Experimental clinical studies on the effect of eburnamonine in cerebrovascular disorders.

Two double-blind, placebo-controlled studies were performed successively to demonstrate the efficacy of Eburnamonine. In the first study, the efficacy of 12 weeks of administration of 3 X 60 mg Eburnamonine per day (n = 25) was investigated in 49 inpatients with cerebrovascular disorders. In the second, the effect of 12 weeks of therapy with 1 X 60 mg Eburnamonine per day (n = 25) was investigated in 50 patients of the same diagnostic category. Results related to the efficacy were analyzed on the basis of the physician's global rating of therapeutic effect, and evaluated by the x2-test. Global therapeutic effect was confirmed and illustrated by effects on specific variables (List of Cerebral Symptoms, function test, NOSIE) evaluated by analysis of covariance. Under the influence of both dosages, therapeutic improvement was observed more frequently than under placebo. The incidence of gastrointestinal side effects was higher under the dose of 3 X 60 mg than under placebo. No effects were observed with respect to parameters of clinical chemistry. In the quasi-experimental comparison of 3 X 60 mg and 1 X 60 mg Eburnamonine, the higher dose was found to yield more therapeutic improvement, but also more frequent side effects than the lower dose, which, in this respect, did not differ from placebo.

Double-blind comparison of diclofensine with nomifensine in outpatients with dysphoric mood.

Depressed outpatients (n = 107, age 26-75 years) were treated with either a 50 mg single morning dose of diclofensine (n = 54) or 75-100 mg nomifensine given in two divided doses (n = 53) over a period of three weeks. The baseline mean values of the Depression Status Inventory (DSI index) of Zung corresponded to those of a mildly depressed population, as given by Zung. At the end of the treatment the mean DSI and Anxiety Status Inventory (ASI-index) values of both groups dropped to the levels of a normal population. The side-effect profile of the two treatments was similar. There were no side-effects indicating sedation. Adverse effects of the anticholinergic type were rare. It can be concluded that both diclofensine and nomifensine are beneficial for the treatment of depressed outpatients and that in a dose relation of 2:3 (diclofensine:nomifensine) they lead to a similar improvement in depressive outpatients.