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Sponsors and Collaborators: |
National Center for Complementary and Alternative Medicine (NCCAM) Pronova Biocare |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00010868 |
This is a 12 month study of omega-3 fatty acids in bipolar disorder. This study will be a 12-month, parallel group, double-blind comparison of the prophylactic efficacy of omega-3 fatty acids vs. placebo in 120 bipolar I patients. All subjects entering the primary prophylactic study will be euthymic or have only subsyndromal mood symptoms for at least 4 weeks. In addition, their concomitant medication (only lithium, divalproex, or no medication will be permitted) will also be stable and at accepted therapeutic levels for at least 4 weeks. An 8-week lead-in phase will be available to subjects who do not meet the current symptom and concomitant medication inclusion criteria (however, subjects must meet all of the other inclusion/exclusion criteria): 1. 4 weeks of euthymic or subsyndromal mood. 2. Subjects who are not already receiving lithium or divalproex. 3. Subjects receiving other psychotropic medications.
Condition | Intervention | Phase |
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Bipolar Disorder |
Drug: Omega-3 Fatty Acids |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Parallel Assignment |
Official Title: | Omega-3 Fatty Acids in Bipolar Disorder Prophylaxis |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
McLean Hospital | |
Belmont, Massachusetts, United States, 02478 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Andrew L. Stoll, M.D. | Mclean Hospital |
Study ID Numbers: | R01 AT000161-02 |
Study First Received: | February 2, 2001 |
Last Updated: | August 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00010868 History of Changes |
Health Authority: | United States: Federal Government |
bipolar disorder omega-3 fatty acids eicosapentaenoic acid docosahexaenoic acid |
Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Mood Disorders Psychotic Disorders |
Affective Disorders, Psychotic Pathologic Processes Disease |
Mental Disorders Bipolar Disorder Mood Disorders |