APA: Aripipraloze (Abilify) Called Safe and Effective in Teen Schizophrenia

May 25, 2007

SAN DIEGO -- Aripipraloze (Abilify) was significantly superior to placebo at treating schizophrenia among adolescents, an off-label use, reported investigators here.

SAN DIEGO, May 25 -- Aripipraloze (Abilify) was significantly superior to placebo at treating schizophrenia among adolescents, an off-label use, said investigators here.

In a six-week randomized study, teens with schizophrenia had significant improvements over baseline compared with placebo on several items of the Positive and Negative Syndrome Scale (PANSS), said Adelaide S. Robb, M.D., of Children's National Medical Center in Washington, and colleagues.

The drug was effective in daily doses at both 10-mg and 30-mg, reported Dr. Robb at the American Psychiatric Association meeting.

"What we found out is that by six weeks, both groups had improved significantly on medication compared with placebo, and in the 30 mg group even at one week they were separating statistically significantly from placebo," she said.

However, there were more adverse events among patients in the 30-mg group than in the 10-mg group or placebo, Dr. Robb said.

The package insert for Abilify states that the safety and effectiveness in pediatric and adolescent patients have not been established.

The six week, double-blind, randomized placebo-controlled trial was conducted at 101 centers in 13 countries, A total of 302 adolescents, ranging in age from 13 to 17 (mean age 15.5), were enrolled. The patients all had a DSM-IV diagnosis of schizophrenia confirmed by the Kiddie-Sads-Present and Lifetime Version (K-SADS-PL) diagnostic interview, and a Positive and Negative Syndrome Scale total score of 70 or greater.

After a three-day antipsychotic washout, the patients were randomly assigned in equal numbers to placebo or a fixed dose of 10 mg of aripiprazole, titrated upward over five days, or 30 mg of aripiprazole titrated for 11 days. The patients were maintained at the assigned dose of medication for a minimum of two weeks.

The primary endpoint was mean change from baseline to endpoint (week six last observation carried forward) on the Positive and Negative Syndrome Scale total score. Secondary endpoints included the Positive and Negative Syndrome Scale positive and negative subscales, and Clinical Global Impression Improvement score.

More than 85% of the patients completed the study. The mean baseline Positive and Negative Syndrome score was 94.5.

After one week on the full drug dose, patients in the 30-mg group had a significant improvement compared with placebo in total PANSS score (-10.42 compared with -7.2, last observation carried forward, P