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NCT00001146 · ClinicalTrials.gov registry record · Phase 2
Omega-3 Fatty Acids in the Treatment of Bipolar Disorder: A Double-Blind, Placebo-Controlled Trial
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
NCT00001146 is a Phase 2 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 240 participants.
The verdict
NCT00001146, a Phase 2 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
Study Summary
This study will examine the effectiveness of omega-3 fatty acids, compounds found in plants and fish, in treating bipolar disorder. Some studies have indicated that omega-3 fatty acids may be effective in treating mood disorders. For example, one investigator has shown a correlation between the prevalence of major depression and the amount of fish consumed per capita worldwide. Others have found decreased amounts of EPA (one of the active ingredients in omega-3 fatty acids) in the red blood cells of patients with major depression. And a recent small study of patients with bipolar illness indicated that omega-3 fatty acids prevented relapses, especially of depression, in patients. Patients with bipolar disorder who are not benefiting satisfactorily on their current medications are eligible to participate in this study. Candidates will be screened with a psychiatric evaluation, routine blood tests, a urine test and other tests needed to monitor medications. Participants will be randomly assigned to one of two groups: one group will receive 6 grams of omega-3 fatty acid every day for 16 weeks; the second will receive a placebo (inactive capsule). In addition, patients in both groups will continue to take their previous medications. Every 2 weeks, all patients will have their vital signs checked and be evaluated for side effects and mood changes. At the end of the 16-week study period, all patients will be given the opportunity to continue in the study for another 8 months and receive active drug (omega-3 fatty acid). Patients who continue will be evaluated once a month and will have blood drawn on the last visit for routine tests.
Interventions
- DRUG Ethyl Eicosapentaenoic Acid
- DRUG OmegaBrite
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 1999-10 |
| Est. Completion | 2002-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001146
The ClinicalTrials.gov registry entry for NCT00001146 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ethyl Eicosapentaenoic Acid is the first listed.
NCT00001146 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001146 about?
NCT00001146 is a clinical study titled "Omega-3 Fatty Acids in the Treatment of Bipolar Disorder: A Double-Blind, Placebo-Controlled Trial". This study will examine the effectiveness of omega-3 fatty acids, compounds found in plants and fish, in treating bipolar disorder. Some studies have indicated that omega-3 fatty acids may be effective in treating mood disorders. For example, one investigator has shown a correlation between the pr...
What is the current status of trial NCT00001146?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 1999-10. Estimated completion is 2002-08.
What interventions are being tested in trial NCT00001146?
The interventions under investigation include: Ethyl Eicosapentaenoic Acid (DRUG), OmegaBrite (DRUG).
Who is sponsoring clinical trial NCT00001146?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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