A Phase III Trial to Test the Safety and Efficacy of Two Doses of Aripiprazole in Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

Otsuka Pharmaceutical Development & Commercialization, Inc.1 site in 1 country296 target enrollmentMarch 2005

ConditionsBipolar Disorder

InterventionsAripiprazole placebo

DrugsAripiprazole placebo

Overview

Phase: Phase 3
Intervention: Aripiprazole
Conditions: Bipolar Disorder
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Enrollment: 296
Locations: 1
Primary Endpoint: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.

Registry

clinicaltrials.gov

Start Date

March 2005

End Date

February 2007

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Eligibility Criteria

Inclusion Criteria

•Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features

Exclusion Criteria

•Patients with certain other psychological disorders
•Patients with a co-morbid serious, uncontrolled systemic illness
•Patients with significant risk of committing suicide

Arms & Interventions

1

Aripiprazole 10 mg tablet

Intervention: Aripiprazole

2

Aripiprazole 30 mg tablet

Intervention: Aripiprazole

3

Placebo

Intervention: placebo

Outcomes

Primary Outcomes

Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4

Time Frame: Baseline and Week 4

Change from Baseline to Week 4 in Y-MRS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through the continuation phase.) The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).

Secondary Outcomes

Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30(Baseline and Week 30)
Change in Children's Global Assessment Scale (CGAS) Total Score at Week 4(Baseline and Week 4)
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4(Baseline and Week 4)
Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4(Baseline and Week 4)
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4(Baseline and Week 4)
Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4(Baseline and Week 4)
Change in Children's Global Assessment (CGAS) Total Score at Week 30(Baseline and Week 30)
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30(Baseline and Week 30)
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4(Baseline and Week 4)
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30(Baseline and Week 30)
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4(Baseline and Week 4)
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30(Baseline and Week 30)
Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30(Baseline and Week 30)
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30(Baseline and Week 30)
Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4(Baseline and Week 4)
Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30(Baseline and Week 30)
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4(Baseline and Week 4)
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30(Baseline and Week 30)
Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4(Baseline and Week 4)
Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30(Baseline and Week 30)
Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30(Baseline and Week 30)
Subject Response to Treatment at Week 4(Baseline and Week 4)
Subject Response to Treatment at Week 30(Baseline and Week 30)
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4(Baseline and Week 4)
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30(Baseline and Week 30)
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4(Baseline and Week 4)
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30(Baseline and Week 30)
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4(Baseline and Week 4)
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30(Baseline and Week 30)