Carney 2009.
| Study characteristics | ||
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 122 Length of follow‐up: no follow‐up Analysis: ITT with multiple imputation for missing data |
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| Participants | Location: USA Number of study centres and setting: cardiology practices in St Louis, Missouri and from cardiac diagnostic laboratories affliliated with Washington University School of Medicine CAD criteria: CHD documented by at least 50% stenosis in at least 1 major coronary artery, a history of revascularisation or hospitalisation for an acute coronary syndrome Depression criteria: patients who fullfilled DSM‐IV criteria for current major depressive episode (DISH) and scored 16 or higher on the BDI‐II Other entry criteria: none Exclusion criteria: cognitive impairment, comorbid psychiatric disorders, psychosis, high risk of suicide, current substance abuse, acute coronary syndrome within the previous 2 months, a left ventricular ejection fraction of less than 30%, advanced malignancy or physical inability to participate, use of any antidepressants, anticonvulsants, lithium, or omega‐3 supplements, sensitivity to sertraline or omega‐3, physician or patient refusal Treatment N: 62 (35.5% female, mean age: 58.1 (SD: 9.4)) Control N: 60 (31.7% female, mean age: 58.6 (SD: 8.5)) Comparability of groups: no significant baseline differences between groups except for a higher proportion of aspirin use in the placebo group |
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| Interventions | Treatment 1: sertraline (50 mg/d) + omega‐3 (2 g/d) Treatment 2: sertraline (50 mg/d) + corn oil capsules (placebo) Duration of treatment: 10 weeks |
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| Outcomes | Review outcomes: depression score (HAM‐D, also BDI‐II), depression response (50% symptom reduction BDI‐II) and depression remission (BDI‐II ≤ 8), cardiac events, resource utilisation (emergency room visits), pharmacological side effects Other outcomes: anxiety symptoms (Beck Anxiety Inventory), treatment adherence, omega‐3 index |
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| Funding | Study funded by the National Heart, Lung, and Blood Institute. Other support: GlaxoSmithKline Inc supplied omega‐3 and placebo capsules; Pfizer Inc supplied sertraline |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: permuted‐block‐randomisation (SAS institute, Cary, North Carolina) |
| Allocation concealment (selection bias) | Low risk | Comment: assignments sealed envelopes opened at enrolment by a pharmacist blinded to all assessments |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Only the study pharmacist and the chair of the data and safety monitoring committee were unblinded to group assignment during the trial." (p.1652) |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "Only the study pharmacist and the chair of the data and safety monitoring committee were unblinded to group assignment during the trial." (p.1652) Quote: "An independent cardiologist, the study investigators, and the study nurses met quarterly to review adverse events. The study pharmacist and the independent cardiologist were informed immediately about serious adverse events and quarterly about routine adverse events" (pg. 1653) Comment: Unclear how HAMD was rated and by whom |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: ITT, reasons for drop‐out given (drop‐out: 4 patients in the sertraline+placebo, 3 patients in the sertraline+Omega‐3) |
| Selective reporting (reporting bias) | Unclear risk | Comment: Secondary outcomes (biomarkers) were not reported ITT |
| Other bias | Unclear risk | Comment: in‐ and exclusion criteria differ from the trial registry |