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

June 17, 2013 updated by: University of Rochester

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Omega-3 Research Institute, Bethesda, MD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Young Mania Rating Scale (YMRS)
Time Frame: EOW 2,4,6,8,10,12,16
EOW 2,4,6,8,10,12,16
Children's Depression Rating Scale (CDRS-R)
Time Frame: EOW 2,4,6,8,10,12,16
EOW 2,4,6,8,10,12,16
Clinical Global Impression - Bipolar Version (CGI)
Time Frame: EOW 2,4,6,8,10,12,16
EOW 2,4,6,8,10,12,16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Stanley Medical Research Institute

Investigators

  • Principal Investigator: Barbara L Gracious, MD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

November 9, 2005

First Submitted That Met QC Criteria

November 9, 2005

First Posted (Estimate)

November 11, 2005

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00-266

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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