- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03072823
Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases
July 22, 2019 updated by: Pei-Chen Chang, China Medical University Hospital
Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases: a Double-blind Placebo-controlled Therapeutic Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taichung, Taiwan, 404
- China Medical University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
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2 g of Eicosapentaenoic acid (EPA) and 1 g of Docosahexaenoic acid (DHA)
|
Placebo Comparator: placebo
olive oil ethyl esters
|
olive oil ethyl esters
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Hamilton Depression Scale(HAM-D) score at 3 months
Time Frame: Week 0, Week 2, Week 4 Week 8, Week 12
|
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
|
Week 0, Week 2, Week 4 Week 8, Week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Electrocardiogram (EKG)
Time Frame: Week 0, Week 2, Week 4 Week 8, Week 12
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Week 0, Week 2, Week 4 Week 8, Week 12
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mini nutritional assessment (MNA) score
Time Frame: Week 0, Week 2, Week 4 Week 8, Week 12
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Week 0, Week 2, Week 4 Week 8, Week 12
|
Adverse effects
Time Frame: Week 0, Week 2, Week 4 Week 8, Week 12
|
Week 0, Week 2, Week 4 Week 8, Week 12
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plasma level of n-3 polyunsaturated fatty acids
Time Frame: Week 0, Week 12
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Week 0, Week 12
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plasma cytokine/chemokine
Time Frame: Week 0, Week 12
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Week 0, Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 27, 2016
Primary Completion (Actual)
March 31, 2017
Study Completion (Actual)
June 30, 2017
Study Registration Dates
First Submitted
February 24, 2017
First Submitted That Met QC Criteria
March 2, 2017
First Posted (Actual)
March 7, 2017
Study Record Updates
Last Update Posted (Actual)
July 23, 2019
Last Update Submitted That Met QC Criteria
July 22, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH104-REC2-059
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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