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 个研究点开始时间: 2012年7月4日最近更新: 2015年9月14日

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 three 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 1 month prior to inclusion
•-the patients is able to answer questionnaires during a weekly consultation (by telephone) with the researcher
•-the patient is willing and according to the treating physician, able to give informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 33
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-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