NCT01942161

A Short Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

A Multicenter, Double-blind, Randomized, Dose-comparison Study of Three Different Doses of Aripiprazole (2 mg/Day, 6-12 mg/Day, 24-30 mg/Day) Orally Administered Over 6 Weeks in Pediatric Patients (Aged 13-17 Years) With Schizophrenia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 106 (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 efficacy and safety of three different doses of aripiprazole (2 mg/day, 6-12 mg/day, 24-30 mg/day) orally administered over a period of 6 weeks in pediatric patients (aged 13-17 years) with schizophrenia

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Aripiprazole Low (2 mg/day)	administered 2 mg once daily for 6 weeks
DRUG	Aripiprazole Mid (6 - 12 mg/day)	administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg
DRUG	Aripiprazole High (24 - 30 mg/day)	administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg

Timeline

• Start date: 2010-08-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-09-13
• Last updated: 2017-06-28
• Results posted: 2017-06-28

Locations

8 sites across 1 country: Japan