CLOBAZAM - UNCONTROLLED AND STANDARD CONTROLLED CLINICAL-TRIALS

1 In an uncontrolled clinical trial, carried out in 11 psychiatric patients with the clinical diagnoses of anxiety neurosis and depressive neurosis, clobazam, a new benzodiazepine preparation, in the dosage range 10‐60 mg daily produced statistically significant improvement in the total and both factor scores of the Hamilton Anxiety Scale (HAM‐A). The lowest mean total HAM‐A scores occurred with a mean clobazam dosage of 48 mg daily. 2 Results of the uncontrolled clinical trial were further substantiated in a standard‐controlled clinical study in which no statistically significant difference between the therapeutic effectiveness of clobazam and diazepam could be revealed. The lowest mean total HAM‐A scores occurred with a mean clobazam dosage of 49 mg daily. There was a lower incidence of adverse effects reported in patients receiving clobazam than in those taking the control drug (diazepam). 1979 The British Pharmacological Society