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Clinical Trials/NCT00917501
NCT00917501
Completed
Phase 2

Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania

University of Cincinnati1 site in 1 country55 target enrollmentJune 2009
ConditionsMania
InterventionsPlaceboOMega 3

Overview

Phase
Phase 2
Intervention
Placebo
Conditions
Mania
Sponsor
University of Cincinnati
Enrollment
55
Locations
1
Primary Endpoint
Change From Baseline in Depression Symptom Severity at 12 Weeks
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to see if taking a substance called omega-3 fatty acids is effective, safe, and well-tolerated for treating adolescents with major depressive disorder (also called simply "depression" or "clinical depression"). Another purpose of this study is to see how much omega-3 fatty acids are in a patient's blood and if that makes the patient more or less likely to develop mania (i.e. periods of irritability or extreme silliness accompanied by decreased need for sleep, risky behaviors, feeling like the patient has special abilities, inability to sit still, and rapid speech) in the future. Yet another purpose of this study is to see how taking omega-3 fatty acids affect brain scans. Omega-3 fatty acids are not United States Food and Drug Administration (FDA)-approved to treat depression in adults or in children and adolescents.

Omega-3 fatty acids can only be obtained through diet, most often from fish and other sea foods, though they are also found in other food sources such as flax seed. Omega-3 fatty acids have been shown to play a role in affecting brain chemicals responsible for regulating mood and have been found to reduce symptoms of depression in medicated-patients with major depressive disorder.

By completing this study, the investigators hope to better understand who benefits from treatment, why they do or do not respond to medications, and who is at greater risk for developing further mental illness. With this information, the investigators hope to be able to improve treatment and outcome in people with major depressive disorder.

Detailed Description

A. Specific Aims: (1) To collect pilot data regarding the efficacy, safety, and tolerability of omega-3 fatty acid supplementation for the treatment of adolescents with active depressive symptoms and a high risk for developing mania (i.e. the patient has a bipolar parent and meet DSM-IV-TR criteria for major depressive disorder). (2) To use proton magnetic resonance spectroscopy (1H MRS) (i.e. prefrontal neurochemistry) and red blood cell (RBC) omega-3 fatty acid levels to examine potential mediators of treatment response to omega-3 fatty acids in adolescents with a high risk for mania.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
July 2013
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert McNamara

Professor

University of Cincinnati

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Placebo

Placebo to the Omega-3 given in other group taken twice a day.

Intervention: Placebo

Omega 3

Individual omega-3 capsules contain 400 mg EPA and 200 mg DHA \& will be taken twice a day.

Intervention: OMega 3

Outcomes

Primary Outcomes

Change From Baseline in Depression Symptom Severity at 12 Weeks

Time Frame: Baseline and 12 weeks

Change in Children's Depression Rating Scale-revised (CDRS-R) Total Score from Baseline to 12 weeks CDRS-R score ranges from 17 (i.e., not depressed) to 113 (i.e., severe depression)

Study Sites (1)

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