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January 17, 1996

Clozapine for Treatment of Schizophrenia-Reply

Author Affiliations

National Institutes of Health Bethesda, Md

JAMA. 1996;275(3):187. doi:10.1001/jama.1996.03530270026024

In Reply.  —Dr Orr questions the use of a placebo period described in the selected patient who was reported in our article. This patient participated in a carefully controlled, prospective, double-blind treatment trial with the then-experimental and atypical antipsychotic clozapine.1 This study resulted in the first non—industry-supported data indicating the superiority of clozapine in comparison with a representative traditional antipsychotic. Informed written consent was required prior to entry into the study; the patient's continuing assent and understanding of experimental procedures were monitored regularly throughout the study. Withdrawal of consent at any time and for any reason is justification for termination of participation.The inclusion of a placebo period in the crossover design enabled biological and clinical investigation into the effects of clozapine with minimal contamination by prior drug treatment. This approach led to a number of observations pertaining to the mechanism of action and clinical effectiveness of clozapine.2,3