Status:
COMPLETED
Treating Depression in Coronary Artery Disease With Omega-3 Fatty Acids
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Toronto Rehabilitation Institute
Conditions:
Coronary Artery Disease
Depression
Eligibility:
All Genders
45-80 years
Phase:
PHASE3
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-...
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00981383
Start Date
June 1 2010
End Date
May 1 2016
Last Update
April 28 2017
Active Locations (2)
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1
Toronto Rehabilitation Institute
Toronto, Ontario, Canada, M4G 1R7
2
Trillium Health Centre - West Toronto
Toronto, Ontario, Canada, M9C1A5