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
  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?

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Mood Rating Scale Scores [ Time Frame: weekly-biweekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854737

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
Sponsors and Collaborators
Mclean Hospital
Stanley Medical Research Institute
Investigators
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 July 20, 2014