Evaluation of Omega-3 Fatty Acids as a Treatment-adjunct in Adolescent Patients With Major Depressive Disorder Exhibiting Partial Response to SSRI Medications: An Open-label Neuroimaging Trial
Sponsor study identifier
interventional
20
1 country
1
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2011
Actual (reported)Study Completion
March 2011
Actual (reported)The primary objective of the study was to determine the effects of 10-week adjunctive supplementation with 2 doses of LCn-3 fatty acids (fish oil) on cortical functional activity and biochemistry in adolescents with MDD. The primary prediction was that LCn-3 fatty acid supplementation would dose-dependently increase prefrontal cortical functional activation during sustained attention and increase regional biochemical indices of cortical metabolism and integrity concentrations in association with reductions in depressive symptoms.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
August 3, 2007
Actual (reported)August 6, 2007
Actual (reported)March 2011
Actual (reported)March 2011
Actual (reported)December 4, 2014
Actual (reported)Mood Symptoms Ratings
Depression symptom severity was determined with the Children's Depression Rating Scale-Revised (CDRS-R), which is a brief rating scale based on a semi-structured interview with the child. It is a 17-item observer-rated questionnaire where the 17 symptom areas are rated on a 6- or 7-point scale. Total score ranges from a low (not depressed) of 17 to a maximum (very depressed) of 108. Remission was defined as a CDRS-R score of \<28. (The total score is the sum of the ratings on each of the 17 items.)
10 weeks
Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)
Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)
Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Robert McNamara, PhD
University of Cincinnati
20 participants (actual enrollment reported by the registry).
First Submitted
August 3, 2007
First Posted
August 6, 2007
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
A Paroxetine- and Placebo-Controlled Study of 50 mg/Day and 100 mg/Day of EB-1010 Among Outpatients With Major Depressive Disorder Who Have Responded Inadequately to Prior Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)
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Primary Completion
March 2011
Actual (reported)Study Completion
March 2011
Actual (reported)Last Updated
May 27, 2016
Results First Posted
December 4, 2014
Record last verified: 2016-04
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Source: ClinicalTrials.gov.
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