Cytidine and Omega-3 Fatty Acids in Bipolar Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Omega-3 fatty acid and cytidine supplementation

Group Type ACTIVE_COMPARATOR

cytidine

Intervention Type DIETARY_SUPPLEMENT

cytidine (2g po daily for 4 months)

omega-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

omega-3 fatty acids (4g po daily for 4 months)

2

omega-3 fatty acid supplementation

Group Type ACTIVE_COMPARATOR

omega-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

omega-3 fatty acids (4g po daily for 4 months)

placebo

placeno or sugar pill

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

sugar pill

Interventions

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cytidine

cytidine (2g po daily for 4 months)

Intervention Type DIETARY_SUPPLEMENT

omega-3 fatty acids

omega-3 fatty acids (4g po daily for 4 months)

Intervention Type DIETARY_SUPPLEMENT

placebo

sugar pill

Intervention Type DRUG

Other Intervention Names

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arm 2 and 3

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No