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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by University of Rochester.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00252486
First received: November 9, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted
  Purpose

The purpose of this study is to test the hypothesis that omega-3 fatty acids will be superior to placebo in the maintenance treatment of bipolar disorder in chilsren and adolescents. Condition 1, supplementation with omega-3 fatty acids, will be compared to Condition 2, supplementation with placebo (olive oil).


Condition Intervention
Bipolar Disorder
 Drug: Omega-3 Fatty acids - Flax seed oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Further study details as provided by University of Rochester:

Estimated Enrollment: 44
Study Start Date: November 2001
Estimated Study Completion Date: June 2005
  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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00252486     History of Changes
Other Study ID Numbers: 00-266
Study First Received: November 9, 2005
Last Updated: November 9, 2005
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
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013