CGP 12.103 A versus clomipramine in the treatment of depressed inpatients--results of a double-blind study.

In a double-blind study, which was conducted as an interindividual comparison, 41 depressed inpatients were divided into two test groups according to a randomized list and received either the test substance CGP 12.103 A (19 patients) or the comparative substance clomipramine (22 patients). The study was conducted over a period of 28 days and the dosage of each substance, after being gradually increased, was stabilized at 150 mg. Except for a significantly varied distribution of syndrome patterns, the two treatment groups were comparable with regard to relevant criteria. Both treatment groups showed a significant improvement as assessed by both the degree of severity of depression and the Hamilton Depression Rating Scale; on each scale, however, the clomipramine treatment group exhibited a tendency toward better antidepressive efficacy. According to the self-evaluations of the patients, which were conducted with the help of v. Zerssen's Self-Rating Scale, this tendency was not significant. The Kusta activation parameter indicated a tendentially stronger manifestation in the case of clomipramine. In the final evaluation the onset of efficacy for the CGP 12.103 A group lay in the mean on treatment day 6, for the clomipramine group on treatment day 10. The physician's overall assessment of therapeutic effect found no differences between the two treatment groups on day 14 and on day 28. Expected side effects were observed in the CGP 12.103 A group in nine patients, in the clomipramine group in 14. All in all, the test substance CGP 12.103 A, the (-) or R-enantiomer of the antidepressant oxaprotiline, which itself is derived from maprotiline, showed no essential differences in its antidepressive efficacy compared with clomipramine.