Results of an open phase II study with zotepine--a new neuroleptic compound.

Zotepine is a new tricyclic neuroleptic with a pharmacological profile comparable to substances such as thioridazine and chlorpromazine. Ten patients fulfilling DSM-III criteria of paranoid schizophrenia were included in an open pilot study at the Department of Psychiatry in Innsbruck. Neuroleptic efficacy, optimal dose, side effects, and the influence on serum prolactin levels were evaluated. Definite onset of antipsychotic action could be demonstrated between days 5-10, and approximately 400 mg/die seems to be an optimal dose. Four patients showed side effects of a minor degree that had no influence on the course of therapy. These results suggest that Zotepine is a rapidly acting neuroleptic with a high benefit-risk ratio. Further double-blind studies will be needed to reinforce these preliminary data.