[Open study of clotiazepam (Clozan) in ambulatory anxious patients centered on a multifactorial evaluation using the AMDP and on a study of the rebound effect]

The efficacy and tolerance of the first thienodiazepine, clotiazepam, is well established but its clinical spectrum and the possibility of a rebound effect upon its cessation needed further research. Moreover, the validity of the AMDP Anxiety scale had been tested but not yet its sensitivity to change. Clotiazepam was given in an "open" design to 42 anxious outpatients at the dosage of 3 X 5 to 3 X 10 mg daily during 1 month, followed by a 1-week "single blind" placebo period. No other psychotropic drug was needed in 74% of the cases. A battery of observer rating scales (CGI, VAS, HAMA, BPRS, AMDP-4 and -5, AMDP-AT) confirmed the anxiolytic and tensiolytic efficacy of clotiazepam as well as its excellent tolerance. The 13-factor AMDP profile proved superior to short scales in the sample description and in the illustration of the clinical spectrum of the drug. Both the HAMA and the AMDP-AT were sensitive to change but the HAMA more significantly than the AMDP-AT.