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Trial record 1 of 1 for:    NCT00167310
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Decreasing Risk of Coronary Artery Disease in Schizophrenia by Omega-3 Fatty Acid Supplementation (CAD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
American Heart Association
VA Pittsburgh Healthcare System
Information provided by (Responsible Party):
Jeffrey Yao, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00167310
First received: September 9, 2005
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CAD Risk in Schizophrenia: Effect of Omega-3 Fatty Acid Supplementation

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • To assess whether EPA supplementation can lead to improvement in further reducing CAD risk profile [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To test whether EPA supplementation can simultaneously improve the psychiatric status of patients with schizophrenia [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2005
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167310

Locations
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
Investigators
Principal Investigator: Jeffrey K Yao, Ph.D., FACB University of Pittsburgh and VA Pittsburgh Healthcare System
  More Information

No publications provided

Responsible Party: Jeffrey Yao, Research Professor of Psychiatry and Pharmaceutical Sciences, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00167310     History of Changes
Other Study ID Numbers: AHA 0455676U, VA IRB Protocol ID:02063
Study First Received: September 9, 2005
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Omega-3 fatty acids
Statins
Antipsychotic drug
Antidepressant drug
Antimanic drug
Placebos
Double-blind method
Bipolar (depressed phase)

Additional relevant MeSH terms:
Bipolar Disorder
Coronary Artery Disease
Coronary Disease
Depression
Depressive Disorder, Major
Disease
Myocardial Ischemia
Psychotic Disorders
Schizophrenia
Affective Disorders, Psychotic
Arterial Occlusive Diseases
Arteriosclerosis
Behavioral Symptoms
Cardiovascular Diseases
Depressive Disorder
Heart Diseases
Mental Disorders
Mood Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Vascular Diseases
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014