Aripiprazole in Adolescents With Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Registration Number
- NCT00102063
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 302
- Primary diagnosis of Schizophrenia 1
- Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aripiprazole 10 mg/day Group Aripiprazole tablet, 10 mg 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 Aripiprazole 30 mg/day Group Aripiprazole tablet, 30 mg 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 Placebo Group Placebo tablet Participants were given a single pill administered once daily
- Primary Outcome Measures
Name Time Method Change in Positive and Negative Syndrome Scale (PANSS) Total Score 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 Outcome Measures
Name Time Method Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score Baseline and Day 42 Change from baseline to last observed post-baseline value in PANSS positive subscale score, using the last observation carried forward.
Scale consists of 7 positive symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome.Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score Baseline and Day 42 Change from baseline to last observed post-baseline value in PANSS Negative Subscale score, using the last observation carried forward.
Scale consists of 7 negative symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome.Change in Clinical Global Impression (CGI) Severity Score Baseline and Day 42 Change from baseline to last observed post-baseline value in CGI severity score, using the last observation carried forward.
Scale refers to the global impression of the subject with respect to severity of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe).Clinical Global Impression (CGI) Improvement Score Baseline and Day 42 Last observed post-baseline value in CGI improvement score, using the last observation carried forward.
Scale refers to the global impression of the subject with respect to improvement of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe).Change in Children's Global Assessment Scale (CGAS) Score Baseline and Day 42 Change from baseline to last observed post-baseline value in CGAS score, using the last observation carried forward.
Scale is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome).
Trial Locations
- Locations (1)
Local Institution
🇵🇷San Juan, Puerto Rico