A Multiple-Center, Randomized, Double-Blind, Placebo-Controlled Study of Oral Aripiprazole for Treatment of Adolescents With Schizophrenia

Sep 4, 2008The American journal of psychiatry

Oral aripiprazole treatment for adolescents with schizophrenia in a controlled clinical trial

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Abstract

85% of the 302 adolescent participants completed the 6-week trial assessing aripiprazole for schizophrenia.

Both 10 mg and 30 mg doses of aripiprazole resulted in statistically significant reductions in the PANSS total score compared to placebo.
Common adverse events reported in more than 5% of participants included extrapyramidal disorder, somnolence, and tremor.
Mean changes in prolactin levels were -8.45 ng/ml for placebo, -11.93 ng/ml for 10 mg, and -15.14 ng/ml for 30 mg of aripiprazole.
Body weight changes were minimal, with mean changes of -0.8 kg for placebo, 0.0 kg for 10 mg, and 0.2 kg for 30 mg of aripiprazole.
Aripiprazole was generally well tolerated among adolescents with schizophrenia.

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OBJECTIVE: Aripiprazole is a dopamine partial agonist approved for use in adults for short- and long-term treatment of schizophrenia and bipolar disorder. This study was designed to examine the acute efficacy, safety, and tolerability of aripiprazole for adolescents with schizophrenia.

METHOD: This was a 6-week multicenter, double-blind, randomized, placebo-controlled trial. Subjects 13 to 17 years old with a DSM-IV diagnosis of schizophrenia and a Positive and Negative Syndrome Scale (PANSS) total score of 70 or more were randomly assigned (1:1:1 ratio) to placebo or 10 or 30 mg/day of aripiprazole. The primary endpoint was mean change from baseline to endpoint (last observation carried forward) in PANSS total score. Assessments of safety and tolerability included spontaneously reported adverse events, extrapyramidal symptom scores, serum prolactin concentration, body weight, and metabolic measures.

RESULTS: Of 302 patients, 85% completed the 6-week study. The mean baseline PANSS score was 94.1. At the end of the study, both aripiprazole doses showed statistically significant differences from placebo in reduction in PANSS total score. Adverse events occurring in more than 5% of either aripiprazole group and with a combined incidence at least twice the rate for placebo were extrapyramidal disorder, somnolence, and tremor. Mean changes in prolactin were -8.45, -11.93, and -15.14 ng/ml for placebo and 10 mg and 30 mg of aripirazole, respectively. Mean body weight changes were -0.8, 0.0, and 0.2 kg for placebo and 10 mg and 30 mg of aripiprazole, respectively.

CONCLUSION: Both 10- and 30-mg/day doses of aripiprazole were superior to placebo in the acute treatment of adolescents with schizophrenia. Aripiprazole was generally well tolerated.

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A Multiple-Center, Randomized, Double-Blind, Placebo-Controlled Study of Oral Aripiprazole for Treatment of Adolescents With Schizophrenia

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