Placebo washout in trials of antipsychotic drugs.
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.
Volavka
J
J
Clinical Research Division, Nathan S. Kline Institute for Psychiatric Research. Orangeburg, NY 10962, USA.
Cooper
T B
TB
Laska
E M
EM
Meisner
M
M
D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017326:Clinical Trials, Phase III as Topic / Q000379:methods* / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D006801:Humans; D010919:Placebos / Q000627:therapeutic use; D011569:Psychiatric Status Rating Scales; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D013375:Substance Withdrawal Syndrome / Q000175:diagnosis / Q000517:prevention & control
D014150:Antipsychotic Agents; D010919:Placebos