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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborator:
Toronto Rehabilitation Institute
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00981383
First received: September 10, 2009
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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 who show 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 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. This research will answer the critical clinical question of whether there is an antidepressant effect of ω-3 fatty acids in CAD patients with depression. If successful, it will provide strong clinical evidence to guide health-care providers in the recommendation and use of these supplements in this population.


Condition Intervention Phase
Coronary Artery Disease
Depression
Dietary Supplement: Omega-3 Fatty Acid Supplement
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CAROTID: CAD Randomized Omega-3 Trial In Depression

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Hamilton Rating Scale of Depression (HAM-D) [ Time Frame: Baseline, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medical Outcomes Study health survey 36-item Short Form (SF-36) [ Time Frame: Baseline, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: Baseline, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 254
Study Start Date: June 2010
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Dietary Supplement: Omega-3 Fatty Acid Supplement
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 Other: Placebo
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

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnostic and Statistical Manual (DSM)-IV criteria for major depressive episode or minor depression as assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) depression module
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981383

Contacts
Contact: Maisha Khan, BSc 416-480-6100 ext 3185 mkhan@sri.utoronto.ca
Contact: Abby Li, MSc, CCRP 416-480-6100 ext 3185 abby.li@sunnybrook.ca

Locations
Canada, Ontario
Toronto Rehabilitation Institute Recruiting
Toronto, Ontario, Canada, M4G 1R7
Contact: Paul Oh, MD, MSc       Oh.PaulDr@TorontoRehab.on.ca   
Principal Investigator: Paul Oh, MD         
Trillium Health Centre - West Toronto Recruiting
Toronto, Ontario, Canada, M9C1A5
Contact: Michelle Johnson, RPh, BSc       MIJohnson@thc.on.ca   
Principal Investigator: Cheng Tao Wang, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Toronto Rehabilitation Institute
Investigators
Principal Investigator: Krista Lanctôt, PhD Sunnybrook Health Sciences Centre
Principal Investigator: Nathan Herrmann, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00981383     History of Changes
Other Study ID Numbers: CAROTID-2009
Study First Received: September 10, 2009
Last Updated: November 25, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Fatty Acids, Omega-3

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Depression
Depressive Disorder
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Behavioral Symptoms
Cardiovascular Diseases
Heart Diseases
Mental Disorders
Mood Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014