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A Comparison of Omega-3 Fatty Acids vs. Placebo in Children and Adolescents With Bipolar Disorder

ClinicalTrials.gov · COMPLETED, 2005

65 participants

Abstract

The purpose of this study is to test the hypothesis that flax oil, as an omega-3 fatty acid, will be superior to placebo in the maintenance treatment of bipolar disorder in children and adolescents.

Our primary objective was to determine if flax oil is efficacious in the pediatric bipolar population for reducing symptoms of mania and depression. A secondary objective was to examine fatty acid levels as predictors of treatment response and symptom severity. This clinical trial evaluated whether supplementation with flax oil, containing the omega-3 fatty acid alpha-linolenic acid (alpha-LNA), safely reduced symptom severity in youth with bipolar disorder.

Conditions: Bipolar Disorder.

Primary outcome: Young Mania Rating Scale (YMRS); Children's Depression Rating Scale (CDRS-R); Clinical Global Impression - Bipolar Version (CGI).

Enrollment: 65 participants.

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 65 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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