Journal Article

Placebo Washout in Trials of Antipsychotic Drugs

Jan Volavka, Thomas B. Cooper, Eugene M. Laska and Morris Meisner

in Schizophrenia Bulletin

Published on behalf of Maryland Psychiatric Research Center

Volume 22, issue 4, pages 567-576
Published in print January 1996 | ISSN: 0586-7614
e-ISSN: 1745-1701 | DOI: http://dx.doi.org/10.1093/schbul/22.4.567
Placebo Washout in Trials of Antipsychotic Drugs

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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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Subjects: Child and Adolescent Psychiatry

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