Omega-3 Fatty Acids in Children and Adolescents With Bipolar Disorder

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: Stanley Medical Research Institute

Criteria

Inclusion Criteria:

• male and female outpatients aged 6-17

• DSM-IV diagnosis of bipolar I or II disorder

• currently symptomatic with a CGI of 3 or greater, Y-MRS of 4 or greater, or CDRS-R of 22 or greater

• have failed stabilization with lithium and valproate combined therapy with therapeutic levels documented or are intolerant to these medications

• ability and willingness to provide assent and informed written consent from at least one parent/ legal guardian

Exclusion Criteria:

• mental retardation (IQ less than 70)

• comorbid autism, pervasive developmental disorder, history of substance abuse or positive toxicology screen, or acute post-traumatic stress disorder

• presence of a serious chronic medical illness

• inability to swallow capsules

• pregnant or sexually active without reliable contraception