Aripiprazole in Adolescents With Schizophrenia
Overview
- Phase
- Phase 3
- Intervention
- Aripiprazole tablet, 10 mg
- Conditions
- Schizophrenia
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Enrollment
- 302
- Locations
- 1
- Primary Endpoint
- Change in Positive and Negative Syndrome Scale (PANSS) Total Score
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Primary diagnosis of Schizophrenia 1
Exclusion Criteria
- •Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder
Arms & Interventions
Aripiprazole 10 mg/day Group
Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
Intervention: Aripiprazole tablet, 10 mg
Aripiprazole 30 mg/day Group
Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
Intervention: Aripiprazole tablet, 30 mg
Placebo Group
Participants were given a single pill administered once daily
Intervention: Placebo tablet
Outcomes
Primary Outcomes
Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Time Frame: Baseline and Day 42
Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward. This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome.
Secondary Outcomes
- Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score(Baseline and Day 42)
- Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score(Baseline and Day 42)
- Change in Clinical Global Impression (CGI) Severity Score(Baseline and Day 42)
- Clinical Global Impression (CGI) Improvement Score(Baseline and Day 42)
- Change in Children's Global Assessment Scale (CGAS) Score(Baseline and Day 42)