Aripiprazole Open-Label, Safety and Tolerability Study (APEX 241)
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| ClinicalTrials.gov Identifier: NCT00102518 |
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Recruitment Status :
Completed
First Posted : January 31, 2005
Results First Posted : August 31, 2012
Last Update Posted : August 31, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia Bipolar Disorder | Drug: Aripiprazole | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 325 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239).
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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
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).
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| Ages Eligible for Study: | 10 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
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| Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| ClinicalTrials.gov Identifier: | NCT00102518 |
| Other Study ID Numbers: |
31-03-241 |
| First Posted: | January 31, 2005 Key Record Dates |
| Results First Posted: | August 31, 2012 |
| Last Update Posted: | August 31, 2012 |
| Last Verified: | July 2012 |
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Open Label Aripiprazole Bipolar I Disorder, Manic or Mixed Episode |
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Schizophrenia Bipolar Disorder Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Bipolar and Related Disorders Aripiprazole Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |
Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Dopamine D2 Receptor Antagonists Dopamine Antagonists |