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

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00252486
First received: November 9, 2005
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Bipolar Disorder
Drug: Flax oil

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Omega-3 Fatty Acids vs. Placebo in Children and Adolescents With Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Young Mania Rating Scale (YMRS) [ Time Frame: EOW 2,4,6,8,10,12,16 ] [ Designated as safety issue: No ]
  • Children's Depression Rating Scale (CDRS-R) [ Time Frame: EOW 2,4,6,8,10,12,16 ] [ Designated as safety issue: No ]
  • Clinical Global Impression - Bipolar Version (CGI) [ Time Frame: EOW 2,4,6,8,10,12,16 ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: November 2001
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Flax oil, placebo oil Drug: Flax oil
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 Name: Omega-3 Research Institute, Bethesda, MD

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252486

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Stanley Medical Research Institute
Investigators
Principal Investigator: Barbara L Gracious, MD University of Rochester
  More Information

Publications:
Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00252486     History of Changes
Other Study ID Numbers: 00-266
Study First Received: November 9, 2005
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Bipolar
Omega-3 Fatty acids

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014