Asenapine was shown to decrease the time to recurrence of manic and depressive episodes among patients with bipolar I disorder, according to research published in the American Journal of Psychiatry.
To evaluate the safety and efficacy of asenapine for bipolar I disorder, the study authors enrolled 549 participants with DSM-IV-TR-diagnosed acute manic or mixed episode in a randomized controlled trial. After a 12-week to 16-week open-label period of asenapine 10 mg twice daily with the option of titrating down to 5 mg, the researchers randomly assigned 253 stable responders to either placebo (withdrawal) or asenapine continued for 26 weeks. Efficacy was assessed by time to recurrence of any mood event, and safety was evaluated throughout the study.
Compared with the placebo group, time to recurrence of mood episodes was significantly longer for the asenapine group (hazard ratio [HR] 0.22, 95% CI: 0.11-0.43; P <.0001). The study authors defined recurrence of any mood episode as a Young Mania Rating Scale or Montgomery-Åsberg Depression Rating Scale score of ≥16 groups, requirement or initiation of a nonstudy medication to treat symptoms, discontinuation of study due to mood event, or a need for psychiatric hospitalization.
Time to recurrence of manic and depressive episodes individually was also improved in the asenapine group compared with placebo (HR 0.16 and 0.35; P <.0001 and =.0452, respectively).
During the open-label period, common treatment-emergent adverse events included somnolence (10.0%), akathisia (7.7%), and sedation (7.7%). In the withdrawal period, adverse events included mania (11.9% vs 4.0% for placebo vs asenapine) and bipolar I disorder (6.3% vs 1.6%).
The study authors concluded that “long-term asenapine therapy was more effective than placebo in preventing recurrence of mood events in stabilized adult subjects with bipolar I disorder.”
Szegedi A, Durgam S, Mackle M, et al. Randomized, double-blind, placebo-controlled trial of asenapine maintenance therapy in adults with an acute manic or mixed episode associated with bipolar I disorder [published online September 26, 2017]. doi:10.1176/appi.ajp.2017.16040419