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Sponsored by: |
University Hospitals of Cleveland |
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Information provided by: | University Hospitals of Cleveland |
ClinicalTrials.gov Identifier: | NCT00221975 |
Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling: This study recruits males and females age 18 and older who currently meet diagnostic criteria for rapid cycling bipolar disorder (type I or II) and who have met the criteria for substance abuse or dependence of cocaine, marijuana and/or alcohol within the past six months. Patients begin treatment with a combination of lithium and divalproex. Once these medications are tolerated, they are randomly assigned to double-blind treatment with lamotrigine or placebo. Patients remain in this study until they experience a marked bimodal response for four consecutive weeks. This study is sponsored by the Stanley Foundation.
Condition | Intervention | Phase |
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Bipolar Disorder |
Drug: Divalproex Drug: Lamotrigine Drug: Lithium |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Combination Therapy in Dual Diagnosis Rapid Cycling Bipolar Disorder |
Ages Eligible for Study: | 16 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
University Hospitals of Cleveland | |
Cleveland, Ohio, United States, 44106 |
Principal Investigator: | Keming Gao, MD, PhD | Case Western Reserve University / University Hospitals of Cleveland |
Responsible Party: | Case Western Reserve University / University Hospitals of Cleveland ( Keming Gao, MD, PhD ) |
Study ID Numbers: | 02T 183 |
Study First Received: | September 13, 2005 |
Last Updated: | December 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00221975 History of Changes |
Health Authority: | United States: Institutional Review Board |
Calcium, Dietary Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Lamotrigine Mood Disorders |
Calcium Channel Blockers Lithium Carbonate Psychotic Disorders Cardiovascular Agents Anticonvulsants Lithium |
Disease Molecular Mechanisms of Pharmacological Action Bipolar Disorder Calcium Channel Blockers Cardiovascular Agents Pharmacologic Actions Membrane Transport Modulators Affective Disorders, Psychotic |
Pathologic Processes Mental Disorders Therapeutic Uses Mood Disorders Lamotrigine Central Nervous System Agents Anticonvulsants |