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NCT00116857 · ClinicalTrials.gov registry record · Phase 3
Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors
A Phase 3 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 3
- Development phase
- 122
- Enrollment target
NCT00116857: Completed Phase 3 study, sponsored by Washington University School of Medicine.
NCT00116857 is a Phase 3 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 122 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00116857, a Phase 3 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 122 participants
- Enrollment target
Study Summary
This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline on depression and cardiac endpoints after myocardial infarction (MI).
Primary Outcome
Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment.
Interventions
- DRUG Sertraline/omega-3
- DRUG Sertraline/Corn Oil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2005-02 |
| Est. Completion | 2009-11 |
| Phase | Phase 3 |
What the finished NCT00116857 record still lists
NCT00116857 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Sertraline/omega-3 is the first listed.
NCT00116857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00116857 about?
NCT00116857 is a clinical study titled "Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors". This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline on depression and cardiac endpoints after myocardial infarction (MI).
What is the current status of trial NCT00116857?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 122 participants. The study started on 2005-02. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00116857?
The interventions under investigation include: Sertraline/omega-3 (DRUG), Sertraline/Corn Oil (DRUG).
Who is sponsoring clinical trial NCT00116857?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00116857's enrollment target sits among peer trials
122 1617th of 2000 higher than 382 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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