PLACEBO WASHOUT IN TRIALS OF ANTIPSYCHOTIC-DRUGS

For antipsychotic phase 3 clinical trials, we compare the relative mer its of a placebo washout period with an alternate design strategy usin g a low-dose antipsychotic treatment. Evaluations are made with respec t to the achievement of specific clinical trial design goals including the effect on power for detecting between-treatment and within-treatm ent 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 fo r those not on medication immediately before that period.