Double-blind randomized trial of the benzodiazepine derivative metaclazepam as compared with placebo treatment of outpatients with anxiety syndromes.

In a double-blind randomized study the therapeutic anxiolytic efficacy and the tolerance of metaclazepam were tested in comparison with placebo. The study was performed according to the model of the "Study Group - Psychotropic Drugs in Medical Practice" (Laakmann and Hippius, 1981; Laakmann et al., 1982). A total of 121 male and female patients aged between 18 and 50 years were treated either with placebo, or with 15 mg or with 30 mg metaclazepam/day for two weeks, during which period they were examined on Day 0, Day 7 and Day 14. The patients suffered from a neurotic anxiety syndrome. In the physician's rating metaclazepam showed a therapeutic effect significantly superior to that of placebo, both in the Clinical Global Impressions (CGI) and in the Hamilton Anxiety Scale (HAMA). This effect was already noticeable at the end of the first week. Similarly, a significantly superior anxiolytic activity of metaclazepam as compared with placebo was observed in the patients' ratings in the course of treatment. This was true for the Erlangen Anxiety Scale (EKSA) as well as for the Scale of Well-being (Befindlichkeits-Skala [Bf-S]) and the List of Complaints (Beschwerden-Liste [B-L]) by von Zerssen. No difference in efficacy could be found between the doses of 15 mg and 30 mg metaclazepam/day, neither in the physicians' nor in the patient's ratings. Compared with placebo, twice as many undesirable side effects were recorded with 15 mg metaclazepam and three times as many with 30 mg metaclazepam. This was clearly demonstrated by the significantly higher frequency of daytime fatigue after 30 mg metaclazepam.(ABSTRACT TRUNCATED AT 250 WORDS)