CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00854737
NCT00854737Phase 2Completed

A Combination of Cytidine and Omega-3 Fatty Acids in Bipolar Disorder: Are There Additive or Synergistic Mood Stabilizing Effects?

Mclean Hospital·interventional·Posted Mar 3, 2009·Updated Apr 20, 2012

In Brief

A Phase 2 clinical trial evaluating cytidine, omega-3 fatty acids, and 1 other intervention for Bipolar Disorder. Completed, enrolled 90 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 3, 2009
Enrollment StartJul 1, 2004
Primary CompletionAug 1, 2007
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.3 years ago

Interventions

cytidinedietary

cytidine (2g po daily for 4 months)

omega-3 fatty acidsdietary

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

placebodrug

sugar pill