A Phase 2 interventional study of Eicosapentaenoic acid (omega-3 fatty acid) and Placebo in Schizophrenia, Schizoaffective Disorder and Major Depression, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-10.
Sponsored by University of Pittsburgh · Phase 2, Interventional, and Treatment
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).
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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This study's enrollment of 57 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
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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:
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:
Exclusion Criteria:
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)
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 Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
Also known as: EPA
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
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.
Time frame: 4 months
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.
Time frame: 4 months
| Milestone | Omega-3 Fatty Acid | Placebo |
|---|---|---|
| Started | 29 | 28 |
| Completed | 21 | 18 |
| Not completed | 8 | 10 |
| Withdrew: Protocol violation | 5 | 3 |
| Withdrew: Withdrawal by subject | 3 | 7 |
Biochemical measures: Plasma levels of triglycerides, small dense LDL (LDL3- and LDL4-) cholesterol, large buoyant LDL (LDL1- and LDL2-) cholesterol, and HDL2-cholesterol.
| mg/dL | Omega-3 Fatty Acid | Placebo |
|---|---|---|
| Plasma triglyceride | 155 ± 78 | 182 ± 67 |
| Plasma LDL-1 cholesterol | 12.68 ± 4.93 | 16.92 ± 7.10 |
| Plasma LDL-2 cholesterol | 14.62 ± 11.36 | 15.79 ± 12.37 |
| Plasma LDL-3 cholesterol | 40.93 ± 14.69 | 43.47 ± 23.44 |
| Plasma LDL-4 cholesterol | 15.61 ± 10.47 | 17.66 ± 12.50 |
| Plasma HDL-2 cholesterol | 8.00 ± 3.96 | 8.56 ± 2.41 |
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.
| mg/dL | Omega-3 Fatty Acid | Placebo |
|---|---|---|
| Plasma total cholesterol | 158 ± 38 | 175 ± 45 |
| Plasma LDL cholesterol | 98.14 ± 30.50 | 109.83 ± 37.55 |
| Plasma HDL cholesterol | 38.95 ± 11.79 | 40.22 ± 8.61 |
| Plasma VLDL cholesterol | 21.24 ± 5.27 | 24.67 ± 6.06 |
| Plasma Lp(a) cholesterol | 6.10 ± 4.06 | 4.83 ± 2.71 |
| Plasma IDL cholesterol | 8.24 ± 5.70 | 11.17 ± 6.14 |
| Plasma HDL3 cholesterol | 31.00 ± 8.26 | 31.61 ± 7.28 |
| Plasma VLDL1 + VLDL2 cholesterol | 9.62 ± 2.85 | 11.45 ± 3.26 |
| Plasma VLDL3 cholesterol | 11.67 ± 2.82 | 13.39 ± 3.09 |
Collected over 4 months. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omega-3 Fatty Acid | — | 0/28 (0%) | 2/28 (7.1%) |
| Placebo | — | 0/24 (0%) | 1/24 (4.2%) |
| Event | Omega-3 Fatty Acid | Placebo |
|---|---|---|
| Patient experiences mental problemPsychiatric disorders | 1/28 | 1/24 |
| EKG report indicated sinus bradycardia with HR of 39. Patient asymptomatic.Cardiac disorders | 1/28 | 0/24 |
The participants withdraw voluntarily after signing the consent form.
| Age, Continuous(years) | Omega-3 Fatty Acid | Placebo | Total |
|---|---|---|---|
| Mean | 56 ± 8 | 54 ± 8 | 55 ± 8 |
| Sex: Female, Male(Participants) | Omega-3 Fatty Acid | Placebo | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 26 | 24 | 50 |
| Region of Enrollment(participants) | Omega-3 Fatty Acid | Placebo | Total |
|---|---|---|---|
| United States | 28 | 24 | 52 |
| Body Mass Index(kg/m^2) | Omega-3 Fatty Acid | Placebo | Total |
|---|---|---|---|
| Mean | 31 ± 7 | 31 ± 6 | 31 ± 6 |
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