Abilify Delays Manic Relapse in Bipolar Disorder

Study in Journal of Clinical Psychiatry Shows ABILIFY Significantly Delayed the Time to Manic Relapse

(May 16, 2006) -- Maintenance therapy with the Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. atypical antipsychotic ABILIFY® (aripiprazole) significantly delayed the time to relapse in adults with Bipolar I Disorder who had been stabilized and maintained on ABILIFY for at least six (6) weeks, according to findings of a randomized, double-blind placebo-controlled study of patients with a recent manic or mixed episode published in the current issue of the Journal of Clinical Psychiatry.1 These study results were based on rigorous criteria used to define stability for Bipolar I Disorder.

"These findings are important because Bipolar I Disorder is a lifelong episodic illness and an important goal of treatment is to prevent or delay recurrent mood symptoms," said lead investigator Paul E. Keck, Jr., M.D., professor of psychiatry and pharmacology and vice chairman for research, Department Of Psychiatry, University Of Cincinnati College Of Medicine. "Up to 40 percent of adults who respond to initial treatment have relapses within one year,2,3 emphasizing the need for maintenance treatment."

Bipolar I Disorder can be treated with antipsychotic medications.4 ABILIFY is one of only two atypical antipsychotics indicated for maintenance therapy in Bipolar I Disorder. ABILIFY® (aripiprazole) is indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder, and for maintaining efficacy in adults with Bipolar I Disorder with a recent manic or mixed episode who had been stabilized and then maintained for at least six (6) weeks. Physicians who elect to use ABILIFY for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual.

Study Design and Findings 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 ABILIFY 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 (6) 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. Relapse was defined by a discontinuation from the study attributed to a lack of efficacy (indicated by hospital admission for a mood episode, or addition to or increase in psychotropic medication other than ABILIFY to treat affective symptoms).

Results from the study show:

• ABILIFY was superior to placebo in delaying the time to relapse (p=0.020; hazard ratio=0.52).
• Adults treated with ABILIFY experienced significantly fewer relapses than placebo: 25 percent vs 43 percent (p-value equals 0.013), respectively.
  • Adults treated with ABILIFY experienced fewer manic relapses than placebo: 8 percent vs 23 percent (p-value equals 0.009), respectively.

The majority of relapses were due to manic rather than depressive symptoms. There were insufficient data to know whether ABILIFY is effective in delaying the time to occurrence of depression in adults with Bipolar I Disorder.

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More adults in the placebo group than in the ABILIFY® (aripiprazole) group (19.3 percent vs 10.4 percent, respectively) discontinued the study because of treatment-emergent adverse events. Adverse events among adults treated with ABILIFY with an incidence of 5 percent or more and at least twice the rate of placebo were: tremor (9.1%), akathisia (6.5%), vaginitis (6.4%), and pain in the extremities (5.2%). The safety profile demonstrated during this trial was generally consistent with data reported in other long-term placebo controlled trials of ABILIFY including changes in weight, prolactin, QTc and Extrapyramidal symptoms.5

Sources: Journal of Clinical Psychiatry and Bristol Myers Squibb Press Release.

Last updated: 05/06

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