Placebo Washout in Trials of Antipsychotic Drugs

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Abstract
For antipsychotic phase 3 clinical trials, we compare the relative merits of a placebo washout period with an alternate design strategy using a low-dose antipsychotic treatment. Evaluations are made with respect to the achievement of specific clinical trial design goals including the effect on power for detecting between-treatment and within-treatment pre-post differences. The relative merits of these two designs are discussed separately for those patients who enter the initial lead-in period after withdrawal from previous antipsychotic medication and for those not on medication immediately before that period.

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