Agomelatine or placebo as adjunctive therapy to a mood stabiliser in bipolar I depression: randomised double-blind placebo-controlled trial.

Abstract

Adjunctive antidepressant therapy is commonly used to treat acute bipolar depression but few studies have examined this strategy. To examine the efficacy of agomelatine v. placebo as adjuncts to lithium or valproate in bipolar depression. Patients who were currently depressed despite taking lithium or valproate for at least 6 weeks were randomised to treatment with agomelatine (n = 172) or placebo (n = 172) for 8 weeks of acute therapy and 44 weeks of continuation therapy (trial registration: ISRCTN28588282). No significant differences in improvement of depressive symptoms were observed between the two groups either at 8 weeks or 52 weeks on the primary efficacy measure of change in Montgomery-Åsberg Depression Rating Scale scores from baseline to end-point. Adverse events including switches into mania/hypomania were low and similar in both groups. Agomelatine adjunctive therapy was not superior to placebo adjunctive therapy for acute bipolar depression.