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Tracking Information | |||||||||
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First Received Date † | September 11, 2005 | ||||||||
Last Updated Date | February 12, 2009 | ||||||||
Start Date † | August 2004 | ||||||||
Current Primary Outcome Measures † |
YMRS [ Time Frame: Baseline and last study visit ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00194012 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † | |||||||||
Original Secondary Outcome Measures † | |||||||||
Descriptive Information | |||||||||
Brief Title † | Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder | ||||||||
Official Title † | Aripiprazole in At-Risk Children With Symptoms of Bipolar Disorder | ||||||||
Brief Summary | The purpose of this study is to test the effectiveness and tolerability/safety of aripiprazole (abilify) in children with subsyndromal symptoms of bipolar disorder who also have a bipolar parent and other family member with a mood disorder. |
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Detailed Description | This will be a double-blind, placebo-controlled, parallel-arm, randomized clinical trial that will last up to 12 weeks. This placebo-controlled portion will be followed by a 6-week open label extension/stabilization phase. In order to be eligible for participation in the extension/stabilization phase, subjects must: 1) in the investigator's opinion have had no dose-limiting side effects likely to be attributable to APZ; 2) participated in the blinded portion of the clinical trial for a minimum of 4 weeks. |
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Study Phase | Phase III | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
Condition † | Bipolar Disorder | ||||||||
Intervention † | Drug: abilify | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 60 | ||||||||
Completion Date | |||||||||
Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
tardive dyskinesia)
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Gender | Both | ||||||||
Ages | 5 Years to 17 Years | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00194012 | ||||||||
Responsible Party | Robert L Findling, MD, University Hospitals Case Medical Center | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | University Hospitals of Cleveland | ||||||||
Collaborators †† | Bristol-Myers Squibb | ||||||||
Investigators † |
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Information Provided By | University Hospitals of Cleveland | ||||||||
Verification Date | February 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |