Treating Depression in Coronary Artery Disease With Omega-3 Fatty Acids (CAROTID)
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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 fatty acids (ω-3 FAs) 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 FAs in brain function, suggests that deficiencies may contribute to depression. However, it is unknown if increasing consumption of ω-3 FAs would alleviate depression and improve quality of life. While intake of adequate levels of ω-3 FAs 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 FA supplements or placebo daily during their final 6 months of cardiac rehabilitation. The investigators hypothesize that patients randomized to receive ω-3 FA 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 FAs 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 |
- Hamilton Rating Scale of Depression (HAM-D) [ Time Frame: Baseline, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
- 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 2013 (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 |
Inclusion Criteria:
- 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 CAD (based on no hospitalization for cardiac events for at least 7 weeks prior)
- Angiographic documentation of presence and extent of CAD (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 (MMSE<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 defibrillator116
- Killip class greater than II (indicates high risk of mortality in post-MI 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 ω-3 FA 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 HAM-D score >23
- Current or history of psychotic episode or personality disorder.
Contacts and Locations| Contact: Russanthy Velummailum, BSc | 416-480-6100 ext 3185 | rvelumm@sri.utoronto.ca |
| 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 | |
| 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: | May 24, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Sunnybrook Health Sciences Centre:
|
Fatty Acids, Omega-3 |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Depression Depressive Disorder Heart Diseases Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013