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Changes in the Assessments of Involuntary Movement Scales were similar for the ABILIFY and placebo groups.

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The primary efficacy measure used for assessing agitation signs and symptoms in these trials was the change from baseline in the PANSS Excited Component at 2 hours post-injection.

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The drug company that sponsored the trial, Novartis, plans to meet with regulators this fall and file for approval by the end of the year.

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The recommended dosage for schizophrenia is 10 to 15 mg once daily, titrate no more frequently than every 2 weeks, to maximum of 30 mg daily.

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The number of observed manic episodes in the aripiprazole group (7) were fewer than that in the placebo group (19), while the number of depressive episodes in the aripiprazole group (14) was similar to that in the placebo group (18).

CBC) monitored frequently during the first few months of therapy and discontinuation of REXULTI should be considered at the first sign of a clinically significant decline in WBC count in the absence of other causative factors.

ABILIFY was superior to placebo on the primary endpoint, time from randomization to relapse to any mood event.

If promising, study results will be used to design larger, definitive clinical trials to determine the efficacy of aripiprazole in reducing methamphetamine use and corresponding methamphetamine-associated sexual risk among MSM.

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During the double-blind, randomized treatment phase in Berman et al, two patients experienced suicidal ideation, both in subjects who were receiving placebo ().

Indeed, almost 70% of patients scored 1 or 2 on the CGI-S at the end of treatment.

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Inadequate response for prospective treatment was defined as less than 50% improvement on the 17-item version of the Hamilton Depression Rating Scale (HAMD17), minimal HAMD17 score of 14, and a Clinical Global Impressions Improvement rating of no better than minimal improvement.

Reductions in manic and mixed relapse rates compared to placebo were achieved in a study combining aripiprazole with lamotrigine; however, the results were not statistically significant.

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The efficacy of ABILIFY (aripiprazole) in the treatment of irritability associated with autistic disorder was established in two 8-week, placebo-controlled trials in pediatric patients (6 to 17 years of age) who met the DSM-IV criteria for autistic disorder and demonstrated behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems.

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