Status:
COMPLETED
Treatment of Clozapine-Induced Hypersalivation Ipratropium Bromide
Lead Sponsor:
Centre for Addiction and Mental Health
Conditions:
Hypersalivation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Hypersalivation (Too much saliva) and drooling is a side effect experienced by 31% of people taking the antipsychotic clozapine. This study aims to determine if using the medication ipratropium bromid...
Detailed Description
With the recent questions regarding the effectiveness of newer atypical antipsychotic medications in treating schizophrenia, clozapine continues to remain the gold standard for treatment-refractory sc...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia or schizoaffective disorder as per DSM IV-TR criteria
- Receiving clozapine for at least 2 months
- No change in their clozapine dose for at least 2 weeks
- Have a Clinical Global Impression scale score for hypersalivation of greater than or equal to 4
- Have the capacity to provide voluntary, informed consent
- Able to speak English
- Have a minimum score of 2 on the TNHS prior to study entry
- No change in medications for at least 2 weeks
Exclusion
- Subjects with co-morbid medical conditions that could influence hypersalivation (e.g. Idiopathic Parkinson's Disease)
- Subjects currently receiving ipratropium bromide for the treatment of hypersalivation or other medical conditions
- History of narrow-angle glaucoma, prostatic hyperplasia or bladder neck obstruction
- History of an allergic reaction to ipratropium bromide
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00381589
Start Date
October 1 2006
Last Update
February 12 2009
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8