Maintenance therapy with Bristol-Myers Squibb's and Otsuka Pharmaceutical's atypical antipsychotic Abilify (aripiprazole) significantly delayed the time to relapse in adults with Bipolar I Disorder who had been stabilized and maintained on the medication for at least six weeks, according to findings of a randomized, double-blind placebo-controlled study of patients with a recent manic or mixed episode. The study was published in the Journal of Clinical Psychiatry.
In the study, adults with Bipolar I Disorder who had recently been hospitalized and treated for a manic or mixed episode were initially stabilized with Ablify monotherapy (15 or 30 mg/day for 6-18 weeks). In the open-label stabilization phase, the adults in the study were required to maintain a total score of 10 or less on the Young Mania Rating Scale (YMRS) and 13 or less on the Montgomery-Asberg Depression Rating Scale (MADRS) for six consecutive weeks prior to randomization into the double-blind phase. In the double-blind phase, 161 adults were randomly assigned to Abilify or placebo and monitored for relapse. The primary endpoint was time to relapse for a manic, mixed, or depressive episode.