NCT00167310

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_2 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 10, 2017

Completed
Last Updated

April 10, 2017

Status Verified

February 1, 2017

Enrollment Period

10.3 years

First QC Date

September 9, 2005

Results QC Date

January 6, 2017

Last Update Submit

February 24, 2017

Conditions

SchizophreniaSchizoaffective DisorderMajor DepressionBipolar DisorderCoronary Artery Disease

Keywords

Omega-3 fatty acidsStatinsAntipsychotic drugAntidepressant drugAntimanic drugPlacebosDouble-blind methodBipolar (depressed phase)

Outcome Measures

Primary Outcomes (1)

  • Plasma Levels of Triglycerides and Lipoprotein Cholesterol

    Biochemical measures: Plasma levels of triglycerides, small dense LDL (LDL3- and LDL4-) cholesterol, large buoyant LDL (LDL1- and LDL2-) cholesterol, and HDL2-cholesterol.

    4 months

Secondary Outcomes (1)

  • Plasma Cholesterol Levels in Various Lipoprotein Fractions

    4 months

Study Arms (2)

1

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

Eicosapentaenoic acid (omega-3 fatty acid)DRUG

2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months

Also known as: EPA
1
PlaceboDRUG

2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months

Also known as: Soy bean oil
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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%
  • mg/dL having 2 or more risk factors; and
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pittsburgh Healthcare System (University Drive)

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (1)

  • Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.

    PMID: 34817851DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersDepressive Disorder, MajorBipolar DisorderCoronary Artery Disease

Interventions

Eicosapentaenoic AcidFatty Acids, Omega-3Soybean Oil

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersDepressive DisorderMood DisordersBipolar and Related DisordersCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsEicosanoidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Dr. Jeffrey K. Yao, Research Professor
Organization
UPittsburgh
jkyao@pitt.edu
412-360-6781

Study Officials

  • Jeffrey K Yao, Ph.D., FACB

    University of Pittsburgh and VA Pittsburgh Healthcare System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor of Psychiatry and Pharmaceutical Sciences

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 10, 2017

Results First Posted

April 10, 2017

Record last verified: 2017-02

Locations

US(1)