Treatment of Clozapine-Induced Hypersalivation Ipratropium Bromide

Center for Addiction and Mental Health (CAMH)

Status

Completed

Conditions

Hypersalivation

Treatments

Drug: ipratropium bromide 0.03% spray

Study type

Interventional

Funder types

Other

Identifiers

NCT00381589

150/2006

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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