Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania (R34)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00917501|
Recruitment Status : Completed
First Posted : June 10, 2009
Results First Posted : June 9, 2016
Last Update Posted : June 9, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Mania||Drug: OMega 3 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|