Aripiprazole in Adolescents With Schizophrenia

Study 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.

Official Title
-----------------
Aripiprazole in Adolescents With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Aripiprazole tablet, 10 mg
* Drug: Aripiprazole tablet, 30 mg
* Drug: Placebo tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of Schizophrenia 1 Exclusion Criteria: Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aripiprazole 10 mg/day Group<br>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 | Drug: Aripiprazole tablet, 10 mg<br>* Aripiprazole tablet 10 mg po qd x 42 days<br>* Other names: OPC-14597;|
| Active Comparator: Aripiprazole 30 mg/day Group<br>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 | Drug: Aripiprazole tablet, 30 mg<br>* Aripiprazole tablet 30 mg po qd x 42 days<br>* Other names: OPC-14597;|
| Placebo Comparator: Placebo Group<br>Participants were given a single pill administered once daily | Drug: Placebo tablet<br>* Placebo tablet po qd x 42 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Positive and Negative Syndrome Scale (PANSS) Total Score | 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. | Baseline and Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score | 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. | Baseline and Day 42 | 
| Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score | 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. | Baseline and Day 42 | 
| Change in Clinical Global Impression (CGI) Severity Score | 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). | Baseline and Day 42 | 
| Clinical Global Impression (CGI) Improvement Score | 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). | Baseline and Day 42 | 
| Change in Children's Global Assessment Scale (CGAS) Score | 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). | Baseline and Day 42 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Aripiprazole