Aripiprazole Open-Label, Safety and Tolerability Study (APEX 241)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00102518|
Recruitment Status : Completed
First Posted : January 31, 2005
Results First Posted : August 31, 2012
Last Update Posted : August 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Bipolar Disorder||Drug: Aripiprazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||325 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2004|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||February 2007|
Experimental: NCT00102063 and NCT00110461 Subjects
All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239).
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
Other Name: OPC-14597
- Percentage of Subjects Experiencing SAEs [ Time Frame: 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.
- Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102518