A pilot study of the short-term psychotropic effects of GPA 2640.
Thirty-two anxious nonpsychotic inpatients participated in a four-day, double-blind repeat crossover study of a new drug, GPA 2640, and placebo. Each treatment period lasted for one day, and the study lasted for four days. Twenty patients completed the study, and 28 completed two or three days. The doses were individually adjusted and mostly ranged between 1100 and 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 two to four days, but the significance of this finding cannot be evaluated from this design. Two patients developed temporary paranoid delusions which may have been drug related. Two patients had raised SGOT levels after the study. There were no significant differences in vital signs between drug days and placebo days. The results signify that the drug has no immediate antianxiety effects (such as have been demonstrated with benzodiazepines in two previous studies utilizing the same design). This does not preclude the possibility of delayed anxiolytic effects or of other delayed psychotropic effects such as can be observed with antipsychotic drugs or antidepressants.
D000328:Adult; D000368:Aged; D001007:Anxiety / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010078:Oxazines / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000627:therapeutic use*; D011807:Quinolizines
D007546:Isoquinolines; D010078:Oxazines; D010919:Placebos; D011619:Psychotropic Drugs; D011807:Quinolizines; C012126:GPA 2640