Conditions: Schizophrenia
Keywords: Schyzophrenia, pediatric patients
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 106
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). arm 2: Subjects in the 6-12 mg/day group will be 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 in accordance with the criteria below. arm 3: Subjects in the 24-30 mg/day group will be 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 in accordance with the criteria below.

Interventions: intervention 1: Aripiprazole Low (2 mg/day) intervention 2: Aripiprazole Mid (6 - 12 mg/day) intervention 3: Aripiprazole High (24 - 30 mg/day)
Intervention descriptions: intervention 1: administered 2 mg once daily for 6 weeks intervention 2: 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 intervention 3: 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

Protocol document: