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NCT00917501 · ClinicalTrials.gov registry record · Phase 2
Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania
A Phase 2 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT00917501 is a Phase 2 study that has completed, run by University of Cincinnati. The registered enrollment target is 55 participants.
The verdict
NCT00917501, a Phase 2 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG OMega 3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2009-06 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00917501
The ClinicalTrials.gov registry entry for NCT00917501 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Cincinnati, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00917501 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00917501 about?
NCT00917501 is a clinical study titled "Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania". 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 fat...
What is the current status of trial NCT00917501?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2009-06. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00917501?
The interventions under investigation include: Placebo (DRUG), OMega 3 (DRUG).
Who is sponsoring clinical trial NCT00917501?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
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