Aripiprazole Open-Label, Safety and Tolerability Study

Phase 3

Completed

• Conditions: Schizophrenia; Bipolar Disorder
• Interventions: Drug: Aripiprazole

• Registration Number: NCT00102518
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted QC: 2005-01-28
• Study First Submitted: 2005-01-29
• Study First Posted: 2005-01-31
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Results First Submitted: 2012-05-16
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-31
• Last Update Submitted: 2012-07-31
• Results First Posted: 2012-08-31
• Last Update Posted: 2012-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

• Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NCT00102063 and NCT00110461 Subjects	Aripiprazole	All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239).

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Experiencing SAEs	Baseline and Week 23	Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.

Secondary Outcome Measures

Name	Time	Method
Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score	Baseline and Week 26	Change from baseline to the last scheduled post-baseline evaluation in PANSS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).; 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.
Change in Young Mania Rating Scale (Y-MRS) Total Score	Baseline and Week 26	Change from baseline to last scheduled post-baseline evaluation in YMRS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).; 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).

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Wauwatosa, Wisconsin, United States