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NCT00511810 · ClinicalTrials.gov registry record · Phase 2
Omega-3 Fatty Acids as Adjunct Treatment for Major Depressive Disorder
A Phase 2 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00511810: Completed Phase 2 study, sponsored by University of Cincinnati.
NCT00511810 is a Phase 2 study that has completed, run by University of Cincinnati. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00511810, a Phase 2 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The primary objective of the study was to determine the effects of 10-week adjunctive supplementation with 2 doses of LCn-3 fatty acids (fish oil) on cortical functional activity and biochemistry in adolescents with MDD. The primary prediction was that LCn-3 fatty acid supplementation would dose-dependently increase prefrontal cortical functional activation during sustained attention and increase regional biochemical indices of cortical metabolism and integrity concentrations in association with reductions in depressive symptoms.
Primary Outcome
Depression symptom severity was determined with the Children's Depression Rating Scale-Revised (CDRS-R), which is a brief rating scale based on a semi-structured interview with the child. It is a 17-item observer-rated questionnaire where the 17 symptom areas are rated on a 6- or 7-point scale. Total score ranges from a low (not depressed) of 17 to a maximum (very depressed) of 108. Remission was defined as a CDRS-R score of \<28. (The total score is the sum of the ratings on each of the 17 item
Interventions
- DRUG High Dose Fish Oil
- DRUG Low Dose Fish Oil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-08 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
What the finished NCT00511810 record still lists
NCT00511810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which High Dose Fish Oil is the first listed.
NCT00511810 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00511810 about?
NCT00511810 is a clinical study titled "Omega-3 Fatty Acids as Adjunct Treatment for Major Depressive Disorder". The primary objective of the study was to determine the effects of 10-week adjunctive supplementation with 2 doses of LCn-3 fatty acids (fish oil) on cortical functional activity and biochemistry in adolescents with MDD. The primary prediction was that LCn-3 fatty acid supplementation would dose-de...
What is the current status of trial NCT00511810?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2007-08. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00511810?
The interventions under investigation include: High Dose Fish Oil (DRUG), Low Dose Fish Oil (DRUG).
Who is sponsoring clinical trial NCT00511810?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00511810's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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