Status:
COMPLETED
Omega-3 Fatty Acids in Children and Adolescents With Bipolar Disorder
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Bipolar Disorder
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief 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. ...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00252486
Start Date
November 1 2001
End Date
June 1 2005
Last Update
June 19 2013
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14642