Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001146
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Omega-3 Fatty Acids in the Treatment of Bipolar Disorder A Double-Blind Placebo-Controlled Trial
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Omega-3 Fatty Acids in the Treatment of Major Depression and Bipolar Disorder A Double-Blind Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2002-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
The aim of this study is to examine the efficacy of omega-3 fatty acids in the form of eicosapentaenoic ethyl esters EPA - in the treatment of bipolar disorder Omega-3 fatty acids are long-chain polyunsaturated fatty acids found in plant and marine sources There are preliminary data to suggest that omega-3 fatty acids may be efficacious in the treatment of mood disorders Patients in our bipolar outpatient clinic will be at one of the five NIMH - Stanley Foundation Bipolar Network the Network sites participating in this project Subjects will be randomly assigned in a double-blind manner to 6 grams per day of omega-3 fatty acids or placebo paraffin capsules as an add-on to ongoing treatment with mood stabilizing medications which have proven unsatisfactorily effective within therapeutic ranges or at maximum tolerated doses The double-blind trial will continue for 4 months duration Patients will then be offered the option of entering an eight month open-label trial of omega-3 fatty acid The hypothesis of this study is that omega-3 polyunsaturated fatty acids in the form of eicosapentaenoic acid EPA acting on some of the same signal transduction mechanisms as the mood stabilizers will be beneficial in breakthrough depression mania and cycling of bipolar disorder
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-M-0004 | None | None | None |