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Decreasing Risk of Coronary Artery Disease in Schizophrenia by Omega-3 Fatty Acid Supplementation (CAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00167310
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
American Heart Association
VA Pittsburgh Healthcare System
Information provided by (Responsible Party):
Jeffrey Yao, University of Pittsburgh

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 (e.g., statins).

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Major Depression Bipolar Disorder Coronary Artery Disease Drug: Eicosapentaenoic acid (omega-3 fatty acid) Drug: Placebo Phase 2

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 (n=30 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-, Lp(a)-, and IDL-), and VLDL- (VLDL1,2- 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CAD Risk in Schizophrenia: Effect of Omega-3 Fatty Acid Supplementation
Study Start Date : September 2005
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: 1
Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Drug: Eicosapentaenoic acid (omega-3 fatty acid)
2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
Other Name: EPA

Placebo Comparator: 2
Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Drug: Placebo
2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
Other Name: Soy bean oil

Primary Outcome Measures :
  1. Plasma Levels of Triglycerides and Lipoprotein Cholesterol [ Time Frame: 4 months ]
    Biochemical measures: Plasma levels of triglycerides, small dense LDL (LDL3- and LDL4-) cholesterol, large buoyant LDL (LDL1- and LDL2-) cholesterol, and HDL2-cholesterol.

Secondary Outcome Measures :
  1. Plasma Cholesterol Levels in Various Lipoprotein Fractions [ Time Frame: 4 months ]
    Biochemical Measures: Plasma levels of total cholesterol, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol, Lp(a) cholesterol, IDL-cholesterol, HDL3-cholesterol, VLDL1,2-cholesterol, and VLDL3-cholesterol.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients meeting Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for schizophrenia (or schizoaffective disorder), major depression, or bipolar (depressed phase) disorder who are treated with antipsychotic, antidepressant or antimanic drugs and a lipid-lowering drug (statin) for 2 months or longer will be screened to participate in the proposed project.
  • Based upon the CAD risk determinants (see below) and the National Cholesterol Education Program (NCEP) recommendation of goals for LDL-lowering therapy, the investigators will only enroll schizophrenic patients with baseline (before statin treatment) LDL-cholesterol exceeding:

    • 70 mg/dL having CAD and CAD risk equivalents, e.g., peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease, and diabetes, as well as multiple risk factors that confer a 10-year risk for CAD > 20%
    • 130 mg/dL having 2 or more risk factors; and
    • 160 mg/dL having less than 2 risk factors to participate in the EPA trial.

In addition, these CAD-risk patients have not reached the NCEP goal level within the past year following statin treatment.

  • Risk factors for CAD. The NCEP Expert Panel (NIH Publication No. 01-3670, May 2001) on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III or ATPIII) recognizes the following CAD risk factors:

    • being male, 45 years or older, or being female 55 years or older;
    • family history of premature CAD;
    • current cigarette smoking;
    • hypertension with 140/90 mmHg or greater; and
    • low HDL-cholesterol (less than 40 mg/dL).

Exclusion Criteria:

  • Patients with history of bleeding disorders, current drug or alcohol abuse (within one month), neurological disorders (including head injury with loss of consciousness for greater than 10 minutes), antisocial personality disorder, borderline personality disorder, or mental retardation as indicated in medical records
  • Patients who are pregnant (as determined by urine pregnancy test)
  • Patients who have already achieved their NCEP goal in terms of their lipid profile (as indicated in laboratory tests) will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00167310

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United States, Pennsylvania
VA Pittsburgh Healthcare System (University Drive)
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
University of Pittsburgh
American Heart Association
VA Pittsburgh Healthcare System
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Principal Investigator: Jeffrey K Yao, Ph.D., FACB University of Pittsburgh and VA Pittsburgh Healthcare System

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Responsible Party: Jeffrey Yao, Research Professor of Psychiatry and Pharmaceutical Sciences, University of Pittsburgh Identifier: NCT00167310     History of Changes
Other Study ID Numbers: AHA 0455676U
VA IRB Protocol ID:02063
First Posted: September 14, 2005    Key Record Dates
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017
Last Verified: February 2017
Keywords provided by Jeffrey Yao, University of Pittsburgh:
Omega-3 fatty acids
Antipsychotic drug
Antidepressant drug
Antimanic drug
Double-blind method
Bipolar (depressed phase)
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Bipolar Disorder
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Bipolar and Related Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs