Aripiprazole in Adolescents With Schizophrenia

Schizophrenia Clinical Trial

— APEX 239  

Official title:

Aripiprazole in Adolescents With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102063
• Other study ID #: 31-03-239
• Status: Completed
• Phase: Phase 3
• First received: January 19, 2005
• Last updated: August 6, 2012
• Start date: July 2004
• Est. completion date: August 2006

Study information

• Verified date: August 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 trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• Primary diagnosis of Schizophrenia 1

Exclusion Criteria:

• Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Aripiprazole tablet, 10 mg
Aripiprazole tablet 10 mg po qd x 42 days
• Aripiprazole tablet, 30 mg
Aripiprazole tablet 30 mg po qd x 42 days
• Placebo tablet
Placebo tablet po qd x 42 days

Locations

Country	Name	City	State
Puerto Rico	Local Institution	Rio Piedras
Puerto Rico	Local Institution	San Juan
United States	Local Institution	Altamonte Springs	Florida
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 Township	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	Flowood	Mississippi
United States	Local Institution	Ft. Lauderdale	Florida
United States	Local Institution	Gainesville	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	Missouri
United States	Local Institution	Kansas City	Kansas
United States	Local Institution	Kirkland	Washington
United States	Local Institution	Lake Charles	Louisiana
United States	Local Institution	Las Vegas	Nevada
United States	Local Institution	Lexington	Kentucky
United States	Local Institution	Little Rock	Arkansas
United States	Local Institution	Los Angeles	California
United States	Local Institution	Lyndhurst	Ohio
United States	Local Institution	Medford	Massachusetts
United States	Local Institution	Memphis	Tennessee
United States	Local Institution	Miami	Florida
United States	Local Institution	National City	California
United States	Local Institution	New Orleans	Louisiana
United States	Local Institution	New York	New York
United States	Local Institution	Newnan	Georgia
United States	Local Institution	North Miami	Florida
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	Pasadena	California
United States	Local Institution	Philadelphia	Pennsylvania
United States	Local Institution	Richmond	Virginia
United States	Local Institution	Rochester	New York
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	San Diego	California
United States	Local Institution	Smyrna	Georgia
United States	Local Institution	Spokane	Washington
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.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score	Change from baseline to last observed post-baseline value in PQLES total score, using the last observation carried forward.; Scale consists of 14 items pertaining to daily life activities and satisfaction, and an overall assessment item. Each item will be rated on a five-point scale (1=very poor, 2=poor, 3=fair, 4=good, 5=very good) with a minimum score of 14 (better outcome) and a maximum score of 70 (worse outcome).	Baseline and Day 42	No
Other	Patients Achieving Remission	The number of subjects achieving remission. Remission was defined as a score of mild or less (= 3) for items P1, P2, P3, N1, N4, N6, G5, and G9 in the PANSS score.	Baseline and Day 42	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No