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

Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases: a Double-blind Placebo-controlled Therapeutic Trial

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Major Depressive Disorder
• Intervention / Treatment: Dietary supplement: n-3 Polyunsaturated fatty acid; Dietary supplement: placebo

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Dietary supplement: n-3 Polyunsaturated fatty acid; 2 g of Eicosapentaenoic acid (EPA) and 1 g of Docosahexaenoic acid (DHA)
Placebo Comparator: placebo; olive oil ethyl esters	Dietary supplement: placebo; olive oil ethyl esters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
Adverse effects	Week 0, Week 2, Week 4 Week 8, Week 12
plasma level of n-3 polyunsaturated fatty acids	Week 0, Week 12
plasma cytokine/chemokine	Week 0, Week 12

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Collaborators: National Science Council, Taiwan

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2016
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: depression; n-3 polyunsaturated fatty acids; cardiovascular diseases; CVDs
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Cardiovascular Diseases; Depressive Disorder, Major
• Other Study ID Numbers: CMUH104-REC2-059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No