SADHART 2002.
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 369 Length of follow‐up: No follow up Analysis: Intention‐to‐treat (53 discontinued treatment, 46 discontinued placebo) |
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| Participants | Location: USA, Europe, Canada, Australia Number of study centres and setting: Outpatients from 40 cardiology centres and psychiatry clinics CAD criteria: Patients hospitalized for Myocardial Infarction (MI) or unstable angina in the past 30 days. Criteria for acute MI: at least 1 criterion from each of the following 2 categories: Category A: 1) creatine kinase isoenzyme MB (CK‐MB) level greater than the upper limit of normal, 2) CK or troponin T or troponin 1 level more than 2 times the upper limit of normal, 3) a total lactate dehydrogenase (LDH) level more than 1.5 times the upper limit of normal (with LDH 1 greater than LDH 2). Category B: 1) typical ischemic symptoms (chest pain or shortness of breath) lasting for more than 10 minutes, 2) ECG evidence of ischemic ST‐segment depression, ST‐segment elevation, or new pathological Q waves. Criteria for unstable angina: 1) experienced angina of anginal equivalent symptoms at rest, with episodes lasting for at least 10 minutes and leading to hospitalization, and had ECG documentation of transient ST‐segment elevation or depression of more than 0.5 mm, or had T wave inversion of greater han 1 mm within 12 hours of an episode of chest pain; 2) were hospitalized for symptoms of unstable angina and had known CAD with a documented history of a prior MI, had undergone a prior revascularization procedure, or had documented coronary artery stenosis greater than 75% in one of the major epicardial vessels. Depression criteria: Major depression according to structured Diagnostic Interview Schedule (DIS) for DSM‐IV, Beck Depression Inventory (BDI) score of 10 or greater Other entry criteria: None Exclusion criteria: Uncontrolled hypertension, cardiac surgery anticipated during the next 6 months, MI or unstable angina developed less than 3 months after CABG, resting heart rate of less than 40/min, MI or unstable angina of nonatherosclerotic etiology, Killip class III or IV status, persistent clinically significant laboratory abnormalities, renal dysfunction, hepatic dysfunction, other significant noncardiac disease, women of childbearing potential not using adequate contraception, current use of class 1 antiarrhythmic medications, use of reserpine, guanethidine, clonidine, methyldopa, anticonvulsants, neuroleptics, antidepressants, benzodiazepines, initiation of psychotherapy in the 3 months prior to study entry, alcohol or substance abuse or dependence in past 6 months, psychotic symptoms, history of psychosis, bipolar disorder, organic brain syndrome, dementia, significant suicide risk Treatment N: 186 (37% female, mean age: 56.8 (SD: 11.1)) Control N: 183 (36% female, mean age: 57.6 (SD: 10.4)) Comparability of groups: No significant baseline differences |
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| Interventions | Treatment: Sertraline 50 mg/d for the first 6 weeks, up to 100 mg/d for weeks 6‐10, up to 150 mg/d for weeks 10‐12, up to 200 mg/d for weeks 12‐24 Control: Placebo Duration of treatment: 24 weeks |
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| Outcomes | Review outcomes: Cardiac events, mortality, Hamilton Rating Scale for Depression (HAM‐D) score, direct medical costs (inpatient hospitalizations, emergency room visits, cardiac procedures), quality of life (Quality of Life Enjoyment and Satisfaction scale (Q‐LES‐Q) and Medical Outcomes Study Short‐Form 36 (SF‐36)) Other outcomes: Left Ventricular Dysfunction (LVEF), heart rate, blood pressure, standard ECG, heart rate variability, Clinical Global Impression ‐Severity (CGI‐S) and ‐Improvement (CGI‐I), ventricular premature complexes |
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| Funding | Pfizer Inc.; Suzanne C. Murphy Foundation; Thomas and Caroline Royster Research Fund; Perry and Martin Granoff Family Foundation | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: No details reported |
| Allocation concealment (selection bias) | Unclear risk | Comment: No details reported |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "double‐blind" (p. 702) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: Last observation carried forward |
| Selective reporting (reporting bias) | Unclear risk | Comment: No protocol or design paper available |
| Other bias | High risk | Comment: Conflicting interests: Funded by Pfizer Inc. |