Ryan E. Lawrence, Paul S. Appelbaum, Jeffrey A. Lieberman
JAMA Psychiatry. Published online April 10, 2019.
Randomized, placebo-controlled trials have been the gold standard for evaluating the safety and efficacy of new psychotropic drugs for more than half a century. Although the US Food and Drug Administration (FDA) does not require placebo-controlled trial data to approve new drugs or marketing indications, they have become the industry standard for psychotropic drug development.
Placebos are controversial. The FDA guidelines state “when a new treatment is tested for a condition for which no effective treatment is known, there is usually no ethical problem with a study comparing the new treatment to placebo.”1 However, “in cases where an available treatment is known to prevent serious harm, such as death or irreversible morbidity, it is generally inappropriate to use a placebo control”. When new antipsychotics are developed for schizophrenia, it can be debated which guideline applies.
From the Conclusion:
We believe the time has come to cease the use of placebo in relapse prevention studies and encourage the use of active comparators that would protect patients from relapse and provide information on the comparative effectiveness of the drugs studied. We recommend that pharmaceutical companies not seek maintenance labeling if it would require placebo-controlled, relapse prevention trials. However, for putative antipsychotics with a novel mechanism of action, placebo-controlled, relapse prevention trials may still be justifiable.
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