Placebo washout in trials of antipsychotic drugs

Schizophrenia Bulletin
J VolavkaM Meisner

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 leadin period after withdrawal from previous antipsychotic medication and for those not on medication immediately before that period.

Citations

Mar 3, 2004·Social Science & Medicine·Charles W LidzMichelle Renaud
Aug 3, 2006·Behavioral Sciences & the Law·Charles W Lidz
Mar 7, 2006·Nature Reviews. Drug Discovery·T Scott StroupJeffrey A Lieberman
Mar 24, 2016·The Pharmacogenomics Journal·R D HolmesJ L Kennedy
Feb 7, 2004·Canadian Journal of Psychiatry. Revue Canadienne De Psychiatrie·Gordon DuVal

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