Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-27

Study Completion Date

2017-06-30

Brief Summary

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N-3 polyunsaturated fatty acids(N-3 PUFAs) is important in balancing the immune function and physical health by reducing membrane arachidonic acid (AA) and prostaglandin E2 (PGE2) synthesis, which might be linked to the somatic manifestations physical morbidity, such as Cardiovascular disease in depression. n-3 polyunsaturated fatty acids appears to be a promising treatment that is safe, beneficial to patients with Cardiovascular disease and depression. In this proposal, investigators aim the test the hypothesis that n-3 polyunsaturated fatty acids will be more effective than placebo in treating Cardiovascular disease patients with major depression after 12 weeks of intervention.

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Detailed Description

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This is a 3-year study and a randomized, double-blind, and placebo controlled Clinical the study. investigators plan to enroll 60 subjects from cardiovascular department of China Medical University Hospital.Participants will be randomized into omega-3 polyunsaturated fatty acids or placebo group.The intervention period is 12 weeks. Evaluation of the depressive symptoms ( using Hamilton Depression Scale, HAM-D, and Beck Depression Inventory, BDI ) of the subjects who are enrolled into the study will take place at -1st, 0, 2nd, 4th, 8th, 12th week. The plasma level of n-3 polyunsaturated fatty acids, chemokines/cytokines, and Electrocardiogram will also be measured at the beginning and at the end of the study.

Conditions

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Cardiovascular Diseases Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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n-3 polyunsaturated fatty acids

n-3 polyunsaturated fatty acids dosage of 2 g of Eicosapentaenoic acid(EPA) and 1 g of Docosahexaenoic acid (DHA).

Group Type ACTIVE_COMPARATOR

n-3 Polyunsaturated fatty acid

Intervention Type DIETARY_SUPPLEMENT

2 g of Eicosapentaenoic acid (EPA) and 1 g of Docosahexaenoic acid (DHA)

placebo

olive oil ethyl esters

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

olive oil ethyl esters

Interventions

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n-3 Polyunsaturated fatty acid

2 g of Eicosapentaenoic acid (EPA) and 1 g of Docosahexaenoic acid (DHA)

Intervention Type DIETARY_SUPPLEMENT

placebo

olive oil ethyl esters

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Cardiovascular disease patients
2. The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder.
3. Capacity and willingness to give written informed consent.

Exclusion Criteria

1. cognitive impairment (Mini-mental state examination score \<24)
2. comorbid psychiatric disorders, psychosis, high risk of suicide, current substance use
3. an acute coronary syndrome within previous 2 months, left ventricular ejection fraction (LVEF)\<30%, advanced malignancy, or physical inability to participate
4. use of antidepressants, anticonvulsants, lithium, or n-3 polyunsaturated fatty acids supplements
5. coagulation disorders or sensitivity to n-3 polyunsaturated fatty acids

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No