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Sponsored by: |
Tuscaloosa Research & Education Advancement Corporation |
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Information provided by: | Tuscaloosa Research & Education Advancement Corporation |
ClinicalTrials.gov Identifier: | NCT00451542 |
This study is a retrospective chart review of patients treated for bipolar disorder at the TVAMC in the past four years cross-referenced with the electronic pharmacy file for having received a prescription of divalproex or lamotrigine.
Study Type: | Observational |
Study Design: | Natural History, Cross-Sectional, Defined Population, Retrospective Study |
Official Title: | Time to Relapse During Treatment With Divalproex vs. Lamotrigine for Bipolar Disorder |
Estimated Enrollment: | 1000 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | February 2008 |
The primary objective of the study is to assess the long-term outcome in bipolar patients treated with divalproex versus lamotrigine in a retrospective chart review of veterans as measured by time to relapse into any significant mood episode (i.e. mania or depression). The primary hypothesis is that bipolar patients will demonstrate significantly greater time to relapse in those treated with divalproex compared to those treated with lamotrigine. The secondary objective of the study is to assess the safety and relative tolerability of divalproex and lamotrigine in this population based on discontinuation due to side or adverse effect.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 0063 |
Study First Received: | March 21, 2007 |
Last Updated: | March 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00451542 |
Health Authority: | United States: Institutional Review Board |
Bipolar Disorder Relapse Retropspective |
Calcium, Dietary Affective Disorders, Psychotic Mental Disorders Bipolar Disorder |
Lamotrigine Mood Disorders Psychotic Disorders |
Membrane Transport Modulators Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Calcium Channel Blockers Cardiovascular Agents Central Nervous System Agents Anticonvulsants Pharmacologic Actions |