Please select the eligibility criteria that correspond to the clinical trial below.
Title: Omega-3 for Depression and Other Cardiac Risk Factors
Brief Summary: This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline on depression and cardiac endpoints after myocardial infarction (MI).


Options:
A: Inclusion Criteria:

* Eligible participants were pregnant women, aged 18 to 40 years, with major depressive disorder onset between their 16th week (second trimester) and 32nd week (third trimester) of gestation at the Department of Obstetrics.

Exclusion Criteria:

* Subjects were excluded with a DSM-IV diagnosis of bipolar disorders, psychotic disorders, substance abuse or dependence for at least 3 months, or any Axis-II diagnosis of borderline or antisocial personality disorder.
B: Inclusion Criteria:

* Adult male and female patients, age greater than or equal to 21 years
* Diagnosis of Major Depressive Disorder determined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria with a Hamilton Depression Rating Scale Score greater than or equal to 18\*
* New York Heart Association Class greater than or equal to II

  * For patients with with left ventricular ejection fraction greater than 40 %, abnormal brain natriuretic peptide and/or previous hospitalization due to heart failure is also required
  * For inpatients, the Hamilton Depression Rating Scale scores need to be remain at 18 or above for two weeks following the discharge

Exclusion Criteria:

* Significant cognitive impairment, indicated as a Mini-Mental State Examination (MMSE) total score of 23 or lower
* History of alcohol or other drug dependence within the past 90 days
* Severe physical disability (visual, sensory, or motor) that may interfere with psychiatric assessment
* History or presence of psychoses, bipolar disorder, and/or severe personality disorders
* Life-threatening comorbidity with the likelihood of 50% mortality in one year
* Active suicidal ideations
* Current use of antipsychotic medications or psychotropic medications except Selective Serotonin Reuptake Inhibitors (SSRIs) and /or benzodiazepine
* Female patients who have a positive pregnancy test or are lactating. If female patients are of childbearing potential, they must use an effective and accepted means of contraception, such as oral contraceptives or a double-barrier method (condom and diaphragm) to protect against pregnancy
* Documented history of hypersensitivity or intolerance to omega 3 products; or use of omega 3 supplement for greater than or equal to 3 months at an equivalent or greater dose of the proposed study
* Treatment with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within 90 days\*
* Uncorrected hypothyroidism or hyperthyroidism
* Treatment with any investigational agent within 1 month before randomization
* Acute coronary syndrome, i.e., Myocardial Infarction (MI) or unstable angina, revascularization procedure within the preceding month, or planned cardiac surgery within 3 months postrandomization

  * The exclusion of patients who received ECT or TMS within 90 days is adopted from other depression-intervention trials and meant to eliminate confounders. It is believed that the effects of ECT on mood and cognition may last for a couple of months, and duration of TMS effects is poorly known and may be similar to the ECT intervention.
C: Inclusion Criteria:

* Meets the DSM-IV criteria for a current major depressive episode
* Score of 15 or higher on the Beck Depression Inventory II
* History of acute myocardial infarction, unstable angina, or documented coronary disease

Exclusion Criteria:

* Physician or patient refusal
* Lives far away from study site
* Current alcohol or drug abuse
* Psychosis, dementia, or bipolar disorder
* Already taking Omega-3
* Medically ill or disabled such that patient is unable to participate
* Comorbid illness likely to be fatal within 1 year of study entry
* Seizure disorder or takes anticonvulsants
* Pregnant or breast feeding
* Liver or kidney disease
* Severe hypertriglyceridemia (greater than 400 mg/dL)
* Bleeding or clotting disorder
* Type 2 diabetes with a hemoglobin A1c (HbA1c) level greater than 10
* Taking lithium or monoamine oxidase inhibitor (MAO-I)
D: Inclusion Criteria:

1. Males or females ages 25-60. Must be able to read and understand English.
2. Currently meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-IV) criteria for a major depressive episode. (History of either unipolar major depression (depressive episodes only) or bipolar I disorder (history of manias and depressions) or bipolar II disorder (hypomanias and depressions), current episode depressed acceptable).
3. Must meet criteria for "treatment resistant" depression defined by failure to respond to, or intolerance of, at least 2 treatment trials (antidepressants or ECT) during the current episode.
4. All subjects will be fully ambulatory and in good medical health.
5. Are required to either be antidepressant free for 2 weeks prior to study entry (4 weeks for fluoxetine secondary to long half-life) or be on a fixed psychotropic medication regimen for at least 4 weeks. Subjects and their primary care providers must agree to continue their status (i.e. without antidepressant or on a fixed regimen) until the 12-week assessment is complete.
6. Pre-menopausal female subjects must not be pregnant and must be willing to use adequate contraception during the study period.

Exclusion Criteria:

1. Current or history of psychotic symptoms.
2. Active suicidal ideation (defined as a score of ≥3 on Hamilton Depression Rating Scale (HDRS) suicide item).
3. Prior use of a TNF-alpha antagonist (i.e. etanercept, infliximab, adalimumab) and use of any other immunosuppressant agent (i.e. systemic corticosteroids or anti-proliferative agents such as methotrexate) within one year of study entry.
4. Current use of aspirin, non-steroidal anti-inflammatory agents (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors during the study. Acetaminophen will be allowed.
5. History of any of the following conditions: Congestive heart failure, abnormal electrocardiogram, malignancy, schizophrenia, neurological disease, auto-immune condition (e.g. rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, lupus), chronic infection (e.g. human immunodeficiency virus, hepatitis B or C), and hematologic, renal or hepatic abnormality.
6. Subjects will be excluded for a positive anti-double stranded DNA antibody test.

Answer: C