Safety and efficacy from a 6‐week double‐blind study and a 52‐week open‐label extension of aripiprazole in adolescents with schizophrenia in Japan

Aim The purpose of this study was to evaluate the safety and efficacy of aripiprazole in adolescents with schizophrenia (SCZ) in Japan. Methods In a 6‐week, randomized, double‐blind, dose‐comparison study, adolescents (aged 13–17 years) with SCZ were randomized to receive aripiprazole 2, 6–12, or 24–30 mg/day. Patients who completed the 6‐week study participated in a 52‐week, flexible‐dose, open‐label extension (OLE) study of aripiprazole (initial dose: 2 mg/day, maintenance dose: 6–24 mg/day, maximum dose: 30 mg/day). Results In the 6‐week study, the percentage of patients completing treatment was: 77.1% (27/35) for 2 mg/day; 80.0% (24/30) for 6–12 mg/day; and 85.4% (35/41) for 24–30 mg/day. The least squares mean change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to endpoint (primary efficacy endpoint, last observation carried forward) was −19.6 for 2 mg/day, −16.5 for 6–12 mg/day, and − 21.6 for 24–30 mg/day. The most common (≥20% patients in any group) treatment‐emergent adverse events (TEAE) were nausea, akathisia, insomnia, and somnolence. Most TEAE were mild or moderate in severity. There were no deaths. In the OLE, 60.3% (41/68) of patients completed treatment, and the PANSS total score decreased by −7.9 from OLE baseline to week 52. The most common (≥20% patients) TEAE were nasopharyngitis and somnolence. Most TEAE were mild or moderate in severity. There were no deaths. Conclusion These study results suggest that aripiprazole would be safe and well tolerated in both short‐ and long‐term treatment for adolescents with SCZ in Japan.