Overview

Cytidine and Omega-3 Fatty Acids in Bipolar Disorder

Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mclean Hospital
Collaborator:
Stanley Medical Research Institute
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