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Sponsors and Collaborators: |
Massachusetts General Hospital Bristol-Myers Squibb |
Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00181779 |
This is an open-labeled study of Aripiprazole, testing its efficacy in the treatment of mania in children and adolescents with Bipolar I, Bipolar II and Bipolar Spectrum Disorder over 8 weeks. This is an exploratory, pilot study, seeking to determine whether Aripiprazole is efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum disorder. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Condition | Intervention | Phase |
Bipolar Disorder Mania |
Drug: aripiprazole (Abilify) |
Phase IV |
MedlinePlus related topics: | Bipolar Disorder |
Drug Information available for: | Aripiprazole |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label Pilot Study of Aripiprazole for the Treatment of Mania in Children and Adolescents With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder |
Estimated Enrollment: | 20 |
Study Start Date: | February 2003 |
Study Completion Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Initial clinical evidence suggests that atypical neuroleptics may play a unique therapeutic role in the management of pediatric bipolar disorder. Aripiprazole is a novel neuroleptic recently approved by the FDA for the treatment of schizophrenia, and it has a unique pharmacological profile believed to be fundamentally different from other available antipsychotics. Many previous studies have reported increased efficacy of Aripiprazole compared to placebo. Unfortunately, Aripiprazole has not been investigated in children and adolescents, and as such, safety and efficacy has not been established for these populations.
This is an exploratory, pilot study, seeking to determine whether Aripiprazole is efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum disorder. The study results, gathered from an 8 week open-label treatment period and subsequent 10 month extension period, will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |||||
Massachusetts General Hospital | |||||
Cambridge, Massachusetts, United States, 02138 |
Massachusetts General Hospital |
Bristol-Myers Squibb |
Principal Investigator: | Joseph Biederman, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Joseph Biederman, MD ) |
Study ID Numbers: | 2003-P-000153 |
First Received: | September 13, 2005 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00181779 |
Health Authority: | United States: Food and Drug Administration |
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