Cytidine and Omega-3 Fatty Acids in Bipolar Disorder
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Purpose
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 Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Combination of Cytidine and Omega-3 Fatty Acids in Bipolar Disorder: Are There Additive or Synergistic Mood Stabilizing Effects? |
- Mood Rating Scale Scores [ Time Frame: weekly-biweekly ] [ Designated as safety issue: No ]
- Study Retention Time [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- functional recovery [ Time Frame: weekly-biweekly ] [ Designated as safety issue: No ]
| Enrollment: | 90 |
| Study Start Date: | July 2004 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
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)
|
|
Active Comparator: 2
omega-3 fatty acid supplementation
|
Dietary Supplement: omega-3 fatty acids
omega-3 fatty acids (4g po daily for 4 months)
|
|
Placebo Comparator: placebo
placeno or sugar pill
|
Drug: placebo
sugar pill
Other Name: arm 2 and 3
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- bipolar disorder
- mood episode within past year
- stable medication regimen
Exclusion Criteria:
- primary psychiatric disorder other than bipolar disorder
- significant suicide or homicide risk
- unstable medical conditions
- current or planned pregnancy
- lactose intolerance
- medications affecting lipid absorption or metabolism
- clozapine treatment
Contacts and Locations| 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 |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Beth L. Murphy MD, PhD, Investigator, Mclean Hospital |
| ClinicalTrials.gov Identifier: | NCT00854737 History of Changes |
| Other Study ID Numbers: | 2009-P-000149 |
| Study First Received: | February 27, 2009 |
| Last Updated: | April 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mclean Hospital:
|
bipolar disorder bipolar depression bipolar mania manic depression |
depression mania hypomania |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013