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)

Phase 3

Completed

Conditions: drooling
hypersalivation
10062915
behandeling van een bijwerking (speekselverlies) van een geneesmiddel (iatrogeen effect)
10039404

Registration Number: NL-OMON39699

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 33

Inclusion Criteria

-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.

Exclusion Criteria

-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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The percentage of patients showing a clinically significant improvement on the<br /><br>severity of complaints of nocturnal sialorrhea, defined as a score<br /><br>of 1 (very much improved) or 2 (much improved) on the PGI-I (Patient Global<br /><br>Impression of improvement questionnaire).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The mean score on the PGI-I, PGI-S, NHRS (Nocturnal Hypersalivation Rating<br /><br>Scale) and MSQ (Medication Satisfaction Questionnaire), the<br /><br>occurence of side effects and patients satisfaction with oral<br /><br>glycopyrroniumbromide.</p><br>