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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Major Depressive Disorder
• Interventions: Dietary Supplement: n-3 Polyunsaturated fatty acid; Dietary Supplement: placebo

• Registration Number: NCT03072823
• Lead Sponsor: China Medical University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-01-27
• Study First Submitted: 2017-02-24
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-07
• Primary Completion: 2017-03-31
• Study Completion: 2017-06-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
n-3 polyunsaturated fatty acids	n-3 Polyunsaturated fatty acid	n-3 polyunsaturated fatty acids dosage of 2 g of Eicosapentaenoic acid(EPA) and 1 g of Docosahexaenoic acid (DHA).
placebo	placebo	olive oil ethyl esters

Primary Outcome Measures

Name	Time	Method
Change in Hamilton Depression Scale(HAM-D) score at 3 months	Week 0, Week 2, Week 4 Week 8, Week 12
Change in Beck's Depression Inventory(BDI) score at 3 months	Week 0, Week 2, Week 4 Week 8, Week 12

Secondary Outcome Measures

Name	Time	Method
Electrocardiogram (EKG)	Week 0, Week 2, Week 4 Week 8, Week 12
mini nutritional assessment (MNA) score	Week 0, Week 2, Week 4 Week 8, Week 12
plasma cytokine/chemokine	Week 0, Week 12
plasma level of n-3 polyunsaturated fatty acids	Week 0, Week 12
Adverse effects	Week 0, Week 2, Week 4 Week 8, Week 12

Trial Locations

Locations (1)

China Medical University; 🇨🇳 Taichung, Taiwan