Method for Evaluation of Neuroleptic Dosage Reduction

Abstract

This paper describes a new approach to the evaluation for reduction of maintenance neuroleptic dosages. The proposed methodology reduces the ethical and experimental problems associated with the two design strategies employed in the past studies of drug reduction, the end point and interrupted designs, respectively. The proposed procedure, an interrupted design with statistical criteria for clinical relapse, uses double-blind objective ratings of patients' psychiatric status. The mean level of function and degree of variability for each subject are statistically determined and an a priori probability for clinical relapse is applied across all subjects. Unlike end-point designs, this procedure is responsive to the clinical decompensation of patients. In addition, the use of statistical criteria for clinical relapse reduces the introduction of experimenter bias of results, common to past interrupted designs which relied on subjective decision processes of the experimenter to define clinical relapse.