UPBEAT 2012.
| Study characteristics | ||
| Methods | RCT design: 3‐arm parallel‐group trial Total N randomised: 101 Length of follow‐up: no follow‐up Analysis: ITT with multiple imputation (4 dropouts from intervention group, 1 dropout from control group) |
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| Participants | Location: USA Number of study centres and setting: physician referrals, community‐based screenings, mass media advertisements CAD criteria: documented CHD (e.g. prior MI, revascularisation procedure, or significant (> 70% stenosis) coronary atherosclerosis) Depression criteria: BDI ≥ 7 Other entry criteria: age 35 years or older Exclusion criteria: presence of another primary mental disorder diagnosis; medical comorbidities that would preclude participation in the trial (e.g. significant musculoskeletal disease, cancer); current psychotherapy; use of antidepressants or other psychotropic medications; history of inability to tolerate or benefit from sertraline; use of dietary supplements or herbal therapies with psychoactive indications; current active alcohol or drug abuse or dependence; active suicidal intent; participation in regular excercise > 1 day/week Treatment N: 40 (63% male, mean age: 63.4 (SD: 10.2)) Control N: 37 (65% male, mean age: 64.7 (SD: 11.0)) Comparability of groups: no baseline differences |
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| Interventions | Treatment: sertraline once daily, dosage dependent on clinical response, but participants usually started at 50 mg and progressed up to 200 mg, contingent on therapeutic response and the presence of side effects Control 1: placebo Control 2: aerobic exercise (3 classes per week, 16 weeks); ineligible for inclusion in this review Duration of treatment: 4 months |
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| Outcomes | Review outcomes: depression symptoms (HAM‐D), platelet biomarkers, ECG waves, pharmacological side effects | |
| Funding | National Heart, Lung, and Blood Institute Other support: sertraline and matching placebo pills were supplied by Pfizer Inc NY |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "participants assigned to exercise, sertraline, or placepo in a pre‐determined 2:2:1 ratio. Randomization was performed centrally by computer with conditional randomization (stratified by age [35 to 59 vs ≥60], CHD status (prior MI vs. no MI) and depression severity [HAM‐D score > 18 vs. ≤ 18)]; patients were provided with sealed envelopes containing their group assignments" Comment: no |
| Allocation concealment (selection bias) | Low risk | Comment: sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: treating psychiatrist blinded to pill condition; only research pharmacist was aware of which patients were assigned to sertraline or to placebo Comment: group randomized to exercise were unblinded and not used in this review |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: primary HAMD assessments were performed blinded to treatment allocation Quote: "Outcome assessors were unaware of patients’ treatment assignments" (pg. 1056) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: Reasons for drop‐out provided; 1 patient randomized to sertraline and 4 patients randomized to placebo did not complete the study Quote: "unless otherwise indicated, treatment effects were analyzed following the intent‐to‐treat principle..." (pg. 1056) |
| Selective reporting (reporting bias) | Unclear risk | Comment: predetermined endpoints are reported; no protocol paper available Comment: measures of variance (e.g. SD or SE) not reported for biomarkers in paper, only p values for between group comparisons ‐ e.g. active treatment vs. placebo, thereby incorporating the exercise group which were not relevant to this review. Biomarker data obtained from trial repository |
| Other bias | Low risk | Comment: No indication of other bias |