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Aripiprazole Efficacious for Acute Mania in Relapsing Bipolar 1 Patients: Presented at ECNP

By Bruce Sylvester
Special to DG News

BARCELONA, SPAIN -- October 9, 2002 -- Aripiprazole appears to be effective and well tolerated in the treatment of acute mania in patients with bipolar disorder.

The finding was reported here October 8 at the 15^th Congress of the European College of Neuropsychopharmacology (ECNP).

"These results suggest that aripiprazole has efficacy, is safe and is well tolerated by relapsing patients with bipolar 1 [mania] who also have acute mania or mixed episode symptoms," said lead investigator Ronald Marcus, MD, clinical investigator at Bristol-Myers Squibb, in Wallingford, United States. "We saw an excellent response to aripiprazole compared to placebo among these patients."

The researchers enrolled 262 patients with acute, relapsing bipolar 1 mania for this phase III, multicentre, double-blind, placebo-controlled study. They randomised the subjects to aripiprazole 30 mg/day or placebo for three weeks, reducing the dose to 15 mg/day if therapeutically necessary. Patients remained hospitalised for a minimum of two weeks.

The primary measure of efficacy was change in Young Mania Rating Scale (Y-MRS) total score. The researchers defined "response" as a decrease of 50 percent in Y-MRS total score.

At end point, the aripiprazole group showed statistically significant improvements in Y-MRS total score compared to placebo (-8.15 versus -3.35, p=0.01 or less). The aripiprazole group also showed a significantly higher response rate compared to the placebo group (40 percent versus 19 percent, p=0.01 or less). Aripiprazole separated from placebo by day 4 for all efficacy variables.

Both treatment groups had the same level of discontinuation of therapy and they had no significant variation in body weight.

Aripiprazole is an investigational antipsychotic with a unique mechanism of action through partial agonism at D2 receptors, partial agonism at 5HT1A receptors, and antagonism at 5HT2A receptors.

Bristol-Myers Squibb funded the study.

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