Antidepressant efficacy of agomelatine: meta-analysis of published and unpublished studies

David Taylor*, Anna Sparshatt, Seema Varma, Olubanke Olofinjana

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

148 Citations (Scopus)
114 Downloads (Pure)

Abstract

Objective To systematically review published and unpublished efficacy studies of agomelatine in people with depression.

Design Systematic review and meta-analysis.

Data sources Literature search (Pubmed, Embase, Medline), Cochrane Central Register of Controlled Trials, European Medicines Agency (EMA) regulatory file for agomelatine, manufacturers of agomelatine (Servier).

Eligibility criteria Double blind randomised placebo and comparator controlled trials of agomelatine in depression with standard depression rating scales.

Data synthesis Studies were pooled by using a random effects model with DerSimonian and Laird weights for comparisons with placebo and comparator antidepressant. The primary efficacy measure (change in rating scale score) was summarised with standardised mean difference (SMD; a measure of effect size) and secondary outcome measures with relative risks. All results were presented with 95% confidence intervals. Statistical heterogeneity was explored by visual inspection of funnel plots and by the I-2 statistic. Moderators of effect were explored by meta-regression.

Results We identified 20 trials with 7460 participants meeting inclusion criteria (11 in the published literature, four from the European Medicines Agency file, and five from the manufacturer). Almost all studies used the 17 item Hamilton depression rating scale (score 0-50). Agomelatine was significantly more effective than placebo with an effect size (SMD) of 0.24 (95% confidence interval 0.12 to 0.35) and relative risk of response 1.25 (1.11 to 1.4). Compared with other antidepressants, agomelatine showed equal efficacy (SMD 0.00, -0.09 to 0.10). Significant heterogeneity was uncovered in most analyses, though risk of bias was low. Published studies were more likely than unpublished studies to have results that suggested advantages for agomelatine.

Conclusions Agomelatine is an effective antidepressant with similar efficacy to standard antidepressants. Published trials generally had more favourable results than unpublished studies.

Original languageEnglish
Article numberg1888
Number of pages19
JournalBMJ
Volume348
Issue number0
Early online date19 Mar 2014
DOIs
Publication statusPublished - 29 Mar 2014

Keywords

  • MAJOR DEPRESSIVE DISORDER
  • PLACEBO-CONTROLLED DISCONTINUATION
  • SEROTONIN REUPTAKE INHIBITORS
  • DOUBLE-BLIND
  • SUBJECTIVE SLEEP
  • CONTROLLED-TRIAL
  • POOLED ANALYSIS
  • ESCITALOPRAM
  • SYMPTOMS
  • TOLERABILITY

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