Omega-3 Fatty Acids in Children and Adolescents With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

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.
    

Detailed description: 
      Pediatric bipolar disorder is a difficult-to-treat recurrent mental illness characterized by
      a predominant mood state of irritability, and often mixed, rapid-cycling, and psychotic
      symptoms. Results of randomized controlled trials of lithium, valproic acid, and
      antipsychotics for early onset bipolar disorder offer hope of improvement for many, yet also
      demonstrate need for additional treatment options for those children who do not respond
      adequately to, or cannot tolerate, a first-line mood stabilizer alone or in combination with
      an atypical antipsychotic. As popular over-the-counter dietary supplements, omega-3 fatty
      acids represent an appealing option for treatment in the younger bipolar population as they
      are likely to be better tolerated and cost less compared with conventional mood stabilizing
      agents. In addition, they have appeal to parents and adolescents due to their perception as a
      'natural' substance and relative lack of systemic side effects. To our knowledge, there are
      no prospective, randomized, controlled trials of flax oil for the treatment of bipolar
      disorder or selectively evaluating omega-3 fatty acids in the child and adolescent bipolar
      population.

      Children and adolescents aged 6-17 years with symptomatic Bipolar I or II disorder (n=51),
      manic, hypomanic, mixed, or depressed, were randomized to either flax oil capsules containing
      550 mg alpha-linolenic acid per 1 gram or an olive oil placebo adjunctively or as
      monotherapy. Doses were titrated to 12 capsules per day as tolerated over 16 weeks. Primary
      outcomes included changes in the Young Mania Rating Scale (YMRS), Child Depression Rating
      Scale-Revised (CDRS-R), and Clinical Global Impressions- Bipolar (CGI-BP) ratings using
      Kaplan-Meier survival analyses. Baseline and end-of-study free fatty acids were measured and
      examined for change and relevance to effect.
    

Intervention name(s): Flax oil
Intervention type(s): Drug
Intervention description(s): Flax oil and olive oil placebo were analyzed for quality and purity; sufficient bioactivity was confirmed for the flax oil independently at the University of Massachusetts mid-way through the study. Each capsule of omega -3 fatty acid concentrate contained 550 mg of α-linolenic acid (α-LNA) from flax seed oil.A stepped but flexible dose-titration schedule was carried out with doses increased by 1-2 grams at each visit as tolerated, to an attempted total dose of 6 capsules twice per day, as requested by the FDA (up to 6.6 grams of daily α-linolenic acid).
Other intervention name(s): Omega-3 Research Institute, Bethesda, MD
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar; Omega-3 Fatty acids