SADHART 2002.

Study characteristics
Methods	RCT design: 2‐arm parallel‐group trial Total N randomised: 369 Length of follow‐up: no follow‐up Analysis: ITT (53 discontinued treatment, 46 discontinued placebo)
Participants	Location: USA, Europe, Canada, Australia Number of study centres and setting: outpatients from 40 cardiology centres and psychiatry clinics CAD criteria: patients hospitalised for 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 ischaemic symptoms (chest pain or shortness of breath) lasting for more than 10 minutes, 2) ECG evidence of ischaemic 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 hospitalisation, and had ECG documentation of transient ST‐segment elevation or depression of more than 0.5 mm, or had T wave inversion of greater than 1 mm within 12 hours of an episode of chest pain; 2) were hospitalised for symptoms of unstable angina and had known CAD with a documented history of a prior MI, had undergone a prior revascularisation procedure, or had documented coronary artery stenosis greater than 75% in 1 of the major epicardial vessels Depression criteria: major depression according to structured Diagnostic Interview Schedule (DIS) for DSM‐IV, 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 non‐atherosclerotic aetiology, Killip class III or IV status, persistent clinically significant laboratory abnormalities, renal dysfunction, hepatic dysfunction, other significant non‐cardiac 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
Interventions	Treatment: sertraline 50 mg/d for the first 6 weeks, up to 100 mg/d for weeks 6 to 10, up to 150 mg/d for weeks 10 to 12, up to 200 mg/d for weeks 12 to 24 Control: placebo Duration of treatment: 24 weeks
Outcomes	Review outcomes: depression symptoms (HAM‐D), depression response, all‐cause mortality, cardiac events, healthcare costs, hospitalisations, quality of life (Quality of Life Enjoyment and Satisfaction scale (Q‐LES‐Q, Medical Outcomes Study Short‐Form 36), cardiovascular vital signs, platelet biomarkers, ECG waves, pharmacological side effects Other outcomes: left ventricular function, ventricular premature complexes, heart rate variability, clinical global impression
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: Single‐blind placebo treatment preceded double‐blind randomization to intervention or placebo
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: Single‐blind placebo treatment preceded double‐blind randomization to intervention or placebo
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: Serious adverse events and ECG reporting blinded to treatment allocation; other outcomes unclear
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: author involved in design, analysis and reporting of data was an employee of Pfizer