• IRB: ETHICS & HUMAN RESEARCH

The Antidepressant Debate and Ethically Defensible Placebo-Controlled Trials

The expert clinical community is split about whether the difference between antidepressant treatment and treatment with placebos stems from the efficacy of the drug or from subjects’ heightened expectancy enhanced by side effects—i.e., enhanced placebo effects. Proving whether pharmacological efficacy has been established reliably by randomized controlled trials of antidepressant drugs is difficult, primarily because substituting a placebo for an effective treatment in the control arm of a trial is ethically questionable. I argue that clinical equipoise permits the use of active placebo controls in trials that test antidepressants. Placebo controls for drug trials are ethically defensible and scientifically justified when we have evidence that a standard treatment might only work because of enhanced placebo effects, and when a respectable minority of the expert clinical community endorses these concerns.

Key words/concepts: randomized controlled trials, placebo effects, antidepressants, clinical equipoise, drug/placebo difference

Duff R. Waring, “The Antidepressant Debate and Ethically Defensible Placebo-Controlled TrialsThe Antidepressant Debate and Ethically Defensible Placebo-Controlled Trials,” IRB: Ethics and Human Research 30, no. 6 (2008).