Aripiprazole Open-Label, Safety and Tolerability Study

Schizophrenia Clinical Trial

— APEX 241  

Official title:

A Multi-Center, Open-Label, Safety and Tolerability Study of Flexible-Dose Oral Aripiprazole (2 Mg-30 mg) in the Treatment of Adolescent Patients With Schizophrenia and Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102518
• Other study ID #: 31-03-241
• Status: Completed
• Phase: Phase 3
• First received: January 29, 2005
• Last updated: July 31, 2012
• Start date: September 2004
• Est. completion date: February 2007

Study information

• Verified date: July 2012
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Schizophrenia

Intervention

Drug:
• Aripiprazole
2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses

Locations

Country	Name	City	State
United States	Local Institution	Altamonte Springs	Florida
United States	Local Institution	Atlanta	Georgia
United States	Local Institution	Bala Cynwyd	Pennsylvania
United States	Local Institution	Bellaire	Texas
United States	Local Institution	Birmingham	Alabama
United States	Local Institution	Chapel Hill	North Carolina
United States	Local Institution	Chicago	Illinois
United States	Local Institution	Cleveland	Ohio
United States	Local Institution	Clinton	Michigan
United States	Local Institution	Costa Mesa	California
United States	Local Institution	DeSoto	Texas
United States	Local Institution	Elmsford	New York
United States	Local Institution	Fresno	California
United States	Local Institution	Ft. Lauderdale	Florida
United States	Local Institution	Hialeah	Florida
United States	Local Institution	Honolulu	Hawaii
United States	Local Institution	Houston	Texas
United States	Local Institution	Jacksonville	Florida
United States	Local Institution	Kansas City	Kansas
United States	Local Institution	Kansas City	Missouri
United States	Local Institution	Kirkland	Washington
United States	Local Institution	Lake Charles	Louisiana
United States	Local Institution	Lexington	Kentucky
United States	Local Institution	Little Rock	Arkansas
United States	Local Institution	Louisville	Kentucky
United States	Local Institution	Lyndhurst	Ohio
United States	Local Institution	Memphis	Tennessee
United States	Local Institution	Metairie	Louisiana
United States	Local Institution	Miami	Florida
United States	Local Institution	New Orleans	Louisiana
United States	Local Institution	New York	New York
United States	Local Institution	Oklahoma City	Oklahoma
United States	Local Institution	Olean	New York
United States	Local Institution	Orange	California
United States	Local Institution	Orange City	Florida
United States	Local Institution	Philadelphia	Pennsylvania
United States	Local Institution	Riverside	California
United States	Local Institution	Rochester	New York
United States	Local Institution	Rosemead	California
United States	Local Institution	Sacramento	California
United States	Local Institution	Salt Lake City	Utah
United States	Local Institution	San Antonio	Texas
United States	Local Institution	Seattle	Washington
United States	Local Institution	Somerville	Massachusetts
United States	Local Institution	Spokane	Washington
United States	Local Institution	St. Charles	Missouri
United States	Local Institution	Tampa	Florida
United States	Local Institution	Temecula	California
United States	Local Institution	Washington	District of Columbia
United States	Local Institution	Wauwatosa	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Experiencing SAEs	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.	Baseline and Week 23	Yes
Secondary	Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score	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.	Baseline and Week 26	No
Secondary	Change in Young Mania Rating Scale (Y-MRS) Total Score	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).	Baseline and Week 26	No