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NCT Number: NCT03072823

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

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.

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Key information

Conditions

Cardiovascular Diseases Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Taichung, 404, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

n-3 Polyunsaturated fatty acid

Dietary Supplement

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

Placebo

Dietary Supplement

olive oil ethyl esters

Primary outcomes

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

    Time frame: Week 0, Week 2, Week 4 Week 8, Week 12

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

    Time frame: Week 0, Week 2, Week 4 Week 8, Week 12

Secondary outcomes

  1. Electrocardiogram (EKG)

    Time frame: Week 0, Week 2, Week 4 Week 8, Week 12

  2. mini nutritional assessment (MNA) score

    Time frame: Week 0, Week 2, Week 4 Week 8, Week 12

  3. Adverse effects

    Time frame: Week 0, Week 2, Week 4 Week 8, Week 12

  4. plasma level of n-3 polyunsaturated fatty acids

    Time frame: Week 0, Week 12

  5. plasma cytokine/chemokine

    Time frame: Week 0, Week 12

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 7, 2017
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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