Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania (R34)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania|
- Change From Baseline in Depression Symptom Severity at 12 Weeks [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]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 Start Date:||June 2009|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo to the Omega-3 given in other group taken twice a day.
Placebo given twice a day which will be compared to Omega 3
Other Name: Olive oil
Active Comparator: Omega 3
Individual omega-3 capsules contain 400 mg EPA and 200 mg DHA & will be taken twice a day.
Drug: OMega 3
Individual omega-3 capsules contain 400 mg EPA and 200 mg DHA taken twice a day
Other Name: Fish oil
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917501
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45219|
|Principal Investigator:||Melissa DelBello, MD||University of Cincinnati|
|Principal Investigator:||Robert McNamara, PhD||University of Cincinnati|