An open, multicenter study was carried out in order to evaluate the efficacy and tolerability of two doses of ketazolam on a large population of patients with moderate-to-severe anxiety symptoms, characterized by a total score ≥18 on the Hamilton Rating Scale for Anxiety (HAM-A). One hundred and seventy one psychiatrists enrolled a total of 2,056 patients. Three protocols were planned: the first two were open, randomized, between-patients studies, while the third was an open, noncomparative, add-on study. In the first two protocols patients were randomly given either ketazolam 15-mg tablets or ketazolam 30-mg tablets in the evening, for two weeks. In the third protocol patients were given ketazolam 15-mg tablets in the evening for one week; at the end of this period, if a decrease of at least 25% in baseline values in the HAM-A score was observed, the treatment was kept unchanged for a further week, otherwise the dose was doubled (30 mg). In the first two protocols both total score and clusters of HAM-A decreased by about 50%; in protocol 1 the total score of the Italian Questionnaire for Social Behavior (IQSB) increased by 22% and, in protocol 2 a similar improvement was observed in the Post-flep Questionnaire. As a whole, no difference was observed between the two doses of the drug, in terms of efficacy. In protocol 3, after one week of treatment, the dose was doubled in 45.9% of patients, and by the end of the study an improvement similar to that seen in protocol 1 was observed in the HAM-A total scores and clusters as well as in the IQSB score. Tolerability was good in the majority of cases. In conclusion, this study confirms the efficacy of ketazolam in the treatment of anxiety, thus supporting some published data obtained by using more standardized protocols and rigorous evaluation criteria.
|Number of pages||11|
|Journal||Current Therapeutic Research|
|Publication status||Published - 1989|
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