The effect of glycopyrroniumbromide oral solution for nocturnal drooling due to the use of clozapine.
Completed
- Conditions
- English: CIS, clozapine-induced-sialorrhea, hypersalivation, droolingNederlands: sialorroe, hypersalivatie, kwijlen
- Registration Number
- NL-OMON26368
- Lead Sponsor
- Mw. Dr. Ingeborg WiltingziekenhuisapothekerUniversitair Medisch Centrum Utrechtziekenhuisapotheek
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 33
Inclusion Criteria
1. Patients using clozapine who are diagnosed with schizophrenia, a schizoaffective disorder or other psychiatric condition meeting DSM-IV criteria;
2. A clozapine dosage that remained unchanged for three months prior to inclusion;
Exclusion Criteria
1. Known hypersensitivity to glycopyroniumbromide, sorbic acid or saccharine sodium;
2. A comorbidity associated with sialorrhea (Parkinsons disease, cerebral palsy);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of patients showing a clinically significant improvement on the severity of complaints of nocturnal sialorrhea, defined as a score of 1 (very much improved) or 2 (much improved) on the PGI-I (Patient Global Impression of improvement questionnaire).
- Secondary Outcome Measures
Name Time Method The mean score on the PGI-I, PGI-S, NHRS (Nocturnal Hypersalivation Rating Scale) and MSQ (Medication Satisfaction Questionnaire), the occurence of side effects and patients satisfaction with oral glycopyrroniumbromide.