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

Primary Purpose

Cardiovascular Diseases, Major Depressive Disorder

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

n-3 Polyunsaturated fatty acid

placebo

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring CVDs, cardiovascular diseases, n-3 polyunsaturated fatty acids, depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

China Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

n-3 polyunsaturated fatty acids

placebo

Arm Description

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

olive oil ethyl esters

Outcomes

Primary Outcome Measures

Change in Hamilton Depression Scale(HAM-D) score at 3 months

Change in Beck's Depression Inventory(BDI) score at 3 months

Secondary Outcome Measures

Electrocardiogram (EKG)

mini nutritional assessment (MNA) score

Adverse effects

plasma level of n-3 polyunsaturated fatty acids

plasma cytokine/chemokine

Full Information

NCT ID

NCT03072823

First Posted

February 24, 2017

Last Updated

July 22, 2019

Sponsor

China Medical University Hospital

Collaborators

National Science Council, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT03072823

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

January 27, 2016 (Actual)

Primary Completion Date

March 31, 2017 (Actual)

Study Completion Date

June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

China Medical University Hospital

Collaborators

National Science Council, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Diseases, Major Depressive Disorder

Keywords

CVDs, cardiovascular diseases, n-3 polyunsaturated fatty acids, depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

n-3 polyunsaturated fatty acids

Arm Type

Active Comparator

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

olive oil ethyl esters

Intervention Type

Dietary Supplement

Intervention Name(s)

n-3 Polyunsaturated fatty acid

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Description

olive oil ethyl esters

Primary Outcome Measure Information:

Title

Change in Hamilton Depression Scale(HAM-D) score at 3 months

Time Frame