[Clinical trial of a novel benzodiazepine derivative in a double-blind study using the Wittenborn psychiatric rating scale (author's transl)]

From testing a new benzodiazepine derivative, 8-chloro-1-phenyl-2,3,4,5-tetrahydro-1H-1,5-benzodiazepin-2-one (Bu 1014), as measured against a placebo in a double-blind trial, the following conclusions can be drawn. The test was carried out over two periods of a fortnight each with a change-over between the two periods. 1. The change-over method has proven suitable to reveal side effects of the substance which last for at least two weeks. Owing to the substance's sequelae, however, statistical analysis of the second treatment period's information is not possible with this experimental design. 2. The statistical methods used proved more effective than the usual methods as they allow clearer statements to be made on the efficacy of the substance. 3. Within the first period of 14 days both the group receiving the placebo and the drug treated group showed a decrease in the intensity of anxiety. 4. The sequelae of Bu 1014 can be described as an increase in restiveness and anxiety in those patients who received the placebo in the second treatment period.

PMID: 1043 [PubMed - indexed for MEDLINE]