Treatment of Clozapine-Induced Hypersalivation Ipratropium Bromide

Hypersalivation Clinical Trial

Official title:

Treatment of Clozapine-Induced Hypersalivation Ipratropium Bromide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381589
• Other study ID #: 150/2006
• Status: Completed
• Phase: N/A
• First received: September 26, 2006
• Last updated: February 11, 2009
• Start date: October 2006

Study information

• Verified date: February 2009
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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 schizophrenia. However, treatment with clozapine continues to be limited by its many side effects. The second most common side effect, occurring in 31% of clozapine treated patients, is hypersalivation or sialorrhea. Sialorrhea can be profoundly stigmatizing and functionally disabling in certain patients, and may increase discontinuation rates in this high-risk patient population. Several studies have evaluated the efficacy of anticholinergic agents mainly in small, uncontrolled studies or anecdotal reports and are often complicated by difficulties in medication administration and systemic side effects. Open label and case series studies have demonstrated promising results with ipratropium bromide (IPB) treatment of clozapine-induced hypersalivation, acting on anticholinergic receptors with minimal systemic absorption. However, no randomized controlled trials have evaluated IPB in the treatment of this problematic side effect.The primary goals of this study is to determine the efficacy of ipratropium bromide in reducing clozapine-induced hypersalivation, as per the Toronto Nocturnal Hypersalivation Scale, which is a modified hypersalivation scale incorporating the Drooling Severity Scale and the Nocturnal Hypersalivation Rating Scale, and reduced measurements on visual analogue scales for hypersalivation distress and severity. Our hypothesis that Ipratropium bromide use at bedtime will result in a significant reduction in nocturnal clozapine-induced hypersalivation as measured by the Toronto Nocturnal Hypersalivation Scale (TNHS) through its local anticholinergic activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypersalivation
• Sialorrhea

Intervention

Drug:
• ipratropium bromide 0.03% spray

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toronto Nocturnal Hypersalivation Scale scores		intermittent	No
Primary	Visual Analogue Scale - Severity		intermittent	No
Primary	Visual Analogue Scale - Distress		Intermittent	No
Primary	Simpson-Angus Rating Scale		Each study visit	No
Primary	Clinical Global Improvement Scale		Each study visit	No

External Links

•   Information about research at the Centre for Addiction and Mental Health