Pharmaceutical Raw Material of Agomelatine

  • Author:Ray Dean
  • Release on :2016-12-05

Agomelatine is indicated for the treatment of major depressive episodes in adults.Ten placebo controlled trials have been performed to investigate the short term efficacy of agomelatine in major depressive disorder. At the end of treatment, significant efficacy was demonstrated in six of the ten short-term double-blind placebo-controlled studies.Two were considered "failed" trials, as comparators of established efficacy failed to differentiate from placebo. Efficacy was also observed in more severely depressed patients in all positive placebo-controlled studies.The maintenance of antidepressant efficacy was demonstrated in a relapse prevention study.


Results of the meta-analysis of three positive, randomized, double-blind, placebo controlled studies in 357 patients treated with agomelatine and 360 patients treated with placebo show that agomelatine is effective in treating severe depression. Its antidepressant effect is greater for more severe depression. In patients with a greater baseline score (>30 on HAMD17 scale), the agomelatine-placebo difference was of 4.53 points.Controlled studies in humans have shown that agomelatine is at least as effective as the SSRI antidepressants paroxetine, sertraline, escitalopram, venlafaxine and fluoxetine in the treatment of major depression.A small open-label study has suggested efficacy in the treatment of atypical and melancholic depression.Well-designed clinical trials have demonstrated efficacy in the treatment of anxious depression.Agomelatine’s onset of action has been reported to occur as early as the first week of treatment.


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