Agomelatine bears promising potential in treating bipolar depression- a systematic review.

Introduction: The controversy of antidepressant use in bipolar depression remains controversial. Agomelatine (AGO) is an effective antidepressant in major depressive disorder (MDD), but its application in bipolar depression was little discussed. We aimed to provide a comprehensive systematic review of clinical evidence from studies examining the efficacy and safety of AGO for bipolar depression.

Methods: We conducted a systematic review about AGO trials for the treatment of bipolar patients. We searched PubMed, MEDLINE, Embase, and Cochrane for relevant studies published since each database's inception. We synthesised evidence regarding efficacy (mood and rhythm) and tolerability across studies.

Results: We identified 6 studies including 272 participants (44% female). All studies used 25-50 mg AGO per day for treatment combined or not combined with mood stabilisers (MS). Across all 6 studies, there were improvements in depression evaluated by depression rating scores and response rate over time. The response rates varied from 43% to 91% within 6-12 weeks. Although AGO was found of better efficacy in bipolar depression compared to recurrent depression, its efficacy remains controversial. Most studies have shown AGO to be effective after just about a week. AGO was reasonably well tolerated both in acute and extension period, without obvious risk in inducing mood switching.

Conclusion: AGO is promising in treating bipolar depression with significant efficacy and well tolerability. However, more strictly designed and large-sample trials are needed in further research with homogeneity within intervention and treatment groups.