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Cited by 20Treatment of Major DepressionAnxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesBipolar Disorder and Treatment

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Is it time to shift to better characterization of patients in trials assessing novel antidepressants? An example of two relapse prevention studies with agomelatine

Goodwin, Guy M., Boyer, Patrice, Emsley, Robin, Rouillon, Frédéric, de Bodinat, Christian·2013·International Clinical Psychopharmacology
DOI 10.1097/yic.0b013e32835b0814
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Abstract

The present paper reports in parallel the findings of the two studies that evaluated the efficacy of agomelatine in preventing relapse of depression. It describes the methodological adjustments made between the first and the second trial, particularly in relation to patient selection and accuracy of diagnosis of depression. Patients with major depressive disorder who responded to an 8/10-week course of agomelatine 25-50 mg treatment were randomly assigned to receive continuation treatment with agomelatine or placebo during a 24-week, randomized, double-blind treatment period with an optional 18- or 20-week double-blind extension period. The cumulative probability of relapse was calculated using the Kaplan-Meier method of survival analysis. Study 1 lacked assay sensitivity because of an unexpectedly low relapse rate in the placebo arm, but was instructive in showing that the agomelatine effect was better than placebo only in those patients with higher symptom levels at baseline. Study 2 showed a robust benefit of agomelatine - a two-fold reduction in the relapse rate - observed at least up to 10 months in both the overall population and the more severely depressed patients. The methodological adjustments introduced in study 2 (e.g. a minimum subscore calculated from eight specific Hamilton Depression Rating Scale items, the use of the self-rating questionnaire Hospital Anxiety Depression Scale and the Sheehan questionnaire) have assured an adequate severity of depression not only on the basis of ratings of symptom severity but also on measures of functional impairment. We did not find increased severity of symptoms in study 2, but we hypothesize that the increased demands on investigators improved the quality of recruitment to represent more real-world patients. Adopting these innovations could contribute towards lower failure rates for future placebo-controlled clinical trials in the field.

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Metadata

Authors
Goodwin, G. M., Boyer, P., Emsley, R., Rouillon, F., & de Bodinat, C.
Affiliations
  • Warneford Hospital (GB)
  • University of Ottawa (CA)
  • Stellenbosch University (ZA)
  • Ste. Anne's Hospital (CA)
  • Institut de Recherches Internationales Servier (France) (FR)
Corresponding author
Goodwin, Guy M.
ORCID
Venue
International Clinical Psychopharmacology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2013-01
Volume
28
Issue
1
Pages
20-28
ISSN
0268-1315 (ISSN-L)
DOI
10.1097/yic.0b013e32835b0814
OpenAlex
W2055658079
Cited by
20
References
0
Citations by year
2025: 1 · 2023: 1 · 2022: 1 · 2021: 1 · 2020: 4 · 2019: 2 · 2017: 3 · 2016: 1 · 2015: 3 · 2014: 2 · 2013: 1
FWCI
1.41
Type
journal article
Language
en
Open access
closed
Locations
  • International Clinical Psychopharmacology (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • AstraZeneca
  • Sanofi
  • Servier
Topics
  • Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
  • Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
Keywords
agomelatine, relapse prevention, major depressive disorder, antidepressant trials, patient selection, depression severity assessment, assay sensitivity, placebo response, functional disability, trial recruitment
MeSH terms
Acetamides, Adult, Antidepressive Agents, Australia, Major Depressive Disorder, Depressive Disorder, Major, Double-Blind Method, Europe, Female, Humans, Male, Middle Aged, Naphthalenes, Predictive Value of Tests, Psychiatric Status Rating Scales, Surveys and Questionnaires, Severity of Illness Index, South Africa, Time Factors, Proportional Hazards Models, Treatment Outcome, Patient Selection, Kaplan-Meier Estimate, Secondary Prevention

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