Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252486
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2005-11-09
Brief Title:
Omega-3 Fatty Acids in Children and Adolescents With Bipolar Disorder
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
A Comparison of Omega-3 Fatty Acids vs Placebo in Children and Adolescents With Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 n51 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
Children and adolescents aged 6-17 years with symptomatic Bipolar I or II disorder n51 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None