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NCT00312897 · ClinicalTrials.gov registry record · Phase 2
Omega-3 Fatty Acids in Adolescent Depression
A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT00312897 is a Phase 2 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 57 participants.
The verdict
NCT00312897, a Phase 2 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
Aim. To provide preliminary data about the efficacy of omega-3FA in the treatment of adolescent MDD. To address this aim, a 10-week double blind, placebo-controlled study of omega-3FA, using a flexible dose titration is proposed. Primary outcome measures will be: (1) change in the total score of the Children's Depression Rating Scale-Revised (CDRS-R) at the end of treatment (2) response rate on the Clinical Global Improvement scale (CGI) at the end of 10-week treatment. Hypothesis. Omega-3FA treatment in adolescents with MDD will result in a significant reduction of CDRS-R total scores, and a significantly higher improvement rate on the CGI at the end of treatment compared to placebo.
Interventions
- DRUG Omega-3 Fatty Acids
- DRUG corn oil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2005-12 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00312897
The ClinicalTrials.gov registry entry for NCT00312897 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Omega-3 Fatty Acids is the first listed.
NCT00312897 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00312897 about?
NCT00312897 is a clinical study titled "Omega-3 Fatty Acids in Adolescent Depression". Aim. To provide preliminary data about the efficacy of omega-3FA in the treatment of adolescent MDD. To address this aim, a 10-week double blind, placebo-controlled study of omega-3FA, using a flexible dose titration is proposed. Primary outcome measures will be: (1) change in the total score of the...
What is the current status of trial NCT00312897?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2005-12. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00312897?
The interventions under investigation include: Omega-3 Fatty Acids (DRUG), corn oil (DRUG).
Who is sponsoring clinical trial NCT00312897?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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