Cardiovascular DiseasesNCT03072823
Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases
A study testing n-3 Polyunsaturated fatty acid in people with Cardiovascular Diseases and Major Depressive Disorder, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Major Depressive Disorder
- What is being tested?
- n-3 Polyunsaturated fatty acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Jan 2016to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Major Depressive Disorder
- Being tested
- n-3 Polyunsaturated fatty acid, placebo
- Keywords
- CVDs, cardiovascular diseases, n-3 polyunsaturated fatty acids, depression
- Medical subject headings
- Cardiovascular Diseases, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-3 Polyunsaturated fatty acidDietary supplement
2 g of Eicosapentaenoic acid (EPA) and 1 g of Docosahexaenoic acid (DHA)
placeboDietary supplement
olive oil ethyl esters
| Study group | Role | What they receive |
|---|---|---|
| n-3 polyunsaturated fatty acids | Active comparator | n-3 polyunsaturated fatty acids dosage of 2 g of Eicosapentaenoic acid(EPA) and 1 g of Docosahexaenoic acid (DHA). Receives: Dietary Supplement: n-3 Polyunsaturated fatty acid |
| placebo | Placebo comparator | olive oil ethyl esters Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Scale(HAM-D) score at 3 months
Measured: Week 0, Week 2, Week 4 Week 8, Week 12
Change in Beck's Depression Inventory(BDI) score at 3 months
Measured: Week 0, Week 2, Week 4 Week 8, Week 12
Secondary outcomes (5)
Electrocardiogram (EKG)
Measured: Week 0, Week 2, Week 4 Week 8, Week 12
mini nutritional assessment (MNA) score
Measured: Week 0, Week 2, Week 4 Week 8, Week 12
Adverse effects
Measured: Week 0, Week 2, Week 4 Week 8, Week 12
plasma level of n-3 polyunsaturated fatty acids
Measured: Week 0, Week 12
plasma cytokine/chemokine
Measured: Week 0, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start27 Jan 2016
- Primary completion31 Mar 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Pei-Chen Chang, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072823
- Sponsor's protocol ID
- CMUH104-REC2-059
- Status last verified
- Jul 2019
- First submitted
- 24 Feb 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34817851
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases: a Double-blind Placebo-controlled Therapeutic Trial
- ClinicalTrials.gov ID
- NCT03072823
- Acronym / sponsor ID
- CMUH104-REC2-059
- Conditions
- Cardiovascular Diseases, Major Depressive Disorder
- Keywords
- CVDs, cardiovascular diseases, n-3 polyunsaturated fatty acids, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 27 Jan 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| n-3 polyunsaturated fatty acids | Active comparator | Dietary Supplement: n-3 Polyunsaturated fatty acidn-3 polyunsaturated fatty acids dosage of 2 g of Eicosapentaenoic acid(EPA) and 1 g of Docosahexaenoic acid (DHA). |
| placebo | Placebo comparator | Dietary Supplement: placeboolive oil ethyl esters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n-3 Polyunsaturated fatty acid2 g of Eicosapentaenoic acid (EPA) and 1 g of Docosahexaenoic acid (DHA) | Dietary supplement | n-3 polyunsaturated fatty acids |
| placeboolive oil ethyl esters | Dietary supplement | placebo |
Primary outcome
Change in Hamilton Depression Scale(HAM-D) score at 3 months
Time frame: 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
5 secondary outcomes
Electrocardiogram (EKG)
Time frame: Week 0, Week 2, Week 4 Week 8, Week 12
mini nutritional assessment (MNA) score
Time frame: Week 0, Week 2, Week 4 Week 8, Week 12
Adverse effects
Time frame: Week 0, Week 2, Week 4 Week 8, Week 12
plasma level of n-3 polyunsaturated fatty acids
Time frame: Week 0, Week 12
plasma cytokine/chemokine
Time frame: Week 0, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Derived from this study: PubMed 34817851Appleton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing n-3 Polyunsaturated fatty acid in people with Cardiovascular Diseases and Major Depressive Disorder, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Scale(HAM-D) score at 3 months (time frame: Week 0, Week 2, Week 4 Week 8, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03072823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019; AzTrials last refreshed its copy on 6 Nov 2026.