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SchizophreniaPhase 2CADNCT00167310

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

A Phase 2 study testing Eicosapentaenoic acid (omega-3 fatty acid) in people with Schizophrenia and Schizoaffective Disorder, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Eicosapentaenoic acid (omega-3 fatty acid)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
57 participants
Where
1 siteUnited States
Study dates
Sep 2005to Dec 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Pittsburgh Healthcare System (University Drive)

    Pittsburgh, Pennsylvania, 15240

Other trials in United States

About this study

Official title: CAD Risk in Schizophrenia: Effect of Omega-3 Fatty Acid Supplementation

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).

Read the 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.

Being tested
Eicosapentaenoic acid (omega-3 fatty acid), Placebo
Keywords
Omega-3 fatty acids, Statins, Antipsychotic drug, Antidepressant drug, Antimanic drug, Placebos, Double-blind method, Bipolar (depressed phase)
Medical subject headings
Schizophrenia, Psychotic Disorders, Depressive Disorder, Major, Bipolar Disorder, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eicosapentaenoic acid (omega-3 fatty acid)Drug

    Also called EPA

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

  • PlaceboDrug

    Also called Soy bean oil

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

Study groups in NCT00167310
Study groupRoleWhat they receive
1ExperimentalEicosapentaenoic 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.
Receives: Drug: Eicosapentaenoic acid (omega-3 fatty acid)
2Placebo comparatorPlacebo (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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 months

Secondary outcomes (1)

  1. Plasma Cholesterol Levels in Various Lipoprotein Fractions

    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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00167310
Sponsor's protocol ID
AHA 0455676U
Other IDs
VA IRB Protocol ID:02063
Acronym
CAD
Status last verified
Feb 2017
First submitted
9 Sep 2005
Last updated
10 Apr 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 34817851

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eicosapentaenoic acid (omega-3 fatty acid) in people with Schizophrenia and Schizoaffective Disorder, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma Levels of Triglycerides and Lipoprotein Cholesterol (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00167310, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.

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