By Bryan DeBusk
MUNICH, Germany -- July 17, 2008 -- Treatment with aripiprazole 2 to 30 mg daily for 26 weeks is safe in adolescents with schizophrenia or bipolar 1 disorder, according to research presented here at the 26th Collegium Internationale Neuro-Psychopharmacologicum (CINP) Congress.
Andrew Forbes, PhD, Global Medical Affairs, Otsuka Pharmaceutical Development & Commercialization, Princeton, New Jersey, presented the results in a poster session on July 14.
Investigators evaluated the safety of aripiprazole at a dose of 2 to 30 mg daily for 26 weeks in 281 patients with schizophrenia and in 233 patients with bipolar 1 disorder aged 10 to 17 years in a 6-month, multicentre, open-label, roll-over, flexible-dose study.
The cohort consisted of patients with schizophrenia who had previously participated in a 6-week double-blind aripiprazole trial and patients with bipolar 1 disorder who had dropped out of an extension of a 30-week double-blind trial.
Six percent of the participants with schizophrenia and 8.6% of the participants with bipolar 1 disorder discontinued the study due to adverse events.
Rates of other adverse effects were 23.2% for drowsiness, 21.6% for extrapyramidal effects, 17.7% for headache, and 12.3% for restlessness or akathisia. Although 4 patients reported suicidal ideation, none followed through. Weight changes from normal to abnormal were observed in 19 patients over the course of the study, but mean change in weight z-score was not clinically significant over the course of the study (<0.5 standard deviations).
Dr. Forbes noted that the results are consistent with safety data obtained in trials with shorter durations of treatment. Aripiprazole was generally well tolerated over a course of up to 32 weeks, he concluded.
Funding for the studies was provided by Otsuka Pharmaceutical Development & Commercialization.
[Presentation title: Long-Term Tolerability and Safety of Aripiprazole in Pediatric Patients With Schizophrenia or Bipolar I Disorder. Abstract P02-05]
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