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Sponsored by: |
Centre for Addiction and Mental Health |
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Information provided by: | Centre for Addiction and Mental Health |
ClinicalTrials.gov Identifier: | NCT00381589 |
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.
Condition | Intervention |
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Hypersalivation |
Drug: ipratropium bromide 0.03% spray |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Clozapine-Induced Hypersalivation Ipratropium Bromide |
Estimated Enrollment: | 25 |
Study Start Date: | October 2006 |
Arms | Assigned Interventions |
---|---|
A: Experimental
Random assignment to investigational spray
|
Drug: ipratropium bromide 0.03% spray |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gary Remington, MD | 416-535-8501 ext 4750 | gary_remington@camh.net |
Canada, Ontario | |
Centre for Addiction and Mental Health | Recruiting |
Toronto, Ontario, Canada, M5T 1R8 | |
Principal Investigator: Gary Remington, MD | |
Sub-Investigator: Sanjeev Sockalingam, MD | |
Sub-Investigator: Chekkera Shammi, MD |
Principal Investigator: | Gary Remington, MD | Centre for Addiction and Mental Health |
Responsible Party: | Centre for Addiction and Mental Health ( Dr. Gary Remington ) |
Study ID Numbers: | 150/2006 |
Study First Received: | September 26, 2006 |
Last Updated: | May 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00381589 |
Health Authority: | Canada: Health Canada |
clozapine-induced hypersalivation |
Mouth Diseases Sialorrhea Ipratropium Bromides |
Clozapine Stomatognathic Diseases Salivary Gland Diseases Serotonin |
Respiratory System Agents Neurotransmitter Agents Tranquilizing Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Anti-Asthmatic Agents Central Nervous System Depressants Cholinergic Agents Antipsychotic Agents |
Pharmacologic Actions GABA Antagonists Serotonin Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses GABA Agents Peripheral Nervous System Agents Bronchodilator Agents Central Nervous System Agents Anticonvulsants |