Nocturnal sialorrhea caused by the use of clozapine
Conditions
Interventions
Product Name: Glycopyrroniumbromide
Pharmaceutical Form: Oral solution
INN or Proposed INN: GLYCOPYRRONIUM BROMIDE
CAS Number: 596-51-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of oral glycopyrroniumbromide in comparison with placebo on the severity of nocturnal sialorrhea in psychiatric patients treated with clozapine;Primary end point(s): The percentage of patients showing a clinically significant improvement in nocturnal sialorrhea severity. A clinically significant improvement is defined as a reduction of at least 1 point on the PGI-I (Patient Global Impression of improvement questionnaire).;Timepoint(s) of evaluation of this end point: After 6 days of treatment;Secondary Objective: 1) to determine patient's satisfaction with oral glycopyrroniumbromide compared to placebo regarding nocturnal sialorrhea 2) to determine the effect of oral glycopyrroniumbromide compared to placebo on patient's opinion to clozapine 3) to determine the effect of oral glycopyrroniumbromide compared to placebo on the occurence of side effects 4) previously mentioned primary and secundary objectives in a subset of patients receiving a double dose of oral glycopyrroniumbromide in an open label extension compared to single dose oral glycopyrroniumbromide treatment in the randomized, double-blind phase | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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;Timepoint(s) of evaluation of this end point: After 6 days of treatment | — |
Countries
Netherlands
Contacts
Public ContactZiekenhuisapotheek UMC Utrecht
Universitair Medisch Centrum Utrecht
Outcome results
None listed