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NCT00010868 · ClinicalTrials.gov registry record · Phase 2
Omega-3 Fatty Acids in Bipolar Disorder
A Phase 2 study, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- Completed
- Registry status
- Phase 2
- Development phase
NCT00010868 is a Phase 2 study that has completed, run by National Center for Complementary and Integrative Health (NCCIH).
The verdict
NCT00010868, a Phase 2 study, has completed, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
Study Summary
This is a 12 month study of omega-3 fatty acids in bipolar disorder. This study will be a 12-month, parallel group, double-blind comparison of the prophylactic efficacy of omega-3 fatty acids vs. placebo in 120 bipolar I patients. All subjects entering the primary prophylactic study will be euthymic or have only subsyndromal mood symptoms for at least 4 weeks. In addition, their concomitant medication (only lithium, divalproex, or no medication will be permitted) will also be stable and at accepted therapeutic levels for at least 4 weeks. An 8-week lead-in phase will be available to subjects who do not meet the current symptom and concomitant medication inclusion criteria (however, subjects must meet all of the other inclusion/exclusion criteria): 1. 4 weeks of euthymic or subsyndromal mood. 2. Subjects who are not already receiving lithium or divalproex. 3. Subjects receiving other psychotropic medications.
Interventions
- DRUG Omega-3 Fatty Acids
Trial Details
| Field | Value |
|---|---|
| Start Date | 2000-07 |
| Est. Completion | 2004-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00010868
The ClinicalTrials.gov registry entry for NCT00010868 describes a study currently listed as completed, categorized as Phase 2. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Center for Complementary and Integrative Health (NCCIH), which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Omega-3 Fatty Acids is the first listed.
NCT00010868 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00010868 about?
NCT00010868 is a clinical study titled "Omega-3 Fatty Acids in Bipolar Disorder". This is a 12 month study of omega-3 fatty acids in bipolar disorder. This study will be a 12-month, parallel group, double-blind comparison of the prophylactic efficacy of omega-3 fatty acids vs. placebo in 120 bipolar I patients. All subjects entering the primary prophylactic study will be euthymic...
What is the current status of trial NCT00010868?
This trial is currently completed. It is a Phase 2 study. The study started on 2000-07. Estimated completion is 2004-07.
What interventions are being tested in trial NCT00010868?
The interventions under investigation include: Omega-3 Fatty Acids (DRUG).
Who is sponsoring clinical trial NCT00010868?
This trial is sponsored by National Center for Complementary and Integrative Health (NCCIH), which has 203 total clinical trials registered on ClinicalTrials.gov.
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