Pizzi 2009.
| Study characteristics | ||
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 100 Length of follow‐up: 5 months Analysis: per‐protocol (method of analysis not explicitly stated; 3 dropouts in the treatment group, 2 dropouts in the control group) |
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| Participants | Location: Italy Number of study centres and setting: secondary care referral to visit the Department of International Medicine, Aging and Nephrological Diseases CAD criteria: documented CAD (diagnosis of at least 1 of the following: previous MI, previous or current angina with objective evidence of atherosclerosis, and a previous surgical procedure for coronary revascularisation) Depression criteria: symptoms of depression (BDI ≥ 10) Other entry criteria: none Exclusion criteria: neoplasms, kidney or liver failure, systemic inflammatory disease, uncontrolled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg), recent AMI or unstable angina, ejection fraction < 50%, current antidepressant treatment, current psychotherapy Treatment N: 47 (53.2% female, mean age: 57.4 (SD: 8.7)) Control N: 48 (47.9% female, mean age: 56.3 (SD: 8.2)) Comparability of groups: no significant baseline differences |
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| Interventions | Treatment: sertraline (week 1 to 6: 50 mg daily, week 7 to 12: gradually increase to attain a maximum daily dose of 200 mg, depending on each participant's clinical response and tolerance, week 13 to 20: constant dose (= maximum of milligrams reached at the end of week 12) Control: placebo Duration of treatment: 20 weeks |
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| Outcomes | Review outcomes: depression symptoms (BDI), depression response, platelet biomarkers, pharmacological side effects Other outcomes: inflammatory markers, flow‐dependent endothelium‐mediated dilation |
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| Funding | No information provided. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: Randomisation carried out by a central office, no other information on sequence generation |
| Allocation concealment (selection bias) | Unclear risk | Comment: No sufficient information provided, steps taken to conceal the allocation unclear |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Double‐blind trial, researchers were blind to patients group allocation during recruitment, data collection and data analyses, physicians who were not involved in the study design performed treatment assignment and implementation of the therapy |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Self‐reported primary outcome (BDI); no other information on blinded outcome assessments for biomarkers |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: Low drop‐out, authors reported reasons for early drop‐out per group |
| Selective reporting (reporting bias) | Unclear risk | Comment: No study protocol available but mentioned (p.531) |
| Other bias | Low risk | Comment: No indication of other bias |