Agomelatine adjunctive therapy for acute bipolar depression: preliminary open data.

Agomelatine has been shown to be safe and efficient in the treatment of major depressive disorder at 25 mg daily. The aim of this study was to gather preliminary data regarding the antidepressant efficacy of agomelatine in patients with bipolar I disorder experiencing a major depressive episode. Bipolar I patients on lithium (n = 14) or valpromide (n = 7), with a Hamilton Rating Scale for Depression (HAM-D-17) total score > or = 18, were given adjunctive open-label agomelatine at 25 mg/day for a minimum of 6 weeks followed by an optional extension of up to an additional 46 weeks. Using intent-to-treat data, 81% of patients met criteria for marked improvement (>50% improvement from baseline in HAM-D score) at study endpoint. Patients were severely depressed at study entry (HAM-D of 25.2) and 47.6% responded as early as at one week of treatment. Nineteen patients entered the optional extension period for a mean of 211 days (range 6-325 days). Eleven patients completed the one-year extension on agomelatine. There were no dropouts due to adverse events during the acute phase of treatment (6 weeks). Six patients experienced serious adverse events during the one-year period. Three lithium-treated patients experienced manic or hypomanic episodes during the optional extension period, one of which was treatment-related. These results indicate the effectiveness of agomelatine 25 mg in the treatment of depressed bipolar I patients co-medicated with lithium or valpromide. A randomized controlled trial is planned to confirm these results.