Back to resultsAripiprazole Open-Label, Safety and Tolerability Study (APEX 241)
Primary Purpose
Schizophrenia, Bipolar Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Open Label, Aripiprazole, Bipolar I Disorder, Manic or Mixed Episode
Eligibility Criteria
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
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NCT00102063 and NCT00110461 Subjects
Arm Description
All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
Full Information
NCT ID
NCT00102518
First Posted
January 29, 2005
Last Updated
July 31, 2012
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00102518
Brief Title
Aripiprazole Open-Label, Safety and Tolerability Study
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder
Keywords
Open Label, Aripiprazole, Bipolar I Disorder, Manic or Mixed Episode
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
325 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NCT00102063 and NCT00110461 Subjects
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
OPC-14597
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of Subjects Experiencing SAEs
Description
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.
Time Frame
Baseline and Week 23
Secondary Outcome Measure Information:
Title
Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Description
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.
Time Frame
Baseline and Week 26
Title
Change in Young Mania Rating Scale (Y-MRS) Total Score
Description
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).
Time Frame
Baseline and Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
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Birmingham
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Little Rock
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Elmsford
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Wauwatosa
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United States
12. IPD Sharing Statement
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Aripiprazole Open-Label, Safety and Tolerability Study
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