NCT01942148

A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

A Multicenter, Open-label, Long-term Safety Study of Aripiprazole (Initial Dose 2 mg/Day, Maintenance Dose 6-24 mg/Day, Maximum Dose 30 mg/Day) Orally Administered Over 52 Weeks in Patients Who Complete a Short-term Treatment Study of Aripiprazole in Pediatric Patients (Aged 13-17 Years) With Schizophrenia (031-09-003 Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate the safety and efficacy of aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over a period of 52 weeks in subjects who complete a short-term treatment study of pediatric patients (aged 13-17 years) with schizophrenia (031-09-003 study).

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Aripiprazole

Timeline

• Start date: 2010-08-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2013-09-13
• Last updated: 2017-06-28
• Results posted: 2017-06-28

Locations

8 sites across 1 country: Japan