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Cited by 67Anxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesTreatment of Major DepressionMaternal Mental Health During Pregnancy and Postpartum

Agomelatine in Generalized Anxiety Disorder: An Active Comparator and Placebo-Controlled Study

Stein, Dan J., Ahokas, Antti, Márquez, Miguel S., Höschl, Cyril, Oh, Kang Seob, Jarema, Marek, Avedisova, Alla S., Albarran, Cristina +1 more·2014·The Journal of Clinical Psychiatry
DOI 10.4088/jcp.13m08433
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Abstract

BACKGROUND: Agomelatine was efficacious in reducing symptoms in a short-term placebo-controlled trial in generalized anxiety disorder (GAD) and in preventing relapse in a longer term placebo-controlled study. An additional short-term placebo-controlled study is required by regulatory agencies to confirm the efficacy of agomelatine in GAD. METHOD: This 12-week, placebo-controlled, double-blind, randomized, parallel group, international, multicenter study was designed to confirm the efficacy of agomelatine 25-50 mg/d in the treatment of patients with a primary DSM-IV-TR diagnosis of GAD. The primary outcome measure was the Hamilton Anxiety Rating Scale (HARS) total score. Assay sensitivity was evaluated by including an escitalopram (10-20 mg/d) group. SETTINGS: The study was undertaken in 45 clinical centers in Argentina, Czech Republic, Finland, South Korea, Poland, Russia, and Slovakia from April 2010 to July 2011. RESULTS: One hundred thirty-nine outpatients were included in the agomelatine group, 131 in the placebo group, and 142 in the escitalopram group. Agomelatine significantly reduced mean (SD) HARS total score (agomelatine-placebo difference: 4.71 [1.03], P <.0001) and had significant effects on secondary outcome measures, including psychic and somatic HARS subscales, response rate (estimate [standard error]) (agomelatine-placebo difference: 27.4% [5.9%], P< .0001), remission on the HARS (agomelatine-placebo difference: 16.8% [5.4%], P = .002), Clinical Global Impressions-Severity of Illness scale (CGI-S) (P < .001), functional impairment (P < .0001), and sleep quality (P < .001). Findings were confirmed in the subset of more severely ill patients (HARS total score ≥ 25 with or without CGI-S ≥ 5 at baseline). Agomelatine was well tolerated by patients, with no more adverse events than placebo. Escitalopram was similarly efficacious but was accompanied by a higher incidence of adverse events compared to placebo. CONCLUSIONS: In clinical practice, agomelatine has at least similar efficacy to that of escitalopram for the short-term treatment of GAD and is well tolerated. TRIAL REGISTRATION: Controlled-Trials.com identifier: ISRCTN03554974.

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Crossref · 10.4088/jcp.13m08433

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Authors
Stein, D. J., Ahokas, A., Márquez, M. S., Höschl, C., Oh, K. S., Jarema, M., Avedisova, A. S., Albarran, C., & Olivier, V.
Affiliations
University of Cape Town (ZA)
Corresponding author
Stein, Dan J.
ORCID
Venue
The Journal of Clinical Psychiatry
Publisher
Physicians Postgraduate Press, Inc
Published
2014-02-18
Volume
75
Issue
04
Pages
362-368
ISSN
0160-6689 (ISSN-L)
DOI
10.4088/jcp.13m08433
OpenAlex
W2031231452
Cited by
67
References
39
Citations by year
2025: 3 · 2024: 8 · 2022: 3 · 2021: 5 · 2020: 7 · 2019: 4 · 2018: 6 · 2017: 10 · 2016: 4 · 2015: 13 · 2014: 4
FWCI
14.35
Type
journal article
Language
en
Open access
closed
Locations
  • The Journal of Clinical Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Maternal Mental Health During Pregnancy and Postpartum
Keywords
agomelatine, generalized anxiety disorder, escitalopram, antidepressant efficacy, Hamilton Anxiety Rating Scale, sleep quality, functional disability, adverse events, treatment tolerability, relapse prevention, selective serotonin reuptake inhibitors, melatonergic antidepressants, outpatients, remission
MeSH terms
Acetamides, Adolescent, Adult, Aged, Anxiety Disorders, Double-Blind Method, Female, Humans, Male, Middle Aged, Naphthalenes, Psychiatric Status Rating Scales, Anti-Anxiety Agents, Citalopram, Treatment Outcome, Young Adult

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