Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
6230661 | Journal of Affective Disorders | 2016 | 8 Pages |
â¢Fixed-dose asenapine (ASN) 5 mg bid, ASN 10 mg bid, and placebo were evaluated.â¢Patients suffered from a mixed/manic episode associated with bipolar I disorder.â¢Both ASN doses showed similar efficacy in improving manic and depressive symptoms.â¢ASN 5 mg bid was associated with fewer adverse events than the 10 mg bid dose.
BackgroundAsenapine is an atypical antipsychotic for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. The recommended asenapine starting dose is 10Â mg bid with the option to reduce the dose to 5Â mg bid if needed due to adverse effects/tolerability.MethodsPhase IIIb, international, double-blind, fixed-dose, parallel-group, 3-week placebo-controlled trial of asenapine 5 and 10Â mg bid in adults with an acute bipolar I disorder manic or mixed episode. Primary outcome was difference in asenapine versus placebo in mean change from baseline to day 21 in the Young-Mania Rating Scale (YMRS) total score. Others included difference in asenapine versus placebo in the Clinical Global Impression Scale for Bipolar Severity (CGI-BP-S) and rate of YMRS responders.ResultsBoth asenapine doses were statistically superior to placebo in mean change from baseline to day 21 in YMRS total score (â10.9, â14.4, and â14.9 for placebo, asenapine 5Â mg bid, 10Â mg bid, respectively). Both asenapine doses had statistically superior improvement in mean change in CGI-BP-S score at day 21. Neither asenapine dose had significantly more YMRS responders at day 21 than placebo.LimitationsResults may not be generalizable to the entire population with bipolar I disorder owing to strict inclusion criteria.ConclusionsThis study evaluated, by a fixed-dose design, the efficacy and safety of asenapine versus placebo in patients with bipolar I disorder. Both asenapine 5 and 10Â mg bid were efficacious in treating mania associated with bipolar I disorder and were generally well tolerated.