatment"
NCT02918097 (3) [back to overview]Quality of Life Instrument Scores
NCT03002012 (8) [back to overview]Number of Laboratory Grade 3-5 Adverse Events
NCT03002012 (8) [back to overview]Adherence to Study Drug
NCT03002012 (8) [back to overview]Prevalence of Depression by Patient Health Questionnaire (PHQ-9) Over Time
NCT03002012 (8) [back to overview]6-month Survival
NCT03002012 (8) [back to overview]6 Month Meningitis-free Survival
NCT03002012 (8) [back to overview]Cumulative Incidence of Symptomatic Cryptococcal Meningoencephalitis
NCT03002012 (8) [back to overview]All-Cause Premature Study Drug/Placebo Discontinuation
NCT03002012 (8) [back to overview]Number of Clinical Adverse Events (Grade 3-5)
NCT03033069 (1) [back to overview]Change From Baseline in Clinician-Administered Post-traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5) Total Score
NCT03342963 (4) [back to overview]Cmax of Aripiprazole and Sertraline in Cohort 2
NCT03342963 (4) [back to overview]AUC168h of Aripiprazole and Sertraline in Cohort 2
NCT03342963 (4) [back to overview]Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1
NCT03342963 (4) [back to overview]Area Under the Plasma Concentration Versus Time Curve 168h (AUC168h) of Aripiprazole in Cohort 1
NCT03434041 (12) [back to overview]Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score to the End of Double-blind Treatment Phase (Day 28)
NCT03434041 (12) [back to overview]Percentage of Participants With Onset of Clinical Response
NCT03434041 (12) [back to overview]Percentage of Participants in Remission at the End of Double-blind Treatment Phase (Day 28)
NCT03434041 (12) [back to overview]Change From Baseline in Participant-Reported Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to the Endpoint (Double-blind Treatment Phase [Day 28]): Sum Score
NCT03434041 (12) [back to overview]Change From Baseline in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score up to the Endpoint (Double-blind Treatment Phase [Day 28])
NCT03434041 (12) [back to overview]Change From Baseline in Depressive Symptoms as Measured by the MADRS Total Score to 24 Hours Post First Dose (Day 2)
NCT03434041 (12) [back to overview]Percentage of Participants With Sustained Remission
NCT03434041 (12) [back to overview]Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score up to the Endpoint (Double-blind Treatment Phase [Day 28])
NCT03434041 (12) [back to overview]Change From Baseline in Participant-Reported Health-Related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score up to the Endpoint (Double-blind Treatment Phase [Day 28]): Health Status Index
NCT03434041 (12) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Total Score to the End of Double-blind Treatment Phase (Day 28)
NCT03434041 (12) [back to overview]Change From Baseline in Participant-Reported Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score up to the Endpoint (Double-blind Treatment Phase [Day 28]): Visual Analogue Scale (VAS)
NCT03434041 (12) [back to overview]Percentage of Responders at the End of Double-blind Treatment Phase (Day 28)
NCT04094870 (12) [back to overview]Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study
NCT04094870 (12) [back to overview]Percentage of Women Experiencing Anti Depressant Medication Toxicity
NCT04094870 (12) [back to overview]Number of Women Pre-Screened Who Have an EPDS Score >/= 6
NCT04094870 (12) [back to overview]Number of Women Retained in the Study
NCT04094870 (12) [back to overview]Number of Women Approached Who Agreed to Pre-Screening With EPDS
NCT04094870 (12) [back to overview]Acceptability of Trial Participation for Treatment of Postpartum Depression
NCT04094870 (12) [back to overview]Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)
NCT04094870 (12) [back to overview]Changes in the Viral Load Between Study Entry and the Last Visit
NCT04094870 (12) [back to overview]Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)
NCT04094870 (12) [back to overview]Number of Women With a CGI Score Decline of One Point From Baseline
NCT04094870 (12) [back to overview]Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI
NCT04094870 (12) [back to overview]Number of Women With an EPDS Score Decline of 3 Points From Baseline
NCT04476030 (16) [back to overview]Change From Baseline in the HAMD-17 Total Score Over the Double-Blind Treatment Period
NCT04476030 (16) [back to overview]Percentage of Participants With MADRS Remission at Day 15
NCT04476030 (16) [back to overview]Percentage of Participants With TEAEs, Graded by Severity
NCT04476030 (16) [back to overview]Percentage of Participants With MADRS Response at Day 15
NCT04476030 (16) [back to overview]Change From Baseline in HAM-A Total Score at Day 15
NCT04476030 (16) [back to overview]Change From Baseline in Depressive Symptoms at Day 15, as Assessed by PHQ-9
NCT04476030 (16) [back to overview]Change From Baseline in CGI-S Score at Day 15
NCT04476030 (16) [back to overview]Change From Baseline in the HAMD-17 Total Score at Day 3
NCT04476030 (16) [back to overview]Change From Baseline in MADRS Total Score at Day 15
NCT04476030 (16) [back to overview]Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
NCT04476030 (16) [back to overview]Time to First HAMD-17 Response
NCT04476030 (16) [back to overview]Percentage of Participants With HAMD-17 Remission at Day 15 and Day 42
NCT04476030 (16) [back to overview]Change From Baseline in the HAMD-17 Total Score at Days 15 and 42
NCT04476030 (16) [back to overview]Percentage of Participants With HAMD-17 Response at Day 15 and Day 42
NCT04476030 (16) [back to overview]Percentage of Participants With CGI-I Response, at Day 3 and Day 15
NCT04476030 (16) [back to overview]Change From Baseline in the HAMD-17 Total Score Around End of Blinded Treatment

HAMILTON Rating Scale for DEPRESSION Range

Hamilton scale range 0-40, values below 7 are considered normal. the higher the number the more severe the depression weekly assessments, The primary outcome is a comparison of the baseline Hamilton to the 12 week measurement (NCT00000378)
Timeframe: BASELINE COMPARED TO 12 WEEK MEASUREMENT

,
Interventionunits on a scale (Mean)
BASELINE12 WEEK DATA
Nortriptyline27.18.4
Sertaline27.310.7

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Hamilton Rating Scale for Depression-17 Item

Hamilton Rating Scale for Depression (HRSD) (Hamilton, 1960). We used the 17-item version of the 27-item HRSD, a measure of depression severity. The Structured Interview Guide was used to conduct the interviews (SIGH-D; Williams, 1988). The reliability and validity of the HRSD are well documented (Rabkin & Klein, 1987). Interjudge reliability as assessed by interclass correlations was .92 in our sample. Total 17-item scores could range from 17-48 with higher scores indicating greater distress. (NCT00043550)
Timeframe: symptoms assessed during past 7 days, measure taken at baseline, week 8 and week 16

,,
Interventionunits on a scale (Mean)
Initial HRSD-17Mid-treatment HRSD-17LOCF HRSD-17
1 Sertraline19.013.914.2
2 Supportive-expressive Psychotherapy19.912.514.5
3 Pill Placebo19.412.714.3

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Clinical Global Impression - Improvement Scale

The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1-Very much improved; 2-Much improved; 3-Minimally improved; 4-No change; 5-Minimally worse; 6-Much worse; 7-Very much worse. Response rates are reported as a percentage of participants who score 1-Very much improved; 2-Much improved on the The Clinical Global Impression - Improvement scale. (NCT00052078)
Timeframe: Measured at Week 12

Interventionpercentage of participants (Number)
1 Setraline54.9
2 CBT59.7
3 Combination Setraline and CBT80.7
4 Placebo23.7

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Remission of Depression Hamilton Depression Scale (Ham-D) and Psychosis Schedule for Affective Disorders in Schizophrenia - Delusional Item (SADS) During the Course of the Trial

"Remission was defined as scores on Ham-D of less than 10 at two consecutive assessments and the absence of delusions (measured as SADS delusional item scores of 1) at the second assessment of the two-assessment remission of depression interval.~Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression. Scores on SADS range from 1 to 7 with higher scores indicating the delusions(s) more adversely effect the subject's behavior." (NCT00056472)
Timeframe: Weeks 1 to 12

Interventionparticipants (Number)
Pharmacotherapy54
Monotherapy31

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Scores on CGI-S Compared to Baseline Over the Course of the Trial

A measure of overall symptom severity, the Clinical Global Impressions, Severity of Illness Scale (CGI-S). It is a seven point scale with a one indicating not at all ill, and seven indicating the most extremely ill. This rating was done each week after baseline by the PI at each site after visiting with the patient. (NCT00056472)
Timeframe: Weeks 1 to 12

Interventionunits on CGI scale (Mean)
Pharmacotherapy2.24
Monotherapy2.48

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Mean Score Hamilton Depression Rating Scale (Ham-D) Over the Course of the Trial From Week to Week.

The Ham-D measures depression severity. Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression. (NCT00056472)
Timeframe: Weeks 1 to 12

InterventionScores on Ham-D (Mean)
Pharmacotherapy13.27
Monotherapy16.63

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Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

"OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 - 20), and a composite symptom severity score (0 to 40).~Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure." (NCT00074815)
Timeframe: Measured at baseline and Week 12.

InterventionProportion of Participants with RESPONSE (Number)
MM + CBT0.69
MM + ICBT0.34
MM Only0.30

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Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo

"Symptoms of depression (as measured by the Hamilton Depression Rating Scale, HDRS) in congestive heart failure patients with clinical depression after treatment with sertraline or placebo.~The 17-item Hamilton Depression Rating Scale (HDRS) is a rater-administered assessment of depression severity, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). Change in depression was measured as the difference between the 12-week HDRS scores and the baseline HDRS scores. Thus, a negative value reflects an improvement in depressive symptoms over the 12-week period." (NCT00078286)
Timeframe: Measured at Week 12

InterventionHDRS Change Score (Mean)
Sertraline-7.1
Placebo-6.8

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Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo.

Composite cardiovascular scores are calculated for each participant using recorded cardiac events, morbidity/mortality, rehospitalization, and discontinuation due to cardiovascular events. Composite score is compared for sertraline and placebo treatment groups. (NCT00078286)
Timeframe: Measured at Week 12

,
Interventionpercentage of participants (Number)
Cardiovascular Status WorsenedCardiovascular Status ImprovedCardiovascular Status Unchanged
Placebo31.143.825.1
Sertraline29.940.629.5

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Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC)

"At each study visit, based on patient examination and caregiver interview, clinicians rated overall impression of clinical change from baseline using the modified Alzheimer's Disease Cooperative Study Clinical Global Impression of Change index (mADCS-CGIC), which in addition to the original scale incorporates a global rating of mood and associated symptoms of depression. The mADCS-CGIC uses a seven-point Likert scale, with scores ranging from 1 (much better) to 7 (much worse), with a score of 4 being no change." (NCT00086138)
Timeframe: Measured at Week 12

,
Interventionparticipants (Number)
"much worse""worse""a bit worse""no change""a bit better""better""much better"
Placebo0291118213
Sertraline1561018189

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Remission According to Cornell Scale for Depression in Dementia Scale

The Cornell Scale for Depression in Dementia (CSDD), a 19-item scale measuring the severity of depression in dementia, utilizing input from both the caregiver and the participant. CSDD scores were imputed for 2 participants for week 2, 4 participants for week 4, 7 participants for week 8, and 12 participants for week 12. (NCT00086138)
Timeframe: Measured at Weeks 12

Interventionpercentage of participants (Number)
Sertraline33
Placebo19

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Beck Depression Inventory-II

Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment. (NCT00116857)
Timeframe: Measured at Baseline and 10 weeks

Interventionunits on a scale (Mean)
Sertraline Plus Omega-3 Supplement16.1
Sertraline/Corn Oil14.8

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Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6)

This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87. (NCT00118417)
Timeframe: Measured at baseline and after Phase 1 (6 weeks)

InterventionPoints on a scale (Mean)
Moderate Sertraline Treatment4.3

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Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24)

This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87. (NCT00118417)
Timeframe: Measured after Phase 2 (Week 12) and Phase 3 (Week 24)

InterventionPoints on a scale (Mean)
Medication Optimization3.78
Augmented Cognitive Behavior Therapy2.9

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Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12)

This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87. (NCT00118417)
Timeframe: Measured after Phase 1 (Week 6) and Phase 2 (Week 12)

InterventionPoints on a scale (Mean)
Increased Sertraline2.36
Sertraline Plus Placebo2.31

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Depression Symptoms

Hamilton Depression Rating Scale (HAMD), total score, scoring range 0-50, with higher scores more severe depression (NCT00127673)
Timeframe: Measured at Post-Treatment, at 10 weeks

Interventionunits on a scale (Mean)
CBT no Choice10.33
CBT Choice12.13
Sertraline no Choice15.24
Sertraline Choice12.11

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PTSD Symptoms

total score, range from 0-80, higher scores are more severe (NCT00127673)
Timeframe: Post-treatment, ten weeks

Interventionunits on a scale (Mean)
CBT no Choice10.02
CBT Choice10.87
Sertraline no Choice15.12
Sertraline Choice10.78

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Quality of Life Functioning

Sheehan Disability Scale (SDS), total score, scoring range 0-30 , higher scores indicative of worse functional impairment (NCT00127673)
Timeframe: Measured at Post-Treatment, at 10 weeks

Interventionunits on a scale (Mean)
CBT no Choice8.82
CBT Choice11.68
Sertraline no Choice14.06
Sertraline Choice10.78

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State Anxiety

State-Trait Anxiety Inventory - State version, total score, scoring range, 0-63, with higher scores more severe (NCT00127673)
Timeframe: Measured at Post-Treatment, at 10 weeks

Interventionunits on a scale (Mean)
NoChoice_CBT39.16
Choice_CBT38.79
NoChoice_SER46.89
Choice_SER38.72

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Davidson Trauma Scale (DTS)

The DTS is a 17-item self-report scale measuring each Diagnostic and Stastical Manual of Mental Disorders-4th Edition (DSM-IV) symptom of post-traumatic stress disorder (PTSD) on 5-point frequency (0-not at all to 4-everyday) and severity (0-not at all distressing to 4-extremely distressing) scales. The highest possible score is 136 and relates to the worst outcome. (NCT00159965)
Timeframe: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)

,
Interventionunits on a scale (Mean)
BaselineExit
Placebo48.143.4
Sertraline52.540.3

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Dissociative Experiences Scale (DES)

"The DES is a 28 item self-report questionnaire designed to quantify dissociative experiences which identifies disturbances in memory, identity, cognition, derealization, depersonalization, absorption and imagination. A visual analogue scale is used ranging from 0% (This never happens to you) to 100% (This always happens to you). The score is divided by 28 items to yield a range of 0 to 100%, with a higher score relating to a higher degree of dissociation." (NCT00159965)
Timeframe: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)

,
Interventionunits on a scale (Mean)
BaselineExit
Placebo17.412.1
Sertraline21.08.5

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Global Assessment of Functioning (GAF)

This GAF rating scale ranges from 0 (worst) to 100 (best) and is used for evaluating the overall functioning of a subject during a specified time period on a continuum from psychological or psychiatric sickness to health. (NCT00159965)
Timeframe: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)

,
InterventionUnits on a scale (Mean)
BaselineExit
Placebo49.152.0
Sertraline53.356.8

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Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)

"The LIFE-RIFT interview is a brief semi-structured interview, which measures functional impairment, targeting four domains: work, interpersonal relations, recreation and global satisfaction. Work, recreation and global satisfaction are rated on a 1 (very good/ no impairment) to 5 (very poor/ severe impairment) scale, and interpersonal relations is rated on a 1 (very good) to 7 (variable) scale. The highest score possible is 20 and relates to a more severe impairment. The lowest possible score is 3." (NCT00159965)
Timeframe: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)

,
InterventionUnits on a scale (Mean)
BaselineExit
Placebo13.913.8
Sertraline11.811.8

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Modified Hamilton Depression Scale (MHRS)

"The MHRS assesses the severity of Depression-related symptoms from 0 (not present) to 2, 3 or 4 (severe) on each question. The highest possible score is 72, relating to the worst outcome." (NCT00159965)
Timeframe: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)

,
Interventionunits on a scale (Mean)
BaselineExit
Placebo16.813.3
Sertraline17.811.6

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Number of Nonepileptic Seizures (NES)

psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar; aggregated into biweekly intervals. (NCT00159965)
Timeframe: bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12

,
Interventionseizures (Median)
Baseline (retrospective 2 weeks prior)Week 2 (prospectively collected from day 1-14)Week 4Week 6Week 8Week 10Week 12
Placebo6.06.05.03.03.07.06.0
Sertraline5.03.02.01.01.02.50.0

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Oxford Handicap Scale (OHS)

"The OHS is a brief clinician scored assessment of symptoms and lifestyle interference and the 6 grades of disability are based on the modified Rankin Scale, ranging from 0 (no symptoms) to 5 (severe handicap). A higher score relates to a worse outcome." (NCT00159965)
Timeframe: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)

,
InterventionUnits on a scale (Mean)
BaselineExit
Placebo3.42.6
Sertraline3.12.3

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Symptom Checklist 90 (SCL-90)

"The SCL-90 is a 90 item self-report clinical rating scale oriented toward symptomatic behavior of outpatients, assessing from 0 (not at all bothered) to 4 (extremely bothered). The highest possible overall score is 360 and relates to a worse outcome." (NCT00159965)
Timeframe: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)

,
InterventionUnits on a scale (Mean)
BaselineExit
Placebo109.491.4
Sertraline84.978.9

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Clinical Global Impressions - Improvement (CGI-I)

"The CGI-I is the second item of a two item global rating scale, where each item is on a 7 point scale ranging from very much improved (1) to very much worse (7). A lower score represents a higher improvement." (NCT00159965)
Timeframe: Weeks 2, 6, 10

InterventionUnits on a scale (Mean)
Sertraline2.9
Placebo3.5

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Family Assessment Device (FAD)

"The FAD is a 60 item self-report questionnaire designed to assess the six dimensions of the McMaster Model of Family Functioning, as well as overall level of family functioning through the General Functioning Scale. Each question is scored on a 1 to 4 scale, with a higher mean score relating to a worse general functioning." (NCT00159965)
Timeframe: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)

,
InterventionGeneral Functioning Subscale Score (Mean)
BaselineExit
Placebo2.02.2
Sertraline2.02.0

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Barratt Impulsivity Scale (BIS)

"The BIS is a 30 item self-report measure that characterizes four aspects of impulsiveness, and ranges from rarely/ never to almost always with a score of 1 to 4 possible on each question, giving a maximum possible score of 120 and minimum possible score of 30. Selected questions are reversed scored. Higher scores relate to a worse outcome." (NCT00159965)
Timeframe: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)

,
InterventionUnits on a scale (Mean)
BaselineExit
Placebo72.666.2
Sertraline57.864.9

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Beck Depression Inventory-II (BDI-II)

"The BDI-II assesses depression severity from 0 (no Depression-related symptom) to 3 (severe) on each question. The highest possible score is 51, relating to the worst outcome." (NCT00159965)
Timeframe: bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12

,
InterventionUnits on a scale (Mean)
BaselineExit
Placebo22.117.0
Sertraline16.711.7

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Quality of Life in Epilepsy-31 (QOLIE-31)

This is a 31-item self-report scale used in the seizure population to evaluate Quality of Life. The lowest possible score is 0 and the highest possible score is 100, reflecting a better quality of life. (NCT00159965)
Timeframe: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)

,
InterventionUnits on a scale (Mean)
BaselineExit
Placebo38.246.9
Sertraline48.456.7

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Clinical Global Impressions - Severity (CGI-S)

"The CGI-S is the first item of a two-item global rating scale, where each item is on a 7 point scale ranging from normal (1) to among the most extremely ill patients (7). A higher score relates to a higher severity of illness." (NCT00159965)
Timeframe: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)

,
InterventionUnits on a scale (Mean)
BaselineExit
Placebo5.13.9
Sertraline4.93.3

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Diagnostic Interview for Children and Adolescents (DICA) - Child

The DICA is a semi-structured interview, and was used to measure Post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to children who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined. (NCT00182078)
Timeframe: Baseline to Week 24

Interventionunits on a scale (Mean)
Placebo-3.8
Sertraline-4.7

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The Child Depression Inventory (CDI)

The CDI contains 27 items, and measures symptoms of depression in children and adolescents. The CDI ranges in score from 0-54, where higher scores are indicative of a greater number of symptoms. Changes in scores from Baseline to Week 12 were examined. (NCT00182078)
Timeframe: Baseline to Week 12

Interventionunits on a scale (Mean)
Placebo-7.5
Sertraline-2.4

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Diagnostic Interview Schedule for Children and Adolescents (DICA) - Parent

The DICA is a semi-structured interview, and was used to measure post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to parents who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined. (NCT00182078)
Timeframe: Baseline to Week 24

Interventionunits on a scale (Mean)
Placebo-0.2
Sertraline-4.0

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Brief Social Phobia Scale(BSPS)

An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items. (NCT00215150)
Timeframe: Baseline, 8 and 16 weeks

,,
Interventionunits on a scale (Mean)
Beginning of Study PhaseEnd of Study Phase
Open Label Phase44.031.2
Randomization Phase for Placebo Group31.824.6
Randomization Phase for Ziprasidone Group31.821.0

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BAI

The Beck Anxiety Inventory (BAI) is a 21-item self-report measure that assesses subjective, somatic, or panic-related symptoms associated with anxiety rated on a scale from 0 (not at all) to 3(severely). Total score: 0-7 = minimal level of anxiety, 8-15 = mild anxiety, 16-25 = moderate anxiety, and 26-63 = severe depression (NCT00233103)
Timeframe: Immediately post-intervention

Interventionunits on a scale (Mean)
Sertraline11.1
Placebo13.1

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Life-3

Life-3 is a single-item Quality of life (QOL) measure that uses a 7-point Likert-type scale to assess satisfaction with life during the past month. It is typically administered twice during an evaluation, and the mean of the 2 obtained scores is used. Higher scores on this measure indicate higher levels of subjective QOL. Range from 1 to 7. (NCT00233103)
Timeframe: Immediately post-intervention at 10 weeks

Interventionunits on a scale (Mean)
Sertraline6.3
Placebo4.9

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Depression at End of Treatment

"Self-report of depression and Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) diagnosis (HAM-D score) compared at end of treatment to baseline. Participants were considered treatment responders if their initial HAM-D decreased by 50% or dropped below a score of 10 at the end of the intervention.~The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression." (NCT00233103)
Timeframe: end of treatment, average of 10 weeks

Interventionunits on a scale (Mean)
Sertraline13.7
Placebo16.2

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Depression at Baseline

"The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression.~Self-report of depression and DSM-IV diagnosis (HAM-D score) at baseline." (NCT00233103)
Timeframe: baseline

Interventionunits on a scale (Mean)
Sertraline27.5
Placebo25.2

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Geriatric Depression Scale

This is a depression severity rating scale measuring symptoms of depression. Scale is from 0 (no depression symptoms) up to a maximum of 15 (severe depression symptoms). (NCT00245557)
Timeframe: baseline at study entry week 0

InterventionUnits on a scale (Mean)
Healthy Controls (Baseline)0.6
Depressed (Baseline)9.1

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Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)

"The primary outcome is a phosphorus magnetic resonance spectroscopy (31P-MRS) signal quantified using a spectral time-domain fitting program based on the Marquadt-Levenberg non-linear, least-squares algorithm, that incorporates prior knowledge of spectral peak assignments, chemical shifts and J-coupling constants. Least squares means were calculated for average total signal using linear mixed effects models. Results are expressed as a spectroscopic index.~beta-nucleoside triphosphate (bNTP) Phosphocreatine (PCr) Total nucleoside triphosphate (NTP)" (NCT00245557)
Timeframe: at week 0 for both control and depressed, and at week 12 for depressed

,,
InterventionSpectroscopic Index (Least Squares Mean)
bNTPPCrTotal NTP
Depressed (Baseline).0397.0512.1420
Healthy Controls (Baseline).0432.0496.1509
Post-treatment Depressed.0410.0515.1396

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HAM-D 17 (Hamilton Depression Rating Scale)

"This is a depression severity rating scale measuring symptoms of depression including mood, sleep, appetite, energy, motivation, guilt, suicidal ideation, concentration, physical complaints, paranoia, anxiety, effect on daily functioning and awareness of illness.~Scale is from 0 (no depression symptoms) up to a maximum of 66 (severe depression symptoms)." (NCT00245557)
Timeframe: baseline at study entry week 0

InterventionUnits on a scale (Mean)
Healthy Controls (Baseline)1.0
Depressed (Baseline)18.5

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Heavy Drinking Days/Week

(NCT00262223)
Timeframe: Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up

,
InterventionDays/Week (Mean)
BaselineEnd-of-treatment6-month12-month
1) Seeking Safety + Sertraline3.131.05.860.30
2) Seeking Safety + Placebo2.890.480.750.24

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PTSD Symptom Severity / Clinician Administered PTSD Scale

Clinician Administered PTSD Scale (CAPS) is a 17-item, semi-structured interview of PTSD symptoms. Range of scores is 0-136. Five rationally derived severity score ranges for interpreting CAPS total score have been proposed: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and >80 = extreme PTSD symptomology (Weathers et. al., 2001). A 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change (Weathers et. al., 2001). (NCT00262223)
Timeframe: Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up

,
Interventionunits on a scale (Mean)
BaselineEnd-of-treatment6-month12-month
1) Seeking Safety + Sertraline65.5036.2530.0924.90
2) Seeking Safety + Placebo59.5041.8837.4631.82

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Post-treatment Social Phobia Severity as Defined by Endpoint LSAS Scores

The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). We analyzed the overall change in LSAS (last Phase II LSAS minus Week 10 LSAS). Higher numbers reflect greater drops in social anxiety disorder severity. Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology. (NCT00282828)
Timeframe: Change from Week 10 to Week 22

Interventionunits on a scale (Mean)
Sertraline and Clonazepam27
Venlafaxine18
Sertraline and Placebo16

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Rates of Remission (LSAS≤30) After 12 Weeks of Randomized Treatment During Phase II, Among Phase I Non-responders

The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology. (NCT00282828)
Timeframe: Measured at Week 22 (Endpoint)

Interventionparticipants (Number)
Sertraline and Clonazepam17
Venlafaxine11
Sertraline and Placebo10

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Interleuken 6 (IL-6)

(NCT00302068)
Timeframe: Baseline, 16 weeks

,,
Interventionpg/ml (Mean)
Baseline16 Week
Placebo Control1.951.85
Sertraline (Zoloft)1.72.1
Supervised Aerobic Exercise1.981.80

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Heart Rate Variability (HRV)

HRV is the variation in the time interval between heart beats. ECG was recorded for 24 hours on a 3-channel digital compact ash Holter recorder. During the recording period, patients engaged in their normal patterns of activity. ECG data were downloaded and edited using the Pathfinder digital ambulatory ECG analyzer (DelMar Reynolds, lrvine, California) and HRV was estimated from the standard deviation of all normal R-R intervals (SDNN) (NCT00302068)
Timeframe: Baseline, 16 weeks

,,
Interventionmillisecond (Mean)
Baseline16 Weeks
Placebo Control123112
Sertraline (Zoloft)120118
Supervised Aerobic Exercise116122

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C-reactive Protein (CRP)

(NCT00302068)
Timeframe: Baseline, 16 weeks

,,
Interventionug/ml (Mean)
Baseline16 Week
Placebo Control2.42.5
Sertraline (Zoloft)2.52.5
Supervised Aerobic Exercise2.52.1

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Percent Change in Flow Mediated Dilation (FMD)

Endothelial function assessed by flow mediated dilation (FMD). Brachial artery FMD was assessed following overnight fasting. Longitudinal B-mode ultrasound images of the brachial artery, 4-6 cm proximal to the antecubital crease, were obtained using an Aeuson (Mountain View, California) Aspen ultrasoundplatformwith an 11MHZ linear array transducer. lmages were obtained after 10 min of supine relaxation and during reactive hyperemia, induced following in ation of a forearm pneumatic occlusion cuff to supra-systolic pressure (~200 mmHg) for 5 minutes. FMD was defined as the maximum percent change inarterial diameter relative to restingbaseline from 10-120 sec post-deflation of the occlusion cuff. (NCT00302068)
Timeframe: Baseline, 16 weeks

Interventionpercentage change (Number)
Supervised Aerobic Exercise0.2
Sertraline (Zoloft)0.9
Placebo Control0

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Hamilton Depression Rating Scale

The Hamilton Depression Rating Scale ranges from 0 to 52, with lower scores reflecting lower levels of depression and higher scores greater severity of depression. (NCT00302068)
Timeframe: Measured at 16 weeks

InterventionRaw changes in Ham-D scores (Mean)
Supervised Aerobic Exercise-7.5
Sertraline (Zoloft)-6.1
Placebo Control-4.5

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Baroreflex Sensitivity (BRS)

(NCT00302068)
Timeframe: Baseline, 16 weeks

,,
Interventionmsec/mmHg (Mean)
BaselineWeek 16
Placebo Control4.94.1
Sertraline (Zoloft)4.75.1
Supervised Aerobic Exercise4.84.0

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Platelet Factor 4

(NCT00302068)
Timeframe: Baseline, 16 weeks

,,
InterventionIU/ml (Mean)
Baseline16 Week
Placebo Control32.034.4
Sertraline (Zoloft)34.134.0
Supervised Aerobic Exercise44.135.5

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21 Item Hamilton Depression Rating Scale

The scale rates 21 symptoms related to major depression. A total score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Total scores range from a minimum of 0(not ill) to a maximum of 64 (severely ill). (NCT00340379)
Timeframe: 12 week

InterventionUnits on Hamilton Depression Scale (Mean)
Ziprasidone13.6
Sertraline/Haloperidol11.0

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Clinical Global Impression Improvement Scale

A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Overall the scale goes from a minimum of 1(very much improved) to a maximum of 7(very much worse). (NCT00340379)
Timeframe: 12 weeks

Interventionunits on a Clinical Impressions Scale (Mean)
Ziprasidone3.1
Sertraline/Haloperidol2.5

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Brief Psychiatric Rating Scale at 12 Weeks

A rating scale used to measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behaviour. Each symptom is rated 1-7 and in this version a total of 24 symptoms are scored. Thus the total range of scores is from a minimum of 24 to a maximum of 168. Lower scores are considered better, so the minimum total score of 24 indicates someone with no psychiatric symptoms, while any score over 40 is considered at least moderately severe, with only the most severely ill patients scoring over 60. (NCT00340379)
Timeframe: 12 weeks

Interventionunits on a Psychiatric Rating scale (Mean)
Ziprasidone28.7
Sertraline/Haloperidol25.8

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Number of Days of Heavy Drinking (Defined as Days on Which Women Drank >= 4 Drinks and Men Drank >= 5 Drinks)

Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as heavy drinking days. (NCT00368550)
Timeframe: 12-week treatment period

Interventiondays (Mean)
Sertraline31.9
Placebo26.4

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Number of Days on Which Subjects Drank

Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as drinking days. (NCT00368550)
Timeframe: 12-week treatment period

Interventiondays (Mean)
Sertraline37.0
Placebo33.8

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Psychotic Symptoms

Psychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms. (NCT00531518)
Timeframe: two years

Interventionunits on a scale (Mean)
Control9.2
Family-aided Assertive Community Treatment6.7

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Adverse Events

A measurement of frequency of adverse events by random assignment (NCT00536198)
Timeframe: Baseline through Cycle 6

,
Interventionparticipants (Number)
NauseaDiarrheaHeadacheInsomniaFatigueMouth drynessDifficulty concentratingAnxiety, agitationDiaphoresisDizziness/lightheadedness
Placebo35221422151381069
Sertraline151419914596106

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Clinical Global Impressions-Improvement (CGI-I)

The Clinical Global Impressions-Improvement (CGI-I) scale is a 7-point scale with 7 being the least improvement. (NCT00536198)
Timeframe: Cycle 1 to Cycle 6

,
Interventionunits on a scale (Mean)
Cycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Average change from Cycle 1
Placebo3.22.72.42.52.12.2-0.8
Sertraline2.72.42.32.12.01.8-0.9

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Clinical Global Severity (CGI-S)

Clinical Global Impressions-Severity is measured on a scale of 1-7, with 7 as most severe. (NCT00536198)
Timeframe: Baseline through Cycle 6

,
Interventionunits on a scale (Mean)
BaselineCycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Average change from baseline
Placebo4.53.83.33.02.92.72.5-1.9
Sertraline4.53.43.12.82.62.42.2-2.3

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DRSP

DRSP (Daily Rating of Severity Problems) is composed of 21 items reflecting the 11 candidate symptoms for PMDD according to DSM IV and DSM V. Each symptom is scored 1-6. A diagnosis of PMDD requires a minimum average luteal phase score of greater than or equal to 3 (mild) for at least 5 PMDD symptoms during the five most symptomatic of the final seven luteal phase days and the first two days of menses onset, and we require that the average follicular phase score not be >2 on these same items. The minimum score is 0 and maximum is 126 for the total score. A higher score indicates greater severity of symptoms. (NCT00536198)
Timeframe: Baseline to Cycle 6

,
Interventionunits on a scale (Mean)
BaselineCycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Average change from baseline
Placebo59.546.144.440.736.935.236.1-22.4
Sertraline60.343.738.736.835.331.732.2-29.7

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DRSP Anger/Irritability Subscale

Anger/irritability included anger/irritability and conflicts with people. Symptoms were scored on a scale 1-6. The range is 0 to 12 with a higher score indicating greater symptom severity. (NCT00536198)
Timeframe: Baseline to Cycle 6

,
Interventionunits on a scale (Mean)
BaselineCycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Average change from baseline
Placebo6.34.64.54.03.83.53.5-2.8
Sertraline6.44.13.53.33.22.92.8-3.7

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DRSP Depression Subscale

Depressive symptoms included: felt depressed, felt hopeless, felt worthless or guilt, slept more, trouble sleeping, felt overwhelmed. Symptoms were scored on a scale of 1-6 The score range is 0-36 with higher indicating greater severity. (NCT00536198)
Timeframe: Baseline to Cycle 6

,
Interventionunits on a scale (Mean)
BaselineCycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Average change from baseline
Placebo7.25.74.94.64.34.24.2-2.7
Sertraline7.55.54.84.64.33.93.9-4.0

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DRSP Physical Subscale

Physical symptoms included breast tenderness, bloating, headache, joint or muscle pain. Symptoms were scored on a scale of 1-6. The severity range is 0-24 with 24 being more symptomatic. (NCT00536198)
Timeframe: Baseline to Cycle 6

,
Interventionunits on a scale (Mean)
BaselineCycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Average change from baseline
Placebo10.68.48.88.17.37.17.4-2.9
Sertraline10.68.48.27.87.46.96.9-4.2

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Inventory of Depression Symptoms (IDS-C)

Inventory of Depressive Symptomatology-Clinician version (IDS-C) - a depression measure that has 28 items and detects appropriate variations between follicular and luteal phases in subjects with PMDD. Min score is 0, max is 84.Lower score is less symptomatic. (NCT00536198)
Timeframe: Measured from baseline to Cycle 6

,
Interventionunits on a scale (Mean)
BaselineCycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Average change from baseline
Placebo32.824.022.819.619.116.717.8-15.3
Sertraline35.423.721.019.217.315.215.5-20.0

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Michelson SSRI Withdrawal Checklist

Michelson SSRI Withdrawal Checklist - 16-item (not exactly 17-item, mood swings and crying were in DRSP) including dizziness, nausea, unusual dreams, chills, increased sweating, loose stools, agitation, ringing or noises in the ears. Items were summed for 3 days after pill-taking ended for each menstrual cycle.Scale is 0-80 for total range of the scale with lower less severe. There are no units (NCT00536198)
Timeframe: Measured from Cycle 1 to Cycle 6

,
Interventionunits on a scale (Mean)
Cycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6
Placebo68.175.271.765.462.176.2
Sertraline72.973.470.362.363.967.5

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Number of Days Pills Were Taken

The number of days that pills were taken on. (NCT00536198)
Timeframe: Measured from Cycle 1 to Cycle 6

,
Interventionnumber of days (Mean)
Cycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Average Change from Cycle 1
Placebo6.66.77.16.96.76.1-0.3
Sertraline6.57.48.27.07.66.90.3

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Premenstrual Tension Scale (PMTS)

The PMTS is a 10-item scale constructed to study premenstrual syndromes. It is sensitive to change with treatment. It includes items of irritability-hostility, tension, efficiency, dysphoria, motor coordination, mental-cognitive functioning, eating habits, social impairment, sex drive, and physical symptoms. PMTS-O or PMTS-SR? Min=0 (asymptomatic), Max=40 (Highly symptomatic), higher scores indicate most severe problems (NCT00536198)
Timeframe: Measured from baseline to Cycle 6

,
Interventionunits on a scale (Mean)
BaselineCycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Average change from baseline
Placebo21.416.815.614.013.912.412.8-8.9
Sertraline22.315.614.113.012.911.411.7-10.6

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Number of Symptomatic Days Before Pills Were Taken

"Symptomatic days were those that participant experienced at least 3 symptoms at a severity of at least 3, which is a mean of at least mild." (NCT00536198)
Timeframe: Cycle 1 to Cycle 6

,
Interventiondays (Mean)
Cycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Average Change from Cycle 1
Placebo2.62.72.02.01.82.0-1.0
Sertraline2.82.01.92.01.91.7-0.7

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Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)

Measure total ranges from 1 to 5, with lower scores indicating better outcomes. (NCT00602355)
Timeframe: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up

,,
Interventionunits on a scale (Mean)
BaselinePost-Treatment3-Month Follow-up6-Month Follow-up
1 (Placebo)2.72.42.32.3
2 (Sertraline)2.72.22.12.1
3 (IPT)2.62.32.32.2

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Depression Illness Severity Based on Beck Depression Inventory (BDI)

Measure total ranges from 0 to 56, with lower scores indicating better outcomes. (NCT00602355)
Timeframe: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up

,,
Interventionunits on a scale (Mean)
BaselinePost-Treatment3-Month Follow-up6-Month Follow-up
1 (Placebo)26.210.88.59.2
2 (Sertraline)27.010.07.35.1
3 (IPT)25.910.510.77.8

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Global Illness Severity Based on Clinical Global Impression (CGI) Scale

Measure total ranges from 1 to 7, with lower scores indicating better outcomes. (NCT00602355)
Timeframe: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up

,,
Interventionunits on a scale (Mean)
BaselinePost-treatment3-Month Follow-up6-Month Follow-up
1 (Placebo)4.12.11.91.7
2 (Sertraline)4.02.01.81.7
3 (IPT)3.92.02.01.8

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Hamilton Anxiety Rating Scale (HARS)

Measure total ranges from 0 to 56, with lower scores indicating better outcomes. (NCT00602355)
Timeframe: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up

,,
Interventionunits on a scale (Mean)
BaselinePost-Treatment3-Month Follow-up6-Month Follow-up
1 (Placebo)20.99.97.47.5
2 (Sertraline)20.39.46.66.2
3 (IPT)19.48.37.07.3

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Hamilton Depression Rating Scale (HAM-D)

Measure total ranges from 0 to 50, with lower scores indicating better outcomes. (NCT00602355)
Timeframe: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up

,,
Interventionunits on a scale (Mean)
BaselinePost-Treatment3-Month Follow-up6-Month Follow-up
1 (Placebo)22.08.86.76.5
2 (Sertraline)21.88.15.84.9
3 (IPT)22.08.27.36.1

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Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt)

Number of participants with responders of Sertraline to determine whether present or past history of intentional suicidal ideation (including suicide attempt) is significant factor (NCT00605813)
Timeframe: Baseline up to 52 weeks

Interventionparticipants (Number)
Past History of Intentional Suicidal Ideation29
Present History of Intentional Suicidal Ideation63

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Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies

Number of participants with responders of Sertraline to determine whether with or without non-pharmaceutical therapies is significant factor (NCT00605813)
Timeframe: Baseline up to 52 weeks

Interventionparticipants (Number)
With Non-pharmaceutical Therapies141
Without Non-pharmaceutical Therapies255

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Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not

Number of participants with responders of Sertraline to determine whether 15 years and higher of age or not is significant factor (NCT00605865)
Timeframe: Baseline up to 16 weeks

Interventionparticipants (Number)
15 Years and Higher1508
Under 15 Years1

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Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments.

Number of participants with responders of Sertraline to determine whether with or without complication is significant factor (NCT00605865)
Timeframe: Baseline up to 16 weeks

Interventionparticipants (Number)
With Complications528
Without Complications981

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Factors Considered to Affect the Efficacy of Sertraline: Age

Number of participants with responders of Sertraline to determine whether age is significant factor (NCT00605865)
Timeframe: Baseline up to 16 weeks

Interventionparticipants (Number)
Under 18 Years of Age23
18-44 Years of Age829
45-64 Years of Age412
Over 65 Years of Age245

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Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity

Number of participants with responders of Sertraline to determine whether target disease severity is significant factor (NCT00605865)
Timeframe: Baseline up to 16 weeks

Interventionparticipants (Number)
Mild416
Moderate1000
Severe93

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Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient

Number of participants with responders of Sertraline to determine whether outpatient or inpatient is significant factor (NCT00605865)
Timeframe: Baseline up to 16 weeks

Interventionparticipants (Number)
Inpatient99
Outpatient1410

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Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride

Number of participants with responders of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline hydrochloride is significant factor (NCT00605865)
Timeframe: Baseline up to 16 weeks

Interventionparticipants (Number)
With History of Treatment Prior to Sertraline398
Without History of Treatment Prior to Sertraline1046

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Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt)

Number of participants with responders of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant factor (NCT00605865)
Timeframe: Baseline up to 16 weeks

Interventionparticipants (Number)
With Suicidal Ideation (Including Suicide Attempt)319
Without Suicidal Ideation (Including Suicide Attempt)1136

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Factors Considered to Affect the Efficacy of Sertraline: Complication

Number of participants with responders of Sertraline to determine whether with or without complication is significant factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.) (NCT00605917)
Timeframe: Baseline up to 52 weeks

Interventionparticipants (Number)
With Complications246
Without Complications535

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Factors Considered to Affect the Efficacy of Sertraline: Drinking Status

Number of participants with responders of Sertraline to determine whether drinking status is significant factor (NCT00605917)
Timeframe: Baseline up to 52 weeks

Interventionparticipants (Number)
Didn't Drink Alcohol at All, and Had Never Drunk Alcohol171
Drank Alcohol Very Occasionally312
Used to Drink Alcohol But Did Not Then23
Drank Alcohol Moderately118
Drank Alcohol Every Day53

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Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug

Number of participants with responders of Sertraline to determine whether with or without concomitant drug is significant factor (NCT00605917)
Timeframe: Baseline up to 52 weeks

Interventionparticipants (Number)
With Concomitant Drug565
Without Concomitrant216

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Dyadic Adjustment Scale (DAS)

The DAS is a self-report measure of marital adjustment that includes questions about agreement on lifestyle and household decisions, level of conflict, level of cooperation, and affection. Scores range from 0 to 151, with higher scores representing better relationship functioning. (NCT00612807)
Timeframe: pre-treatment, monthly, post-treatment, 6 month follow-up

,
InterventionScore on DAS measure (Mean)
Baseline assessment (Depressed spouse)Post-test assessment (Depressed spouse)Follow-up assessment (Depressed spouse)Baseline assessment (Non-depressed spouse)Post-test assessment (Non-depressed spouse)Follow-up assessment (Non-depressed spouse)
Semi-weekly Medication Management72.1484.1789.6791.093.33104.17
Semi-weekly Medication Management + Weekly Marital Therapy84.4392.2791.0788.2997.5798.31

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Hamilton Depression Rating Scale (HDRS)

The HDRS is a semi-structured interview administered by a trained independent evaluator, and used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression. (NCT00612807)
Timeframe: pre-treatment, monthly, post-treatment, 6 month follow-up

,
InterventionScore on HDRS (Mean)
Baseline assessment (Depressed spouse)Post-test assessment (Depressed spouse)Follow-up assessment (Depressed spouse)Baseline assessment (Non-depressed spouse)Post-test assessment (Non-depressed spouse)Follow-up assessment (Non-depressed spouse)
Semi-weekly Medication Management17.865.009.175.145.333.83
Semi-weekly Medication Management + Weekly Marital Therapy19.07.298.148.863.295.71

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HbA1C (%)

Change in HbA1C (%) at month 0 and month 6 (NCT00624013)
Timeframe: Month 0 and month 6

,
InterventionPercentage of glycosylated hemoglobin (Mean)
HbA1C (%) Month 0HbA1C (%) Month 6
Placebo9.78.8
Sertraline10.08.0

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Quality of Life

Quality of life (QOL) was assed at baseline and at month 6 using validated instrument Diabetes-39 Quality of Life Questionnaire. It consists of 39-item questionnaire designed to help us learn more about what affects the quality of life of people with diabetes in five dimensions of patients' lives: Diabetes Control, Anxiety and Worry, Social Burden, Sexual Functioning and Energy and Mobility. The Diabetes-39 questionnaire uses a Not Affected At All -Extremely Affected point scale score ranging from 1-7. Raw scale scores were transformed to a 0-100 scale using a linear transformation. Higher values represent a worse outcome. Overall rating of Quality-of-Life was assessed using a Lowest quality-Highest quality scale ranging from 1-7. Higher values represent an increase or improvement in overall QOL. Pattern of Diabetes Severity was measured with a Not Severe at all-Extremely Severe scale ranging from 1-7. Higher values represent increase in diabetes severity. (NCT00624013)
Timeframe: Month 0 and month 6

,
Interventionunits on a scale (Mean)
Overall Quality of Life at Month 0Overall Quality of Life at month 6Diabetes Severity at Month 0Diabetes Severity at Month 6Diabetes Control at Month 0Diabetes Control at Month 6Anxiety and Worry at Month 0Anxiety and Worry at Month 6Social Burden at Month 0Social Burden at Month 6Sexual Function at Month 0Sexual Function at Month 6Energy and Mobility at Month 0Energy and Mobility at Month 6
Placebo3.04.06.05.066.755.776.761.963.750.466.661.163.149.7
Sertraline (Zoloft)3.55.06.05.069.649.878.857.168.243.867.856.767.644.6

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Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites

Thrice-weekly urine samples were analyzed for the presence of cocaine/cocaine metabolite. Days to Relapse was defined as time to the second of two urine results consecutively positive for cocaine. (NCT00654953)
Timeframe: 70 days

InterventionDays to relapse (two consec coc+ urines) (Mean)
Placebo19.93
Sertraline23.38
Sertraline Plus Gabapentin17.27

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Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure)

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

Interventionunits on a scale (Least Squares Mean)
Duloxetine-5.99
Selective Serotonin Reuptake Inhibitor (SSRI)-5.49

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Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure)

"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

Interventionunits on a scale (Least Squares Mean)
Duloxetine-9.01
Selective Serotonin Reuptake Inhibitor (SSRI)-8.16

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Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure)

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

Interventionunits on a scale (Least Squares Mean)
Duloxetine-9.21
Selective Serotonin Reuptake Inhibitor (SSRI)-8.40

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Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint

Mean change from baseline to endpoint in systolic blood pressure (NCT00666757)
Timeframe: Baseline, 12 Weeks

Interventionmillimeters of mmercury (mmHg) (Least Squares Mean)
Duloxetine0.58
Selective Serotonin Reuptake Inhibitor (SSRI)0.55

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Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]

Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score [TS]NCT00666757)
Timeframe: 12 weeks

InterventionProbability of remission (Least Squares Mean)
Duloxetine0.36
Selective Serotonin Reuptake Inhibitor (SSRI)0.32

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Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure)

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

Interventionunits on a scale (Least Squares Mean)
Duloxetine-4.51
Selective Serotonin Reuptake Inhibitor (SSRI)-3.94

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Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure)

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

Interventionunits on a scale (Least Squares Mean)
Duloxetine-4.52
Selective Serotonin Reuptake Inhibitor (SSRI)-3.85

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Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure)

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

Interventionunits on a scale (Least Squares Mean)
Duloxetine-4.69
Selective Serotonin Reuptake Inhibitor (SSRI)-4.04

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Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint

"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

Interventionunits on a scale (Least Squares Mean)
Duloxetine24.56
Selective Serotonin Reuptake Inhibitor (SSRI)20.73

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Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure)

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

Interventionunits on a scale (Least Squares Mean)
Duloxetine-4.89
Selective Serotonin Reuptake Inhibitor (SSRI)-4.24

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Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]

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

InterventionProbability of response (Least Squares Mean)
Duloxetine0.73
Selective Serotonin Reuptake Inhibitor (SSRI)0.61

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Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]

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

InterventionProbability of response (Least Squares Mean)
Duloxetine0.71
Selective Serotonin Reuptake Inhibitor (SSRI)0.64

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Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint

Mean change from baseline to endpoint in diastolic blood pressure (NCT00666757)
Timeframe: Baseline, 12 Weeks

InterventionmmHg (Least Squares Mean)
Duloxetine-0.14
Selective Serotonin Reuptake Inhibitor (SSRI)0.45

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Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure)

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

Interventionunits on a scale (Least Squares Mean)
Duloxetine-1.83
Selective Serotonin Reuptake Inhibitor (SSRI)-1.43

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Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint

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

Interventiondollars (Least Squares Mean)
Duloxetine-3978.98
Selective Serotonin Reuptake Inhibitor (SSRI)-1932.46

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Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint

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

Interventionhours lost per week (Least Squares Mean)
Duloxetine-9.56
Selective Serotonin Reuptake Inhibitor (SSRI)0.41

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Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint

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

Interventiondollars (Least Squares Mean)
Duloxetine7250.93
Selective Serotonin Reuptake Inhibitor (SSRI)5074.09

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Change From Baseline in Weight at Week-12 Endpoint

Mean change from baseline to endpoint in weight (NCT00666757)
Timeframe: Baseline, 12 Weeks

Interventionkilograms (kg) (Least Squares Mean)
Duloxetine-0.32
Selective Serotonin Reuptake Inhibitor (SSRI)-0.17

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Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)

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

Interventionunits on a scale (Least Squares Mean)
Duloxetine-13.4
Selective Serotonin Reuptake Inhibitor (SSRI)-12.6

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Change From Baseline in Pulse Rate at Week-12 Endpoint

Mean change from baseline to endpoint in pulse rate (NCT00666757)
Timeframe: Baseline, 12 Weeks

Interventionbeats per minute (bpm) (Least Squares Mean)
Duloxetine2.74
Selective Serotonin Reuptake Inhibitor (SSRI)0.47

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Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure)

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

Interventionunits on a scale (Least Squares Mean)
Duloxetine-2.77
Selective Serotonin Reuptake Inhibitor (SSRI)-2.58

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Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint]

Visitwise percentages of participants meeting remission criteria HAMD-17 total score [TS] NCT00666757)
Timeframe: 12 weeks

InterventionProbability of remission (Least Squares Mean)
Duloxetine0.53
Selective Serotonin Reuptake Inhibitor (SSRI)0.44

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Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure)

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

Interventionunits on a scale (Least Squares Mean)
Duloxetine-2.95
Selective Serotonin Reuptake Inhibitor (SSRI)-2.39

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Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure)

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

Interventionunits on a scale (Least Squares Mean)
Duloxetine-13.56
Selective Serotonin Reuptake Inhibitor (SSRI)-11.53

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Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)

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

Interventionunits on a scale (Least Squares Mean)
Duloxetine-17.03
Selective Serotonin Reuptake Inhibitor (SSRI)-15.3

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Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase

Panic and Agoraphobia Scale has 13 items with a 5-point scale (range: 0 to 4). The total possible score is ranged from 0 to 52. The increasing value are considered worse outcome. The scale is grouped into 5 subscores (not including item U in total score): panic attacks ; agoraphobia/avoidance behavior ; anticipatory anxiety; disability; and health worries. Four point difference in reduction of the PAS total score has been identified as not clinically meaningful in the assessment of Panic Disorder symptomatology. (NCT00677352)
Timeframe: Baseline and 12 weeks

InterventionScores on scale (Least Squares Mean)
Sertraline-17.4
Paroxetine-17.0

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Mean Change From Baseline in Panic Attack at the End of Treatment Phase

Panic attacks were defined as having four or more of the following Diagnostic and Statistical Manual of Mental Disorders symptoms. Palpitations or increased heart rate, Sweating, Trembling or shaking, Shortness of breath or smothering sensations, Choking, Chest pain or discomfort, Nausea or upset stomach, Dizziness, unsteady feelings or faintness, Feeling unlike yourself, or detached from a situation and/or like things happening around you are strange and unreal, Fear of going crazy or doing something uncontrolled, Fear of dying, Abnormal sense, Hot flashes or chills. (NCT00677352)
Timeframe: Baseline and 12 weeks

Interventionpanic attacks per week (Mean)
Sertraline-4.07
Paroxetine-4.59

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Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement

"The ratings were rated to compare with baseline by 7-point 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.~Responder was defined as number of participants who were assessed as very much improved or much improved." (NCT00677352)
Timeframe: 12 weeks

InterventionPercentage of participants (Number)
Sertraline83.5
Paroxetine85.0

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Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase

The percentage of participants divided was calcurated as follows: Devide the number of participants who had experienced new symptoms in Week 16, regardless of causal relationship with the study drug, or worsening of the severity in Week 16 compared with Week 12, by total number of participants in each treatment group. (NCT00677352)
Timeframe: 4 weeks

InterventionPercentage of participants (Number)
Sertraline59.7
Paroxetine76.3

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Number of Participants With Summary of Adverse Events in Treatment Phase

Number of sparticipants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants were counted only once per treatment in each row. (NCT00677352)
Timeframe: 1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug

,
InterventionParticipants (Number)
Subjects with adverse eventsSubjects with serious adverse eventsSubjects with severe adverse eventsSubjects discontinued due to adverse eventsDose reduced or temporary discontinuation
Paroxetine1341142314
Sertraline127131413

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Summary of Adverse Events in Tapering Phase

Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects were counted only once per treatment in each row. (NCT00677352)
Timeframe: 4 weeks

,
InterventionParticipants (Number)
Subjects with adverse eventsSubjects with serious adverse eventsSubjects with severe adverse eventsSubjects discontinued due to adverse eventsDose reduced or temporary discontinuation
Paroxetine8701640
Sertraline7311110

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Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase

"The Hamilton Anxiety Rating Scale provided a 5-point intensity rating (0=None to 4=Very severe) of anxiety symptoms in 14 items.~The increasing values are considered worse outcome. The total possible score is ranged from 0 to 52." (NCT00677352)
Timeframe: Baseline and 12 weeks

InterventionScores on a scale (Mean)
Sertraline-11.35
Paroxetine-10.36

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Comparisons of End of Study HAM-A Score Means for Sertraline 50 mg vs Placebo, Sertraline 100 mg vs Placebo, and Sertraline 50 mg vs. Sertraline 100 mg

Least squares (LS) means estimate and p-value from mixed effects model with baseline and site as covariates and Tukey-Kramer adjustment for multiple comparisons Hamilton Rating Scale for Anxiety (HAM-A) is a widely used rating scale for anxiety describes the presence/absence of the severity of anxiety symptoms. It's clinician-rated scale of 14 items rated from 0-4. Generally, total score of <17 is mild anxiety; 18-24 is mild to moderate, and 25 and up is moderate to severe. (NCT00701675)
Timeframe: 11 weeks from baseline

Interventionunits on a scale (Least Squares Mean)
Sertraline 50mg10.638
Sertraline 100mg10.008
Placebo9.357

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Iowa Gambling Task Score

The Iowa Gambling Task (IGT) evaluates decision making ability. During IGT subjects have to choose between decks of cards which yield high immediate gain but larger future loss (i.e., long term loss), and decks which yield lower immediate gain but a smaller future loss (i.e., a long term gain). The task consists of four decks of cards: A, B, C, and D. The goal in the task is to maximize profit. Subjects are required to make a series of card selections. The decks A and B are long term loss decks and the decks C and D are long term gain decks. The IGT Score reported is the combination of the raw score for each deck combined in the following way: (C+D) - (A+B). The range for this score is: -100 to 100. Higher values of this score indicate better decision making ability. (NCT00704379)
Timeframe: 6 months after TBI

Interventionunits on a scale (Mean)
Placebo16.67
Sertraline-0.77

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Neuroimaging Variables (i.e., Fractional Anisotropy [FA] of Frontal White Matter Such as the Cingulate Gyrus)

"FA is a measured obtained from Diffusion Tensor Imaging, an image modality of Magnetic Resonance Imaging (MRI). FA is a unitless index. Range: 0 to 1. FA describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is unrestricted or equally restricted in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. In the context of this study, FA measures the integrity of the cingulate gyrus white matter. Higher FA values reflect higher integrity of the cingulate gyrus white matter tract. Average FA values for the right and left cingulate gyri were summed.~One aim of this project was to identify predictors of the occurrence of mood disturbances during the first 6 months following TBI. The hypothesis for this aim was that patients who develop a mood or anxiety disorder six months after TBI present at baseline with lower FA of the cingulate gyrus than those who do not." (NCT00704379)
Timeframe: Baseline

Interventionunitless index (Mean)
Patients Who Developped a Mood or Anxiety Disorder0.91
Patients Who Did Not Developped a Mood or Anxiety Disorder0.94

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Social Functioning Examination Total Score

The Social Functioning Examination (SFE) is a semi-structured interview that measures social functioning in areas such as interpersonal relationships, work adjustment, use of community resources and satisfaction with living environment. Range: 0 to 1. Higher scores denote lower levels of social functioning. (NCT00704379)
Timeframe: 6 months after TBI

Interventionunits on a scale (Mean)
Placebo0.04
Sertraline0.04

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Time to Onset of Diagnostic and Statistical Manual (DSM) IV Defined Mood and Anxiety Disorders Associated With Traumatic Brain Injury (TBI)

"Following the DSM-IV (now updated by the DSM-5), depressive disorders associated with TBI are categorized as Mood Disorder Due to Another Medical Condition with subtypes: 1) With major depressive-like episode (if the full criteria for a major depressive episode [MDE] are met) or 2) With depressive features (prominent depressed mood but full criteria for a MDE are not met); and 3) with mixed features (e.g. significant irritability, pressured speech and formal thought disorder).~On the other hand, bipolar and related disorders due to TBI are subdivided in: 1) with manic or hypomanic like episode; 2) with manic features; and 3) with mixed features.~A similar conceptual framework has been used to define Anxiety Disorder due to another Medical Condition, in this case, TBI. According to DSM-IV/DSM-5, such diagnosis can be made when, besides an evident pathophysiological relationship with TBI, panic attacks or generalized anxiety are the prominent features of the clinical presentation." (NCT00704379)
Timeframe: 6 months after TBI

Interventionweeks (Mean)
Placebo21.4264
Sertraline15.7833

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Total Community Integration Questionnaire Scores

The Community Integration Questionnaire (CIQ) is intended as a brief, reliable measure of an individual's level of integration into the home and community following traumatic brain injury. Total CIQ scores were used as the outcome measure. Range: 0 to 25. Higher scores indicate higher levels of integration into the home and community following TBI. (NCT00704379)
Timeframe: 6 months after TBI

Interventionunits on a scale (Mean)
Placebo16.77
Sertraline17.67

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Memory Function Composite

This outcome measures memory function and is a composite of five standardized scores: Brief Visuospatial Memory Test - Revised, Delayed Recall and California Verbal Learning Test, Short Delay Free Recall Number Correct and Discriminability, and Long Delay Free Recall Number Correct and Discriminability. Standardized scores (i.e., z-scores) for each test of this composite were obtained by subtracting the mean raw score of all participants to the raw score of each participant and dividing the result by the standard deviation of the raw scores of all participants. The composite score was obtained by averaging the z-scores of the four memory tests mentioned previously. Range: -3 to 3. Higher scores represent better memory function. (NCT00704379)
Timeframe: 6 months following traumatic brain injury

Interventionz-scores (Mean)
Placebo-0.08
Sertraline0.07

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To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29

Depression was assessed with the Structured Interview Guide for the Hamilton Depression Rating Scale - Atypical Depression Symptoms Version (SIGH-ADS29). The scale incorporates the 17 and 21-item Hamilton Rating Scales for Depression (HRSD) as well as 8 atypical symptoms of depression. Scores range from 0 to 90, where a higher score corresponds to a higher level of depressive symptomatology. (NCT00744328)
Timeframe: Week 8

Interventionpercentage change in SIGH-ADS29 Score (Mean)
Estradiol-38
Sertraline-49
Placebo-48

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Infant Serum Concentrations of Estradiol in 3 Treatment Arms

As expected due to being stopped and therefore underpowered (NCT00744328)
Timeframe: monthly

Interventionpg/mL (Mean)
Estradiol2.45
Sertraline2.1
Placebo5.59

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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.

CGI-S items are: 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 score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14. (NCT00797966)
Timeframe: Week 8 to Week 14

InterventionUnits on a scale (Least Squares Mean)
OPC-34712 0.15 mg Fixed Dose-0.83
OPC-34712 0.5 ± 0.25 mg Low Dose-0.81
OPC-34712 1.5 ± 0.5 mg High Dose-1.06
Placebo-0.71

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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 15 Score (Satisfaction With Medication).

The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 15 (Satisfaction with Medication) will yield a separate subscore. (NCT00797966)
Timeframe: Week 8 to Week 14

InterventionUnits on a scale (Mean)
OPC-34712 0.15 mg Fixed Dose0.02
OPC-34712 0.5 ± 0.25 mg Low Dose0.01
OPC-34712 1.5 ± 0.5 mg High Dose0.02
Placebo0.00

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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 16 Score (Overall Life Satisfaction).

The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 16 (Overall Life Satisfaction) will yield a separate subscore. (NCT00797966)
Timeframe: Week 8 to Week 14

InterventionUnits on a scale (Mean)
OPC-34712 0.15 mg Fixed Dose0.30
OPC-34712 0.5 ± 0.25 mg Low Dose0.30
OPC-34712 1.5 ± 0.5 mg High Dose0.35
Placebo0.28

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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Score (the Mean of 3 Individual Item Scores).

The Sheehan Disability Scale (SDS) is a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable. (NCT00797966)
Timeframe: Week 8 to Week 14

InterventionUnits on a scale (Least Squares Mean)
OPC-34712 0.15 mg Fixed Dose-0.84
OPC-34712 0.5 ± 0.25 mg Low Dose-0.80
OPC-34712 1.5 ± 0.5 mg High Dose-1.27
Placebo-0.61

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Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.

"The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place." (NCT00797966)
Timeframe: Week 8 to Week 14

InterventionUnits on a scale (Least Squares Mean)
OPC-34712 0.15 mg Fixed Dose-6.62
OPC-34712 0.5 ± 0.25 mg Low Dose-6.46
OPC-34712 1.5 ± 0.5 mg High Dose-8.23
Placebo-6.09

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Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.

"The IDS-SR is a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. 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 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items are recorded. If the number of items was 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." (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14

,,,
InterventionUnits on a scale (Mean)
Week 9 (N=61, 117,116,121)Week 10 (N=62, 119, 118, 126)Week 11 (N=62, 119, 118, 126)Week 12 (N=62, 119, 118, 126)Week 13 (N=62, 119, 118, 126)Week 14 (N=62, 119, 118, 126)
OPC-34712 0.15 mg Fixed Dose-0.98-2.13-3.58-5.11-5.34-5.55
OPC-34712 0.5 ± 0.25 mg Low Dose-1.88-2.58-3.41-3.77-5.22-4.96
OPC-34712 1.5 ± 0.5 mg High Dose-2.04-4.08-4.82-5.77-5.65-6.74
Placebo-0.98-1.62-2.09-2.07-2.37-3.08

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Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.

"The MADRS is utilized as the primary efficacy assessment of a patient's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place." (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12 and 13.

,,,
InterventionUnits on a scale (Mean)
Week 9 (N=61,117,116,121)Week 10 (N=62,119,118,126)Week 11 (N=62,119,118,126)Week 12 (N=62,119,118,126)Week 13 (N=62,119,118,126)
OPC-34712 0.15 mg Fixed Dose-2.13-3.69-5.53-6.97-6.90
OPC-34712 0.5 ± 0.25 mg Low Dose-3.00-3.78-5.71-6.31-6.76
OPC-34712 1.5 ± 0.5 mg High Dose-2.75-4.97-5.88-7.01-7.18
Placebo-2.48-3.64-4.40-4.41-5.47

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Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.

CGI-S items are: 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 score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14. (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12 and 13.

,,,
InterventionUnits on a scale (Mean)
Week 9 (N=62,117,116,121)Week 10 (N=62,119,118,126)Week 11 (N=62,119,118,126)Week 12 (N=62,119,118,126)Week 13 (N=62,119,118,126)
OPC-34712 0.15 mg Fixed Dose-0.21-0.42-0.53-0.76-0.74
OPC-34712 0.5 ± 0.25 mg Low Dose-0.26-0.39-0.53-0.66-0.78
OPC-34712 1.5 ± 0.5 mg High Dose-0.33-0.61-0.69-0.86-0.88
Placebo-0.21-0.40-0.47-0.52-0.59

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Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.

CGI-I items are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI-I was assessed at each visit in Phase B, and improvement is judged with respect to the participant's condition at baseline. CGI-I was also assessed at each visit in Phase B, but in that phase improvement is judged with respect to the partcipant's condition at the end of Phase A. (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14.

,,,
InterventionUnits on a scale (Mean)
Week 9 (N=62, 117, 116, 121)Week 10 (N=62, 119, 118, 126)Week 11 (N=62, 119, 118, 126)Week 12 (N=62, 119, 118, 126)Week 13 (N=62, 119, 118, 126)Week 14 (N=62, 119, 118, 126)
OPC-34712 0.15 mg Fixed Dose3.393.162.942.872.852.74
OPC-34712 0.5 ± 0.25 mg Low Dose3.303.193.022.902.762.78
OPC-34712 1.5 ± 0.5 mg High Dose3.202.952.802.702.642.52
Placebo3.313.112.942.952.902.83

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Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).

CGI-I response is defined as CGI-I of 1 [very much improved] or 2 [much improved]. (NCT00797966)
Timeframe: Week 9, 10, 11, 12, 13 and 14.

,,,
Interventionpercentage of participants (Number)
Week 9 (N=62, 117, 116, 121)Week 10 (N=62, 119, 118, 126)Week 11 (N=62, 119, 118, 126)Week 12 (N=62, 119, 118, 126)Week 13 (N=62, 119, 118, 126)Week 14 (N=62, 119, 118, 126)
OPC-34712 0.15 mg Fixed Dose16.125.832.335.537.138.7
OPC-34712 0.5 ± 0.25 mg Low Dose11.117.629.433.637.037.0
OPC-34712 1.5 ± 0.5 mg High Dose14.724.635.642.449.252.5
Placebo14.927.029.431.733.341.3

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Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).

A MADRS remission was defined as MADRS Total Score /= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit). (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14.

,,,
InterventionPercentage of participants (Number)
Week 9 (N=61, 117, 116, 121)Week 10 (N=62, 119, 118, 126)Week 11 (N=62, 119, 118, 126)Week 12 (N=62, 119, 118, 126)Week 13 (N=62, 119, 118, 126)Week 14 (N=62, 119, 118, 126)
OPC-34712 0.15 mg Fixed Dose3.288.0612.921.019.422.6
OPC-34712 0.5 ± 0.25 mg Low Dose1.715.0410.110.116.815.1
OPC-34712 1.5 ± 0.5 mg High Dose1.7210.214.419.515.323.7
Placebo4.138.7311.110.315.113.5

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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (QLES-Q-SF) Subscale Score - the Overall General Subscore (Sum of First 14 Items).

The Q-LES-Q is a self-report measure to enable physicians to obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. The Overall-General Subscore will be defined by summing the scores on all 14 items and expressing it as the percent of the maximum possible score. When expressing the total score as a percentage, if items are left blank the range will be modified to reflect the number of items scored. Raw score is sum of non-missing ratings from items 1 to 14. Minimum score is number of non-missing items. Maximum score is 5*(minimum score). Range is maximum score minus minimum score. Total score is 100*(Raw score minus minimum score)/ Range, rounded to nearest integer. (NCT00797966)
Timeframe: Week 8 to Week 14

InterventionPercentage of maximum possible score (Least Squares Mean)
OPC-34712 0.15 mg Fixed Dose7.60
OPC-34712 0.5 ± 0.25 mg Low Dose6.53
OPC-34712 1.5 ± 0.5 mg High Dose7.46
Placebo5.92

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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Depression Rating Scale (HAM-D17) Score.

"The HAM-D17 is utilized as a secondary assessment of a participant's level of depression. The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the best rating and the highest score (2 or 4) is the worst rating. The possible total scores are from 0 to 52." (NCT00797966)
Timeframe: Week 8 to Week 14

InterventionUnits on a scale (Least Squares Mean)
OPC-34712 0.15 mg Fixed Dose-5.77
OPC-34712 0.5 ± 0.25 mg Low Dose-5.28
OPC-34712 1.5 ± 0.5 mg High Dose-6.59
Placebo-5.23

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Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).

A MADRS response was defined as >/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit). (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14.

,,,
InterventionPercentage of participants (Number)
Week 9 (N=61, 117, 116, 121)Week 10 (N=62, 119, 118, 126)Week 11 (N=62, 119, 118, 126)Week 12 (N=62, 119, 118, 126)Week 13 (N=62, 119, 118, 126)Week 14 (N=62, 119, 118, 126)
OPC-34712 0.15 mg Fixed Dose4.928.0619.430.624.227.4
OPC-34712 0.5 ± 0.25 mg Low Dose6.848.4015.115.122.720.2
OPC-34712 1.5 ± 0.5 mg High Dose2.5911.018.625.425.434.7
Placebo8.269.5213.511.918.319.8

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Change of Beck Depression Inventory-II Scores Over 16 Weeks

Beck Depression Inventory-II (BDI) scores 0-63, minimum score =0, maximum score =63, Higher scores represent worse outcome. Baseline scores are compared to scores after treatment. (NCT00834652)
Timeframe: Measured at Baseline and 16 Weeks

,
Interventionunits on a scale (Mean)
BDI Change ScoresBDI at BaselineBDI at Week 16
Sertraline Plus Metformin18.8222.683.86
Sertraline Plus Placebo17.5022.034.53

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The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score

CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) (NCT00857584)
Timeframe: baseline, week 2

Interventionscore on a scale (Mean)
Quetiapine Extended Release-1.36
Setraline-1.00

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The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score

HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms) (NCT00857584)
Timeframe: baseline, week 8

Interventionscore on a scale (Mean)
Quetiapine Extended Release-13.1
Setraline-10.6

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The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score

HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms) (NCT00857584)
Timeframe: baseline, week 4

Interventionscore on a scale (Mean)
Quetiapine Extended Release-13.4
Setraline-8.9

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The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score

CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) (NCT00857584)
Timeframe: baseline, week 4

Interventionscore on a scale (Mean)
Quetiapine Extended Release-2.09
Setraline-2.56

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The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) (NCT00857584)
Timeframe: baseline, week 2

Interventionscore on a scale (Mean)
Quetiapine Extended Release-13.1
Setraline-6.6

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Number of Patients With Response at Week 4.

"Number of patients responded to the treatment at week 4, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 4.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 4

InterventionParticipants (Number)
Quetiapine Extended Release8
Setraline6

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The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) (NCT00857584)
Timeframe: baseline, week 1

Interventionscore on a scale (Mean)
Quetiapine Extended Release-9.5
Setraline-8.6

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The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score

CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) (NCT00857584)
Timeframe: baseline, week 1

Interventionscore on a scale (Mean)
Quetiapine Extended Release-0.79
Setraline-1.08

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Number of Patients With Response at Week 8.

"Number of patients responded to the treatment at week 8, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 8.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 8

InterventionParticipants (Number)
Quetiapine Extended Release8
Setraline5

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The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) (NCT00857584)
Timeframe: baseline, week 4

Interventionscore on a scale (Mean)
Quetiapine Extended Release-16.1
Setraline-17.7

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Number of Patients With Response at Week 2

"Number of patients responded to the treatment at week 2, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 2.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 2

InterventionParticipants (Number)
Quetiapine Extended Release8
Setraline2

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Number of Patients With Remission at Week 8.

"Number of patients who achieved remission at week 8, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 8

InterventionParticipants (Number)
Quetiapine Extended Release3
Setraline4

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Number of Patients Response at Week 1

"Number of patients responded to the treatment at week 1, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 1.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 1

InterventionParticipants (Number)
Quetiapine Extended Release4
Setraline4

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Number of Patients With Remission at Week 2.

"Number of patients who achieved remission at week 2, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 2

InterventionParticipants (Number)
Quetiapine Extended Release6
Setraline5

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Number of Patients With Remission at Week 4.

"Number of patients who achieved remission at week 4, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 4

InterventionParticipants (Number)
Quetiapine Extended Release3
Setraline3

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Number of Patients With Remission at Week 1.

"Number of patients who achieved remission at week 1, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 1

InterventionParticipants (Number)
Quetiapine Extended Release6
Setraline5

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The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score

CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 (higher scores indicating a greater clinical severity) (NCT00857584)
Timeframe: baseline, week 8

Interventionscore on a scale (Mean)
Quetiapine Extended Release-2.9
Setraline-2.88

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The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) (NCT00857584)
Timeframe: baseline. week 8

Interventionscore on a scale (Mean)
Quetiapine Extended Release-19.4
Setraline-18.2

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Change in Quality of Life From Baseline to Exit in the Kidney Disease Quality of Life -Short Form, Version 1.3, Patient-reported Overall Health.

Raw scores from version 1.3 were transformed to a scale from 0 to 100, in which higher numbers signify more favorable quality of life. (NCT00946998)
Timeframe: baseline to 12 weeks

Interventionunits on a scale (Median)
Sertraline0.0
Placebo0.0

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Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale

Each item is rated on a 0 to 8 Likert scale with 0 indicating no impairment and 8 indicating severe impairment and a total score range of 0 to 40. (NCT00946998)
Timeframe: baseline to 12 weeks

Interventionunits on a scale (Mean)
Sertraline-5.0
Placebo-3.2

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Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.

The score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression. (NCT00946998)
Timeframe: baseline to 12 weeks

Interventionunits on a scale (Mean)
Sertraline-4.1
Placebo-4.2

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Serious Adverse Events During the 12 Week Study Duration.

death, dialysis initiation, hospitalizations, or bleeding requiring transfusion (NCT00946998)
Timeframe: during 12 week study duration

,
InterventionParticipants (Count of Participants)
DeathDialysis initiationHospitalization other than dialysis initiationacute suicidal intentbleed with transfusion or hospitalization
Placebo05712
Sertraline07802

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Response to Treatment Defined as a Decline of 50% in the Baseline QIDS-C-16 Score and Remission of Depression Defined as a QIDS-C-16 Score of 5

The score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression. (NCT00946998)
Timeframe: baseline to 12 weeks

,
Interventionparticipants (Number)
Response (>/=50% decline in score)Remission (score =/<5)
Placebo2414
Sertraline3115

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Blood Hemoglobin A1C at Baseline and Week 8.

Blood hemoglobin A1C at Baseline and Week 8. Normal range: 3.8%-6.4%. (NCT00955474)
Timeframe: 8 weeks

,
Intervention% glycated hemoglobin (Mean)
BaselineWeek 8
Quetiapine5.65.4
Quetiapine With SSRI5.75.8

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale.

RBANS Visuospatial/Constructional sub-scales at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 8
Quetiapine70.670.5
Quetiapine With SSRI75.678.3

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Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8.

Cholesterol levels were collected at Baseline and Week 8. Normal cholesterol levels should be <200mg/dl. (NCT00955474)
Timeframe: 8 weeks

,
Interventionmg/dl (Mean)
BaselineWeek 8
Quetiapine184.2188
Quetiapine With SSRI171.8201.7

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score

Neuropsychological Assessment. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. RBANS measured at baseline and 8 weeks. (NCT00955474)
Timeframe: 8

,
Interventionunits on a scale (Mean)
BaselineLast visit
Quetiapine77.3877.25
Quetiapine With SSRI70.0078.29

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score.

RBANS Language sub-scale scores at Baseline and Week 8 of study. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 8
Quetiapine80.487.9
Quetiapine With SSRI77.691.1

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score

RBANS Immediate Memory sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 8
Quetiapine83.382.8
Quetiapine With SSRI71.177.9

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Depression

Depression measured with Hamilton Rating Scale for Depression 17 (HAM-D) at baseline and 8 weeks. Ham D 17 scores range from 0-52, 52 being the most severe. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineLast visit
Quetiapine279.57
Quetiapine With SSRI26.7310.14

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Blood Level of Triglycerides at Baseline and Week 8.

Level of triglycerides at Baseline and Week 8. Normal range: 40-150mg/dl. (NCT00955474)
Timeframe: 8 weeks

,
Interventionmg/dl (Mean)
BaselineWeek 8
Quetiapine144.9170.6
Quetiapine With SSRI154.25190.5

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CPFQ (Cognitive and Psychological Functioning Questionnaire)

Score on the Cognitive and Psychological Functioning Questionnaire (CPFQ). Scores range from 7-42 with 42 referring to the worst functioning. CPFQ measured at baseline and 8 weeks. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineLast visit
Quetiapine30.823.56
Quetiapine With SSRI29.321.00

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8.

RBANS Attention sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 8
Quetiapine95.8104.6
Quetiapine With SSRI85.486.1

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8.

RBANS Delayed Memory subscale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 8
Quetiapine82.472.9
Quetiapine With SSRI69.674.7

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Psychosis

Psychosis measured by Brief Psychosis Rating Scale (BPRS) at baseline and 8 weeks. Scores range from 24-168, with 168 bring the most severe. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineLast visit
Quetiapine56.0934.25
Quetiapine With SSRI60.4532.83

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LDL Blood Levels at Baseline and Week 8.

LDL levels at Baseline and Week 8. Normal range < 100 mg/dl. (NCT00955474)
Timeframe: 8 weeks

,
Interventionmg/dl (Mean)
BaselineWeek 8
Quetiapine109121.1
Quetiapine With SSRI94.6123.3

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HDL Blood Levels at Baseline and Week 8.

HDL levels at Baseline and Week 8. Normal range: 35-100 mg/dl. (NCT00955474)
Timeframe: 8 weeks

,
Interventionmg/dl (Mean)
BaselineWeek 8
Quetiapine47.740.8
Quetiapine With SSRI45.340.5

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Fasting Blood Glucose

Fasting glucose levels collected at Baseline and Week 8. Normal range for fasting glucose is 70-110 mg/dl. (NCT00955474)
Timeframe: 8 weeks

,
Interventionml/dl (Mean)
BaselineWeek 8
Quetiapine91.689.1
Quetiapine and SSRI89.496.8

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Blood Oxygen-level Dependent Activations During an Emotional Distractor Task Between fMRI Scans of Depressed Participants in the CBT Group and Control Participants.

MRI imaging was completed on 50 participants (26 depressed who were randomized to the CBT group and 24 controls) for this analysis, including fMRI scans to evaluate regional brain activation in depression during an emotional distractor task. Image data from their baseline visit was processed and analyzed to show differences in blood oxygen-level dependent (BOLD) activations between depressed participants in the CBT group and control participants in a priori regions (amygdala and dorsolateral prefrontal cortex) during the task. The specified regions were masked on the images, and voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these masked regions Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region. (NCT01027559)
Timeframe: baseline visit and 8-week follow-up

,
InterventionVoxels (Mean)
Amygdala - baselineDLPFC - baselineAmygdala - Time 2DLPFC - Time 2
Depressed Group-18.74316.24-16.82403.72
Healthy Control Group2.71411.2-46.06421.51

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Hamilton Depression Rating Scale Score at Baseline and 12 Weeks

The patient was rated by a research team member among 17 dimensions/items pertaining to depression symptoms experienced over the last week. Each item is scored from 0 (=absent), up to 2 or 4 (depending on the item). The maximum total score on the assessment, indicating the most severe depression, would be 52. A total score of 0-7 is considered to be normal. Total scores of 20 or higher indicate moderate, severe, or very severe depression. A 50% or greater drop in Hamilton Depression Rating Scale signifies response to treatment. (NCT01027559)
Timeframe: Baseline and 12 weeks

,,
Interventionunits on a scale (Mean)
BaselineWeek 12
Depressed Group: CBT19.945.94
Depressed Group: Sertraline20.794.43
Healthy Control Group1.381.07

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Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)

(NCT01032018)
Timeframe: 6 months after randomization

Interventiondollars (Mean)
Referred Care4289.23
Stepped Care4358.02

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Depressive Symptom Reduction

Symptoms of depression were assessed using the Beck Depression Inventory (BDI). This 21-question, multiple choice self-report instrument includes items pertaining to symptoms of depression, including hopelessness and irritability, physical symptoms such as fatigue, and thoughts such as guilt. Each item has at a set of four possible responses, ranging in intensity for least intense to most intense. The total score is calculated by adding the responses to each item. Higher scores indicate more severe depressive symptoms. The total score on the scale ranges from 0 to 63. Total scores on the scale of less 10 indicate minimal depression; total scores between 10 and 15 indicate mild depression; and total scores greater than 16 indicate a probable clinical diagnosis of depression. (NCT01032018)
Timeframe: Change from depression at baseline to depression at 6-months

InterventionScores on a scale (Mean)
Referred Care-6.6
Stepped Care-10.1

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Number of Participants With Treatment Emergent Side Effects

(NCT01098318)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Rhodiola Rosea6
Sertraline12
Sugar Pill3

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Change in Sexual Function

This is a patient completed rating of sexual function and satisfaction. It is used to assess current sexual health and changes in sexual health over time measured by the overall sexual satisfaction score. The reported score is the overall degree of sexual satisfaction attained. The score ranges from 0 to 100. Higher score indicates more sexual satisfaction. (NCT01098318)
Timeframe: 12 weeks

,,
Interventionscores on a scale (Median)
BaselineWK12
Rhodiola Rosea4849
Sertraline3625.5
Sugar Pill1712

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Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (17-items) at Week 8 and Week 12.

Hamilton Depression Rating Scale (HAM-D) is a validated, clinician-rated instrument for ascertaining the severity of MDD symptoms. The 28-item Hamilton Depression Rating Scale was used to determine the primary outcome of 17-item HAM-D score. The HAM-D will serves as the primary outcome measure. HAM-D17 score ranges from 0 to 68. Higher score indicates more depressed symptom. (NCT01098318)
Timeframe: 12 weeks

,,
Interventionunits on a scale (Mean)
HAM-D17@WK8HAM-D17@WK12
Rhodiola Rosea87.9
Sertraline8.37.8
Sugar Pill8.98.5

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Number of Participants With Suicide Ideation as Determined by the Columbia Suicide Form

Descriptive analysis of number of subjects in each treatment group who had suicidal ideation at baseline and WK12. (NCT01098318)
Timeframe: 12 weeks

,,
InterventionParticipants (Count of Participants)
BaselineWK12
Rhodiola Rosea60
Sertraline60
Sugar Pill92

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The Clinical Global Impression (CGI) Severity and Change

"A clinician-rated measure of global symptom severity (CGI/S) and symptom change (CGI/C) of MDD. Severity was rated as Not ill; Borderline ill; Mild; Moderate; Moderately severe; Severe and Extremely severe. Global change was rates as Very much improved; Much improved; Minimally improved; Unchanged;Minimally worse;Much worse and Very much worse. Here in severity, we reported the N(%) of subjects who were not ill or borderline ill. In change, we reported N(%) of subjects who were Very much improved or Much imp[roved.Subjects started the study with mild to moderate MDD (moderate or above rating in the CGI-S). At WK12, the #/% of subjects in each treatment group who were not ill at WK12 (CGI-S) and who had much improved or very much improved at WK12 (CGI-C) was reported." (NCT01098318)
Timeframe: 12 weeks

,,
InterventionParticipants (Count of Participants)
WK12 CGI-Severity (Not ill and Borderline ill)WK12 CGI-C (Much improved and very much improved)
Rhodiola Rosea910
Sertraline67
Sugar Pill77

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Change in Depressive Symptoms as Measured by the Beck Depression Inventory

All enrolled subjects were analyzed. Mean change in Beck Depression Inventory (BDI) total scores were reported. BDI is a self-reported outcome measuring the severity of depression. A negative # means a reduction in BDI score at the end of treatment compared to baseline which represents an improvement in depression symptoms. BDI total score ranges from 0-63. BDI score of 1-16 represents low level of depression;17-30 represents moderate level of depression; >=31 represents significant level of depression. A reduction in the BDI score represents improvement in the depression symptoms. (NCT01098318)
Timeframe: 12 weeks

Interventionscores on a scale (Mean)
Rhodiola Rosea-14.0
Sertraline-13.7
Sugar Pill-7.5

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Changes in the Meal Calories Consumed

The changes in the meal calories consumed was measured upon telenzepine treatment at the dose of 1 mg, 2 mg and 3 mg (i.e. end of every 7 days). The baseline was defined as on day 7 of sertraline treatment with no telenzepine for the specified meal. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination. (NCT01155531)
Timeframe: The baseline was defined as on day 7 of sertraline treatment with no telenzepine. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination.

,,,
Interventioncalorie (Mean)
1 mg telenzepine (breakfast)2 mg telenzepine (breakfast)3 mg telenzepine (breakfast)1 mg telenzepine (lunch)2 mg telenzepine (lunch)3 mg telenzepine (lunch)1 mg telenzepine (supper)2 mg telenzepine (supper)3 mg telenzepine (supper)
Sertraline Plus Telenzepine - Group C-88.93-2.3268.2159.69144.502.9287.01-13.10-22.98
Sertraline Plus Telenzepine - Group D-53.91-67.36-28.8160.9212.09-4.94-79.49-12.2142.85
Telenzepine - Group A-63.7036.3258.5913.9833.91-22.36-19.92-26.169.26
Telenzepine Plus Sertraline - Group B-42.3223.7080.2114.3258.39-119.0147.66-20.8561.88

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Safety of Sertraline and Telenzepine Combination

safety of the drug combination was measured in terms of number of adverse events during the study period. (NCT01155531)
Timeframe: 7 days

,,,
Interventionnumber of adverse events (Number)
TotalMildModerateSevere
Sertraline Plus Telenzepine - Group C252041
Sertraline Plus Telenzepine - Group D474340
Telenzepine - Group A10910
Telenzepine Plus Sertraline - Group B171520

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Changes in the VAS Score From Baseline.

"The baseline VAS self-assessment was completed for each subject on day 7 of each dose combination. Appetite VAS was completed in the subject's room approximately 30 min before and 1 h after each meal serving. Appetite was not assessed prior to snacks. VAS assessment was based on response to the question: How hungry are you now? The anchor points of the 100mm scale were I am not hungry at all and Never more hungry corresponding to 0 mm and 100 mm respectively. The subjects' VAS scores were measured by the clinic staff and entered into the CRF. The description listed below (VAS after meal minus and VAS before meal) refers only to the mean VAS score of each group." (NCT01155531)
Timeframe: The baseline was defined on day 7 of sertraline treatment with no telenzepine before and meal. Appetite VAS was measured 30 min before and 1hour after to meal

,,,
Interventionmm (Mean)
1 mg of Telenzepine (30 min before breakfast)2 mg of Telenzepine (30 min before breakfast)3 mg of Telenzepine (30 min before breakfast)1 mg of Telenzepine (1 hour after breakfast)2 mg of Telenzepine (1 hour after breakfast)3 mg of Telenzepine (1 hour after breakfast)1 mg of Telenzepine (30 min before lunch)2 mg of Telenzepine (30 min before lunch)3 mg of Telenzepine (30 min before lunch)1 mg of Telenzepine (1 hour after lunch)2 mg of Telenzepine (1 hour after lunch)3 mg of Telenzepine (1 hour after lunch)1 mg of Telenzepine (30 min before supper)2 mg of Telenzepine (30 min before supper)3 mg of Telenzepine (30 min before supper)1 mg of Telenzepine (1 hour after supper)2 mg of Telenzepine (1 hour after supper)3 mg of Telenzepine (1 hour after supper)
Sertraline Plus Telenzepine - Group C-10.818.5014.33-9.600.1-2.89-2.109.600.444.605.7012.119.904.50-13.33-17-7-6.33
Sertraline Plus Telenzepine - Group D6.70-4.5-4.601.206.703.504.602.40-2.701125.6012.5012.60-113.70-3.30-8.10
Telenzepine - Group A2.905.5012.225.502.304.111.60-8.60-16.78-2-1.10.44-4.10-14.10-20.671.701.10-0.78
Telenzepine Plus Sertraline - Group B2.70-4.40-7.60-2.40-5.20-7.60-14.50-16.30-23.40-3.90-6.10-4.60-1.20-10.60-17-3.10-3.30-4.30

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Time to Discontinuation of Study Treatment

(NCT01178671)
Timeframe: up to 24 weeks

Interventiondays (Mean)
Sertraline and Mirtazapine95.2
Sertraline and Sugar Pill90.0

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Sexual Functioning

as measured by Arizona Sexual Experiences Scale, which rates impairment in sexual functioning from 5 (least impaired) to 30 (most impaired). (NCT01178671)
Timeframe: up to 24 weeks

Interventionunits on a scale (Mean)
Sertraline and Mirtazapine16.3
Sertraline and Sugar Pill17.4

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Sleep Quality

as measured by Pittsburgh Sleep Quality Index, which rates severity of impairment in sleep quality from 0 (least impaired) to 21 (most impaired). (NCT01178671)
Timeframe: up to 24 weeks

Interventionunits on a scale (Mean)
Sertraline and Mirtazapine4.4
Sertraline and Sugar Pill9.1

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Adverse Effects

as assessed by Side Effect Checklist (NCT01178671)
Timeframe: up to 24 weeks

Interventionpercentage of subject dropped due to AEs (Number)
Sertraline and Mirtazapine22.2
Sertraline and Sugar Pill33.3

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Alternative Measure of PTSD Severity

as measured by the Short Posttraumatic Stress Disorder Rating Interview, which rates severity of PTSD from 0 (least severe) to 32 (most severe) (NCT01178671)
Timeframe: up to 24 weeks

Interventionunits on a scale (Mean)
Sertraline and Mirtazapine3.4
Sertraline and Sugar Pill6.7

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Depression Severity

as measured by the 17-item Hamilton Rating Scale for Depression, which rates severity of depression on a scale from 0 (least depression) to 50 (greatest depression). (NCT01178671)
Timeframe: up to 24 weeks

Interventionunits on a scale (Mean)
Sertraline and Mirtazapine6.4
Sertraline and Sugar Pill11.6

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PTSD Self-rated Severity

as measured by the PTSD Checklist which rates severity of PTSD from 17 (least severe) to 85 (most severe). (NCT01178671)
Timeframe: up to 24 weeks

Interventionunits on a scale (Mean)
Sertraline and Mirtazapine33.2
Sertraline and Sugar Pill39.2

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PTSD Severity

PTSD severity will be measured by the Clinician-Administered Posttraumatic Stress Disorder Scale, from 0 (least severe) to 136 (most severe). (NCT01178671)
Timeframe: up to 24 weeks

Interventionunits on a scale (Mean)
Sertraline and Mirtazapine23.8
Sertraline and Sugar Pill34.6

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Remission Status

Remitter as defined by Clinician Administered Posttraumatic Stress Disorders Scale total score <20 at endpoint (NCT01178671)
Timeframe: up to 24 weeks

Interventionpercentage of subjects (Number)
Sertraline and Mirtazapine39
Sertraline and Sugar Pill11

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Response Status

Responders defined by Clinician Administered Posttraumatic Stress Disorder Scale total score decreased by at least 30% compared with baseline and Clinical Global Impression improvement score of =1 or 2 at endpoint (NCT01178671)
Timeframe: up to 24 weeks

Interventionpercentage of subjects (Number)
Sertraline and Mirtazapine56
Sertraline and Sugar Pill22

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Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)]

AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours (0-72). (NCT01235195)
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose

Interventionnanogram hour per milliliter (ng*h/mL) (Mean)
Sertraline 50 mg Hard Gelatin Capsule419.9
Sertraline 50 mg Film-Coated Tablet442.1

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). (NCT01235195)
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose

Interventionng*h/mL (Mean)
Sertraline 50 mg Hard Gelatin Capsule471.4
Sertraline 50 mg Film-Coated Tablet493.8

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Maximum Observed Plasma Concentration (Cmax)

(NCT01235195)
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose

Interventionnanogram per milliliter (ng/mL) (Mean)
Sertraline 50 mg Hard Gelatin Capsule17.96
Sertraline 50 mg Film-Coated Tablet19.03

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Plasma Decay Half-Life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT01235195)
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose

Interventionhours (Mean)
Sertraline 50 mg Hard Gelatin Capsule25.45
Sertraline 50 mg Film-Coated Tablet25.40

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Time to Reach Maximum Observed Plasma Concentration (Tmax)

(NCT01235195)
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose

Interventionhours (Median)
Sertraline 50 mg Hard Gelatin Capsule5.00
Sertraline 50 mg Film-Coated Tablet5.00

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Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of LY2216684

The Least Squares (LS) geometric mean AUCτ of LY2216684 was calculated based on the LY2216684 plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau [τ]) when LY221684 was administered alone (Day 3) and when LY2216684 was coadministered with sertraline (Day 13). The Day 13-to-Day 3 ratio of the LY2216684 LS geometric mean of AUCτ and the associated 90% confidence interval (CI) of the ratio were calculated. (NCT01250873)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 3 and Day 13

Interventionhour*nanogram per milliliter (h*ng/mL) (Geometric Least Squares Mean)
LY2216684 aloneLY2216684 + sertraline
LY2216684/Sertraline/LY2216684 + Sertraline675792

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Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of LY2216684

The Least Squares (LS) geometric mean Cmax of LY2216684 was determined when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with sertraline (Day 13). The Day 13-to-Day 3 ratio of the LY2216684 LS geometric mean of Cmax and the associated 90% confidence interval (CI) of the ratio were calculated. (NCT01250873)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 3 and Day 13

Interventionnanogram per milliliter (ng/mL) (Geometric Least Squares Mean)
LY2216684 aloneLY2216684 + sertraline
LY2216684/Sertraline/LY2216684 + Sertraline65.974.9

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Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Sertraline

The Least Squares (LS) geometric mean Cmax of sertraline was determined when sertraline was administered alone (Day 10) and when sertraline was coadministered with LY2216684 (Day 13). The Day 13-to-Day 10 ratio of the sertraline LS geometric mean of Cmax and the associated 90% confidence interval (CI) of the ratio were calculated. (NCT01250873)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10 and Day 13

Interventionnanogram per milliliter (ng/mL) (Geometric Least Squares Mean)
sertraline alonesertraline + LY2216684
LY2216684/Sertraline/LY2216684 + Sertraline70.786.4

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Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of LY2216684

Tmax of LY2216684 was determined using the median of paired differences between the 2 treatment groups when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with sertraline (Day 13). The 90% confidence interval (CI) for the median of differences was calculated. (NCT01250873)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 3 and Day 13

Interventionhours (Median)
LY2216684 aloneLY2216684 + sertraline
LY2216684/Sertraline/LY2216684 + Sertraline2.003.00

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Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of Sertraline

Tmax of sertraline was determined using the median of paired differences between the 2 treatment groups when sertraline was administered alone (Day 10) and when sertraline was coadministered with LY2216684 (Day 13). The 90% confidence interval (CI) for the median of differences was calculated. (NCT01250873)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10 and Day 13

Interventionhours (Median)
sertraline alonesertraline + LY2216684
LY2216684/Sertraline/LY2216684 + Sertraline6.008.00

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Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of Sertraline

The Least Squares (LS) geometric mean AUCτ of sertraline was calculated based on the sertraline plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau [τ]) when sertraline was administered alone (Day 10) and when sertraline was coadministered with LY2216684 (Day 13). The Day 13-to-Day 10 ratio of the sertraline LS geometric mean of AUCτ and the associated 90% confidence interval (CI) of the ratio were calculated. (NCT01250873)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10 and Day 13

Interventionhour*nanogram per milliliter (h*ng/mL) (Geometric Least Squares Mean)
sertraline alonesertraline + LY2216684
LY2216684/Sertraline/LY2216684 + Sertraline12401570

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Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score

The PGI-S is a clinician-rated scale that rates was used to rate the severity of the patient's current state of overall fatigue. Patients were rated on a scale from 1 to 7, with 1 indicating no symptoms of fatigue and 7 indicating extreme fatigue. (NCT01254305)
Timeframe: From Baseline to Week 8

Interventionunits on a scale (Mean)
Placebo-1.4
Levomilnacipran ER-1.7
SSRI-1.7

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Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward

The Cognitive and Physical Functioning Questionnaire is a patient-rated, 7-item scale used to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ is sensitive to change with treatment and displays convergent validity by significant correlations with other measures of sleepiness, fatigue, apathy, and neuropsychological functioning. Patients are rated on a scale from 1 to 6 for seven common complaints of depressed patients reporting fatigue or cognitive/executive problems-with 1 indicating greater than normal functioning, 2 indicating normal functioning, and 3 to 6 indicating degrees of impaired functioning. The CPFQ ranges from the best possible score of 7 (greater than normal functioning) to the worst possible score of 42 (totally absent). (NCT01254305)
Timeframe: From Baseline to Week 8

Interventionunits on a scale (Mean)
Placebo-5.9
Levomilnacipran ER-7.0
SSRI-6.4

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Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score

The CGI-S is a clinician-rated scale that rates the severity of the patient's current state of fatigue based on the Investigator's clinical opinion with regard to the patient population with Major Depressive Disorder (MDD). Patient were rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating that the patient was among the most extremely fatigued (NCT01254305)
Timeframe: From Baseline to Week 8

Interventionunits on a scale (Mean)
Placebo-1.5
Levomilnacipran ER-1.8
SSRI-1.9

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Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36

CGAS was to rate the general functioning of the study participants on a numeric scale of 1 to 100, where 1= extremely impaired and 100= doing very well. (NCT01302080)
Timeframe: Baseline, Month 3, 6, 12, 18, 24, 30 and 36

,,
InterventionUnits on scale (Mean)
BaselineChange at Month 3Change at Month 6Change at Month 12Change at Month 18Change at Month 24Change at Month 30Change at Month 36
Other Antidepressants56.67-7.671.084.486.768.449.948.77
Psychotherapy59.864.618.2310.6612.4611.2912.5415.28
Sertraline55.806.588.2410.0210.5111.2912.3713.05

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Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. (NCT01302080)
Timeframe: Baseline, Month 3

,,
InterventionZ-score (Mean)
BaselineChange at Week 3
Other Antidepressants57.674.50
Psychotherapy59.27-1.88
Sertraline62.93-2.29

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Change From Baseline in Cognitive Function Using Trails B at Month 3

"Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation." (NCT01302080)
Timeframe: Baseline, Month 3

,,
InterventionZ-score (Mean)
BaselineChange at Week 3
Other Antidepressants1.23-0.09
Psychotherapy0.61-0.03
Sertraline1.03-0.39

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Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36

HoNOSCA scale had 13-sub-scales used to assess general health and social functioning. 13 sub-scales were as the following: disruptive or aggressive behavior, attention deficit hyperactivity disorder (ADHD), self-harm, substance abuse, school problems, physical illness, psychosis, physical symptoms, internalizing symptoms, peer relationships, self-care, family relationships and school attendance problems. Each sub-scale had a range of 0 (no problems) to 4 (severe problems). Scores from all 13 sub-scales were summed up to give overall possible HoNOSCA total score range of 0 to 52. Higher score indicated worse condition. (NCT01302080)
Timeframe: Baseline, Month 3, 6, 12, 18, 24, 30 and 36

,,
InterventionUnits on scale (Mean)
BaselineChange at Month 3Change at Month 6Change at Month 12Change at Month 18Change at Month 24Change at Month 30Change at Month 36
Other Antidepressants8.334.33-0.14-2.46-3.53-5.07-4.75-4.69
Psychotherapy9.19-2.05-3.21-3.88-3.79-4.57-4.80-5.30
Sertraline10.51-2.75-3.23-3.79-3.98-3.96-4.04-4.33

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Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36

CGI-S scale was a 7-point scale used to assess severity of illness on a range of 1 to 7; where, 1= normal, not mentally ill, 2= borderline mentally ill, 3= mildly mentally ill, 4= moderately mentally ill, 5= markedly mentally ill, 6= severely mentally ill, and 7= among the most extremely mentally. Higher score indicated worse condition. (NCT01302080)
Timeframe: Baseline, Month 3, 6, 12, 18, 24, 30 and 36

InterventionParticipants (Count of Participants)
Baseline72315216Baseline72315218Baseline72315217Month 372315218Month 372315217Month 372315216Month 672315217Month 672315218Month 672315216Month 1272315216Month 1272315217Month 1272315218Month 1872315216Month 1872315217Month 1872315218Month 2472315216Month 2472315218Month 2472315217Month 3072315216Month 3072315218Month 3072315217Month 3672315216Month 3672315217Month 3672315218
Normal, Not Mentally illSeverely Mentally illAmong the Most Extremely Mentally illBorderline Mentally illMildly Mentally illModerately Mentally illMarkedly Mentally ill
Sertraline21
Sertraline28
Psychotherapy17
Sertraline138
Psychotherapy57
Sertraline377
Psychotherapy107
Sertraline116
Sertraline12
Psychotherapy2
Sertraline32
Psychotherapy18
Sertraline87
Psychotherapy19
Sertraline163
Psychotherapy60
Sertraline216
Psychotherapy54
Sertraline55
Psychotherapy23
Sertraline3
Other Antidepressants1
Other Antidepressants0
Sertraline44
Psychotherapy28
Sertraline93
Other Antidepressants4
Psychotherapy33
Sertraline139
Other Antidepressants9
Psychotherapy51
Sertraline162
Other Antidepressants15
Psychotherapy43
Sertraline31
Psychotherapy14
Sertraline10
Psychotherapy3
Sertraline0
Sertraline42
Other Antidepressants2
Psychotherapy32
Sertraline80
Other Antidepressants6
Sertraline133
Psychotherapy39
Other Antidepressants26
Sertraline22
Other Antidepressants11
Psychotherapy11
Sertraline35
Psychotherapy26
Sertraline66
Sertraline106
Psychotherapy53
Sertraline76
Other Antidepressants33
Psychotherapy34
Sertraline16
Psychotherapy7
Sertraline5
Sertraline39
Sertraline61
Sertraline100
Other Antidepressants17
Psychotherapy48
Sertraline48
Other Antidepressants35
Sertraline13
Psychotherapy5
Psychotherapy1
Sertraline30
Other Antidepressants5
Sertraline58
Other Antidepressants13
Psychotherapy27
Sertraline78
Other Antidepressants25
Sertraline45
Other Antidepressants19
Psychotherapy29
Sertraline6
Other Antidepressants3
Psychotherapy4
Sertraline1
Sertraline36
Other Antidepressants10
Psychotherapy46
Sertraline54
Psychotherapy31
Sertraline72
Other Antidepressants20
Psychotherapy55
Sertraline33
Other Antidepressants16
Psychotherapy25
Sertraline7
Psychotherapy6
Sertraline2
Psychotherapy0

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Change From Baseline in Height at Month 3

Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on centers for disease control (CDC) norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 3

,,
InterventionZ-score (Mean)
BaselineChange at Month 3
Other Antidepressants0.76-0.03
Psychotherapy0.32-0.01
Sertraline0.310.00

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Change From Baseline in Weight at Month 3

Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 3

,,
InterventionZ-score (Mean)
BaselineChange at Month 3
Other Antidepressants0.88-0.22
Psychotherapy0.42-0.03
Sertraline0.580.02

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Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36

CGI-T scale was a 7-point scale used to assess the tolerability of the study medication with respect to adverse events. Scale range/categories: 1= very high, 2= high, 3= above average, 4= average, 5= low, 6= very low, and 7= extremely low. Higher score indicated less tolerability with study medication. (NCT01302080)
Timeframe: Month 3, 6, 12, 18, 24, 30 and 36

InterventionParticipants (Count of Participants)
Month 372315218Month 372315216Month 372315217Month 672315218Month 672315217Month 672315216Month 1272315216Month 1272315217Month 1272315218Month 1872315217Month 1872315218Month 1872315216Month 2472315218Month 2472315216Month 2472315217Month 3072315218Month 3072315216Month 3072315217Month 3672315216Month 3672315217Month 3672315218
HighAverageLowVery LowExtremely LowVery HighAbove Average
Sertraline274
Psychotherapy25
Sertraline123
Sertraline40
Psychotherapy18
Sertraline69
Other Antidepressants2
Psychotherapy30
Sertraline22
Psychotherapy3
Sertraline10
Sertraline8
Sertraline245
Other Antidepressants14
Psychotherapy33
Sertraline116
Psychotherapy12
Sertraline28
Psychotherapy20
Sertraline49
Psychotherapy23
Sertraline19
Sertraline5
Psychotherapy4
Sertraline6
Psychotherapy1
Sertraline217
Other Antidepressants23
Sertraline84
Sertraline35
Psychotherapy14
Other Antidepressants4
Sertraline1
Sertraline170
Other Antidepressants32
Sertraline77
Other Antidepressants15
Sertraline16
Sertraline26
Other Antidepressants10
Psychotherapy11
Psychotherapy0
Sertraline149
Other Antidepressants37
Sertraline67
Other Antidepressants17
Sertraline9
Psychotherapy8
Sertraline4
Sertraline132
Other Antidepressants29
Psychotherapy35
Sertraline55
Other Antidepressants18
Psychotherapy5
Other Antidepressants6
Sertraline12
Other Antidepressants5
Psychotherapy9
Other Antidepressants1
Other Antidepressants0
Sertraline125
Other Antidepressants35
Psychotherapy32
Sertraline51
Other Antidepressants12
Psychotherapy10
Sertraline11
Other Antidepressants3
Psychotherapy6
Sertraline7
Psychotherapy7
Sertraline0
Psychotherapy2
Sertraline2

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Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36

The CGI-E was the value at which the participant's therapeutic benefit and adverse impact to the study drug intersected. Firstly clinician identified the degree of therapeutic benefit on scale range: very much improved, much improved, minimally improved, unchanged or worse. Secondly, the clinician rater identified the degree to which problems with tolerability adversely impact the participant on scale range: no adverse impact, mild adverse impact, moderate adverse impact, outweighs therapeutic effect. Finally, clinician identified in which participants benefits and adverse impacts intersected. Participants were then determined to be responders or non-responders to the study medication. (NCT01302080)
Timeframe: Month 3, 6, 12, 18, 24, 30 and 36

,,
InterventionParticipants (Count of Participants)
Responders at Month 3Responders at Month 6Responders at Month 12Responders at Month 18Responders at Month 24Responders at Month 30Responders at Month 36
Other Antidepressants1142844475246
Psychotherapy55725254546672
Sertraline296309268219206173169

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Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36

CGI-I scale was a 7-point scale used to rate improvement in the participant's condition (benefits). Scale range/categories: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = Not changed, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher score indicated worse condition. (NCT01302080)
Timeframe: Month 3, 6, 12, 18, 24, 30 and 36

InterventionParticipants (Count of Participants)
Month 372315218Month 372315216Month 372315217Month 672315217Month 672315216Month 672315218Month 1272315218Month 1272315217Month 1272315216Month 1872315217Month 1872315216Month 1872315218Month 2472315216Month 2472315217Month 2472315218Month 3072315216Month 3072315217Month 3072315218Month 3672315216Month 3672315217Month 3672315218
Very Much ImprovedMinimally WorseVery Much WorseMuch ImprovedMinimally ImprovedNot ChangedMuch Worse
Sertraline77
Psychotherapy17
Sertraline223
Psychotherapy51
Sertraline151
Other Antidepressants1
Psychotherapy69
Sertraline63
Sertraline20
Psychotherapy3
Psychotherapy5
Sertraline96
Psychotherapy29
Sertraline220
Other Antidepressants14
Psychotherapy64
Sertraline87
Other Antidepressants7
Psychotherapy48
Sertraline44
Other Antidepressants8
Psychotherapy21
Sertraline15
Sertraline93
Psychotherapy32
Sertraline174
Other Antidepressants19
Psychotherapy55
Sertraline80
Other Antidepressants20
Psychotherapy28
Sertraline16
Other Antidepressants6
Psychotherapy18
Sertraline7
Psychotherapy2
Sertraline9
Psychotherapy6
Sertraline3
Sertraline86
Sertraline136
Other Antidepressants34
Sertraline53
Other Antidepressants11
Sertraline14
Other Antidepressants10
Psychotherapy11
Sertraline6
Sertraline2
Psychotherapy34
Sertraline113
Other Antidepressants39
Sertraline34
Psychotherapy27
Other Antidepressants9
Psychotherapy9
Other Antidepressants2
Sertraline0
Other Antidepressants0
Psychotherapy4
Sertraline73
Other Antidepressants12
Psychotherapy43
Sertraline102
Other Antidepressants41
Psychotherapy63
Sertraline21
Psychotherapy23
Sertraline12
Psychotherapy12
Psychotherapy1
Psychotherapy0
Other Antidepressants22
Psychotherapy53
Sertraline85
Other Antidepressants27
Psychotherapy77
Sertraline22
Psychotherapy15
Sertraline5
Other Antidepressants3
Psychotherapy8
Sertraline4
Sertraline1

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Change From Baseline in Weight at Month 30

Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 30

InterventionZ-score (Mean)
Sertraline0.16
Other Antidepressants0.11
Psychotherapy0.04

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Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. (NCT01302080)
Timeframe: Baseline, Month 12

InterventionZ-score (Mean)
Sertraline-5.42
Other Antidepressants-2.44
Psychotherapy-5.01

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Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. (NCT01302080)
Timeframe: Baseline, Month 18

InterventionZ-score (Mean)
Sertraline-5.21
Other Antidepressants-3.59
Psychotherapy-4.48

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Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. (NCT01302080)
Timeframe: Baseline, Month 24

InterventionZ-score (Mean)
Sertraline-6.21
Other Antidepressants-5.78
Psychotherapy-6.05

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Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. (NCT01302080)
Timeframe: Baseline, Month 30

InterventionZ-score (Mean)
Sertraline-6.92
Other Antidepressants-5.23
Psychotherapy-6.53

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Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. (NCT01302080)
Timeframe: Baseline, Month 36

InterventionZ-score (Mean)
Sertraline-7.44
Other Antidepressants-7.24
Psychotherapy-6.22

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Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. (NCT01302080)
Timeframe: Baseline, Month 6

InterventionZ-score (Mean)
Sertraline-4.06
Other Antidepressants-3.14
Psychotherapy-3.62

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Change From Baseline in Body Mass Index (BMI) at Month 12

BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 12

InterventionZ-score (Mean)
Sertraline0.13
Other Antidepressants0.06
Psychotherapy0.04

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Change From Baseline in Body Mass Index (BMI) at Month 18

BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 18

InterventionZ-score (Mean)
Sertraline0.18
Other Antidepressants0.07
Psychotherapy-0.04

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Change From Baseline in Body Mass Index (BMI) at Month 24

BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 24

InterventionZ-score (Mean)
Sertraline0.17
Other Antidepressants0.20
Psychotherapy-0.01

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Change From Baseline in Body Mass Index (BMI) at Month 30

BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 30

InterventionZ-score (Mean)
Sertraline0.16
Other Antidepressants0.15
Psychotherapy0.03

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Change From Baseline in Body Mass Index (BMI) at Month 36

BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 36

InterventionZ-score (Mean)
Sertraline0.17
Other Antidepressants0.21
Psychotherapy0.01

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Change From Baseline in Body Mass Index (BMI) at Month 6

BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 6

InterventionZ-score (Mean)
Sertraline0.04
Other Antidepressants-0.03
Psychotherapy-0.06

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Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. (NCT01302080)
Timeframe: Baseline, Month 12

InterventionZ-score (Mean)
Sertraline-3.12
Other Antidepressants-1.97
Psychotherapy-2.81

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Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. (NCT01302080)
Timeframe: Baseline, Month 18

InterventionZ-score (Mean)
Sertraline-2.40
Other Antidepressants-1.57
Psychotherapy-3.13

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Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. (NCT01302080)
Timeframe: Baseline, Month 24

InterventionZ-score (Mean)
Sertraline-3.37
Other Antidepressants-3.14
Psychotherapy-4.16

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Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. (NCT01302080)
Timeframe: Baseline, Month 30

InterventionZ-score (Mean)
Sertraline-3.60
Other Antidepressants-4.39
Psychotherapy-4.53

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Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. (NCT01302080)
Timeframe: Baseline, Month 36

InterventionZ-score (Mean)
Sertraline-3.96
Other Antidepressants-3.87
Psychotherapy-4.62

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Change From Baseline in Cognitive Function Using Trails B at Month 12

"Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation." (NCT01302080)
Timeframe: Baseline, Month 12

InterventionZ-score (Mean)
Sertraline-0.72
Other Antidepressants-0.22
Psychotherapy-0.27

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Change From Baseline in Cognitive Function Using Trails B at Month 18

"Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation." (NCT01302080)
Timeframe: Baseline, Month 18

InterventionZ-score (Mean)
Sertraline-0.57
Other Antidepressants-0.65
Psychotherapy-0.22

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Change From Baseline in Cognitive Function Using Trails B at Month 24

"Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation." (NCT01302080)
Timeframe: Baseline, Month 24

InterventionZ-score (Mean)
Sertraline-0.44
Other Antidepressants-1.08
Psychotherapy-0.18

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Change From Baseline in Cognitive Function Using Trails B at Month 30

"Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation." (NCT01302080)
Timeframe: Baseline, Month 30

InterventionZ-score (Mean)
Sertraline-0.74
Other Antidepressants-0.61
Psychotherapy-0.18

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Change From Baseline in Cognitive Function Using Trails B at Month 36

"Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation." (NCT01302080)
Timeframe: Baseline, Month 36

InterventionZ-score (Mean)
Sertraline-0.25
Other Antidepressants-0.13
Psychotherapy-0.59

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Change From Baseline in Cognitive Function Using Trails B at Month 6

"Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation." (NCT01302080)
Timeframe: Baseline, Month 6

InterventionZ-score (Mean)
Sertraline-0.64
Other Antidepressants-0.65
Psychotherapy-0.16

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Change From Baseline in Height at Month 12

Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 12

InterventionZ-score (Mean)
Sertraline-0.01
Other Antidepressants0.06
Psychotherapy-0.04

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Change From Baseline in Height at Month 18

Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 18

InterventionZ-score (Mean)
Sertraline-0.03
Other Antidepressants0.00
Psychotherapy-0.02

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Change From Baseline in Height at Month 24

Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 24

InterventionZ-score (Mean)
Sertraline0.01
Other Antidepressants-0.02
Psychotherapy-0.02

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Change From Baseline in Height at Month 30

Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 30

InterventionZ-score (Mean)
Sertraline0.01
Other Antidepressants-0.10
Psychotherapy0.00

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Change From Baseline in Height at Month 36

Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 36

InterventionZ-score (Mean)
Sertraline0.00
Other Antidepressants-0.04
Psychotherapy-0.02

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Change From Baseline in Height at Month 6

Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 6

InterventionZ-score (Mean)
Sertraline-0.02
Other Antidepressants0.07
Psychotherapy0.00

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Change From Baseline in Weight at Month 12

Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 12

InterventionZ-score (Mean)
Sertraline0.10
Other Antidepressants0.06
Psychotherapy0.00

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Change From Baseline in Weight at Month 18

Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 18

InterventionZ-score (Mean)
Sertraline0.14
Other Antidepressants0.07
Psychotherapy-0.01

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Change From Baseline in Weight at Month 24

Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 24

InterventionZ-score (Mean)
Sertraline0.16
Other Antidepressants0.15
Psychotherapy0.00

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Change From Baseline in Weight at Month 36

Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 36

InterventionZ-score (Mean)
Sertraline0.17
Other Antidepressants0.17
Psychotherapy0.02

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Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. (NCT01302080)
Timeframe: Baseline, Month 6

InterventionZ-score (Mean)
Sertraline-2.53
Other Antidepressants-1.54
Psychotherapy-2.74

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Change From Baseline in Weight at Month 6

Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 6

InterventionZ-score (Mean)
Sertraline0.03
Other Antidepressants0.01
Psychotherapy-0.05

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Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. (NCT01302080)
Timeframe: Baseline, Month 3

,,
InterventionZ-score (Mean)
BaselineChange at Week 3
Other Antidepressants58.67-1.50
Psychotherapy61.88-2.39
Sertraline65.15-3.08

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Change From Baseline in Body Mass Index (BMI) at Month 3

BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender. (NCT01302080)
Timeframe: Baseline, Month 3

,,
InterventionZ-score (Mean)
BaselineChange at Month 3
Other Antidepressants0.79-0.26
Psychotherapy0.27-0.03
Sertraline0.480.02

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Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score

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

Interventionunits on a scale (Mean)
Prior Placebo2.60
Prior Brexpiprazole2.63
Prior ADT2.63
Prior Seroquel2.40

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Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score

"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

Interventionunits on a scale (Mean)
Prior Placebo-5.25
Prior Brexpiprazole-4.76
Prior ADT-3.94
Prior Seroquel-7.44

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Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score

"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

Interventionunits on a scale (Mean)
Prior Placebo-0.77
Prior Brexpiprazole-0.63
Prior ADT-0.48
Prior Seroquel-0.93

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Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score

"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

Interventionunits on a scale (Mean)
Prior Placebo-0.80
Prior Brexpiprazole-0.70
Prior ADT-0.40
Prior Seroquel-1.00

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Adverse Events (AEs) - All Participants

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

,,,
InterventionParticipants (Count of Participants)
Participants with adverse eventsParticipants with treatment emergent AE (TEAE)Participants with serious TEAEParticipants with severe TEAEPartcipants discontinued due to AEs
Prior ADT116511633399134
Prior Brexpiprazole511510236458
Prior Placebo400399144855
Prior Seroquel5151146

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Hamilton Rating Scale for Depression

"The Hamilton Rating Scale for depression is a measure of depressive severity (HAM-D17; HDRS)~Scores range from 0-52~Lower scores indicate less depressive symptomatology, and so are the more desirable." (NCT01407094)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Sertraline11.06
Placebo12.52

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Changes in Metabolic Measure: Cholesterol

Change in cholesterol from entry into randomized phase (baseline) and 36 weeks. (NCT01427608)
Timeframe: From entry into randomized phase (baseline) and 36 weeks

Interventionmg/dL (Mean)
Sertraline + Olanzapine-0.46
Sertraline + Placebo-22.28

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Changes in Metabolic Measures: Triglycerides

Change in triglycerides from entry into randomized phase (baseline) and 36 weeks. (NCT01427608)
Timeframe: From entry into randomized phase (baseline) and 36 weeks

Interventionmg/dL (Mean)
Sertraline + Olanzapine-3.85
Sertraline + Placebo-18.18

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Changes in Metabolic Measures: Weight

Change in weight from entry into randomized phase (baseline) and 36 weeks. (NCT01427608)
Timeframe: From entry into randomized phase (baseline) and 36 weeks

Interventionpounds (Mean)
Sertraline + Olanzapine5.70
Sertraline + Placebo-3.11

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Number of Subjects at Risk of Relapse During the Randomized Phase.

"Relapse criteria include at least one of the following:~1)Structured Clinical Interview for Diagnostic Statistical Manual #4 Trade Revision (DSM-IV-TR) Axis 1 Disorders (SCID) symptoms of major depression maintained over two weeks 2)17-item Hamilton Depression Rating Scale score of >17 maintained for more than one week + a mean increase of 5 points from entry into randomized phase 3)Re-emergence of psychosis for more than one week, with a SADS (Schedule for Affective Disorders and Schizophrenia) score of >2 on delusion or hallucination severity items 4)Significant clinical worsening defined as either emergence of high-risk of suicide, and/or development of mania for greater than one week, and/or psychiatric hospitalization." (NCT01427608)
Timeframe: From entry into randomized phase (baseline) and 36 weeks or earlier relapse

InterventionParticipants (Count of Participants)
Sertraline + Olanzapine13
Sertraline + Placebo34

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Mullen Scales of Early Learning - Fine Motor Age-equivalent Score

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean age-equivalent scores from the Fine Motor scale at the 6-month follow-up visit. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's fine motor skills are at a level typical of younger ages, and higher scores indicating that a child's fine motor skills are at a level typical of older ages. (NCT01474746)
Timeframe: At six-month visit

Interventionmonths (Mean)
Placebo25.0
Active28.4

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Clinical Global Impression - Improvement

The Clinical Global Impression - Improvement (CGI-I) is used to measure the overall behavioral change of an individual and their therapeutic response. The CGI-I is a 3-item observer-rated scale administered by the physician to the caregiver, who assesses improvement using a 7-point scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse. Therefore, the lower the score, the greater the behavioral improvement as rated by the caregiver. Shown here are the CGI-I mean scores from the 6-month follow-up visit. (NCT01474746)
Timeframe: 6-month follow-up visit score

Interventionunits on a scale (Mean)
Placebo2.59
Active2.28

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Eye Tracking

There are several eye tracking measures, each intended to measure different outcomes including social gaze, social reciprocity, and attention. All stimuli are presented on a Tobii T120 binocular eye tracker monitor. The system consists of a high-resolution camera embedded in a 17-inch TFT monitor. Stimuli consist of sixty colored photographs of adult human face (equal numbers of males and females, different races and ethnicities) from the NimStim Face Stimulus Set, each showing a calm, happy, or fearful expression, and sixty scrambled versions of the face images. Shown here are the averaged response times (in seconds) to the presented stimuli, at the 6-month follow-up visit. (NCT01474746)
Timeframe: At six-month visit

Interventionseconds (Mean)
Placebo0.505969231
Active0.538312222

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Eye Tracking

There are several eye tracking measures, each intended to measure different outcomes including social gaze, social reciprocity, and attention. All stimuli are presented on a Tobii T120 binocular eye tracker monitor. The system consists of a high-resolution camera embedded in a 17-inch TFT monitor. Stimuli consist of sixty colored photographs of adult human face (equal numbers of males and females, different races and ethnicities) from the NimStim Face Stimulus Set, each showing a calm, happy, or fearful expression, and sixty scrambled versions of the face images. Shown here are the averaged response times (in seconds) to the presented stimuli, at the baseline visit. (NCT01474746)
Timeframe: At baseline visit

Interventionseconds (Mean)
Placebo0.510136154
Active0.451205556

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Mullen Scales of Early Learning - Cognitive T Score Sum

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor (not administered because it was out of age range for most subjects), visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores for each scale separately. Each scale's T score has a range of 20 to 80, a mean of 50, and a standard deviation of 10, and the lower the T score, the lower the child's cognitive and developmental ability. Cognitive T score sum is the sum of the T scores for each scale administered; since 4 scales were administered, the sum's range is 80 to 320, with lower sums indicating lower overall ability. The MSEL was administered at the baseline and 6-month follow-up visits, and mean cognitive T score sums from the 6-month follow-up visit for the placebo and treatment groups are shown here. (NCT01474746)
Timeframe: At six-month visit

InterventionT scores (Mean)
Placebo93.0
Active105.4

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Mullen Scales of Early Learning - Cognitive T Score Sum

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor (not administered because it was out of age range for most subjects), visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores for each scale separately. Each scale's T score has a range of 20 to 80, a mean of 50, and a standard deviation of 10, and the lower the T score, the lower the child's cognitive and developmental ability. Cognitive T score sum is the sum of the T scores for each scale administered; since 4 scales were administered, the sum's range is 80 to 320, with lower sums indicating lower overall ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean baseline cognitive T score sums for the placebo and treatment groups are shown here. (NCT01474746)
Timeframe: At baseline visit

InterventionT scores (Mean)
Placebo96.0
Active99.7

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Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score

The Preschool Language Scale-fifth edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children birth to 7 years 11 months. The measure examines the child's attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The PLS-5 has expanded coverage of early play behaviors, concepts, Theory of Mind, as well as emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the 6-month follow-up visit. (NCT01474746)
Timeframe: At six-month visit

Interventionunits on a scale (Mean)
Placebo59.89
Active62.80

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Mullen Scales of Early Learning - Fine Motor Age-equivalent Score

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean baseline age-equivalent scores from the Fine Motor scale. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's fine motor skills are at a level typical of younger ages, and higher scores indicating that a child's fine motor skills are at a level typical of older ages. (NCT01474746)
Timeframe: At baseline visit

Interventionmonths (Mean)
Placebo24.5
Active22.7

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Mullen Scales of Early Learning - Fine Motor Raw Score

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean raw scores from the Fine Motor scale at the 6-month follow-up visit. This scale's raw scores range from 0 to 49. The lower the score on this scale, the weaker the child's fine motor skills; the higher the score, the greater the child's fine motor skills. (NCT01474746)
Timeframe: At six-month visit

Interventionunits on a scale (Mean)
Placebo25.2
Active27.3

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Mullen Scales of Early Learning - Fine Motor Raw Score

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean raw scores from the Fine Motor scale at the baseline visit. This scale's raw scores range from 0 to 49. The lower the score on this scale, the weaker the child's fine motor skills; the higher the score, the greater the child's fine motor skills. (NCT01474746)
Timeframe: At baseline visit

Interventionunits on a scale (Mean)
Placebo24.8
Active23.1

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Mullen Scales of Early Learning - Summary Age-equivalent Score

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately, as well as a cognitive T score sum and summary age-equivalent score to characterize overall early developmental ability. Summary age-equivalent scores range from 0 to 70 months, with lower scores indicating that a child's ability is at a level typical of younger ages, and higher scores indicating that a child's ability is at a level typical of older ages. The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean baseline summary age-equivalent scores for the placebo and treatment groups are shown here. (NCT01474746)
Timeframe: At baseline visit

Interventionmonths (Mean)
Placebo24.8
Active26.8

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Mullen Scales of Early Learning - Summary Age-equivalent Score

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately, as well as a cognitive T score sum and summary age-equivalent score to characterize overall early developmental ability. Summary age-equivalent scores range from 0 to 70 months, with lower scores indicating that a child's ability is at a level typical of younger ages, and higher scores indicating that a child's ability is at a level typical of older ages. The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean summary age-equivalent scores at the 6-month follow-up visit for the placebo and treatment groups are shown here. (NCT01474746)
Timeframe: At six-month visit

Interventionmonths (Mean)
Placebo23.6
Active30.1

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Mullen Scales of Early Learning - Visual Reception Age-equivalent Score

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean age-equivalent scores from the Visual Reception scale at the 6-month follow-up visit. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's visual reception is at a level typical of younger ages, and higher scores indicating that a child's visual reception is at a level typical of older ages. (NCT01474746)
Timeframe: At six-month visit

Interventionmonths (Mean)
Placebo30.6
Active33.7

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Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) - Adaptive Behavior Composite Standard Score

The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups baseline. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning. (NCT01474746)
Timeframe: At baseline visit

Interventionunits on a scale (Mean)
Placebo73.3
Active66.5

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Sensory Processing Measure-Preschool (SPM-P) Social Participation: Raw Score

The Sensory Processing Measure - Preschool (SPM-P) is a questionnaire that was used to measure specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old. The SPM-P provides norm-referenced standard scores for two higher level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). The SPM-P was administered to the caregiver at baseline and again at the 6-month follow-up visit. Reported here is the Social Participation subscale mean raw score from the 6-month visit, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation. (NCT01474746)
Timeframe: At six-month visit

Interventionunits on a scale (Mean)
Placebo19.7
Active18.0

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Sensory Processing Measure - Preschool (SPM-P) Social Participation: Raw Score

The Sensory Processing Measure - Preschool (SPM-P) is a questionnaire that was used to measure specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old. The SPM-P provides norm-referenced standard scores for two higher level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). Reported here is the Social Participation subscale mean raw score, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation. (NCT01474746)
Timeframe: At baseline visit

Interventionunits on a scale (Mean)
Placebo20.6
Active20.5

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Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score

The Preschool Language Scale-fifth edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children birth to 7 years 11 months. The measure examines the child's attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The PLS-5 has expanded coverage of early play behaviors, concepts, Theory of Mind, as well as emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the baseline visit. (NCT01474746)
Timeframe: At baseline visit

Interventionunits on a scale (Mean)
Placebo53.90
Active55.59

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Change in Mullen Scales of Early Learning - Expressive Language Standard T Score

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately. Shown here are the baseline and 6-month follow-up T scores from the expressive language scale. T scores have a range of 20 to 80, a mean of 50, and a standard deviation of 10. Any child scoring at or below 1.5 standard deviations below the average is considered presenting significant delays. The lower the T score, the worse the outcome. The MSEL was administered at the baseline visit and at the 6-month follow-up visit. (NCT01474746)
Timeframe: From baseline visit to six-month visit

,
InterventionT scores (Mean)
Baseline6-Month Follow-Up
Active25.825.8
Placebo23.322.6

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Change in Mullen Scales of Early Learning - Expressive Language Raw Score

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the baseline and 6-month follow-up raw scores from the expressive language scale. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the ability; the higher the score, the greater the ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit. (NCT01474746)
Timeframe: From baseline visit to six-month visit.

,
Interventionunits on a scale (Mean)
BaselineFollow-Up
Active21.325.04
Placebo19.321.3

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Visual Analog Scale

"The Visual Analog Scale will be used to measure the severity of three specific behavioral symptoms chosen by the caregiver(s). Parents mark on a visual line measuring 10 cm with worst behavior at 0 cm and best behavior at 10 cm. The parents choose two key behaviors that they want to target for this trial (e.g., aggression, hyperarousal, anxiety, hyperactivity) and the third target measurement is language/communication. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 6-month visit. The calculated distance in cm between the baseline and 6-month visit marks thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side, at baseline. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm." (NCT01474746)
Timeframe: At baseline visit

Interventioncentimeters (Mean)
Placebo2.95
Active2.62

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Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score

The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups at the 6-month visit. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning. (NCT01474746)
Timeframe: At six-month visit

Interventionunits on a scale (Mean)
Placebo74.5
Active66.4

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Mullen Scales of Early Learning - Visual Reception Raw Score

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean raw scores from the Visual Reception scale at the 6-month follow-up visit. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the child's ability for visual reception; the higher the score, the greater the ability for visual reception. (NCT01474746)
Timeframe: At six-month visit

Interventionunits on a scale (Mean)
Placebo30.9
Active32.4

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Mullen Scales of Early Learning - Visual Reception Raw Score

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean baseline raw scores from the Visual Reception scale. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the child's ability for visual reception; the higher the score, the greater the ability for visual reception. (NCT01474746)
Timeframe: At baseline visit

Interventionunits on a scale (Mean)
Placebo28.9
Active26.3

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Mullen Scales of Early Learning - Visual Reception Age-equivalent Score

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean baseline age-equivalent scores from the Visual Reception scale. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's visual reception is at a level typical of younger ages, and higher scores indicating that a child's visual reception is at a level typical of older ages. (NCT01474746)
Timeframe: At baseline visit

Interventionmonths (Mean)
Placebo28.2
Active25.3

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Sensory Profile - Sensation Seeking Subscale Raw Score

"The Sensory Profile is designed to measure sensory-related difficulties. This measure will be administered to the primary caregiver of each subject to measure the caregiver's sensory ability and its impact on the subject. Of the four subscales scored in the Sensory Profile, the Sensation Seeking subscale mean raw scores for the placebo and treatment groups are reported here. This subscale has a raw scores range from 0 to 95, with scores 0-6 indicating that the child is sensation seeking much less than others, 7-19 less than others, 20-47 just like the majority of others, 48-60 more than others, and 61-95 much more than others." (NCT01474746)
Timeframe: At baseline visit

Interventionunits on a scale (Mean)
Placebo47.86364
Active47.83333

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The Autism Diagnostic Observation Schedule (ADOS-2)

The Autism Diagnostic Observation Schedule (ADOS-2) assesses and diagnoses autism spectrum disorder. This test was administered at baseline and at the six-month follow-up visit. The choice to administer Module 1 or Module 2 depends on the verbal ability of each subject: Module 1 is used for children who are 31 months and older and/or who do not consistently use phrase speech, and Module 2 is used for children of any age who use phrase speech but are not verbally fluent. The scoring algorithm gives an overall total, which ranges from 0 to 28. The higher the score, the higher the level of autism-related symptoms. The overall total ranges from 0 to 28. On Module 1, for children with few to no words, scores at 11 and above indicate autism spectrum; for children with some words, the cutoff is scores 8 and above. On Module 2, the cutoff for autism spectrum is 7 or above for kids under 5 years, and 8 or above for those 5 years and older. (NCT01474746)
Timeframe: At six month visit

Interventionunits on a scale (Mean)
Placebo11.00
Active11.67

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The Visual Analog Scale

"The Visual Analog Scale will be used to measure the severity of three specific behavioral symptoms chosen by the caregiver(s). Parents mark on a visual line measuring 10 cm with worst behavior at 0 cm and best behavior at 10 cm. The parents choose two key behaviors that they want to target for this trial (e.g., aggression, hyperarousal, anxiety, hyperactivity) and the third target measurement is language/communication. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 6-month visit. The calculated distance in cm between the baseline and 6-month visit marks thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side, at the 6-month visit. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm." (NCT01474746)
Timeframe: At six-month visit

Interventionunits on a scale (Mean)
Placebo5.16
Active5.58

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Autism Diagnostic Observation Schedule

The Autism Diagnostic Observation Schedule (ADOS-2) assesses and diagnoses autism spectrum disorder. This test was administered at baseline and at the six-month follow-up visit. The choice to administer Module 1 or Module 2 depends on the verbal ability of each subject: Module 1 is used for children who are 31 months and older and/or who do not consistently use phrase speech, and Module 2 is used for children of any age who use phrase speech but are not verbally fluent. The scoring algorithm gives an overall total, which ranges from 0 to 28. The higher the score, the higher the level of autism-related symptoms. The overall total ranges from 0 to 28. On Module 1, for children with few to no words, scores at 11 and above indicate autism spectrum; for children with some words, the cutoff is scores 8 and above. On Module 2, the cutoff for autism spectrum is 7 or above for kids under 5 years, and 8 or above for those 5 years and older. (NCT01474746)
Timeframe: At baseline visit

Interventionunits on a scale (Mean)
Placebo10.73
Active11.00

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Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)

Total Score; Range 0-136 with increasing PTSD severity as scores increase (NCT01524133)
Timeframe: 24 weeks

InterventionScores on a scale (Mean)
Sertraline + Enhanced Medication Management (SERT/EMM)41.7
Prolonged Exposure + Sertraline (PE/SERT)43.3
Prolonged Exposure + Placebo (PE/PLB)51.5

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Patient Health Questionnaire-15

PHQ-15; measures somatization and ranges from 0 to 30 and 0-9 is considered minimal/low, 10-14 is moderate, and 15-30 is severe (NCT01524133)
Timeframe: 24 weeks

InterventionScores on a scale (Mean)
Sertraline + Enhanced Medication Management (SERT/EMM)8.6
Prolonged Exposure + Sertraline (PE/SERT)9.8
Prolonged Exposure + Placebo (PE/PLB)10.5

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Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation

Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. (NCT01607593)
Timeframe: Start of administration

InterventionParticipants (Number)
Normal at startBorderline at startMild at startModerate at startMarked at startSevere at startThe most severe at start
Sertraline (Zoloft)00166817201

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Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation

Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. (NCT01607593)
Timeframe: Up to 6 years

InterventionParticipants (Number)
Normal at endBorderline at endMild at endModerate at endMarked at endSevere at endThe most severe at end
Sertraline (Zoloft)13194040451

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Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation

Number of participants in each category of CGI-I at end of administration/observation. CGI-I is a 7-point clinician-rated scale, ranging from (1) Very much improved, (2)Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, and (7) Very much worse. (NCT01607593)
Timeframe: Up to 6 years

InterventionParticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Sertraline (Zoloft)23382532400

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Number of Patients Experiencing an Antidepressant Response (>50% Reduction in HDRS) at Endpoint of 8 Weeks

The Hamilton Depression Rating Scale (HDRS) is a clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher HDRS scores indicate a worse outcome. The scale has a minimum value of 0 and a maximum value of 52. (NCT01703039)
Timeframe: 0 weeks-8 weeks

InterventionParticipants (Count of Participants)
Sertraline + Riluzole1
Sertraline + Placebo3

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Number of Patients Experiencing Remission From Depression (HDRS<7) at Endpoint of 8 Weeks

The Hamilton Depression Rating Scale (HDRS) is a clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher HDRS scores indicate a worse outcome. The scale has a minimum value of 0 and a maximum value of 52. (NCT01703039)
Timeframe: 0 weeks-8 weeks

InterventionParticipants (Count of Participants)
Sertraline + Riluzole0
Sertraline + Placebo1

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Mean Change in Clinical Global Impression (CGI) Scale From Baseline (0 Weeks) to Endpoint at 8 Weeks

The Clinical Global Impression Scale (CGI) is a brief clinician-rated instrument. The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Treatment response ratings should take account of both therapeutic efficacy and treatment-related adverse events and range from 0 (marked improvement and no side-effects) and 4 (unchanged or worse and side-effects outweigh the therapeutic effects). Each component of the CGI is rated separately; the instrument does not yield a global score. (NCT01703039)
Timeframe: 0 weeks-8 weeks

Interventionscore on a scale (Mean)
Sertraline + Riluzole-0.67
Sertraline + Placebo-2.71

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Mean Change in Hamilton Anxiety Rating Scale (HARS) Score From Baseline (0 Weeks) to Endpoint at 8 Weeks

The HARS scale is a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It has 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicate less anxiety. (NCT01703039)
Timeframe: 0 weeks-8 weeks

Interventionscore on a scale (Mean)
Sertraline + Riluzole-9.50
Sertraline + Placebo-15.57

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Mean Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline (0 Weeks) to Endpoint at 8 Weeks

The Hamilton Depression Rating Scale (HDRS) is a clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher HDRS scores indicate a worse outcome. The scale has a minimum value of 0 and a maximum value of 52. (NCT01703039)
Timeframe: 0 weeks-8 weeks

Interventionscore on a scale (Mean)
Sertraline + Riluzole-5.67
Sertraline + Placebo-13.43

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Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16)

Self-report measure of depression severity (range 0 - 27, higher scores indicate more severe depressive symptoms). This applies to the candesartan Phase 2 arm. (NCT01794455)
Timeframe: Week 20

Interventionunits on a scale (Number)
Phase 2: Candesartan11

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Montgomery-Asberg Depression Rating Scale

MADRS is a measure of depression severity (range 0 - 60, higher scores indicate more severe depressive symptoms). This outcome applies to the candesartan Phase 2 arm. (NCT01794455)
Timeframe: Week 20

Interventionunits on a scale (Number)
Phase 2: Candesartan22

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Center for Epidemiologic Studies in Depression (CES-D) Scale

Center for Epidemiologic Studies in Depression (CES-D) scale at 14 weeks. CES-D scores are based on a 20 item survey with total scores ranging from 0 to 60. Higher scores suggest a greater presence of depressive symptoms. A CES-D score of 16 or higher is interpreted to indicate a risk for depression. (NCT01802385)
Timeframe: 14 weeks

Interventionscore on a scale (Mean)
Placebo16.6
Sertraline 400mg13.2

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Event Free Survival

Event free survival of composite events of: death,central nervous system (CNS) cryptococcal-related paradoxical immune reconstitution inflammatory syndrome (IRIS) or culture-positive relapse. (NCT01802385)
Timeframe: 18 weeks

InterventionParticipants (Count of Participants)
Placebo116
Sertraline 400mg103

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Safety (Occurence of Adverse Events)

Safety and tolerability of adjunctive sertraline (grade 4-5) adverse reactions (NCT01802385)
Timeframe: 18 weeks

Interventionevents (Number)
Placebo121
Sertraline 400mg141

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Survival

18-week survival. The comparison will be between sertraline 400mg group and placebo (NCT01802385)
Timeframe: 18 weeks

InterventionParticipants (Count of Participants)
Placebo125
Sertraline 400mg109

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Fungal Clearance as Determined by Early Fungicidal Activity of CDF

To determine whether adjunctive sertraline will lead to a faster rate of fungal clearance from cerebrospinal fluid (CSF), as measured by early fungicidal activity (EFA) of clearance of the Cryptococcus colony forming units (cfu) per mL of CSF per day, compared to standard therapy alone. (NCT01802385)
Timeframe: 14 days

,
Intervention-log10 CFU/ml/day (Mean)
General Linear RegressionMixed-Effects Regression
Placebo0.470.33
Sertraline 400mg.43.33

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Number of Participants Experiencing IRIS OR Relapse

Cumulative incidence of central nervous system (CNS) cryptococcal-related paradoxical immune reconstitution inflammatory syndrome (IRIS) or culture-positive relapse (NCT01802385)
Timeframe: 18 weeks

InterventionParticipants (Count of Participants)
Placebo9
Sertraline 400mg5

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Count of Participants With Cerebrospinal Fluid Sterility

Number of participants with sterile cerebrospinal fluid at 2 weeks (NCT01802385)
Timeframe: 14 days

InterventionParticipants (Count of Participants)
Placebo90
Sertraline 400mg101

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Quantitative Neurocognitive Performance Score (QNPZ-8)

Quantitative neurocognitive performance Z-score (QNPZ-8) at 14 weeks. The QNPZ-8 is a mean score of testing of 8 neurocognitive domains. Eqach domain is scaled based on a Z-score where the mean = 0 for the HIV-negative Ugandan population, accounting for age and educational status. Each +1 unit is one standard deviation better than the population norm. Each -1 unit is one standard deviation worse than the population norm. (NCT01802385)
Timeframe: 14 weeks

Interventionscore (Mean)
Placebo-1.4
Sertraline 400mg-1.3

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Change in Clinician-rated Depression Severity

Change in depression severity will be measured by the clinician-rated Montgomery Asberg Depression Rating Scale (MADRS), range of 0-60, with higher scores indicating more severe depression (NCT01896934)
Timeframe: Assessed every 2 weeks from baseline to week 12, change from baseline to week 12 is reported

Interventionunits on a scale (Mean)
Sertraline16.14

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Remission of Depression

Montgomery-Asberg Depression Rating Scale (MADRS) is a measure of depression severity. This will be used to define remission as a score of 7 or less. (NCT01896934)
Timeframe: Week 12

InterventionParticipants (Count of Participants)
Sertraline10

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Change in Patient-rated Depression Severity

Change in depression severity measured by the patient-rated Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16). The QIDS-SR16 is a self-report measure of depression severity with a range of 0-27, with higher scores indicative of more severe depression. (NCT01896934)
Timeframe: Assessed every 2 weeks from baseline to week 12, change from baseline to week 12 is reported

Interventionunits on a scale (Mean)
Sertraline3.82

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Money Earned

"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

,
InterventionUS Dollars (Mean)
Baseline VisitAfter 6 Weeks of Treatment
Healthy Controls25.021.9
Participants With Major Depressive Disorder23.220.5

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Self Paced Walking Test (SPWT)

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).

Interventionmeters (Mean)
Medical Care130.5
Group Exercise219.2
Manual Therapy and Exercise267.8

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Sense Wear Armband

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).

Interventionminutes per day (Mean)
Medical Care-23.1
Group Exercise4.3
Manual Therapy and Exercise-6.0

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Swiss Spinal Stenosis (SSS) Questionnaire Score

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).

Interventionunits on a scale (Mean)
Medical Care-2.0
Group Exercise-1.7
Manual Therapy and Exercise-4.1

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Cost of Health Care Utilization

Total cost of health care utilization from baseline through 18 months post-randomization (NCT01993017)
Timeframe: Baseline through 18 months

InterventionUS dollars (Mean)
AHA Depression Screen, Notify & Treat6745
Depression Screen & Notify6204
No Depression Screen7440

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Depression-free Days

Depression-free days from baseline through 18 months post-randomization (NCT01993017)
Timeframe: Baseline through 18 months

Interventioncumulative depression-free days (Mean)
AHA Depression Screen, Notify & Treat343.1
Depression Screen & Notify351.3
No Depression Screen339.0

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Quality-Adjusted Life Years (QALYs)

Change in QALYs from baseline through 18 months. QALYs are a generic measure of disease burden, including both the quality and the quantity of life lived. One QALY equates to one year in perfect health. To measure change in QALYs, utility scores [an overall assessment of well-being on a scale from 0 (death) to 1 (perfect health)], were estimated using the Short Form-6 dimension, with scores derived from responses to the 12-Item Short-Form Health Survey, version 2, at baseline and 6, 12, and 18 months. QALYs for the period from baseline to 18 months were then calculated as the area under the curve by linearly interpolating the utility scores at the 4 assessments. Change in QALYs was then obtained by subtracting the baseline QALY from the observed QALY for an 18-month period, where baseline QALY was calculated under the assumption that the baseline utility score remained constant during the 18-month period. (NCT01993017)
Timeframe: Baseline, 6, 12 and 18 months

Interventionquality-adjusted life years (QALYs) (Mean)
AHA Depression Screen, Notify & Treat-0.06
Depression Screen & Notify-0.06
No Depression Screen-0.06

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Number of Remission From Major Depressive Episode Events

Remission from major depressive episode as assessed by 17-item Hamilton Depression Rating Scale. (NCT02137369)
Timeframe: 12 weeks

Interventionnumber of events (Number)
SSRI15
Cognitive Behavioral Therapy4

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Number of Response to Treatment Events

Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks (NCT02137369)
Timeframe: 12 weeks

Interventionnumber of events (Number)
SSRI21
Cognitive Behavioral Therapy5

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Clinical Global Impression-Improvement (CGI-I) Score

"The CGI-I score at the final visit will determine treatment response.~The CGI-Improvement scale comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale.~The following one query is rated on a seven-point scale: Compared to the patient's condition at admission to the project [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.~CGI-I scale of 1-2 is considered response to treatment. Anything below that is considered non-response to sertraline treatment." (NCT02189213)
Timeframe: Final visit, at 12 weeks of treatment

Interventionunits on a scale (Mean)
Sertraline Responders1.00
Sertraline Non-Responders3.66

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Reported Infant Weight at 12 Weeks Following Delivery

(NCT02235064)
Timeframe: 12 weeks postpartum

InterventionGrams (Mean)
Sertraline5301
Placebo4734

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Number of Participants With Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital

The Antidepressant Side-Effect Checklist (ASEC) was employed to detect any adverse reaction to treatment regimens (NCT02235064)
Timeframe: Discharge from hospital to 12 weeks postpartum

InterventionParticipants (Count of Participants)
Sertraline0
Placebo1

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Number of Participants With Perceived Infant Feeding Difficulties 12 Weeks Postpartum

(NCT02235064)
Timeframe: 12 weeks postpartum

InterventionParticipants (Count of Participants)
Sertraline0
Placebo0

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Number of Participants With Perceived Infant Feeding Difficulties 4 Weeks Postpartum

(NCT02235064)
Timeframe: 4 weeks postpartum

InterventionParticipants (Count of Participants)
Sertraline0
Placebo0

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Number of Participants With Perceived Infant Feeding Difficulties 8 Weeks Postpartum

(NCT02235064)
Timeframe: 8 weeks postpartum

InterventionParticipants (Count of Participants)
Sertraline0
Placebo0

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Number of Participants With Perceived Infant Sleeping Difficulty at 12 Weeks Postpartum

(NCT02235064)
Timeframe: 12 weeks postpartum

InterventionParticipants (Count of Participants)
Sertraline0
Placebo0

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Number of Participants With Development of Postpartum Depression up to 12 Weeks Following Discharge From Hospital

"Patients met with single psychiatrist (co-investigator), blinded to group assignment, who evaluated the patient using Edinburgh Postpartum Depression Screen, Hamilton Depression Rating Scale, Global Assessment of Functioning Scale, and clinical assessment~0 = No postpartum depression up to 12 weeks following discharge from hospital~1 = Postpartum depression up to 12 weeks following discharge from hospital" (NCT02235064)
Timeframe: Discharge from hospital to 12 weeks postpartum

InterventionParticipants (Count of Participants)
Sertraline0
Placebo0

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Reported Infant Weight at 4 Weeks Following Delivery

(NCT02235064)
Timeframe: 4 weeks postpartum

InterventionGrams (Mean)
Sertraline3033
Placebo2750

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Reported Infant Weight at 8 Weeks Following Delivery

(NCT02235064)
Timeframe: 8 weeks postpartum

InterventionGrams (Mean)
Sertraline5301
Placebo3685

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Number of Participants With Perceived Infant Sleeping Difficulty at 4 Weeks Postpartum

(NCT02235064)
Timeframe: 4 weeks postpartum

InterventionParticipants (Count of Participants)
Sertraline0
Placebo0

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Number of Participants With Perceived Infant Sleeping Difficulty at 8 Weeks Postpartum

(NCT02235064)
Timeframe: 8 weeks postpartum

InterventionParticipants (Count of Participants)
Sertraline0
Placebo0

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Serum Phosphorus Level

Treatment Adherence with Diet and/or Medications as defined by Serum phosphorus level measured as a part of routine clinical care during the third month of participation in the study. (NCT02358343)
Timeframe: Week 12

Interventionmg/dl (Mean)
Cognitive Behavioral Therapy6.1
Antidepressant Drug Therapy6.3

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Satisfaction With Life Scale

range 1-35, higher scores indicate better satisfaction (NCT02358343)
Timeframe: Week 12

Interventionscore on a scale (Mean)
Cognitive Behavioral Therapy16.8
Antidepressant Drug Therapy20.1

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GAD-7

Generalized Anxiety Disorder 7-item Scale, range 0-21, higher scores indicate worse anxiety (NCT02358343)
Timeframe: Week 12

Interventionscore on a scale (Mean)
Cognitive Behavioral Therapy7.5
Antidepressant Drug Therapy6.5

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SF-36 Energy/Vitality

Energy/vitality subscale of the 36-Item Short Form Health Survey, range 0-100, higher scores indicate better energy/vitality (NCT02358343)
Timeframe: Week 12

Interventionscore on a scale (Mean)
Cognitive Behavioral Therapy39.2
Antidepressant Drug Therapy53

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Sheehan Disability Scale

range 0-30, higher scores indicate worse disability (NCT02358343)
Timeframe: Week 12

Interventionscore on a scale (Mean)
Cognitive Behavioral Therapy15.2
Antidepressant Drug Therapy11.0

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BDI-II

Beck Depression Inventory-II, range 0-63, higher scores indicate worse depression (NCT02358343)
Timeframe: Week 12

Interventionscore on a scale (Mean)
Cognitive Behavioral Therapy18.7
Antidepressant Drug Therapy14.1

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Exercise

Single item activity measure, range 1-6, higher indicates less activity (NCT02358343)
Timeframe: Week 12

Interventionscore on a scale (Mean)
Cognitive Behavioral Therapy3.5
Antidepressant Drug Therapy3.2

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Global Quality of Life Scale

range 0-10, higher scores indicate better quality of life (NCT02358343)
Timeframe: Week 12

Interventionscore on a scale (Mean)
Cognitive Behavioral Therapy5.6
Antidepressant Drug Therapy6.4

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Number of Participants Who Accepted Depression Treatment

"The secondary measure of efficacy of the Engagement Interview will be the % of patients undergoing hemodialysis with co-morbid depression who are willing to accept treatment.~This will be measured by the patient's intent and will be defined as one of the following:~Signing the informed consent to be randomly assigned to individual CBT or drug therapy~Receiving a referral by the research team and/or primary care physician and/or treating nephrologist to a therapist for psychotherapy in the community.~Receiving a prescription for anti-depressant drug therapy from primary care physician and/or treating nephrologist within two weeks of establishing a diagnosis of major depression/dysthymia." (NCT02358343)
Timeframe: within two weeks of engagement interview or control visit

InterventionParticipants (Count of Participants)
Engagement Interview70
Control Visit70

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Number of Participants Who Initiated Depression Treatment

"The primary measure of efficacy of the Engagement Interview will be the number of patients undergoing hemodialysis with co-morbid depression who initiate treatment for the condition.~This will be defined as one of the following:~Completing at least one psychotherapy session either as a part of the clinical trial or in the community within four weeks of establishing a diagnosis of major depression and/or dysthymia.~Receiving a supply of anti-depressant drug either as a part of the clinical trial or the treating physician within four weeks of establishing a diagnosis of major depression and/or dysthymia." (NCT02358343)
Timeframe: within four weeks of engagement interview or control visit

InterventionParticipants (Count of Participants)
Engagement Interview57
Control Visit54

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Perceived Social Support

Multi-Dimensional Scale of Perceived Social Support, range 1-7, higher scores indicate better social support (NCT02358343)
Timeframe: Week 12

Interventionscore on a scale (Mean)
Cognitive Behavioral Therapy4.7
Antidepressant Drug Therapy4.6

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Percent Inter-dialytic Weight Gain

Treatment Adherence with Fluid Intake as defined by inter-dialytic weight gain (as % of post-dialysis weight) during Week 12 of the study (NCT02358343)
Timeframe: Week 12

Interventionpercentage of body weight (Mean)
Cognitive Behavioral Therapy2.6
Antidepressant Drug Therapy2.9

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Percentage of Dialysis Treatment Sessions Skipped and/or Shortened

Treatment Adherence with Dialysis as defined by the percentage of all dialysis sessions skipped and/or requested by the patient to be shortened by ≥ 10 minutes over the 12-week intervention period. Dialysis sessions missed due to hospitalization will not be included as a skipped treatment. (NCT02358343)
Timeframe: Over 12 Weeks

Interventionpercentage of sessions skipped/shortened (Mean)
Cognitive Behavioral Therapy22.2
Antidepressant Drug Therapy17.3

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PSQI

Pittsburgh Sleep Quality Index, range 0-21, higher scores indicate worse sleep quality (NCT02358343)
Timeframe: Week 12

Interventionscore on a scale (Mean)
Cognitive Behavioral Therapy9.5
Antidepressant Drug Therapy6.8

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QIDS-C Score

The Quick Inventory of Depressive Symptomatology Clinician-rated (QIDS-C) scale ranges from 0-27, higher scores indicate worse depression. The primary measure of efficacy of Intervention will be the mean difference in QIDS-C score at Week 12 between treatment groups. (NCT02358343)
Timeframe: Week 12 of treatment

Interventionscore on a scale (Mean)
Cognitive Behavioral Therapy8.1
Antidepressant Drug Therapy5.9
Observational Cohort7.9

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Change in Mullen Scales of Early Learning - Combined Age Equivalent Score

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the baseline and 6-month follow-up combined age equivalent scores, calculated as the sum of the age equivalent scores from each scale. The combined score ranges from 0 to 280. The lower the score on this scale, the weaker the ability; the higher the score, the greater the ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit. (NCT02385799)
Timeframe: From baseline visit to six-month visit

,
Interventionscore on a scale (Mean)
BaselineFollow-up
Sertraline Active Medication24.9828.16
Sertraline Liquid Placebo25.6130.30

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Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score

The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups at baseline. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning. (NCT02385799)
Timeframe: At baseline visit

Interventionscore on a scale (Mean)
Sertraline Liquid Placebo68.50
Sertraline Active Medication60.03

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Change in Mullen Scales of Early Learning - Expressive Language Raw Score

The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the baseline and 6-month follow-up raw scores from the expressive language scale. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the ability; the higher the score, the greater the ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit. (NCT02385799)
Timeframe: From baseline visit to six-month visit

,
Interventionscore on a scale (Mean)
BaselineFollow-up
Sertraline Active Medication18.1920.31
Sertraline Liquid Placebo19.6921.81

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Visual Analog Scale - Language/Communication Score

"The Visual Analog Scale measures the severity of three specific behavioral symptoms as reported by the parent/caregiver: Language/Communication, Anxiety/Obsessive Compulsive Behaviors, and Aggression/Hyperactivity/Hyperarousal. Caregivers mark on a visual line measuring 10 cm with worst behavior at 0 cm and best behavior at 10 cm. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the six-month visit. The calculated distance in cm between the marks drawn at the baseline and six-month visits thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side for the Language/Communication scale, at the six-month visit. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm." (NCT02385799)
Timeframe: At six-month visit

Interventioncentimeters (Mean)
Sertraline Liquid Placebo5.53
Sertraline Active Medication4.70

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Visual Analog Scale - Language/Communication Score

"The Visual Analog Scale measures the severity of three specific behavioral symptoms as reported by the parent/caregiver: Language/Communication, Anxiety/Obsessive Compulsive Behaviors, and Aggression/Hyperactivity/Hyperarousal. Caregivers mark on a visual line measuring 10 cm with worst behavior at 0 cm and best behavior at 10 cm. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the six-month visit. The calculated distance in cm between the marks drawn at the baseline and six-month visits thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side for the Language/Communication scale, at baseline. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm." (NCT02385799)
Timeframe: At baseline visit

Interventioncentimeters (Mean)
Sertraline Liquid Placebo2.84
Sertraline Active Medication2.03

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Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score

The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups at the six-month visit. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning. (NCT02385799)
Timeframe: At six-month visit

Interventionscore on a scale (Mean)
Sertraline Liquid Placebo71.52
Sertraline Active Medication69.68

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Sensory Processing Measure-Preschool - Social Participation Raw Score

The Sensory Processing Measure-Preschool (SPM-P) is a questionnaire measuring specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old, as reported by the parent/caregiver. The SPM-P provides norm-referenced standard scores for two higher-level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). Reported here is the Social Participation subscale mean raw score at the six-month visit, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation. (NCT02385799)
Timeframe: At six-month visit

Interventionscore on a scale (Mean)
Sertraline Liquid Placebo20.86
Sertraline Active Medication21.16

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Sensory Processing Measure-Preschool - Social Participation Raw Score

The Sensory Processing Measure-Preschool (SPM-P) is a questionnaire measuring specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old, as reported by the parent/caregiver. The SPM-P provides norm-referenced standard scores for two higher-level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). Reported here is the Social Participation subscale mean raw score at baseline, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation. (NCT02385799)
Timeframe: At baseline visit

Interventionscore on a scale (Mean)
Sertraline Liquid Placebo21.96
Sertraline Active Medication22.39

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Preschool Language Scale-Fifth Edition - Total Language Raw Score

The Preschool Language Scale-Fifth Edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children from birth to 7 years 11 months. The measure examines the child's attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The PLS-5 has expanded coverage of early play behaviors, concepts, theory of mind, and emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the six-month visit. (NCT02385799)
Timeframe: At six-month visit

Interventionscore on a scale (Mean)
Sertraline Liquid Placebo57.24
Sertraline Active Medication51.40

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Preschool Language Scale-Fifth Edition - Total Language Raw Score

The Preschool Language Scale-Fifth Edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children from birth to 7 years 11 months. The measure examines the child's attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The PLS-5 has expanded coverage of early play behaviors, concepts, theory of mind, and emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the baseline visit. (NCT02385799)
Timeframe: At baseline visit

Interventionscore on a scale (Mean)
Sertraline Liquid Placebo48.65
Sertraline Active Medication43.03

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Preschool Anxiety Scale-Revised - Total Score

Preschool Anxiety Scale-Revised (PAS-R) is a questionnaire designed to assess symptoms of anxiety and fears in young children aged 6 and below as reported by their parents. The PAS-R consists of 34 questions, each with a rating option of 0 to 4 where 0=not true at all, 1=seldom true, 2=sometimes true, 3=quite often true, and 4=very often true. The total score is calculated as the sum of all responses and therefore ranges from 0 to 136. Lower scores indicate less anxiety/fear; higher scores indicate more anxiety/fear. Reported here are the mean total scores for the placebo and treatment groups at the six-month visit. (NCT02385799)
Timeframe: At six-month visit

Interventionscore on a scale (Mean)
Sertraline Liquid Placebo11.43
Sertraline Active Medication14.77

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Preschool Anxiety Scale-Revised - Total Score

Preschool Anxiety Scale-Revised (PAS-R) is a questionnaire designed to assess symptoms of anxiety and fears in young children aged 6 and below as reported by their parents. The PAS-R consists of 34 questions, each with a rating option of 0 to 4 where 0=not true at all, 1=seldom true, 2=sometimes true, 3=quite often true, and 4=very often true. The total score is calculated as the sum of all responses and therefore ranges from 0 to 136. Lower scores indicate less anxiety/fear; higher scores indicate more anxiety/fear. Reported here are the mean total scores for the placebo and treatment groups at baseline. (NCT02385799)
Timeframe: At baseline visit

Interventionscore on a scale (Mean)
Sertraline Liquid Placebo15.38
Sertraline Active Medication14.75

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Clinical Global Impression Scale-Severity (CGI-S)

The Clinical Global Impression-Severity (CGI-S) is a 7-point scale completed by a clinician that yields a rating of the patient's illness severity at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The 7-point scale ranges from: 1 = Normal; 2 = Borderline Ill; 3 = Mildly Ill; 4 = Moderately Ill; 5 = Markedly Ill; 6 = Severely Ill; and 7 = Extremely Ill. Therefore, the higher the score, the greater the severity of the patient's illness. The CGI-S was administered at baseline only for the purpose of characterizing the study population. Shown here are the CGI-S mean scores from the baseline visit. (NCT02385799)
Timeframe: At baseline visit

Interventionscore on a scale (Mean)
Sertraline Liquid Placebo4.38
Sertraline Active Medication4.66

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Clinical Global Impression Scale-Improvement (CGI-I)

The Clinical Global Impression-Improvement (CGI-I) is a 7-point scale completed by a clinician that yields a score measuring the overall behavioral change of an individual and their therapeutic response. The 7-point scale ranges from: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse. Therefore, the lower the score, the greater the behavioral improvement as rated by the clinician. The CGI-I was administered at the three-month and six-month visits. Shown here are the CGI-I mean scores from the 6-month follow-up visit. (NCT02385799)
Timeframe: At six-month visit

Interventionscore on a scale (Mean)
Sertraline Liquid Placebo1.14
Sertraline Active Medication1.23

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Clinical Global Impression Scale-Improvement (CGI-I)

The Clinical Global Impression-Improvement (CGI-I) is a 7-point scale completed by a clinician that yields a score measuring the overall behavioral change of an individual and their therapeutic response. The 7-point scale ranges from: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse. Therefore, the lower the score, the greater the behavioral improvement as rated by the clinician. The CGI-I was administered at the three-month and six-month visits. Shown here are the CGI-I mean scores from the 3-month follow-up visit. (NCT02385799)
Timeframe: At three-month visit

Interventionscore on a scale (Mean)
Sertraline Liquid Placebo2.65
Sertraline Active Medication2.70

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Change From Baseline in Generalized Anxiety Disorder-7 Item (GAD-7) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])

"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)

InterventionUnits 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

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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 of Double- Blind Induction Phase- Mixed- Effects Model Using Repeated Measures (MMRM) Analysis

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

InterventionUnits 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

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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis

"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)

InterventionUnits 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

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Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis

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

InterventionUnits 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

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Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis

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

InterventionUnits 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

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Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis

"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)

InterventionUnits 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

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Percentage of Participants With Onset of Clinical Response by Day 2 and Day 8

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

,,
InterventionPercentage of Participants (Number)
Day 2 up to Day 28Day 8 up to Day 28
Intranasal Esketamine 56 mg Plus Oral Antidepressant10.413.0
Intranasal Esketamine 84 mg Plus Oral AD8.811.4
Oral AD Plus Intranasal Placebo1.83.5

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Percentage of Participants Who Achieved at Least 50% Reduction From Baseline in MADRS Total Score at the Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)

"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)

InterventionPercentage of Participants (Number)
Intranasal Esketamine 56 mg Plus Oral Antidepressant53.0
Intranasal Esketamine 84 mg Plus Oral AD47.8
Oral AD Plus Intranasal Placebo37.2

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Percentage of Participants Who Achieved at Least 50% Reduction From Baseline in MADRS Total Score at Day 28 of Double-blind Induction Phase (Observed Data)

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

InterventionPercentage of Participants (Number)
Intranasal Esketamine 56 mg Plus Oral Antidepressant54.1
Intranasal Esketamine 84 mg Plus Oral AD53.1
Oral AD Plus Intranasal Placebo38.9

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Percentage of Participants in Remission (MADRS<=12) at the Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis (LOCF Data)

"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)

InterventionPercentage of participants (Number)
Intranasal Esketamine 56 mg Plus Oral Antidepressant34.8
Intranasal Esketamine 84 mg Plus Oral AD35.4
Oral AD Plus Intranasal Placebo29.2

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Percentage of Participants in Remission (MADRS<=12) at Day 28 of Double-blind Induction Phase (Observed Data)

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

InterventionPercentage of participants (Number)
Intranasal Esketamine 56 mg Plus Oral Antidepressant36
Intranasal Esketamine 84 mg Plus Oral AD38.8
Oral AD Plus Intranasal Placebo30.6

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Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score up to Endpoint (Double-blind Induction Phase [Day 28])

"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)

InterventionUnits 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

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Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis

"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)

InterventionUnits 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

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Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): EQ-VAS

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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant20.9
Intranasal Esketamine 84 mg Plus Oral AD19.1
Oral AD Plus Intranasal Placebo14.9

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Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): Health Status Index

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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant0.224
Intranasal Esketamine 84 mg Plus Oral AD0.243
Oral AD Plus Intranasal Placebo0.181

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Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): Sum Score

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)

InterventionUnits 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

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Change From Baseline in Generalized Anxiety Disorder (GAD-7) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])

"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])

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-7.9
Intranasal Placebo Plus Oral AD-6.8

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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 in the Double-blind Induction Phase- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis

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

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-21.4
Intranasal Placebo Plus Oral AD-17.0

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Percentage of Participants Who Achieved >=50% Reduction From Baseline in MADRS Total Score at the Endpoint (Double-blind Induction Phase [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. 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])

InterventionPercentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)63.4
Intranasal Placebo Plus Oral AD49.5

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Change From Baseline in EQ 5D-5L-Health Status Index to End of Double-blind Induction Phase (Day 28)

"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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)0.288
Intranasal Placebo Plus Oral AD0.231

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Percentage of Participants in Response (SDS Total Score <=12 and Individual Item Scores Each <=4) at the End of 4-Week Double-blind Induction Phase (Day 28)

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]

InterventionPercentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)57.0
Intranasal Placebo Plus Oral AD39.5

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Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis

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

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-13.6
Intranasal Placebo Plus Oral AD-9.4

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Percentage of Participants in Remission (SDS Total Score <=6 and Individual Item Scores Each <=2) at the End of 4-Week Double-blind Induction Phase (Day 28)

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)

InterventionPercentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)39.5
Intranasal Placebo Plus Oral AD20.9

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Percentage of Participants in Remission (MADRS<=12) at the Endpoint (Double-blind Induction Phase [Day 28])

"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])

InterventionPercentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)48.2
Intranasal Placebo Plus Oral AD30.3

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Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis

"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])

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-12.5
Intranasal Placebo Plus Oral AD-9.3

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Change From Baseline in Patient Health Questionnaire - 9-Item Depression Module (PHQ-9) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis

"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])

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-12.2
Intranasal Placebo Plus Oral AD-10.1

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Percentage of Participants With Onset of Clinical Response on Day 2 and Day 8

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

,
InterventionPercentage of participants (Number)
Onset of Clinical response on Day 2Onset of Clinical response on Day 8
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)7.910.5
Intranasal Placebo Plus Oral AD4.66.4

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Change From Baseline in Patient Health Questionnaire - 9-Item Depression Module (PHQ-9) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis

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

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-13.0
Intranasal Placebo Plus Oral AD-10.2

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Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])

"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])

InterventionUnits on a scale (Median)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-2.0
Intranasal Placebo Plus Oral AD-2.0

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Change From Baseline in EQ 5D-5L- European Quality of Life - Visual Analogue Scale (EQ-VAS) to End of Double-blind Induction Phase (Day 28)

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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)29.1
Intranasal Placebo Plus Oral AD20.9

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Change From Baseline in EQ 5D-5L- Sum Score to End of Double-blind Induction Phase (Day 28)

"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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-23.2
Intranasal Placebo Plus Oral AD-17.1

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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis

"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])

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-19.6
Intranasal Placebo Plus Oral AD-16.3

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Percentage of Participants Who Achieved >=50% Reduction From Baseline in MADRS Total Score at Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)

"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]

InterventionPercentage of Participants (Number)
Intranasal Esketamine Plus Oral Antidepressant (AD)23.9
Oral AD Plus Intranasal Placebo12.5

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Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis

"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])

InterventionUnits on a scale (Mean)
Intranasal Esketamine Plus Oral Antidepressant (AD)-9.3
Oral AD Plus Intranasal Placebo-5.6

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Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis

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])

InterventionUnits on a scale (Mean)
Intranasal Esketamine Plus Oral Antidepressant (AD)-10.0
Oral AD Plus Intranasal Placebo-6.3

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Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): Sum Score

"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])

InterventionUnits on a scale (Mean)
Intranasal Esketamine Plus Oral Antidepressant (AD)-6.6
Oral AD Plus Intranasal Placebo-1.6

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Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): EQ-VAS

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])

InterventionUnits on a scale (Mean)
Intranasal Esketamine Plus Oral Antidepressant (AD)6.2
Oral AD Plus Intranasal Placebo4.4

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Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis on Ranks

"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])

InterventionUnits on a scale (Median)
Intranasal Esketamine Plus Oral Antidepressant (AD)-1.0
Oral AD Plus Intranasal Placebo0.0

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Percentage of Participants in Remission (MADRS<=12) at Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)

"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]

InterventionPercentage of Participants (Number)
Intranasal Esketamine Plus Oral Antidepressant (AD)15.5
Oral AD Plus Intranasal Placebo6.3

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Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): Health Status Index

"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])

InterventionUnits on a scale (Mean)
Intranasal Esketamine Plus Oral Antidepressant (AD)0.081
Oral AD Plus Intranasal Placebo0.026

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The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed)

Binding potential (BP) is a ratio of specific to non-displaceable binding (BP = (target region - cerebellum) / cerebellum) (NCT02473783)
Timeframe: 6 weeks (The Healthy control Group only had the scanning at baseline)

Interventiona ratio of target region to background (Mean)
Treatment Group0.34

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Hamilton Depression Rating Scale (HAM-D) Total Scores

The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. It contains 17 items to be rated. Each item on the questionnaire is scored on a 3 or 5 point scale. The range of the total score (summed) is from 0 to 52.The higher total score suggests the more severe depression. (NCT02473783)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Treatment Group5.25

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Safety Assessments - the Tolerability of Injection of I-123-ADAM Solution

Pain Scores as measured by the Visual Analog Scale (0-10) for the tolerability of injection of I-123-ADAM solution. Higher values represent a worse outcome. (NCT02473783)
Timeframe: assessed at -5~0 days and 6 weeks ±5 days, -5~0 days reported (I-123-ADAM SPECT scan)

Interventionunits on a scale (Mean)
Treatment Group1.52
Healthy Control Group0.88

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Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD7.5
Oral AD+ Intranasal Placebo12.5

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Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD4.4
Oral AD+ Intranasal Placebo11.4

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Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD3.3
Oral AD+ Intranasal Placebo5.9

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Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD4.7
Oral AD+ Intranasal Placebo7.2

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Change From Baseline in Sheehan Disability Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD2.2
Oral AD+ Intranasal Placebo6.8

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Time to Relapse in Participants With Stable Remission (Maintenance Phase)

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)

InterventionDays (Median)
Intranasal Esketamine + Oral ADNA
Oral AD+ Intranasal Placebo273.0

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Time to Relapse in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

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)

InterventionDays (Median)
Intranasal Esketamine + Oral AD635.0
Oral AD+ Intranasal Placebo88.0

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Change From Baseline in PHQ-9 Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD1.7
Oral AD+ Intranasal Placebo4.7

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Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

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)

InterventionUnits on a scale (Median)
Intranasal Esketamine + Oral AD0.0
Oral AD+ Intranasal Placebo1.0

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Change From Baseline in Clinical Global Impression-Severity Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

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)

InterventionUnits on a scale (Median)
Intranasal Esketamine + Oral AD0.0
Oral AD+ Intranasal Placebo1.0

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Change From Baseline in EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-10.4
Oral AD+ Intranasal Placebo-16.1

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Change From Baseline in EQ-5D-5L EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-1.3
Oral AD+ Intranasal Placebo-13.8

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Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Remission (Maintenance Phase)

"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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-0.067
Oral AD+ Intranasal Placebo-0.096

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Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

"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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-0.023
Oral AD+ Intranasal Placebo-0.073

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Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Sum Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

"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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD7.5
Oral AD+ Intranasal Placebo10.9

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Change From Baseline in EuroQol-5 Dimension-5 Level Sum Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

"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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD3.0
Oral AD+ Intranasal Placebo8.4

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Change From Baseline in Generalized Anxiety Disorder-7 Items (GAD-7) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD2.2
Oral AD+ Intranasal Placebo4.0

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Change From Baseline in Generalized Anxiety Disorder-7 Items Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

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)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD1.4
Oral AD+ Intranasal Placebo2.6

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Percentage of Participants With Response as Assessed by PHQ-9 Total Score During IND Phase

"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)

InterventionPercentage of participants (Number)
Day 15End point
Intranasal Esketamine + Oral Antidepressant37.262.0

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Change From Baseline to Endpoint in Clinical Global Impression of Severity (CGI-S) Scale Score During IND Phase

"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)

InterventionUnits on a Scale (Median)
Intranasal Esketamine + Oral Antidepressant-2.0

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Change From Baseline to Endpoint in CGI-S Scale Score During OP/MA Phase

"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)

InterventionUnits on a Scale (Median)
Intranasal Esketamine + Oral Antidepressant0.0

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Change From Baseline in Sheehan Disability Scale Total Score During OP/MA Phase

"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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-1.6

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Change From Baseline in Sheehan Disability Scale (SDS) Total Score During IND Phase

"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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-9.3

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Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Total Recall

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)

InterventionNumber correct (Mean)
Intranasal Esketamine + Oral Antidepressant2.8

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Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Recognition Discrimination Index

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)

InterventionNumber of words (Mean)
Intranasal Esketamine + Oral Antidepressant0.5

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Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Number of Words Recalled

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)

InterventionNumber of words recalled (Mean)
Intranasal Esketamine + Oral Antidepressant0.3

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Percentage of Participants With an Increase Score From Predose at Any Time in Clinician-Administered Dissociative States Scale (CADSS) Total Score During IND Phase

"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])

InterventionPercentage of participants (Number)
Intranasal Esketamine + Oral Antidepressant92.0

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Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

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)

InterventionPercentage of participants (Number)
Intranasal Esketamine + Oral Antidepressant90.1

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Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders

"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)

InterventionPercentage of participants (Number)
CystitisUrinary tract infectionsRenal and urinary disordersRenal and urinary tract symptoms
Intranasal Esketamine + Oral Antidepressant0.68.110.517.0

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Percentage of Participants With Remission as Assessed by MADRS Total Score During IND Phase

"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)

InterventionPercentage of participants (Number)
Day 8Day 15Day 22End point
Intranasal Esketamine + Oral Antidepressant7.315.627.247.2

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Percentage of Participants With Remission as Assessed by PHQ-9 Total Score During IND Phase

"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)

InterventionPercentage of participants (Number)
Day 15Endpoint
Intranasal Esketamine + Oral Antidepressant12.726.9

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Percentage of Participants With Response as Assessed by MADRS Total Score During IND Phase

"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)

InterventionPercentage of participants (Number)
Day 8Day 15Day 22End point
Intranasal Esketamine + Oral Antidepressant11.625.042.878.4

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Change From Baseline to Endpoint in GAD-7 Total Score During OP/MA Phase

"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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant0.2

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Percentage of Participants With Treatment-Emergent Acute Hypertension (Systolic and Diastolic) During IND and OP/MA Phases

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)

InterventionPercentage of participants (Number)
Systolic BP >=180Diastolic BP >=110Acute hypertension
Intranasal Esketamine + Oral Antidepressant2.22.44.1

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Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Delayed Recall

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)

InterventionNumber correct (Mean)
Intranasal Esketamine + Oral Antidepressant0.8

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Change From Baseline in Cognitive Test Battery: One Card Learning Test (OCL) Score

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)

InterventionArcsine ([sqrt] of proportion of [CR]) (Mean)
Intranasal Esketamine + Oral Antidepressant0.0502

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Change From Baseline in Cognitive Test Battery: One Back Test (ONB) Score

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)

Interventionlog10 msec (Mean)
Intranasal Esketamine + Oral Antidepressant0.0177

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Change From Baseline to Endpoint in PHQ-9 Total Score During OP/MA Phase

"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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-0.2

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Change From Baseline to Endpoint in Patient Health Questionnaire - 9 (PHQ-9) Total Score During IND Phase

"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)

InterventionUnit on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-8.9

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Change From Baseline in Cognitive Test Battery: Identification Test (IDN) Score

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)

Interventionlog10 msec (Mean)
Intranasal Esketamine + Oral Antidepressant-0.0083

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Change From Baseline in Cognitive Test Battery: Groton Maze Learning Test (GMLT) Score

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)

InterventionNumber of Errors (Mean)
Intranasal Esketamine + Oral Antidepressant6.9

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Change From Baseline in Cognitive Test Battery: Detection Test (DET) Score

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)

Interventionlog10 msec (Mean)
Intranasal Esketamine + Oral Antidepressant-0.0028

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Change From Baseline to Endpoint in Montgomery Asberg Depression Rating Scale (MADRS) Total Score During Induction (IND) Phase

"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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-16.4

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Change From Baseline to Endpoint in MADRS Total Score During Optimization/Maintenance (OP/MA) Phase

"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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant0.3

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Change From Baseline to Endpoint in Generalized Anxiety Disorder (GAD-7) Total Score During IND Phase

"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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-5.9

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Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During OP/MA Phase: Sum Score

"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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-0.7

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Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During IND Phase: Sum Score

"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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-15.3

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Change From Baseline to Endpoint in EQ-5D-5L Score During OP/MA Phase: EQ-VAS

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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant1.6

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Change From Baseline to Endpoint in EQ-5D-5L Score During IND Phase: EQ-VAS

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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant17.0

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Change From Baseline to Endpoint in EQ-5D-5L Scale Score During OP/MA Phase: Health Status Index

"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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-0.009

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Percentage of Participants With an Increase Score From Predose at Any Time in CADSS Total Score During OP/MA Phase

"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])

InterventionPercentage of participants (Number)
Intranasal Esketamine + Oral Antidepressant86.1

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Change From Baseline to Endpoint in EQ-5D-5L Scale Score During IND Phase: Health Status Index

"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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant0.190

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Percent Heavy Drinking Days

Number of heavy drinking days in a 12 week period is reported by subjects and the percentage is calculated. (NCT02504931)
Timeframe: 12 weeks

Interventionpercentage of days (Mean)
Sertraline55.5
Placebo65.1

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PTSD (Post Traumatic Stress Disorder) Symptom Score From PCL (Patient Monitoring Checklist)

"The PCL is a self-report measure that can be completed by patients in a waiting room prior to a session or by participants as part of a research study.~The survey has 20 questions scored as:~0=Not at all~A little bit~Moderately~Quite a bit~Extremely~Interpretation of the PCL should be made by a clinician. The total symptom severity score is obtained by summing the scores for each of the 20 items to give a total of 1-80 points. The lower the score, the less severe the symptoms of PTSD, the higher the score, the more severe the symptoms." (NCT02504931)
Timeframe: 12 weeks of treatment

InterventionUnits on a scale (Mean)
Sertraline59.6
Placebo61.7

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Number of Participants Endorsing a Single Item That Assesses Stimulant Use

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

,
InterventionParticipants (Count of Participants)
Baseline3 Month6 Month12 Month
Intervention58978
Usual Care77172216

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Number of Participants Endorsing a Single Item That Assesses Opioid Use

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

,
InterventionParticipants (Count of Participants)
Baseline3 Month6 Month12 Month
Intervention18446
Usual Care4415206

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Number of Participants Endorsing a Single Item That Assesses Marijuana Use

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

,
InterventionParticipants (Count of Participants)
Baseline3 Month6 Month12 Month
Intervention125606051
Usual Care177728279

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Cognitive Impairment Scale

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

,
Interventionscore on a scale (Mean)
Baseline3 Month6 Month12 Month
Intervention13.513.313.213.8
Usual Care13.413.213.414.2

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Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury

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

,
Interventionscore on a scale (Mean)
Change from Baseline at 3 MonthsChange from Baseline at 6 MonthsChange from Baseline at 12 Months
Intervention-16.78-14.17-13.23
Usual Care-15.90-13.83-11.68

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Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury

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

,
Interventionscore on a scale (Mean)
Change from Baseline at 3 MonthsChange from Baseline at 6 MonthsChange from Baseline at 12 Months
Intervention-1.65-4.02-5.51
Usual Care0.08-1.44-4.25

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Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury

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

,
Interventionscore on a scale (Mean)
Change from Baseline at 3 MonthsChange from Baseline at 6 MonthsChange from Baseline at 12 Months
Intervention-0.79-1.17-1.84
Usual Care-0.50-0.90-2.16

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Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury

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

,
Interventionscore on a scale (Mean)
Change from Baseline at 3 MonthsChange from Baseline at 6 MonthsChange from Baseline at 12 Months
Intervention-2.04-1.69-1.81
Usual Care-1.90-1.63-1.45

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Brief Pain Inventory

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

,
Interventionscore on a scale (Mean)
Baseline3 Month6 Month12 Month
Intervention6.84.34.13.9
Usual Care6.74.74.53.8

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TSOS Patient Satisfaction: Overall Health Care

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

,
Interventionscore on a scale (Mean)
Baseline3 Month6 Month12 Month
Intervention4.43.94.03.9
Usual Care4.43.83.83.8

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TSOS Patient Satisfaction: Mental Health Care

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

,
Interventionscore on a scale (Mean)
Baseline3 Month6 Month12 Month
Intervention4.13.63.63.7
Usual Care4.03.53.43.5

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SF-36 Quality of Life

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

,
Interventionscore on a scale (Mean)
Baseline3 Month6 Month12 Month
Intervention44.338.338.439.2
Usual Care45.139.139.541.4

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Number of Participants With Suicidal Ideation

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

,
InterventionParticipants (Count of Participants)
Baseline3 Month6 Month12 Month
Intervention67696351
Usual Care909910692

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Acoustic Startle Response (ASR) Magnitude Based on Menstrual Cycle Phase

Acoustic startle response (ASR) is measured during the follicular and luteal phase of the menstrual cycle in controls and those with PMDD. Magnitude of ASR is measured using the eyeblink reflex, by recording activity from the orbicularis oculi muscle. Recording is performed via two surface disk electrodes (Ag-AgCl) applied underneath the left eye; one in line with the pupil and one 1-2 cm lateral to the first one. For the primary outcome of baseline ASR magnitude over the menstrual cycle, peak amplitude of the blink reflex was determined in the 20-120-ms time frame following stimulus onset relative to baseline (baseline is the average baseline electromyography (EMG) level for the 50 ms immediately preceding auditory stimulus onset). ASR is measured in microvolts, and raw ASR results are standardized to t-scores. Higher ASR t-score indicates greater contraction of the the orbicularis oculi muscle. A t-score of 50 indicates the population mean with a standard deviation of 10. (NCT02777372)
Timeframe: Month 1 (Follicular), Month 2 (Luteal)

,
Interventiont score (Mean)
Month 1 (Follicular)Month 2 (Luteal)
Control54.256.4
Sertraline53.753.3

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Impact of Sertraline on ASR Magnitude

This outcome examines the impact of luteal phase treatment with a selective serotonin reuptake inhibitor (SSRI) (PMDD group only) on acoustic startle response (ASR). ASR is measured using the eyeblink reflex, measured by recording activity from the orbicularis oculi muscle. Recording is performed via two surface disk electrodes (Ag-AgCl) applied underneath the left eye; one in line with the pupil and one 1-2 cm lateral to the first one. Peak amplitude of the blink reflex is determined in the 20-120-ms time frame following stimulus onset. PMDD participants complete test day 3 (Luteal Month 3) while on sertraline and their ASR magnitude will be compared to their previous luteal test day (Luteal Month 2). ASR is measured in microvolts, and raw ASR results are standardized to t-scores. Higher ASR t-score indicates greater contraction of the the orbicularis oculi muscle. A t-score of 50 indicates the population mean with a standard deviation of 10. (NCT02777372)
Timeframe: Month 2 (Luteal), Month 3 (Luteal)

,
Interventiont score (Mean)
Month 2 (Luteal)Month 3 (Luteal)
Control56.451.8
Sertraline53.352.2

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Interleukin 6 (IL-6) Level

Blood samples were collected to measure serum interleukin-6 (IL-6). IL-6 levels were compared in the follicular and luteal phases, between Control and PMDD groups. Levels are measured in picogram/milliliter (pg/mL). (NCT02777372)
Timeframe: Month 1 (Follicular ), Month 2 (Luteal )

,
Interventionpicogram/milliliter (pg/mL) (Mean)
Month 1 (Follicular)Month 2 (Luteal)
Control0.4.59
Sertraline.34.4

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Tumor Necrosis Factor Alpha (TNF-alpha) Level

Blood samples were collected to measure serum TNF-alpha levels in the Follicular and Luteal 1 phases. Levels are measured in picogram/milliliter (pg/mL). (NCT02777372)
Timeframe: Month 1 (Follicular ), Month 2 (Luteal )

,
Interventionpg/mL (Mean)
Month 1 (Follicular )Month 2 (Luteal )
Control1.271.27
Sertraline1.631.54

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CY-BOCS Total Score at 12-weeks

The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) a clinician-rated semi-structured instrument assessing OCD severity over the previous 7 days in children ages 6 to 17 years. Items are scored from 0 (none) to 4 (extreme) and total score ranges from 0 to 40 with higher scores indicating greater impairment. All 19 items are rated, but only items 1-10 are used to determine the total score. The total CY-BOCS score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. At this time, items 1A and 6A are not being used in the scoring. Items 17 (global severity) and 18 (global improvement) are adapted from the Clinical Global Impression Scale to provide measures of overall functional impairment associated with the presence of obsessive-compulsive symptoms. (NCT02797808)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Children With OCD14.1
Healthy Control Children0

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Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses

Participants had whole brain fMRI at baseline &12 weeks. Whole brain connectivity in 6 striatal ROIs was performed. Two-way mixed effects ANOVAs were performed with FEAT. Clusters were significant if p <.0042 based on .05/(6 ROIs x 2 tests/ROI). Mean z-score was found for each time point in each subject's connectivity map in each significant cluster. Within-group paired-sample t tests examined RSFC change over time in these metrics for each group. To investigate group X time interactions from the 2-way ANOVA, we compared mean z-scores within each significant cluster at baseline & 12 weeks. Resulting numbers represented striatal connectivity for each individual at each time point. Within group paired sample t-tests examined RSFC change over time for each group. Bonferroni correction was applied to alpha level (2-tailed, p<0.5/6 =.0083) for multiple testing. We do not have an a priori hypothesis as to whether increase or decrease in RSFC is a better outcome. Unit of measure is z-score. (NCT02797808)
Timeframe: 12 weeks

,
Interventionz score (Mean)
Connectivity z-scores for right putamen at baselineConnectivity z-scores for right putamen at 12 weeksConnectivity z-scores for left putamen at baselineConnectivity z-scores for left putamen at week 12
Children With OCD0.151.891.463.03
Healthy Control Children1.440.602.410.89

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Number of Participants With Response to Treatment

Response to treatment was defined as a 50% reduction from baseline scores in Hamilton Rating Scale for Depression (HRSD). The HRSD is abbreviated version, consists of 17 items. The cutoff points are: 7-17 for mild depression,18-24 for moderate depression, and 25 or more for severe depression . (NCT02901249)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
Sertraline58

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Quality of Life -WHOQOL Intrument Scores

"QOL scores as measured by World Heath Organization Quality of Life - WHOQOL -BREF instrument.~scores 0-20 . Higher scores means a better outcome. The measure presented is a overall domain with the mean (SD)" (NCT02901249)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
Sertraline9.45

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Number of Participants With Remission to Treatment

The remission outcome was established as obtaining three consecutive scores of values considered asymptomatic in the Hamilton Rating Scale for Depression (HRSD <7 points) . The subjects that were asymptomatic for at least 6-8 month were considered to be in remission, according to the criteria for partial and complete remission in the DSM-IV. (NCT02901249)
Timeframe: 8 months

InterventionParticipants (Count of Participants)
Sertraline32

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Change of Hamilton Rating Scale for Depression Among Different Weeks

"Hamilton Rating Scale for Depression: summed, 0-50~higher value is worse" (NCT02917122)
Timeframe: week 0 and 6

,
Interventionscore on a scale (Mean)
week0week6
Sertraline + Active tDCS27.4010.20
Sertraline + Sham tDCS21.835.83

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Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks

"mds: modified-Unified Parkinson's Disease~mds1 non-motor experiences of daily living: summed, 0-52 mds2 motor experiences of daily living: summed, 0-52 mds3 motor examination: summed, 0-132 mds4 motor complications: summed, 0-24~higher value is worse" (NCT02917122)
Timeframe: week 0 and 6

,
Interventionscore on a scale (Mean)
mds1 non-motor experiences of daily living-week0mds1 non-motor experiences of daily living-week6mds2 motor experiences of daily living-week0mds2 motor experiences of daily living-week6mds3 motor examination-week0mds3 motor examination-week6mds4 motor complications-week0mds4 motor complications-week6
Sertraline + Active tDCS10.008.252.254.7518.7519.502.751.25
Sertraline + Sham tDCS9.006.175.332.1723.5022.170.501.00

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Change of Taiwanese Depression Questionnaire Among Different Weeks

"Taiwanese Depression Questionnaire: summed, 0-54~higher value is worse" (NCT02917122)
Timeframe: week 0 and 6

,
Interventionscore on a scale (Mean)
week0week6
Sertraline + Active tDCS24.8018.60
Sertraline + Sham tDCS25.5014.83

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Number of Participants With Remission to Treatment

The remission outcome was established as obtaining three consecutive visits with scores of values considered asymptomatic Hamilton Rating Scale for Depression(HRSD <7 points) and Young Mania Rating Scale (YMRS <6 points) during the trial. The subjects that were asymptomatic for at least 6-8 month were considered to be in partial remission and complete if at least 12 months without symptoms, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). (NCT02918097)
Timeframe: 8 months

InterventionParticipants (Count of Participants)
Lithium Carbonate21

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"Number of Participants With Response to Treatment"

"Response to treatment was defined as a 50% reduction from baseline scores in Hamilton Rating Scale for Depression (HRSD)and Young Mania Rating Scale (YMRS) scales HRSD was developed to evaluate and quantify depression.Its abbreviated version,. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal. The cutoff points are: 8-17 for mild depression,18-24 for moderate depression, and 25 or more for severe depression. The maximum score being 52 on the 17-point scale.~YMRS is is the most widely used assessment tool for manic symptoms. The scale consists of 11 items .The YMRS follows the style of the Hamilton Rating Scale for Depression (HAM-D) with each item given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/agressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Scores of YMRS > 20 generates indicate mania" (NCT02918097)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
Lithium Carbonate65

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Quality of Life Instrument Scores

"Quality of Life - WHOQOL -BREF instrument scores~scores 0-20 . higher scores mean a better outcome." (NCT02918097)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
Lithium Carbonate10.58

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Number of Laboratory Grade 3-5 Adverse Events

Number of Laboratory Grade 3-5 Adverse Events through 6 months as per the Division of AIDS (DAIDS) grading scale (NCT03002012)
Timeframe: 6 months

Interventionnumber of grade 3-5 adverse events (Number)
Sertraline4
Control1

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Adherence to Study Drug

Participants' percent adherence to study drug regiment by pharmacy medication counts, representing the percent of the total prescribed medication taken by participants. (NCT03002012)
Timeframe: 12 weeks

,
InterventionPercent of total prescribed medication t (Median)
Week 2Week 4Week 8Week 12
Control100100100100
Sertraline1001009789

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Prevalence of Depression by Patient Health Questionnaire (PHQ-9) Over Time

Prevalence of depression by Patient Health Questionnaire (PHQ-9) over 6 months as measured at baseline, 4 weeks, 8 weeks, and 12 weeks. The PHQ-9 is a 9-item instrument for screening, diagnosing, monitoring, and measuring the severity of depression. Items are rated on a scale from 0 (not at all) to 3 (nearly every day). Total score is a sum of 9 item scores (Range 0-27). Greater scores indicate greater depressive symptoms. PHQ-9 scores of: 0-4 Minimal/No depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderate severe depression; 20-27 Severe depression. This endpoint reports the median (interquartile range) of the PHQ-9 scores over time. (NCT03002012)
Timeframe: 12 weeks

,
Interventionscore on a scale (Median)
Week 4Week 8Week 12
Control532
Sertraline562

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6-month Survival

Survival through 6 months (NCT03002012)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Sertraline11
Control10

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6 Month Meningitis-free Survival

"Cryptococcal meningitis free survival with retention-in-care through 6 months~Those who die of any cause are failures~Those developing symptomatic cryptococcal meningitis are failures~Those lost to follow up and unable to be tracked are considered failures" (NCT03002012)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Sertraline11
Control9

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Cumulative Incidence of Symptomatic Cryptococcal Meningoencephalitis

Cumulative incidence of symptomatic cryptococcal meningoencephalitis through 6 months (NCT03002012)
Timeframe: 6 months

Interventionmeningitis events (Number)
Sertraline0
Control1

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All-Cause Premature Study Drug/Placebo Discontinuation

Number of participants whose study drug/placebo use was halted prematurely due to any cause through 6 months (NCT03002012)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Sertraline1
Control0

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Number of Clinical Adverse Events (Grade 3-5)

Number of Clinical Adverse Events by Division of AIDS (DAIDS) Scale for Grade 3-5 events through 6 months (NCT03002012)
Timeframe: 6 months

Interventionnumber of grade 3-5 adverse events (Number)
Sertraline4
Control2

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Change From Baseline in Clinician-Administered Post-traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5) Total Score

CAPS-5:clinician-rated, structured interview to assess PTSD diagnostic status, symptoms severity as defined by DSM-5. CAPS-5 Past Week version of scale was completed at Baseline and at all visits after Baseline. CAPS-5 was calculated by summing severity scores for 20 DSM-5 PTSD symptoms (items 1-20) from categories: Category B:Intrusion symptoms (5 items); Category C:Avoidance symptoms (2 items); Category D:Cognition and mood symptoms (7 items); Category E:Arousal and reactivity symptoms (6 items). CAPS-5 total score was imputed by adding all subscores from categories B,C,D,E. Each symptom was scored 0 (Absent) to 4 (Extreme/incapacitating), to yield a score with range 0-80. Higher scores=worse outcome. Mixed model repeated measure (MMRM) was used for analysis. (NCT03033069)
Timeframe: Baseline, Week 12

Interventionscore on a scale (Least Squares Mean)
Brexpiprazole + Sertraline-16.4
Brexpiprazole-12.2
Sertraline-11.4
Placebo-10.5

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Cmax of Aripiprazole and Sertraline in Cohort 2

(NCT03342963)
Timeframe: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing

,
Interventionng/mL (Mean)
AripiprazoleSertraline
ASC-01 Under Fasted16.928.9
ASC-01 Under Fed16.636.5

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AUC168h of Aripiprazole and Sertraline in Cohort 2

(NCT03342963)
Timeframe: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing

,
Interventionng*h/mL (Mean)
AripiprazoleSertraline
ASC-01 Under Fasted701904
ASC-01 Under Fed8651060

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Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1

(NCT03342963)
Timeframe: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing

Interventionng/mL (Mean)
ASC-0118.8
Aripiprazole/Sertraline Concomitant16.9

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Area Under the Plasma Concentration Versus Time Curve 168h (AUC168h) of Aripiprazole in Cohort 1

(NCT03342963)
Timeframe: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing

Interventionng*h/mL (Mean)
ASC-01783
Aripiprazole/Sertraline Concomitant779

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Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score to the End of Double-blind Treatment Phase (Day 28)

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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant (AD)-10.1
Intranasal Placebo + Oral AD-8.1

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Percentage of Participants With Onset of Clinical Response

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

InterventionPercentage of participants (Number)
Intranasal Esketamine + Oral Antidepressant (AD)6.5
Intranasal Placebo + Oral AD1.6

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Percentage of Participants in Remission at the End of Double-blind Treatment Phase (Day 28)

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

InterventionPercentage of Participants (Number)
Intranasal Esketamine + Oral Antidepressant (AD)12.8
Intranasal Placebo + Oral AD10.4

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Change From Baseline in Participant-Reported Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to the Endpoint (Double-blind Treatment Phase [Day 28]): Sum Score

"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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant (AD)-13.4
Intranasal Placebo + Oral AD-9.5

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Change From Baseline in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score up to the Endpoint (Double-blind Treatment Phase [Day 28])

"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])

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant (AD)-4.3
Intranasal Placebo + Oral AD-2.9

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Change From Baseline in Depressive Symptoms as Measured by the MADRS Total Score to 24 Hours Post First Dose (Day 2)

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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant (AD)-8.0
Intranasal Placebo + Oral AD-4.4

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Percentage of Participants With Sustained Remission

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

InterventionPercentage of Participants (Number)
Intranasal Esketamine + Oral Antidepressant (AD)5.6
Intranasal Placebo + Oral AD6.3

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Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score up to the Endpoint (Double-blind Treatment Phase [Day 28])

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)

InterventionUnits on a Scale (Median)
Intranasal Esketamine + Oral Antidepressant (AD)-1.0
Intranasal Placebo + Oral AD-1.0

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Change From Baseline in Sheehan Disability Scale (SDS) Total Score to the End of Double-blind Treatment Phase (Day 28)

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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant (AD)-6.3
Intranasal Placebo + Oral AD-5.3

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Change From Baseline in Participant-Reported Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score up to the Endpoint (Double-blind Treatment Phase [Day 28]): Visual Analogue Scale (VAS)

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)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant (AD)16.7
Intranasal Placebo + Oral AD11.9

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Percentage of Responders at the End of Double-blind Treatment Phase (Day 28)

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

InterventionPercentage of Responders (Number)
Intranasal Esketamine + Oral Antidepressant (AD)19.3
Intranasal Placebo + Oral AD16.0

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Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study

MINI International Neuropsychiatric Interview (MINI) is a brief structured diagnostic interview and is designed to assess the most common psychiatric disorders in ICD-10 and DSM-5. MINI modules were used: major depressive disorder and generalized anxiety disorder. Questions are rated dichotomously (yes/no) and clinical judgment should be used in coding the responses, asking for examples if needed. Participants will be eligible for the study if they are diagnosed with depression or anxiety based on the MINI assessment. (NCT04094870)
Timeframe: 6-8 weeks postpartum

InterventionParticipants (Count of Participants)
Women Who Met Diagnostic Criteria by MINI and Agreed to Participate in the Study80

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Percentage of Women Experiencing Anti Depressant Medication Toxicity

The percentage of women who are taking the antidepressant medication who discontinue the medication due to a grade II or higher toxicity (NCT04094870)
Timeframe: Enrollment - final visit, approximately 24 weeks after enrollment

Interventionpercentage of women who discontinued (Number)
Women Assigned to the Antidepressant Medication Arm0

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Number of Women Pre-Screened Who Have an EPDS Score >/= 6

The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression with score range 0-30, a higher score indicates greater symptom burden. A score of >/= 6 is indicative of a woman being at risk of perinatal depression. The number of women with an EPDS >/= 6 out of all of the women who were pre-screened with an EPDS. (NCT04094870)
Timeframe: 2-7 weeks postpartum

InterventionParticipants (Count of Participants)
Approached Patients Who Completed Pre-Screening EPDS199

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Number of Women Retained in the Study

Number of women who are enrolled in the study who complete the final study visit (NCT04094870)
Timeframe: Enrollment - final visit, approximately 24 weeks after enrollment

InterventionParticipants (Count of Participants)
Antidepressant Medication39
Interpersonal Therapy39

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Number of Women Approached Who Agreed to Pre-Screening With EPDS

In order to determine feasibility, the number of women who agree to be pre-screened with the Edinburgh Postnatal Depression Screen (EPDS) within 2-7 weeks postpartum (NCT04094870)
Timeframe: 2-7 weeks postpartum

InterventionParticipants (Count of Participants)
Approached Patients240

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Acceptability of Trial Participation for Treatment of Postpartum Depression

"Participants completed a satisfaction survey at the final study visit addressing issues around 4 topics: (1) satisfaction with the study; (2) satisfaction with the intervention received; (3) self-perceived improvement of mental health; and (4) preference for study intervention not received. Responses were recorded using a Likert-type rating scale with the following responses: Strongly disagree, disagree, neutral, agree, and strongly agree. For analysis purposes responses were combined into categories as follows: Agree and Strongly Agree, Disagree and Strongly Disagree, and neutral." (NCT04094870)
Timeframe: Enrollment - final visit, approximately 24 weeks after enrollment

,
InterventionParticipants (Count of Participants)
Satisfaction with the study: Strongly Agree or AgreeSatisfaction with the intervention received: Strongly Agree or AgreeSatisfaction with the intervention received: Strongly Disagree or DisagreeSelf-perceived improvement of mental health: Strongly Agree or AgreePreference for study intervention not received: Strongly Agree or AgreePreference for study intervention not received: NeutralPreference for study intervention not received: Strongly Disagree or Disagree
Antidepressant Medication393723961023
Interpersonal Therapy393723941619

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Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)

Percentage of women randomized to the ADM arm with adequate adherence defined as taking >90% of pills assessed by pill count and report (NCT04094870)
Timeframe: Enrollment - final visit, approximately 24 weeks after enrollment

Interventionpercentage of participants (Number)
All Women Assigned to the Antidepressant Medication Arm14

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Changes in the Viral Load Between Study Entry and the Last Visit

The mean change in the viral load will be measured between all women enrolled between the first and last visits (NCT04094870)
Timeframe: Enrollment - final visit, approximately 24 weeks after enrollment

Interventionlog copies/mL (Mean)
Antidepressant Medication0.6
Interpersonal Therapy1.6

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Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)

Number of women randomized to the IPT arm who complete all IPT sessions (NCT04094870)
Timeframe: Enrollment - final visit, approximately 24 weeks after enrollment

InterventionParticipants (Count of Participants)
All Women Assigned to the Therapy Arm5

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Number of Women With a CGI Score Decline of One Point From Baseline

The Clinical Global Impression (CGI) is a 7-point scale (range 1-7) 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 the patient. Lower scores correlate with clinical improvement. (NCT04094870)
Timeframe: Enrollment - final visit, approximately 24 weeks after enrollment

InterventionParticipants (Count of Participants)
Antidepressant Medication38
Interpersonal Therapy39

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Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI

MINI International Neuropsychiatric Interview (MINI) is a brief structured diagnostic interview and is designed to assess the most common psychiatric disorders in ICD-10 and DSM-5. MINI modules were used: major depressive disorder and generalized anxiety disorder. Questions are rated dichotomously (yes/no) and clinical judgment should be used in coding the responses, asking for examples if needed. Participants will be eligible for the study if they are diagnosed with depression or anxiety based on the MINI assessment. After pre screening with an EPDS, women with an EPDS >/=6 were invited to undergo MINI diagnostic testing after signed consent. (NCT04094870)
Timeframe: 2-7 weeks postpartum

InterventionParticipants (Count of Participants)
All Participants With an EPDS >/=6120

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Number of Women With an EPDS Score Decline of 3 Points From Baseline

The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression with score range 0-30, a higher score indicates greater symptom burden. A score of > 6 is indicative of a woman being at risk of perinatal depression. (NCT04094870)
Timeframe: Enrollment - final study visit, approximately 24 weeks after enrollment

InterventionParticipants (Count of Participants)
Antidepressant Medication37
Interpersonal Therapy39

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Change From Baseline in the HAMD-17 Total Score Over the Double-Blind Treatment Period

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

Interventionscore on a scale (Least Squares Mean)
Placebo + Assigned ADT-10.1
SAGE-217 + Assigned ADT-11.7

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Percentage of Participants With MADRS Remission at Day 15

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

Interventionpercentage of participants (Number)
Placebo + Assigned ADT28.4
SAGE-217 + Assigned ADT30.9

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Percentage of Participants With TEAEs, Graded by Severity

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

,
Interventionpercentage of participants (Number)
MildModerateSevere
Placebo + Assigned ADT38.125.22.3
SAGE-217 + Assigned ADT35.834.43.8

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Percentage of Participants With MADRS Response at Day 15

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

Interventionpercentage of participants (Number)
Placebo + Assigned ADT48.2
SAGE-217 + Assigned ADT51.6

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Change From Baseline in HAM-A Total Score at Day 15

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

Interventionscore on a scale (Least Squares Mean)
Placebo + Assigned ADT-9.0
SAGE-217 + Assigned ADT-9.5

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Change From Baseline in Depressive Symptoms at Day 15, as Assessed by PHQ-9

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

Interventionscore on a scale (Least Squares Mean)
Placebo + Assigned ADT-8.7
SAGE-217 + Assigned ADT-8.9

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Change From Baseline in CGI-S Score at Day 15

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

Interventionscore on a scale (Least Squares Mean)
Active Comparator: Placebo + Assigned ADT-1.7
Experimental: SAGE-217 + Assigned ADT-1.9

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Change From Baseline in the HAMD-17 Total Score at Day 3

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

Interventionscore on a scale (Least Squares Mean)
Placebo + Assigned ADT-7.0
SAGE-217 + Assigned ADT-8.9

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Change From Baseline in MADRS Total Score at Day 15

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

Interventionscore on a scale (Least Squares Mean)
Placebo + Assigned ADT-15.9
SAGE-217 + Assigned ADT-17.2

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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

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

Interventionpercentage of participants (Number)
Placebo + Assigned ADT65.6
SAGE-217 + Assigned ADT74.1

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Time to First HAMD-17 Response

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)

Interventiondays (Median)
Placebo + Assigned ADT15
SAGE-217 + Assigned ADT13

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Percentage of Participants With HAMD-17 Remission at Day 15 and Day 42

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

,
Interventionpercentage of participants (Number)
Day 15Day 42
Placebo + Assigned ADT21.839.2
SAGE-217 + Assigned ADT29.137.9

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Change From Baseline in the HAMD-17 Total Score at Days 15 and 42

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

,
Interventionscore on a scale (Least Squares Mean)
Day 15Day 42
Placebo + Assigned ADT-12.9-14.9
SAGE-217 + Assigned ADT-13.7-14.9

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Percentage of Participants With HAMD-17 Response at Day 15 and Day 42

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

,
Interventionpercentage of participants (Number)
Day 15Day 42
Placebo + Assigned ADT49.265.3
SAGE-217 + Assigned ADT53.459.9

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Percentage of Participants With CGI-I Response, at Day 3 and Day 15

"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

,
Interventionpercentage of participants (Number)
Day 3Day 15
Placebo + Assigned ADT12.954.3
SAGE-217 + Assigned ADT22.956.6

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Change From Baseline in the HAMD-17 Total Score Around End of Blinded Treatment

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)

Interventionscore on a scale (Least Squares Mean)
Placebo + Assigned ADT-12.7
SAGE-217 + Assigned ADT-13.2

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