Aripiprazole Open-Label, Safety and Tolerability Study
APEX 241
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
1 other identifier
interventional
325
1 country
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started Sep 2004
Typical duration for phase_3 schizophrenia
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 29, 2005
CompletedFirst Posted
Study publicly available on registry
January 31, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedResults Posted
Study results publicly available
August 31, 2012
CompletedAugust 31, 2012
July 1, 2012
2.4 years
January 29, 2005
May 16, 2012
July 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Baseline and Week 26
Change in Young Mania Rating Scale (Y-MRS) Total Score
Baseline and Week 26
Study Arms (1)
NCT00102063 and NCT00110461 Subjects
EXPERIMENTALAll subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239).
Interventions
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
Eligibility Criteria
You may qualify if:
- Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode
You may not qualify if:
- Patients with a co-morbid serious, uncontrolled systemic illness
- Patients with a significant risk of committing suicide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Local Institution
Birmingham, Alabama, United States
Local Institution
Little Rock, Arkansas, United States
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Costa Mesa, California, United States
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Fresno, California, United States
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Orange, California, United States
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Riverside, California, United States
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Rosemead, California, United States
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Sacramento, California, United States
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Temecula, California, United States
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Washington D.C., District of Columbia, United States
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Altamonte Springs, Florida, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orange City, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Kansas City, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Lake Charles, Louisiana, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Somerville, Massachusetts, United States
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Clinton, Michigan, United States
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Kansas City, Missouri, United States
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Saint Charles, Missouri, United States
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Elmsford, New York, United States
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New York, New York, United States
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Olean, New York, United States
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Rochester, New York, United States
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Chapel Hill, North Carolina, United States
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Cleveland, Ohio, United States
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Lyndhurst, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Bala-Cynwyd, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Memphis, Tennessee, United States
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Bellaire, Texas, United States
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DeSoto, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Kirkland, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Wauwatosa, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Margaretta Nyilas
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2005
First Posted
January 31, 2005
Study Start
September 1, 2004
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
August 31, 2012
Results First Posted
August 31, 2012
Record last verified: 2012-07