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Sponsors and Collaborators: |
Mclean Hospital Stanley Medical Research Institute |
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Information provided by: | Mclean Hospital |
ClinicalTrials.gov Identifier: | NCT00854737 |
The goal of the proposed clinical trial is to assess the effect of oral cytidine and omega-3 fatty acids (O3FA) on bipolar disorder symptoms. This study is a 4-month, randomized, parallel-group, double-blind, placebo-controlled pilot study of a combination of cytidine and omega-3 fatty acids in 90 recently ill subjects with bipolar disorder. During the 16 week period of the study, subjects are assigned to one of three groups: 1) omega-3 fatty acids + cytidine supplementation, 2) omega-3 fatty acids supplementation alone, and 3) placebo supplementation.
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder |
Dietary Supplement: cytidine Dietary Supplement: omega-3 fatty acids Dietary Supplement: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Combination of Cytidine and Omega-3 Fatty Acids in Bipolar Disorder: Are There Additive or Synergistic Mood Stabilizing Effects? |
Enrollment: | 90 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | August 2009 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Omega-3 fatty acid and cytidine supplementation
|
Dietary Supplement: cytidine
cytidine (2g po daily for 4 months)
Dietary Supplement: omega-3 fatty acids
omega-3 fatty acids (4g po daily for 4 months)
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2: Active Comparator
omega-3 fatty acid supplementation
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Dietary Supplement: omega-3 fatty acids
omega-3 fatty acids (4g po daily for 4 months)
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3: Placebo Comparator
placebo supplementation
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Dietary Supplement: placebo
placebo
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Previous studies examining the effect of omega-3 fatty acids on bipolar depression have had mixed results. Some studies have found that omega-3 fatty acids have a positive effect on bipolar depression symptoms, while other studies have found no difference between placebo and omega-3 fatty acid treatment.
The variable effects noted with omega-3 fatty acids may be due in part to a real effect with limited potency.
Larger effects might be achieved by combining agents with synergistic effects.
Cytidine is necessary to form key intermediates in the biosynthesis of the phospholipids phosphatidylcholine and phosphatidylethanolamine, which are major components of eukaryotic cell membranes. Recent human studies by our group have shown that CDP-choline (a compound composed of cytidine and choline) can modify brain phospholipid synthesis in healthy adults and may have antidepressant effects (Babb et al., 1996; Babb et al., 2002; Carlezon et al., 2002; Renshaw et al., 1999). The combination of omega-fatty acids and the related pyrimidine, uridine, was associated with enhanced antidepressant-like activity in rats (Carlezon et al., 2005). Thus, the combination of omega-3 fatty acid and cytidine, which is interconverted with uridine in the body, may provide a safe and powerful way to treat bipolar disorder, especially bipolar depression.
This study is a 4-month, randomized, parallel-group, double-blind, placebo-controlled pilot study of a combination of cytidine and omega-3 fatty acids in 90 recently ill subjects with bipolar disorder. During the 16 week period of the study, subjects are assigned to one of three groups: 1) omega-3 fatty acids + cytidine supplementation, 2) omega-3 fatty acids supplementation alone, and 3) placebo supplementation.
Ages Eligible for Study: | 18 Years to 55 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, New Jersey | |
Jersey Shore University Medical Center | |
Neptune, New Jersey, United States, 07753 |
Principal Investigator: | Beth L Murphy, MD, PhD | Mclean Hospital |
Responsible Party: | McLean Hospital ( Beth Murphy MD, PhD ) |
Study ID Numbers: | 2009-P-000149 |
Study First Received: | February 27, 2009 |
Last Updated: | February 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00854737 History of Changes |
Health Authority: | United States: Food and Drug Administration |
bipolar disorder bipolar depression bipolar mania manic depression |
depression mania hypomania |
Affective Disorders, Psychotic Depression Mental Disorders Bipolar Disorder |
Omega 3 Fatty Acid Mood Disorders Psychotic Disorders Depressive Disorder |
Affective Disorders, Psychotic Pathologic Processes Disease |
Mental Disorders Bipolar Disorder Mood Disorders |