Effect van glycopyrroniumbromide op nachtelijk clozapinegeïnduceerd speekselverlies bij patiënten met een psychiatrische aandoening

Abstract

OBJECTIVE: To determine the effect of oral glycopyrronium bromide in comparison with placebo on the severity of complaints of nocturnal sialorrhoea in psychiatric patients treated with clozapine and also in a subset of patients using a double dose of glycopyrronium bromide in the open-label extension. DESIGN: Randomised, double-blind, cross-over, placebo-controlled study with extended open-label phase. In this article a subanalysis of the open-label phase is presented. METHODS: We included psychiatric patients (18-65 year) treated with a stable dosage of clozapine, who were suffering from nocturnal sialorrhoea. In the double-blind phase, patients took once a day 1 mg glycopyrronium bromide oral solution or an equal volume placebo solution before the night during 6 days, with a washout period after each treatment period. In the openlabel phase, patients could choose to continue with a double dosage (2 mg). The primary outcome in the open-label phase was the proportion of patients showing a clinically relevant improvement on the severity of complaints of clozapineinduced sialorrhoea (CIS). RESULTS: 10 patients participated in the open-label phase. 3 patients experienced a clinically relevant improvement and 4 patients experienced some improvement on the severity of complaints of CIS after using 2 mg glycopyrronium bromide. CONCLUSION: The results of the open-label phase show that glycopyrronium bromide may potentially be a solution for patients with complaints of CIS. However, first we need to await the results of the double-blind phase to draw any further conclusions.