Clinical trial NCT03072823: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Major Depressive Disorder
Keywords: CVDs
cardiovascular diseases
n-3 polyunsaturated fatty acids
depression
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2017-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hamilton Depression Scale(HAM-D) score at 3 months
timeFrame: Week 0, Week 2, Week 4 Week 8, Week 12
measure: Change in Beck's Depression Inventory(BDI) score at 3 months
timeFrame: Week 0, Week 2, Week 4 Week 8, Week 12
Secondary outcomes:
measure: Electrocardiogram (EKG)
timeFrame: Week 0, Week 2, Week 4 Week 8, Week 12
measure: mini nutritional assessment (MNA) score
timeFrame: Week 0, Week 2, Week 4 Week 8, Week 12
measure: Adverse effects
timeFrame: Week 0, Week 2, Week 4 Week 8, Week 12
measure: plasma level of n-3 polyunsaturated fatty acids
timeFrame: Week 0, Week 12
measure: plasma cytokine/chemokine
timeFrame: Week 0, Week 12
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
References:
citation: 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.