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Omega-3 Fatty Acids in Bipolar Disorder

NCT00010868 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2006-08-18

No results posted yet for this study

Summary

This is a 12 month study of omega-3 fatty acids in bipolar disorder. This study will be a 12-month, parallel group, double-blind comparison of the prophylactic efficacy of omega-3 fatty acids vs. placebo in 120 bipolar I patients. All subjects entering the primary prophylactic study will be euthymic or have only subsyndromal mood symptoms for at least 4 weeks. In addition, their concomitant medication (only lithium, divalproex, or no medication will be permitted) will also be stable and at accepted therapeutic levels for at least 4 weeks. An 8-week lead-in phase will be available to subjects who do not meet the current symptom and concomitant medication inclusion criteria (however, subjects must meet all of the other inclusion/exclusion criteria): 1. 4 weeks of euthymic or subsyndromal mood. 2. Subjects who are not already receiving lithium or divalproex. 3. Subjects receiving other psychotropic medications.

Conditions

Interventions

DRUG

Omega-3 Fatty Acids

Sponsors & Collaborators

  • Pronova BioPharma

    collaborator INDUSTRY

  • National Center for Complementary and Integrative Health (NCCIH)

    lead NIH

Principal Investigators

  • Andrew L. Stoll, M.D. · Mclean Hospital

Study Design

Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-07-31
Completion
2004-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00010868 on ClinicalTrials.gov