The effect of glycopyrroniumbromide on nocturnal clozapine induced sialorrhea in psychiatric patients: a randomized, cross-over, double blind, placebo controlled trial with an extended open label phase (QUITSPIT study) - QUITSPIT-study

niversitair Medisch Centrum Utrecht0 个研究点目标入组 33 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•-patients using clozapine who are diagnosed with schizophrenia, a schizoaffective disorder or other psychiatric condition meeting DSM-IV criteria;
•-a clozapine dosage that remained unchanged for one months prior to inclusion;
•-age between 18 and 65 years;
•-nocturnal sialorrhea defined as a score > 2 on the PGI-S (Patient Global Impression of Severity Questionnaire)
•-no change in dosages of specific comedication (clonidine, sulpride, moclobemide) that potentially reduces salivary flow for 16 days prior to inclusion
•-the patients is able to answer questionnaires during a weekly consultation (by telephone) with the researcher
•- the patient is willing to give informed consent for participating in the study
•-the patient is, according to the treating psychiatrist, competent and able to give informed consent for participating in the study.

•-known hypersensitivity to glycopyroniumbromide, sorbic acid or saccharine sodium;
•-a comorbidity associated with sialorrhea (Parkinsons disease, cerebral palsy);
•-one of the following comorbidities: inadequately treated constipation, urine retention, bladder obstruction
•-concurrent use of anticholinergic agents: tricyclic antidepressants or anticholinergics (atropine, ipratropiumbromide, trihexyfenidyl,
•biperiden, scopolamine, oxybutinine);
•-concurrent use of medications that potentially interact with glycopyrroniumbromide
•(potassium chloride retard tablets, digoxine, corticosteroids)
•-pregnancy or lactation
•-a history of myasthenia gravis, cardiac arrhythmia, symptomatic coronary insufficiency, glaucoma, pyloris stenosis, paralytic ileus, prostate hypertrophy, renal failure
•-unable to autonomic medication intake

发起方

niversitair Medisch Centrum Utrecht