NCT02021669

Brief Summary

The purpose of this 10 week randomized, placebo-controlled, double-blind clinical trial is to determine whether antidepressant augmentation with two grams of EPA omega-3 per day is superior to antidepressant therapy alone for major depression in patients with coronary heart disease (CHD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for phase_2 depression

Timeline
Completed

Started May 2014

Longer than P75 for phase_2 depression

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

First Submitted

Initial submission to the registry

December 19, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

May 14, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 6, 2019

Completed
Last Updated

September 4, 2019

Status Verified

August 1, 2019

Enrollment Period

4.3 years

First QC Date

December 19, 2013

Results QC Date

July 12, 2019

Last Update Submit

August 23, 2019

Conditions

Depression

Keywords

Antidepressive agentsCoronary diseaseDepressionDepressive disorderFatty Acids, Omega-3

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Inventory-II (BDI-II)

    The BDI-II is a 21-item self-report inventory of depression symptoms. The minimum and maximum values for the BDI-II are (0-63). For both instruments, the higher the scores, the greater the severity of depression.

    Change from baseline to 10 weeks (post-treatment)

Secondary Outcomes (1)

  • Hamilton Depression Rating Scale (HAM-D, 17)

    Change from baseline to 10 weeks (post-treatment)

Study Arms (2)

Omega-3 supplement

EXPERIMENTAL

Two grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks

Drug: Omega-3 supplement

Placebo

PLACEBO COMPARATOR

Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.

Drug: Placebo

Interventions

Omega-3 supplementDRUG

Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks

Also known as: EPA Plus Minami Nutrition
Omega-3 supplement
PlaceboDRUG

Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.

Placebo

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented coronary heart disease
  • Diagnosis of major depression based on structured interview

You may not qualify if:

  • Moderate to severe cognitive impairment
  • Meets DSM-5 criteria for depressive disorder due to a general medical condition or medication
  • Major Axis I psychiatric disorder other than unipolar depression or an anxiety disorder, a high risk of suicide, or current substance abuse other than tobacco;
  • Not expected to survive one year or physically unable to tolerate the study protocol
  • Known sensitivity to sertraline or omega-3, or an allergy to fish oil or shellfish
  • Taking an antidepressant or an omega-3 supplement at baseline
  • Exempted by their cardiologist or primary care physician
  • Refuses to provide informed consent
  • Participating in a competing protocol or trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University Medical Center

St Louis, Missouri, 63108, United States

Location

Related Publications (1)

  • Carney RM, Freedland KE, Rubin EH, Rich MW, Steinmeyer BC, Harris WS. A Randomized Placebo-Controlled Trial of Omega-3 and Sertraline in Depressed Patients With or at Risk for Coronary Heart Disease. J Clin Psychiatry. 2019 Jun 4;80(4):19m12742. doi: 10.4088/JCP.19m12742.

    PMID: 31163106DERIVED

MeSH Terms

Conditions

DepressionCoronary DiseaseDepressive Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMood DisordersMental Disorders

Results Point of Contact

Title
Robert M. Carney, Ph.D
Organization
Washington University School of Medicine
carneyr@wustl.edu
314-286-1305

Study Officials

  • Robert M Carney, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2013

First Posted

December 27, 2013

Study Start

May 14, 2014

Primary Completion

September 13, 2018

Study Completion

September 13, 2018

Last Updated

September 4, 2019

Results First Posted

August 6, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)