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Sponsors and Collaborators: |
University of Pittsburgh Bristol-Myers Squibb |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00665444 |
The proposed study is a non-randomized, open label trial that will examine the potential to reduce metabolic risk factors in patients with bipolar I disorder and improve psychiatric and functional outcomes. To accomplish our objective, we plan to conduct a 5-month intervention of 50 obese or overweight adults diagnosed with bipolar disorder. The study will be divided in three steps: Screening, Baseline Period (cross taper to aripiprazole, up to 2 months in duration), Months 1-3 (continued aripiprazole treatment). Subjects will be assessed and meet with their study psychiatrist at least bi-monthly throughout their participation, more frequently when clinically necessary (e.g. during medication tapering or if manic/depressive symptoms emerge). Brief clinical assessments will be conducted at each visit. More thorough assessments will be conducted at Baseline, Week 2, and Month 3.
Condition | Intervention |
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Bipolar Disorder Metabolic Syndrome |
Drug: Aripiprazole |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Reducing Medical Risks in Individuals With Bipolar Disorder: Enhancing Outcomes With Aripiprazole |
Estimated Enrollment: | 50 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Aripiprazole
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Drug: Aripiprazole
All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joan Buttenfield, RN | 412-246-5566 | ButtenfieldJA@upmc.edu |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 |
Responsible Party: | University of Pittsburgh ( Holly Swartz, M.D. ) |
Study ID Numbers: | BMS.WPIC.I#0008449 |
Study First Received: | April 21, 2008 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00665444 |
Health Authority: | United States: Institutional Review Board |
bipolar disorder sedation overweight Abilify medication |
Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Mood Disorders |
Psychotic Disorders Overweight Aripiprazole |
Tranquilizing Agents Pathologic Processes Disease Therapeutic Uses Syndrome Physiological Effects of Drugs |
Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |