Treatment of Clozapine-Induced Hypersalivation Ipratropium Bromide
1 other identifier
interventional
25
1 country
1
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 bromide(IPB)at bedtime will reduce the amount of salivation and the distress people may feel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2006
CompletedFirst Posted
Study publicly available on registry
September 28, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedFebruary 12, 2009
February 1, 2009
1.7 years
September 26, 2006
February 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Toronto Nocturnal Hypersalivation Scale scores
intermittent
Visual Analogue Scale - Severity
intermittent
Visual Analogue Scale - Distress
Intermittent
Simpson-Angus Rating Scale
Each study visit
Clinical Global Improvement Scale
Each study visit
Study Arms (1)
A
EXPERIMENTALRandom assignment to investigational spray
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8, Canada
Related Publications (1)
Sockalingam S, Shammi C, Remington G. Treatment of clozapine-induced hypersalivation with ipratropium bromide: a randomized, double-blind, placebo-controlled crossover study. J Clin Psychiatry. 2009 Aug;70(8):1114-9. doi: 10.4088/JCP.08m04495.
PMID: 19758522DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Remington, MD, PhD
Centre for Addiction and Mental Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 26, 2006
First Posted
September 28, 2006
Study Start
October 1, 2006
Primary Completion
June 1, 2008
Last Updated
February 12, 2009
Record last verified: 2009-02