Cytidine and Omega-3 Fatty Acids in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

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.
    

Intervention name(s): cytidine; omega-3 fatty acids; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): cytidine (2g po daily for 4 months); omega-3 fatty acids (4g po daily for 4 months); sugar pill
Other intervention name(s): arm 2 and 3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bipolar disorder; bipolar depression; bipolar mania; manic depression; depression; mania; hypomania