Approach to Studying Drug Effects in Ambulatory Patients

INTRODUCTION THIS study was designed to demonstrate a method for evaluating the differential effects of drugs on ambulatory patients. The method consists of use of observation controls, quantified scores for observations, and sequential analysis of data. Specifically, this aim was exemplified by a test of whether an anti-depressant medication, pargyline hydrochloride (Eutonyl), is more effective in reducing the manifest symptoms of depression than is an inert placebo.Pargyline is a nonhydrazine monoamine oxidase inhibitor (MAO) chemically identified as N-benzyl-N methyl-2 propynylamine hydrochloride. Previous studies of this agent as a psychic energizer have been for the most part uncontrolled clinical observations. For example, Saunders5 reported on his experience with pargyline using 59 female hospitalized patients as subjects. Kline4 reported his experience with 50 subjects in private practice who had been unsuccessfully treated with other means. With this difficult group of patients