"The intramuscular formulation of aripiprazole is more efficacious than placebo and similar to intramuscular lorazepam [Ativan] in treating agitation in patients with bipolar I disorder," reported principal investigator Dan Oren, MD, Associate Clinical Professor of Psychiatry, Yale University, and Medical Director in Neuroscience, Bristol-Myers Squibb, New Haven, Connecticut, United States.

Aripiprazole has shown promising results in many settings in which atypical antipsychotics are used, Dr. Oren said. To determine whether the agent would also be effective in the setting of acute agitation associated with either a manic or mixed episode of bipolar I disorder, Dr. Oren's team undertook a double blinded, randomized, multicenter study.

The study enrolled subjects with bipolar I disorder who had agitation associated with either the manic phase or with mixed mania and depression; 75 subjects were randomized to IM aripiprazole 10 mg; 75 to 15 mg of IM aripiprazole, 68 to IM lorazepam 2 mg; 73 to placebo.

After the first injection of the assigned treatment, patients were followed on an inpatient basis for 24 hours. If necessary, the investigators gave a second injection at least 2 hours later, and a third injection at least 2 hours after the second one was also allowed.

The investigators judged the treatment's efficacy by an average change from baseline to 2 hours after the initial intramuscular injection, last observation carried forward. Response was measured using the Positive and Negative Syndrome Scale - Excited Component score (PEC).

Two hours after the initial injection, the average change from baseline in PEC scores was a reduction of 8.7 points in both aripiprazole arms. In the lorazepam arm, the average change from baseline was a reduction of 9.6 points. In the placebo arm, the PEC score was reduced by an average of 5.8 points.

For all treatment arms, including both doses of aripiprazole and for lorazepam, the results were significantly superior to placebo (P < .001).

The investigators concluded that the findings show that aripiprazole has similar versatility to other atypical antipsychotics. The United States Food and Drug Administration approved the use of IM aripiprazole on May 25^th by treatment of agitation in both bipolar mania and schizophrenia.

Bristol-Myers Squibb, the manufacturer of Abilify, provided funding for the study.


[Presentation title: Intramuscular Aripiprazole Versus Placebo for Agitation in Acute Mania. Abstract NR275]

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