A Pilot Study of the Short‐Term Psychotropic Effects of GPA 2640

Abstract

Anxious nonpsychotic inpatients participated (32) in a 4-day, double-blind repeat crossover study of a new drug, GPA 2640 [N,N-diethyl-3-carboxamido-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-(1,4)oxazino-(3,4-a) isoquinoline], and placebo. Each treatment period lasted for 1 day, and the study lasted for 4 days. Patients [20] completed the study, and 28 completed 2 or 3 days. The doses were individually adjusted and mostly ranged between 1100-1300 mg daily. Several valid observer-rating and self-rating scales were used. There was a slight trend for GPA 2640 to yield somewhat lower anxiety scores on drug days than on placebo days, but none of the differences between rating and self-rating scores reached a significant level. A few patients reported a marked improvement in mood after 2-4 days, but the significance of this finding cannot be evaluated from ths design. Two patients developed temporary paranoid delusions which were possibly drug related. Two patients had raised SGOT [serum glutamic oxalacetic transaminase] levels after the study. There were no significant differences in vital signs between drug days and placebo days. The drug has no immediate antianxiety effects (as those demonstrated with benzodiazepines in 2 previous studies utilizing the same design). This does not preclude the possibility of delayed anxiolytic effects or of other delayed psychotropic effects such as those observed with antipsychotic drugs or antidepressants.