To the Editor The report of the clinical trial of the effect of escitalopram vs placebo for depression on long-term cardiac outcomes1 helps to answer an important question regarding the known relationship between depression and adverse cardiovascular outcomes: does treating the depression decrease major cardiovascular events over the long term?
I have ethical concerns about the use of placebo controls in trials of patients with current major depressive disorder, even trials focused on nonpsychiatric outcomes. The Declaration of Helsinki asserts that “In any medical study, every patient—including those of a control group, if any—should be assured of the best proven…therapeutic methods.”2 Others have argued that placebo-controlled trials in treatable conditions can still be ethical if key conditions are met.3 The use of placebo seems justified in this case only for the cardiovascular end points because there is cardiovascular equipoise; ie, cardiac outcomes could have been made worse or better by antidepressant drug treatment.
Rust G. Cardiac Outcomes After Treatment for Depression in Patients With Acute Coronary Syndrome. JAMA. 2018;320(20):2152. doi:10.1001/jama.2018.15934
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