Adjunctive asenapine is effective in patients with mania associated with bipolar I disorder who had failed to respond completely to treatment with lithium or valproate, according to study results presented here on March 1 at the European Psychiatric Association (EPA) 18th European Congress of Psychiatry.
Joseph Calabrese, MD, PhD, Mood Disorders Program, Case Western University School of Medicine, Cleveland, Ohio, and colleagues determined the efficacy of asenapine co-treatment with lithium or valproate in a 12-week primary study and a blinded extension study that followed for 40 weeks.
The primary-study endpoint was to evaluate the efficacy, safety, and tolerability of adjunctive asenapine for acute manic or mixed episodes in patients with bipolar disorder who incompletely responded to lithium or valproate monotherapy. The extension study had the same endpoints in addition to determining the maintenance of efficacy of adjunctive asenapine treatment.
The primary study was a randomised, double-blind, placebo-controlled trial wherein patients who had incompletely responded to treatment with a mood stabiliser received sublingual flexible-dose adjunctive asenapine 5 or 10 mg BID (n = 155) or placebo (n = 163). The 40-week blinded extension included 38 patients from the asenapine group and 33 from the placebo group.
At week 3, the mean +- standard deviation changes with asenapine and placebo, respectively, were -9.7 +- 10.1 versus -7.7 +- 9.6 (P = .0257) on the Young Mania Rating Scale (YMRS) and -2.8 +- 7.2 versus -2.2 +- 6.8 (P = .3684) on the Montgomery-Asberg Depression Rating Scale (MADRS). At the 52-week evaluation, changes with asenapine and placebo were -17.2 +- 13.7 versus -19.7 +- 11.8 on YMRS and -3.3 +- 9.8 versus -3.9 +- 7.7 on MADRS, respectively.
The incidence of treatment-emergent adverse events with asenapine and placebo was 73% and 69% in the core study and 78% and 69% in the extension.
The researchers concluded that adjunctive therapy with asenapine was efficacious as determined by changes in YMRS total scores seen at week 3, and it was superior over placebo in the treatment of mania associated with bipolar disorder.
The efficacy of adjunctive asenapine treatment was maintained over a 52-week treatment course. Asenapine together with lithium or valproate was generally well tolerated.
Funding was provided by Merck Pharmaceuticals.
[Presentation title: Asenapine as Adjunctive Treatment for Bipolar Mania: A Placebo-Controlled 12-Week Study and 40-Week Extension. Abstract PW01-28]
By Jenny Powers