HypersalivationNCT00381589
Treatment of Clozapine-Induced Hypersalivation Ipratropium Bromide
A study testing ipratropium bromide 0.03% spray in people with Hypersalivation, run by Centre for Addiction and Mental Health at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypersalivation
- What is being tested?
- ipratropium bromide 0.03% spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2006to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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.
- Conditions
- Hypersalivation
- Being tested
- ipratropium bromide 0.03% spray
- Keywords
- clozapine-induced hypersalivation
- Medical subject headings
- Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ipratropium bromide 0.03% sprayDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Random assignment to investigational spray Receives: Drug: ipratropium bromide 0.03% spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toronto Nocturnal Hypersalivation Scale scores
Measured: intermittent
Visual Analogue Scale - Severity
Measured: intermittent
Visual Analogue Scale - Distress
Measured: Intermittent
Simpson-Angus Rating Scale
Measured: Each study visit
Clinical Global Improvement Scale
Measured: Each study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypersalivationStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Investigators
- Gary Remington, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381589
- Sponsor's protocol ID
- 150/2006
- Status last verified
- Feb 2009
- First submitted
- 26 Sep 2006
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19758522
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Clozapine-Induced Hypersalivation Ipratropium Bromide
- ClinicalTrials.gov ID
- NCT00381589
- Acronym / sponsor ID
- 150/2006
- Conditions
- Hypersalivation
- Keywords
- clozapine-induced hypersalivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jun 2008 (actual)
- First posted
- 28 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ipratropium bromide 0.03% sprayRandom assignment to investigational spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ipratropium bromide 0.03% spray | Drug | A |
Primary outcome
Toronto Nocturnal Hypersalivation Scale scores
Time frame: intermittent
Visual Analogue Scale - Severity
Time frame: intermittent
Visual Analogue Scale - Distress
Time frame: Intermittent
Simpson-Angus Rating Scale
Time frame: Each study visit
Clinical Global Improvement Scale
Time frame: Each study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2009.
- Derived from this study: PubMed 19758522Sockalingam 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.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Remington, MD, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ipratropium bromide 0.03% spray in people with Hypersalivation, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Nocturnal Hypersalivation Scale scores (time frame: intermittent). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00381589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2009.