Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03072823 |
Date of registration:
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24/02/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases
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Scientific title:
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Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases: a Double-blind Placebo-controlled Therapeutic Trial |
Date of first enrolment:
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January 27, 2016 |
Target sample size:
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60 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03072823 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Major Depressive Disorder
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Cardiovascular Diseases
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Intervention(s)
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Dietary Supplement: n-3 Polyunsaturated fatty acid
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Dietary Supplement: placebo
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Primary Outcome(s)
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Change in Hamilton Depression Scale(HAM-D) score at 3 months
[Time Frame: Week 0, Week 2, Week 4 Week 8, Week 12]
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Change in Beck's Depression Inventory(BDI) score at 3 months
[Time Frame: Week 0, Week 2, Week 4 Week 8, Week 12]
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Secondary Outcome(s)
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Electrocardiogram (EKG)
[Time Frame: Week 0, Week 2, Week 4 Week 8, Week 12]
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plasma cytokine/chemokine
[Time Frame: Week 0, Week 12]
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plasma level of n-3 polyunsaturated fatty acids
[Time Frame: Week 0, Week 12]
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Adverse effects
[Time Frame: 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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Secondary ID(s)
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CMUH104-REC2-059
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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