Agomelatine in the treatment of major depressive disorder: An 8-week, multicenter, randomized, placebo-controlled trial

Stephen M. Stahl, Maurizio Fava, Madhukar H. Trivedi, Angelika Caputo, Amy Shah, Anke Post

Research output: Contribution to journalArticle

87 Citations (Scopus)

Abstract

Objective: To evaluate the efficacy, safety, and tolerability of fixed-dose agomelatine 25 and 50 mg/d in the treatment of outpatients with moderate-to-severe major depressive disorder (MDD) compared to placebo. Method: In this 8-week, multicenter, double-blind, parallel-group trial, patients with DSM-IV-defined MDD were randomly assigned (1:1:1) to receive a once-daily dose of agomelatine 25 mg, agomelatine 50 mg, or placebo. The primary efficacy measure was the change from baseline to week 8 in the clinician-rated 17-item Hamilton Depression Rating Scale (HDRS17); other efficacy measures were the clinical remission and response rates (measured by HDRS17), Clinical Global Impressions scales, Hospital Anxiety and Depression Scale (HADS) score, subjective measures on sleep, and the overall quality of life. The study was conducted between December 2006 and January 2008. Results: Agomelatine 25 mg/d was more efficacious based on the HDRS17 total score (P = .01) compared to placebo throughout the treatment period, whereas for agomelatine 50 mg/d, statistically significant reduction in HDRS17 total score could be observed from weeks 2 to 6 but not at week 8 (P = .144). A higher proportion of patients receiving agomelatine 25 mg/d showed clinical response (P = .013), clinical remission (P = .07), and improvement according to the Clinical Global Impressions-Improvement scale (P = .065) compared to those receiving placebo. No statistically significant difference between patients receiving agomelatine 50 mg/d compared to placebo on clinical response (P = .116) or clinical remission (P = .457) was observed. HADS score, quality of sleep, and quality of life significantly improved with agomelatine 25 mg/d compared to placebo. Both agomelatine doses were safe and well tolerated, although clinically notable aminotransferase elevations were observed transiently in the agomelatine 50 mg/d group. Conclusions: Agomelatine 25 mg/d was effective in the treatment of patients with moderate-to-severe MDD and was safe and well tolerated. Agomelatine 50 mg/d provided evidence for its antidepressant efficacy until week 6 and was also safe and well tolerated. Trial Registration: clinicaltrials.gov Identifier: NCT00411242.

Original languageEnglish (US)
Pages (from-to)616-626
Number of pages11
JournalJournal of Clinical Psychiatry
Volume71
Issue number5
DOIs
StatePublished - May 2010

Fingerprint

S 20098
Major Depressive Disorder
Randomized Controlled Trials
Placebos
Therapeutics
Depression
Sleep
Anxiety
Quality of Life

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

Agomelatine in the treatment of major depressive disorder : An 8-week, multicenter, randomized, placebo-controlled trial. / Stahl, Stephen M.; Fava, Maurizio; Trivedi, Madhukar H.; Caputo, Angelika; Shah, Amy; Post, Anke.

In: Journal of Clinical Psychiatry, Vol. 71, No. 5, 05.2010, p. 616-626.

Research output: Contribution to journalArticle

Stahl, Stephen M. ; Fava, Maurizio ; Trivedi, Madhukar H. ; Caputo, Angelika ; Shah, Amy ; Post, Anke. / Agomelatine in the treatment of major depressive disorder : An 8-week, multicenter, randomized, placebo-controlled trial. In: Journal of Clinical Psychiatry. 2010 ; Vol. 71, No. 5. pp. 616-626.
@article{57ea6860eed348029a4599d1eee9146b,
title = "Agomelatine in the treatment of major depressive disorder: An 8-week, multicenter, randomized, placebo-controlled trial",
abstract = "Objective: To evaluate the efficacy, safety, and tolerability of fixed-dose agomelatine 25 and 50 mg/d in the treatment of outpatients with moderate-to-severe major depressive disorder (MDD) compared to placebo. Method: In this 8-week, multicenter, double-blind, parallel-group trial, patients with DSM-IV-defined MDD were randomly assigned (1:1:1) to receive a once-daily dose of agomelatine 25 mg, agomelatine 50 mg, or placebo. The primary efficacy measure was the change from baseline to week 8 in the clinician-rated 17-item Hamilton Depression Rating Scale (HDRS17); other efficacy measures were the clinical remission and response rates (measured by HDRS17), Clinical Global Impressions scales, Hospital Anxiety and Depression Scale (HADS) score, subjective measures on sleep, and the overall quality of life. The study was conducted between December 2006 and January 2008. Results: Agomelatine 25 mg/d was more efficacious based on the HDRS17 total score (P = .01) compared to placebo throughout the treatment period, whereas for agomelatine 50 mg/d, statistically significant reduction in HDRS17 total score could be observed from weeks 2 to 6 but not at week 8 (P = .144). A higher proportion of patients receiving agomelatine 25 mg/d showed clinical response (P = .013), clinical remission (P = .07), and improvement according to the Clinical Global Impressions-Improvement scale (P = .065) compared to those receiving placebo. No statistically significant difference between patients receiving agomelatine 50 mg/d compared to placebo on clinical response (P = .116) or clinical remission (P = .457) was observed. HADS score, quality of sleep, and quality of life significantly improved with agomelatine 25 mg/d compared to placebo. Both agomelatine doses were safe and well tolerated, although clinically notable aminotransferase elevations were observed transiently in the agomelatine 50 mg/d group. Conclusions: Agomelatine 25 mg/d was effective in the treatment of patients with moderate-to-severe MDD and was safe and well tolerated. Agomelatine 50 mg/d provided evidence for its antidepressant efficacy until week 6 and was also safe and well tolerated. Trial Registration: clinicaltrials.gov Identifier: NCT00411242.",
author = "Stahl, {Stephen M.} and Maurizio Fava and Trivedi, {Madhukar H.} and Angelika Caputo and Amy Shah and Anke Post",
year = "2010",
month = "5",
doi = "10.4088/JCP.09m05471blu",
language = "English (US)",
volume = "71",
pages = "616--626",
journal = "Journal of Clinical Psychiatry",
issn = "0160-6689",
publisher = "Physicians Postgraduate Press Inc.",
number = "5",

}

TY - JOUR

T1 - Agomelatine in the treatment of major depressive disorder

T2 - An 8-week, multicenter, randomized, placebo-controlled trial

AU - Stahl, Stephen M.

AU - Fava, Maurizio

AU - Trivedi, Madhukar H.

AU - Caputo, Angelika

AU - Shah, Amy

AU - Post, Anke

PY - 2010/5

Y1 - 2010/5

N2 - Objective: To evaluate the efficacy, safety, and tolerability of fixed-dose agomelatine 25 and 50 mg/d in the treatment of outpatients with moderate-to-severe major depressive disorder (MDD) compared to placebo. Method: In this 8-week, multicenter, double-blind, parallel-group trial, patients with DSM-IV-defined MDD were randomly assigned (1:1:1) to receive a once-daily dose of agomelatine 25 mg, agomelatine 50 mg, or placebo. The primary efficacy measure was the change from baseline to week 8 in the clinician-rated 17-item Hamilton Depression Rating Scale (HDRS17); other efficacy measures were the clinical remission and response rates (measured by HDRS17), Clinical Global Impressions scales, Hospital Anxiety and Depression Scale (HADS) score, subjective measures on sleep, and the overall quality of life. The study was conducted between December 2006 and January 2008. Results: Agomelatine 25 mg/d was more efficacious based on the HDRS17 total score (P = .01) compared to placebo throughout the treatment period, whereas for agomelatine 50 mg/d, statistically significant reduction in HDRS17 total score could be observed from weeks 2 to 6 but not at week 8 (P = .144). A higher proportion of patients receiving agomelatine 25 mg/d showed clinical response (P = .013), clinical remission (P = .07), and improvement according to the Clinical Global Impressions-Improvement scale (P = .065) compared to those receiving placebo. No statistically significant difference between patients receiving agomelatine 50 mg/d compared to placebo on clinical response (P = .116) or clinical remission (P = .457) was observed. HADS score, quality of sleep, and quality of life significantly improved with agomelatine 25 mg/d compared to placebo. Both agomelatine doses were safe and well tolerated, although clinically notable aminotransferase elevations were observed transiently in the agomelatine 50 mg/d group. Conclusions: Agomelatine 25 mg/d was effective in the treatment of patients with moderate-to-severe MDD and was safe and well tolerated. Agomelatine 50 mg/d provided evidence for its antidepressant efficacy until week 6 and was also safe and well tolerated. Trial Registration: clinicaltrials.gov Identifier: NCT00411242.

AB - Objective: To evaluate the efficacy, safety, and tolerability of fixed-dose agomelatine 25 and 50 mg/d in the treatment of outpatients with moderate-to-severe major depressive disorder (MDD) compared to placebo. Method: In this 8-week, multicenter, double-blind, parallel-group trial, patients with DSM-IV-defined MDD were randomly assigned (1:1:1) to receive a once-daily dose of agomelatine 25 mg, agomelatine 50 mg, or placebo. The primary efficacy measure was the change from baseline to week 8 in the clinician-rated 17-item Hamilton Depression Rating Scale (HDRS17); other efficacy measures were the clinical remission and response rates (measured by HDRS17), Clinical Global Impressions scales, Hospital Anxiety and Depression Scale (HADS) score, subjective measures on sleep, and the overall quality of life. The study was conducted between December 2006 and January 2008. Results: Agomelatine 25 mg/d was more efficacious based on the HDRS17 total score (P = .01) compared to placebo throughout the treatment period, whereas for agomelatine 50 mg/d, statistically significant reduction in HDRS17 total score could be observed from weeks 2 to 6 but not at week 8 (P = .144). A higher proportion of patients receiving agomelatine 25 mg/d showed clinical response (P = .013), clinical remission (P = .07), and improvement according to the Clinical Global Impressions-Improvement scale (P = .065) compared to those receiving placebo. No statistically significant difference between patients receiving agomelatine 50 mg/d compared to placebo on clinical response (P = .116) or clinical remission (P = .457) was observed. HADS score, quality of sleep, and quality of life significantly improved with agomelatine 25 mg/d compared to placebo. Both agomelatine doses were safe and well tolerated, although clinically notable aminotransferase elevations were observed transiently in the agomelatine 50 mg/d group. Conclusions: Agomelatine 25 mg/d was effective in the treatment of patients with moderate-to-severe MDD and was safe and well tolerated. Agomelatine 50 mg/d provided evidence for its antidepressant efficacy until week 6 and was also safe and well tolerated. Trial Registration: clinicaltrials.gov Identifier: NCT00411242.

UR - http://www.scopus.com/inward/record.url?scp=77952646342&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77952646342&partnerID=8YFLogxK

U2 - 10.4088/JCP.09m05471blu

DO - 10.4088/JCP.09m05471blu

M3 - Article

C2 - 20361916

AN - SCOPUS:77952646342

VL - 71

SP - 616

EP - 626

JO - Journal of Clinical Psychiatry

JF - Journal of Clinical Psychiatry

SN - 0160-6689

IS - 5

ER -