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The efficacy of buspirone was established in a series of well-controlled trials conducted in the 1970s and 1980s in a patient population with the DSM-II diagnosis of anxiety disorder (Robinson 1991). The clinical development program of buspirone as an anxiolytic agent was undertaken after positive findings in a placebo-controlled proof-of-concept study in anxious patients (Goldberg and Finnerty 1979). It is of interest that the study investigators commented on the possibility that buspirone possesses antidepressant as well as anxiolytic properties. In a series of Phase III placebo-controlled clinical trials comparing buspirone and diazepam, the efficacy of these two anxiolytics was comparable in patients fulfilling diagnostic criteria for DSM-II anxiety neurosis (Boehm et al. 1990a; Goldberg and Finnerty 1982; Rickels et al. 1982). In these double-blind dosage titration studies, buspirone and diazepam were prescribed on a thrice-daily schedule in dosages (mean) ranging from 20 to 25 mg/day during 4 weeks of treatment.

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