NCT00116857

Brief Summary

This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline on depression and cardiac endpoints after myocardial infarction (MI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at below P25 for phase_3 cardiovascular-diseases

Timeline
Completed

Started Feb 2005

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

February 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

September 12, 2012

Completed
Last Updated

September 12, 2012

Status Verified

September 1, 2012

Enrollment Period

4.3 years

First QC Date

June 30, 2005

Results QC Date

July 3, 2012

Last Update Submit

September 11, 2012

Conditions

Cardiovascular DiseasesDepressionHeart DiseasesMyocardial InfarctionAngina, Unstable

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Inventory-II

    Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment.

    Measured at Baseline and 10 weeks

Study Arms (2)

Sertraline/omega-3 supplement

ACTIVE COMPARATOR
Drug: Sertraline/omega-3

Sertraline/corn oil

PLACEBO COMPARATOR
Drug: Sertraline/Corn Oil

Interventions

Sertraline/omega-3DRUG

Sertraline (50 mgs) plus omega-3 (2 grams)

Sertraline/omega-3 supplement
Sertraline/Corn OilDRUG

Sertraline (50 mgs) plus corn oil (2 grams) (placebo)

Sertraline/corn oil

Eligibility Criteria

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

You may qualify if:

  • Meets the DSM-IV criteria for a current major depressive episode
  • Score of 15 or higher on the Beck Depression Inventory II
  • History of acute myocardial infarction, unstable angina, or documented coronary disease

You may not qualify if:

  • Physician or patient refusal
  • Lives far away from study site
  • Current alcohol or drug abuse
  • Psychosis, dementia, or bipolar disorder
  • Already taking Omega-3
  • Medically ill or disabled such that patient is unable to participate
  • Comorbid illness likely to be fatal within 1 year of study entry
  • Seizure disorder or takes anticonvulsants
  • Pregnant or breast feeding
  • Liver or kidney disease
  • Severe hypertriglyceridemia (greater than 400 mg/dL)
  • Bleeding or clotting disorder
  • Type 2 diabetes with a hemoglobin A1c (HbA1c) level greater than 10
  • Taking lithium or monoamine oxidase inhibitor (MAO-I)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63108, United States

Location

Related Publications (4)

  • Carney RM, Freedland KE, Rubin EH, Rich MW, Steinmeyer BC, Harris WS. Omega-3 augmentation of sertraline in treatment of depression in patients with coronary heart disease: a randomized controlled trial. JAMA. 2009 Oct 21;302(15):1651-7. doi: 10.1001/jama.2009.1487.

    PMID: 19843899RESULT

  • 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

  • Carney RM, Steinmeyer BC, Freedland KE, Rubin EH, Rich MW, Harris WS. Baseline blood levels of omega-3 and depression remission: a secondary analysis of data from a placebo-controlled trial of omega-3 supplements. J Clin Psychiatry. 2016 Feb;77(2):e138-43. doi: 10.4088/JCP.14m09660.

    PMID: 26930527DERIVED

  • Bot M, Carney RM, Freedland KE, Rubin EH, Rich MW, Steinmeyer BC, Mann DL. Inflammation and treatment response to sertraline in patients with coronary heart disease and comorbid major depression. J Psychosom Res. 2011 Jul;71(1):13-7. doi: 10.1016/j.jpsychores.2010.11.006. Epub 2011 Jan 15.

    PMID: 21665007DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesDepressionHeart DiseasesMyocardial InfarctionAngina, Unstable

Interventions

SertralineDocosahexaenoic Acids

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsFatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Results Point of Contact

Title
Robert M. Carney, Ph.D.
Organization
Washington University School of Medicine
carneyr@bmc.wustl.edu
314-286-1313

Study Officials

  • Robert M. Carney, PhD

    Washington University School of Medicine

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
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
Professor

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 1, 2005

Study Start

February 1, 2005

Primary Completion

June 1, 2009

Study Completion

November 1, 2009

Last Updated

September 12, 2012

Results First Posted

September 12, 2012

Record last verified: 2012-09

Locations

US(1)