Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167310
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2005-09-09
Brief Title:
Decreasing Risk of Coronary Artery Disease in Schizophrenia by Omega-3 Fatty Acid Supplementation
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
CAD Risk in Schizophrenia Effect of Omega-3 Fatty Acid Supplementation
Status:
COMPLETED
Status Verified Date:
2017-02
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:
CAD
Brief Summary:
The purpose of this study is to determine whether the administration of omega-3 polyunsaturated fatty acids particularly eicosapentaenoic acid EPA can be useful both to reduce coronary artery disease CAD risk and illness severity in clinically-stable patients with schizophrenia or schizoaffective disorder major depression or bipolar disorder depressed phase being treated with lipid lowering drugs eg statins
Detailed Description:
We propose to study the effects of EPA 2 g of EPA in 4 x 500 mg capsules daily compared to placebo supplementation in clinically-stable schizophrenic patients being treated with statins n30 each for 4 months using a randomized double-blind design The National Cholesterol Education Program Adult Treatment Panel III guidelines will be used to select those patients with CAD risk to participate Clinical assessments and comprehensive assessment of the risk for CAD including plasma total high-density lipoprotein HDL- HDL2- and HDL3- low-density lipoprotein LDL- LDL-Real- Lpa- and IDL- and VLDL- VLDL12- and VLDL3- cholesterol plasma triglycerides as well as plasma homocysteine and high sensitivity C-reactive protein will be conducted at baseline 1 month 2 months and 4 months after supplementation It is anticipated that patients who receive EPA supplementation will have significantly greater reduction in plasma triglycerides and LDL4-cholesterol and increases in HDL2-cholesterol measures as well as improvements in psychopathology severity than those patients receiving placebo If indeed EPA is effective in decreasing the risk of CAD any psychiatric benefits from EPA supplementation will be a further boon to the patients and the treatment team A tremendous advantage to the clinical use of EPA includes low cost no significant side effects and ease of use
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 |
|---|---|---|---|
| VA IRB Protocol ID02063 | None | None | None |