Treating Depression in Coronary Artery Disease With Omega-3 Fatty Acids (CAROTID)
April 26, 2017 updated by: Sunnybrook Health Sciences Centre
CAROTID: CAD Randomized Omega-3 Trial In Depression
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
Ontario
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Toronto, Ontario, Canada, M4G 1R7
- Toronto Rehabilitation Institute
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Toronto, Ontario, Canada, M9C1A5
- Trillium Health Centre - West Toronto
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
Omega-3 Fatty Acid Supplement, 1.9 g ω-3 FAs daily
|
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)
|
|
Placebo Comparator: Placebo
Matching placebo, less than 0.12 g ω-3 FAs daily
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hamilton Rating Scale of Depression (HAM-D)
Time Frame: Baseline, Week 4, Week 8, Week 12
|
Baseline, Week 4, Week 8, Week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Medical Outcomes Study health survey 36-item Short Form (SF-36)
Time Frame: Baseline, Week 4, Week 8, Week 12
|
Baseline, Week 4, Week 8, Week 12
|
|
Beck Depression Inventory-II (BDI-II)
Time Frame: Baseline, Week 4, Week 8, Week 12
|
Baseline, Week 4, Week 8, Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
September 10, 2009
First Submitted That Met QC Criteria
September 21, 2009
First Posted (Estimate)
September 22, 2009
Study Record Updates
Last Update Posted (Actual)
April 28, 2017
Last Update Submitted That Met QC Criteria
April 26, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAROTID-2009
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