Omega-3 Fatty Acids in Children and Adolescents With Bipolar Disorder
Completed · Not applicable · Has a placebo group
Conditions studied: Bipolar Disorder
In brief
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.
Key facts
- Study ID
- NCT00252486
- Run by
- University of Rochester
- People needed
- 65
- Starts
- 2001-11-01
- Expected to finish
- 2005-06-01
- Last updated by the study team
- 2013-06-19
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Rochester — Rochester, New York, United States
Full record on ClinicalTrials.gov
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