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

Overview

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.

Full Title of Study: “Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases: a Double-blind Placebo-controlled Therapeutic Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 31, 2017

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.

Interventions

  • Dietary Supplement: n-3 Polyunsaturated fatty acid
    • 2 g of Eicosapentaenoic acid (EPA) and 1 g of Docosahexaenoic acid (DHA)
  • Dietary Supplement: placebo
    • olive oil ethyl esters

Arms, Groups and Cohorts

  • 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).
  • Placebo Comparator: placebo
    • olive oil ethyl esters

Clinical Trial Outcome Measures

Primary Measures

  • Change in Hamilton Depression Scale(HAM-D) score at 3 months
    • Time Frame: Week 0, Week 2, Week 4 Week 8, Week 12
  • Change in Beck’s Depression Inventory(BDI) score at 3 months
    • Time Frame: Week 0, Week 2, Week 4 Week 8, Week 12

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • China Medical University Hospital
  • Collaborator
    • National Science Council, Taiwan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pei-Chen Chang, Attending Physician – China Medical University Hospital

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