english.prescrire.org > Spotlight > Archives : 2009 > Agomelatine for major depression in adults: adverse effects and no proven efficacy

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Agomelatine for major depression in adults: adverse effects and no proven efficacy

FEATURED REVIEW Agomelatine, a melatonin receptor agonist, is approved in the European Union for the treatment of depression. Agomelatine has unproven efficacy and poorly documented adverse effects. It is better to continue to use older antidepressants such as tricyclics or selective serotonin reuptake inhibitors.
Full review (4p) in English available for download by subscribers.

Abstract

  • When an antidepressant is considered a necessary addition to psychological support in treating patients with depression, the first-line drug is a tricyclic such as clomipramine or a selective serotonin reuptake inhibitor (SSRI) such as paroxetine.
  • Agomelatine, a melatonin receptor agonist, is approved in the European Union for the treatment of depression.
  • Available evaluation does not include any clinical trials designed to compare the efficacy of agomelatine with that of a tricyclic or a selective serotonin reuptake inhibitor. Most data come from 7 placebo-controlled trials.
  • Agomelatine (25 mg/day) was statistically more effective (on a rating scale) than placebo in only 3 of these 7 trials. The clinical relevance of the score improvements is questionable. No data are available on the cure rate or on suicide prevention.
  • In one trial, increasing the daily dose from 25 mg to 50 mg provided no supplementary benefit.
  • A trial in 367 patients failed to show that agomelatine was any more effective than placebo in preventing new depressive episodes (29% after one year). In another trial including 339 patients, the relapse rate was statistically lower after 6 months on agomelatine (20.6%) than on placebo (41.4%).
  • Very high doses of agomelatine are oncogenic in animals. The risk in humans is not known. Dizziness, gastrointestinal and cutaneous disorders have been observed. Agomelatine is probably hepatotoxic.
  • In summary, agomelatine has unproven efficacy and poorly documented adverse effects. It is better to continue to use older antidepressants such as tricyclics or selective serotonin reuptake inhibitors.

©Prescrire December 2009

"Agomelatine. Adverse effects and no proven efficacy" Prescrire Int 2009; 18 (104): 241-244 (pdf, subscribers only)

 

 
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