NCT03072823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

February 24, 2017

Last Update Submit

July 22, 2019

Conditions

Cardiovascular DiseasesMajor Depressive Disorder

Keywords

CVDscardiovascular diseasesn-3 polyunsaturated fatty acidsdepression

Outcome Measures

Primary Outcomes (2)

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

    Week 0, Week 2, Week 4 Week 8, Week 12

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

    Week 0, Week 2, Week 4 Week 8, Week 12

Secondary Outcomes (5)

  • Electrocardiogram (EKG)

    Week 0, Week 2, Week 4 Week 8, Week 12

  • mini nutritional assessment (MNA) score

    Week 0, Week 2, Week 4 Week 8, Week 12

  • Adverse effects

    Week 0, Week 2, Week 4 Week 8, Week 12

  • plasma level of n-3 polyunsaturated fatty acids

    Week 0, Week 12

  • plasma cytokine/chemokine

    Week 0, Week 12

Study Arms (2)

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).

Dietary Supplement: n-3 Polyunsaturated fatty acid

placebo

PLACEBO COMPARATOR

olive oil ethyl esters

Dietary Supplement: placebo

Interventions

n-3 Polyunsaturated fatty acidDIETARY_SUPPLEMENT

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

n-3 polyunsaturated fatty acids
placeboDIETARY_SUPPLEMENT

olive oil ethyl esters

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, 404, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 34817851DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesDepressive Disorder, MajorDepression

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

February 24, 2017

First Posted

March 7, 2017

Study Start

January 27, 2016

Primary Completion

March 31, 2017

Study Completion

June 30, 2017

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations

TW(1)