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The recent commentary by Carpenter et al¹ was timely and important. Some of their points regarding the necessity of medication-free research in new drug development merit additional discussion. Their arguments for medication-free periods can be classified into 2 groups: the initial lead-in period and the parallel placebo control group.

Their rationale for the initial medication-free lead-in period was (1) to prevent carry-forward effects of prestudy medication; (2) to establish a medication-free baseline; and (3) to minimize the risk of adverse drug-drug interactions.

These worthwhile goals may not always be accomplished in the typical current trials of antipsychotic drugs using a week-long medication-free lead-in period that may be shortened to 3 days. In the rat, the brain elimination half-life of a single oral dose of haloperidol was more than 2 weeks.² Plasma half-life of a single oral dose of haloperidol in humans is apparently multiphasic, with late elimination half-lives that may . . . [Full Text of this Article]

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