citalopram and Depression, Involutional studies

Citalopram: A furancarbonitrile that is one of the serotonin uptake inhibitors used as an antidepressant. The drug is also effective in reducing ethanol uptake in alcoholics and is used in depressed patients who also suffer from TARDIVE DYSKINESIA in preference to tricyclic antidepressants, which aggravate dyskinesia.
citalopram : A racemate comprising equimolar amounts of (R)-citalopram and its enantiomer, escitalopram. It is used as an antidepressant, although only escitalopram is active.
1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile : A nitrile that is 1,3-dihydro-2-benzofuran-5-carbonitrile in which one of the hydrogens at position 1 is replaced by a p-fluorophenyl group, while the other is replaced by a 3-(dimethylamino)propyl group.

Depression, Involutional: Form of depression in those MIDDLE AGE with feelings of ANXIETY.

Research Excerpts

Excerpt	Relevance	Reference
"TECAS was comparable to escitalopram in improving depression and related symptoms, with high acceptability, better safety profile, and particular efficacy in reducing trauma-associated depression."	9.69	Transcutaneous electrical cranial-auricular acupoint stimulation versus escitalopram for mild-to-moderate depression: An assessor-blinded, randomized, non-inferiority trial. ( Cai, JF; Chen, GB; He, JK; Hou, XB; Jiao, Y; Jin, GX; Liu, Y; Qin, ZS; Rong, PJ; Shi, L; Wang, Y; Wong, YK; Xiao, HB; Xiao, X; Xu, FQ; Yang, XJ; Zhang, JN; Zhang, LL; Zhang, SY; Zhang, ZJ; Zhao, YY; Zheng, Y, 2023)
"Escitalopram may have pain-alleviating effects for patients with comorbid pain and depression."	9.51	Pain severity and pain interference during major depressive episodes treated with escitalopram and aripiprazole adjunctive therapy: a CAN-BIND-1 report. ( Bhat, V; Diep, C; Frey, BN; Gandhi, W; Kennedy, SH; Khoo, Y; Ladha, KS; Lam, RW; Lou, W; Milev, RV; Ravindran, AV; Rosenek, N; Rotzinger, S; Salomons, T; van Reekum, CM, 2022)
"Drugs that target glutamate neuronal transmission, such as memantine, offer a novel approach to the treatment of late-life depression, which is frequently comorbid with cognitive impairment."	9.41	Transcriptomic signatures of treatment response to the combination of escitalopram and memantine or placebo in late-life depression. ( Grzenda, A; Laird, KT; Lavretsky, H; Siddarth, P; Yeargin, J, 2021)
"gov, NCT01278498), a randomized, placebo-controlled, double-blind trial that examined the efficacy of escitalopram on depression in acute stroke patients (237 with placebo, 241 with escitalopram)."	9.41	Post-Stroke Depressive Symptoms: Varying Responses to Escitalopram by Individual Symptoms and Lesion Location. ( Ahn, SH; Cha, JK; Chang, DI; Choi-Kwon, S; Heo, JH; Kim, DE; Kim, HY; Kim, J; Kim, JS; Kim, JY; Kim, MS; Kim, S; Koh, SH; Kwon, DY; Lee, BC; Lee, EJ; Lee, J; Lee, JS; Park, JH; Park, SW; Seo, WK; Sohn, SI, 2021)
" One hundred and sixty patients with MDD and comorbid obesity will be randomised 1:1 to simvastatin or placebo as add-on to standard antidepressant medication with escitalopram."	9.34	Simvastatin add-on to escitalopram in patients with comorbid obesity and major depression (SIMCODE): study protocol of a multicentre, randomised, double-blind, placebo-controlled trial. ( Chae, WR; Ettrich, B; Friede, T; Gold, SM; Grabe, HJ; Hegerl, U; Hinkelmann, K; Hofmann, T; Janowitz, D; Junghanns, K; Kaczmarczyk, M; Kahl, KG; Klein, JP; Krueger, THC; Leicht, G; Lischewski, S; Märschenz, S; Nowacki, J; Otte, C; Piber, D; Prvulovic, D; Reif, A; Roepke, S; Schmidt, S; Schoettle, D; Strauss, M; Westermair, A, 2020)
"Suicidal ideation was more likely to occur early in citalopram treatment, with few subjects showing emergence or worsening occurring after 6 weeks of treatment."	9.22	Time Course and Predictors of Suicidal Ideation During Citalopram Treatment in the STAR*D Trial. ( Bloch, MH; Coughlin, CG; Jakubovski, E, 2016)
" Because the efficacy of escitalopram, a potent serotonin reuptake inhibitor, has not been well evaluated in cancer patients, we investigated its effects on depression and quality of life in outpatients with breast cancer."	9.16	Rapid improvement of depression and quality of life with escitalopram treatment in outpatients with breast cancer: a 12-week, open-label prospective trial. ( Bae, JN; Hahm, BJ; Kim, JH; Lee, BJ; Park, HY, 2012)
"To examine whether preemptive antidepressant treatment with escitalopram can decrease the incidence or severity of depression associated with pegylated IFN-α in HCV-infected patients without a history of psychiatric disorders."	9.16	Escitalopram for the prevention of peginterferon-α2a-associated depression in hepatitis C virus-infected patients without previous psychiatric disease: a randomized trial. ( Baumert, TF; Berg, T; Buggisch, P; Discher, T; Effenberger, S; Friebe, A; Fromm, G; Heinz, A; Heinze, L; Knop, V; Lieb, K; Link, R; Neumann, K; Ockenga, J; Reimer, J; Rentrop, M; Sarkar, R; Schaefer, M; Schlaepfer, T; Spengler, U; Weidenbach, H; Zeuzem, S, 2012)
"To evaluate the efficacy and safety of escitalopram for preventing interferon alfa-2a-induced depression, we conducted an investigator-initiated multicenter, randomized, double-blind, placebo-controlled trial in 133 chronic hepatitis C patients without baseline mental disorders who were randomly assigned to receive escitalopram or placebo during the first 12 weeks of treatment."	9.15	Prophylactic treatment with escitalopram of pegylated interferon alfa-2a-induced depression in hepatitis C: a 12-week, randomized, double-blind, placebo-controlled trial. ( Ardèvol, M; Castellví, P; Costa, J; Diago, M; Diez-Quevedo, C; Giménez, D; Giner, P; Martín-Santos, R; Masnou, H; Morillas, RM; Navinés, R; Planas, R; Pretel, J; Solà, R, 2011)
"Outpatients with chronic or recurrent major depression (MDD) were randomized to initial treatment with escitalopram+placebo (the MONO condition), bupropion-sustained release+escitalopram, or venlafaxine-extended release+mirtazapine (the COMB conditions) in the Combining Medications to Enhance Depression Outcomes (CO-MED) trial."	9.15	Randomized comparison of selective serotonin reuptake inhibitor (escitalopram) monotherapy and antidepressant combination pharmacotherapy for major depressive disorder with melancholic features: a CO-MED report. ( Bobo, WV; Chen, H; Cook, IA; Fava, M; Husain, MM; Kornstein, SG; Kurian, BT; Lesser, IM; Luther, JF; Morris, DW; Nierenberg, AA; Rush, AJ; Shelton, RC; Stewart, JW; Trivedi, MH; Warden, D; Wisniewski, SR, 2011)
"The purpose of this study was to compare escitalopram, problem-solving therapy, and placebo to prevent poststroke depression during 6 months after discontinuation of treatment."	9.15	Increased frequency of first-episode poststroke depression after discontinuation of escitalopram. ( Arndt, S; Fonzetti, P; Hegel, MT; Jang, M; Jorge, RE; Mikami, K; Moser, DJ; Robinson, RG; Small, SL; Solodkin, A, 2011)
"Citalopram treatment of MDD in older patients with heart failure is well-tolerated with low rates of side effects, but was not significantly more effective than placebo in the treatment of depression."	9.14	A double-blind, placebo-controlled treatment trial of citalopram for major depressive disorder in older patients with heart failure: the relevance of the placebo effect and psychological symptoms. ( Alves, TC; Andrei, AM; da Silva Telles, RM; Fraguas, R; Iosifescu, DV; Rays, J; Wajngarten, M, 2009)
"Participants with major depressive disorder (N = 2875) at primary and specialty care sites who received the first step treatment with citalopram in the Sequenced Treatment Alternatives to Relieve Depression study were included."	9.13	Response to a selective serotonin reuptake inhibitor (citalopram) in major depressive disorder with melancholic features: a STAR*D report. ( Fava, M; Khan, AY; McGrath, PJ; Miyahara, S; Morris, DW; Nierenberg, AA; Rush, AJ; Stewart, JW; Trivedi, MH; Wisniewski, SR, 2008)
"The effect of a combination of light therapy and citalopram in stroke victims receiving citalopram was examined by use of two different doses of light therapy under double-blind conditions."	9.12	Dose response to adjunctive light therapy in citalopram-treated patients with post-stroke depression. A randomised, double-blind pilot study. ( Andersen, G; Bech, P; Jarden, JO; Martiny, K; Søndergaard, MP, 2006)
"We conducted a 12-week open-label study of bupropion in 18 depressed asthma patients."	9.12	Bupropion in the treatment of outpatients with asthma and major depressive disorder. ( Brown, ES; Khan, DA; Rush, AJ; Vornik, LA, 2007)
"The aim of this study was to examine the association between polymorphism in the serotonin transporter gene and citalopram effectiveness and side effects in children and adolescents with major depressive disorder (MDD) and/or anxiety disorders."	9.12	Serotonin transporter polymorphism (5-HTTLPR) and citalopram effectiveness and side effects in children with depression and/or anxiety disorders. ( Apter, A; Brent, D; Carmel, M; Frisch, A; Gothelf, D; Kronenberg, S; Melhem, N; Pick, N; Schirman, S; Weizman, A, 2007)
"Ninety adults with asthma and current major depressive disorder were randomized to receive citalopram or placebo for 12 weeks."	9.11	A randomized trial of citalopram versus placebo in outpatients with asthma and major depressive disorder: a proof of concept study. ( Brown, ES; Carmody, TJ; Khan, DA; Liggin, JD; Rush, AJ; Vigil, L, 2005)
"These results suggest that depression in patients with hepatitis C may be effectively and safely treated with citalopram."	9.10	An open-label trial of citalopram for major depression in patients with hepatitis C. ( Gleason, OC; Isbell, MD; Philipsen, MA; Yates, WR, 2002)
"83 weeks) in patients with unipolar depression (studies=4, n=187; monotherapy vs lithium=1, augmentation of antidepressants vs placebo=3) or bipolar depression (studies=14, n=1965; monotherapy vs placebo=5, monotherapy vs lithium or olanzapine+fluoxetine=2, augmentation of antidepressants vs placebo=1, augmentation of mood stabilizers vs placebo=3, augmentation of mood stabilizers vs trancylpromine, citalopram, or inositol=3) were meta-analyzed."	8.93	Lamotrigine compared to placebo and other agents with antidepressant activity in patients with unipolar and bipolar depression: a comprehensive meta-analysis of efficacy and safety outcomes in short-term trials. ( Anghelescu, IG; Correll, CU; Gao, K; Normann, C; Reis, C; Schaffer, A; Solmi, M; van der Loos, ML; Veronese, N; Zaninotto, L, 2016)
"Randomized controlled clinical trials have demonstrated that escitalopram is efficacious in a range of mood and anxiety disorders, but the individual trials are insufficiently large to allow a full exploration of its tolerability."	8.84	Escitalopram therapy for major depression and anxiety disorders. ( Baldwin, DS; Guiton, C; Reines, EH; Weiller, E, 2007)
"Escitalopram, the active (S)-enantiomer of citalopram, has been approved in many countries throughout the world for the treatment of depression and anxiety disorders."	8.84	The use of escitalopram beyond major depression: pharmacological aspects, efficacy and tolerability in anxiety disorders. ( Altamura, AC; Bareggi, SR; Dell'Osso, B; Mundo, E, 2007)
"The suicide-related data on citalopram from controlled clinical trials in depression and anxiety disorders were analysed."	8.83	Citalopram and suicidality in adult major depression and anxiety disorders. ( Pedersen, AG, 2006)
" The current investigation attempted to identify potential predictors of placebo response through examination of the placebo-controlled clinical trial database for escitalopram in 3 anxiety disorders and in major depressive disorder (MDD)."	8.83	Which factors predict placebo response in anxiety disorders and major depression? An analysis of placebo-controlled studies of escitalopram. ( Baldwin, DS; Bandelow, B; Despiegel, N; Dolberg, OT; Stein, DJ, 2006)
"Treatment of major depression disorder with Selective serotonin reuptake inhibitors (SSRIs), such as citalopram (CTM), during pregnancy effects on the neurological trajectory of the offspring and induces enduring consequences, notably emotional and cognitive impairment."	8.12	Prenatal exposure of citalopram elicits depression-like and anxiety-like behaviors and alteration of morphology and protein expression of medial prefrontal cortex in young adult mice. ( Butt, MU; Du, L; Jia, M; Wang, Q; Wang, Y; Wu, J; Zahra, A, 2022)
"These findings suggest that PTPRZ1 variants may serve as a marker of escitalopram-mediated anxiety symptom remission in MDD."	8.02	Anxiety symptom remission is associated with genetic variation of PTPRZ1 among patients with major depressive disorder treated with escitalopram. ( Bousman, CA; Li, JT; Lin, JY; Liu, Q; Lv, XZ; Si, TM; Su, YA; Tian, L; Yu, X, 2021)
" Eighty-seven participants in the first Canadian Biomarker Integration Network in Depression (CAN-BIND-1) protocol received 8 weeks of open-label escitalopram."	7.96	Clinical, behavioral, and neural measures of reward processing correlate with escitalopram response in depression: a Canadian Biomarker Integration Network in Depression (CAN-BIND-1) Report. ( Arnott, SR; Ceniti, AK; Davis, AD; Downar, J; Dunlop, K; Foster, JA; Frey, BN; Harris, JK; Hassel, S; Kennedy, SH; Lam, RW; MacQueen, GM; Mansouri, F; Milev, R; Parikh, SV; Rizvi, SJ; Rotzinger, S; Schulze, L; Soares, CN; Strother, SC; Turecki, G; Uher, R; Zamyadi, M, 2020)
" In this study, we examined the molecular effects associated with a response to a week-long treatment with escitalopram in the chronic escape deficit (CED) model, a validated model of depression based on the induction of an escape deficit after exposure of rats to an unavoidable stress."	7.88	Molecular changes associated with escitalopram response in a stress-based model of depression. ( Alboni, S; Benatti, C; Blom, JMC; Brunello, N; Mendlewicz, J; Tascedda, F, 2018)
"The aim of the present study was to determine the relationship between the polymorphisms of -1438A/G and 102T/C in the 5-HT2A receptor (HTR2A) gene and nausea/vomiting as a side effect induced by sertraline (SERT) or citalopram (CIT) in patients with major depressive disorder."	7.88	The relationship between the serotonin 2A receptor gene -1438A/G and 102T/C polymorphisms and citalopram/sertraline-induced nausea in major depressed patients. ( Baskak, B; Demirbugen Oz, M; Devrimci Ozguven, H; Kizil Ozel, T; Ozdemir, H; Suzen, HS; Uckun, Z; Yuce-Artun, N, 2018)
"Neonatal abstinence syndrome (NAS) due to prenatally exposure to citalopram can develop during the first days of life even with low dose of drug exposure."	7.85	Neonatal abstinence syndrome due to prenatally citalopram exposure: A case report. ( Bas, AY; Celik, IH; Demirel, N; Erol, S; Ozcan, B, 2017)
"Considering the gene X environment hypothesis of depression, the present study investigated the effect of chronic ozone inhalation on depression and anxiety-related behavior, cognition, and brain markers of oxidative stress in the Flinders Sensitive Line (FSL) rat."	7.81	Ozone exposure of Flinders Sensitive Line rats is a rodent translational model of neurobiological oxidative stress with relevance for depression and antidepressant response. ( Brink, CB; Ellis, SM; Harvey, BH; Mokoena, ML; Viljoen, F, 2015)
" citalopram induced delirium."	7.79	Delirium during i. v. citalopram treatment: a case report. ( Delić, M; Pregelj, P, 2013)
" This study compared adherence and persistence rates among MDD patients with comorbid chronic pain-related diseases (CPD, including fibromyalgia, diabetes with neurological manifestations, osteoarthritis, low back pain, and headache) for three antidepressants: duloxetine, venlafaxine XR, and escitalopram."	7.77	Treatment adherence and persistence with duloxetine, venlafaxine XR, and escitalopram among patients with major depressive disorder and chronic pain-related diseases. ( Liu, X; Mullins, CD; Wang, J, 2011)
"Antidepressants are widely used to treat major depressive disorder."	7.01	Acceptability of escitalopram versus duloxetine in outpatients with depression who did not respond to initial second-generation antidepressants: A randomized, parallel-group, non-inferiority trial. ( Abe, T; Furukawa, TA; Iwanami, A; Mimura, M; Nakagawa, A; Nakagome, K; Nishioka, G; Tani, M; Watanabe, K; Yokoi, Y; Yoshimura, N, 2021)
"Suicidal ideation is a frequent and difficult-to-treat clinical challenge among patients with major depressive disorder (MDD)."	6.90	Trajectories of Suicidal Ideation During 12 Weeks of Escitalopram or Nortriptyline Antidepressant Treatment Among 811 Patients With Major Depressive Disorder. ( Aitchison, KJ; Behrendt-Møller, I; Buttenschøn, HN; Dernovsek, MZ; Hauser, J; Henigsberg, N; Köhler-Forsberg, O; Madsen, T; Maier, W; McGuffin, P; Mors, O; Perroud, N; Rietschel, M; Souery, D; Uher, R, 2019)
"Citalopram was superior to placebo in reducing 12-week HAM-D scores (mean difference, 3."	6.73	Effects of citalopram and interpersonal psychotherapy on depression in patients with coronary artery disease: the Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) trial. ( Abramson, BL; Baker, B; Dorian, P; Frasure-Smith, N; Ghatavi, K; Guertin, MC; Koszycki, D; Laliberté, MA; Lespérance, F; Swenson, JR; van Zyl, LT, 2007)
" Study durations ranged from 8 to 16 weeks and MPH dosing ranged from 5 to 90 mg per day."	6.72	Methylphenidate use in geriatric depression: A systematic review. ( Britt, RB; Brown, JN; Kahlon, CH; Smith, KR, 2021)
"Escitalopram has been shown to have better efficacy and safety profile than other selective serotonin reuptake inhibitor and serotonin norepinephrine reuptake inhibitor drugs, including racemic citalopram."	6.50	Clinical pharmacology review of escitalopram for the treatment of depression. ( Gobburu, J; Pastoor, D, 2014)
"Escitalopram is an effective first-line option in the management of patients with major depression, including severe forms, and various anxiety disorders."	6.44	Escitalopram for the treatment of major depression and anxiety disorders. ( Höschl, C; Svestka, J, 2008)
"TECAS was comparable to escitalopram in improving depression and related symptoms, with high acceptability, better safety profile, and particular efficacy in reducing trauma-associated depression."	5.69	Transcutaneous electrical cranial-auricular acupoint stimulation versus escitalopram for mild-to-moderate depression: An assessor-blinded, randomized, non-inferiority trial. ( Cai, JF; Chen, GB; He, JK; Hou, XB; Jiao, Y; Jin, GX; Liu, Y; Qin, ZS; Rong, PJ; Shi, L; Wang, Y; Wong, YK; Xiao, HB; Xiao, X; Xu, FQ; Yang, XJ; Zhang, JN; Zhang, LL; Zhang, SY; Zhang, ZJ; Zhao, YY; Zheng, Y, 2023)
"In 92 patients with MDD, we measured MDD severity with 6- and 17-item versions of the Hamilton Depression Rating Scale (HDRS6 and HDRS17) and the level of sexual function with the Changes in Sexual Functioning Questionnaire at baseline and 4, 8, and 12 weeks after initiating treatment with escitalopram."	5.69	Sexual function improves as depressive symptoms decrease during treatment with escitalopram: results of a naturalistic study of patients with major depressive disorder. ( Armand, S; Frokjaer, VG; Giraldi, A; Joergensen, MB; Knudsen, GM; Nielsen, JH; Stenbaek, DS; Weber, S, 2023)
"This secondary analysis of a randomized clinical trial implemented data-driven clustering in findings from the International Study to Predict Optimized Treatment in Depression, a pragmatic biomarker trial in which patients with MDD were randomized in a 1:1:1 ratio to antidepressant treatment with escitalopram, sertraline, or venlafaxine extended-release and assessed at baseline and 8 weeks on multimodal outcomes between December 1, 2008, and September 30, 2013."	5.69	A Cognitive Biotype of Depression and Symptoms, Behavior Measures, Neural Circuits, and Differential Treatment Outcomes: A Prespecified Secondary Analysis of a Randomized Clinical Trial. ( Hack, LM; Hilton, R; Jubeir, J; Korgaonkar, MS; O'Hara, R; Olmsted, AM; Schatzberg, AF; Tozzi, L; Williams, LM; Yesavage, JA; Zenteno, S, 2023)
"Escitalopram may have pain-alleviating effects for patients with comorbid pain and depression."	5.51	Pain severity and pain interference during major depressive episodes treated with escitalopram and aripiprazole adjunctive therapy: a CAN-BIND-1 report. ( Bhat, V; Diep, C; Frey, BN; Gandhi, W; Kennedy, SH; Khoo, Y; Ladha, KS; Lam, RW; Lou, W; Milev, RV; Ravindran, AV; Rosenek, N; Rotzinger, S; Salomons, T; van Reekum, CM, 2022)
"Drugs that target glutamate neuronal transmission, such as memantine, offer a novel approach to the treatment of late-life depression, which is frequently comorbid with cognitive impairment."	5.41	Transcriptomic signatures of treatment response to the combination of escitalopram and memantine or placebo in late-life depression. ( Grzenda, A; Laird, KT; Lavretsky, H; Siddarth, P; Yeargin, J, 2021)
"gov, NCT01278498), a randomized, placebo-controlled, double-blind trial that examined the efficacy of escitalopram on depression in acute stroke patients (237 with placebo, 241 with escitalopram)."	5.41	Post-Stroke Depressive Symptoms: Varying Responses to Escitalopram by Individual Symptoms and Lesion Location. ( Ahn, SH; Cha, JK; Chang, DI; Choi-Kwon, S; Heo, JH; Kim, DE; Kim, HY; Kim, J; Kim, JS; Kim, JY; Kim, MS; Kim, S; Koh, SH; Kwon, DY; Lee, BC; Lee, EJ; Lee, J; Lee, JS; Park, JH; Park, SW; Seo, WK; Sohn, SI, 2021)
" One hundred and sixty patients with MDD and comorbid obesity will be randomised 1:1 to simvastatin or placebo as add-on to standard antidepressant medication with escitalopram."	5.34	Simvastatin add-on to escitalopram in patients with comorbid obesity and major depression (SIMCODE): study protocol of a multicentre, randomised, double-blind, placebo-controlled trial. ( Chae, WR; Ettrich, B; Friede, T; Gold, SM; Grabe, HJ; Hegerl, U; Hinkelmann, K; Hofmann, T; Janowitz, D; Junghanns, K; Kaczmarczyk, M; Kahl, KG; Klein, JP; Krueger, THC; Leicht, G; Lischewski, S; Märschenz, S; Nowacki, J; Otte, C; Piber, D; Prvulovic, D; Reif, A; Roepke, S; Schmidt, S; Schoettle, D; Strauss, M; Westermair, A, 2020)
"The syndrome has been extensively described in children, but less information is available about adult patienis."	5.31	Wolf-Hirschhorn (4p-)syndrome in a near adult with major depression; successful treatment with citalopram. ( Moog, U; Tuinier, S; Verhoeven, WM; Wagemans, AM, 2002)
" After 4 weeks of open-label treatment with 10-20 mg of escitalopram per day, non-remitters [Montgomery-Åsberg Depression Rating Scale (MADRS) score > 10] were randomized 1:1 for double-blind treatment with either escitalopram (30 mg per day) or escitalopram (20 mg per day) plus placebo for 6 weeks."	5.30	A randomized, double-blind, 6-week prospective pilot study on the efficacy and safety of dose escalation in non-remitters in comparison to those of the standard dose of escitalopram for major depressive disorder. ( Ahn, YM; Kim, EY; Kim, HY; Kim, SH; Lee, HJ; Lee, NY; Park, CHK, 2019)
"A large, randomized, multicenter practical trial (International Study to Predict Optimized Treatment in Depression) in patients with current nonpsychotic MDD (N = 1,008; 722 completers) had three arms: escitalopram, sertraline, and venlafaxine-extended release."	5.30	Heart rate variability as a biomarker of anxious depression response to antidepressant medication. ( Gotlib, IH; Kircanski, K; Williams, LM, 2019)
"This report used acute treatment data from a clinically representative sample of outpatients with nonpsychotic major depressive disorder (N = 665) participating in the Combining Medications to Enhance Depression Outcomes trial, who received up to 12 weeks of escitalopram, escitalopram plus bupropion SR, or venlafaxine XR plus mirtazapine."	5.30	The Concise Health Risk Tracking Self-Report (CHRT-SR) assessment of suicidality in depressed outpatients: A psychometric evaluation. ( Carmody, TJ; De La Garza, N; Grannemann, BD; Killian, MO; Rush, AJ; Trivedi, MH, 2019)
"We analyzed data (collected during 1999-2002) from 174 patients 75 years or older, with unipolar depression (based on DSM-IV), who were randomly assigned to citalopram or placebo."	5.27	Abrupt Symptom Improvements in Antidepressant Clinical Trials: Transient Placebo Effects or Therapeutic Reality? ( Brown, PJ; Roose, SP; Rutherford, BR; Zilcha-Mano, S, 2018)
"Adjunctive ziprasidone, added to escitalopram, led to a greater weight gain and greater but modest akathisia compared to placebo."	5.24	Ziprasidone Augmentation of Escitalopram for Major Depressive Disorder: Cardiac, Endocrine, Metabolic, and Motoric Effects in a Randomized, Double-Blind, Placebo-Controlled Study. ( Baer, L; Bobo, WV; Curren, L; Fava, M; Mischoulon, D; Papakostas, GI; Shelton, RC, 2017)
"Suicidal ideation was more likely to occur early in citalopram treatment, with few subjects showing emergence or worsening occurring after 6 weeks of treatment."	5.22	Time Course and Predictors of Suicidal Ideation During Citalopram Treatment in the STAR*D Trial. ( Bloch, MH; Coughlin, CG; Jakubovski, E, 2016)
" We collected blood samples from a discovery cohort of 34 adult MDD patients with co-occurring anxiety and 33 matched, nondepressed controls at baseline and after 12 weeks (of citalopram plus psychotherapy treatment for the depressed cohort)."	5.20	Testing the predictive value of peripheral gene expression for nonremission following citalopram treatment for major depression. ( Bassi, S; Cyranowski, JM; Ding, Y; Guilloux, JP; Sibille, E; Tseng, G; Turecki, G; Walsh, C, 2015)
"Participants 18-65 years of age (N=1,008) who met criteria for major depressive disorder were randomly assigned to 8 weeks of treatment with escitalopram, sertraline, or extended-release venlafaxine."	5.20	Depression Subtypes in Predicting Antidepressant Response: A Report From the iSPOT-D Trial. ( Arnow, BA; Blasey, C; Etkin, A; Kulkarni, J; Luther, JF; Palmer, DM; Rekshan, W; Rush, AJ; Schatzberg, AF; Williams, LM, 2015)
"To explore relationships between baseline and changes in fatigue during treatment with outcomes in patients with major depressive disorder (MDD) receiving citalopram monotherapy."	5.19	Impact of fatigue on outcome of selective serotonin reuptake inhibitor treatment: secondary analysis of STAR*D. ( Dennehy, EB; Ferguson, M; Marangell, LB; Martinez, J; Wisniewski, SR, 2014)
" The authors tested the hypothesis that C-reactive protein (CRP), a commonly available marker of systemic inflammation, predicts differential response to escitalopram (a serotonin reuptake inhibitor) and nortriptyline (a norepinephrine reuptake inhibitor)."	5.19	An inflammatory biomarker as a differential predictor of outcome of depression treatment with escitalopram and nortriptyline. ( Dernovsek, MZ; Dew, T; Farmer, A; Hauser, J; Henigsberg, N; Maier, W; McGuffin, P; Mors, O; Souery, D; Tansey, KE; Uher, R, 2014)
" In the clinical study, sarcosine substantially improved scores of Hamilton Depression Rating Scale, Clinical Global Impression, and Global Assessment of Function more than citalopram treatment."	5.17	Inhibition of glycine transporter-I as a novel mechanism for the treatment of depression. ( Chang, YC; Chen, KT; Huang, CC; Huang, CL; Huang, KH; Lane, HY; Tsai, GE; Tsai, MH; Tsai, P; Tun, R; Wei, IH, 2013)
" The aim of the present genome-wide association study was to identify additional genetic variants involved in increasing suicidal ideation during escitalopram and nortriptyline treatment."	5.16	Genome-wide association study of increasing suicidal ideation during antidepressant treatment in the GENDEP project. ( Aitchison, KJ; Breen, G; Craig, IW; Dernovsek, MZ; Farmer, A; Gennarelli, M; Guipponi, M; Hauser, J; Henigsberg, N; Lathrop, M; Lewis, CM; Maier, W; McGuffin, P; Mors, O; Ng, MY; Perroud, N; Rietschel, M; Souery, D; Stamp, AS; Uher, R, 2012)
" Because the efficacy of escitalopram, a potent serotonin reuptake inhibitor, has not been well evaluated in cancer patients, we investigated its effects on depression and quality of life in outpatients with breast cancer."	5.16	Rapid improvement of depression and quality of life with escitalopram treatment in outpatients with breast cancer: a 12-week, open-label prospective trial. ( Bae, JN; Hahm, BJ; Kim, JH; Lee, BJ; Park, HY, 2012)
"To examine whether preemptive antidepressant treatment with escitalopram can decrease the incidence or severity of depression associated with pegylated IFN-α in HCV-infected patients without a history of psychiatric disorders."	5.16	Escitalopram for the prevention of peginterferon-α2a-associated depression in hepatitis C virus-infected patients without previous psychiatric disease: a randomized trial. ( Baumert, TF; Berg, T; Buggisch, P; Discher, T; Effenberger, S; Friebe, A; Fromm, G; Heinz, A; Heinze, L; Knop, V; Lieb, K; Link, R; Neumann, K; Ockenga, J; Reimer, J; Rentrop, M; Sarkar, R; Schaefer, M; Schlaepfer, T; Spengler, U; Weidenbach, H; Zeuzem, S, 2012)
"In MDD patients with moderate to severe painful physical symptoms not improving after 4 weeks of treatment with escitalopram, an earlier switch to duloxetine may lead to better pain and functional outcomes."	5.16	Early vs. conventional switching of antidepressants in patients with MDD and moderate to severe pain: a double-blind randomized study. ( Abbar, M; Gilaberte, I; Menchón, JM; Neuhauser, D; Papen, R; Pérez, V; Picard, H; Romera, I; Schacht, A, 2012)
"In genome-based drugs for depression (GENDEP), 811 patients with major depressive disorder treated with escitalopram or nortriptyline were assessed with the clinician-rated Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Rating Scale for Depression (HRSD), and the self-report Beck Depression Inventory (BDI)."	5.16	Self-report and clinician-rated measures of depression severity: can one replace the other? ( Dernovšek, MZ; Farmer, A; Henigsberg, N; Maier, W; McGuffin, P; Mors, O; Perlis, RH; Placentino, A; Uher, R, 2012)
"To evaluate the efficacy and safety of escitalopram for preventing interferon alfa-2a-induced depression, we conducted an investigator-initiated multicenter, randomized, double-blind, placebo-controlled trial in 133 chronic hepatitis C patients without baseline mental disorders who were randomly assigned to receive escitalopram or placebo during the first 12 weeks of treatment."	5.15	Prophylactic treatment with escitalopram of pegylated interferon alfa-2a-induced depression in hepatitis C: a 12-week, randomized, double-blind, placebo-controlled trial. ( Ardèvol, M; Castellví, P; Costa, J; Diago, M; Diez-Quevedo, C; Giménez, D; Giner, P; Martín-Santos, R; Masnou, H; Morillas, RM; Navinés, R; Planas, R; Pretel, J; Solà, R, 2011)
"Outpatients with chronic or recurrent major depression (MDD) were randomized to initial treatment with escitalopram+placebo (the MONO condition), bupropion-sustained release+escitalopram, or venlafaxine-extended release+mirtazapine (the COMB conditions) in the Combining Medications to Enhance Depression Outcomes (CO-MED) trial."	5.15	Randomized comparison of selective serotonin reuptake inhibitor (escitalopram) monotherapy and antidepressant combination pharmacotherapy for major depressive disorder with melancholic features: a CO-MED report. ( Bobo, WV; Chen, H; Cook, IA; Fava, M; Husain, MM; Kornstein, SG; Kurian, BT; Lesser, IM; Luther, JF; Morris, DW; Nierenberg, AA; Rush, AJ; Shelton, RC; Stewart, JW; Trivedi, MH; Warden, D; Wisniewski, SR, 2011)
"The purpose of this study was to compare escitalopram, problem-solving therapy, and placebo to prevent poststroke depression during 6 months after discontinuation of treatment."	5.15	Increased frequency of first-episode poststroke depression after discontinuation of escitalopram. ( Arndt, S; Fonzetti, P; Hegel, MT; Jang, M; Jorge, RE; Mikami, K; Moser, DJ; Robinson, RG; Small, SL; Solodkin, A, 2011)
"Higher BMI and obesity predicted poor response to nortriptyline but did not significantly influence response to escitalopram."	5.14	Body weight as a predictor of antidepressant efficacy in the GENDEP project. ( Aitchison, KJ; Dernovsek, MZ; Farmer, A; Gunasinghe, C; Hauser, J; Henigsberg, N; Kalember, P; Kozel, D; Larsen, ER; Leszczynska-Rodziewicz, A; Linotte, S; Maier, W; McGuffin, P; Mors, O; Pedrini, L; Perroud, N; Placentino, A; Rietschel, M; Souery, D; Strohmaier, J; Uher, R; Zobel, A, 2009)
"Citalopram treatment of MDD in older patients with heart failure is well-tolerated with low rates of side effects, but was not significantly more effective than placebo in the treatment of depression."	5.14	A double-blind, placebo-controlled treatment trial of citalopram for major depressive disorder in older patients with heart failure: the relevance of the placebo effect and psychological symptoms. ( Alves, TC; Andrei, AM; da Silva Telles, RM; Fraguas, R; Iosifescu, DV; Rays, J; Wajngarten, M, 2009)
"Outpatients with nonpsychotic major depressive disorder treated for up to 14 weeks with citalopram in the first step of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study were divided by household incomes of <$20,000, $20,000-<$40,000, and >or=$40,000."	5.14	Income and attrition in the treatment of depression: a STAR*D report. ( Balasubramani, GK; Lesser, IM; Nierenberg, AA; Rush, AJ; Shores-Wilson, K; Thase, ME; Trivedi, MH; Warden, D; Wisniewski, SR, 2009)
"Relatively treatment-naive depressed outpatients (with DSM-IV diagnoses of major depressive disorder, dysthymic disorder, or depression not otherwise specified) were initially treated with a combination of escitalopram (ESC) plus bupropion (BUP), using rapid dose escalation to ESC 40 mg/day plus BUP 400 to 450 mg/day by study day 15 in an open-label, 8-week study."	5.14	Does dual antidepressant therapy as initial treatment hasten and increase remission from depression? ( Deliyannides, RA; McGrath, PJ; Quitkin, FM; Stewart, JW, 2009)
"Bupropion's efficacy for smoking cessation in pregnant women is unknown."	5.14	The relationship between antidepressant use and smoking cessation in pregnant women in treatment for substance abuse. ( Brigham, EP; Chisolm, MS; Jones, HE; Strain, EC; Tuten, M, 2010)
"The CREATE trial reported that coronary artery disease (CAD) patients suffering from a first depression derived less benefit from citalopram relative to placebo than those with a recurrent depression."	5.14	First episode of major depressive disorder and vascular factors in coronary artery disease patients: Baseline characteristics and response to antidepressant treatment in the CREATE trial. ( Baker, B; Butler, G; Frasure-Smith, N; Habra, ME; Koszycki, D; Lespérance, F; Swenson, JR; van Zyl, LT, 2010)
" While it is well known that SSRI are efficient in treating depression or anxiety disorders, the authors tried to determine the influence of baseline anxiety on the response to SSRI treatment in patients with severe depression receiving either escitalopram or paroxetine."	5.14	[Efficacy of escitalopram vs paroxetine on severe depression with associated anxiety: data from the "Boulenger" study]. ( Chauvet-Gélinier, JC, 2010)
"The psychometric properties of the QIDS-SR16 were compared at treatment exit with those of the 30-item self-report Inventory of Depressive Symptomatology (IDS-SR30) and the 17-item clinician-rated Hamilton Rating Scale for Depression (HRSD17) in 73 outpatients with asthma who were treated with citalopram or placebo for nonpsychotic major depressive disorder."	5.13	The Quick Inventory of Depressive Symptomatology-Self-report: a psychometric evaluation in patients with asthma and major depressive disorder. ( Brown, ES; Carmody, TJ; Hughes, CW; Kennard, BD; Khan, DA; Murray, M; Rush, AJ, 2008)
"Participants with major depressive disorder (N = 2875) at primary and specialty care sites who received the first step treatment with citalopram in the Sequenced Treatment Alternatives to Relieve Depression study were included."	5.13	Response to a selective serotonin reuptake inhibitor (citalopram) in major depressive disorder with melancholic features: a STAR*D report. ( Fava, M; Khan, AY; McGrath, PJ; Miyahara, S; Morris, DW; Nierenberg, AA; Rush, AJ; Stewart, JW; Trivedi, MH; Wisniewski, SR, 2008)
" Across pregnancy and postpartum, the mean dose-corrected plasma concentrations (L/D ratios) of S- and R-citalopram and S-sertraline, and the corresponding primary chiral metabolites S- and R-desmethylcitalopram and N-desmethylsertra-line were assessed."	5.13	Changes in antidepressant metabolism and dosing across pregnancy and early postpartum. ( Helsel, JC; Perel, JM; Sit, DK; Wisner, KL, 2008)
"The effect of a combination of light therapy and citalopram in stroke victims receiving citalopram was examined by use of two different doses of light therapy under double-blind conditions."	5.12	Dose response to adjunctive light therapy in citalopram-treated patients with post-stroke depression. A randomised, double-blind pilot study. ( Andersen, G; Bech, P; Jarden, JO; Martiny, K; Søndergaard, MP, 2006)
"Among treatment-seeking elderly persons with MDD, higher anxiety symptoms and lower self-esteem predict poorer response after six weeks of escitalopram treatment."	5.12	Predicting 6-week treatment response to escitalopram pharmacotherapy in late-life major depressive disorder. ( Bensasi, S; Brown, C; Butters, MA; Cyranowski, J; Dew, MA; Frank, E; Gildengers, A; Houck, PR; Karp, JF; Lenze, EJ; Lotrich, F; Martire, L; Mazumdar, S; Miller, MD; Morse, J; Mulsant, BH; Reynolds, CF; Saghafi, R; Stack, J; Weber, E; Whyte, E, 2007)
"We conducted a 12-week open-label study of bupropion in 18 depressed asthma patients."	5.12	Bupropion in the treatment of outpatients with asthma and major depressive disorder. ( Brown, ES; Khan, DA; Rush, AJ; Vornik, LA, 2007)
"The aim of this study was to examine the association between polymorphism in the serotonin transporter gene and citalopram effectiveness and side effects in children and adolescents with major depressive disorder (MDD) and/or anxiety disorders."	5.12	Serotonin transporter polymorphism (5-HTTLPR) and citalopram effectiveness and side effects in children with depression and/or anxiety disorders. ( Apter, A; Brent, D; Carmel, M; Frisch, A; Gothelf, D; Kronenberg, S; Melhem, N; Pick, N; Schirman, S; Weizman, A, 2007)
"Results from randomized, placebo-controlled clinical trials have demonstrated that escitalopram is effective and well tolerated in the treatment of depression and anxiety disorders."	5.11	Escitalopram in clinical practice: results of an open-label trial in a naturalistic setting. ( Bose, A; Rush, AJ, 2005)
"Ninety adults with asthma and current major depressive disorder were randomized to receive citalopram or placebo for 12 weeks."	5.11	A randomized trial of citalopram versus placebo in outpatients with asthma and major depressive disorder: a proof of concept study. ( Brown, ES; Carmody, TJ; Khan, DA; Liggin, JD; Rush, AJ; Vigil, L, 2005)
"These results suggest that depression in patients with hepatitis C may be effectively and safely treated with citalopram."	5.10	An open-label trial of citalopram for major depression in patients with hepatitis C. ( Gleason, OC; Isbell, MD; Philipsen, MA; Yates, WR, 2002)
" For the key efficacy outcomes, escitalopram, mirtazapine, sertraline, citalopram, venlafaxine and paroxetine were associated with larger reduction of the Hamilton Depression Scale (HAMD) total score compared with placebo at 2 weeks."	5.05	Comparative efficacy of nine antidepressants in treating Chinese patients with post-stroke depression: A network meta-analysis. ( Li, X; Zhang, C, 2020)
"We obtained access to IPD from seven placebo-controlled trials comparing bupropion, duloxetine, escitalopram, mirtazapine, paroxetine or venlafaxine with placebo in the acute phase treatment of major depression (total n = 2803)."	5.01	Exploratory analyses of effect modifiers in the antidepressant treatment of major depression: Individual-participant data meta-analysis of 2803 participants in seven placebo-controlled randomized trials. ( Cipriani, A; Furukawa, TA; Ikeda, K; Imai, H; Maruo, K; Noma, H; Shinohara, K; Tanaka, S; Yamawaki, S, 2019)
"83 weeks) in patients with unipolar depression (studies=4, n=187; monotherapy vs lithium=1, augmentation of antidepressants vs placebo=3) or bipolar depression (studies=14, n=1965; monotherapy vs placebo=5, monotherapy vs lithium or olanzapine+fluoxetine=2, augmentation of antidepressants vs placebo=1, augmentation of mood stabilizers vs placebo=3, augmentation of mood stabilizers vs trancylpromine, citalopram, or inositol=3) were meta-analyzed."	4.93	Lamotrigine compared to placebo and other agents with antidepressant activity in patients with unipolar and bipolar depression: a comprehensive meta-analysis of efficacy and safety outcomes in short-term trials. ( Anghelescu, IG; Correll, CU; Gao, K; Normann, C; Reis, C; Schaffer, A; Solmi, M; van der Loos, ML; Veronese, N; Zaninotto, L, 2016)
"Randomized controlled clinical trials have demonstrated that escitalopram is efficacious in a range of mood and anxiety disorders, but the individual trials are insufficiently large to allow a full exploration of its tolerability."	4.84	Escitalopram therapy for major depression and anxiety disorders. ( Baldwin, DS; Guiton, C; Reines, EH; Weiller, E, 2007)
"Escitalopram, the active (S)-enantiomer of citalopram, has been approved in many countries throughout the world for the treatment of depression and anxiety disorders."	4.84	The use of escitalopram beyond major depression: pharmacological aspects, efficacy and tolerability in anxiety disorders. ( Altamura, AC; Bareggi, SR; Dell'Osso, B; Mundo, E, 2007)
"Data from the three available placebo-controlled trials with fixed doses of escitalopram in the acute therapy of DSM-IV major depressive disorder (MDD) were pooled."	4.83	Effective dose of escitalopram in moderate versus severe DSM-IV major depression. ( Andersen, HF; Bech, P; Wade, A, 2006)
" We sought to determine these thresholds by comparing, in a post hoc analysis, scores on the Clinical Global Impressions scale (CGI) and disorder-specific symptom severity rating scales from all available studies of the treatment of major depressive disorder, panic disorder, generalized anxiety disorder, and social anxiety disorder with the same medication (escitalopram)."	4.83	What is the threshold for symptomatic response and remission for major depressive disorder, panic disorder, social anxiety disorder, and generalized anxiety disorder? ( Andersen, HF; Baldwin, DS; Bandelow, B; Dolberg, OT; Stein, DJ, 2006)
"The suicide-related data on citalopram from controlled clinical trials in depression and anxiety disorders were analysed."	4.83	Citalopram and suicidality in adult major depression and anxiety disorders. ( Pedersen, AG, 2006)
" The current investigation attempted to identify potential predictors of placebo response through examination of the placebo-controlled clinical trial database for escitalopram in 3 anxiety disorders and in major depressive disorder (MDD)."	4.83	Which factors predict placebo response in anxiety disorders and major depression? An analysis of placebo-controlled studies of escitalopram. ( Baldwin, DS; Bandelow, B; Despiegel, N; Dolberg, OT; Stein, DJ, 2006)
"Data of 1296 outpatients with nonpsychotic depression who entered a 12-month naturalistic follow-up period after achieving remission with citalopram for up to 14 weeks were analyzed."	4.31	Predicting relapse from the time to remission during the acute treatment of depression: A re-analysis of the STAR*D data. ( Kubo, K; Mimura, M; Sakurai, H; Tani, H; Uchida, H; Watanabe, K, 2023)
"Treatment of major depression disorder with Selective serotonin reuptake inhibitors (SSRIs), such as citalopram (CTM), during pregnancy effects on the neurological trajectory of the offspring and induces enduring consequences, notably emotional and cognitive impairment."	4.12	Prenatal exposure of citalopram elicits depression-like and anxiety-like behaviors and alteration of morphology and protein expression of medial prefrontal cortex in young adult mice. ( Butt, MU; Du, L; Jia, M; Wang, Q; Wang, Y; Wu, J; Zahra, A, 2022)
" Individual and combinations of 19 immunomarkers were modeled as moderators between the three treatment arms (escitalopram monotherapy, escitalopram-bupropion and venlafaxine-mirtazapine) across a variety of depression outcomes."	4.02	Comparison of inflammatory markers as moderators of depression outcomes: A CO-MED study. ( Carmody, T; Chin-Fatt, C; Czysz, AH; Li, Q; Mason, BL; Minhajuddin, A; Trivedi, MH, 2021)
" Twenty LLD patients meeting DSM-IV criteria for a current major depressive episode and 20 non-depressed controls underwent clinical and neuropsychological assessments, magnetic resonance imaging to measure gray matter volumes and high-resolution positron emission tomography (PET) scanning to measure 5-HTT before and after 10-12 weeks of treatment with Citalopram or Sertraline (patients only)."	4.02	Molecular imaging of the serotonin transporter availability and occupancy by antidepressant treatment in late-life depression. ( Bigos, KL; Brasic, J; Dannals, RF; Gould, NF; Hall, AW; Holt, DP; Joo, JH; Kraut, M; Kuwabara, H; Mathews, WB; Nandi, A; Nassery, N; Savonenko, A; Smith, GS; Workman, CI, 2021)
" The current work leverages genome-wide genetic variation and machine learning to predict response to the antidepressant citalopram using data from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial (n = 1257 with both valid genomic and outcome data)."	4.02	Inclusion of genetic variants in an ensemble of gradient boosting decision trees does not improve the prediction of citalopram treatment response. ( Beevers, CG; Mallard, TT; McGeary, JE; Shumake, J, 2021)
"These findings suggest that PTPRZ1 variants may serve as a marker of escitalopram-mediated anxiety symptom remission in MDD."	4.02	Anxiety symptom remission is associated with genetic variation of PTPRZ1 among patients with major depressive disorder treated with escitalopram. ( Bousman, CA; Li, JT; Lin, JY; Liu, Q; Lv, XZ; Si, TM; Su, YA; Tian, L; Yu, X, 2021)
"We identified an overexpression of miR185-5p during escitalopram treatment of major depressive disorder, which was negatively associated with intensity of nausea, and identified a potential mRNA target that may mediate this effect."	3.96	Association Between Side Effects and Blood microRNA Expression Levels and Their Targeted Pathways in Patients With Major Depressive Disorder Treated by a Selective Serotonin Reuptake Inhibitor, Escitalopram: A CAN-BIND-1 Report. ( Fiori, LM; Foster, JA; Frey, BN; Kennedy, SH; Lam, RW; MacQueen, GM; Milev, R; Müller, DJ; Turecki, G; Yrondi, A, 2020)
" Eighty-seven participants in the first Canadian Biomarker Integration Network in Depression (CAN-BIND-1) protocol received 8 weeks of open-label escitalopram."	3.96	Clinical, behavioral, and neural measures of reward processing correlate with escitalopram response in depression: a Canadian Biomarker Integration Network in Depression (CAN-BIND-1) Report. ( Arnott, SR; Ceniti, AK; Davis, AD; Downar, J; Dunlop, K; Foster, JA; Frey, BN; Harris, JK; Hassel, S; Kennedy, SH; Lam, RW; MacQueen, GM; Mansouri, F; Milev, R; Parikh, SV; Rizvi, SJ; Rotzinger, S; Schulze, L; Soares, CN; Strother, SC; Turecki, G; Uher, R; Zamyadi, M, 2020)
" Change in reward sensitivity during the first 2 weeks of treatment was associated with improved depressive symptoms and anhedonia following 8 weeks of treatment with escitalopram."	3.91	Early change in reward and punishment sensitivity as a predictor of response to antidepressant treatment for major depressive disorder: a CAN-BIND-1 report. ( Allen, TA; Frey, BN; Kennedy, SH; Lam, RW; MacQueen, GM; Milev, R; Müller, DJ; Quilty, LC; Rizvi, SJ; Uher, R, 2019)
"In this item-based, patient-level, post-hoc analysis, we pooled data from all completed, acute-phase, placebo-controlled, industry-sponsored, HDRS-based trials of the SSRIs citalopram, paroxetine, or sertraline in adult major depression."	3.91	Influence of baseline severity on the effects of SSRIs in depression: an item-based, patient-level post-hoc analysis. ( Eriksson, E; Hieronymus, F; Lisinski, A; Nilsson, S, 2019)
" In this study, we examined the molecular effects associated with a response to a week-long treatment with escitalopram in the chronic escape deficit (CED) model, a validated model of depression based on the induction of an escape deficit after exposure of rats to an unavoidable stress."	3.88	Molecular changes associated with escitalopram response in a stress-based model of depression. ( Alboni, S; Benatti, C; Blom, JMC; Brunello, N; Mendlewicz, J; Tascedda, F, 2018)
"Thirty-two medication-free patients with depression were treated for 6 weeks with a selective serotonin reuptake inhibitor, escitalopram."	3.88	Predicting Treatment Response in Depression: The Role of Anterior Cingulate Cortex. ( Browning, M; Cowen, PJ; Godlewska, BR; Harmer, CJ; Igoumenou, A; Norbury, R, 2018)
"The aim of the present study was to determine the relationship between the polymorphisms of -1438A/G and 102T/C in the 5-HT2A receptor (HTR2A) gene and nausea/vomiting as a side effect induced by sertraline (SERT) or citalopram (CIT) in patients with major depressive disorder."	3.88	The relationship between the serotonin 2A receptor gene -1438A/G and 102T/C polymorphisms and citalopram/sertraline-induced nausea in major depressed patients. ( Baskak, B; Demirbugen Oz, M; Devrimci Ozguven, H; Kizil Ozel, T; Ozdemir, H; Suzen, HS; Uckun, Z; Yuce-Artun, N, 2018)
"Neonatal abstinence syndrome (NAS) due to prenatally exposure to citalopram can develop during the first days of life even with low dose of drug exposure."	3.85	Neonatal abstinence syndrome due to prenatally citalopram exposure: A case report. ( Bas, AY; Celik, IH; Demirel, N; Erol, S; Ozcan, B, 2017)
"Thirty outpatients with major depressive disorder (DSM-IV criteria) recruited between December 2002 and November 2005 were randomly assigned to receive citalopram + pindolol (5 mg tid) or citalopram + placebo for 6 weeks in a double-blind randomized clinical trial."	3.85	Can we really accelerate and enhance the selective serotonin reuptake inhibitor antidepressant effect? A randomized clinical trial and a meta-analysis of pindolol in nonresistant depression. ( Álvarez, E; Artigas, F; Ballesteros, J; de Diego-Adeliño, J; Oller, S; Pérez, V; Portella, MJ; Puigdemont, D; Santos, B, 2011)
"Considering the gene X environment hypothesis of depression, the present study investigated the effect of chronic ozone inhalation on depression and anxiety-related behavior, cognition, and brain markers of oxidative stress in the Flinders Sensitive Line (FSL) rat."	3.81	Ozone exposure of Flinders Sensitive Line rats is a rodent translational model of neurobiological oxidative stress with relevance for depression and antidepressant response. ( Brink, CB; Ellis, SM; Harvey, BH; Mokoena, ML; Viljoen, F, 2015)
"Dysfunction of cognitive control functions, but not reward-related decision making, may influence the decline of symptoms and the probability of remission of late-life depression treated with escitalopram."	3.81	Cognitive control, reward-related decision making and outcomes of late-life depression treated with an antidepressant. ( Alexopoulos, GS; Banerjee, S; Gunning, F; Kanellopoulos, D; Manning, K; McGovern, A; Seirup, JK, 2015)
"Nine LLD patients and seven non-depressed control subjects underwent clinical and cognitive evaluations as well as brain magnetic resonance imaging and PET studies of cerebral glucose metabolism at baseline, after 8 weeks of treatment with citalopram for a major depressive episode (patients only), and at an approximately 2-year follow-up."	3.79	Longitudinal studies of cerebral glucose metabolism in late-life depression and normal aging. ( Chaly, T; Dhawan, V; Eidelberg, D; Hermann, CR; Kramer, E; Ma, Y; Marano, CM; Smith, GS; Workman, CI, 2013)
" citalopram induced delirium."	3.79	Delirium during i. v. citalopram treatment: a case report. ( Delić, M; Pregelj, P, 2013)
" This study compared adherence and persistence rates among MDD patients with comorbid chronic pain-related diseases (CPD, including fibromyalgia, diabetes with neurological manifestations, osteoarthritis, low back pain, and headache) for three antidepressants: duloxetine, venlafaxine XR, and escitalopram."	3.77	Treatment adherence and persistence with duloxetine, venlafaxine XR, and escitalopram among patients with major depressive disorder and chronic pain-related diseases. ( Liu, X; Mullins, CD; Wang, J, 2011)
"We evaluated treatment response and covariates in 82 depressed patients diagnosed with DSM-IV major depressive (n=50) or bipolar disorders (n=32) treated initially in a day-hospital for 2 weeks, followed by 4 weeks of outpatient treatment, using citalopram given intravenously and then orally, with or without a mood-stabilizer."	3.76	Response to intravenous antidepressant treatment by suicidal vs. nonsuicidal depressed patients. ( Baldessarini, RJ; De Pisa, E; Girardi, P; Innamorati, M; Pompili, M; Tatarelli, R; Tondo, L, 2010)
"An open, multi-centre study was designed to address the effectiveness and tolerability profile of treatment with escitalopram under naturalistic conditions, in elderly outpatients (above 65 years of age) with depression."	3.76	Factors associated with response in depressed elderly outpatients treated with escitalopram in a naturalistic setting in Germany. ( Flürenbrock, W; Möller, HJ; Schnitker, J, 2010)
"Two cases, one of recurrent depression and another of major depressive disorder with hypertension switched to hypomania while on escitalopram."	3.75	Hypomania induced by escitalopram: 2 case reports. ( Sharma, RC, 2009)
"Currently, major depressive disorder (MDD) treatment plans are based on trial-and-error, and remission rates remain low."	3.30	Heartbeat-Evoked Potential in Major Depressive Disorder: A Biomarker for Differential Treatment Prediction between Venlafaxine and rTMS? ( Arns, M; Enriquez-Geppert, S; Gevirtz, R; Gordon, E; Sack, AT; van der Vinne, N; van Dijk, H; Zwienenberg, L, 2023)
"Escitalopram was significantly more effective in daily activity, feeling slowed down and concentration difficulty, while mirtazapine was significantly more effective in improving sleep, appetite and weight of MDD."	3.11	Difference in the regulation of biological rhythm symptoms of Major depressive disorder between escitalopram and mirtazapine. ( Cao, L; Chen, Y; Fang, Y; Hong, W; Huang, H; Huang, Q; Kong, S; Lyu, D; Peng, D; Qian, N; Wang, F; Wei, Z; Wu, C; Wu, Z; Yang, W; Zhang, M; Zhao, J, 2022)
"Antidepressant use for major depressive disorder (MDD) is frequently associated with sexual dysfunction."	3.11	Males and females differ in reported sexual functioning with escitalopram treatment for major depressive disorder: A CAN-BIND-1 study report. ( Bhat, V; Demchenko, I; Espinola, CW; Frey, BN; Ho, K; Kennedy, SH; Khoo, Y; Lam, RW; Lou, W; Milev, RV; Parikh, SV; Parmar, R; Ravindran, AV; Rotzinger, S, 2022)
"Abnormal emotional processing in major depressive disorder (MDD) has been associated with increased activation to negative stimuli in cortico-limbic brain regions."	3.11	The effects of transient receptor potential cation channel inhibition by BI 1358894 on cortico-limbic brain reactivity to negative emotional stimuli in major depressive disorder. ( Beckmann, C; Fuertig, R; Grimm, S; Herich, L; Just, S; Keicher, C; Mack, S; Mennes, M; Niedtfeld, I; Paret, C; Schmahl, C; Schultheis, C; Sharma, V; Thamer, C; Weigand, A; Wunder, A, 2022)
" This guideline updates and expands the 2015 Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline for CYP2D6 and CYP2C19 genotypes and SSRI dosing and summarizes the impact of CYP2D6, CYP2C19, CYP2B6, SLC6A4, and HTR2A genotypes on antidepressant dosing, efficacy, and tolerability."	3.01	Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6, CYP2C19, CYP2B6, SLC6A4, and HTR2A Genotypes and Serotonin Reuptake Inhibitor Antidepressants. ( Bell, GC; Bishop, JR; Bousman, CA; Brown, JT; Caudle, KE; Gaedigk, A; Hicks, JK; Klein, TE; Leeder, JS; Mueller, DJ; Ramsey, LB; Ruaño, G; Sangkuhl, K; Scott, SA; Singh, AB; Stevenson, JM; Strawn, JR; Tsermpini, EE, 2023)
"Escitalopram was shown to be significantly more effective than citalopram in achieving acute response (RR 0."	3.01	Escitalopram versus other antidepressive agents for major depressive disorder: a systematic review and meta-analysis. ( Lin, X; Miao, M; Song, X; Wang, C; Yin, J, 2023)
"Vortioxetine treatment was superior in simple attention efficiency."	3.01	Distinct association of plasma BDNF concentration and cognitive function in depressed patients treated with vortioxetine or escitalopram. ( Dvojkovic, A; Jaksic, N; Kusevic, Z; Mihaljevic-Peles, A; Nikolac Perkovic, M; Pivac, N; Sagud, M; Vuksan-Cusa, B; Zivkovic, M, 2021)
"Antidepressants are widely used to treat major depressive disorder."	3.01	Acceptability of escitalopram versus duloxetine in outpatients with depression who did not respond to initial second-generation antidepressants: A randomized, parallel-group, non-inferiority trial. ( Abe, T; Furukawa, TA; Iwanami, A; Mimura, M; Nakagawa, A; Nakagome, K; Nishioka, G; Tani, M; Watanabe, K; Yokoi, Y; Yoshimura, N, 2021)
"Although major depressive disorder (MDD) is associated with altered functional coupling between disparate neural networks, the degree to which such measures are ameliorated by antidepressant treatment is unclear."	2.94	Intrinsic connectomes are a predictive biomarker of remission in major depressive disorder. ( Fornito, A; Goldstein-Piekarski, AN; Korgaonkar, MS; Williams, LM, 2020)
"Cognitive deficits in major depressive disorder (MDD) are associated with low quality of life and higher suicide risk."	2.94	Cognitive changes after tDCS and escitalopram treatment in major depressive disorder: Results from the placebo-controlled ELECT-TDCS trial. ( Benseñor, IM; Bertola, L; Brunoni, AR; Fraguas, R; Gattaz, WF; Goerigk, SA; Lotufo, PA; Moffa, AH; Moreno, ML; Nogueira, BS; Padberg, F; Razza, LB; Suemoto, CK; Tort, L; Veronezi, BP, 2020)
"Fifty-eight patients with MDD (DSM-V) and Hamilton Depression Rating Scale (HAM-D) score ≥ 19 were randomized to receive either 400 mg twice daily L-Carnosine or placebo in addition to citalopram (maximum dosage of 40 mg/day) for six weeks in a randomized double-blind, and placebo-controlled study."	2.94	L-Carnosine combination therapy for major depressive disorder: A randomized, double-blind, placebo-controlled trial. ( Akhondzadeh, S; Aqamolaei, A; Araminia, B; Ardebili, ME; Ghaffari, S; Mortazavi, SH; Mortezaei, A; Naderi, S; Sahebolzamani, E; Shalbafan, M; Shariati, B; Shirazi, E, 2020)
"Participants with major depressive disorder were randomized in a 1:1:1 ratio to undergo 8 weeks of treatment with escitalopram oxalate (n = 162), sertraline hydrochloride (n = 176), or extended-release venlafaxine hydrochloride (n = 180)."	2.94	Evaluation of a Machine Learning Model Based on Pretreatment Symptoms and Electroencephalographic Features to Predict Outcomes of Antidepressant Treatment in Adults With Depression: A Prespecified Secondary Analysis of a Randomized Clinical Trial. ( Basu, S; Dass, N; Irvin, J; Keller, AS; Ng, A; Rajpurkar, P; Taylor, Z; Vale, V; Williams, LM; Yang, J, 2020)
"Participants with GAD and coprescribed benzodiazepines were treated with a lower mean dosage of escitalopram and were less likely to complete the trial; there was no difference in adherence or treatment response."	2.94	Coprescribed Benzodiazepines in Older Adults Receiving Antidepressants for Anxiety and Depressive Disorders: Association With Treatment Outcomes. ( Altmann, H; Blumberger, DM; Gebara, MA; Karp, JF; Lenze, EJ; Mulsant, BH; Reynolds, CF; Stahl, ST, 2020)
"In a two-year study, forty people with major depressive disorder are randomly assigned to groups that receive a SSRI (escitalopram) or a SNRI (duloxetine), each group receive concomitant ASA (100 mg) or a placebo."	2.90	The therapeutic alliance - its impact on antidepressant therapies in major depressive conditions and on the overall health. ( Sourdeau, A; Zdanowicz, N, 2019)
"Patients with Major Depressive Disorder (MDD) who are non-improvers after two weeks of antidepressant treatment have a high risk of treatment failure."	2.90	Predictors of the effectiveness of an early medication change strategy in patients with major depressive disorder. ( Braus, DF; Dreimüller, N; Elsner, S; Engel, A; Lieb, K; Roll, SC; Tadić, A; Wagner, S, 2019)
"For patients with major depressive disorder (MDD) experiencing side-effects or non-response to their first antidepressant, little is known regarding the effect of switching between a tricyclic antidepressant (TCA) and a selective serotonin reuptake inhibitor (SSRI)."	2.90	Effect of antidepressant switching between nortriptyline and escitalopram after a failed first antidepressant treatment among patients with major depressive disorder. ( Aitchison, KJ; Buttenschøn, HN; Farmer, A; Hauser, J; Köhler-Forsberg, O; Larsen, ER; Maier, W; McGuffin, P; Mors, O; Rietschel, M; Souery, D; Uher, R, 2019)
"Adults with major depressive disorder frequently do not achieve remission with an initial treatment."	2.90	Benefits of Sequentially Adding Cognitive-Behavioral Therapy or Antidepressant Medication for Adults With Nonremitting Depression. ( Cole, SP; Craighead, WE; Dunlop, BW; Kinkead, B; LoParo, D; Mayberg, HS; Mletzko-Crowe, T; Nemeroff, CB, 2019)
" The five most common adverse events (dissociation, nausea, vertigo, dysgeusia, and dizziness) all were observed more frequently in the esketamine plus antidepressant arm than in the antidepressant plus placebo arm; 7% and 0."	2.90	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)
" Adverse events were reported by 313 patients (bupropion XL, n = 157; escitalopram, n = 156); the most common on-treatment adverse event in both groups was nausea (10."	2.90	Efficacy and safety of bupropion hydrochloride extended-release versus escitalopram oxalate in Chinese patients with major depressive disorder: Results from a randomized, double-blind, non-inferiority trial. ( Hu, J; Li, H; Li, Y; Shen, Y; Tan, Y; Wang, Z; Xu, X; Yu, Y; Zhang, H; Zhao, Q; Zhong, J, 2019)
"Suicidal ideation is a frequent and difficult-to-treat clinical challenge among patients with major depressive disorder (MDD)."	2.90	Trajectories of Suicidal Ideation During 12 Weeks of Escitalopram or Nortriptyline Antidepressant Treatment Among 811 Patients With Major Depressive Disorder. ( Aitchison, KJ; Behrendt-Møller, I; Buttenschøn, HN; Dernovsek, MZ; Hauser, J; Henigsberg, N; Köhler-Forsberg, O; Madsen, T; Maier, W; McGuffin, P; Mors, O; Perroud, N; Rietschel, M; Souery, D; Uher, R, 2019)
"Studies of patients with major depressive disorder (MDD) have consistently reported reduced hippocampal volumes; however, the exact pattern of these volume changes in specific anatomical subfields and their functional significance is unclear."	2.87	Increased hippocampal tail volume predicts depression status and remission to anti-depressant medications in major depression. ( Broadhouse, K; Gordon, E; Grieve, SM; Koslow, S; Maller, JJ; Rush, AJ, 2018)
"Escitalopram 5-10 mg/d was used as an active comparator."	2.87	Efficacy of Tianeptine 25-50 mg in Elderly Patients With Recurrent Major Depressive Disorder: An 8-Week Placebo- and Escitalopram-Controlled Study. ( Ahokas, A; Antoine, C; Araszkiewicz, A; Blanchot, FP; Crutel, VS; Didi, R; Dóci, I; Emsley, R; Lee, MS; Lehtmets, A; Marinescu, D; Milanova, V; Penelaud, PF; Suarez, A; Sulaiman, AH, 2018)
"Major depressive disorder is a debilitating illness, which is most commonly treated with antidepressant drugs."	2.84	Investigation of miR-1202, miR-135a, and miR-16 in Major Depressive Disorder and Antidepressant Response. ( Berlim, M; Chachamovich, E; Fiori, LM; Foster, J; Jollant, F; Kennedy, SH; Lopez, JP; Richard-Devantoy, S; Rotzinger, S; Turecki, G, 2017)
"Escitalopram was given at a dose of 10 mg per day for 3 weeks and 20 mg per day thereafter."	2.84	Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression. ( Aparicio, LVM; Benseñor, IM; Borrione, L; Brunoni, AR; Chamorro, R; Fernandes, RA; Fraguas, R; Fregni, F; Gattaz, WF; Lotufo, PA; Moffa, AH; Moreno, ML; Nogueira, BS; Razza, LB; Sampaio-Junior, B; Tort, LC; Veronezi, BP, 2017)
"This randomized, double-blind, placebo-controlled study evaluated dose-response relationships of lisdexamfetamine dimesylate when used as augmentation for major depressive disorder in individuals exhibiting inadequate responses to antidepressant monotherapy."	2.84	A randomized, double-blind, placebo-controlled, dose-ranging study of lisdexamfetamine dimesylate augmentation for major depressive disorder in adults with inadequate response to antidepressant therapy. ( Dauphin, M; Geibel, B; Iosifescu, DV; Mago, R; Reynolds, J; Richards, C; Sarkis, E, 2017)
"In a two-year study, forty people with major depressive disorder were randomly assigned to groups that received an SSRI (escitalopram) or an SNRI (duloxetine), each group received concomitant ASA (100 mg) or a placebo."	2.84	Selective Serotonergic (SSRI) Versus Noradrenergic (SNRI) Reuptake Inhibitors with and without Acetylsalicylic Acid in Major Depressive Disorder. ( Dubois, T; Jacques, D; Lepiece, B; Reynaert, C; Zdanowicz, N, 2017)
"Adult outpatients with major depressive disorder were randomly assigned to open or placebo-controlled citalopram treatment."	2.84	Patient Expectancy as a Mediator of Placebo Effects in Antidepressant Clinical Trials. ( Brown, PJ; Choo, TH; Chung, S; Kirsch, I; Peterson, BS; Roose, SP; Rutherford, BR; Wager, TD; Wall, MM, 2017)
"Escitalopram and placebo treatment have differential effects on delta-theta and alpha frequency oscillations."	2.84	Escitalopram but not placebo modulates brain rhythmic oscillatory activity in the first week of treatment of Major Depressive Disorder. ( Cook, IA; Crump, C; Hunter, AM; Jain, FA; Leuchter, AF; Tartter, M, 2017)
"Patients with comorbid depression and insomnia who experienced the first onset of both disorders in childhood are less responsive to the treatments offered herein than are those with adult onsets of these comorbid disorders."	2.84	Are Patients with Childhood Onset of Insomnia and Depression More Difficult to Treat Than Are Those with Adult Onsets of These Disorders? A Report from the TRIAD Study. ( Buysse, DJ; Edinger, JD; Fairholme, CP; Gehrman, P; Krystal, AD; Luther, J; Manber, R; Thase, ME; Wisniewski, S, 2017)
"Seventy-nine adults with major depressive disorder were enrolled in an open-label study of citalopram (20 mg/day) for 6 weeks."	2.84	Double-blind switch study of vilazodone in the treatment of major depressive disorder. ( Grant, JE; Leppink, EW; Redden, SA, 2017)
"220 patients with major depressive disorder who were non-responders to a previous antidepressant were treated with venlafaxine for 4-6 weeks and in case of non-response with escitalopram for 4-6 weeks."	2.84	Neuroplasticity and second messenger pathways in antidepressant efficacy: pharmacogenetic results from a prospective trial investigating treatment resistance. ( Albani, D; Calabrò, M; Calati, R; Crisafulli, C; Fabbri, C; Forloni, G; Juven-Wetzler, A; Kasper, S; Martines, R; Mendlewicz, J; Montgomery, S; Serretti, A; Souery, D; Zohar, J, 2017)
"Escitalopram was effective and well-tolerated for acute-phase treatment of severe depression in Chinese population."	2.84	Efficacy and safety of escitalopram in treatment of severe depression in Chinese population. ( Cuili, H; Dong, J; Fang, M; Fang, Y; Li, J; Rui, Q; Shen, X; Si, T; Wang, G; Wang, J; Yang, F; Zhuo, J, 2017)
"Ziprasidone augmentation was equally efficacious in treating depression in patients with versus without anxious depression."	2.82	Ziprasidone augmentation for anxious depression. ( Baer, L; Fava, M; Ionescu, DF; Meade, KH; Papakostas, GI; Shelton, RC; Swee, MB, 2016)
"12-week trial of flexibly dosed citalopram."	2.80	Structural imaging in late-life depression: association with mood and cognitive responses to antidepressant treatment. ( Kraut, MA; Lyman, CH; Marano, CM; Munro, CA; Smith, GS; Workman, CI, 2015)
"Individuals with major depressive disorder (MDD) are characterized by maladaptive responses to both positive and negative outcomes, which have been linked to localized abnormal activations in cortical and striatal brain regions."	2.80	Dissociable cortico-striatal connectivity abnormalities in major depression in response to monetary gains and penalties. ( Admon, R; Bogdan, R; Dillon, DG; Dougherty, DD; Fava, M; Holmes, AJ; Iosifescu, DV; Kumar, P; Mischoulon, D; Nickerson, LD; Pizzagalli, DA, 2015)
"The crocin group (n=20) was given one selective serotonin reuptake inhibitor (SSRI) drug (fluoxetine 20mg/day or sertraline 50mg/day or citalopram 20mg/day) plus crocin tablets (30mg/day; 15mg BID) and placebo group (n=20) was administered one SSRI (fluoxetine 20mg/day or sertraline 50mg/day or citalopram 20mg/day) plus placebo (two placebo tablets per day) for 4 weeks."	2.80	Crocin, the main active saffron constituent, as an adjunctive treatment in major depressive disorder: a randomized, double-blind, placebo-controlled, pilot clinical trial. ( Hassanpour Moghadam, M; Mohajeri, SA; Sajadi Tabassi, SA; Talaei, A, 2015)
"Most patients with major depressive disorder (MDD) report clinically significant sleep problems."	2.80	Pre-treatment insomnia as a predictor of single and combination antidepressant outcomes: a CO-MED report. ( Luther, JF; Rush, AJ; Sung, SC; Trivedi, MH; Wisniewski, SR, 2015)
" The most common adverse events (≥5% of vilazodone patients, twice the rate of placebo) were diarrhea, nausea, vomiting (vilazodone 40 mg/day only), and insomnia."	2.80	Efficacy and safety of vilazodone 20 and 40 mg in major depressive disorder: a randomized, double-blind, placebo-controlled trial. ( Chen, D; Gommoll, C; Khan, A; Mathews, M; Nunez, R, 2015)
"Depression commonly co-occurs with alcohol use disorders but predictors of depression treatment outcome in patients with both conditions are not well established."	2.80	Depression outcome in alcohol dependent patients: an evaluation of the role of independent and substance-induced depression and other predictors. ( Adamson, SJ; Boden, JM; Douglas Sellman, J; Foulds, JA; Joyce, PR; Mulder, RT, 2015)
"In the new era of naltrexone for alcohol dependence, it is notable that only 1 study to date has examined the efficacy of antidepressant medication prescribed concurrently with naltrexone."	2.80	A randomized trial of combined citalopram and naltrexone for nonabstinent outpatients with co-occurring alcohol dependence and major depression. ( Adamson, SJ; Berks, J; Cape, G; Deering, D; Dunn, A; Foulds, JA; Frampton, CM; Nixon, L; Sellman, JD, 2015)
"Cognitive impairment in major depressive disorder predicts poor treatment outcome, but ABCB1 genetic effects in patients with cognitive impairment are untested."	2.80	ABCB1 Genetic Effects on Antidepressant Outcomes: A Report From the iSPOT-D Trial. ( DeBattista, C; Etkin, A; Lazzeroni, LC; Murphy, GM; Schatzberg, AF; Williams, LM, 2015)
" Treatment for both groups started at baseline, and patients received either 12 weeks of individual CBT or 12 weeks of escitalopram with flexible dosing (10 to 20 mg)."	2.80	Similar changes in cognitions following cognitive-behavioral therapy or escitalopram for major depressive disorder: Implications for mechanisms of change. ( Alpert, JE; Baer, L; Cardoos, A; Cohen, M; Farabaugh, A; Fava, M; Fisher, L; Holt, D; Huz, I; Nyer, M; Shapero, BG, 2015)
"Sexual dysfunction commonly occurs with major depressive disorder (MDD)."	2.80	Sexual dysfunction during treatment of major depressive disorder with vilazodone, citalopram, or placebo: results from a phase IV clinical trial. ( Chen, D; Clayton, AH; Gommoll, C; Mathews, M; Nunez, R, 2015)
"Major depressive disorder is a devastating mental illness leading to a lifetime prevalence of higher than 16% on individuals."	2.80	Chronic Supplementation of Curcumin Enhances the Efficacy of Antidepressants in Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Pilot Study. ( Pei, LB; Wen, ZY; Yang, JL; Yu, JJ; Zhang, Y, 2015)
"Escitalopram was more effective than placebo for treating depressive disorder in those with a higher methylation, and this effects lead to prevent persistent depressive disorder."	2.80	BDNF methylation and depressive disorder in acute coronary syndrome: The K-DEPACS and EsDEPACS studies. ( Ahn, Y; Bae, KY; Hong, YJ; Jeong, MH; Kang, HJ; Kim, JM; Kim, SW; Shin, IS; Stewart, R; Yoon, JS, 2015)
"escitalopram were significant on four of five dimensions and all three phases of sexual functioning assessed by the CSFQ-14 (P < 0."	2.80	Effect of Vortioxetine vs. Escitalopram on Sexual Functioning in Adults with Well-Treated Major Depressive Disorder Experiencing SSRI-Induced Sexual Dysfunction. ( Chen, Y; Chrones, L; Clayton, AH; Jacobsen, PL; Mahableshwarkar, AR, 2015)
"Citalopram treatment for up to 14 weeks."	2.79	SLC6A4 polymorphisms and age of onset in late-life depression on treatment outcomes with citalopram: a Sequenced Treatment Alternatives to Relieve Depression (STAR*D) report. ( Drews, MS; Geske, JR; Mrazek, DA; Shiroma, PR, 2014)
"In approximately half of the major depressive disorder (MDD) antidepressant trials published in the last decade, 30% or more of the patients assigned to the placebo arm showed clinically significant improvements."	2.79	Debunking the placebo effect in depression: the effect of patient and investigator expectation on escitalopram efficacy. ( Barak, Y; Baruch, Y; Lurie, I; Mandel, A; Nehama, Y; Rabinowitz, I, 2014)
"Treatment approaches for major depressive disorder (MDD) result in approximately one third of patients achieving remission after a first treatment."	2.79	Pretreatment brain states identify likely nonresponse to standard treatments for depression. ( Craighead, WE; Dunlop, BW; Holtzheimer, PE; Kelley, ME; Mayberg, HS; McGrath, CL, 2014)
"Two hundred forty-five outpatients aged 18-65 having non-psychotic, non-bipolar major depression were randomly assigned to double-blind treatment with bupropion or escitalopram or the combination dosed to a maximum of bupropion 450 mg/d and/or escitalopram 40 mg/d for 12 weeks."	2.79	Combination antidepressant therapy for major depressive disorder: speed and probability of remission. ( Amat, J; Bergeron, R; Blier, P; Blondeau, C; Chen, Y; Deliyannides, DA; Hellerstein, D; Laberge, L; McGrath, PJ; Norris, S; O'Shea, D; Pilowsky, DJ; Stewart, JW; Tessier, P; Withers, A, 2014)
"Although many patients with major depressive disorder (MDD) complain of neurocognitive impairment, the effects of antidepressant medications on neurocognitive functions remain unclear."	2.79	Improvement in subjective and objective neurocognitive functions in patients with major depressive disorder: a 12-week, multicenter, randomized trial of tianeptine versus escitalopram, the CAMPION study. ( Chung, S; Fava, M; Ha, JH; Heo, JY; Jeon, HJ; Kim, EJ; Kim, JH; Lee, SH; Mischoulon, D; Woo, JM; Yu, BH, 2014)
"60 inpatients suffering from major depressive disorder (MDD) according to DSM-IV were randomized for a 5 week treatment with Yoga or not (control group) and with either QXR (300 mg/day) or ESC (10 mg/day)."	2.79	The influence of Hatha yoga as an add-on treatment in major depression on hypothalamic-pituitary-adrenal-axis activity: a randomized trial. ( Baghai, TC; Born, C; Bühner, M; Konopka, K; Lieb, M; Nothdurfter, C; Rupprecht, R; Sarubin, N; Schüle, C; Uhr, M; Zimmermannc, R, 2014)
"Patients (N = 245) meeting criteria for major depressive disorder (MDD), diagnosed with DSM-IV-TR, were randomly assigned to double-blind treatment with bupropion extended-release, escitalopram, or the combination."	2.79	Does negative affectivity predict differential response to an SSRI versus a non-SSRI antidepressant? ( Amat, JA; Blier, P; Gerra, ML; Hellerstein, DJ; Marchesi, C; Stewart, JW, 2014)
"Clinical trials in major depressive disorder (MDD) commonly assess remission at a single endpoint."	2.78	Quantitative electroencephalogram biomarkers for predicting likelihood and speed of achieving sustained remission in major depression: a report from the biomarkers for rapid identification of treatment effectiveness in major depression (BRITE-MD) trial. ( Burgoyne, KS; Cook, IA; Gilmer, WS; Greenwald, S; Howland, RH; Hunter, AM; Iosifescu, DV; Jain, R; Leuchter, AF; Trivedi, MH; Zisook, S, 2013)
"Pramipexole was started at 0."	2.78	Combining a dopamine agonist and selective serotonin reuptake inhibitor for the treatment of depression: a double-blind, randomized pilot study. ( Franco-Chaves, JA; Luckenbaugh, DA; Mallinger, AG; Martinez, PE; Mateus, CF; Zarate, CA, 2013)
"The data taken together indicate that TDM-guided dosing of citalopram has the potential to be cost effective by reducing the length of hospitalization."	2.78	Potential cost-effectiveness of therapeutic drug monitoring for depressed patients treated with citalopram. ( Boland, K; Dragicevic, A; Fric, M; Hiemke, C; Laux, G; Mann, K; Müller, MJ; Ostad Haji, E; Rao, ML, 2013)
"Currently, fewer than 40% of patients treated for major depressive disorder achieve remission with initial treatment."	2.78	Toward a neuroimaging treatment selection biomarker for major depressive disorder. ( Craddock, RC; Craighead, WE; Dunlop, BW; Franco, AR; Holtzheimer, PE; Kelley, ME; Mayberg, HS; McGrath, CL, 2013)
"Approximately 50% of patients with major depressive disorder (MDD) do not respond optimally to antidepressant treatments."	2.78	Brain imaging predictors and the international study to predict optimized treatment for depression: study protocol for a randomized controlled trial. ( Etkin, A; Gordon, E; Grieve, SM; Harris, A; Korgaonkar, MS; Koslow, SH; Nemeroff, CB; Schatzberg, AF; Williams, LM; Wisniewski, S, 2013)
"2% (53/88) receiving lisdexamfetamine dimesylate had ≥ 1 treatment-emergent adverse event, the most frequent with lisdexamfetamine dimesylate being dry mouth and headache (both 11."	2.78	A randomized controlled trial of the efficacy and safety of lisdexamfetamine dimesylate as augmentation therapy in adults with residual symptoms of major depressive disorder after treatment with escitalopram. ( Cutler, AJ; Gao, J; Geibel, BB; Lasser, R; Patkar, AA; Richards, C; Sambunaris, A; Trivedi, MH, 2013)
"Major depressive disorder is associated with significant impairment in occupational functioning and reduced productivity, which represents a large part of the overall burden of depression."	2.78	Effects of combined pharmacotherapy and psychotherapy for improving work functioning in major depressive disorder. ( Axler, A; Kennedy, SH; Lam, RW; Manjunath, CV; Michalak, EE; Parikh, SV; Ramasubbu, R; Tam, EM; Yatham, LN, 2013)
"Adolescents (12-17 years) who completed an 8-week randomized, double-blind, flexible-dose, placebo-controlled, lead-in study of escitalopram 10-20 mg versus placebo could enroll in a 16-24-week, multisite extension trial; patients maintained the same lead-in randomization (escitalopram or placebo) and dosage (escitalopram 10 or 20 mg/day, or placebo) during the extension."	2.78	Escitalopram in the treatment of adolescent depression: a randomized, double-blind, placebo-controlled extension trial. ( Bose, A; Findling, RL; Robb, A, 2013)
"Patients with major depressive disorder (MDD) accompanied by physical symptoms may be less responsive to antidepressant treatment."	2.78	Quetiapine as combination treatment with citalopram in unipolar depression with prominent somatic symptoms: a randomised, double-blind, placebo-controlled pilot study. ( Anghelescu, I; Luborzewski, A; Quante, A; Regen, F; Roepke, S; Schindler, F; Severus, E; Urbanek, C; Volkmer, K, 2013)
"Prior studies have suggested that major depressive disorder (MDD) with pre-adult onset represents a distinct subtype with greater symptom severity and higher rates of suicidal ideation."	2.78	Does early-onset chronic or recurrent major depression impact outcomes with antidepressant medications? A CO-MED trial report. ( Balasubramani, GK; Kurian, B; Rush, AJ; Sung, SC; Trivedi, MH; Warden, D; Wisniewski, SR; Zisook, S, 2013)
"Citalopram-treated subjects showed a greater decrease in Hamilton Depression Rating Scale scores (significant at 2 weeks)."	2.78	Acute antidepressive efficacy of lithium monotherapy, not citalopram, depends on recurrent course of depression. ( Baethge, C; Bschor, T; Erbe, S; Ising, M; Lewitzka, U; Ritter, D; Uhr, M; Winkelmann, P, 2013)
"Thirty-five subjects with major depressive disorder and alcohol dependence were recruited and randomly assigned into 17 aripiprazole + escitalopram and 18 escitalopram only groups."	2.78	Adjunctive aripiprazole therapy with escitalopram in patients with co-morbid major depressive disorder and alcohol dependence: clinical and neuroimaging evidence. ( Choi, JE; Han, DH; Kim, SM; Min, KJ; Renshaw, PF, 2013)
"We tested nine symptom dimensions derived from a previously published factor analysis of depression rating scales as predictors of outcome in 811 adults with moderate to severe depression treated with flexibly dosed escitalopram or nortriptyline in Genome-based Therapeutic Drugs for Depression (GENDEP)."	2.77	Depression symptom dimensions as predictors of antidepressant treatment outcome: replicable evidence for interest-activity symptoms. ( Aitchison, KJ; Bajs, M; Dernovsek, MZ; Farmer, A; Hauser, J; Henigsberg, N; Maier, W; McGuffin, P; Mors, O; Perlis, RH; Rietschel, M; Souery, D; Uher, R; Zobel, A, 2012)
"In a 2-week double-blind study with a 2-week extended antidepressant phase, 60 first-episode young major depressive patients were randomly assigned to citalopram in combination with 2 weeks of either active or sham rTMS treatment."	2.77	Repetitive transcranial magnetic stimulation in combination with citalopram in young patients with first-episode major depressive disorder: a double-blind, randomized, sham-controlled trial. ( Hu, JB; Hu, SH; Huang, ML; Luo, BY; Wang, SS; Wei, N; Xu, Y; Zhou, WH, 2012)
"To determine whether distressing adverse events (DAEs) experienced during initial antidepressant treatment are associated with subsequent DAEs after switching to a second antidepressant."	2.77	Distressing adverse events after antidepressant switch in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial: influence of adverse events during initial treatment with citalopram on development of subsequent adverse events with an a ( Castillo, WC; Dusetzina, SB; Ellis, AR; Farley, JF; Gaynes, BN; Hansen, RA; Katz, AJ; Stürmer, T, 2012)
"Apathy in the context of treated major depressive disorder (MDD) is a common but understudied symptom."	2.77	Apathy in currently nondepressed patients treated with a SSRI for a major depressive episode: outcomes following randomized switch to either duloxetine or escitalopram. ( George, T; Granger, RE; Hussain, N; Marangell, LB; Raskin, J; Zhao, GW, 2012)
"The co-occurrence of substance use disorder (SUD) and major depressive disorder (MDD) is common and is often thought to impair response to antidepressant therapy."	2.77	Effect of concurrent substance use disorder on the effectiveness of single and combination antidepressant medications for the treatment of major depression: an exploratory analysis of a single-blind randomized trial. ( Balasubramani, GK; Davis, LL; Fava, M; Gaynes, BN; Howland, RH; Pilkinton, P; Rush, AJ; Trivedi, MH; Wisniewski, SR; Zisook, S, 2012)
"Pioglitazone is a safe and effective adjunctive short-term treatment in patients with moderate-to-severe MDD even in the absence of metabolic syndrome and diabetes."	2.77	Pioglitazone adjunctive therapy for moderate-to-severe major depressive disorder: randomized double-blind placebo-controlled trial. ( Akhondzadeh, S; Ashrafi, M; Modabbernia, A; Modabbernia, MJ; Sepanjnia, K, 2012)
"Fifty-two women with major depressive disorder were enrolled in an 8-week double-blind placebo-controlled clinical trial and randomly assigned to receive escitalopram in addition to either creatine (5 g/day, N=25) or placebo (N=27)."	2.77	A randomized, double-blind placebo-controlled trial of oral creatine monohydrate augmentation for enhanced response to a selective serotonin reuptake inhibitor in women with major depressive disorder. ( Bae, S; Hwang, J; Kim, JE; Kim, TS; Lyoo, IK; Renshaw, PF; Won, W; Yoon, S, 2012)
"Forty patients (18-55 years) with major depressive disorder (DSM-IV-TR criteria) and 17-Item Hamilton Depression Rating Scale (HDRS) score ≥ 22 were randomly assigned to scopolamine hydrobromide (1 mg/d) (n = 20) or placebo (n = 20) in addition to citalopram for 6 weeks."	2.77	Oral scopolamine augmentation in moderate to severe major depressive disorder: a randomized, double-blind, placebo-controlled study. ( Abbasi, SH; Akhondzadeh, S; Ashrafi, M; Farokhnia, M; Khajavi, D; Modabbernia, A; Tabrizi, M, 2012)
" It has been shown in many studies to be an effective and safe antidepressant for treating major depressive disorder (MDD)."	2.76	Efficacy and safety of escitalopram versus citalopram in major depressive disorder: a 6-week, multicenter, randomized, double-blind, flexible-dose study. ( Du, B; Fang, MS; Li, LH; Ou, JJ; Shi, JG; Wu, RR; Xie, SP; Xun, GL; Yuan, XQ; Zhang, HG; Zhao, JP, 2011)
"Open treatment with citalopram followed by up to 3 sequential next-step treatments."	2.76	Association between bipolar spectrum features and treatment outcomes in outpatients with major depressive disorder. ( Fava, M; Goldberg, JF; Ostacher, M; Perlis, RH; Rush, AJ; Trivedi, MH; Uher, R, 2011)
"Escitalopram was well tolerated in both age groups with adverse events reported by 53."	2.76	Are old-old patients with major depression more likely to relapse than young-old patients during continuation treatment with escitalopram? ( Gorwood, P; Katona, C; Lyketsos, CG; Weiller, E, 2011)
"Time to suicidal ideation was significantly longer in patients allocated to SSRI compared to those allocated to IPT (HR = 2."	2.76	Treatment-emergent suicidal ideation during 4 months of acute management of unipolar major depression with SSRI pharmacotherapy or interpersonal psychotherapy in a randomized clinical trial. ( Calugi, S; Cassano, GB; Fagiolini, A; Frank, E; Miniati, M; Rucci, P; Scocco, P, 2011)
"Postmenopausal women with major depressive disorder who did not respond to acute, double-blind treatment with escitalopram or desvenlafaxine achieved modest, continued improvement with long-term, open-label desvenlafaxine therapy."	2.76	Open-label treatment with desvenlafaxine in postmenopausal women with major depressive disorder not responding to acute treatment with desvenlafaxine or escitalopram. ( Clayton, A; Focht, K; Guico-Pabia, CJ; Jiang, Q; Kane, CP; Kornstein, SG; Ninan, PT; Soares, CN; Thase, ME, 2011)
"Pipamperone acts as a highly selective 5-HT2A/D4 antagonist when administered in low doses."	2.76	Citalopram plus low-dose pipamperone versus citalopram plus placebo in patients with major depressive disorder: an 8-week, double-blind, randomized study on magnitude and timing of clinical response. ( Buntinx, E; Crawford, GM; Haazen, L; McConnachie, A; Nemeroff, CB; Schatzberg, AF; Schlaepfer, T; Wade, AG, 2011)
" Twelve (20%) patients had adverse events leading to discontinuation."	2.76	Efficacy, safety and tolerability of escitalopram in doses up to 50 mg in Major Depressive Disorder (MDD): an open-label, pilot study. ( Crawford, GM; Wade, AG; Yellowlees, A, 2011)
"An antidepressant's tolerability, generally captured as the frequency and severity of adverse events (AEs), is often as important as its efficacy in determining treatment success."	2.76	Remission of major depressive disorder without adverse events: a comparison of escitalopram versus serotonin norepinephrine reuptake inhibitors. ( Ben-Hamadi, R; Dworak, H; Erder, MH; Ramakrishnan, K; Signorovitch, J; Wu, EQ; Yu, AP, 2011)
" Despite therapeutic doses, a significant number of patients had serum concentrations less than 50 ng/mL, and these were associated with an unfavorable treatment outcome; therapeutic drug monitoring is recommended to optimize dosing citalopram in the early phase of treatment."	2.76	Association between citalopram serum levels and clinical improvement of patients with major depression. ( Boland, K; Dragicevic, A; Fric, M; Hiemke, C; Laux, G; Müller, MJ; Ostad Haji, E; Rao, ML; Tadić, A; Wagner, S, 2011)
"To assess the early therapeutic and cognitive effect of repetitive transcranial magnetic stimulation (rTMS) combined with antidepressant medication in treatment of first-episode patients with major depression."	2.76	[Repetitive transcranial magnetic stimulation combined with antidepressant medication in treatment of first-episode patients with major depression]. ( Hu, JB; Hu, SH; Huang, ML; Luo, BY; Qi, HL; Wei, N; Xu, Y; Zhou, WH, 2011)
"Treatment guidelines for major depressive disorder (MDD) recommend a continuous use of antidepressants for several weeks, while recent meta-analyses indicate that antidepressant efficacy starts to appear within 2 weeks and early treatment nonresponse is a predictor of subsequent nonresponse."	2.76	Is switching antidepressants following early nonresponse more beneficial in acute-phase treatment of depression?: a randomized open-label trial. ( Abe, T; Hirano, J; Kashima, H; Mimura, M; Nakajima, S; Suzuki, T; Takeuchi, H; Uchida, H; Watanabe, K; Yagihashi, T, 2011)
"Baseline suicidal ideation was associated with greater depressive severity, childhood neglect, childhood abuse, early major depressive disorder onset, greater psychiatric comorbidity, and worse functioning and quality of life."	2.76	Effect of antidepressant medication treatment on suicidal ideation and behavior in a randomized trial: an exploratory report from the Combining Medications to Enhance Depression Outcomes Study. ( Fava, M; Kallenberg, G; Lebowitz, B; Lesser, IM; Luther, JF; Morris, DW; Nierenberg, AA; Rush, AJ; Trivedi, MH; Wisniewski, SR; Zisook, S, 2011)
" Blood samples were collected for pharmacokinetic analysis of ADTs."	2.75	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)
"Many patients with major depressive disorder (MDD) who experience full symptomatic remission after antidepressant treatment still have residual depressive symptoms."	2.75	Residual symptoms after remission of major depressive disorder with citalopram and risk of relapse: a STAR*D report. ( Fava, M; Husain, MM; Miyahara, S; Nierenberg, AA; Rush, AJ; Trivedi, MH; Warden, D; Wisniewski, SR, 2010)
"Escitalopram was used as a control for assay sensitivity."	2.75	A study of the effects of LY2216684, a selective norepinephrine reuptake inhibitor, in the treatment of major depression. ( Dellva, MA; Dubé, S; Jones, M; Kielbasa, W; Padich, R; Rao, P; Saha, A, 2010)
"Many patients with major depressive disorder (MDD) present with concurrent substance use disorders (SUDs), which has been thought to impair their response to antidepressants."	2.75	Does comorbid substance use disorder impair recovery from major depression with SSRI treatment? An analysis of the STAR*D level one treatment outcomes. ( Balasubramani, GK; Davis, LL; Fava, M; Howland, RH; Husain, MM; McGrath, PJ; Rush, AJ; Trivedi, MH; Warden, D; Wisniewski, SR, 2010)
"More than half of older adults with major depressive disorder require extended treatment because of incomplete response during acute treatment."	2.75	Anxiety impairs depression remission in partial responders during extended treatment in late-life. ( Andreescu, C; Dew, MA; Greenlee, A; Houck, P; Karp, JF; Reynolds, CF, 2010)
"Our results suggest that the genetic polymorphisms in CYP2C19 may be influencing S-CIT serum concentrations, and that specific CYP2D6 polymorphisms may be predicting patient treatment outcomes based on gene dosage analyses."	2.75	Genetic polymorphisms of cytochrome P450 enzymes influence metabolism of the antidepressant escitalopram and treatment response. ( Chen, CY; Fang, CK; Hsiao, MC; Lin, KM; Liu, SC; Liu, YL; Lu, ML; Lu, SC; Shen, WW; Tang, HS; Tsai, MH; Wu, CS, 2010)
"Some studies of major depressive disorder have linked episodic memory performance to treatment response."	2.75	Medial prefrontal cortex activity during memory encoding of pictures and its relation to symptomatic improvement after citalopram treatment in patients with major depression. ( Beaulieu, MM; Berlim, MT; Harvey, PO; Lepage, M; Mamdani, F; Roy, M; Turecki, G, 2010)
"To present an economic model and cost-effectiveness estimates of switching to bupropion compared to combination with bupropion after failure of an SSRI for major depressive disorder (MDD)."	2.75	Developing thai economic model to study cost-effectiveness of switching to bupropion compared to combination with bupropion after the failure of an SSRI for major depressive disorder. ( Leelahanaj, T, 2010)
"Escitalopram was well tolerated."	2.74	Escitalopram: an open-label study of bereavement-related depression and grief. ( Clayton, PJ; Hensley, PL; Slonimski, CK; Uhlenhuth, EH, 2009)
"Attrition rates are high during treatment for major depressive disorder (MDD), and patients who drop out are less likely to reach remission."	2.74	What predicts attrition in second step medication treatments for depression?: a STAR*D Report. ( Balasubramani, GK; Kornstein, SG; Lesser, IM; Nierenberg, AA; Preskorn, SH; Rush, AJ; Shores-Wilson, K; Thase, ME; Trivedi, MH; Warden, D; Wisniewski, SR; Young, EA, 2009)
"Patients with major depressive disorder (MDD) usually suffer from altered cognitive functions of episodic memory, working memory, mental processing speed and motor response."	2.74	Effects of selective serotonin reuptake and dual serotonergic-noradrenergic reuptake treatments on memory and mental processing speed in patients with major depressive disorder. ( Guàrdia-Olmos, J; Gudayol-Ferré, E; Herrera-Abarca, JE; Herrera-Guzmán, D; Herrera-Guzmán, I; Hinojosa-Calvo, E, 2009)
"Untreated major depressive disorder (MDD) is a major risk factor for suicide, but some data suggest antidepressants may be associated with increased suicidal ideation (SI) in some depressed patients."	2.74	Clinical correlates of the worsening or emergence of suicidal ideation during SSRI treatment of depression: an examination of citalopram in the STAR*D study. ( Fava, M; Lebowitz, B; Luther, J; Moutier, C; Rush, AJ; Stewart, JW; Thase, ME; Trivedi, MH; Warden, D; Wisniewski, SR; Zisook, S, 2009)
"The authors sought to identify predictors of self-harm adverse events in treatment-resistant, depressed adolescents during the first 12 weeks of treatment."	2.74	Predictors of spontaneous and systematically assessed suicidal adverse events in the treatment of SSRI-resistant depression in adolescents (TORDIA) study. ( Asarnow, J; Birmaher, B; Brent, DA; Clarke, GN; Debar, LL; Emslie, GJ; Iyengar, S; Keller, MB; Kennard, B; Leonard, H; Mayes, TL; McCracken, JT; Onorato, M; Porta, G; Ritz, L; Ryan, ND; Spirito, A; Strober, M; Suddath, R; Vitiello, B; Zelazny, J, 2009)
" Despite similar medication dosing and time at exit dose, the efficacy participants tolerated citalopram better."	2.74	Can phase III trial results of antidepressant medications be generalized to clinical practice? A STAR*D report. ( Fava, M; Gaynes, BN; Lavori, PW; Luther, JF; McGrath, PJ; Nierenberg, AA; Rush, AJ; Thase, ME; Trivedi, MH; Warden, D; Wisniewski, SR, 2009)
"Citalopram was delivered using measurement-based care and flexible dosing with the aim of achieving symptom remission."	2.74	Sociodemographic, clinical, and treatment characteristics associated with worsened depression during treatment with citalopram: results of the NIMH STAR(*)D trial. ( Balasubramani, GK; Fava, M; Friedman, ES; Gilmer, W; Nierenberg, AA; Rush, AJ; Trivedi, MH; Wisniewski, SR; Zisook, S, 2009)
"Chronic insomnia and depression are often associated."	2.74	Validation of the sleep impact scale in patients with major depressive disorder and insomnia. ( Crawford, B; Joish, VN; Lasch, K; Qiu, C; Rosa, K; Zhu, Y, 2009)
" A total of 796 adult patients with major depressive disorder who were treated with a flexible dosage of escitalopram or nortriptyline in Genome-based Therapeutic Drugs for Depression (GENDEP) were included in the sample and provided data on suicidal ideation."	2.74	Genetic predictors of increase in suicidal ideation during antidepressant treatment in the GENDEP project. ( Aitchison, KJ; Bonvicini, C; Craig, I; Farmer, AE; Gray, J; Gupta, B; Hauser, J; Henigsberg, N; Huezo-Diaz, P; Jorgensen, L; Kalember, P; Kapelski, P; Lewis, CM; Maier, W; Marusic, A; McGuffin, P; Mors, O; Perroud, N; Petrovic, A; Placentino, A; Rietschel, M; Schulze, TG; Smith, R; Souery, D; Uher, R; Zobel, A, 2009)
"Treatment with citalopram was associated with greater increase in tNO over 12 weeks compared to placebo (P = 0."	2.74	Platelet and endothelial activity in comorbid major depression and coronary artery disease patients treated with citalopram: the Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy Trial (CREATE) biomarker sub-study. ( Atar, D; Frasure-Smith, N; Laliberté, MA; Lespérance, F; Malinin, AI; Serebruany, VL; van Zyl, LT, 2009)
"Anhedonia is a core symptom of major depressive disorder (MDD), long thought to be associated with reduced dopaminergic function."	2.73	Abnormal temporal difference reward-learning signals in major depression. ( Ahearn, T; Kumar, P; Milders, M; Reid, I; Steele, JD; Waiter, G, 2008)
"Sertraline hydrochloride was started at 50 mg/d and incrementally increased to 200 mg/d."	2.73	Selecting among second-step antidepressant medication monotherapies: predictive value of clinical, demographic, or first-step treatment features. ( Davis, LL; Fava, M; Luther, JF; Nierenberg, AA; Rush, AJ; Trivedi, MH; Warden, D; Wisniewski, SR, 2008)
"Buspirone plasma levels were not measured."	2.73	Interaction between serotonin 5-HT1A receptors and beta-endorphins modulates antidepressant response. ( Gastó, C; Gómez-Gil, E; Martín-Santos, R; Martínez de Osaba, MJ; Navinés, R, 2008)
"Memantine was at least as effective with regard to drinking as escitalopram."	2.73	Treatment of alcohol dependence in patients with co-morbid major depressive disorder--predictors for the outcomes with memantine and escitalopram medication. ( Alho, H; Lahti, J; Lönnqvist, J; Muhonen, LH; Sinclair, D, 2008)
"Escitalopram was associated with significantly lower duration of sick leave and significant savings in the total cost compared with duloxetine; it dominated duloxetine when effectiveness was assessed on the SDS scale."	2.73	Escitalopram and duloxetine in major depressive disorder: a pharmacoeconomic comparison using UK cost data. ( Danchenko, N; Despiegel, N; Fernández, JL; François, C; Hansen, K; Wade, AG, 2008)
"All mothers had been diagnosed with major depressive disorder and were treated initially with citalopram; 33% of mothers experienced remission of depressive symptoms."	2.73	Remission of maternal depression: relations to family functioning and youth internalizing and externalizing symptoms. ( Alpert, JE; Cerda, G; Fava, M; Foster, CE; Garber, J; Hughes, CW; King, CA; Kornstein, SG; Malloy, E; Pilowsky, DJ; Rush, AJ; Talati, A; Trivedi, MH; Webster, MC; Weissman, MM; Wickramaratne, PJ; Wisniewski, SR, 2008)
"Escitalopram was well tolerated, safe, and efficacious."	2.73	Escitalopram in the treatment of major depressive disorder in primary-care settings: an open-label trial. ( Chokka, P; Legault, M, 2008)
"Escitalopram was significantly superior to placebo in all comparisons."	2.73	Escitalopram in the treatment of anxiety symptoms associated with depression. ( Andersen, HF; Bandelow, B; Dolberg, OT, 2007)
"Escitalopram was administered over a 12-week treatment period to 790 depressed patients, including 482 patients with at least one concomitant anxiety disorder."	2.73	A prospective study of escitalopram in the treatment of major depressive episodes in the presence or absence of anxiety. ( Galinowski, A; Ménard, F; Olié, JP; Tonnoir, B, 2007)
"Patients (N = 27) with major depressive disorder received a standard antidepressant treatment (Venlafaxine, Escitalopram) plus flexible dose of quetiapine."	2.73	Effects of adjunctive antidepressant therapy with quetiapine on clinical outcome, quality of sleep and daytime motor activity in patients with treatment-resistant depression. ( Baune, BT; Caliskan, S; Todder, D, 2007)
"Citalopram was superior to placebo in reducing 12-week HAM-D scores (mean difference, 3."	2.73	Effects of citalopram and interpersonal psychotherapy on depression in patients with coronary artery disease: the Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) trial. ( Abramson, BL; Baker, B; Dorian, P; Frasure-Smith, N; Ghatavi, K; Guertin, MC; Koszycki, D; Laliberté, MA; Lespérance, F; Swenson, JR; van Zyl, LT, 2007)
"Those with concurrent drug abuse and recurrent major depressive disorder were less likely to accept a switch strategy."	2.73	Acceptability of second-step treatments to depressed outpatients: a STAR*D report. ( Biggs, MM; Fava, M; Friedman, ES; Lavori, PW; McGrath, PJ; Miyahara, S; Niederehe, G; Rush, AJ; Sackeim, HA; Shores-Wilson, K; Thase, ME; Trivedi, MH; Warden, D; Wisniewski, SR, 2007)
"Patients Individuals with nonpsychotic major depressive disorder for whom DNA was available and who did not report suicidal ideation at study entry were subsequently treated with citalopram hydrobromide for up to 12 weeks."	2.73	Association between treatment-emergent suicidal ideation with citalopram and polymorphisms near cyclic adenosine monophosphate response element binding protein in the STAR*D study. ( Fagerness, J; Fava, M; Perlis, RH; Purcell, S; Rush, AJ; Smoller, JW; Trivedi, MH, 2007)
"Escitalopram was superior to duloxetine in acute treatment and at least as efficacious and better tolerated in long-term treatment of MDD."	2.73	A comparative study of the efficacy of acute and continuation treatment with escitalopram versus duloxetine in patients with major depressive disorder. ( Florea, I; Gembert, K; Wade, A, 2007)
"Escitalopram was well tolerated with 53 patients (13%) withdrawn as a result of adverse events during the open-label period and three (2%) escitalopram-treated patients and six (4%) placebo-treated patients during double-blind treatment (not significant)."	2.73	Escitalopram prevents relapse in older patients with major depressive disorder. ( Gorwood, P; Katona, C; Lemming, O; Weiller, E, 2007)
"About half of outpatients with major depressive disorder also have clinically meaningful levels of anxiety."	2.73	Difference in treatment outcome in outpatients with anxious versus nonanxious depression: a STAR*D report. ( Alpert, JE; Balasubramani, GK; Biggs, MM; Carmin, CN; Fava, M; Howland, R; Leuchter, A; Rush, AJ; Trivedi, MH; Warden, D; Wisniewski, SR; Zisook, S, 2008)
"Escitalopram was well tolerated, with only 2 patients (1."	2.73	An open-label multicentric study of the tolerability and response to escitalopram treatment in Indian patients with major depressive disorder. ( Narasimha, V; Pinto, C; Sharma, PS; Trivedi, JK; Vankar, GK, 2007)
"Whether the acute outcomes of major depressive disorder (MDD) treated in primary (PC) or specialty care (SC) settings are different is unknown."	2.73	Primary versus specialty care outcomes for depressed outpatients managed with measurement-based care: results from STAR*D. ( Balasubramani, GK; Fava, M; Gaynes, BN; Klinkman, M; McGrath, PJ; Nierenberg, AA; Rush, AJ; Thase, ME; Trivedi, MH; Wisniewski, SR; Yates, WR, 2008)
"In patients with medication-resistant major depression we administered in a randomised trial 15 sessions of sham-controlled rTMS over three weeks in combination with 20 mg escitalopram daily."	2.73	Repetitive transcranial magnetic stimulation (rTMS) in combination with escitalopram in patients with treatment-resistant major depression: a double-blind, randomised, sham-controlled trial. ( Bech, P; Bretlau, LG; Dissing, S; Lindberg, L; Lunde, M; Undén, M, 2008)
"Escitalopram was started at 10 mg/day, then increased and maintained at 20 mg/day for 10 weeks at the end of which completers were randomly assigned to placebo or escitalopram for 9 additional weeks."	2.73	Escitalopram in the treatment of impulsive-compulsive internet usage disorder: an open-label trial followed by a double-blind discontinuation phase. ( Allen, A; Baker, B; Chaplin, WF; Dell'Osso, B; Hadley, S; Hollander, E, 2008)
"Aripiprazole is an effective and safe adjunctive therapy as demonstrated in this short-term study for patients who are nonresponsive to standard ADT."	2.73	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)
"Insomnia impacts the course of major depressive disorder (MDD), hinders response to treatment, and increases risk for depressive relapse."	2.73	Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia. ( Edinger, JD; Gress, JL; Kalista, T; Kuo, TF; Manber, R; San Pedro-Salcedo, MG, 2008)
" Study durations ranged from 8 to 16 weeks and MPH dosing ranged from 5 to 90 mg per day."	2.72	Methylphenidate use in geriatric depression: A systematic review. ( Britt, RB; Brown, JN; Kahlon, CH; Smith, KR, 2021)
"Major depressive disorders have a significant impact on children and adolescents, including on educational and vocational outcomes, interpersonal relationships, and physical and mental health and well-being."	2.72	New generation antidepressants for depression in children and adolescents: a network meta-analysis. ( Badcock, PB; Bailey, AP; Cox, GR; Hetrick, SE; McKenzie, JE; Meader, N; Merry, SN; Moller, CI; Sharma, V, 2021)
"Escitalopram is a selective serotonin reuptake inhibitor antidepressant indicated for use in adults."	2.72	A double-blind, randomized, placebo-controlled trial of escitalopram in the treatment of pediatric depression. ( Findling, RL; Jonas, J; Saikali, K; Ventura, D; Wagner, KD, 2006)
" The safety and tolerability of hypericum extract in comparison to citalopram and placebo was investigated on the basis of CGI, the occurrence of adverse events and the investigation of laboratory parameters and vital signs."	2.72	Comparative efficacy and safety of a once-daily dosage of hypericum extract STW3-VI and citalopram in patients with moderate depression: a double-blind, randomised, multicentre, placebo-controlled study. ( Gastpar, M; Singer, A; Zeller, K, 2006)
"Diagnosis of major depressive disorder was assessed with the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and mood was evaluated with the 21-item Hamilton Depression Rating Scale (HAM-D) at baseline and at weekly follow-ups for 12 weeks."	2.72	Mood and neuropsychological changes in women with midlife depression treated with escitalopram. ( Keller, J; Kenna, HA; Rasgon, NL; Reynolds, MF; Shelton, SD; Williams, KE; Wroolie, TE; Zappert, LN, 2006)
"The authors treated 14 Parkinson's disease patients with major depression with escitalopram in an open-label study."	2.72	Escitalopram for major depression in Parkinson's disease: an open-label, flexible-dosage study. ( Duda, JE; Katz, IR; Morales, KH; Stern, MB; Taraborelli, D; Weintraub, D, 2006)
"Escitalopram is a selective serotonin reuptake inhibitor (SSRI) that has shown efficacy in both acute and continuation treatment of major depressive disorder."	2.72	Escitalopram maintenance treatment for prevention of recurrent depression: a randomized, placebo-controlled trial. ( Bose, A; Gandhi, C; Kornstein, SG; Li, D; Saikali, KG, 2006)
"Citalopram treatment may benefit patients with primary social anxiety disorder and comorbid major depression, and it should be further studied in controlled trials."	2.71	Citalopram treatment of social anxiety disorder with comorbid major depression. ( Blanco, C; Campeas, R; Lewis-Fernandez, R; Liebowitz, MR; Lin, SH; Marshall, R; Sanchez-Lacay, JA; Schmidt, AB; Schneier, FR; Simpson, HB, 2003)
"Citalopram appears to be a safe and effective treatment for compulsive shopping disorder."	2.71	Citalopram for compulsive shopping disorder: an open-label study followed by double-blind discontinuation. ( Bullock, KD; Chuong, HW; Koran, LM; Smith, SC, 2003)
"Methylphenidate was tapered and discontinued during weeks 9 and 10."	2.71	Combined treatment with methylphenidate and citalopram for accelerated response in the elderly: an open trial. ( Kim, MD; Kumar, A; Lavretsky, H; Reynolds, CF, 2003)
"Patients with DSM-IV major depressive disorder who had not responded to at least 1 previous antidepressant and at least 6 weeks of treatment with citalopram or bupropion-SR were treated in a standard clinical protocol."	2.71	Citalopram and bupropion-SR: combining versus switching in patients with treatment-resistant depression. ( Hossie, H; Lam, RW; Solomons, K; Yatham, LN, 2004)
"In continuation of a previous psychometric analysis of dose-response data for citalopram in depression, the corresponding study data for escitalopram is of interest, since escitalopram is the active enantiomer of citalopram and because citalopram was used as the active control."	2.71	Escitalopram dose-response revisited: an alternative psychometric approach to evaluate clinical effects of escitalopram compared to citalopram and placebo in patients with major depression. ( Andersen, HF; Bech, P; Cialdella, P; Pedersen, AG; Tanghøj, P, 2004)
"Three cases of patients presenting a substance use disorder with comorbid major depression episodes are presented, who were treated with a reboxetine/escitalopram combination and who showed a rapid response of their depressive syndrome."	2.71	Escitalopram/reboxetine combination in depressed patients with substance use disorder. ( Camarasa, X; Duboc, A; Khazaal, Y; Lopez-Martinez, E; Zullino, DF, 2005)
" Citalopram dosing began at 20 mg/day and could be titrated to 60 mg/day."	2.70	Naturalistic study of the early psychiatric use of citalopram in the United States. ( Bose, A; Heydorn, WE; Rush, AJ, 2002)
"Citalopram therapy was well tolerated, and more than one half of the patients who began treatment improved significantly."	2.70	Citalopram treatment of paroxetine-intolerant depressed patients. ( Ferguson, JM; Lydiard, RB; Thase, ME; Wilcox, CS, 2002)
"Selective serotonin reuptake inhibitors are commonly used to treat major depression; however, the percentage of serotonin (5-HT) transporter (5-HTT) sites occupied during clinical dosing is unknown."	2.70	Occupancy of serotonin transporters by paroxetine and citalopram during treatment of depression: a [(11)C]DASB PET imaging study. ( Ginovart, N; Goulding, V; Hood, K; Houle, S; Hussey, D; Meyer, JH; Wilson, AA, 2001)
" 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."	2.70	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)
"The purpose of this study was to identify specific pharmacokinetic (PK) and pharmacodynamics (PD) factors that affect the likelihood of treatment remission with a serotonin norepinephrine reuptake inhibitor (SNRI) in depressed patients whose initial selective serotonin reuptake inhibitor (SSRI) failed."	2.61	Pharmacokinetic-Pharmacodynamic interaction associated with venlafaxine-XR remission in patients with major depressive disorder with history of citalopram / escitalopram treatment failure. ( Ahmed, AT; Biernacka, JM; Bobo, WV; Frye, MA; Hall-Flavin, DK; Jenkins, G; Kung, S; Rush, AJ; Shinozaki, G; Veldic, M; Wang, L; Weinshilboum, RM, 2019)
" Side effect data were available at weeks 2-4, 6 and 9 in three samples."	2.58	Effect of cytochrome CYP2C19 metabolizing activity on antidepressant response and side effects: Meta-analysis of data from genome-wide association studies. ( Aitchison, KJ; Biernacka, JM; Breen, G; Craig, I; Curtis, C; Fabbri, C; Farmer, A; Hauser, J; Henigsberg, N; Jenkins, G; Lee, SH; Lewis, CM; Lewis, G; Maier, W; McGuffin, P; Mors, O; Newhouse, S; O'Donovan, M; Patel, H; Perlis, RH; Placentino, A; Rietschel, M; Schruers, K; Souery, D; Tansey, KE; Uher, R; Weinshilboum, RM, 2018)
" The present study was designed to clarify the relationship between dosage and treatment response in major depressive disorder."	2.53	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)
"It has been suggested that the efficacy of antidepressants has been overestimated in clinical trials owing to unblinding of drug treatments by adverse events."	2.53	Efficacy of selective serotonin reuptake inhibitors and adverse events: meta-regression and mediation analysis of placebo-controlled trials. ( Barbui, C; Barth, M; Cipriani, A; Klostermann, S; Kriston, L; Linde, K, 2016)
"Vortioxetine is approved for the treatment of major depressive disorder and differs from other antidepressants in terms of its pharmacodynamic profile."	2.53	Vortioxetine for major depressive disorder: An indirect comparison with duloxetine, escitalopram, levomilnacipran, sertraline, venlafaxine, and vilazodone, using number needed to treat, number needed to harm, and likelihood to be helped or harmed. ( Citrome, L, 2016)
"Major depressive disorder is one of the most common mental disorders in children and adolescents."	2.53	Comparative efficacy and tolerability of antidepressants for major depressive disorder in children and adolescents: a network meta-analysis. ( Cipriani, A; Coghill, D; Cohen, D; Cuijpers, P; Del Giovane, C; Hazell, P; Hetrick, SE; Leucht, S; Liu, L; Liu, Y; Michael, KD; Pu, J; Qin, B; Ravindran, AV; Whittington, C; Xie, P; Yang, L; Zhang, Y; Zhou, X, 2016)
"Cognitive functioning is a symptom of major depressive disorder (MDD) that deserves particular attention by clinicians and researchers."	2.52	Antidepressants and their effect on cognition in major depressive disorder. ( Papakostas, GI, 2015)
"Escitalopram has been shown to have better efficacy and safety profile than other selective serotonin reuptake inhibitor and serotonin norepinephrine reuptake inhibitor drugs, including racemic citalopram."	2.50	Clinical pharmacology review of escitalopram for the treatment of depression. ( Gobburu, J; Pastoor, D, 2014)
"Vortioxetine is an antidepressant with multimodal activity which has shown efficacy in major depressive disorder (MDD) patients in six of ten short-term, randomized, placebo-controlled trials (completed end 2012)."	2.50	Relative efficacy and tolerability of vortioxetine versus selected antidepressants by indirect comparisons of similar clinical studies. ( Brignone, M; Ereshefsky, L; Francois, C; Lançon, C; Llorca, PM; Rive, B; Salah, S, 2014)
"Such a prevalent disease as Major Depressive Disorder (MDD), associated with prominent impairment in physical and social functioning, implies as well an increased morbidity and mortality."	2.48	[Clinical efficacy and achievement of a complete remission in depression: increasing interest in treatment with escitalopram]. ( Favré, P, 2012)
"Escitalopram was significantly more effective than citalopram in overall treatment effect, with an estimated mean treatment difference of 1."	2.47	Efficacy of escitalopram compared to citalopram: a meta-analysis. ( Hansen, T; Kasper, S; Montgomery, S, 2011)
"Escitalopram treatment is generally well tolerated by adolescents, but treatment-emergent agitation, suicidal behavior and manic symptoms should be closely monitored."	2.47	Escitalopram for the treatment of major depressive disorder in youth. ( Ahn, JH; Patkar, AA, 2011)
"Disturbed sleep is a key symptom in major depressive disorder (MDD) and generalized anxiety disorder (GAD)."	2.47	Effects of escitalopram on sleep problems in patients with major depression or generalized anxiety disorder. ( Lopez, AG; Stein, DJ, 2011)
"Escitalopram has at least comparable efficacy to available serotonin-norepinephrine reuptake inhibitors, venlafaxine XR and duloxetine, and may offer some tolerability advantages over these agents."	2.46	Escitalopram--translating molecular properties into clinical benefit: reviewing the evidence in major depression. ( Leonard, B; Taylor, D, 2010)
"Escitalopram treatment was also associated with higher clinical response (73 vs."	2.46	Escitalopram versus serotonin noradrenaline reuptake inhibitors as second step treatment for patients with major depressive disorder: a pooled analysis. ( Despiégel, N; Lam, RW; Lönn, SL, 2010)
"Escitalopram is a selective serotonin reuptake inhibitor (SSRI), and is the second antidepressant to be approved for use in treating major depressive disorder (MDD) in adolescent patients (aged 12-17 years) in the US."	2.46	Escitalopram: in the treatment of major depressive disorder in adolescent patients. ( Scott, LJ; Yang, LP, 2010)
"Mirtazapine-treated patients had a 74% higher likelihood of achieving remission during the first 2 weeks of therapy compared with patients treated with SSRIs."	2.46	Remission with mirtazapine and selective serotonin reuptake inhibitors: a meta-analysis of individual patient data from 15 controlled trials of acute phase treatment of major depression. ( Nierenberg, AA; Schutte, AJ; Simmons, JH; Thase, ME; van Oers, HJ; Vrijland, P, 2010)
"Escitalopram has a predictable tolerability profile with generally mild to moderate and transient adverse events, and a low propensity for drug interactions."	2.46	Escitalopram: a review of its use in the management of major depressive disorder in adults. ( Garnock-Jones, KP; McCormack, PL, 2010)
"The treatment of major depressive disorder requires prolonged pharmacotherapy with antidepressants in order to resolve the current episode and reduce the risk for recurrence of depressive symptoms."	2.46	Improving medication compliance in patients with depression: Use of orodispersible tablets. ( Navarro, V, 2010)
"Escitalopram was significantly more effective than comparators in overall treatment effect, with an estimated mean treatment difference of 1."	2.45	Escitalopram in the treatment of major depressive disorder: a meta-analysis. ( Andersen, HF; Kennedy, SH; Thase, ME, 2009)
" A pooled analysis suggests that build-up of the R-enantiomer after repeated citalopram dosing may lead to increased inhibition of S-enantiomer occupancy of SERT."	2.45	Differences in the dynamics of serotonin reuptake transporter occupancy may explain superior clinical efficacy of escitalopram versus citalopram. ( Asenbaum, S; Attarbaschi-Steiner, T; Dudczak, R; Holik, A; Kasper, S; Klein, N; Lanzenberger, R; Mossaheb, N; Sacher, J; Spindelegger, C, 2009)
"Escitalopram (n=280) was superior to duloxetine (n=284) with respect to mean change from baseline in MADRS score at weeks 1, 2, 4 and 8 with a mean treatment difference at week 8 of 2."	2.44	Escitalopram and duloxetine in the treatment of major depressive disorder: a pooled analysis of two trials. ( Andersen, HF; Lam, RW; Wade, AG, 2008)
"Bupropion is presumed to be a dopamine-norepinephrine reuptake inhibitor and is an effective antidepressant."	2.44	Bupropion: a review of its use in the management of major depressive disorder. ( Curran, MP; Dhillon, S; Yang, LP, 2008)
"Escitalopram is an effective first-line option in the management of patients with major depression, including severe forms, and various anxiety disorders."	2.44	Escitalopram for the treatment of major depression and anxiety disorders. ( Höschl, C; Svestka, J, 2008)
"Escitalopram was superior to all comparators in overall treatment effect, with an estimated difference in treatment effect of 1."	2.43	Efficacy of escitalopram in the treatment of major depressive disorder compared with conventional selective serotonin reuptake inhibitors and venlafaxine XR: a meta-analysis. ( Andersen, HF; Kennedy, SH; Lam, RW, 2006)
"Citalopram is a racemate consisting of a 1:1 mixture of the R(-)- and S(+)-enantiomers."	2.42	Escitalopram versus citalopram: the surprising role of the R-enantiomer. ( Braestrup, C; Bøgesø, KP; Ebert, B; Reines, EH; Sánchez, C, 2004)
"Citalopram is an SSRI antidepressant with a more specific and selective pharmacological profile than other antidepressants of its class."	2.41	Citalopram--a review of pharmacological and clinical effects. ( Aleksic, I; Bezchlibnyk-Butler, K; Kennedy, SH, 2000)
" The proportion of patients dosed above the new limit decreased from 8 to 1% in patients ≤ 65 years and from 46 to 23% in patients > 65 years old for citalopram versus 14-5% and 47-31% for escitalopram."	1.91	Dear Doctor Letters regarding citalopram and escitalopram: guidelines vs real-world data. ( Bleich, S; Bridler, R; de Bardeci, M; Greil, W; Grohmann, R; Hasler, G; Kasper, S; Köberle, U; Rüther, E; Seifert, J; Stassen, H; Toto, S; Willms, J, 2023)
"Vortioxetine had a lower risk of low adherence compared to duloxetine, paroxetine, and venlafaxine and a higher risk compared to citalopram, escitalopram, and sertraline."	1.91	Adherence to, and Persistence of, Antidepressant Therapy in Patients with Major Depressive Disorder: Results from a Population-based Study in Italy. ( Cipelli, R; Dell'Osso, B; Di Nicola, M; Martinotti, G; Peduto, I; Pugliese, AC; Signorelli, MS; Ventriglio, A, 2023)
"4041 adults screened positive for major depressive disorder."	1.91	What are the treatment remission, response and extent of improvement rates after up to four trials of antidepressant therapies in real-world depressed patients? A reanalysis of the STAR*D study's patient-level data with fidelity to the original research p ( Amsterdam, J; Kim, T; Kirsch, I; Pigott, HE; Xu, C, 2023)
"We hypothesized that in adults with major depressive disorder, the peripheral biomarker, CRP, was associated with the response to escitalopram (SSRI)."	1.72	The association of C-reactive protein with responses to escitalopram antidepressant treatment in patients with major depressive disorder. ( Chen, X; Feng, L; Feng, Y; Sun, Z; Xiao, L; Yang, J; Zhou, J, 2022)
"A sample of 46 older adults with major depressive disorder received 12 weeks of escitalopram treatment at a daily target dose of 20 mg."	1.62	Cortical Thickness of the Salience Network and Change in Apathy Following Antidepressant Treatment for Late-Life Depression. ( Alexopoulos, GS; Bress, JN; Gunning, FM; Hoptman, MJ; Kanellopoulos, T; Oberlin, L; Pimontel, MA; Solomonov, N, 2021)
"Our study enrolled 130 patients with major depressive disorder and comorbid alcohol use disorder (average age-38."	1.62	Effects of CYP2C19 genetic polymorphism on the steady-state concentration of citalopram in patients with major depressive disorder. ( Bryun, EA; Grishina, EA; Pankratenko, EP; Petukhov, AE; Ryzhikova, KA; Shipitsyn, VV; Skryabin, VY; Sychev, DA; Torrado, MV; Zastrozhin, MS; Zastrozhina, AK, 2021)
"Many individuals with major depressive disorder (MDD) do not respond to initial antidepressant monotherapy."	1.62	Impacts on Quality of Life with Escitalopram Monotherapy and Aripiprazole Augmentation in Patients with Major Depressive Disorder: A CAN-BIND Report. ( Bhat, V; Chakrabarty, T; Frey, BN; Giacobbe, P; Kennedy, SH; Lam, RW; Lou, W; Michalak, EE; Milev, RV; Morton, E; Müller, DJ; Parikh, SV; Rotzinger, S, 2021)
"A 32-year old man with major depressive disorder showed partial response to Escitalopram 10 mg daily."	1.62	Suspected Agomelatine-induced restless legs syndrome: a case report. ( Abdul Karim, M; Al-Baz, N; Alabdulla, M; Haddad, PM; Ouanes, S, 2021)
"The response of patients with major depressive disorders (MDD) to antidepressant treatments have been shown to be affected by multiple factors, including disease severity and inflammation."	1.56	The relationship between plasma serotonin and kynurenine pathway metabolite levels and the treatment response to escitalopram and desvenlafaxine. ( Drevets, W; Li, QS; Sun, Y; Turecki, G, 2020)
"Management of Major Depressive Disorder (MDD) might be improved by a biomarker to predict whether a selected medication is likely to lead to remission."	1.56	Prospective testing of a neurophysiologic biomarker for treatment decisions in major depressive disorder: The PRISE-MD trial. ( Abrams, MJ; Caudill, MM; Cook, IA; Hunter, AM; Leuchter, AF, 2020)
"Fifty-one females with major depressive disorder or anxiety disorder were stratified into three groups: 1) those treated with SSRIs <23 years of age, 2) those treated with SSRIs >23 years of age, and 3) those that were never treated with SSRIs."	1.56	The influence of age-of-onset of antidepressant use on the acute CBF response to a citalopram challenge; a pharmacological MRI study. ( Homberg, JR; Lucassen, PJ; Reneman, L; Schrantee, A; Solleveld, MM, 2020)
"Kynurenic acid was lower in MDD, and lower levels showed a better therapeutic response to escitalopram."	1.56	Kynurenic acid is a potential overlapped biomarker between diagnosis and treatment response for depression from metabolome analysis. ( Erabi, H; Fuchikami, M; Kang, D; Kato, TA; Kurata, A; Okada, G; Okamoto, Y; Setoyama, D; Shibasaki, C; Takamura, M; Yamawaki, S; Yoshino, A, 2020)
"Approximately two-thirds of major depressive disorder (MDD) patients do not respond adequately to current therapies."	1.51	Opioid system modulators buprenorphine and samidorphan alter behavior and extracellular neurotransmitter concentrations in the Wistar Kyoto rat. ( Cunningham, JI; Dean, RL; Deaver, DR; Eyerman, DJ; Sanchez, C; Smith, KL, 2019)
"Similar rates of remission from Major Depressive Disorder (MDD) have been documented between ethnic groups in response to antidepressant treatment."	1.48	Quality of life and functioning of Hispanic patients with Major Depressive Disorder before and after treatment. ( Chang, T; Dang, J; Danovitch, I; Ganjian, S; IsHak, WW; López, E; Manier, K; Mirocha, J; Parisi, T; Shapiro, BB; Steiner, AJ; Vanle, B, 2018)
" The primary analyses, which compared completers on active treatment without early adverse events to completers on placebo (with or without adverse events) with respect to reduction in the HDRS depressed mood item showed larger symptom reduction in patients given active treatment, the effect sizes being 0."	1.48	Efficacy of selective serotonin reuptake inhibitors in the absence of side effects: a mega-analysis of citalopram and paroxetine in adult depression. ( Eriksson, E; Hieronymus, F; Lisinski, A; Nilsson, S, 2018)
"The presence of Major Depressive Disorder (MDD) is often comorbid in patients with a variety of general medical conditions (GMCs) which could lead to less favorable outcomes."	1.48	Major Depression Comorbid with Medical Conditions: Analysis of Quality of Life, Functioning, and Depressive Symptom Severity. ( Dang, J; Danovitch, I; Elzahaby, C; IsHak, WW; Kauzor, K; Klimowicz, A; Reid, M; Steiner, AJ; Sumner, L; Vanle, B, 2018)
"Metabolic profiles were derived from major depressive disorder subject blood samples collected after ECTP treatment."	1.48	Liquid chromatography/mass spectrometry-based plasma metabolic profiling study of escitalopram in subjects with major depressive disorder. ( Bandu, R; Ha, K; Ha, TH; Kim, KP; Kim, SJ; Lee, HJ; Lee, HM, 2018)
"Escitalopram-treated MDD patients with higher social desirability achieved more rapid decrease in symptom severity."	1.48	Personality traits and escitalopram treatment outcome in major depression. ( Aluoja, A; Eller, T; Maron, E; Raag, M; Tõru, I; Võhma, Ü, 2018)
" To this aim, we exploited the Sequenced Treatment Alternatives to Relieve Depression (STARD) data set, selected a subpopulation of 591 patients with an overlapping clinical history and analyzed treatment outcome according to dosage -20 or 40 mg per day of citalopram*."	1.46	Citalopram amplifies the influence of living conditions on mood in depressed patients enrolled in the STAR*D study. ( Branchi, I; Chiarotti, F; Giuliani, A; Viglione, A, 2017)
"Some residual symptoms, including restlessness, insomnia, and weight change, may help better identify patients with MDD vulnerable to relapse."	1.46	Predicting relapse with individual residual symptoms in major depressive disorder: a reanalysis of the STAR*D data. ( Mimura, M; Sakurai, H; Suzuki, T; Uchida, H; Yoshimura, K, 2017)
"Anhedonia is a core symptom of major depressive disorder (MDD)."	1.46	Patients with major depressive disorder exhibit reduced reward size coding in the striatum. ( Akiyama, Y; Awai, K; Fujii, Y; Ichikawa, N; Kaichi, Y; Minagawa, H; Mori, A; Okada, G; Okamoto, Y; Takaishi, Y; Takamura, M; Toki, S; Yamamoto, T; Yamawaki, S, 2017)
"Forty-six medication-free patients with major depressive disorder participated in a diffusion tensor imaging scan prior to completing an 8-week treatment regime with citalopram or quetiapine XR."	1.46	The 5-HTTLPR and BDNF polymorphisms moderate the association between uncinate fasciculus connectivity and antidepressants treatment response in major depression. ( Clark, D; Foster, J; Hall, GB; Ramasubbu, R; Tatham, EL, 2017)
"Predicting treatment response for major depressive disorder can provide a tremendous benefit for our overstretched health care system by reducing number of treatments and time to remission, thereby decreasing morbidity."	1.46	Multidimensional prediction of treatment response to antidepressants with cognitive control and functional MRI. ( Bhaumik, R; Crane, NA; Dion, C; Gowins, JR; Jenkins, LM; Langenecker, SA; Mickey, BJ; Zubieta, JK, 2017)
"Patients suffering from major depressive disorders (MDD) report anhedonia, low concentration and lack of goal-oriented behavior."	1.46	In patients suffering from major depressive disorders, quantitative EEG showed favorable changes in left and right prefrontal cortex. ( Ahmadpanah, M; Bajoghli, H; Brand, S; Esnaashari, F; Haghighi, M; Holsboer-Trachsler, E; Jahangard, L; Ludyga, S; Nazaribadie, M; Rahimi, B; Sadeghi Bahmani, D; Torabian, S, 2017)
"In treated patients with major depressive disorder (MDD), residual symptoms are common and challenging to disentangle from possible antidepressant side effects."	1.46	Differentiating residual symptoms of depression from adverse events among patients initiating treatment with an antidepressant. ( Baer, L; Clain, A; Fava, M; Fisher, L; Freeman, MP; Pooley, J; Rabbitt, R, 2017)
"Current pharmacological treatments for major depressive disorder (MDD) are ineffective in a significant proportion of patients, and the identification of new antidepressant compounds has been difficult."	1.46	Transcriptomic profiling of human hippocampal progenitor cells treated with antidepressants and its application in drug repositioning. ( Breen, G; Lee, SH; Murphy, T; Powell, TR; Price, J; Thuret, S, 2017)
" However, while the chronic administration of the SSRIs escitalopram or fluoxetine elicited a progressive increased in the firing rate of 5-HT neurons in 5-HT2A(+/+) mice, it failed to do so in 5-HT2A(-/-) mutants."	1.43	Genetic dysfunction of serotonin 2A receptor hampers response to antidepressant drugs: A translational approach. ( Becquemont, L; Colle, R; Corruble, E; Dahan, L; David, D; Gardier, AM; Guiard, BP; Guilloux, JP; Nguyen, HT; Petit, AC; Qesseveur, G; Robert, P; Rotenberg, S; Seif, I; Verstuyft, C, 2016)
"Millions of patients suffer from major depressive disorder (MDD), but many do not respond to selective serotonin reuptake inhibitor (SSRI) therapy."	1.43	TSPAN5, ERICH3 and selective serotonin reuptake inhibitors in major depressive disorder: pharmacometabolomics-informed pharmacogenomics. ( Batzler, A; Bhasin, SS; Biernacka, J; Bobo, WV; Frye, MA; Gupta, M; Hall-Flavin, D; Jenkins, GD; Kaddurah-Daouk, R; Kalari, K; Kubo, M; Liu, D; Matson, W; Mushiroda, T; Nakamura, Y; Neavin, D; Skime, M; Wang, L; Weinshilboum, RM; Zhu, H, 2016)
" In contrast, among doses above these, there was no indication of a dose-response relationship."	1.43	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)
" 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."	1.42	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)
"The treatment goal of major depressive disorder (MDD) is achieving and maintaining remission."	1.42	Community pharmacists' support improves antidepressant adherence in the community. ( Barak, Y; Ben-Amnon, Y; Cohen, Y; Klang, SH, 2015)
"Older subjects with non-psychotic major depressive disorder were treated with citalopram in an 8-week open-label study."	1.40	Emotion recognition processing as early predictor of response to 8-week citalopram treatment in late-life depression. ( Johns, B; Lim, KO; Shiroma, PR; Thuras, P, 2014)
"We therefore believe that "melancholia" thus defined could be a valuable construct under the Research Domain Criteria (RDoC), which specifically aims at identifying the neurobiology underlying mental disorders and providing drugable targets."	1.40	Brief, unidimensional melancholia rating scales are highly sensitive to the effect of citalopram and may have biological validity: implications for the research domain criteria (RDoC). ( Bech, P; Fava, M; Ostergaard, SD; Rush, AJ; Trivedi, MH; Wisniewski, SR, 2014)
"We suggest the hypothesis that neonatal withdrawal syndrome may follow citalopram serotonin toxicity."	1.39	Neonatal toxicity following maternal citalopram treatment. ( Bonati, M; Butera, R; Cotti Cottini, F; Eleftheriou, G; Farina, M, 2013)
"In patients suffering from major depressive disorders (MDD), improvements in MDD are related to increased activation of brain-derived neurotrophic factor (BDNF), an endogenous protein that facilitates neural functioning."	1.39	Additional ECT increases BDNF-levels in patients suffering from major depressive disorders compared to patients treated with citalopram only. ( Bajoghli, H; Brand, S; Erfani, P; Haghighi, M; Holsboer-Trachsler, E; Jahangard, L; Salehi, I, 2013)
"Patients with Major Depressive Disorder (MDD) often experience unexpected relapses, despite achieving remission."	1.39	Predicting relapse in major depressive disorder using patient-reported outcomes of depressive symptom severity, functioning, and quality of life in the Individual Burden of Illness Index for Depression (IBI-D). ( Cohen, RM; Greenberg, JM; Ishak, WW, 2013)
"Patients diagnosed with Major Depressive Disorder, without comorbid psychopathology/medical disorder/alcohol/nicotine use for the past year with a CGI-S severity score of 4 were included."	1.39	Discerning the effects of psychopathology and antidepressant treatment on sexual dsyfunction*. ( Cerit, C; Isik, S; Ozten, E; Tufan, AE, 2013)
" Moderate to high dosing was the only significant associated factor for FSD (odds ratio = 4."	1.38	Female sexual dysfunction in patients treated with antidepressant-comparison between escitalopram and fluoxetine. ( Asmidar, D; Guan, NC; Hod, R; Sidi, H, 2012)
"Citalopram (CIT) is a widely used antidepressant which acts by a selective serotonin reuptake inhibition."	1.38	Correlation of QTc interval prolongation and serum level of citalopram after intoxication--a case report. ( Deckert, J; Pfuhlmann, B; Unterecker, S; Warrings, B, 2012)
"73) and moderate to high dosage of antidepressant (adjusted OR = 4."	1.38	Hypoactive sexual desire among depressed female patients treated with selective serotonin reuptake inhibitors: a comparison between escitalopram and fluoxetine. ( Asmidar, D; Guan, NC; Hod, R; Jaafar, NR; Sidi, H, 2012)
"Escitalopram therapy was also associated with $736 lower medical costs related to mental disorder (P=0."	1.38	Treatment persistence & health care costs of adult MDD patients treated with escitalopram vs. citalopram in a medicaid population. ( Beaulieu, N; Ben-Hamadi, R; Erder, MH; Lu, M; Wu, EQ; Yu, AP, 2012)
"99) and escitalopram dosage (r = -0."	1.38	An integrative assessment of the psychophysiologic alterations in young women with recurrent major depressive disorder. ( Chang, JS; Choi, HM; Ha, K; Ha, TH; Her, JY; Park, T; Yi, SH; Yoo, CS, 2012)
"Escitalopram was associated with a cost savings per patient of €263 versus venlafaxine XR and €1992 versus citalopram over a period of 26 weeks from a societal perspective."	1.38	Cost-effectiveness of escitalopram in major depressive disorder in the Dutch health care setting. ( Brignone, M; den Boer, JA; Hoencamp, E; Marteau, F; Nuijten, MJ, 2012)
" While a range of effective antidepressants are now available, failure and relapse rates remain substantial, with intolerable side effect burden the most commonly cited reason for discontinuation."	1.38	Genome-wide pharmacogenomic study of citalopram-induced side effects in STAR*D. ( Åberg, K; Adkins, DE; Bukszár, J; Clark, SL; Hettema, JM; McClay, JL; Souza, RP; van den Oord, EJ, 2012)
"Treatment with citalopram abolished the abnormal amygdala responses to sad faces in currently depressed patients but did not alter responses to fearful faces."	1.38	Increased amygdala responses to sad but not fearful faces in major depression: relation to mood state and pharmacological treatment. ( Anderson, IM; Arnone, D; Deakin, JF; Downey, D; Elliott, R; Juhasz, G; McKie, S; Thomas, EJ; Williams, SR, 2012)
"Sertraline had lower total costs per QALY than venlafaxine (34,788 Baht vs."	1.38	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)
" Functional polymorphisms of ABCB1 may influence central nervous system bioavailability of antidepressants subject to efflux."	1.38	ABCB1 polymorphism predicts escitalopram dose needed for remission in major depression. ( Berk, M; Bousman, CA; Byron, K; Ng, CH; Singh, AB, 2012)
"Escitalopram was more effective than placebo, and as effective as the SSRIs and SNRIs, in the treatment of anxious MDD."	1.37	Testing anxious depression as a predictor and moderator of symptom improvement in major depressive disorder during treatment with escitalopram. ( Larsen, K; Papakostas, GI, 2011)
"Escitalopram was associated with a significantly greater improvement in depressive symptoms, along with a significantly lower number and duration of sick-leave certificates."	1.37	[Depression and professional activity: results of the NEXTEP study]. ( Biro, G; Caparros Panduro, C; Dardennes, R; Raffaitin, F, 2011)
"Risk of relapse is more likely as age increases, partly because aging confers lower resilience."	1.37	Incidence and predictors of relapse during continuation treatment of major depression with SSRI, interpersonal psychotherapy, or their combination. ( Benvenuti, A; Calugi, S; Cassano, GB; Fagiolini, A; Frank, E; Kupfer, DJ; Maggi, L; Miniati, M; Rucci, P; Wallace, M, 2011)
"Five patients in their first episode of major depressive disorder (MDD) on a single SSRI underwent [(123)I]5-I-A85380- SPECT neuroimaging prior to stopping their medication and again 6 weeks following medication cessation."	1.36	SSRI antidepressants do not confound single photon emission computed tomography (SPECT) imaging studies using the alpha4beta2 nicotinic acetylcholine receptor [123I]5-I-A85380 ligand: in vivo and in vitro evidence. ( Cavanagh, J; Dewar, D; Patterson, J; Pimlott, S; Wyper, D, 2010)
"Cognitive disturbances in Major Depressive Disorder (MDD) could persist beyond the symptomatic phase of the illness."	1.36	Major Depressive Disorder in recovery and neuropsychological functioning: effects of selective serotonin reuptake inhibitor and dual inhibitor depression treatments on residual cognitive deficits in patients with Major Depressive Disorder in recovery. ( Guàrdia-Olmos, J; Gudayol-Ferré, E; Herrera-Abarca, JE; Herrera-Guzmán, D; Herrera-Guzmán, I; Montelongo-Pedraza, P; Padrós Blázquez, F; Peró-Cebollero, M, 2010)
"Patients Individuals with nonpsychotic major depressive disorder for whom DNA was available who were subsequently treated with citalopram hydrobromide for 4 to 12 weeks."	1.36	Association of polymorphisms in genes regulating the corticotropin-releasing factor system with antidepressant treatment response. ( Binder, EB; Bradley, B; Deveau, TC; Fava, M; Liu, W; Nemeroff, CB; Owens, MJ; Ressler, KJ; Rush, AJ; Trivedi, MH, 2010)
"Major depressive disorder is associated with increased cardiac mortality."	1.36	Reduced cardio-respiratory coupling after treatment with nortriptyline in contrast to S-citalopram. ( Bär, KJ; Höfels, S; Maier, W; Schuhmacher, A; Schulz, S; Voss, A; Yeragani, VK; Zobel, A, 2010)
"Escitalopram has shown some different pharmacologic properties compared to its racemic molecule, citalopram."	1.35	[Escitalopram versus serotonin reuptake inhibitors]. ( Millet, B, 2008)
"Escitalopram (ESC) is a novel selective serotonin reuptake inhibitor that seems to have a favorable side effect profile."	1.35	The safety of the electroconvulsive therapy-escitalopram combination. ( Florakis, A; Markatou, M; Masdrakis, VG; Oulis, P; Papadimitriou, GN; Valamoutopoulos, T, 2008)
"Citalopram was generally begun at 20 mg/day and raised to 40 mg/day by weeks 2 through 4 and to 60 mg/day (final dose) by weeks 4 through 6."	1.35	Does the duration of index episode affect the treatment outcome of major depressive disorder? A STAR*D report. ( Alpert, JE; Fava, M; Fleck, J; Gilmer, WS; Gollan, JK; Howland, RH; Miyahara, S; Nierenberg, AA; Rush, AJ; Thase, ME; Trivedi, MH; Warden, D; Wisniewski, SR, 2008)
"Escitalopram-treated patients (N = 459) were less likely to discontinue treatment (HR = 0."	1.35	Comparison of treatment persistence, hospital utilization and costs among major depressive disorder geriatric patients treated with escitalopram versus other SSRI/SNRI antidepressants. ( Ben-Hamadi, R; Erder, MH; Greenberg, P; Wu, E; Yang, E; Yu, A, 2008)
"High blood pressure is a risk factor for cerebrovascular disease and white matter changes."	1.35	Blood pressure and white matter integrity in geriatric depression. ( Alexopoulos, GS; Ardekani, BA; Etwaroo, GR; Gunning-Dixon, FM; Hoptman, MJ; Hrabe, J; Kanellopoulos, D; Lim, KO; Murphy, CF, 2009)
" Participants received citalopram for up to 14 weeks, with dosage adjustments based on routine clinical assessments."	1.35	Depression outcomes of Spanish- and english-speaking Hispanic outpatients in STAR*D. ( Alpert, J; Cook, I; Epstein, M; Flores, D; Gonzalez, C; Lesser, I; Luther, J; Rosales, A; Rush, AJ; Sciolla, A; Trivedi, M; Wisniewski, S; Zisook, S, 2008)
"Participants with either anxiety or substance use disorder showed outcomes generally intermediate between those with both and those with neither."	1.35	Concurrent anxiety and substance use disorders among outpatients with major depression: clinical features and effect on treatment outcome. ( Balasubramani, GK; Berman, SR; Davis, LL; Fava, M; Howland, RH; McGrath, PJ; Rush, AJ; Trivedi, MH; Warden, D; Wisniewski, SR, 2009)
" Escitalopram and aripiprazole were flexibly dosed for 7 weeks, with maximum dosages of 20 and 30 mg/d, respectively."	1.35	An open study of aripiprazole and escitalopram for psychotic major depressive disorder. ( Denninger, JW; Dording, C; Fava, M; Hilliker, S; Homberger, C; Matthews, JD; Park, L; Rooney, K; Siefert, C; Sklarsky, K; van Nieuwenhuizen, AO, 2009)
"The objective of this study was to compare population pharmacokinetic models of escitalopram developed from dosage times recorded by a medication event monitoring system (MEMS) versus the reported times from patients with diagnosed depression."	1.35	The effect of reporting methods for dosing times on the estimation of pharmacokinetic parameters of escitalopram. ( Bies, RR; Fagiolini, A; Feng, Y; Florian, J; Frank, E; Gastonguay, MR; Jin, Y; Kepple, G; Kirshner, M; Kupfer, DJ; Pollock, BG, 2009)
"Major depressive disorder is characterized by impaired reward processing, possibly due to dysfunction in the basal ganglia."	1.35	Reduced caudate and nucleus accumbens response to rewards in unmedicated individuals with major depressive disorder. ( Birk, JL; Bogdan, R; Dillon, DG; Dougherty, DD; Fava, M; Goetz, EL; Holmes, AJ; Iosifescu, DV; Pizzagalli, DA; Rauch, SL, 2009)
"Patients with a diagnosis for major depressive disorder (MDD) and at least one prescription for an SSRI or SNRI were identified from the Ingenix Impact Database (2002-2005)."	1.35	Treatment persistence, healthcare utilisation and costs in adult patients with major depressive disorder: a comparison between escitalopram and other SSRI/SNRIs. ( Ben-Hamadi, R; Erder, MH; Greenberg, PE; Wu, EQ; Yang, E; Yu, AP, 2009)
"Patients who met the criteria for major depressive disorder were treated for 6 weeks with fluoxetine, paroxetine or citalopram."	1.35	5-HTR1A, 5-HTR2A, 5-HTR6, TPH1 and TPH2 polymorphisms and major depression. ( Huhtala, H; Illi, A; Kampman, O; Lehtimäki, T; Leinonen, E; Mononen, N; Poutanen, O; Setälä-Soikkeli, E; Viikki, M, 2009)
"Patients with Major Depressive Disorder (MDD) may not respond to antidepressants for 8 weeks or longer."	1.35	Comparative effectiveness of biomarkers and clinical indicators for predicting outcomes of SSRI treatment in Major Depressive Disorder: results of the BRITE-MD study. ( Burgoyne, KS; Cook, IA; Fava, M; Gilmer, WS; Greenwald, S; Howland, RH; Iosifescu, D; Jain, R; Leuchter, AF; Marangell, LB; McCracken, JT; Trivedi, MH; Zisook, S, 2009)
"In citalopram treated subjects, basal glucose and lactate concentrations were higher compared with controls or with the trimipramine treated group."	1.35	Metabolism in adipose tissue in response to citalopram and trimipramine treatment--an in situ microdialysis study. ( Adler, G; Alt, A; Ditschuneit, HH; Flechtner-Mors, M; Jenkinson, CP, 2008)
"Thirty youth with major depressive disorder (MDD) and 23 control youth reported on caffeine use, sleep, and affect in their natural environment using ecological momentary assessment at baseline and over 8 weeks, while MDD youth received treatment."	1.35	Caffeine consumption, sleep, and affect in the natural environments of depressed youth and healthy controls. ( Axelson, DA; Birmaher, B; Dahl, RE; Forbes, EE; Ryan, ND; Semel, M; Silk, JS; Whalen, DJ, 2008)
"In the group with major depressive disorder, treatment with antidepressants showed an increase from 15% to 30%."	1.35	Trends in antidepressant use in the older population: results from the LASA-study over a period of 10 years. ( Beekman, AT; Comijs, HC; Deeg, DJ; Sonnenberg, CM; van Tilburg, W, 2008)
" In 9% of patients, RLS was recorded as a side effect related to the administration of AD."	1.35	Restless legs syndrome as side effect of second generation antidepressants. ( Gallwitz, T; Kirch, MH; Messer, T; Rottach, KG; Schaner, BM; Teufel, LM; Zivotofsky, AZ, 2008)
"Treatment for major depressive disorder does not achieve remission in about 50% of patients following 2 treatment trials."	1.34	Limitations in efficacy of antidepressant monotherapy. ( Rush, AJ, 2007)
"Augmentation strategies for the treatment of major depressive disorder (MDD) are needed when patients with MDD have not tolerated or responded to antidepressant monotherapies."	1.34	Augmentation strategies to increase antidepressant efficacy. ( Shelton, RC, 2007)
"Citalopram is a selective serotonin reuptake inhibitor used in the treatment of depression."	1.33	Activity of citalopram on adenosine and serotonin circulating levels in depressed patients. ( Auteri, A; Blardi, P; Bossini, L; Castrogiovanni, P; de Lalla, A; Dell'Erba, A; Urso, R, 2005)
"Citalopram was administered for 4 weeks to the 71 patients who completed this study."	1.33	Serotonin receptor 2A gene polymorphism (-1438A/G) and short-term treatment response to citalopram. ( Choi, MJ; Ham, BJ; Jeong, HY; Kang, RH; Lee, MS, 2005)
"Citalopram was administered for 8 weeks to the 83 patients who completed this study."	1.33	Brain-derived neurotrophic factor gene polymorphism (Val66Met) and citalopram response in major depressive disorder. ( Choi, MJ; Kang, RH; Lee, MS; Lim, SW; Oh, KS, 2006)
"Escitalopram was found to be non-inferior to venlafaxine XR in both indirect and direct comparisons with results of mean -0."	1.33	Using meta-regression in performing indirect-comparisons: comparing escitalopram with venlafaxine XR. ( Eckert, L; Falissard, B, 2006)
" In all, 57 patients (33%) reported at least 1 adverse event, and 7 patients (4%) were withdrawn due to an adverse event."	1.33	Safety and efficacy of oral escitalopram as continuation treatment of intravenous citalopram in patients with major depressive disorder. ( Arbus, C; Schmitt, L; Tonnoir, B, 2006)
"In the outcome analysis for depression recurrence, the conventional cutoff scores of the three scales are used."	1.32	The validity of the depression rating scales in discriminating between citalopram and placebo in depression recurrence in the maintenance therapy of elderly unipolar patients with major depression. ( Andersen, M; Bech, P; Bent-Hansen, J; Klysner, R; Lunde, M; Solstad, K; Tanghøj, P, 2003)
"Both pseudoseizures and hysterical stridor are associated commonly with sexual abuse, eating disorders, depression, substance abuse, anxiety disorders, and personality disorders."	1.32	Pseudoseizures and hysterical stridor. ( Kaufman, KR; Mohebati, A; Sotolongo, A, 2004)
"Escitalopram is a cost-effective alternative compared to (generic) citalopram in the first-line treatment of MDD in Austria."	1.32	Cost-effectiveness analysis of escitalopram: a new SSRI in the first-line treatment of major depressive disorder in Austria. ( Einarson, TR; Hemels, ME; Kasper, S; Walter, E, 2004)
" 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."	1.32	Repetition of serotonin syndrome after reexposure to SSRI--a case report. ( Modestin, J; Tomaselli, G, 2004)
"The syndrome has been extensively described in children, but less information is available about adult patienis."	1.31	Wolf-Hirschhorn (4p-)syndrome in a near adult with major depression; successful treatment with citalopram. ( Moog, U; Tuinier, S; Verhoeven, WM; Wagemans, AM, 2002)
" However, patients may require dosage adjustment for tolerability of this combination."	1.31	Methylphenidate augmentation of citalopram in elderly depressed patients. ( Kumar, A; Lavretsky, H, 2001)
"No relapses were observed."	1.31	Long-term treatment with citalopram in patients with highly recurrent forms of unipolar depression. ( Franchini, L; Rampoldi, R; Smeraldi, E; Spagnolo, C; Zanardi, R, 2001)
"Citalopram is a chiral antidepressant drug."	1.31	Carbamazepine augmentation in depressive patients non-responding to citalopram: a pharmacokinetic and clinical pilot study. ( Baumann, P; Brawand-Amey, M; Eap, CB; Steinacher, L; Vandel, P; Zullino, DF, 2002)

Research

Studies (1,004)

Authors

Clinical Trials (178)

Trial Overview

Trial Outcomes

Change From Baseline in Beck Anxiety Inventory (BAI) Score at Week 8 (Visit 5)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	4 (0.40)	18.2507
2000's	348 (34.66)	29.6817
2010's	543 (54.08)	24.3611
2020's	109 (10.86)	2.80

Authors	Studies
Bang-Andersen, B	2
Ruhland, T	1
Jørgensen, M	1
Smith, G	1
Frederiksen, K	1
Jensen, KG	1
Zhong, H	2
Nielsen, SM	2
Hogg, S	2
Mørk, A	2
Stensbøl, TB	2
Kofod, J	1
Elfving, B	2
Nielsen, EH	1
Mors, O	27
Köhler-Forsberg, O	3
Joyce, JB	1
Grant, CW	1
Liu, D	3
MahmoudianDehkordi, S	2
Kaddurah-Daouk, R	4
Skime, M	3
Biernacka, J	4
Frye, MA	5
Mayes, T	2
Carmody, T	4
Croarkin, PE	4
Wang, L	11
Weinshilboum, R	4
Bobo, WV	9
Trivedi, MH	67
Athreya, AP	3
Huang, H	1
Wang, F	2
Chen, Y	5
Kong, S	1
Huang, Q	1
Lyu, D	1
Yang, W	1
Wei, Z	1
Qian, N	1
Zhang, M	1
Wu, C	1
Zhao, J	2
Cao, L	2
Wu, Z	2
Peng, D	2
Fang, Y	5
Hong, W	1
Czysz, AH	1
Mason, BL	1
Li, Q	2
Chin-Fatt, C	1
Minhajuddin, A	4
Desmidt, T	1
Dujardin, PA	1
Brizard, B	1
Réméniéras, JP	1
Gissot, V	1
Dufour-Rainfray, D	1
Atanasova, B	1
Kazour, F	1
Belzung, C	2
Camus, V	2
El-Hage, W	2
Li, S	3
Rong, P	1
Wang, Y	10
Jin, G	1
Hou, X	1
Xiao, X	4
Zhou, W	1
Wu, Y	1
Liu, Y	5
Zhang, Y	5
Zhao, B	1
Huang, Y	1
Cao, J	1
Chen, H	3
Hodges, S	1
Vangel, M	1
Kong, J	1
Asada, R	1
Ogushi, Y	1
Hori, H	1
Kawasaki, H	1
Dell'Osso, B	6
Di Nicola, M	2
Cipelli, R	2
Peduto, I	2
Pugliese, AC	2
Signorelli, MS	2
Ventriglio, A	2
Martinotti, G	3
de Bardeci, M	1
Greil, W	1
Stassen, H	1
Willms, J	1
Köberle, U	1
Bridler, R	1
Hasler, G	1
Kasper, S	16
Rüther, E	1
Bleich, S	2
Toto, S	1
Grohmann, R	1
Seifert, J	1
Zhou, J	3
Sun, Z	1
Feng, L	2
Feng, Y	2
Xiao, L	2
Chen, X	1
Yang, J	4
Zahra, A	1
Du, L	1
Jia, M	1
Butt, MU	1
Wang, Q	2
Wu, J	1
Diep, C	1
Rosenek, N	1
Khoo, Y	2
Gandhi, W	1
van Reekum, CM	1
Ravindran, AV	7
Ladha, KS	1
Frey, BN	16
Milev, RV	5
Rotzinger, S	13
Lam, RW	24
Kennedy, SH	25
Lou, W	3
Salomons, T	1
Bhat, V	3
Fang, F	1
Godlewska, B	1
Cho, RY	1
Savitz, SI	1
Selvaraj, S	4
Espinola, CW	1
Parmar, R	1
Demchenko, I	1
Parikh, SV	13
Ho, K	1
Zhang, C	3
Virani, S	1
Rush, AJ	78
Trivedi, M	4
Peters, EM	1
Balbuena, L	1
Lodhi, RJ	1
Hart, XM	1
Heesen, S	1
Schmitz, CN	1
Dörfler, S	1
Wedekind, D	1
Gründer, G	1
Hiemke, C	4
Havemann-Reinecke, U	1
Kubo, K	1
Sakurai, H	4
Tani, H	1
Watanabe, K	3
Mimura, M	6
Uchida, H	4
Kishi, T	1
Ikuta, T	1
Sakuma, K	1
Okuya, M	1
Hatano, M	1
Matsuda, Y	1
Iwata, N	1
Grimm, S	1
Keicher, C	1
Paret, C	1
Niedtfeld, I	1
Beckmann, C	1
Mennes, M	1
Just, S	1
Sharma, V	3
Fuertig, R	1
Herich, L	1
Mack, S	1
Thamer, C	1
Schultheis, C	1
Weigand, A	1
Schmahl, C	1
Wunder, A	1
Zhang, ZJ	3
Zhang, SY	3
Yang, XJ	3
Qin, ZS	3
Xu, FQ	3
Jin, GX	3
Hou, XB	3
Cai, JF	3
Xiao, HB	3
Wong, YK	3
Zheng, Y	3
Shi, L	3
Zhang, JN	3
Zhao, YY	3
Zhang, LL	3
Jiao, Y	3
He, JK	3
Chen, GB	3
Rong, PJ	3
Salem, H	1
Huynh, T	1
Topolski, N	1
Mwangi, B	1
Soares, JC	1
Szmulewicz, AG	1
Wanis, KN	1
Perlis, RH	9
Hernández-Díaz, S	1
Öngür, D	1
Hernán, MA	1
Langley, C	1
Armand, S	2
Luo, Q	1
Savulich, G	1
Segerberg, T	1
Søndergaard, A	1
Pedersen, EB	1
Svart, N	1
Overgaard-Hansen, O	1
Johansen, A	1
Borgsted, C	1
Cardinal, RN	1
Robbins, TW	1
Stenbæk, DS	1
Knudsen, GM	3
Sahakian, BJ	1
Weber, S	1
Frokjaer, VG	1
Nielsen, JH	1
Joergensen, MB	1
Stenbaek, DS	1
Giraldi, A	1
Jessop, JP	1
Russell, J	1
DeJesus, A	1
Bardolia, C	1
Hanna, A	1
Turgeon, J	1
Michaud, V	1
Amin, NS	1
Nichols, AL	1
Blumenfeld, Z	1
Luebbert, L	1
Knox, HJ	1
Muthusamy, AK	1
Marvin, JS	1
Kim, CH	1
Grant, SN	1
Walton, DP	1
Cohen, BN	1
Hammar, R	1
Looger, L	1
Artursson, P	1
Dougherty, DA	1
Lester, HA	1
Zwienenberg, L	1
van Dijk, H	1
Enriquez-Geppert, S	1
van der Vinne, N	3
Gevirtz, R	1
Gordon, E	8
Sack, AT	1
Arns, M	5
Bousman, CA	5
Stevenson, JM	1
Ramsey, LB	1
Sangkuhl, K	1
Hicks, JK	1
Strawn, JR	2
Singh, AB	3
Ruaño, G	1
Mueller, DJ	2
Tsermpini, EE	1
Brown, JT	1
Bell, GC	1
Leeder, JS	1
Gaedigk, A	1
Scott, SA	1
Klein, TE	1
Caudle, KE	1
Bishop, JR	1
Hack, LM	2
Tozzi, L	1
Zenteno, S	1
Olmsted, AM	1
Hilton, R	1
Jubeir, J	1
Korgaonkar, MS	6
Schatzberg, AF	9
Yesavage, JA	1
O'Hara, R	1
Williams, LM	17
Pigott, HE	1
Kim, T	1
Xu, C	1
Kirsch, I	3
Amsterdam, J	1
Lu, Z	1
Xun, G	1
Yin, J	1
Song, X	1
Wang, C	1
Lin, X	1
Miao, M	1
Vollebregt, MA	2
Boutros, NN	1
Fallahpour, K	2
van Putten, MJAM	2
Kim, EY	1
Kim, SH	2
Lee, HJ	4
Lee, NY	1
Kim, HY	2
Park, CHK	1
Ahn, YM	1
Sourdeau, A	1
Zdanowicz, N	2
Lavretsky, H	11
Laird, KT	3
Krause-Sorio, B	1
Heimberg, BF	1
Yeargin, J	2
Grzenda, A	2
Wu, P	1
Thana-Udom, K	1
Ercoli, LM	3
Siddarth, P	7
Yokoi, Y	2
Nakagawa, A	2
Yoshimura, N	2
Furukawa, TA	5
Iwanami, A	2
Abe, T	4
Nakagome, K	2
Ju, C	1
Fiori, LM	4
Belzeaux, R	2
Theroux, JF	2
Chen, GG	1
Aouabed, Z	2
Blier, P	9
Farzan, F	5
Giacobbe, P	6
Leri, F	4
MacQueen, GM	10
Milev, R	12
Müller, DJ	11
Soares, CN	9
Uher, R	41
Foster, JA	9
Turecki, G	18
Qin, S	1
Eugene, AR	1
Zhang, L	1
Neavin, D	3
Biernacka, JM	6
Yu, J	2
Weinshilboum, RM	9
Goldstein-Piekarski, AN	1
Fornito, A	1
Brunoni, AR	6
Carracedo, A	1
Amigo, OM	1
Pellicer, AL	1
Talib, L	1
Carvalho, AF	2
Lotufo, PA	4
Benseñor, IM	4
Gattaz, W	1
Cappi, C	1
L Carpenter, L	1
R Tyrka, A	1
Price, LH	4
I Papakostas, G	1
Dording, CM	2
Yeung, AS	1
Cusin, C	2
Ludington, E	2
Bernard-Negron, R	1
Fava, M	70
Mischoulon, D	10
Alders, GL	2
Davis, AD	2
MacQueen, G	3
Strother, SC	7
Hassel, S	5
Zamyadi, M	3
Sharma, GB	1
Arnott, SR	4
Downar, J	4
Harris, JK	2
Ravindran, A	1
Minuzzi, L	4
Hall, GB	5
Tian, S	1
Sun, Y	2
Shao, J	1
Zhang, S	2
Mo, Z	1
Liu, X	3
Zhao, P	1
Chattun, MR	1
Yao, Z	2
Si, T	6
Lu, Q	1
Oz, MD	1
Baskak, B	3
Uckun, Z	3
Artun, NY	1
Ozdemir, H	3
Ozel, TK	1
Ozguven, HD	1
Suzen, HS	3
Yrondi, A	1
Holper, L	1
Zhdanov, A	1
Atluri, S	1
Wong, W	1
Vaghei, Y	1
Daskalakis, ZJ	4
Blumberger, DM	3
Brenner, CA	2
Vila-Rodriguez, F	3
McAndrews, MP	2
Kleffner, K	1
Alonso-Prieto, E	1
Bharwani, A	1
Bala, A	1
Surette, M	1
Bienenstock, J	1
Vigod, SN	1
Taylor, VH	1
Moreno, ML	2
Goerigk, SA	2
Bertola, L	1
Suemoto, CK	1
Razza, LB	3
Moffa, AH	2
Veronezi, BP	2
Tort, L	1
Nogueira, BS	2
Gattaz, WF	3
Fraguas, R	3
Padberg, F	3
Drevets, W	1
Li, QS	2
Suh, JS	1
Raamana, PR	1
Davis, A	1
Harris, J	1
Sassi, RB	2
Li, X	4
Araminia, B	1
Shalbafan, M	2
Mortezaei, A	1
Shirazi, E	2
Ghaffari, S	1
Sahebolzamani, E	1
Mortazavi, SH	1
Shariati, B	1
Ardebili, ME	2
Aqamolaei, A	1
Naderi, S	1
Akhondzadeh, S	7
Lee, J	2
Lee, KH	1
Han, JY	1
Hong, SB	1
Cho, SC	1
Kim, JW	1
Brent, D	4
Liao, XM	2
Su, YA	3
Yu, X	5
Si, TM	3
Cook, IA	9
Hunter, AM	6
Caudill, MM	1
Abrams, MJ	1
Leuchter, AF	9
Wu, L	1
Wang, XQ	1
Yang, Y	1
Dong, TF	1
Lei, L	1
Cheng, QQ	1
Li, SX	2
Funes, CM	1
Ercoli, L	1
Mandal, T	1
Bairy, LK	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Vortioxetine Monotherapy for Major Depressive Disorder in Type 2 Diabetes: Role of Inflammation, Kynurenine Pathway, and Structural and Functional Brain Connectivity as Biomarkers[NCT03580967]	Phase 4	0 participants (Actual)	Interventional	2019-07-01	Withdrawn (stopped due to COVID-19 Pandemic interfered with Pt recruitment)
Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) a Multicentre Open-label Randomized Controlled Trial Protocol[NCT05814640]	Phase 1/Phase 2	520 participants (Anticipated)	Interventional	2023-02-20	Recruiting
Vortioxetine for Menopausal Depression and Associated Symptoms[NCT02234362]	Phase 4	47 participants (Actual)	Interventional	2015-06-12	Completed
Integrated Biological Markers for the Prediction of Treatment Response in Depression[NCT01655706]	Phase 3	211 participants (Actual)	Interventional	2012-04-23	Completed
Treatment of Geriatric Depression With Mild Cognitive Impairment: A Double-blind Placebo-Controlled Trial of Namenda (Memantine) Augmentation of Lexapro (Escitalopram) in Depressed Patients at Least 60 Years of Age[NCT01902004]	Phase 4	115 participants (Actual)	Interventional	2013-10-31	Completed
International Study to Predict Optimised Treatment - in Depression[NCT00693849]	Phase 4	2,688 participants (Anticipated)	Interventional	2008-09-30	Active, not recruiting
Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)[NCT05017311]	Phase 4	400 participants (Anticipated)	Interventional	2023-01-20	Recruiting
A Multicenter, Double Blind Trial to Compare the Efficacy and Safety of Escitalopram With Placebo in Patients With Acute Stroke for the Prevention of Poststroke Depression and Related Symptoms (Emotional Incontinence, Anger Proneness), and for Improvement[NCT01278498]	Phase 4	444 participants (Anticipated)	Interventional	2011-01-31	Active, not recruiting
Incomplete Response in Late Life Depression: Getting to Remission[NCT00892047]	Phase 4	468 participants (Actual)	Interventional	2009-08-31	Completed
Pharmacotherapy of Late-Life Generalized Anxiety Disorder[NCT00105586]	Phase 4	177 participants (Actual)	Interventional	2004-12-31	Completed
Simvastatin add-on to Escitalopram in Patients With Comorbid Obesity and Major Depression: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial[NCT04301271]	Phase 2	160 participants (Anticipated)	Interventional	2020-08-13	Recruiting
Evaluation of the Acceptability, Safety, Feasibility, and Efficacy of Psilocybin-assisted Psychotherapy (PaP) for the Treatment of Post-traumatic Stress Disorder (PTSD) in Military Veterans[NCT05876481]	Phase 2	8 participants (Anticipated)	Interventional	2023-06-30	Not yet recruiting
Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms[NCT03429075]	Phase 2	59 participants (Actual)	Interventional	2019-01-07	Active, not recruiting
Testing an Imaging Biomarker for Treatment Stratification in Major Depression[NCT02137369]	Phase 4	77 participants (Actual)	Interventional	2014-09-30	Completed
A Prospective, Randomized, Double-Blind (Subject and Rater) Controlled Study to Confirm the Effectiveness of Predictix Genetics Antidepressant -Guided Treatment in Adults With Major Depressive Disorder (MDD)[NCT05137197]		354 participants (Anticipated)	Interventional	2021-10-04	Recruiting
The Antidepressant Advisor: A Decision Support System for UK Primary Care - a Feasibility Study: Study 3[NCT04342299]		45 participants (Actual)	Observational	2018-08-01	Completed
Predictors of Antidepressant Treatment Response: The Emory CIDAR[NCT00360399]		344 participants (Actual)	Interventional	2006-08-31	Completed
Examining Immune-Based Mechanisms of Action for Mild-Intensity Whole Body Hyperthermia (WBH) in the Treatment of Major Depressive Disorder[NCT03787290]	Phase 2	35 participants (Anticipated)	Interventional	2023-12-01	Not yet recruiting
Escitalopram and Transcranial Direct Current Stimulation in Major Depressive Disorder: a Double-blind, Placebo-controlled, Randomized, Non-inferiority Trial[NCT01894815]	Phase 3	245 participants (Actual)	Interventional	2013-10-31	Completed
Psychological Interventions and Transcranial Direct Current Stimulation for the Treatment of Major Depressive Disorder[NCT04889976]		210 participants (Actual)	Interventional	2021-05-22	Completed
The DiSCoVeR Project: Examining the Synergistic Effects of a Cognitive Control Videogame and a Self-administered Non-invasive Brain Stimulation on Alleviating Depression[NCT04953208]		114 participants (Anticipated)	Interventional	2021-06-22	Recruiting
Home-based Transcranial Direct Current Stimulation in Postpartum Depression: the Feasibility Study and Pilot Study[NCT05046405]		50 participants (Anticipated)	Interventional	2022-10-02	Not yet recruiting
Assessment of Efficacy and Safety of Anodal Transcranial Direct Current Stimulation (TDCS) in Pediatric and Teenage Patients With Major Depressive Disorder During COVID-19 Pandemics[NCT04780152]	Phase 2/Phase 3	172 participants (Anticipated)	Interventional	2021-10-31	Recruiting
TBS Treatment for Treatment-Resistant Depression: a Randomized, Sham-Controlled Trial[NCT05388539]		100 participants (Anticipated)	Interventional	2022-06-06	Recruiting
An Open Label Home-administered Transcranial Direct Current Stimulation (tDCS) Clinical Trial of Unipolar Depression[NCT04781127]	Phase 1	50 participants (Actual)	Interventional	2021-02-10	Completed
Sequenced Treatment Alternatives to Relieve Depression[NCT00021528]	Phase 4	4,000 participants	Interventional	2001-07-31	Completed
A Phase 2, Multicenter, Double- Blind, Parallel-group, Randomized, Placebo-controlled, Forced-dose Titration, Dose-ranging Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder [NCT01435759]	Phase 2	1,197 participants (Actual)	Interventional	2011-05-31	Completed
Calmer Life: Treating Worry Among Older Adults In Underserved, Low-income, Minority Communities[NCT02391363]		247 participants (Actual)	Interventional	2014-11-30	Completed
Randomized, Controlled, Open and Unicentric Phase II Clinical Trial, With Two Parallel Groups, to Evaluate the Antidepressant Efficacy of Psychotherapy and Citalopram in Women Diagnosed With Breast Cancer and Major Depression[NCT05063604]	Phase 2	40 participants (Actual)	Interventional	2022-05-10	Terminated (stopped due to The CAMAD clinical trial has been terminated due to difficulties in recruiting patients.)
White Matter and Emotional and Cognitive Control in Late-Onset Depression[NCT01728194]	Phase 4	121 participants (Actual)	Interventional	2012-07-31	Completed
A Randomized Controlled Trial of Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation Associated With Major Depressive Disorder[NCT04502758]		80 participants (Anticipated)	Interventional	2022-04-04	Recruiting
Combining Medications to Enhance Depression Outcomes[NCT00590863]	Phase 4	665 participants (Actual)	Interventional	2008-03-31	Completed
An Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced (Paroxetine), Fixed-dose Study on the Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder[NCT02279966]	Phase 3	152 participants (Actual)	Interventional	2014-10-31	Completed
An Interventional, Randomised, Double-blind, Parallel-group, Active-comparator, Flexible-dose Study on the Efficacy of Vortioxetine Versus Escitalopram on Cognitive Dysfunction in Patients With Inadequate Response to Current Antidepressant Treatment of Ma[NCT02272517]	Phase 3	101 participants (Actual)	Interventional	2014-12-31	Completed
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Flexible Dose Study on the Efficacy of Lu AA21004 on Cognitive Dysfunction in Adult Subjects With Major Depressive Disorder (MDD)[NCT01564862]	Phase 2	602 participants (Actual)	Interventional	2012-04-30	Completed
A Double-blind, Controlled, Randomized Study Comparing Escitalopram Combined With Scopolamine or Escitalopram in Patients With Major Depressive Disorder[NCT03131050]	Phase 4	66 participants (Actual)	Interventional	2017-03-15	Completed
Randomised Clinical Trial Comparing Early Medication Change (EMC) Strategy With Treatment as Usual (TAU) in Patients With Major Depressive Disorder - the EMC Trial[NCT00974155]	Phase 4	889 participants (Actual)	Interventional	2009-09-30	Completed
Integrated Biological Markers for the Prediction of Treatment Response in Depression: Validation Study[NCT04162522]	Phase 3	1 participants (Actual)	Interventional	2019-12-23	Completed
Observational Longitudinal Study of Individuals With Stimulant Use Disorder: Research and Development of a Biosignature[NCT06073340]		1,500 participants (Anticipated)	Observational	2023-11-16	Recruiting
Suicide Assessment Methodology Study (SAMS)[NCT00532103]		300 participants (Anticipated)	Observational	2007-07-31	Completed
Effect of S-ketamine on Depressed Patients Undergoing Electroconvulsive Therapy-a Randomized, Double-blind, Controlled Clinical Study[NCT04399070]		150 participants (Anticipated)	Interventional	2020-08-01	Not yet recruiting
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression[NCT02418585]	Phase 3	236 participants (Actual)	Interventional	2015-08-07	Completed
Placebo Effects in the Treatment of Depression: Cognitive and Neural Mechanisms[NCT01919216]	Phase 4	65 participants (Actual)	Interventional	2010-01-31	Completed
A Multi-centre, Randomised, Double-blind, Parallel Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Bupropion Hydrochloride Extended-release (Bupropion XL 300mg Once Daily), Escitalopram Oxalate (Escitalopram, 10mg-20mg Once Dai[NCT02191397]	Phase 3	534 participants (Actual)	Interventional	2015-02-10	Completed
Biomarkers for Rapid Identification of Treatment Effectiveness in Major Depression (BRITE-MD), a Prospective, Randomized, Multi-center Study to Determine the Efficacy of Selected EEG and Genotype Biomarkers for Predicting Response to Antidepressant Therap[NCT00289523]		375 participants (Actual)	Observational	2006-01-31	Completed
N-methylglycine (Sarcosine) for Treatment of Major Depressive Disorder[NCT00977353]	Phase 2	40 participants (Actual)	Interventional	2009-04-30	Completed
Evaluation of Efficacy and Safety of add-on Sarcosine in Patients With Major Depressive Disorder: A Randomized Controlled Trial[NCT04975100]	Phase 4	60 participants (Actual)	Interventional	2021-08-26	Completed
Ethnic Variations in Antidepressant Response[NCT00047671]	Phase 4	400 participants (Anticipated)	Interventional	2002-06-30	Completed
Biological Predictors of Response to Antidepressants[NCT00456014]		37 participants (Actual)	Interventional	2006-09-30	Completed
Imaging Predictors of Treatment Response in Depression[NCT00367341]		82 participants (Actual)	Interventional	2006-08-31	Completed
Venlafaxine for the Prevention of Depression in Patients With Head and Neck Cancer[NCT05724849]	Phase 2	64 participants (Anticipated)	Interventional	2023-08-01	Not yet recruiting
Prevention of Depression in Patients Being Treated for Head and Neck Cancer[NCT00536172]	Phase 4	160 participants (Actual)	Interventional	2007-12-01	Completed
Cocktail Phenotypic Approach to Explore Antidepressant Pharmacokinetic Variability: a Pilot Study[NCT02438072]		100 participants (Anticipated)	Interventional	2014-12-31	Recruiting
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Exploratory Efficacy and Safety Study of SPD489 in Adults 18-55 Years With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant[NCT00905424]	Phase 2	246 participants (Actual)	Interventional	2009-07-30	Completed
The WORKER Study: A Randomized Controlled Trial of Escitalopram and Telephone-based Cognitive Behaviour Therapy in Working Patients With Major Depressive Disorder[NCT00702598]		105 participants (Actual)	Interventional	2008-06-30	Completed
The Effect and Reliability of Escitalopram in the Treatment of Adolescents With Major Depressive Disorder or Anxiety Disorders[NCT03122158]	Phase 4	60 participants (Anticipated)	Interventional	2017-04-08	Active, not recruiting
Impact of Quetiapine Prolong and Escitalopram on the Hypothalamic-pituitary-adrenocortical (HPA)-Axis Activity in Depressed Patients[NCT00953108]	Phase 3	60 participants (Actual)	Interventional	2009-09-30	Completed
Escitalopram and Language Intervention for Subacute Aphasia (ELISA)[NCT03843463]	Phase 2	88 participants (Anticipated)	Interventional	2021-07-18	Recruiting
Combining Antidepressants to Hasten Remission From Depression[NCT00519428]	Phase 4	245 participants (Actual)	Interventional	2007-08-31	Completed
A Double-Blind, Placebo-Controlled Study of the Alternative Therapy S-Adenosyl-L-Methionine (SAMe) vs Escitalopram in Major Depressive Disorder (MDD)[NCT00101452]		199 participants (Actual)	Interventional	2005-04-30	Completed
Functional and Physiological Effects of High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) for Neurological, Cardiovascular and Psychophysiological Disorders[NCT02709369]		300 participants (Actual)	Interventional	2011-08-23	Completed
Pharmacodynamics and Pharmacokinetics of Citalopram and Escitalopram[NCT00613470]	Phase 1	927 participants (Actual)	Interventional	2005-03-31	Completed
Vortioxetine Versus Sertraline in Control Metabolic, Distress and Depression in Mexican Patients With Type 2 Diabetes[NCT03978286]	Phase 4	21 participants (Actual)	Interventional	2016-06-30	Completed
A Double-blind, Placebo- and Active-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder[NCT01473381]	Phase 4	1,162 participants (Actual)	Interventional	2011-12-31	Completed
Efficacy of the Digital Self-help Programme Edupression.Com® Evaluated Within a Randomized Controlled Trial in Mild to Moderate Unipolar Depressive Patients[NCT04839822]		250 participants (Actual)	Interventional	2021-04-28	Completed
A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressants in Patients With Major Depressive Disorder Who Exhibit an[NCT01197508]	Phase 3	696 participants (Actual)	Interventional	2010-09-30	Completed
A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III,Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit an I[NCT01153347]	Phase 3	2,409 participants (Actual)	Interventional	2010-06-30	Completed
Computerized Interventions for College Students' Cognitive Functioning and Mental Well-being[NCT01694303]		38 participants (Actual)	Interventional	2012-09-30	Completed
A Three-phase Study Designed to Test the Efficacy, Tolerability and Safety of the Combination of Ziprasidone With Selective Serotonin Reuptake Inhibitors (SSRI) for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatmen[NCT00633399]	Phase 2	458 participants (Actual)	Interventional	2008-07-31	Completed
Comparison of Tianeptine Versus Escitalopram for the Treatment of Depression and Cognitive Impairment in Patients With Major Depressive Disorder: A Randomized, Multicenter, Open-label Study[NCT01309776]	Phase 4	164 participants (Actual)	Interventional	2011-03-31	Completed
Efficacy and Safety of Escitalopram in the Treatment of Depressive Patients With Acute Coronary Artery Syndrome: A Double-blind Placebo-controlled Trial[NCT00419471]	Phase 4	300 participants (Actual)	Interventional	2007-05-31	Completed
The Use of Methylphenidate to Improve Clinical Outcomes in Geriatric Depression: A Double-blind Placebo-Controlled Trial of Methylphenidate (Ritalin) Augmentation of Citalopram (Celexa) in Depressed Elderly Patients[NCT00602290]	Phase 4	181 participants (Actual)	Interventional	2008-02-29	Completed
Evaluation of the Antidepressant Effects of Nitrous Oxide in People With Major Depressive Disorder[NCT05357040]	Phase 2	172 participants (Anticipated)	Interventional	2021-06-30	Recruiting
Relapse Prevention in Patients With a Major Depressive Episode Treated With Electroconvulsive Treatment Using a Fixed Dose Range of Escitalopram Compared to a Fixed Dose of Nortriptyline (DUAG-7) A Randomised Controlled 6 Month Double-blind Study[NCT00660062]	Phase 4	47 participants (Actual)	Interventional	2009-08-31	Terminated (stopped due to Slow inclusion)
Personalise Antidepressant Treatment for Unipolar Depression Combining Individual Choices, Risks and Big Data[NCT05608330]		504 participants (Anticipated)	Interventional	2022-11-30	Not yet recruiting
Measuring Self-blame-related Action Tendencies and Prediction of Prognosis in Major Depressive Disorder[NCT04593537]		140 participants (Actual)	Observational	2020-06-01	Completed
Efficacy and Safety of Augmentation of Creatine for the Patients With Major Depressive Disorder[NCT00729755]		59 participants (Actual)	Interventional	2008-08-31	Completed
Prediction of the Therapeutic Response in Depression Based on an Early Neuro-computational Modeling Assessment of Motivation[NCT05866575]		136 participants (Anticipated)	Interventional	2023-06-01	Not yet recruiting
A Collaborative Investigation of Predictors of Relapse in Major Depressive Disorder: CAN-BIND-1 Extension Study[NCT02934334]		100 participants (Actual)	Observational	2016-05-31	Completed
CAN-BIND (Canadian Biomarker Integration Network for Depression): Long-Term Follow Up Study[NCT02998762]		96 participants (Actual)	Observational	2016-02-03	Completed
The Effect of Seven-Day Atorvastatin Administration on Emotional Processing, Reward Processing, and Inflammation in Healthy Volunteers[NCT03966859]		50 participants (Actual)	Interventional	2019-06-19	Completed
Development and Evaluation of an Ecological Momentary Assessment (EMA) Baseline Screening System for Therapists Who Treat Youths With Depressive Symptoms[NCT04830527]		60 participants (Actual)	Interventional	2020-11-24	Terminated (stopped due to The study was terminated early due to the difficulty in recruiting cases during a pandemic period.)
The SPD489-323 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder[NCT01436162]	Phase 3	1,105 participants (Actual)	Interventional	2011-10-19	Completed
The SPD489-322 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder[NCT01436149]	Phase 3	1,262 participants (Actual)	Interventional	2011-10-27	Completed
The BrainDrugs-Epilepsy Study: A Prospective Open-label Cohort Precision Medicine Study in Epilepsy[NCT05450822]		550 participants (Anticipated)	Observational	2022-02-18	Recruiting
Double-Blind Switch Study of Vilazodone in the Treatment of Major Depressive Disorder Following Partial Response to or Inability to Tolerate a Generic SSRI[NCT01742832]	Phase 2	79 participants (Actual)	Interventional	2013-05-31	Completed
Piloting an Adaption of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)[NCT05965609]		60 participants (Anticipated)	Interventional	2023-12-08	Recruiting
Ventrostriatal Dopamine Release and Reward Motivation in MDD[NCT02033369]	Phase 4	52 participants (Actual)	Interventional	2014-02-28	Completed
A Pilot Double-Blind Randomized Placebo-Controlled Crossover Study to Investigate Rapid Antidepressant Effects of Leucine[NCT03079297]	Phase 2	16 participants (Actual)	Interventional	2017-03-09	Terminated (stopped due to Covid-19)
A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder[NCT00095758]	Phase 3	1,200 participants	Interventional	2004-09-30	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Aripiprazole as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder.[NCT00095823]	Phase 3	1,200 participants	Interventional	2004-06-30	Completed
Effects of Aripiprazole on the Steady-State Pharmacokinetics of Venlafaxine in Healthy Subjects[NCT00362271]	Phase 1	38 participants	Interventional	2006-08-31	Completed
Effects on Aripiprazole on the Steady-State Pharmacokinetics of Escitalopram in Healthy Subjects[NCT00361790]	Phase 1	25 participants	Interventional	2006-08-31	Completed
Phase Four Double-Blind Randomized Comparative Study on Thestudy on the Efficacy of Memantine Hydrochloride and Escitalopram for the Treatment of Co-Morbid Depression and Alcoholism[NCT00368862]	Phase 4	80 participants	Interventional	2005-12-31	Completed
Melancholic Depression and Insomnia as Predictors of Response to Quetiapine in Patients With Major Depression[NCT03207438]	Phase 4	1,790 participants (Actual)	Interventional	2006-04-30	Completed
Efficacy Of Switching From SSRI to Desvenlafaxine on Cognitive Function In Patients With an Acute Episode of Major Depression[NCT03432221]		36 participants (Anticipated)	Observational	2018-04-03	Recruiting
The Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants in the Acute Treatment of Psychotic Major Depression: Efficacy and Tolerability[NCT00556140]	Phase 3	16 participants (Actual)	Interventional	2003-06-30	Completed
Maintenance Therapies in Late-Life Depression: MTLD III[NCT00177671]	Phase 4	220 participants (Actual)	Interventional	2003-12-31	Completed
Treatment of SSRI-Resistant Depression in Adolescents (TORDIA)[NCT00018902]	Phase 2/Phase 3	334 participants (Actual)	Interventional	2001-01-31	Completed
A Preliminary Study of the Efficacy and Safety of Carbamazepine in Severe Liver Disease Due to Alpha-1 Antitrypsin Deficiency[NCT01379469]	Phase 2	20 participants (Actual)	Interventional	2012-01-31	Terminated
Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Elevated Depression Symptoms[NCT03878160]		27 participants (Actual)	Interventional	2018-07-01	Completed
Study of Antidepressants in Parkinson's Disease[NCT00086190]	Phase 3	115 participants (Actual)	Interventional	2005-06-30	Completed
Neuroimaging Studies of Reward Processing in Depression[NCT00183755]		87 participants (Actual)	Observational	2005-04-30	Completed
A Mechanistic Examination of Continuous Cycle Oral Contractive Administration in Binge Eating[NCT04278755]	Phase 2	8 participants (Actual)	Interventional	2020-09-24	Terminated (stopped due to Halted prematurely due to COVID-19-related enrollment challenges.)
A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder[NCT00107120]	Phase 3	312 participants (Actual)	Interventional	2005-03-31	Completed
Optimizing Care for Older Adults With Back Pain and Depression[NCT01124188]	Phase 4	263 participants (Actual)	Interventional	2010-05-31	Completed
A Prospective Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform the Prescription of Medications to Subjects With a Primary Diagnosis of a Depressive Disorder and Comorbidity of Non-psychotic Behavioral Disorders[NCT03625271]		150 participants (Anticipated)	Interventional	2016-06-16	Recruiting
Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication.[NCT00296712]	Phase 4	55 participants (Actual)	Interventional	2005-02-28	Completed
Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder[NCT03748446]	Early Phase 1	20 participants (Anticipated)	Interventional	2019-12-05	Recruiting
Subanesthetic Sevoflurane for Treatment-Resistant Depression: A Proof-of-Concept Trial[NCT05008939]		15 participants (Anticipated)	Interventional	2021-08-31	Not yet recruiting
The Effects of Fludrocortisone on Information Processing in Healthy Female Volunteers[NCT01648998]	Phase 1	40 participants (Actual)	Interventional	2012-05-31	Completed
Phase 4 Clinical Pharmacogenomics of Antidepressant Response[NCT00384020]		402 participants (Actual)	Observational	2006-01-31	Completed
A Randomized, Single Blind, Controlled, Longitudinal Study of the Effects of Venlafaxine Hydrochloride Capsules on the Language Function of Stroke Patients With Subcortical Aphasia Using fMRI[NCT03588572]		43 participants (Actual)	Interventional	2018-08-01	Completed
The Language Functional Reorganization Following Subcortical Cerebral Infarction: A Longitudinal fMRI Study[NCT03668132]		80 participants (Actual)	Observational	2016-01-19	Completed
A Randomized Controlled Trial of Antidepressant Maintenance for Major Depression Following Mild Traumatic Brain Injury[NCT00162916]	Phase 4	21 participants (Actual)	Interventional	2005-05-31	Active, not recruiting
Exploring Alterations of Central Autonomic Modulation in Patients With Bipolar Depression[NCT01213121]	Phase 4	60 participants (Anticipated)	Interventional	2010-09-30	Recruiting
Citalopram Improves Vasomotor and Urogenital Syndromes in Mexican Patients With Post-menopause[NCT05346445]		91 participants (Actual)	Interventional	2021-01-20	Completed
Study of the Efficacy and Safety of Escitalopram for the Prevention of Depressive Episodes Induced by Peg-Interferon Alpha2a and Ribavirin in Chronic Hepatitis C Patients. Randomized, Double-Blind, Placebo-Controlled Clinical Trial[NCT00166296]	Phase 2	133 participants (Actual)	Interventional	2005-03-31	Completed
Citalopram Versus Citalopram Plus Pindolol in Latency of Antidepressant Response Shortening in Major Depressive Disorder[NCT00931775]	Phase 2	30 participants (Actual)	Interventional	2002-12-31	Completed
Using Smartphones to Enhance the Treatment of Childhood Anxiety[NCT02259036]		40 participants (Actual)	Interventional	2014-08-31	Completed
Efficacy of Individualized Homeopathic Treatment for Moderate to Severe Depression in Peri- and Postmenopausal Women: a Randomized Placebo-controlled, Double-blind, Double-dummy, Study Protocol[NCT01635218]	Phase 2	133 participants (Actual)	Interventional	2012-03-31	Completed
Comparison of Zolpidem Tartrate Extended-Release vs. Placebo in Treatment of Insomnia Associated With Newly Diagnosed Major Depressive Disorder(MDD) or Untreated MDD Relapse, When Used Concomitantly With Escitalopram[NCT00296179]	Phase 4	372 participants	Interventional	2006-02-28	Completed
A Multicenter, Randomized, 8-Week Double-Blind Acute Phase Followed By a 6-Month Continuation Phase (Open-Label Or Double-Blind) Study to Evaluate the Efficacy, Safety, and Tolerability of DVS SR Versus Escitalopram in Postmenopausal Women With Major Depr[NCT00406640]	Phase 3	595 participants (Actual)	Interventional	2006-12-31	Completed
Phase IIa Proof of Concept Study of Pipamperone/Citalopram (PipCit) Versus Citalopram in the Treatment of Major Depressive Disorder (MDD)[NCT00672659]	Phase 2	165 participants (Actual)	Interventional	2008-02-29	Completed
Brain Connectivity and Response to Tai Chi in Geriatric Depression[NCT02460666]		220 participants (Actual)	Interventional	2016-01-31	Completed
Phase IV Pilot Study to Examine the Efficacy and Safety of Escitalopram in Doses up to 50 mg for the Treatment of Patients With Major Depressive Disorder (MDD).[NCT00785434]	Phase 4	60 participants (Actual)	Interventional	2008-10-31	Completed
Double-Blind Study of Escitalopram in Adult Patients With Major Depressive Disorder[NCT00108979]	Phase 3	240 participants	Interventional	2005-03-31	Completed
Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients[NCT00384436]	Phase 4	580 participants (Anticipated)	Interventional	2006-10-31	Completed
Investigation of the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Therapy in Patients With Post-stroke Depression (PSD)[NCT03761303]		0 participants (Actual)	Interventional	2018-05-01	Withdrawn (stopped due to No eligible patients could be recruited.)
Associations Between Gene-Polymorphisms, Endo-Phenotypes for Depression and Antidepressive Treatment (AGENDA)[NCT00386841]	Phase 4	80 participants (Actual)	Interventional	2007-04-30	Completed
Prevention of Post-Stroke Depression - Treatment Strategy[NCT00071643]		201 participants (Actual)	Interventional	2002-09-30	Completed
Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study of Escitalopram in Combination With Two Fixed Doses of Gaboxadol Compared to Escitalopram in Major Depressive Disorder[NCT00807248]	Phase 2	490 participants (Actual)	Interventional	2008-11-30	Completed
A Prophylactic Trial of Omega-3 Polyunsaturated Fatty Acids in Bipolar Disorder[NCT04210804]	Phase 2	80 participants (Actual)	Interventional	2014-04-01	Completed
Phase 4 Study of Escitalopram Treatment and Biomarkers in Major Depressive Disorder[NCT01997580]	Phase 4	600 participants (Anticipated)	Interventional	2013-07-31	Recruiting
Mood Disorder Cohort Research Consortium (MDCRC) in Korea[NCT03088657]		500 participants (Anticipated)	Observational [Patient Registry]	2015-09-30	Recruiting
Predictors of Treatment Response in Late-onset Major Depressive Disorder[NCT02546024]		40 participants (Anticipated)	Observational	2015-09-30	Suspended (stopped due to Revision of recruitment strategies due to difficulties in recruitment)
Nicotinic Modulation of the Cognitive Control System in Late-life Depression[NCT04433767]	Phase 2	29 participants (Actual)	Interventional	2020-12-15	Completed
Open Label Extension Study of Depressed Mood Improvement Through Nicotine (Depressed MIND3)[NCT05746546]	Phase 2	60 participants (Anticipated)	Interventional	2023-04-15	Recruiting
Nicotinic Modulation of the Cognitive Control System in Late-Life Depression (R33 Phase)[NCT05746273]	Phase 2	60 participants (Anticipated)	Interventional	2023-04-15	Recruiting
Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder[NCT01109030]	Phase 2/Phase 3	50 participants (Actual)	Interventional	2010-04-30	Completed
Efficacy and Tolerability of Escitalopram for the Prevention of Pegylated Interferon Alfa Associated Depression in Patients With Chronic Hepatitis C Infection: a Randomized Controlled Trial.[NCT00136318]	Phase 3	208 participants (Actual)	Interventional	2004-01-31	Completed
Creatine Augmentation in Female & Male Veterans With Selective Serotonin Reuptake Inhibitor-Resistant Major Depressive Disorder[NCT01175616]	Phase 4	0 participants (Actual)	Interventional	2012-09-30	Withdrawn (stopped due to Study withdrawn from ClinicalTrials.gov.)
Creatine Monohydrate Use for Preventing Altitude Induced Depression[NCT03433651]	Phase 4	0 participants (Actual)	Interventional	2019-01-01	Withdrawn (stopped due to Unable to locate grant funding.)
Efficacy and Safety Analyses of Mirtazapine in the Treatment of Malignant Tumor Related Depression: A Phase II, Placebo-controlled, Randomized, Double-blinded Clinical Trial in Advanced Non-small Cell Lung Cancer Patients[NCT02650544]	Phase 2	236 participants (Anticipated)	Interventional	2015-12-31	Active, not recruiting
Changes in Serum miRNA and BDNF Levels in Bipolar II Depression Treated by Theta-burst Stimulation: A Randomized Sham-controlled Exploratory Study[NCT04998097]		60 participants (Anticipated)	Interventional	2022-05-23	Recruiting
Inter-relationships Among Iron Stores, the Gut Metagenome, Glucose Levels, and Different Cognitive Domains: the Role of Circulating MicroRNAs (IRONmiRNA Study).[NCT05345106]		120 participants (Anticipated)	Observational	2022-03-28	Recruiting
A Double-Blind, Placebo-Controlled Study of Acamprosate Added to Escitalopram and Behavioral Treatment in Major Depressive Disorder (MDD) With Comorbid Alcohol Abuse/Dependence[NCT00452543]	Phase 4	23 participants (Actual)	Interventional	2007-03-31	Completed
A Randomised Double-Blinded Placebo-Controlled Trial to Assess the Efficacy and Safety of Scopolamine Compared to Placebo in Individuals With Bipolar Disorder Who Are Experiencing a Depressive Episode[NCT04211961]	Phase 2	50 participants (Anticipated)	Interventional	2021-03-23	Recruiting
A Double-blind, Placebo-controlled Study Evaluating the Pharmacodynamic Effects of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) on Hypothalamic-pituitary-adrenal Axis Function in Outpatients With Major Depressive Disorder[NCT01606384]	Phase 2	100 participants (Actual)	Interventional	2006-12-31	Completed
An Eight-Week, Multicenter, Double-Blind, Placebo- and Paroxetine-Controlled Study Evaluating the Efficacy, and Tolerability of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) in Patients With Major Depressive Disorder[NCT00361491]	Phase 2	324 participants (Actual)	Interventional	2006-08-31	Completed
An Eight-Week, Multicenter, Double-Blind, Placebo- and Escitalopram-Controlled Study Evaluating the Efficacy and Tolerability of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) in Outpatients With Major Depressive Disorder[NCT00358631]	Phase 2	319 participants (Actual)	Interventional	2006-07-31	Completed
An Eight-week, Multicenter, Double-blind, Placebo- and Paroxetine-controlled Study Evaluating the Efficacy and Tolerability of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) in Outpatients With Generalized Anxiety Disorder[NCT00374166]	Phase 2	325 participants (Actual)	Interventional	2006-08-31	Completed
Reducing Depressive Symptoms During HCV Therapy: A Randomized Study[NCT00495768]		90 participants (Anticipated)	Interventional	2004-07-31	Active, not recruiting
The Amplitude Change of the Auditory Evoked N1 Component as a Predictor of Response to Escitalopram Treatment in Patients With Generalized Anxiety Disorder[NCT00613067]		35 participants (Anticipated)	Interventional	2007-12-31	Completed
Increasing Access to Evidence-based Treatments for Depression: The Development and Evaluation of a Digital Training Platform for Interpersonal Psychotherapy.[NCT04619615]		44 participants (Actual)	Interventional	2020-07-27	Active, not recruiting
A Prospective, Double Blind, Randomized, Controlled, Multisite Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform Medication Prescription to Subjects With a Primary Diagnosis of a Depressive Disorder(SMART-MD)[NCT02988076]	Phase 2/Phase 3	468 participants (Anticipated)	Interventional	2016-11-30	Suspended (stopped due to Lack of recruiting at primary study site)
Digital Interventions as an Add-on Tool in Generalized Anxiety Disorder Treatment: A Randomized Clinical Trial[NCT05375851]		60 participants (Anticipated)	Interventional	2022-05-01	Recruiting
Dallas 2K: A Natural History Study of Depression[NCT02919280]		2,000 participants (Anticipated)	Observational	2016-09-30	Recruiting
Double-Blind, Placebo-Controlled, Randomized Trial of Adjunctive Lisdexamfetamine Dimesylate in Residual Symptoms of Major Depressive Disorder Partially Responsive to Selective Serotonin or Norepinephrine Reuptake Inhibitor Monotherapy[NCT01148979]	Phase 4	35 participants (Actual)	Interventional	2010-09-30	Completed
Evaluation of Schemes of Administration of Intravenous Ketamine in Treatment-resistant Depression: Clinical-neuroimaging Correlation[NCT03742557]	Phase 3	30 participants (Anticipated)	Interventional	2018-10-01	Recruiting
Conscious Dying/Conscious Living: Ketamine-Assisted Psychotherapy (KAP) for Patients at End of Life-A Pilot Study for Palliative and Hospice Care[NCT05214417]	Phase 2	120 participants (Anticipated)	Interventional	2022-05-01	Not yet recruiting
Treating Comorbid Depression During Care Transitions Using Relational Agents[NCT02845102]		4 participants (Actual)	Interventional	2014-08-31	Completed
Motivational Interviewing to Reduce Substance Use Among Depression Patients[NCT02420561]		307 participants (Actual)	Interventional	2010-10-31	Completed
Duloxetine Versus Escitalopram and Placebo in the Treatment of Patients With Major Depression[NCT00073411]	Phase 3	675 participants	Interventional	2003-11-30	Completed
A Double-blind, Randomised, Multicenter, Comparative Study of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder[NCT01148472]	Phase 4	294 participants (Actual)	Interventional	2005-09-30	Completed
A Brief Intervention Targeting Anhedonia in Adolescents: a Feasibility Randomised Controlled Trial[NCT05507385]		0 participants (Actual)	Interventional	2022-09-30	Withdrawn (stopped due to Difficulties with recruitment)
The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes[NCT02575001]		207 participants (Actual)	Observational	2015-07-31	Completed
Cortical/Subcortical Circuits in Late-Life Depression[NCT01327417]		400 participants (Anticipated)	Observational	2009-09-30	Recruiting
Efficacy of Escitalopram in the Treatment of Internet Addiction[NCT00565422]	Phase 4	31 participants (Actual)	Interventional	2002-12-31	Completed
Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior[NCT05390918]		190 participants (Anticipated)	Interventional	2022-10-20	Recruiting
The Use of Electronic Communications-based Automated Technologies to Augment Traditional Mental Health Care[NCT03925038]		100 participants (Anticipated)	Interventional	2019-04-01	Recruiting
Stepped Approach to Reducing Risk of Suicide in Primary Care[NCT06018285]		4,648 participants (Anticipated)	Interventional	2023-08-08	Recruiting
A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy (ADT) Among Outpatients With Major Depressive Disorder Who Have Responded Inadequately to Prior ADT[NCT00683852]	Phase 3	225 participants (Actual)	Interventional	2008-09-30	Completed
Antidepressant Use During Pregnancy[NCT00279370]		283 participants (Actual)	Observational	1999-09-30	Completed
A Prospective Study of Pregnant and Postpartum Women With and Without Mood Disorders[NCT03615794]		400 participants (Anticipated)	Observational	2017-10-01	Recruiting
Efficacy Potential of an Internet-based Sleep Program to Improve Sleep Quality in People With HIV[NCT02571595]		27 participants (Actual)	Interventional	2015-05-31	Terminated
[NCT00149825]	Phase 2	30 participants (Actual)	Interventional	2004-06-30	Completed
Feasibility of a Personalized Short Message Service Intervention for Insomnia[NCT05108194]	Early Phase 1	50 participants (Anticipated)	Interventional	2021-11-15	Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Anxiety was measured by self-report responses to Beck Anxiety Inventory (BAI). It is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. Several studies have found the Beck Anxiety Inventory to be an accurate measure of anxiety symptoms in children and adults. Higher scores on the BAI indicate more anxiety symptoms. The range of BAI scores is from 0 to 63, with 0-9=Minimal anxiety, 10-16=Mild anxiety, 17-29=Moderate anxiety, and 30-63=Severe anxiety. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)

Change From Baseline in Clinical Global Impression-Fatigue (CGI-F) Scale Score at Week 8 (Visit 5)

Intervention	units on a scale (Median)
Open-label Vortioxetine	-7

Fatigue symptoms were assessed by the Clinical Global Impression-Fatigue (CGI-F) scale.The CGI-F is a single item global assessment scales to specifically evaluate symptoms of fatigue. Higher scores indicate more fatigue symptoms. The range of scores is from 0-7. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score at Week 8 (Visit 5)

Intervention	units on a scale (Median)
Open-label Vortioxetine	-1

Severity of illness was assessed by the Clinical Global Impression-Severity (CGI-S) Scale. The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. The range of scores is 0-7. Higher scores indicate greater severity of illness. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)

Change From Baseline in Cognitive and Physical Functioning Questionnaire (CPFQ) Score at Week 8 (Visit 5)

Intervention	units on a scale (Median)
Open-label Vortioxetine	-1

Cognition and physical functioning was measured by self-report responses to Cognitive and Physical Functioning Questionnaire (CPFQ).The range of scores is from 7-42. Higher scores indicate lower cognitive and executive functioning. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)

Change From Baseline in Digit Symbol Substitution Test (DSST) Score at Week 8 (Visit 5)

Intervention	units on a scale (Median)
Open-label Vortioxetine	-13

"Processing speed, working memory, visuospatial processing and attention was assessed by the Digit Symbol Substitution Test (DSST).~The DSST test requires the examinee to transcribe a unique geometric symbol with its corresponding Arabic number. The examinee is initially shown a key containing the numbers from 1 to 9. Under each number there is a corresponding geometric symbol. The examinee is then shown a series of boxes containing numbers in the top boxes, and blank boxes below them. After a short practice trial, they are then asked to copy the corresponding geometric symbol under each number. The raw score is the number of correct items completed within the prescribed time limit. Higher scores indicate faster processing speed, working memory, and visuospatial processing and attention. The range of scores is 0-63." (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)

Change From Baseline in Greene Climacteric Scale (GCS) Score at Week 8 (Visit 5)

Intervention	units on a scale (Median)
Open-label Vortioxetine	8.5

"Menopause related symptoms were assessed using the Greene Climacteric Scale (GCS). The Greene Scale provides a brief measure of menopause symptoms. It can be used to assess changes in different symptoms, before and after menopause treatment. Three main areas are measured:~1. Psychological (items 1-11). 2. Physical (items 12-18). 3. Vasomotor (items 19, 20).~A higher score indicates that menopause symptoms are more bothersome. The range of scores is from 0 to 63." (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)

Change From Baseline in Menopause Specific Quality of Life (MENQOL) Score at Week 8 (Visit 5)

Intervention	units on a scale (Median)
Open-label Vortioxetine	-18.5

"Quality of life, menopause-specific, is assessed by the Menopause Specific Quality of Life (MENQOL).~The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. Non-endorsement of an item is scored a 1 and endorsement a 2, plus the number of the particular rating, so that the possible score on any item ranges from 1-8. Total score also ranges from 1-8. Higher scores indicate that menopause symptoms are more bothersome." (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)

Change From Baseline in Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5)

Intervention	units on a scale (Median)
Open-label Vortioxetine	-1.74

The efficacy of vortioxetine for trea-ting depressive symptoms was measured by mean change in Montgomery-Asberg Depression Rating Scale (MADRS) depression score from Baseline (Visit 1) to Week 8 (Visit 5). The MADRS score was assessed at every study visit (Visits 1-5). Participants were considered to have responded to vortioxetine if their MADRS score was reduced by 50% or more from baseline to the end of treatment, and to be in remission if their final MADRS score was less than 10. Higher MADRS score indicates more severe depression. The overall MADRS score ranges from 0 to 60. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)

Change From Baseline in Pain Assessment (PEG) Score at Week 8 (Visit 5)

Intervention	units on a scale (Mean)
Open-label Vortioxetine	-22.8

Pain symptoms were assessed by the Pain Assessment (PEG). The PEG is a three-item scale assessing pain intensity and interference. A higher score indicates more pain symptoms. The range of scores is from 0 to 30. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)

Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 8 (Visit 5)

Intervention	units on a scale (Median)
Open-label Vortioxetine	-4

Sleep quality and disturbances during the past month were assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI also incorporates daytime functioning into the total score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. The range of scores is 0-21. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)

Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Daytime at Week 8 (Visit 5)

Intervention	units on a scale (Median)
Open-label Vortioxetine	-5

Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)

Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Nighttime at Week 8 (Visit 5)

Intervention	hot flashes per day (Mean)
Open-label Vortioxetine	-1.33

Change From Baseline in Vasomotor Symptoms (VMS) Severity During Daytime at Week 8 (Visit 5)

Intervention	hot flashes per night (Mean)
Open-label Vortioxetine	-1.15

"Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.~Severity of VMS:~The range of scores for severity of VMS is 0-2, with higher scores indicating greater severity. 0=mild, 1=moderate, 2=severe" (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)

Change From Baseline in Vasomotor Symptoms (VMS) Severity During Nighttime at Week 8 (Visit 5)

Intervention	units on a scale (Mean)
Open-label Vortioxetine	-0.28

Change in Cognitive Domain Scores

Intervention	units on a scale (Mean)
Open-label Vortioxetine	-0.27

Neuropsychological battery of tests which included the following domains: learning, delayed recall, and executive functioning. Raw scores were transformed to z-scores for each test score of interest for each participant, and then averaged. These z-scores were averaged within each neuropsychological domain to produce composite scores and then averaged over all tests to calculate a global performance score. Higher scores are indicative of better performance. (NCT01902004)
Timeframe: Measured at 6 months and 12 months

Change in Hamilton Depression Rating Scale

Intervention	z score (Mean)
	Baseline	6 Months	12 Months
Escitalopram and Memantine	.02	0.03	.15
Escitalopram and Placebo	-.04	-.1	-.26

Clinician administered scale measures severity of depressive symptoms. This measure includes 24 items. Response options vary item to item and include the following ranges: [0-2], [0-3], and [0-4]. A score of 0 suggests absence of symptoms and/or difficulties and higher scores represent more severe difficulties. Possible overall score range [0-74], higher scores representing more severe difficulties. (NCT01902004)
Timeframe: Measured at 3 months; 6 months and 12 months

Change in Montgomery Asberg Depression Rating Scale

Intervention	units on a scale (Mean)
	Baseline	3 Months	6 Months	12 Months
Escitalopram and Memantine	17.8	6.0	5.9	7.2
Escitalopram and Placebo	17.7	6.7	6.9	5.4

Clinician administered item scale measures severity of depressive symptoms. The 10 items are measured on a 7-point scale ranging from 0 to 6; creating a total range of 0-60. A score of 0 suggests absence of symptoms and higher scores represent greater severity of depression.Severity gradations for the MADRS have been proposed (9-17 = mild, 18-34 = moderate, and ≥ 35 = severe). Treatment remission is defined as an endpoint total score ≤ 10. (NCT01902004)
Timeframe: Measured at 3 months; 6 months and 12 months

Number of Participants With Adverse Events

Intervention	units on a scale (Mean)
	Baseline	3 Months	6 Months	12 Months
Escitalopram and Memantine	16.7	7.1	6.0	8.8
Escitalopram and Placebo	14.8	8.7	8.6	8.0

The UKU (Udvalg for Kliniske Undersogelser) Side Effect Rating Scale organizes symptoms into 4 categories (i.e., Psychic, Neurologic, Autonomic, Other) containing 8-19 symptoms each. Each symptom receives a score for degree and causal relationship. Degree is scored between 0-3 with higher scores being more severe. Causal relationship is scored as improbable, possible, or probable. (NCT01902004)
Timeframe: Measured at 3, 6 months and 12 months

Akathisia

Intervention	Participants (Count of Participants)
	3 Months	6 Months	12 Months
Escitalopram and Memantine	3	3	1
Escitalopram and Placebo	2	5	0

Percentage of participants who developed clinically significant akathisia. (NCT00892047)
Timeframe: 12 weeks

Emergent Suicidal Ideation in Those With no Ideation at the Start of Treatment

Intervention	percentage of participants (Number)
1: Venlafaxine Plus Aripiprazole	26.7
2: Placebo Comparator	12.2

percentage of participants who reported suicidal ideation during treatment but not at baseline (NCT00892047)
Timeframe: 12 weeks

Parkinsonism

Intervention	percent of participants (Number)
1: Venlafaxine Plus Aripiprazole	21.3
2: Placebo Comparator	29.2

Percentage of participants who develop signs of parkinsonism (NCT00892047)
Timeframe: 12weeks

Percentage of Subjects Who Met Criteria for Remission Based on the Montgomery-Asberg Depression Rating Scale (MADRS)

Intervention	percentage of participants (Number)
1: Venlafaxine Plus Aripiprazole	17.4
2: Placebo Comparator	2.5

The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten item instrument assessing depression symptoms. Possible scores range from 0-60; higher scores indicate greater severity of depression. Remission defined as score of 10 or less based on the MADRS. (NCT00892047)
Timeframe: 12 weeks

QTc Prolongation on EKG (to Greater or Equal to 480 Msec)

Weight

Response Using Clinical Global Impressions-Improvement Scale (CGI-I)

Intervention	percentage of participants (Number)
1: Venlafaxine Plus Aripiprazole	44
2: Placebo Comparator	29

Intervention	percent of participants (Number)
1: Venlafaxine Plus Aripiprazole	1.3
2: Placebo Comparator	0

Intervention	kilograms (Mean)
1: Venlafaxine Plus Aripiprazole	1.93
2: Placebo Comparator	0.01

Cumulative incident response of anxiety symptom improvement on CGI-I, with 1 (very much improved) to 2 (much improved) indicated as response. Scores synthesized from anxiety rating scale scores, including Penn State Worry Questionnaire (PSWQ) and Hamilton Anxiety Scale (HamA). (NCT00105586)
Timeframe: Measured at Weeks 1-12

Quality of Life

Intervention	participants (Number)
Placebo	51
Escitalopram	69

Role -emotional impairment score from the Late-Life Function and Disability Instrument (min score=0, significant impairment; max score=100, no impairment). (NCT00105586)
Timeframe: Measured at Week 12

Number of Remission From Major Depressive Episode Events

Intervention	units on a scale (Mean)
	Week 0 SF-36 Role-Emotional Impairment	Week 12 SF-36 Role-Emotional Impairment
Escitalopram (1)	42.19	62.50
Placebo (2)	53.42	56.16

Remission from major depressive episode as assessed by 17-item Hamilton Depression Rating Scale. (NCT02137369)
Timeframe: 12 weeks

Number of Response to Treatment Events

Intervention	number of events (Number)
SSRI	15
Cognitive Behavioral Therapy	4

Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks (NCT02137369)
Timeframe: 12 weeks

Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy

Intervention	number of events (Number)
SSRI	21
Cognitive Behavioral Therapy	5

The number of participants achieving remission from major depressive episode after 12 weeks of combined treatment consisting of antidepressant plus cognitive behavioral therapy (CBT) treatments. Those originally randomized to receive one of the antidepressants remained on that medication and had CBT sessions added. Participants originally randomized to CBT had escitalopram added at a dose of 10 to 20 mg per day for 12 weeks (NCT00360399)
Timeframe: Measured after 12 weeks of combined treatment

Remission From Major Depressive Episode Among Participants Who Completed the Intervention

Intervention	participants (Number)
Escitalopram	22
Duloxetine	10
Cognitive Behavioral Therapy (CBT)	18

The percentage of participants who achieved remission from a major depressive episode. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) after 10 weeks and 12 weeks of the assigned study treatment was considered to be remission from depression. (NCT00360399)
Timeframe: Measured at Weeks 10 and 12

Remission From Major Depressive Episode in Intent to Treat Sample

Intervention	percentage of participants (Number)
Escitalopram	44.2
Duloxetine	51.9
Cognitive Behavioral Therapy (CBT)	43.5

The percentage of participants who achieved remission from a major depressive episode, using a last observation carried forward (LOCF) dataset, defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) at the last observation was considered to be remission from depression. (NCT00360399)
Timeframe: Up to 12 Weeks

Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment

Intervention	percentage of participants (Number)
Escitalopram	46.7
Duloxetine	54.7
Cognitive Behavioral Therapy (CBT)	41.9

The number of participants experiencing a recurrence of depression after they had been in remission with the monotherapy treatment they were randomized to receive. (NCT00360399)
Timeframe: Measured at 6, 9, 12, 15, 18, 21, and 24 months

Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention

Intervention	participants (Number)
	6 Months	9 Months	12 Months	15 Months	18 Months	21 Months	24 Months
Cognitive Behavioral Therapy (CBT)	1	1	3	5	5	5	5
Duloxetine	0	2	2	4	4	5	5
Escitalopram	0	1	1	1	2	3	3

"Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the Week 10 and Week 12 visits:~Non-response: <30% reduction from baseline~Partial Response: 30-49% reduction from baseline~Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7~Remission: HDRS score ≤7" (NCT00360399)
Timeframe: Measured at Weeks 10 and 12

Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample

Intervention	participants (Number)
	Non-Response	Partial Response	Response without remission	Remission
Cognitive Behavioral Therapy (CBT)	15	13	11	30
Duloxetine	10	12	16	41
Escitalopram	15	10	23	38

"Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the last observation:~Non-response: <30% reduction from baseline~Partial Response: 30-49% reduction from baseline~Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7~Remission: HDRS score ≤7" (NCT00360399)
Timeframe: Up to 12 Weeks

Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16

Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16

Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16

Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set)

Intervention	participants (Number)
	Non-Response	Partial Response	Response without remission	Remission
Cognitive Behavioral Therapy (CBT)	32	19	10	44
Duloxetine	21	16	11	58
Escitalopram	26	12	18	49

Intervention	mmHg (Mean)
Antidepressant + Double-blind Placebo	-0.1
Antidepressant + Double-blind SPD489 10mg	-0.9
Antidepressant + Double-blind SPD489 30mg	-0.1
Antidepressant + Double-blind SPD489 50mg	2.8
Antidepressant + Double-blind SPD489 70mg	1.9

Intervention	bpm (Mean)
Antidepressant + Double-blind Placebo	-0.8
Antidepressant + Double-blind SPD489 10mg	0.8
Antidepressant + Double-blind SPD489 30mg	5.3
Antidepressant + Double-blind SPD489 50mg	4.0
Antidepressant + Double-blind SPD489 70mg	6.0

Intervention	mmHg (Mean)
Antidepressant + Double-blind Placebo	-0.2
Antidepressant + Double-blind SPD489 10mg	0.2
Antidepressant + Double-blind SPD489 30mg	0.5
Antidepressant + Double-blind SPD489 50mg	3.5
Antidepressant + Double-blind SPD489 70mg	2.6

MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. CHange in MADRS total score in Augmentsion Baseline to Week 16. (NCT01435759)
Timeframe: Augmentation Baseline (Week 8) to Week 16

Generalized Anxiety Disorder-7 (GAD-7) at 6 Months

Intervention	units on a scale (Least Squares Mean)
Antidepressant + Double-blind Placebo	-5.4
Antidepressant + Double-blind SPD489 10mg	-6.7
Antidepressant + Double-blind SPD489 30mg	-5.3
Antidepressant + Double-blind SPD489 50mg	-6.1
Antidepressant + Double-blind SPD489 70mg	-6.3

Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms. (NCT02391363)
Timeframe: Baseline, 6 months

Generalized Anxiety Disorder-7 (GAD-7) at 9 Months

Intervention	units on a scale (Mean)
	Baseline	6 months
Calmer Life	11.00	7.13
Enhanced Community Care	10.56	8.11

Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months

Intervention	units on a scale (Mean)
	Baseline	9 months
Calmer Life	11.00	7.54
Enhanced Community Care	10.56	6.62

Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety. (NCT02391363)
Timeframe: Baseline, 6 months

Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months

Intervention	units on a scale (Mean)
	Baseline	6 months
Calmer Life	3.39	2.25
Enhanced Community Care	3.30	2.48

Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety. (NCT02391363)
Timeframe: Baseline, 9 months

Geriatric Depression Scale Short Form (GDS) at 6 Months

Intervention	units on a scale (Mean)
	Baseline	9 months
Calmer Life	3.39	2.65
Enhanced Community Care	3.30	2.31

Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression. (NCT02391363)
Timeframe: Baseline, 6 months

Geriatric Depression Scale Short Form (GDS) at 9 Months

Intervention	units on a scale (Mean)
	Baseline	6 months
Calmer Life	5.97	3.75
Enhanced Community Care	5.61	4.33

Health Service Use at 6 Months

Intervention	units on a scale (Mean)
	Baseline	9 months
Calmer Life	5.97	3.80
Enhanced Community Care	5.61	3.92

Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months. (NCT02391363)
Timeframe: Baseline, 6 months

Health Service Use at 9 Months

Intervention	Participants (Count of Participants)
	Baseline	6 months
Calmer Life	64	47
Enhanced Community Care	56	45

Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months. (NCT02391363)
Timeframe: Baseline, 9 months

Hospital Admissions at 6 Months

Intervention	Participants (Count of Participants)
	Baseline	9 months
Calmer Life	64	52
Enhanced Community Care	56	39

Number of participants who were admitted to a hospital in the past 3 months. (NCT02391363)
Timeframe: Baseline, 6 months

Hospital Admissions at 9 Months

Number of participants who were admitted to a hospital in the past 3 months. (NCT02391363)
Timeframe: Baseline, 9 months

Insomnia Severity Index (ISI) at 6 Months

Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties. (NCT02391363)
Timeframe: Baseline, 6 months

Insomnia Severity Index (ISI) at 9 Months

Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties. (NCT02391363)
Timeframe: Baseline, 9 months

Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months

Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning. (NCT02391363)
Timeframe: Baseline, 6 months

Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months

Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation

Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning. (NCT02391363)
Timeframe: Baseline, 9 months

Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months

Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS)

Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning. (NCT02391363)
Timeframe: Baseline, 9 months

Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months

Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months

Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning. (NCT02391363)
Timeframe: Baseline, 6 months

Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months

Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months

Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity. (NCT02391363)
Timeframe: Baseline, 6 months

Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months

Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months

Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety. (NCT02391363)
Timeframe: Baseline, 6 months

Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months

Psychological Service Use at 6 Months

Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months (NCT02391363)
Timeframe: Baseline, 6 months

Psychological Service Use at 9 Months

PTSD Checklist-5 (PCL-5) Total at 6 Months

Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity. (NCT02391363)
Timeframe: Baseline, 6 months

PTSD Checklist-5 (PCL-5) Total at 9 Months

Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity. (NCT02391363)
Timeframe: Baseline, 9 months

Social Service or Resource Use at 6 Months

Number of participants who received social services or resources over the past 3 months (NCT02391363)
Timeframe: Baseline, 6 months

Social Service or Resource Use at 9 Months

Number of participants who received social services or resources over the past 3 months (NCT02391363)
Timeframe: Baseline, 9 months

Change in Depression Severity (Measured by Hamilton Depression Rating Scale)

Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Hamilton Depression Rating Scale (HAM-D). This measure is a clinical rating of mood with a score range from 0 to 76. Higher scores indicate greater depression severity. (NCT01728194)
Timeframe: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)

Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale)

Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Montgomery Asberg Depression Rating Scale (MADRS). This measure is a clinical rating of mood with a score range from 0 to 60. Higher scores indicate greater depression severity. (NCT01728194)
Timeframe: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)

Quality of Life Inventory

The Quality of Life Inventory (QOLI) is a 32-item comprehensive self-report of satisfaction in 16 areas of life, such as love, work, and health. Each area is rated in terms of satisfaction and the relationship of that area to overall quality of life. It yields an overall raw score and satisfaction ratings for the 16 individual areas of life. The QOLI raw score is an average of weighted satisfaction ratings computed only over areas of life judged to be Important or Extremely Important to the respondent. Higher scores indicate higher reported quality of life. (NCT00590863)
Timeframe: Measured at Month 7

Quick Inventory of Depressive Symptoms

Percentage of patients that achieve remission, as defined as QIDS total score below 6 for last 2 study visits. QIDS depression scores range from 0 (normal) to 27 (very severe). (NCT00590863)
Timeframe: Measured at Month 7

Change From Baseline to Week 8 in the Detection Task (DT)

"The DT is a computerized test that measures simple reaction time and psychomotor speed. The task requires participants to respond by pressing a yes button as soon as an onscreen playing card is turned over and is red, and by pressing a no button if the card is not red. It takes 2 minutes to be administered. There is no minimum or maximum scores since it is a time-based assessment. Lower score equals better performance. A decrease in score over the course of the study indicates improved speed of processing and psychomotor function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate." (NCT01564862)
Timeframe: Baseline and Week 8

Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST)

The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Participants are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time for a total possible score of 0 to 133. Higher scores-correct number of symbols reflects greater objective cognitive functioning. An increase in score represents an improvement in an integrated measure of cognitive function. An Analysis of Covariance (ANCOVA) model was used with treatment and center as fixed factors and the Baseline value as a covariate. (NCT01564862)
Timeframe: Baseline and Week 8

Change From Baseline to Week 8 in the Groton Maze Learning Test (GMLT)

"The GMLT measures executive functioning and spatial problem solving. Participants learn a hidden pathway through a maze of 10 x 10 grid of tiles on a computer touch screen using step-by-step guess, with trial and error feedback after each step. Once the pathway is learned, participants repeat the same pathway four more times. It usually takes 5-6 minutes to administer this test. Lower score equals better performance. A decrease in score over the course of the study indicates improved executive function.~An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate." (NCT01564862)
Timeframe: Baseline and Week 8

Change From Baseline to Week 8 in the Identification Task (IT)

"The IT measured choice reaction time: the participant pressed a yes button whenever an onscreen playing card turned face up and was red, or a no button if the card was not red. The IT took on average 2 minutes to complete. Lower scores equal better performance. A decrease in score over the course of the study indicates improved visual attention/vigilance. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate." (NCT01564862)
Timeframe: Baseline and Week 8

Change From Baseline to Week 8 in the One-Back Task

The One-Back test measures the cognitive domain of attention and working memory through yes or no responses to 30 trials. The task requires participants to report when a stimulus item presented serially is the same as an item one step back from the item at hand for a total correct responses 0 to 100. It usually takes 2-3 minutes to be administered. Higher scores equal better performance. An increase in score over the course of the study indicates improved attention/working memory. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate. (NCT01564862)
Timeframe: Baseline and Week 8

Change From Baseline to Week 8 in the Perceived Deficits Questionnaire (PDQ) Attention/Concentration and Planning/Organization Subscore

PDQ is a patient-rated scale designed to subjectively assess cognitive dysfunction, comprising four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization for a total possible score of 0 to 40. The subscale Attention/Concentration is the sum of items 1, 5, 9, 13, and 17 with a range of 0-20; while the subscale Planning/Organization is the sum of items 4, 8, 12, 16, and 20 with the score range of 0 to 20. The scores of the subscales Attention/Concentration and Planning/Organization were summed. Higher scores reflect greater participant-perceived cognitive dysfunction in the domains identified. A decrease in score represents an improvement in subjective cognitive function in the domains identified. A Mixed Model Repeated Measures (MMRM) model was used with baseline*week, center, week, treatment and week*treatment as factors in the analysis. (NCT01564862)
Timeframe: Baseline and Week 8

Change From Baseline to Week 8 in the Trail Making Test (TMT-A)

The TMT is a two-part cognitive test. TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower scores represent better speed of processing. A decrease in score over the study represents an improvement in speed in processing. An ANCOVA model was used with treatment and center as fixed factors and the baseline value as a covariate. (NCT01564862)
Timeframe: Baseline and Week 8

Change From Baseline to Week 8 in the Trail Making Test B (TMT-B)

The TMT is a two-part cognitive test. TMT-B assesses executive functioning and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower score for TMT-B represents better executive function. A decrease in score over the study represents an improvement in executive function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate. (NCT01564862)
Timeframe: Baseline and Week 8

Clinical Global Impressions-Improvement (CGI-I) Score at Week 8

"The CGI-I assesses the clinician's impression of the subject's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater worsening of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. A MMRM model was used with baseline*week, center, week, treatment and week*treatment as factors in the analysis." (NCT01564862)
Timeframe: Baseline, Week 8

Percentage of Participants in MADRS Remission at Week 8

MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Remission was defined as a MADRS total score ≤10. (NCT01564862)
Timeframe: Week 8

Percentage of Participants With MADRS Response at Week 8

MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Response was defined as a ≥50% decrease in MADRS Total Score from Baseline. (NCT01564862)
Timeframe: Baseline and Week 8

Proportion of Cognitive Dysfunction Improvement Due to Improvement of Depression

Improvement of Cognitive Dysfunction is determined using the change from Baseline to Week 8 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score and the Digital Symbol Substitution Test (DSST) total number of correct symbols. The MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression). The DSST assesses relative contributions of speed, memory, executive function and visual scanning. The proportion of direct effect from treatment = DSST difference / (DSST difference + coefficient*MADRS difference). (NCT01564862)
Timeframe: Baseline and Week 8

Change From Baseline to Week 8 in the Clinical Global Impressions-Severity (CGI-S) Score

"The CGI-S assesses the clinician's impression of the subject's current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill). A MMRM model with baseline*week, center, week, treatment and week*treatment as factors was used for analyses." (NCT01564862)
Timeframe: Baseline, Week 1, Week 4 and Week 8

Change From Baseline to Week 8 in the MADRS Total Score

MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. (NCT01564862)
Timeframe: Baseline, Week 1, Week 4 and Week 8

Change in Time From Baseline to Week 8 in the Stroop Test

The STROOP test assesses the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises of 2 sheets with 50 words each, up to 50 correct responses for each of the congruent and incongruent Stroop tests. Participants have 4 minutes to name the ink color of each word. Lower time to complete the test indicates better performance. Higher number of correct responses indicates better responses. A decrease in the time to complete the tests and an increase in the number of correct responses both indicate improvement over the course of the study. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate. (NCT01564862)
Timeframe: Baseline and Week 8

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])

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)

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)

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)

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])

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

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])

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

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])

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

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])

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])

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)

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]

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])

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

Hamilton Rating Scale for Depression

The patient is rated by a clinician among 24 dimensions with a score on a 3 or 5 point scale. A score of 0-9 is considered to be normal. Score between 10-18 is considered as mild depression, Scores between 19-26 indicate moderate, scores between 27-34 indicate severe, and score between 35-75 indicate very severe depression. (NCT01919216)
Timeframe: 8 weeks

Change From Baseline in Changes in Sexual Function Questionnaire (CSFQ)

CSFQ is a questionnaire about sexual activity and sexual function (sexual intercourse, masturbation, sexual fantasies and other activity). CSFQ is a gender-specific questionnaire. Both male and female versions consist of 14 items, each with 5 possible answers. CSFQ has a score in a range of 14 to 70. Higher score indicates higher sexual activity and sexual function. Value at Day 0 (Week 0) was considered as Baseline value. Change from Baseline at Week 8 was calculated by subtracting the Baseline score from the specific post-Baseline score. Only those participants with data available at the specified time points were analyzed. (NCT02191397)
Timeframe: Baseline (Day 0) and Week 8

Mean Change in Hamilton Depression Rating Scale - 17 (HAMD-17) Total Score From Baseline to End of Acute Treatment Phase (Week 8)

HAMD-17 is used to assess the severity of depression and symptom improvement. It consisted of 17 questions. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Change from Baseline was calculated by subtracting the Baseline total score (at Day 0, Week 0) from Week 8 observed total score. The Per Protocol (PP) Population is defined as all randomized participants in the Intent-To-Treat (ITT) Population who do not meet criteria of a major protocol deviation, with overall compliance of active drug for acute treatment phase in the range of 75%-125% and complete the first 6 weeks treatment and has HAMD-17 assessment at/after week 6 (that is >=35 days). All participants in the PP population were included in the mixed model repeated measures analysis. Only those participants with data available at the specified time point were analyzed. (NCT02191397)
Timeframe: Baseline (Week 0) and Week 8

Remission Rate Based on HAMD-17 Total Score

Response Rate Based on HAMD-17 Total Score

HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Response was defined as decrease in HAMD-17 total scores at end of acute treatment phase (Week 8) relative to Baseline by at least 50%. Non-responder Imputation was used in calculation of rates. (NCT02191397)
Timeframe: Up to Week 8

Sustained Remission Rate Based on HAMD-17 Total Score

HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Sustained remission was defined as remission at end of acute treatment phase and an earlier visit and non-missing HAMD-17 total scores at all visits between these two visits <=8. (NCT02191397)
Timeframe: Up to Week 8

Sustained Response Rate Based on HAMD-17 Total Score

HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Sustained response was defined as response at end of acute treatment phase and an earlier visit and the decrease from Baseline in non-missing HAMD-17 total scores at all visits between these two visits by at least 40%. (NCT02191397)
Timeframe: Up to Week 8

"Percentage of Participants With a Clinical Global Impression Global Improvement (CGI-I) Score of 1 (Very Much Improved) or 2 (Much Improved) at Weeks 1, 2, 4, 6 and 8"

"For CGI-I rating, the raters indicated their assessment of the participant's total improvement or worsening compared to the participant's condition at the Baseline visit, whether or not the improvement or worsening was thought to be treatment related. Scores ranges from 0 to 7 where 0 represents Not assessed, and the remaining values 1-7 represent Very much improved (1) to Very much worse (7). Participants with score 0 were excluded from analysis. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points." (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8

Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points

Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10

Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points

Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Weeks 1, 2, 4, 6 and 8

"CGI-S records the severity of illness at specific time points, with a range of responses from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants with zero values (0) representing Not assessed were excluded from analysis. Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was obtained by subtracting the Baseline value from the specific post-Baseline value. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points." (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8

Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score (Sum of Scores of Items 10, 11, 12, 13, 15 and 17) at Weeks 1, 2, 4, 6 and 8

HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Anxiety/Somatization subscale score was derived as sum of scores of items 10, 11, 12, 13, 15 and 17 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 18 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8

Change From Baseline in HAMD-17 Depressed Mood Subscale Score (Score of Item 1) at Weeks 1, 2, 4, 6 and 8

HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Depressed Mood Subscale is a factor score of item-1 (Depressed Mood) of HAMD-17 scale. This subscale has a score in a range of 0 (absence of depressed mood feelings) to 4 (when participants report virtually only these feeling states in his/her spontaneous verbal and non-verbal communicationtotal score). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8

Change From Baseline in HAMD-17 Retardation Subscale Score (Sum of Scores of Items 1, 7, 8 and 14) at Weeks 1, 2, 4, 6 and 8

HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Retardation subscale score was derived as sum of scores of items 1, 7, 8 and 14 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 14 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8

Change From Baseline in HAMD-17 Sleep Disorder Subscale Score (Sum of Scores of Items 4, 5 and 6) at Weeks 1, 2, 4, 6 and 8

HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Sleep Disorder subscale score was derived as sum of scores of items 4, 5 and 6 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 6 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8

Change From Baseline in Hematocrit at the Indicated Time Points

Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points

Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points

Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Weeks 1, 2, 4, 6 and 8

MADRS is a 10-point rating scale. Each item is scored on a scale of 0-6, with a total score range of 0-60. Higher score indicates worst symptoms. This scale is mainly used to assess the efficacy of antidepressant treatment. The ratings were based on the signs and symptoms during the preceding week prior to the visit. Values at Day0, Week 0 was considered as Baseline value. The observed MADRS total score was considered as missing if any item is missing. Change from Baseline in MADRS was obtained by subtracting the Baseline value from the specific post-Baseline value. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8

Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points

Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points

Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points

Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious AE (SAE)

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Participants who received any of the study treatment and had any non-serious AE or SAE were considered for analysis. Safety Population comprised of all participants who took at least one dose of the study medication. (NCT02191397)
Timeframe: Up to Week 10

Number of Participants With Electrocardiogram (ECG) Data Outside the Clinical Concern Range

ECG was recorded at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). PR interval <110 or >220 millisecond (msec); QRS interval <60 or >120 msec and corrected QT (QTc) interval >450 msec were considered as values outside of clinical concern range and were presented as 'High' or 'Low' values. Number of participants with ECG data outside of clinical concern range at any post-Baseline visit are presented. Only those participants with data available at the specified time points were analyzed. (NCT02191397)
Timeframe: Up to Week 10

Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)

"C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. It consists of 10 items, each with two possible answers (yes/no). Suicidal ideation was interpreted if yes answer at any time during treatment to any one of the five suicidal ideation questions (item 1-5) on the C-SSRS. Suicidal behavior was interpreted if a yes answer at any time during treatment to any one of the five suicidal behavior questions (item 6-10) on the C-SSRS. Suicidal ideation or behavior is interpreted if a yes answer at any time during treatment to any one of the ten suicidal ideation and behavior questions (item 1-10) on the C-SSRS. Number of participants with at least one on-treatment C-SSRS assessment were analyzed. Only those participants with data available at the specified time points were analyzed." (NCT02191397)
Timeframe: Baseline and up to Taper visit (Week 9)

Number of Participants With Urinalysis Data Outside the Normal Range

Urine samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Number of participants with urine specific gravity and potential of hydrogen (pH) outside (higher or lower) the normal range are presented. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10

Number of Participants With Vital Sign Parameters Outside the Clinical Concern Range

Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were taken at Screening (within 14 days prior to dosing), randomization visit (Week 0) and at Weeks 1, 2, 4, 6, 8, Taper visit (Week 9) and Follow-up visit (Week 10). SBP <30 or >170 millimeter of mercury (mmHg); DBP <20 or >110 mmHg and heart rate <40 or >120 beats per minute (bpm) were considered as values outside of clinical concern range and were presented as 'High' or 'Low' values. Number of participants with vital signs outside of clinical concern range at any post-Baseline visit are presented. Only those participants with data available at the specified time points were analyzed. (NCT02191397)
Timeframe: Up to Week 10

Improvement in Scores on the Hamilton Depression Rating Scale - SSRI Phase

Mean % improvement from baseline to end of treatment trial using the 24-item Hamilton Depression Rating Scale. Percent improvement of depressive symptoms was calculated for the 28 completers of the SSRI phase. The higher the score on the 24-item HDRS, the greater the depression severity. Minimum score on the scale is 0, and maximum score is 74. Subscales are not used for this analysis. (NCT00456014)
Timeframe: Measured at Week 8

Remission of Depressive Symptoms

Remission in this study is defined as both a ≥50% decrease in the 24-item Hamilton Depression Rating Scale (HDRS) Score and a final 24-item HDRS score <10. Remission of depressive symptoms was calculated for the 28 completers of the SSRI phase. (NCT00456014)
Timeframe: Measured at Week 8

Remission of Depressive Symptoms - Tricyclic Phase

Participants who did not achieve remission during the SSRI phase advanced to the tricyclic phase of the study. Participants were treated with either desipramine or nortriptyline. Seven participants started the tricyclic phase. Four completed the tricyclic phase. The completers (n=4) were analyzed for remission status. (NCT00456014)
Timeframe: Measured over 8 weeks

Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks

# of study participants with Hamilton Depression-17-item score less than or equal to 7. (NCT00367341)
Timeframe: Measured at week 12

Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks

Number of participants with a 50% change from Baseline on the Hamilton Depression Rating Scale-17-item score (NCT00367341)
Timeframe: Measured at week 12.

Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16)

Number of participants reaching pre-defined threshold on the QIDS-SR-16 of >/=11. The QIDS-SR-16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression. (NCT00536172)
Timeframe: Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28

Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)

MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. (NCT00905424)
Timeframe: Augmentation Baseline, 6 weeks

Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF

The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression. (NCT00905424)
Timeframe: Augmentation Baseline, 6 weeks

Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6

MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks

Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6

QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks

Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6

Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment. (NCT00905424)
Timeframe: Augmentation Baseline, 6 weeks

Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF

MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks

Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF

Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6

Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6

Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6

Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT00905424)
Timeframe: 6 weeks

Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF

Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT00905424)
Timeframe: Augmentation baseline

Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT00905424)
Timeframe: 6 weeks

Assessment in Remitters of CGI-S at Augmentation Baseline

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT00905424)
Timeframe: Augmentation Baseline

Assessment in Remitters of CGI-S at Week 6

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT00905424)
Timeframe: 6 weeks

Change From Augmentation Baseline for Non-Remitters in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Scale Total Score at Week 6

BRIEF-A is a validated 75-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to develop interpretive reports. Lower scores reflect better functioning. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks

Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6

BRIEF-A is a validated 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning. (NCT00905424)
Timeframe: Augmentation baseline and 6 weeks

Functioning, as Measured by the Social Adjustment Scale (SAS) Summary Score

Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning (NCT00519428)
Timeframe: 12 weeks

Quality of Life, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form (SF)

"The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) intends to measure quality of life in 16 domains. A summary score is computed by adding the scores and dividing by 16 (or the number of answered items if some are not answered).~The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Higher score means more satisfaction." (NCT00519428)
Timeframe: 12 weeks

Remission: Persistent Hamilton Rating Scale for Depression, 17 Items (HAM-D 17) <= 7, With no HAM-D 17 >7 Through Week 12

Chi square comparison of rates of persistent remission (i.e., no subsequent Hamilton Rating Scale for Depression, 17 items [HAMD-D 17] > 7 once HAMD-D 17 <= 7); Dual rate vs. Escitalopram only rate and Dual rate vs. Bupropion only rate. (NCT00519428)
Timeframe: 12 weeks

Severity of Depressive Symptoms as Measured by Hamilton Rating Scale for Depression (HAM-D 17)

"Last summary score rating on the 17-item Hamilton Rating Scale for Depression Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Range 0-58.~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥ 23 = Very Severe Depression" (NCT00519428)
Timeframe: 12 weeks

Time to Remission, Defined by the Week of Onset of Persistent Hamilton Rating Scale for Depression (HAM-D 17) <= 7, With no Subsequent HAM-D 17 > 7

Life Table Survival Analysis run twice, once comparing Dual Therapy (i.e., Bupropion + Escitalopram) to Bupropion alone (i.e., Bupropion + Placebo) and once comparing Dual Therapy to Escitalopram alone (i.e., Escitalopram + Placebo). Because both analyses must significantly favor Dual Therapy, each individual analysis must reach a critical alpha = .0916 in order to reach an over-all alpha = .05. (NCT00519428)
Timeframe: 12 weeks

Hamilton Rating Scale for Depression (HAM-D)

The change in total HAM-D score between baseline and endpoint was the primary outcomes measure. This measure is a clinician rated inventory of depressive symptoms. All items are scored on a scale of zero to four and the sum of the scores provides the total score for the measure. Scores can range from 0- 68. On this scale, higher scores indicate poorer outcomes. (NCT00101452)
Timeframe: baseline and 24 weeks

Baroreflex Sensitivity High Frequency (HF) Alpha

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. (NCT02709369)
Timeframe: Baseline/Enrollment visit

Baroreflex Sensitivity High Frequency (HF) Alpha

Baroreflex Sensitivity Sequence All

Baroreflex Sensitivity Sequence Down

Baroreflex Sensitivity Sequence Up

Center for Epidemiologic Studies Depression Scale (CES-D)

The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology. (NCT02709369)
Timeframe: 1-2 weeks after intervention is completed

Center for Epidemiologic Studies Depression Scale (CES-D)

Drop Stick Reaction Testing

Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100. (NCT02709369)
Timeframe: 1-2 weeks after the intervention is completed

Drop Stick Reaction Testing

Euro Quality of Life--Five Dimension (EQ-5D)

The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome. (NCT02709369)
Timeframe: 1-2 weeks after the intervention is completed

Euro Quality of Life--Five Dimension (EQ-5D)

Generalized Anxiety Disorder-7 (GAD-7)

The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety. (NCT02709369)
Timeframe: 1-2 weeks after the intervention is completed

Generalized Anxiety Disorder-7 (GAD-7)

Heart Rate Variability (SDNN)

Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval (NCT02709369)
Timeframe: Up to 2 weeks after the intervention is completed

Heart Rate Variability Standard Deviation of NN Intervals (SDNN)

Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval (NCT02709369)
Timeframe: Baseline/Enrollment visit

Insomnia Severity Index (ISI)

The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality. (NCT02709369)
Timeframe: 1-2 weeks after the intervention is completed

Insomnia Severity Index (ISI)

Posttraumatic Stress Disorder Checklist (PCL-C)

The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD. (NCT02709369)
Timeframe: enrollment visit/baseline

Posttraumatic Stress Disorder Checklist (PCL)

Rivermead Post-Concussion Symptoms Questionnaire (RPQ)

The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity. (NCT02709369)
Timeframe: 4-8 weeks after completion of the intervention

Rivermead Post-Concussion Symptoms Questionnaire (RPQ)

The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with a higher score denoting the greatest symptom severity. (NCT02709369)
Timeframe: 1-2 weeks after the intervention is completed

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10

The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement. (NCT01473381)
Timeframe: Baseline to Week 10

Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score

"The Clinical Global Impressions-Severity scale is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. In particular, the clinician is asked to respond to the following question: Considering your total clinical experience with this population, how mentally ill is the patient at this time? The patient is rated on the following 7-point scale: 1-normal, not at all ill, 2-borderline ill, 3-mildly ill, 4-moderately ill, 5-markedly ill, 6-severely ill, 7-among the most extremely ill patients. A higher score indicates more mental illness. A negative change score indicates improvement." (NCT01473381)
Timeframe: Baseline to Week 10

Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response

The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A MADRS sustained response was defined as a MADRS total score ≤ 12 for at least the last 2 visits during the double-blind treatment period (Weeks 1-10). A total MADRS score ≤ 12 corresponds to an average score of 1 per item and is indicative of very low level of depressive symptoms. (NCT01473381)
Timeframe: Baseline to Week 10

"Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of Very Much Improved or Much Improved From Randomization (Week 8) to End of Treatment (Week 16)"

A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement. (NCT01197508)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15

The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life. The 15th item queries respondents' satisfaction with the medication they are taking. Higher scores are indicative of greater enjoyment or satisfaction in each domain. (NCT01197508)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16

The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment. Higher scores are indicative of greater enjoyment or satisfaction in each domain. (NCT01197508)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score

A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression. (NCT01197508)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score

A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'. (NCT01197508)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score

A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'. (NCT01197508)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score

A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'. (NCT01197508)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score

Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired). (NCT01197508)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)

A 14-item clinician-administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 to 4 scale. Higher HAM-A scores indicate higher levels of anxiety. (NCT01197508)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in MADRS Total Score From Randomization (Week 8) to Week 10

A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms. (NCT01197508)
Timeframe: Randomization (Week 8) to Week 10

Change in MADRS Total Score From Randomization (Week 8) to Week 12

Change in MADRS Total Score From Randomization (Week 8) to Week 14

Change in MADRS Total Score From Randomization (Week 8) to Week 9

Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score

The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%. (NCT01197508)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)

A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity. (NCT01197508)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.

Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)

"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms." (NCT01197508)
Timeframe: Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16

Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)

"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms." (NCT01197508)
Timeframe: Week 16

Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)

"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms." (NCT01197508)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)

"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms." (NCT01197508)
Timeframe: Week 12, Week 14, Week 16

Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)

"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms." (NCT01197508)
Timeframe: Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16

Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)

A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state. (NCT01197508)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

"Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of Very Much Improved or Much Improved From Randomization (Week 8) to End of Treatment (Week 16)"

A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement. (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16

The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment, rated on a 1 to 5 scale. Higher scores are indicative of greater satisfaction. (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form(Q LES-Q-SF)Item 15

The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life. The 15th item queries respondents' satisfaction with the medication they are taking, rated on a 1 to 4 scale, score 0 indicates that no medication was taken. Higher scores are indicative of greater satisfaction. (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score

A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression. (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score

A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'. (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score

A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'. (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score

A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'. (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score

Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired). (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)

A 14-item clinician-administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 to 4 scale, the total score can range from 0 to 56. Higher HAM-A scores indicate higher levels of anxiety. (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in Irritability Symptoms as Measured by the Sheehan Irritability Scale (SIS) Total Score From Randomization (Week 8) to End of Treatment (Week 16)

A self-administered scale to be used by clinical subjects to rate suffering over the past week with regard to irritability symptoms. The total SIS score is the sum of 7 items, and ranges from 0 to 70. Each item is assessed on an 11- point scale where 0=not at all, 1-3=mildly, 4-6=moderately, 7-9=markedly, and 10=extremely. The SIS also records the number of days impaired by irritability. (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in MADRS Total Score From Randomization (Week 8) to Week 10

A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms. (NCT01153347)
Timeframe: Randomization (Week 8) to Week 10

Change in MADRS Total Score From Randomization (Week 8) to Week 12

A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms. (NCT01153347)
Timeframe: Randomization (Week 8) to Week 12

Change in MADRS Total Score From Randomization (Week 8) to Week 14

A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms. (NCT01153347)
Timeframe: Randomization (Week 8) to Week 14

Change in MADRS Total Score From Randomization (Week 8) to Week 9

The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%. (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)

A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity. (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.

A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms. (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms." (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16

Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)

"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms." (NCT01153347)
Timeframe: Week 16

Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)

"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms." (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)

"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms." (NCT01153347)
Timeframe: Week 12, Week 14, Week 16

Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)

"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms." (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16

Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)

A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values (minimum -0.415) to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state. (NCT01153347)
Timeframe: Randomization (Week 8) to end of treatment (Week 16)

Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8

This will involve looking at the change in HAM-D 17 scores during phase 2. For HAMD-17 the minimum is 0, the maximum is 52, and greater scores represent more symptoms. (NCT00633399)
Timeframe: 8 weeks

Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2.

A secondary outcome measure will be remission rates (HAM-D 17 scores of less than 8) after treatment phase 2.. A remitted will be a patient with a final score of 7 or less on the HAMD-17 during phase 2. (NCT00633399)
Timeframe: 8 weeks

The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2

The primary outcome measure will be response rates (50% decrease in HAM-D-17 scores) during phase 2. A responder will be a patient who experiences a 50% or greater decrease in symptoms according to the HAM-D-17 during phase 2. (NCT00633399)
Timeframe: 8 Weeks

Hamilton Depression Rating Scale (HDRS) Maintained Scores at Week 16

The Hamilton Depression Rating Scale (HDRS) is a 24-item depression scale and the total score is summed with a minimum score=0 and maximum score=76. There are no subscales and the higher values represent a worse outcome. Outcomes are measured and defined as follows: 1) Response will be defined as HDRS scores of 10 or less; 2) Sustained response will be defined as maintained response at week 16; 4) Remission will be defined as HDRS scores of 6 or less. (NCT00602290)
Timeframe: Maintained response measured at Week 16

Quality of Life Assessment

The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item self-administered questionnaire that captures life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). The total score is reported for items 1-14. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70 with higher values representing a better outcome. (NCT00602290)
Timeframe: Measured at Baseline and Week 16

Amphetamine Cessation Symptom Assessment (ACSA) - Total Aggregate Score

ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity. (NCT01436162)
Timeframe: 8 weeks

Mean Change From Baseline in Abbreviated Brief Assessment of Cognition Affective Disorders (ABAC-A) Composite T-Scores

The ABAC-A is a rater-administered series of activities designed to be sensitive to the critical cognitive deficits in affective disorders and schizophrenia. There are 6 subtests of the ABAC-A: List Learning (verbal memory); Digit Sequencing Task (working memory); Token Motor Task (motor speed); Verbal Fluency; Symbol Coding (attention and processing speed); and Tower of London Test (executive functions). The ABAC-A Composite T-score change from Augmentation Baseline Visit (Visit 8; Week 8) at Visit 14/Early Termination (ET) (Week 16/ET) was analyzed. (NCT01436162)
Timeframe: up to 8 weeks

Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 8 Weeks

Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score at 8 Weeks

Mean Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Global Fatigue Index (GFI)

Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Female

The CSFQ-14 is a short-form interview/questionnaire that measures illness- and medication-related changes in sexual functioning. A 5-point Likert scale is used ranging from 1 (never) to 5 (always). The CSFQ-14 total score can range from 14 to 70, with lower scores being associated with worsened sexual functioning. (NCT01436162)
Timeframe: Up to 8 weeks

Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Male

Percent of Participants Achieving Remission on the MADRS

MADRS remission was defined as a MADRS total score of ≤10. (NCT01436162)
Timeframe: Up to 8 weeks

Percentage of Participants Achieving a 25% Response on the MADRS

The percentage of subjects who achieved a 25% response (i.e. ≥25% reduction in MADRS total score from the Lead-in Baseline, Visit 2). (NCT01436162)
Timeframe: Up to 8 weeks

Percentage of Participants Achieving a 50% Response on the MADRS

The percentage of subjects who achieved a 50% response (i.e. ≥50% reduction in MADRS total score from the Lead-in Baseline, Visit 2). (NCT01436162)
Timeframe: Up to 8 weeks

Clinical Global Impressions - Global Improvement (CGI-I)

Columbia Suicide Severity Rating Scale (C-SSRS)

C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. (NCT01436162)
Timeframe: Up to 8 weeks

Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)

Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life. (NCT01436162)
Timeframe: Up to 8 weeks

Mean Change From Baseline Over Time in MADRS Total Score

Amphetamine Cessation Symptom Assessment (ACSA)

Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks

Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks

Mean Change From Baseline in the Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)

The short form is a 16-item self-report questionnaire which evaluates general subject satisfaction with health, mood, relationships, functioning in daily life, and the treatment being taken. Overall level of satisfaction is evaluated on a 5-point scale from 1 (very poor) to 5 (very good). The total score ranges from 14-70 (last two items on the form are not included in the total score). A higher score indicates a better quality of life. (NCT01436149)
Timeframe: up to 8 weeks

Mean Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR)

The QIDS-SR is a self-administered questionnaire designed to rate depressive symptoms. The scale contains 16 items, each scored using a 4-point scale ranging from 0 (representing the most favorable response [low amount of symptom]) to 3 (representing the least favorable response [frequent/intense symptom]). The total score could range from 0 (no depression) to 27 (very severe depression). Higher scores represent more severe depressive symptoms. (NCT01436149)
Timeframe: up to 8 weeks

Percentage of Participants Achieving a 25% Response on the MADRS

The percentage of subjects who achieved a 25% response (i.e., ≥25% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/Early Termination (ET) (Week 16/ET). (NCT01436149)
Timeframe: up to 8 weeks

Percentage of Participants Achieving a 50% Response on the MADRS

The percentage of subjects who achieved a 50% response (i.e., ≥50% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/ET (Week 16/ET). (NCT01436149)
Timeframe: up to 8 weeks

Percentage of Participants Achieving Remission on the MADRS

MADRS remission was defined as a MADRS total score of ≤10. A comparison was performed at Visit 14/ET (Week 16/ET). (NCT01436149)
Timeframe: up to 8 weeks

Clinical Global Impressions - Global Improvement (CGI-I)

Columbia Suicide Severity Rating Scale (C-SSRS)

C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The assessment is done by the nature of the responses, not by a numbered scale. (NCT01436149)
Timeframe: up to 8 weeks

Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)

Mean Change From Baseline Over Time in MADRS Total Score

MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. (NCT01436149)
Timeframe: Baseline and up to 8 weeks

Montgomery-Åsberg Depression Rating Scale (MADRS)

"The entire study will last 18 weeks. For the first 6 weeks, subjects will come in once every 2 weeks. For the next 4 weeks, subjects will come in once per week. For the next 6 weeks, subjects will come in once every 2 weeks. The final visit will come 2 weeks later for a total of 11 visits where the MADRS will be administered. Only the baseline and final (last observation) assessments for the outcome measure was used in determining results, thus these are the only values included.~MADRS scores range from 0-60, with higher scores indicating a greater level of severity. No subscales were used." (NCT01742832)
Timeframe: Baseline and final MADRS scores during the double-blind phase.

Change in Clinical Global Improvement - Severity Scale

Seven-point Likert scale rating clinical severity of mental illness from 1 (least severe) to 7 ( most severe). Physician-rated scale. One item. (NCT02033369)
Timeframe: 6 weeks

Change in Hamilton Rating Scale for Depression

Hamilton Rating Scale for Depression (HRSD), 17-item version. This standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 6, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression) (NCT02033369)
Timeframe: Baseline and 6 weeks

Change in Mood and Anxiety Symptom Questionnaire, Short Form

Change in Mood and Anxiety Symptom Questionnaire, Short Form. A 62-item scale assessing anxiety and depression. Items were measured on a scale of 1-5, higher number indicating higher levels of symptoms.The lowest possible score was 62, and the highest 310. (NCT02033369)
Timeframe: Baseline and 6 weeks

Change in Snaith Hamilton Pleasure Scale

"Fourteen-item self-rated anhedonia scale. Items were comprised of statements that participants rated as strongly disagree (1), disagree (2), agree (3), or strongly agree (4). The lowest possible score was 14, the highest possible score was 56." (NCT02033369)
Timeframe: Baseline and 6 weeks

Change in Temporal Experience of Pleasure Scale - Anticipatory Subscale

"A validated self-rated scale shown to assess anticipatory pleasure. It will be used for exploratory analyses of anhedonia.~18 items were measured on a scale of 1 (very false for me) to 6 (very true for me). Higher scores indicate higher pleasure. Item scores were added for a lowest possible score of 18 and highest possible score of 108." (NCT02033369)
Timeframe: Baseline and 6 weeks

Change in Temporal Experiences of Pleasure Scale -- Consummatory Subscale

"A validated self-rated scale shown to assess consummatory pleasure. It will be used for exploratory analyses of anhedonia.~18 items were measured on a scale of 1 (very false for me) to 6 (very true for me). Higher scores indicate higher pleasure. Item scores were added for a lowest possible score of 18 and highest possible score of 108." (NCT02033369)
Timeframe: Baseline and 6 weeks

Change in the Apathy Evaluation Rating Scale

A validated self-rated 18 item scale assessing apathy. Items were rated from 1 (not at all true) to 4 (very true). Higher scores indicate lower apathy, lower scores indicate higher apathy. Lowest possible score is 18, highest possible score is 72. (NCT02033369)
Timeframe: Baseline and 6 weeks

Change in QIDS-SR From Baseline at 14 Days

"The Quick Inventory of Depressive Symptomatology, self-report (QIDS-SR), self-report is a 16-item measure of depression severity that includes the 9 criterion symptoms for MDD. Items are scored on a 4-point Likert scale, ranging from 0 to 3 (total score range, 0-27). Totals scores of ≤ 5 indicate no depression; 6-10 indicates mild depression; 11-15 indicates moderate depression; 16-20 indicates severe depression; and ≥ 21 indicates very severe depression. For purposes of this report, severe and very severe categories were combined as severe to very severe depression (≥ 16). The QIDS-A self-report has demonstrated acceptable psychometric properties." (NCT03079297)
Timeframe: Baseline to 14 days

Percentage of MDD Patients With 50% or Greater Reduction in Depression Severity After 14 Days of LEU and PBO Treatments.

"Response criteria defined based on QIDS-SR score at baseline and 14 days after treatment initiation.~The Quick Inventory of Depressive Symptomatology, self-report (QIDS-SR), self-report is a 16-item measure of depression severity that includes the 9 criterion symptoms for MDD. Items are scored on a 4-point Likert scale, ranging from 0 to 3 (total score range, 0-27). Totals scores of ≤ 5 indicate no depression; 6-10 indicates mild depression; 11-15 indicates moderate depression; 16-20 indicates severe depression; and ≥ 21 indicates very severe depression. For purposes of this report, severe and very severe categories were combined as severe to very severe depression (≥ 16). The QIDS-A self-report has demonstrated acceptable psychometric properties." (NCT03079297)
Timeframe: Baseline to 14 days

Percentage of MDD Patients With QIDS-SR Score Less Than or Equal to 5 at 14 Days of LEU and PBO Treatments.

"Remission operationalized as QIDS-SR <=5.~The Quick Inventory of Depressive Symptomatology, self-report (QIDS-SR), self-report is a 16-item measure of depression severity that includes the 9 criterion symptoms for MDD. Items are scored on a 4-point Likert scale, ranging from 0 to 3 (total score range, 0-27). Totals scores of ≤ 5 indicate no depression; 6-10 indicates mild depression; 11-15 indicates moderate depression; 16-20 indicates severe depression; and ≥ 21 indicates very severe depression. For purposes of this report, severe and very severe categories were combined as severe to very severe depression (≥ 16). The QIDS-A self-report has demonstrated acceptable psychometric properties." (NCT03079297)
Timeframe: 14 days

Change in Anhedonia From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured Using Snaith-Hamilton Pleasure Scale (SHAPS)

"Anhedonia will be measured using Snaith-Hamilton Pleasure Scale (SHAPS).~The Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item scale that measures anhedonia, the inability to experience pleasure. The items cover the domains of: social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a normal score, while an abnormal score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the disagree responses score one point, and either of the agree responses score 0 points. Thus, the final score ranges from 0 to 14." (NCT03079297)
Timeframe: Baseline to 3 days, 7 days, and 14 days

Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory.

"Fatigue will be measured with Multidimensional fatigue inventory~The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It contains five scales: general fatigue (items 1, 5, 12, 16), mental fatigue (items 7, 11, 13, 19), physical fatigue (items 2, 8, 14, 20), reduced motivation (items 4, 9, 15, 18) and reduced activity (items 3, 6, 10, 17). Items are scored on a 5-point scale on which the participant expressed the degree to which the statement applied to him or her (from agreement yes, that is true to disagreement no, that is not true) in the previous days. Item scores are summed to create a sum score for each scale, ranging between 4 (best condition) and 20 (worst condition). Higher scores indicate more fatigue." (NCT03079297)
Timeframe: Baseline to 3 days, 7 days, and 14 days

Change in Psychosocial Function From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured Using Work and Social Adjustment Scale.

"Psychosocial function will be measured using Work and Social Adjustment Scale~The Work and Social Adjustment Scale (WSAS) is a 5-item measure for impairment in functioning. Items are scored on an 8-point scale on how much participants' problems impaired their ability to carry out the activity (from Not at all to Very severely). Item scores are summed to create a sum score. The maximum score of the WSAS is 40, lower scores are better. A WSAS score above 20 appears to suggest moderately severe or worse psychopathology. Scores between 10 and 20 are associated with significant functional impairment but less severe clinical symptomatology. Scores below 10 appear to be associated with subclinical populations." (NCT03079297)
Timeframe: Baseline to 3 days, 7 days, and 14 days

Rates of Adverse Effects After 3 Days, 7 Days and 14 Days of LEU and PBO Treatments.

"Adverse effect burden will be measured with Frequency Intensity and Burden of Side-effect rating scale (FIBSER).~The Frequency, Intensity, Burden of Side Effects Rating (FIBSER) scale was designed by Dr. Stephen Wisniewski for use in the U.S. STAR*D effectiveness study. It is a 3-item scale to assess side effects from antidepressant treatment. To use the FIBSER in measurement-based care, clinicians should consider item 3 (Burden). If the score is 0 to 2 (None to Mild interference with activities), no change in medication is needed. If the score is 3-4 (Moderate to Marked interference with activites), the side effects need to be addressed (i.e., change in dose, side effect antidote, etc). If the score is 5-6 (Severe interference with activities or Unable to Function), the dose needs to be decreased or the medication needs to be switched." (NCT03079297)
Timeframe: Baseline to 3 days, 7 days, and 14 days

MADRS Response Rates

Defined as a 50% score reduction from baseline. (NCT03207438)
Timeframe: Day 4 - Week 6

Modified MADRS Response Rate

Calculated without Item 4 (reduced sleep). (NCT03207438)
Timeframe: Day 4 - Week 6

Modified MADRS Response Rates

50% score reduction from baseline calculated without Item 4 (reduced sleep). (NCT03207438)
Timeframe: 1 - 6 weeks

Number of Participants With 50 Percent Or Greater Reduction in the MADRS Score Over Time for the Quetiapine XR 150-300mg and Placebo 2 Arms/Groups Stratified by Depression Type (Melancholic vs. Nonmelancholic)

MADRS is the Montgomery-Asberg Depression Rating Scale. Total scores on this scale range from 0-60. However the response variable is binary coded (0 = No Response, 1 = Response). (NCT03207438)
Timeframe: 1 - 6 weeks

Depression and Psychosis Remission Rate

This remission rate refers to a Hamilton Depression Rating Scale 17 (HAM-D-17) score of 7 or less and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed. (NCT00556140)
Timeframe: Baseline and 7 weeks

Depression and Psychosis Response Rate

This response rate refers to the percentage of patients who experienced a 50 percent or greater reduction in symptoms. Specifically, this refers to a 50 percent reduction in Hamilton Depression Rating Scale 17 (HAM-D-17) scores from baseline and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed. (NCT00556140)
Timeframe: Baseline and 7 weeks

Number of Participants With Recurrence of Major Depression

Recurrence of major depressive episodes as determined by SCID/DSM IV: two weeks of low mood and/or anhedonia, together with at least five of the following symptoms: suicidal ideation, low energy, sleep disturbance, appetite disturbance, psychic anxiety or somatic anxiety. In addition, a diagnosis of major depression requires evidence of distress or impairment. (NCT00177671)
Timeframe: 2 years

Percentage of Participants With Mild Cognitive Impairment Converting to Dementia.

Conversion to dementia was ascertained by the University of Pittsburgh Alzheimer Disease Research Center (ADRC), using data on neuropsychological performance and IADL functioning, as well as other relevant clinical data. Diagnoses were made according to National Alzheimer Coordinating Center criteria. (NCT00177671)
Timeframe: 2 year

Cognitive Instrumental Activities of Daily Living (IADL)

The PASS (a performance-based assessment of instrumental activities of daily living)generates a composite measure of 13 cognitive IADL items capturing performance on activities such as shopping, bill paying, medication management, and home safety. We report the percentage of subjects at each assessment point adjudged to have independent functioning. This was determined by a clinician rater observing subjects perform each task and rating them according to predetermined criteria on a 4 point scale, ranging from 0 (unable) to 3 (independent). (NCT00177671)
Timeframe: baseline, year 1 and year 2

Global Cognitive Performance

Cognitive performance was assessed with 17 well established and validated individual tests measuring multiple domains. We transformed raw scores for individual tests into Z-scores using the baseline distribution of a non-depressed, cognitively normal, older adult comparison group (N=36)of similar age, education, and medical health recruited concurrently with the depressed participants. These Z-scores were averaged within each neuropsychological area to produce domain scores and then averaged over all 17 tests to calculate a global cognition performance score. (NCT00177671)
Timeframe: Measured at baseline and Years 1 and 2 in maintenance

Interpersonal Reactivity Index (IRI)

This is a 14-item scale that measures empathy. The scoring scale ranges from 0, does not describe me well, to 4, describes me very well. The score values range from 0-56, where high values represent higher levels of empathy and lower values represent lower levels of empathy. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval. (NCT03878160)
Timeframe: 30-90-minute study session

Medical Outcomes Study - Specific Adherence Scale (MOS- SAS)

This is a 3-item scale that measures health behaviors. The scoring scale ranges from 1, none of the time, to 6, all of the time. The scoring values range from 3-18, where higher values represent good health behavior and lower values represent poor health behavior. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval. (NCT03878160)
Timeframe: 30-90-minute study session

Patient Health Questionnaire-9 (PHQ-9)

This is a 9-item scale that measures depression. The scoring scale ranges from 0, not at all, to 3, nearly every day. The scoring values range from 0-18, where high values represent higher levels of depression and lower values represent lower levels of depression. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval. (NCT03878160)
Timeframe: 30-90-minute study session

Patient Reported Outcome Measurement Information System-Physical Function (PROMIS-29-PF)

This is a 4-item scale that measures and evaluates physical health. The scoring scale ranges from 5, without any difficulty, to 1, unable to do. The scoring values range from 4-20, where high values represent good physical function and low values represent poor physical function. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval. (NCT03878160)
Timeframe: 30-90-minute study session

Perceived Stress Scale-4 (PSS-4)

This is a 4-item scale that measures stress. The scoring scale ranges from 0,never, to 4, very often. The scale values range from 0-16 with higher values representing higher levels of individual stress and lower values representing lower levels of individual stress. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval. (NCT03878160)
Timeframe: 30-90-minute study session

Positive Affect Negative Affect Schedule (PANAS)

This is a 20-question scale, composed of 2, 10-item scales that measure positive and negative affect. The scoring scale ranges from 1, very slightly or not at all, to 5, extremely. For this study, we will only use the positive affect sub-scale. The scale values for the positive affect sub-scale range from 10-50. Higher values on the positive affect scale represent higher levels of positive affect, whereas, lower values on the negative affect scale represent lower levels of positive affect. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval. (NCT03878160)
Timeframe: 30-90-minute study session

Rumination Response Scale (RRS)

This is a 22-item scale that measures rumination. The scoring scale ranges from 1,almost never, to 4, almost always. The score values range from 22 to 88, where higher values represent higher levels of rumination and lower values represent lower levels of rumination. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval. (NCT03878160)
Timeframe: 30-90-minute study session

Self-Other Four Immeasurables (SOFI) Scale

This is a 16-item scale that measures views toward the self and others. This measure consists of four sub-scales with four items each. The sub-scales measure positive views toward self, negative views toward self, positive views toward others, and negative views toward other. Only the positive-other sub-scale was used. The scoring scale ranges from 1, very slightly or not at all to 5, extremely, with sub-scale scores ranging from 4-20. Higher values represent higher levels of positive feelings toward others, and lower values represent lower levels of positive feelings toward others. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval. (NCT03878160)
Timeframe: 30-90-minute study session

Short-Form-12 (SF-12)

This is a 12-item scale that measures health-related quality of life. The scoring scale from item 1 ranges from 1, excellent to 5, poor. The scoring scale for items 2 and 3 ranges from 1, limit you a lot to 3, not limit you at all. The scoring scale for questions 5-7 is represented by 1, yes or 2, no. The scoring scale for item 8 ranges from 1, not at all, to 5, extremely. The scoring scale for items 9-11 ranges from 1, all of the time, to 6, none of the time. The scoring scale for item 12 ranges from 1, all of the time to 5, none of the time. The total scoring values range from 12- 47, where higher values represent a higher quality of life and lower values represent a lower quality of life. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval. (NCT03878160)
Timeframe: 30-90-minute study session

Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15)

This is a 15-item measure that measures mindfulness. This scale has five sub-scales: observing, describing, acting with awareness, accepting without judgment, and non-reactivity. The scoring scale ranges from 1, never or very rarely true to 5, very often or always true. Scale values range from 3-15 for each sub-scale, with higher values representing greater levels of individual mindfulness and lower values representing lowers levels of individual mindfulness. There is no total score for the measure; only individual sub-scales are reported. Data collection for this measurement is cross-sectional, and is collected during one, 30-90 minute time interval. (NCT03878160)
Timeframe: 30-90-minute study session

Number of Participants Reporting Changes After ACS

This portion of the individual interview will focus on exploring changes experienced after an ACS, such as psychosocial changes and health behavior changes. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. The identified themes are reported, and the criteria used to determine the outcome measure is the number of participants who endorsed each theme. (NCT03878160)
Timeframe: one 30-90-minute session

Number of Participants With Perspectives on Blood Spot Data Collection

This portion of the individual interview will focus on exploring ACS patients who had perspectives on participating in a remote dried blood spot procedure. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. The criteria used to determine the outcome measure is the number of participants upon interview who reported any type of perspective on participating in a remote dried blood spot procedure (self-collection of dried blood spot via finger-prick). Please note that the number of perspectives reported for each theme can exceed the number of people per group because each participant reported multiple perspectives (e.g., both pros and cons of videoconferencing). (NCT03878160)
Timeframe: one 30-90-minute session

Number of Participants With Perspectives on MBCT

This portion of the individual interview will focus on exploring patients' perspectives toward an MBCT treatment approach. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. The identified themes are reported, and the criteria used to determine the outcome measure is the number of participants who endorsed each theme. (NCT03878160)
Timeframe: one 30-90-minute session

Number of Participants With Perspectives on Videoconferencing

This portion of the individual interview will focus on exploring perspectives regarding videoconferencing intervention delivery. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. Identified themes are reported, and the criteria used to determine the outcome measure is the number of participants upon interview who reported expressed each theme. (NCT03878160)
Timeframe: one 30-90-minute session

Change in Beck Depression Inventory II (BDI-II)

Beck Depression Inventory II ranges from 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Brief Psychiatric Rating Scale (BPRS)

Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Geriatric Depression Rating Scale (GDS)

Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Hamilton Depression Rating Scale (HAM-D) Scores

Change in Hamilton Rating Scale for Depression over 12 weeks. Hamilton Depression Rating Scale ranges from 0-50. Higher scores represent more significant depression. Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Montgomery-Asberg Depression Rating Scale (MADRS)

Montgomery-Asberg Depression Rating Scale ranges from 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being

Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall

Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Pittsburgh Sleep Quality Index (PSQI)

Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Short Form 36 Health Survey - Mental Component Summary

Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Short Form 36 Health Survey - Mental Health

Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Short Form 36 Health Survey - Role-Emotional

Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Short Form 36 Health Survey - Vitality

Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Snaith Clinical Anxiety Scale (CAS)

Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Unified Parkinson's Disease Rating Scale (UPDRS)

Unified Parkinson's Disease Rating Scale. Higher score indicates more severe Parkinson's disease symptoms. Total maximum = 176. Mental maximum = 52, Activities of Daily Living maximum = 52, Motor maximum = 72. Minimum = 0. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar

Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor

Unified Parkinson's Disease Rating Scale - Motor has a maximum score of 72, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor

Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms. (NCT00086190)
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Change From Pre-intervention to Intervention Endpoint in Behavioral Inhibition Subscale Score

The Behavioral Inhibition/Behavioral Activation questionnaire will be used to assess behavioural inhibition (BI). The minimum score on the BI subscale is 7, maximum 28. Greater scores indicate greater BI. Change is defined as the average change in BI from pre-intervention to intervention. (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Change From Pre-intervention to Intervention Endpoint in Binge Eating Sum Score

"Binge eating will be measured using the 8-item binge eating subscale of the Eating Pathology Symptoms Inventory (EPSI), which measures features of binge eating (e.g., consumption of large quantities of food, mindless eating) on a 5-point Likert scale from never to very often. The EPSI scale is designed to assess behavior over the past 28 days. Items are summed for a scale score ranging from 0-32. Higher scores indicate more frequent experiences with binge eating behavior. Change is defined as the average change in the binge eating scale score from pre-intervention to intervention." (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Change From Pre-intervention to Intervention Endpoint in Delay Discounting Parameter k

The Monetary Choice Questionnaire will be used to measure delay discounting. Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical monetary outcomes. k is a hyperbolic function with larger k values indicating more valuation of a larger delayed reward and smaller values indicating preference for more immediate, smaller rewards (more impulsivity). k can range from 0 to .25 with scores of .25 indicating complete valuation of the immediate reward and 0 indicating complete valuation of the larger, delayed reward. Change is defined as the average change in k from pre-intervention to intervention. (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Change From Pre-intervention to Intervention Endpoint in Nucleus Accumbens Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)

"Nucleus Accumbens (NAcc) reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment." (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Change From Pre-intervention to Intervention Endpoint in Prefrontal Cortex Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)

"Prefrontal cortex reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment." (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Change From Pre-intervention to Intervention Endpoint in Self-reported Reward Sensitivity Subscale Score

Sensitivity to Punishment/Sensitivity to Reward Questionnaire will be used to measure reward sensitivity. The reward sensitivity subscale will be used, which is rated on a true/false scale with scores ranging 0-24. Higher scores indicate more sensitivity to reward. Change is defined as the average change in reward sensitivity from pre-intervention to intervention. (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Change From Pre-intervention to Intervention Endpoint in Weekly Average Binge-eating Frequency

Binge eating frequency is based on a weekly diary of self-reported binge eating frequency. Participants were asked how many times during the past week they had a binge eating episode. Scores can range from 0 to infinity as frequency is self-reported as the number of binge eating episodes in the previous week. Higher scores indicate more episodes of binge eating. Change is defined as the average change in self-reported binge eating frequency from pre-intervention to intervention. (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Change From Pre-intervention to Intervention Endpoint in Dorsal Striatum Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)

"Dorsal striatum reactivity (defined as caudate signal intensity and putamen signal intensity) to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment." (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score

Change from baseline to week 8 in Children's Depression Rating Scale total score. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113. (NCT00107120)
Timeframe: Baseline to end of week 8

Children's Global Assessment Scale

Change from baseline to week 8 in CGAS score which rates the patient's general level of functioning for the past 14 days on a scale of 1 (most impaired) to 100 (healthiest). (NCT00107120)
Timeframe: At baseline and end of week 8

Clinical Global Impressions - Improvement

Clinical Global Impressions - Improvement score at the end of week 8. The scale rates improvement or worsening of patient mental health relative to baseline on a scale from 1 (very much improved) to 7 (very much worse). (NCT00107120)
Timeframe: CGI-I score at the end of Week 8

Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks

"Change in RMDQ from randomization to 14 weeks. The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability).~Improvement of 30% is clinically meaningful" (NCT01124188)
Timeframe: Baseline and 14 weeks

Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks

"Change in SPPB scores from randomization to 14 weeks for both arms.~The Short Physical Performance Battery (SPPB) assesses physical performance. The SPPB scores range from 0-12 and assess lower extremity strength, balance, and gait speed, three meaningful predictors of morbidity and mortality in late-life. Lower scores on the SPPB indicates greater limitations. Improvement of 0.5 points indicate clinically meaningful improvement in physical performance" (NCT01124188)
Timeframe: Baseline and 14 weeks

Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization

The PHQ-9 depression questionnaire scores range from 0 to 27. The higher the score the more severe the depression. A PHQ-9 score less than or equal to 5 represents absence of depression. The Numeric Rating scale is a self report pain scale ranging from 0 to 20. Higher numbers indicate more pain. Response in this study was defined as two consecutive PHQ-9 scores < or = to 5 AND Numeric Rating Scale for pain (NRS) > or = 30% reduction from study entry. (NCT01124188)
Timeframe: 14 weeks

A Change of Outcome Measure:Picture Naming Test(PNT)

This test mainly assesses the ability of picture name of participants.we used a program for displaying named pictures on a computer screen (60 photos in total, of which 20 were Chinese celebrity faces). Each image was displayed in 3 seconds, and 1 point was correctly named for an image.The faces of celebrities were selected from the picture database of Chinese celebrities in the State Key Laboratory of Cognitive Neuroscience and Learning at Beijing Normal University.Score fluctuation is 0-60 points, the higher the score, the better the ability of picture name. (NCT03588572)
Timeframe: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.

A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT)

This test mainly assesses spontaneous speech fluency of participants.It requires participants name as many food names as possible within one minute, and each correct one to give one point.The higher the score, the better the language function. (NCT03588572)
Timeframe: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.

A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB)

The main outcome measure for this scale is Aphasia Quotient(AQ) which mainly tests the ability of spontaneous speech, oral comprehension, repetition, and naming, and reflects the severity of aphasia, and can be used as a reliable indicator to evaluate the improvement and deterioration of aphasia. Score fluctuation is 0-100 points, the normal value is 98.4-100 points, AQ<93.8 can be judged as language dysfunction. (NCT03588572)
Timeframe: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.

Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA)

The Hamilton Anxiety Rating Scale (HAMA) is a widely used and well-validated tool for measuring the severity of a patient's anxiety. The HAMA is composed of 14 items and takes 15-20 minutes to complete the interview and score the results. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe.HAMA Scoring Instructions:0-8=Normal, 8-13= Possible Anxiety, 14-17 = Mild Anxiety, 18-24 = Moderate Anxiety, 25-30 = Severe Anxiety(i.e.,the higher the score, the greater the likelihood of anxiety). (NCT03588572)
Timeframe: We must determine that the participant is not in anxiety at each follow-up. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.

Follow-up Measurement: Hamilton Depression Rating Scale (HAMD)

The Hamilton Depression Rating Scale (HAMD) has proven useful for many years as a way of determining a patient's level of depression before, during, and after treatment. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored from 0-2. HAMD Scoring Instructions:0-7=Normal, 8-13 = Mild Depression, 14-18 = Moderate Depression, 19-22 = Severe Depression, ≥ 23 = Very Severe Depression(i.e.,Minimum 0 points and maximum 50 points, the higher the score, the greater the likelihood of depression). (NCT03588572)
Timeframe: We must determine that the participant is not in depression at each follow-up. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.

Follow-up Measurement: Mini-Mental State Examination (MMSE)

The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Administration of the test takes between 5 and 10 minutes. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating lists of words, arithmetic such as the serial sevens, language use and comprehension, and basic motor skills. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.The raw score may also need to be corrected for educational attainment and age. (NCT03588572)
Timeframe: We must determine that the participant is not in moderate or more cognitive impairment at each follow-up. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.

Number of Participants Who Developed a Major Depressive Episode According to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Criteria During the First 12 Weeks of Antiviral Treatment.

"At least five of the symptoms have been present during the same 1-week period: depressed mood, loss of interest or pleasure, weight or appetite changes, insomnia, agitation or retardation, fatigue, feelings of worthlessness or guilt, diminished ability to think or concentrate, recurrent thoughts of death.~At least one of the symptoms is either depressed mood or loss of interest. Diagnoses were made by a trained psychiatrist who applied the mood disorders module from the Structured Clinical Interview for DSM-IV Axis I Disorders, non-patient edition (SCID-I/NP) at each study evaluation." (NCT00166296)
Timeframe: First three months of interferon treatment.

Number of Participants With Sustained Hepatitis C Viral Response (Negativization of Serum Hepatitis C Virus Ribonucleic Acid).

"Number of participants with negativization of serum hepatitis C Virus Ribonucleic Acid (HCV RNA) 6 months after concluding antiviral therapy (sustained viral response).~Negativization was defined as the absence of detectable levels of serum HCV RNA using a polymerase chain reaction." (NCT00166296)
Timeframe: Six months after the end of interferon treatment

Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale.

"The Hospital Anxiety and Depression Scale (HADS) is 14-item scale, patient-administered, that allows two independent scores of depression and anxiety. It has been specially designed to apply in patients with comorbid medical conditions as it excludes somatic or vegetative symptoms from the depression subscale.~We present data of de depression subscale. The seven-item Depression subscale yields a score of 0-21, with higher scores meaning higher levels of depressive symptoms." (NCT00166296)
Timeframe: 12 weeks after interferon treatment onset

Total Score in the Montgomery-Asberg Depression Rating Scale

"The MADRS is a 10-item scale, clinician-administered, which is sensitive to symptom change during antidepressant treatment. It has been frequently used to measure depressive symptoms during interferon-alpha therapy and exhibits improved internal consistency in patients with co-morbid medical conditions compared with other clinician-administered questionnaires.~Items are rated on a scale of 0-6. Scores range from 0 to 60, higher scores meaning higher levels of depression." (NCT00166296)
Timeframe: 12 weeks after interferon treatment onset

Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.

17-item Hamilton Rating Scale for Depression (HRSD) is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in HRSD was assessed at baseline and after six weeks of treatment. For this study the change was calculated as the later time point (total score in 17- HRSD at 6 weeks) minus the earlier time point (total score at baseline). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression). (NCT01635218)
Timeframe: Baseline and 6 weeks

Change From Baseline in Beck Depression Inventory at 6 Weeks.

Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory that assess severity of depression. A total score range was assessed at baseline and after six weeks of treatment. A score 0 (without depression) up to 63 (most severe depression). For this study the change was calculated as the later time point (total score in BDI at 6 weeks) minus the earlier time point (total score in BDI at baseline). A score 0 - 8 is considered normal, 9 - 18 (mild to moderate depression), 19 - 28 (moderate to severe depression), > 29 (severe depression). (NCT01635218)
Timeframe: Baseline and 6 weeks

Change From Baseline in Greene´s Scale at 6 Weeks.

Greene Climacteric Scale (GS) is intended to be a standard measure of core climacteric symptoms. For this study a total range was assessed at baseline and after six weeks of treatment. A total score 0 (without climacteric symptoms) up to 63 (most severe climacteric symptoms). The change was calculated as the later time point (total score in GS at 6 weeks) minus the earlier time point (total score at baseline).The scale measures four separate sub-scales (anxiety, depression, somatic symptoms and sexual function). The score of the four sub-scales was summed. A total score of 0 -10 is considered without symptoms, 11 - 29 (mild symptoms), 30 - 49 (moderate symptoms) and > 50 (severe symptoms). (NCT01635218)
Timeframe: Baseline and 6 weeks

Remission Rates at 6 Weeks

17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression). Remission rate definition: 17-item Hamilton Rating Scale for Depression score < 7 points after 6 weeks of treatment. (NCT01635218)
Timeframe: 6 weeks

Responder Rates at 6 Weeks.

17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression). Responder rate definition: a decrease of 50% or more from baseline score using 17-item Hamilton Rating Scale for Depression after six weeks treatment. (NCT01635218)
Timeframe: 6 weeks

Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week

CGI-S is a global rating scale that measures the severity of a patient's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with patients who have the same diagnosis (1= normal; 7= extremely ill). (NCT00406640)
Timeframe: Baseline and 8 weeks

Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8

EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score. (NCT00406640)
Timeframe: Baseline and week 8

Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score

The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A total score minus baseline adjusted mean total score. (NCT00406640)
Timeframe: Baseline and Week 8

Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8

HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4) with 0=none/absent and 4=most severe,for a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17. (NCT00406640)
Timeframe: Baseline and 8 weeks

Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks

CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse). (NCT00406640)
Timeframe: 8 weeks

Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase

Patients who did not achieve a response to treatment at the end of the 8-week acute double blind phase entered into an open label (OL) treatment phase with DVS SR for 6 months and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 6 months

Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase

Patients who didn't achieve a response to treatment at the end of the 8-week acute double blind phase entered into an OL treatment phase with DVS SR for 6 months and were evaluated to see if a response was achieved. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 6 months

Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase)

Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 8 weeks

Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase)

A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 8 weeks

Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase)

Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 6 months

Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase

Patients achieving a response to treatment (Responders) at the end of the 8-week acute double blind (DB) phase continued into a 6-month DB phase. Responders without remission at 8 weeks were assessed for remission status during the 6-month continuation. Remission defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale assessing 17 items characteristically associated with major depression. Individual items scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 6 months

Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase)

Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if the response was maintained. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 6 months

Discontinuation-Emergent Signs and Symptoms (DESS) Total Score

DESS is a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms. The DESS score was assessed by status of taper. (NCT00406640)
Timeframe: 6 months

Change in Attention/Executive Function Cognitive Domain Scores

"Neuropsychological battery of tests which included the following domains:~Attention/Executive Function (Trail Making Test A and B, Stroop Interference [Golden version])~Raw scores were transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants. Thus the sample mean (across both arms) is zero for each test score. These z-scores were then averaged within each neuropsychological domain to produce composite scores. Higher scores are indicative of better performance." (NCT02460666)
Timeframe: Measured at baseline and 3 months

Change in Delayed Recall Cognitive Domain Scores

"Neuropsychological battery of tests which included the following domains:~Delayed Recall (CVLT-II [Long-Delay Free Recall], Rey-Osterrieth Complex Figure Test [30-minute Delayed Recall])~Raw scores were transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants. Thus the sample mean (across both arms) is zero for each test score. These z-scores were then averaged within each neuropsychological domain to produce composite scores. Higher scores are indicative of better performance." (NCT02460666)
Timeframe: Measured at baseline and 3 months

Change in Hamilton Depression Rating Scale (HDRS) Scores

Clinician administered scale measures severity of depressive symptoms. This measure includes 24 items. Response options vary item to item and include the following ranges: [0-2], [0-3], and [0-4]. A score of 0 suggests absence of symptoms and/or difficulties and higher scores represent more severe difficulties. Possible overall score range [0-74], higher scores representing more severe difficulties. (NCT02460666)
Timeframe: Measured at baseline and 3 months

Change in Language Cognitive Domain Scores

"Neuropsychological battery of tests which included the following domains:~Language (Controlled Oral Word Association test [FAS], Animal Fluency, and Boston Naming Test)~Raw scores were transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants. Thus the sample mean (across both arms) is zero for each test score. These z-scores were then averaged within each neuropsychological domain to produce composite scores. Higher scores are indicative of better performance." (NCT02460666)
Timeframe: Measured at baseline and 3 months

Number of Participants With Adverse Events

Clinical Global Impression - Global Improvement (CGI-I)

The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00807248)
Timeframe: at Week 8

Clinical Global Impression - Severity of Illness (CGI-S)

The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). (NCT00807248)
Timeframe: Mean change from baseline to Week 8

Hospital Anxiety and Depression Scale (HADS)

The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21, and are analysed separately. The total HADS score ranges from 0 to 42. (NCT00807248)
Timeframe: Mean change from baseline to Week 8

Insomnia Severity Index (ISI)

The ISI is both a brief screening measure of insomnia and an outcomes measure for use in treatment research. It is a brief self-report instrument measuring the patient's perception of his or her insomnia, and it comprises 7 items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28. 0 = no symptoms and 28 = severe symptoms. (NCT00807248)
Timeframe: Mean change from baseline to Week 8

MADRS

The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60. (NCT00807248)
Timeframe: From baseline to Week 8

Montgomery and Åsberg Depression Rating Scale (MADRS)

SDS: Social Subscale

The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. (NCT00807248)
Timeframe: Mean change from baseline to Week 8

SDS: Work Subscale

Sheehan Disability Scale (SDS): Family Subscale

Anxiety Sensitivity Index 3 (ASI-3) Score Change

The ASI-3 is a self-report questionnaire assesses anxiety sensitivity, or the fear of arousal-related sensations. Specifically these derive from the belief that anxiety- or arousal-based sensations have negative consequences. This self-report scale includes 18 items with scores ranging from 0 to 72, where higher scores indicate greater anxiety sensitivity. (NCT04433767)
Timeframe: Assessed at baseline, Week 6, and Week 12; only baseline to week 12 reported.

Apathy Evaluation Scale (AES) Score Change

Secondary Mood Outcomes: Change in apathy as measured by the self-report AES, a questionnaire with a range of 0-54, where higher scores indicate greater apathy. Measured at baseline, week 6, and week 12. (NCT04433767)
Timeframe: Assessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.

Attentional Control Scale Score Change

Secondary Attention outcome: The Attentional Control Scale (ACS) is a self-report questionnaire that has been developed to measure individual differences in attentional control. The scale ranges from 0-80, with higher scores indicative of better attentional control, and a positive change indicated improved attentional control. Assessed at baseline, week 6, and week 12. (NCT04433767)
Timeframe: Assessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.

Choice Reaction Time (CRT) Performance Change

Secondary cognitive outcome, a neuropsychological test measure of attention. We will examine change in total reaction time for the CRT. Lower reaction time indicates better performance. (NCT04433767)
Timeframe: Baseline to week 12

Dimensional Anhedonia Rating Scale (DARS) Score Change

Secondary mood outcome: Change in anhedonia measured by DARS, a self-report questionnaire that ranges from 0-68, where lower scores indicate greater anhedonia. Conversely, higher scores indicate greater ability to enjoy activities. Assessed at baseline, week 6, and week 12. (NCT04433767)
Timeframe: Assessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.

Fatigue Severity Scale Score Change

Secondary outcome examining fatigue using a self-report questionnaire that ranges from 0- 56, where higher scores indicate more severe fatigue. Questionnaire administered at baseline, week 6, and week 12. (NCT04433767)
Timeframe: Assessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.

General Anxiety Disorder-7 Item Scale (GAD7) Score Change

Secondary Mood outcome: self-reported questionnaire to measure the severity of anxiety. Questionnaire ranges 0-24, higher scores indicates greater anxiety state. Assessed at baseline, week 6, and week 12. (NCT04433767)
Timeframe: Assessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.

Insomnia Severity Index Score Change

Secondary Mood Outcomes: Change in the severity of insomnia measures as self-report , a questionnaire with the range of 0-21 ,where higher scores indicate increase in severity. Assessed at baseline, week 6, and week 12. (NCT04433767)
Timeframe: Assessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.

MADRS (Montgomery Asberg Depression Rating Scale) Score Change

Primary mood outcome measured by the total score of the clinician rated MADRS. MADRS will be measured every 3 weeks (baseline, week 3, week 6, week 9, and week 12). MADRS total score range is 0-60, where higher scores indicate greater depression severity. Change is calculated as the difference between week 12 and baseline. (NCT04433767)
Timeframe: Baseline to week 12

NIH EXAMINER Test Battery Cognitive Control Factor Change

"Secondary Cognitive Outcome: This neuropsychological test battery assesses a range of executive functions. Its Cognitive Control Factor Score is a single score that represents cognitive control function performance across multiple individual neuropsychological tests, including the Flanker task, a continuous performance test, anti-saccades test, and a set shifting test. Higher scores indicate better executive function, with a range of -3.0 to 3.0. This is calculated independently of the executive composite or other factor scores.~Secondary Cognitive Outcome: This neuropsychological test battery assesses a range of executive functions. We will examine its Executive Composite Score and the three factor scores (Cognitive Control, Fluency, and Working Memory). Higher scores indicate better performance." (NCT04433767)
Timeframe: Baseline to week 12

NIH EXAMINER Test Battery Executive Composite Score Change

Secondary Cognitive Outcome: This neuropsychological test battery assesses a range of executive functions. Its Executive Composite Score is a single score that represents overall executive function performance across multiple individual neuropsychological tests, including the Dot counting test, the N-back test, the Flanker task, a continuous performance test, anti-saccades test, a set shifting test, and fluency tests. Higher scores indicate better executive function, with a range of -3.0 to 3.0. This composite is generated separately from EXAMINER sub scales. (NCT04433767)
Timeframe: Baseline to week 12

NIH EXAMINER Test Battery Fluency Factor Change

Secondary Cognitive Outcome: This neuropsychological test battery assesses a range of executive functions. Its Fluency Factor Score is a single score that represents verbal fluency performance across phonemic and categorical fluency assessments. Higher scores indicate better executive function, with a range of -3.0 to 3.0. This is calculated independently of the executive composite or other factor scores. (NCT04433767)
Timeframe: Baseline to week 12

NIH EXAMINER Test Battery Working Memory Factor Change

"Secondary Cognitive Outcome: The EXAMINER test battery Working Memory Factor Score is a single score that represents working memory performance across multiple individual neuropsychological tests, including the Dot counting and n-back tests. Higher scores indicate better executive function, with a range of -3.0 to 3.0. This is calculated independently of the executive composite or other factor scores.~Secondary Cognitive Outcome: This neuropsychological test battery assesses a range of executive functions. We will examine its Executive Composite Score and the three factor scores (Cognitive Control, Fluency, and Working Memory). Higher scores indicate better performance." (NCT04433767)
Timeframe: Baseline to week 12

Patient Reported Outcome Measurement Information System (PROMIS) Applied Cognition Abilities Short Form Score Change

Secondary Cognitive outcome:PROMIS (Patient reported outcome measurement information system) is a self-reported questionnaire to measure mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions, ranges from 0-32 , where higher scores indicate improvement. Assessed at baseline, week 6, and week 12. (NCT04433767)
Timeframe: Assessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.

Penn State Worry Questionnaire (PSWQ) Score Change

Secondary mood outcome: Change in anxiety and worry measured by PSWQ, a self-report questionnaire with a range of 16-80, where higher scores indicate greater anxiety and worry. Assessed at baseline, week 6, and week 12. (NCT04433767)
Timeframe: Assessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.

Ruminative Response Scale Score Change

Secondary mood outcome: Change in rumination measured by the Ruminative Response Scale total score measured at Screening visit, week 6 and week 12. This is a self-report scale with a range of 0-66, where higher scores indicate higher levels of rumination (NCT04433767)
Timeframe: Assessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.

Selective Reminding Task Performance Change

Secondary cognitive outcome, Selective Reminding Task as a test of immediate and delayed verbal memory. This is an 8-trial, 16-word test where the interviewer reads unrelated words to the participant who must recall them. Any missed items are then repeated before the next attempt. Scores range from 0-60, with higher scores indicating better performance. Change in the recall over 12 weeks reflect the verbal memory function, with higher scores indicating better verbal memory performance. (NCT04433767)
Timeframe: Baseline to week12

Trait Adjectives Task, Change in Negative Items Rejected

Participants view a series of randomized, rapidly presented positive and negative characteristics and quickly indicate whether each adjective does or does not apply to them. Positive and negative adjectives are balanced. Measures include number of adjectives endorsed or rejected, and RT for those trials. These are assessed separately for positive items endorsed and negative items rejected. Task performance assesses self-referential negativity bias and is associated with antidepressant response. Task completed at baseline, week 6, and week 12. Scores for negative items rejected range from 0 to 24, with higher scores indicating that more negative items are rejected, thus a reduction in negativity bias. (NCT04433767)
Timeframe: Assessed at baseline, week 6, and week 12, change from baseline to week 12 reported

Trait Adjectives Task, Change in Positive Items Endorsed

Participants view a series of randomized, rapidly presented positive and negative characteristics and quickly indicate whether each adjective does or does not apply to them. Positive and negative adjectives are balanced. Measures include number of adjectives endorsed or rejected, and RT for those trials. These are assessed separately for positive items endorsed and negative items rejected. Task performance assesses self-referential negativity bias and is associated with antidepressant response. Task completed at baseline, week 6, and week 12. Scores for positive items endorsed range from 0 to 24, with higher scores indicating more positive items being endorsed, so a reduction in negativity bias. (NCT04433767)
Timeframe: Assessed at baseline, week 6, and week 12, change from baseline to week 12 reported

Trait Adjectives Task, Change in Reaction Time to Endorse Positive Items

Participants view a series of randomized, rapidly presented positive and negative characteristics and quickly indicate whether each adjective does or does not apply to them. Positive and negative adjectives are balanced. Measures include number of adjectives endorsed or rejected, and RT for those trials. These are assessed separately for positive items endorsed and negative items rejected. Task performance assesses self-referential negativity bias and is associated with antidepressant response. Task completed at baseline, week 6, and week 12. A score reduction represents increased reaction time. (NCT04433767)
Timeframe: Assessed at baseline, week 6, and week 12, change from baseline to week 12 reported

Trait Adjectives Task, Change in Reaction Time to Reject Negative Items

Participants view a series of randomized, rapidly presented positive and negative characteristics and quickly indicate whether each adjective does or does not apply to them. Positive and negative adjectives are balanced. Measures include number of adjectives endorsed or rejected, and RT for those trials. These are assessed separately for positive items endorsed and negative items rejected. Task performance assesses self-referential negativity bias and is associated with antidepressant response. Task completed at baseline, week 6, and week 12. A reduction in score indicates a faster reaction time. (NCT04433767)
Timeframe: Assessed at baseline, week 6, and week 12, change from baseline to week 12 reported

Number of Participants Exhibiting Reduction in Frontal Activation During the Emotional Stroop Task During Functional Magnetic Resonance Imaging (MRI)

"MRI scans will be performed at baseline, week 6 and week 12. MRI will measure cognitive control network function, operationalized as a reduction in the emotional Stroop task functional MRI response in the middle and superior frontal gyri. The Stroop functional MRI response is calculated as the activation difference between incongruent and congruent conditions of the emotional Stroop task.~The primary outcome is change in activation difference across the three time points. This is examined as a categorical variable, operationalized as those subjects who exhibit a middle / superior frontal gyri z-score reduction in activation over time of 0.5 or greater, relative to baseline at either week 6 and/or week 12. The a priori threshold being tested was that 60% or more of participants would exhibit a z-score reduction of 0.5 or greater, examined separately in the left and right middle and superior frontal gyri." (NCT04433767)
Timeframe: Baseline, week 6, week 12

Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria

(NCT00136318)
Timeframe: major depression during 24 or 48 weeks of antiviral therapy

Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher

"Clinically relevant depression (MADRS score of 13 or higher) during antiviral treatment presented as percentage of participants with MADRS scores > 13 (entire time period: from starting study medication until end of antiviral treatment = 48 weeks in patients with genotype 1 or 4 and 24 weeks for patients with genotype 2 or 3)" (NCT00136318)
Timeframe: 50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3

Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher)

Number of patients who did not develop at any time of antiviral treatment (up to 48 weeks) a MADRS score of 13 or more as a sign of clinically relevant depression (NCT00136318)
Timeframe: Patients free of depression during 24 or 48 weeks of antiviral therapy

Severe Depression Defined as a MADRS Score of 25 or Higher

(NCT00136318)
Timeframe: severe depression during 24 or 48 weeks of antiviral therapy

Sustained Virologic Response

(negative Polymerase Chain Reaction (PCR) 6 months after the end of antiviral treatment) (NCT00136318)
Timeframe: assessed 24 weeks after end of antiviral treatment

Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17)

Scores on the HAM-D-17 typically fall into the following ranges: a) Not depressed: 0-7; b) Mildly depressed: 7-15; c) Moderately depressed: 15-25; d) Severely depressed: over 25. A decrease of 50% or more in the Hamilton-D score is considered to be a positive response to treatment, while a score of 7 or less is considered typical of remission. We measure the change in total score from Baseline to Week 12 or week of early termination visit. (NCT00452543)
Timeframe: From baseline visit to Week 12 (or early discontinuation visit)

Total Drinking Days on the Alcohol Timeline Followback (TLFB)

The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period ranging from 7 days to 24 months prior to the interview, and thus the measure provides quantitative estimates of alcohol use. One standard drink on the TLFB was defined as: 12 oz beer (5% alcohol by volume), 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). We measure the change from Baseline to Week 12 or week of early termination visit. (NCT00452543)
Timeframe: From Baseline visit to Week 12 (or early discontinuation visit)

Total Drinks Consumed Per Drinking Day on the TLFB

Total Drinks Consumed per Drinking Day on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit. (NCT00452543)
Timeframe: From Baseline visit to Week 12 (or early discontinuation visit)

Total Drinks Consumed Per Week on the TLFB

Total Drinks Consumed per Week on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit. (NCT00452543)
Timeframe: From Baseline visit to Week 12 (or early discontinuation visit)

Change From Baseline in the Dysphoric Apathy/Retardation Sub-factor (MDAR) of Montgomery-Asberg Depression Rating Scale (MADRS) at 4 Weeks.

The Montgomery-Asberg Depression Rating Scale Dysphoric Apathy Retardation subfactor (MDAR) is a 5-item subscale of the clinician-administered 10-item Montgomery-Asberg Depression Rating Scale (MADRS). MDAR score can range from 0-30 with a higher score representing a greater severity of depressive symptoms. (NCT01148979)
Timeframe: Baseline to 4 weeks of treatment

MADRS (Montgomery-Asberg Depression Rating Scale) Readmission Rate

MADRS readmission rate is defined as MADRS score<11. The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression. (NCT00683852)
Timeframe: 12 weeks

MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate

The primary outcome was the difference in response rate (decrease in MADRS total score of at least 50%) using the SPCD (sequential parallel comparison design). The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression. (NCT00683852)
Timeframe: 12 weeks

Mean Change in Clinical Global Impression of Severity (CGI-S)

The CGI-S scale was administered by clinicians based on assessment of the patient's clinical status. They measured, based on history and scores on other instruments, depressive severity. It consists of one question scored on a seven-point scale (1 = normal to 7 = among the most severe), so a higher total score indicates greater depressive severity. The minimum score is 1, and the maximum score is 7. (NCT00683852)
Timeframe: Baseline and 12 weeks

Mean Change in MADRS (Montgomery-Asberg Depression Rating Scale) Score From Baseline to the End of Follow-up

The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression. (NCT00683852)
Timeframe: Baseline and 12 Weeks

Number of Patients With Treatment Emergent AEs in Two Treatment Groups - People Exclusively on Drug or Placebo Throughout the Study

Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. This analysis compared AEs between the arms that received exclusively drug throughout the study or placebo throughout the study. (NCT00683852)
Timeframe: 12 Weeks

Number of Patients With Treatment Emergent AEs in Two Treatment Groups - Placebo Non-Responders

Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. This analysis focused on placebo non-responders in phase 1 and presented them by their treatment assignment in phase 2. (NCT00683852)
Timeframe: 12 Weeks

Treatment Emergent AEs in Two Treatment Groups - Safety Sample

Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. In this analysis, AEs were summarized according to person-phase of occurrence. Each AE was attributed to the person and then to phase 1 or phase 2, depending on the initial date of onset. (NCT00683852)
Timeframe: 12 Weeks

Mean Change in Symptom Questionnaire (SQ)

The SQ, a 92-item (yes/no) self-rating questionnaire, includes 4 distress and 4 well-being subscales. There are 68 items for the distress subscales and 24 items for the well-being subscales. Each item has either a Yes/No or True/False answer. For the distress symptom score, add together the following items and score 1 when the answer is Yes/True: 1, 2, 3, 5, 6, 8, 11, 12, 15, 18, 20, 22, 24, 25, 26, 27, 28, 29, 30, 32, 33, 34, 36, 37, 39, 41, 42, 44, 45, 47, 48, 49, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 72, 73, 74, 75, 76, 77, 79, 80, 81, 82, 84, 85, 86, 87, 88, 90, 91, 92. Minimum score is 0 and maximum score is 68. A higher score indicates more distress symptoms. For the well-being subscale score, add together the following items and score 1 when the answer is No/False: 4, 7, 9, 10, 13, 14, 16, 17, 19, 21, 23, 29, 31, 35, 38, 40, 43, 46, 50, 51, 71, 78, 83, 89. Minimum score is 0 and maximum score is 24. A higher score indicates more well-being. (NCT00683852)
Timeframe: Baseline and 12 weeks

Remission of Depression (%)

"Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID.~The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms.~The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains)." (NCT00149825)
Timeframe: After 12 weeks or at the last available time point

Remission of Insomnia

Percent of participants in insomnia remission. Remission of insomnia was defined by an Insomnia Severity Index (ISI)score < 8. The ISI (Insomnia Severity index) scores range between 0 and 38. A score < 8 indicates absence of insomnia. (NCT00149825)
Timeframe: After 12 weeks or at the last available time point

Intervention	score on a scale (Mean)
	Baseline Depression Severity	Week 12 Depression Severity
Control	1.24	1.52
Escitalopram	23.48	12.44

Intervention	units on a scale (Mean)
Escitalopram + Bupropion SR	0.6
Venlafaxine XR + Mirtazapine	0.4
Escitalopram + Placebo	0.4

Intervention	percentage of participants (Number)
Escitalopram + Bupropion SR	46.6
Venlafaxine XR + Mirtazapine	41.8
Escitalopram + Placebo	46.0

Intervention	Log10 milliseconds (Least Squares Mean)
Vortioxetine (Lu AA21004)	-0.050
Duloxetine	-0.039
Placebo	-0.033

Intervention	Log10 milliseconds (Least Squares Mean)
Vortioxetine (Lu AA21004)	-0.037
Duloxetine	-0.030
Placebo	-0.024

Intervention	Log 10 milliseconds (Least Squares Mean)
Vortioxetine (Lu AA21004)	-0.028
Duloxetine	-0.024
Placebo	-0.022

Intervention	score on a scale (Least Squares Mean)
	Change from Baseline at Week 1 (n=174, 187,167)	Change from Baseline at Week 4 (n=173,184,165)	Change from Baseline at Week 8 (n=169,179,161)
Duloxetine	-0.353	-1.170	-1.698
Placebo	-0.243	-0.617	-1.225
Vortioxetine (Lu AA21004)	-0.289	-0.951	-1.546

Intervention	score on a scale (Mean)
	Change at Week 1	Change at Week 4	Change at Week 8
Duloxetine	-4.6	-11.6	-15.5
Placebo	-3.4	-8.0	-12.3
Vortioxetine (Lu AA21004)	-3.7	-9.8	-14.3

Intervention	seconds (Mean)
	Congruent (n=174,187,167)	Incongruent (n=172,186,166)
Duloxetine	-4.54	-9.83
Placebo	-4.37	-8.11
Vortioxetine (Lu AA21004)	-3.30	-8.17

Intervention	Units on a scale (Median)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	-2.0
Intranasal Placebo Plus Oral AD	-2.0

Intervention	Units on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	29.1
Intranasal Placebo Plus Oral AD	20.9

Intervention	Units on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	-23.2
Intranasal Placebo Plus Oral AD	-17.1

Intervention	Units on a Scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	0.288
Intranasal Placebo Plus Oral AD	0.231

Intervention	Units on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	-7.9
Intranasal Placebo Plus Oral AD	-6.8

Intervention	Units on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	-21.4
Intranasal Placebo Plus Oral AD	-17.0

Intervention	Units on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	-19.6
Intranasal Placebo Plus Oral AD	-16.3

Intervention	Units on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	-13.0
Intranasal Placebo Plus Oral AD	-10.2

Intervention	Units on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	-12.2
Intranasal Placebo Plus Oral AD	-10.1

Intervention	Units on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	-13.6
Intranasal Placebo Plus Oral AD	-9.4

Intervention	Units on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	-12.5
Intranasal Placebo Plus Oral AD	-9.3

Intervention	Percentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	48.2
Intranasal Placebo Plus Oral AD	30.3

Intervention	Percentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	39.5
Intranasal Placebo Plus Oral AD	20.9

Intervention	Percentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	57.0
Intranasal Placebo Plus Oral AD	39.5

Intervention	Percentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	63.4
Intranasal Placebo Plus Oral AD	49.5

Intervention	Percentage of participants (Number)
	Onset of Clinical response on Day 2	Onset of Clinical response on Day 8
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)	7.9	10.5
Intranasal Placebo Plus Oral AD	4.6	6.4

Intervention	units on a scale (Mean)
Open Track	10.79
Placebo Track - Citalopram	15.30
Placebo Track - Placebo	12.75

Intervention	Percentage of Participants (Number)
	Week 1, n=184, 199	Week 2, n=182, 199	Week 4, n=184, 198	Week 6, n=183, 197	Week 8, n=176, 188
Bupropion XL	6	21.4	38.6	67.8	80.7
Escitalopram	7.5	22.1	52.5	71.6	83.5

Intervention	International Units per liter (IU/L) (Mean)
	ALT, Week 8, n=176, 183	ALT, Taper, n=12, 16	ALT, Follow-up, n=8, 12	ALP, Week 8, n=176, 181	ALP, Taper, n=12, 15	ALP, Follow-up, n=7, 12	AST, Week 8, n=176, 183	AST, Taper, n=12, 16	AST, Follow-up, n=8, 12	GGT, Week 8, n=175, 181	GGT, Taper, n=12, 15	GGT, Follow-up, n=7, 12	LD, Week 8, n=176, 182	LD, Taper, n=13, 13	LD, Follow-up, n=8, 10
Bupropion XL	2.254	7.993	-7.337	1.866	3.674	5.643	0.330	3.193	0.925	0.688	1.403	-2.029	1.292	14.463	11.037
Escitalopram	1.315	-1.812	5.938	0.407	3.480	-3.953	1.099	0.381	2.867	-0.694	-3.133	3.916	2.879	-8.092	-4.150

Intervention	Millimole per liter (mmol/L) (Mean)
	Calcium, Week 8, n=173, 183	Calcium, Taper, n=12, 12	Calcium, Follow-up, n=8, 11	Chloride, Week 8, n=173, 182	Chloride, Taper, n=10, 13	Chloride, Follow-up, n=8, 8	Cholesterol, Week 8, n=175, 181	Cholesterol, Taper, n=12, 14	Cholesterol, Follow-up, n=9, 11	Glucose, Week 8, n=173, 181	Glucose, Taper, n=12, 16	Glucose, Follow-up, n=9, 11	Potassium, Week 8, n=173, 182	Potassium, Taper, n=10, 13	Potassium, Follow-up, n=8, 8	Sodium, Week 8, n=173, 182	Sodium, Taper, n=10, 13	Sodium, Follow-up, n=8, 8	Triglycerides, Week 8, n=175, 181	Triglycerides, Taper, n=13, 15	Triglycerides, Follow-up, n=9, 11	Urea, Week 8, n=174, 183	Urea, Taper, n=12, 16	Urea, Follow-up, n=8, 11
Bupropion XL	-0.017	-0.019	-0.060	0.259	-0.498	-0.287	-0.122	0.022	-0.124	-0.051	0.352	-0.194	-0.021	-0.114	-0.110	-0.205	-0.611	-0.175	0.003	-0.032	0.637	-0.068	0.517	0.687
Escitalopram	-0.020	0.012	-0.060	-0.293	-0.566	-0.178	0.051	0.082	-0.122	-0.050	0.106	0.025	0.009	0.046	0.036	-0.178	0.978	0.770	0.022	0.574	0.181	0.015	-0.269	-0.419

Intervention	Proportion of red blood cells in blood (Mean)
	Hematocrit, Week 8, n=176, 183	Hematocrit, Taper, n=13, 16	Hematocrit, Follow-up, n=10, 8
Bupropion XL	0.0016	-0.0051	-0.0076
Escitalopram	-0.0044	0.0017	0.0051