Magazine article Clinical Psychiatry News

Cariprazine Targets Acute Mania in Bipolar Patients

Magazine article Clinical Psychiatry News

Cariprazine Targets Acute Mania in Bipolar Patients

Article excerpt

AT A MEETING OF THE NEW CLINICAL DRUG EVALUATION UNIT SPONSORED BY THE NATIONAL INSTITUTE OF MENTAL HEALTH

PHOENIX--The novel atypical antipsychotic drug cariprazine is effective for the treatment of acute mania associated with bipolar I disorder, according to findings from a randomized, placebo-controlled phase III study.

In 158 patients who were randomized to receive 3 weeks of double-blind treatment with the orally active dopamine D3-preferring D31 D2 receptor partial agonist, the mean improvement on the Young Mania Rating Scale (YMRS), based on a mixed-effects model of repeated measures, was significantly greater than the mean improvement in 151 patients who had been randomized to receive placebo, Anjana Bose, Ph.D., and her colleagues reported.

Significantly more patients in the active treatment group than in the placebo group met the YMRS criteria for response (59% vs. 44%, respectively, achieved at least a 50% score reduction from baseline) and remission (52% vs. 35% achieved a total score of 12 or less) at 3 weeks, she said.

The mean improvement on the Clinical Global Impressions-Severity scale also was significantly greater in the treatment group at week 3, as was the reduction in Positive and Negative Syndrome Scale (PANSS) score, according to Dr. Bose of Forest Research Institute, Jersey City NJ.

Of note, cariprazine demonstrated fast onset of action, with a statistically greater improvement compared with placebo seen by day 4 of treatment and at every visit thereafter, she said.

Patients in the 6-week multicenter study were adults aged 18-65 years with acute mania associated with bipolar I disorder (as defined by the DSM-IV-TR) and a YMRS score of 20 or higher. The mean YMRS scores at baseline were similar at 32.3 (treatment group) and 32.1 (placebo).

Patients were hospitalized for a 4-to 7-day washout period and for at least the first 14 days of the 3-week treatment period. Those randomized to the treatment group received between 3 and 12 mg of cariprazine daily during those 3 weeks; treatment was initiated at a dose of 1.5 mg/day and increased in increments of 3 mg to a maximum of 12 mg/day by day 7, based on patient response and tolerability. The mean dose given was 7.5 mg/day. …

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