Source: Rheumatologia  |  Posted 9 years ago

By Alison Palkhivala

PHILADELPHIA, PA -- May 23, 2002 -- Aripiprazole, a new investigational antipsychotic drug, is showing promise for the treatment of acute mania in patients with bipolar disorder.

Studies on the drug were presented here this week at the annual meeting of the American Psychiatric Association (APA).

As part of a phase III, multicenter, double-blind, randomized, placebo-controlled trial, 262 patients diagnosed with acute mania were treated with either aripiprazole or placebo. The study?s lead author was Paul E. Keck Jr., MD, from the department of psychiatry at the University of Cincinnati College of Medicine in Cincinnati, Ohio.

On day 4, patients in the treatment group began to show more improvement than the placebo group with respect to acute manic symptoms. These included elevated mood, irritability, thought disorder, abnormal thought content, and disruptive-aggressive behavior.

A significant difference was also found between the two groups with respect to mean change from baseline on the total score of the Young Mania Rating Scale (Y-MRS), with the aripiprazole group showing more improvement than the placebo group. This difference increased as the three-week trial progressed.

Response to therapy was defined as a decrease of 50 percent or more in Y-MRS total score. Based on this criterion, 40 percent of patients on aripiprazole responded to treatment compared to 19 percent on placebo.

A second placebo-controlled study of aripiprazole did not reveal a difference between the drug and a placebo with respect to response rate. However, response rate in the placebo group was abnormally high: both the treatment and placebo groups had response rates of 40 percent.

The most common side effects associated with aripiprazole therapy were headache, nausea, dyspepsia, somnolence, and agitation. Most side effects began early in treatment and few lasted more than a week.

Aripiprazole has a mechanism of action that is different from other antipsychotic drugs, affecting both dopamine and serotonin receptors. It is the product of a cooperative effort between Bristol-Myers Squibb and Otsuka Pharmaceuticals. Together, they filed a regulatory applications in the US and Europe in 2001 for the drug to be approved for the treatment of schizophrenia.