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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072823
• Other study ID #: CMUH104-REC2-059
• Status: Completed
• Phase: N/A
• Start date: January 27, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: July 2019
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hamilton Depression Scale(HAM-D) score at 3 months		Week 0, Week 2, Week 4 Week 8, Week 12
Primary	Change in Beck's Depression Inventory(BDI) score at 3 months		Week 0, Week 2, Week 4 Week 8, Week 12
Secondary	Electrocardiogram (EKG)		Week 0, Week 2, Week 4 Week 8, Week 12
Secondary	mini nutritional assessment (MNA) score		Week 0, Week 2, Week 4 Week 8, Week 12
Secondary	Adverse effects		Week 0, Week 2, Week 4 Week 8, Week 12
Secondary	plasma level of n-3 polyunsaturated fatty acids		Week 0, Week 12
Secondary	plasma cytokine/chemokine		Week 0, Week 12