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<jats:sec><jats:title>Background</jats:title><jats:p>Adjunctive antidepressant therapy is commonly used to treat acute bipolar depression but few studies have examined this strategy.</jats:p></jats:sec><jats:sec><jats:title>Aims</jats:title><jats:p>To examine the efficacy of agomelatine <jats:italic>v.</jats:italic> placebo as adjuncts to lithium or valproate in bipolar depression.</jats:p></jats:sec><jats:sec><jats:title>Method</jats:title><jats:p>Patients who were currently depressed despite taking lithium or valproate for at least 6 weeks were randomised to treatment with agomelatine (<jats:italic>n</jats:italic> = 172) or placebo (<jats:italic>n</jats:italic> = 172) for 8 weeks of acute therapy and 44 weeks of continuation therapy (trial registration: ISRCTN28588282).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Agomelatine adjunctive therapy was not superior to placebo adjunctive therapy for acute bipolar depression.</jats:p></jats:sec>

Original publication




Journal article


British Journal of Psychiatry


Royal College of Psychiatrists

Publication Date





78 - 86