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Treating Depression in Coronary Artery Disease With Omega-3 Fatty Acids (CAROTID)

Primary Purpose

Coronary Artery Disease, Depression

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Omega-3 Fatty Acid Supplement
Placebo
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Fatty Acids, Omega-3

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Language (speaks and understands English)
  • Between 45-80 years old
  • Stable coronary artery disease (based on no hospitalization for cardiac events for at least 7 weeks prior)
  • Angiographic documentation of presence and extent of coronary artery disease (number of vessels involved, extent of stenosis, etc.)
  • Written, informed consent

Exclusion Criteria:

  • Significant acute medical illness (sepsis, autoimmune condition, drug overdose, uncontrolled diabetes, severely disturbed liver, kidney or lung function, anemia, hypothyroidism)
  • Clinically significant cognitive impairment (Mini-Mental State Examination < 24)
  • Other neurologic conditions (Parkinson's disease, Huntington's chorea, history of epilepsy, birth trauma, significant traumatic brain injury, clinical stroke, progressive supranuclear paralysis, brain tumour, subdural hematoma, multiple sclerosis)
  • Canadian Cardiovascular Society Class 4 (indicating unstable angina)
  • Ventricular tachycardia and/or implantable cardioverter defibrillator
  • Killip class greater than II (indicates high risk of mortality in post-myocardial infarction group)
  • Premorbid or concurrent psychiatric diagnoses of schizophreniform or bipolar depressive disorders, current ethanol or substance abuse or any premorbid psychiatric condition requiring hospitalization
  • Current use of a concentrated omega-3 fatty acid supplement, or contraindication to soybean/corn oil
  • Pregnant women
  • Women who become pregnant during the course of the study will be excluded immediately.
  • Women of childbearing potential must be using an approved method of birth control.
  • Allergies or hypersensitivity to fish
  • Pre-existing bleeding disorder
  • History of electroconvulsive therapy.
  • Suicidal ideation or a history of suicidal ideation/attempts (determined during SCID-I at screening/baseline visits)
  • Severe depression, defined by Hamilton Depression Rating score >23
  • Current or history of psychotic episode or personality disorder.

Sites / Locations

  • Toronto Rehabilitation Institute
  • Trillium Health Centre - West Toronto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

Omega-3 Fatty Acid Supplement, 1.9 g ω-3 FAs daily

Matching placebo, less than 0.12 g ω-3 FAs daily

Outcomes

Primary Outcome Measures

Hamilton Rating Scale of Depression (HAM-D)

Secondary Outcome Measures

Medical Outcomes Study health survey 36-item Short Form (SF-36)
Beck Depression Inventory-II (BDI-II)

Full Information

First Posted
September 10, 2009
Last Updated
April 26, 2017
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Toronto Rehabilitation Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00981383
Brief Title
Treating Depression in Coronary Artery Disease With Omega-3 Fatty Acids
Acronym
CAROTID
Official Title
CAROTID: CAD Randomized Omega-3 Trial In Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Toronto Rehabilitation Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Depressive disorders are common in patients with Coronary Artery Disease (CAD), occurring in up to 47% of patients. Left untreated, these symptoms not only have a strong negative impact on quality-of-life, but also increase risk of future cardiac events and death. Unfortunately, about 64% of CAD patients do not respond to current antidepressant treatments. Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are two omega-3 (ω-3) fatty acids found in fatty fish that are important for brain function. Recent evidence showed that depressed CAD patients have lower levels of EPA and DHA than non-depressed CAD patients. This information, taken together with the known roles of ω-3 fatty acids in brain function, suggests that deficiencies may contribute to depression. However, it is unknown if increasing consumption of ω-3 fatty acids would alleviate depression and improve quality of life. While intake of adequate levels of ω-3 fatty acids is difficult to obtain through diet, concentrated supplements containing EPA and DHA that are safe, readily available, and inexpensive are now obtainable in Canada. CAROTID (CAD Randomized Omega-3 Trial In Depression) will randomize patients with CAD, with and without depressive symptoms, after 6 months of cardiac rehabilitation and usual care to receive either ω-3 fatty acid supplements or placebo daily during their final 6 months of cardiac rehabilitation. The investigators hypothesize that CAD patients randomized to receive ω-3 fatty acid supplements will show greater improvement in depressive symptoms and quality-of-life over time. The investigators will also evaluate possible improvements in other important determinants of quality of life: memory and other cognitive abilities.
Detailed Description
Coronary artery disease (CAD) poses a serious risk to the health and well-being of the elderly. Depression is common among CAD patients and has a major negative impact on treatment outcomes and life expectancy. Late-life depression is also associated with symptoms of cognitive impairment and subsequent nonresponse to medications. Coronary artery disease and depression together can detrimentally affect autonomous seniors, resulting in increased caregiver dependence and health care resource use. Forty-seven percent of patients with CAD have depressive disorders. About 64% of these do not respond to antidepressant treatments. Recent evidence shows that depressed CAD patients have lower levels of omega-3 fatty acids than do non-depressed CAD patients. Along with the known role of omega-3 fatty acids in brain health, this suggests that deficiencies may affect depression. Our study, CAROTID (CAD Randomized Omega-3 Trial In Depression), is a randomized, double-blind, placebo-controlled parallel group trial in persons with CAD who are attending a cardiac rehabilitation program. Patients will receive either omega-3 fatty acids supplements or placebo daily during three months of cardiac rehab. We hypothesize that patients who receive omega-3 fatty acids will show greater improvements in depressive symptoms and quality of life. This research will determine whether there is an antidepressant effect of omega-3 fatty acids in CAD patients undergoing cardiac rehabilitation. If successful, then CAROTID will provide evidence to guide health care providers in the recommendation and use of these supplements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Depression
Keywords
Fatty Acids, Omega-3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Omega-3 Fatty Acid Supplement, 1.9 g ω-3 FAs daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo, less than 0.12 g ω-3 FAs daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 Fatty Acid Supplement
Intervention Description
3 capsules (3x1g) fish oil-derived concentrated ethyl esters, providing 1.9 g omega-3 fatty acids (1.2 g EPA and 0.6 g DHA, with 0.1 g other omega-3 fatty acids)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
3 capsules (3x1g) of 50/50 soybean/corn oil blend containing less than 0.12 g of omega-3 fatty acids with negligible EPA and DHA
Primary Outcome Measure Information:
Title
Hamilton Rating Scale of Depression (HAM-D)
Time Frame
Baseline, Week 4, Week 8, Week 12
Secondary Outcome Measure Information:
Title
Medical Outcomes Study health survey 36-item Short Form (SF-36)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Beck Depression Inventory-II (BDI-II)
Time Frame
Baseline, Week 4, Week 8, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Language (speaks and understands English) Between 45-80 years old Stable coronary artery disease (based on no hospitalization for cardiac events for at least 7 weeks prior) Angiographic documentation of presence and extent of coronary artery disease (number of vessels involved, extent of stenosis, etc.) Written, informed consent Exclusion Criteria: Significant acute medical illness (sepsis, autoimmune condition, drug overdose, uncontrolled diabetes, severely disturbed liver, kidney or lung function, anemia, hypothyroidism) Clinically significant cognitive impairment (Mini-Mental State Examination < 24) Other neurologic conditions (Parkinson's disease, Huntington's chorea, history of epilepsy, birth trauma, significant traumatic brain injury, clinical stroke, progressive supranuclear paralysis, brain tumour, subdural hematoma, multiple sclerosis) Canadian Cardiovascular Society Class 4 (indicating unstable angina) Ventricular tachycardia and/or implantable cardioverter defibrillator Killip class greater than II (indicates high risk of mortality in post-myocardial infarction group) Premorbid or concurrent psychiatric diagnoses of schizophreniform or bipolar depressive disorders, current ethanol or substance abuse or any premorbid psychiatric condition requiring hospitalization Current use of a concentrated omega-3 fatty acid supplement, or contraindication to soybean/corn oil Pregnant women Women who become pregnant during the course of the study will be excluded immediately. Women of childbearing potential must be using an approved method of birth control. Allergies or hypersensitivity to fish Pre-existing bleeding disorder History of electroconvulsive therapy. Suicidal ideation or a history of suicidal ideation/attempts (determined during SCID-I at screening/baseline visits) Severe depression, defined by Hamilton Depression Rating score >23 Current or history of psychotic episode or personality disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krista Lanctôt, PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nathan Herrmann, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Rehabilitation Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 1R7
Country
Canada
Facility Name
Trillium Health Centre - West Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9C1A5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27529771
Citation
Mazereeuw G, Herrmann N, Oh PI, Ma DW, Wang CT, Kiss A, Lanctot KL. Omega-3 Fatty Acids, Depressive Symptoms, and Cognitive Performance in Patients With Coronary Artery Disease: Analyses From a Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Psychopharmacol. 2016 Oct;36(5):436-44. doi: 10.1097/JCP.0000000000000565.
Results Reference
result
PubMed Identifier
29730646
Citation
Chan P, Suridjan I, Mohammad D, Herrmann N, Mazereeuw G, Hillyer LM, Ma DWL, Oh PI, Lanctot KL. Novel Phospholipid Signature of Depressive Symptoms in Patients With Coronary Artery Disease. J Am Heart Assoc. 2018 May 5;7(10):e008278. doi: 10.1161/JAHA.117.008278.
Results Reference
derived
PubMed Identifier
26379437
Citation
Mazereeuw G, Herrmann N, Xu H, Blanchard AP, Figeys D, Oh PI, Bennett SA, Lanctot KL. Platelet activating factors are associated with depressive symptoms in coronary artery disease patients: a hypothesis-generating study. Neuropsychiatr Dis Treat. 2015 Sep 4;11:2309-14. doi: 10.2147/NDT.S87111. eCollection 2015.
Results Reference
derived

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Treating Depression in Coronary Artery Disease With Omega-3 Fatty Acids

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