Van Melle et al (2007) present findings from their randomised controlled trial examining the effects of antidepressant treatment for depression following myocardial infarction. I would like to comment on the design of the study. Patients were allocated to two arms: antidepressant treatment and care as usual. Patients in the care-as-usual arm were not told about their research diagnosis of depression. The authors quote Zelen (Reference Zelen1979), thus implying that they are following the research design he proposed. However, Zelen's method seems best suited to trials where there is a ‘gold standard’ control treatment available and the trial is attempting to evaluate a new experimental treatment (Reference ZelenZelen, 1979). In this design, the ethical concerns are mainly about randomising before consent is sought. It must be pointed out that after randomisation, consent is sought from patients in the experimental arm. If they decline, they are moved to the ‘gold standard’ arm (Reference TorgersonTorgerson, 2001). I am not sure whether the trial of van Melle et al fits into this category.
Furthermore, there are ethical issues about not informing patients about their diagnosis of depression. I am disappointed that the paper did not discuss these in further detail. Their information pack stated that all patients were free to seek help for their mood problems. Patients may feel tired and low in mood but may not recognise this as depression, for which there are effective interventions available. Is it ethical to with-hold information regarding the diagnosis from such patients? Will patients seek help if they are not told they have depression?
Performing research can raise difficult ethical issues and I hope this letter will encourage some debate on this.
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