English: CIS, clozapine-induced-sialorrhea, hypersalivation, drooling Nederlands: sialorroe, hypersalivatie, kwijlen
Conditions
Interventions
Alternating treatment with 1 mg glycopyrroniumbromide oral solution or placebo oral solution for 1 week interrupted by 1 week wash-out.
Patients who have no problems enduring the treatment with 1 mg
Sponsors
Mw. Dr. Ingeborg Wilting
ziekenhuisapotheker
Universitair Medisch Centrum Utrecht
ziekenhuisapotheek
Eligibility
Inclusion criteria
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; 3. Age between 18 and 65 years; 4. Nocturnal sialorrhea defined as a score > 2 on the PGI-S (Patient Global Impression of Severity Questionnaire); 5. No change in dosages of specific comedication (clonidine, sulpride, moclobemide) that potentially reduces salivary flow for 1 month prior to inclusion; 6. The patient is able to answer questionnaires during a weekly consultation (by telephone) with the researcher; 7. The patient is willing to give informed consent for participating in the study; 8. The patient is, according to the treating psychiatrist, competent and able to give informed consent for participating in the study.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to glycopyroniumbromide, sorbic acid or saccharine sodium; 2. A comorbidity associated with sialorrhea (Parkinsons disease, cerebral palsy); 3. One of the following comorbidities: Inadequately treated constipation, urine retention, bladder obstruction; 4. Concurrent use of anticholinergic agents: Tricyclic antidepressants or anticholinergics (atropine, ipratropiumbromide, trihexyfenidyl, biperiden, scopolamine, oxybutinine); 5. Concurrent use of medications that potentially interact with glycopyrroniumbromide (potassium chloride retard tablets, digoxine, corticosteroids); 6. Pregnancy or lactation; 7. A history of myasthenia gravis, cardiac arrhythmia, symptomatic coronary insufficiency, glaucoma, pyloris stenosis, paralytic ileus, prostate hypertrophy, renal failure; 8. Unable to autonomic medication intake.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactW.H. Man
AIOS Ziekenhuisfarmacie en klinisch onderzoeker Universitair Medisch Centrum Utrecht, apotheek Heidelberglaan 100
Outcome results
None listed