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Sponsors and Collaborators: |
University Hospitals of Cleveland Bristol-Myers Squibb |
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Information provided by: | University Hospitals of Cleveland |
ClinicalTrials.gov Identifier: | NCT00194012 |
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.
Condition | Intervention | Phase |
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Bipolar Disorder |
Drug: abilify |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Aripiprazole in At-Risk Children With Symptoms of Bipolar Disorder |
Estimated Enrollment: | 60 |
Study Start Date: | August 2004 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo: Placebo Comparator |
Drug: abilify
dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
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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.
Ages Eligible for Study: | 5 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Denise Bedoya, MA | 216-844-3922 | denise.bedoya@uhhospitals.org |
Contact: Intake Line, MA | 216-844-3922 |
United States, Ohio | |
University Hospitals Case Medical Center | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Denise Bedoya, MA 216-844-3922 denise.bedoya@uhhospitals.org | |
Contact: Intake Line 216-844-3922 |
Principal Investigator: | Robert L Findling, MD | University Hospitals of Cleveland |
Responsible Party: | University Hospitals Case Medical Center ( Robert L Findling, MD ) |
Study ID Numbers: | At Risk |
Study First Received: | September 11, 2005 |
Last Updated: | July 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00194012 History of Changes |
Health Authority: | United States: Food and Drug Administration |
bipolar disorder |
Affective Disorders, Psychotic Tranquilizing Agents Mental Disorders Bipolar Disorder Psychotropic Drugs |
Mood Disorders Central Nervous System Depressants Psychotic Disorders Aripiprazole Antipsychotic Agents |
Disease Tranquilizing Agents Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions |
Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Mood Disorders Aripiprazole Central Nervous System Agents |