CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
OMega 3 +1 moredrug
Likely dose
OMega 3 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00917501
NCT00917501Phase 2Completed

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

University of Cincinnati·interventional·Posted Jun 10, 2009·Updated Nov 13, 2019

In Brief

A Phase 2 clinical trial evaluating OMega 3 and Placebo for Mania. Completed, enrolled 55 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMania
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 10, 2009
Enrollment StartJun 1, 2009
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 17.1 years ago

Interventions

OMega 3drug

Individual omega-3 capsules contain 400 mg EPA and 200 mg DHA taken twice a day

Placebodrug

Placebo given twice a day which will be compared to Omega 3