Asenapine safely prevents recurrence of mood events in bipolar I disorder
Long-term treatment with asenapine is well-tolerated and effective in preventing recurrence of mood events in adults with bipolar I disorder compared with placebo, according to a recent study.
Of the 549 patients in the open-label period, 253 were enrolled in the double-blind randomized withdrawal period (127 in the placebo group and 126 in the asenapine group).
Patients treated with asenapine had statistically significantly longer time to recurrence of any mood episode than those treated with placebo. Posthoc analyses showed significant differences in time to recurrence of manic and depressive episodes in favour of asenapine over placebo.
Somnolence (10.0 percent), akathisia (7.7 percent) and sedation (7.7 percent) were the most common treatment-emergent adverse events in the open label period, and mania (11.9 percent of the placebo groups vs 4.0 percent of the asenapine group) and bipolar I disorder (6.3 percent vs 1.6 percent) in the double-blind period.
Researchers enrolled adults with an acute manic or mixed episode per DSM-IV-TR criteria in this randomized, placebo-controlled trial consisting of an initial 12‒16-week open-label period and a 26-week double-blind randomized withdrawal period.
The target asenapine dosage in the open-label period was 10 mg b.i.d., but it could be titrated down to 5 mg b.i.d. After completing the open-label period, those who met the stabilization/stable-responder criteria were randomly assigned to asenapine or placebo treatment in the double-blind period.
Time to recurrence of any mood event during the double-blind period was the primary efficacy endpoint. Researchers performed Kaplan-Meier estimation and determined 95 percent confidence intervals. They also assessed the safety of the study drug.