Please select the eligibility criteria that correspond to the clinical trial below.
Title: CAROTID: CAD Randomized Omega-3 Trial In Depression
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.


Options:
A: Inclusion Criteria:

* Recently underwent CABG (combined or redo procedure) at one of 8 Pittsburgh area study hospitals
* A PHQ score greater than 10 OR if nondepressed control, a PHQ score less than 5 at both 2 days post CABG to the date of discharge following CABG and when reassessed 2 weeks after hospital discharge
* Folstein Mini-Mental State Examination (MMSE) score greater than or equal to 24
* Able to be evaluated and treated for depression as an outpatient post CABG
* Has a household telephone

Exclusion Criteria:

* Presently in treatment with a mental health specialist
* Actively suicidal
* History of psychotic illness
* History of bipolar illness according to subject self-report and past medical history
* Current alcohol dependence or other substance abuse as evidenced by chart review and the CAGE questionnaire
* Organic mood syndromes, including those secondary to medical illness or drugs
* Presence of non-cardiovascular conditions that are likely to be fatal within 1 year
* Unstable medical condition as indicated by history, physical, and/or laboratory findings
* Previous enrollment in the study cohort
* Non-English speaking, illiterate, or possessing any other communication barrier
* If nondepressed control, current or previous diagnosis or treatment of depression
B: Inclusion Criteria:

* Persistent depressive symptoms that may include the following: depressed mood; diminished interest or pleasure in activities; change in appetite; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue or loss of energy; feelings of worthlessness or inappropriate guilt; diminished ability to think or concentrate; or recurrent thoughts of death or suicidal ideations
* Documented history of coronary heart disease (i.e., a prior heart attack, coronary artery bypass graft, or greater than 75% stenosis in at least one coronary artery)

Exclusion Criteria:

* Experienced an acute heart attack or any revascularization procedure (i.e., CABG or percutaneous transluminal coronary angioplasty) within 60 days of study entry
* Left ventricular ejection fraction \<30% with labile ECG changes prior to testing
* Currently using a pacemaker
* Resting blood pressure greater than 160/100 mmHg
* Left main disease \>50%
* Failure to meet our criteria for depression or achieve a score of ≥9 on the Beck Depression Inventory-II
* Any other concurrent psychiatric intervention
* Primary psychiatric diagnosis other than Major or Minor Depressive Episode
* Primary diagnosis of the following psychiatric disorders: schizophrenia, bipolar disorder, schizoaffective disorder, other psychotic disorder, dementia, current delirium, current obsessive compulsive disorder
* Experienced psychotic symptoms during the current depressive episode
* Current abuse or dependence on alcohol or other drugs
* Acute suicide risk
* Patients who, during the course of the study, would likely require treatment with additional psychotherapeutic agents
* Significant medical conditions that would make exercise or sertraline use medically inadvisable (e.g., unstable angina, heart attack within the 3 months prior to study entry, musculoskeletal problems, or congestive heart failure)
* Abnormal thyroid-stimulating hormone (TSH) level and glucose level greater than or equal to 126 mg/dL
* Patients who would not be able to be randomized to either the drug (e.g., adverse cardiac events such as prolonged QT interval, allergic responses) or exercise (e.g., musculoskeletal problems, abnormal cardiac response to exercise, such as exercise-induced VT, abnormal blood pressure response, etc.)
* Currently using medications that would make exercise or sertraline use medically inadvisable (e.g., clonidine, dicumarol, warfarin, anticonvulsants, or MAO inhibitors)
* Current uncontrolled medical condition that could be causing the depressive symptoms (e.g., thyroid dysfunction, anemia)
* Pregnant, planning to get pregnant during the study period, or lactating
* Herbal supplements with purported mood effects (e.g., St. John's wort, valerian, gingko)
* Current use of antidepressant medication
* Currently participating in psychotherapy
* Currently participating in regular aerobic exercise
* Documented failure to respond to sertraline therapy
C: 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.
D: Inclusion Criteria:

* Hospitalized for ACS defined as unstable angina or MI
* BDI greater or equal to 10 and \< 15 2-6 months post-ACS on each of 2 occasions, or BDI greater than 15 on one occasion
* Age at least 35 years
* Fluent in English or Spanish
* Able to complete baseline assessment within 2-6 months of index ACS event
* Able and willing to provide informed consent

Exclusion Criteria:

* Presence of non-cardiac condition likely to terminate fatally within 1 year
* Inaccessibility for intervention or follow-up (e.g., plans to move from the area)
* Cognitive impairment
* Need for immediate psychiatric intervention (i.e., requiring hospitalization or psychiatric intervention within 72 hours)
* Suicidal ideation
* Major psychiatric co-morbidity (current or by history) including active psychosis, bipolar disorder, or overt personality disorder
* Active substance abuse or dependency
* Chronic renal failure (receiving chronic dialysis treatment, or estimated glomerular filtration rate"...\[eGFR\] \< 30 ml/min/1.73 m2) or moderate/severe liver disease (e.g., esophageal varices, portal hypertension, encephalopathy, GI bleeding)
* Participation in another clinical trial for the treatment of depression.

Answer: C