Cytidine and Omega-3 Fatty Acids in Bipolar Disorder

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00854737
First received: February 27, 2009
Last updated: April 19, 2012
Last verified: April 2012

February 27, 2009
April 19, 2012
July 2004
August 2007   (final data collection date for primary outcome measure)
Mood Rating Scale Scores [ Time Frame: weekly-biweekly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00854737 on ClinicalTrials.gov Archive Site
  • Study Retention Time [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • functional recovery [ Time Frame: weekly-biweekly ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cytidine and Omega-3 Fatty Acids in Bipolar Disorder
A Combination of Cytidine and Omega-3 Fatty Acids in Bipolar Disorder: Are There Additive or Synergistic Mood Stabilizing Effects?

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar Disorder
  • 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)
  • Drug: placebo
    sugar pill
    Other Name: arm 2 and 3
  • Active Comparator: 1
    Omega-3 fatty acid and cytidine supplementation
    Interventions:
    • Dietary Supplement: cytidine
    • Dietary Supplement: omega-3 fatty acids
  • Active Comparator: 2
    omega-3 fatty acid supplementation
    Intervention: Dietary Supplement: omega-3 fatty acids
  • Placebo Comparator: placebo
    placeno or sugar pill
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
July 2010
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00854737
2009-P-000149
No
Beth L. Murphy MD, PhD, Mclean Hospital
Mclean Hospital
Stanley Medical Research Institute
Principal Investigator: Beth L Murphy, MD, PhD Mclean Hospital
Mclean Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP