Prevalence of Sialorrhea in Patients Treated With Clozapine

September 27, 2022 updated by: Alicia Valiente, Parc de Salut Mar

Prevalence Study of Sialorrhea in Inpatients and Outpatients Treated With Clozapine

Clozapine is the "gold standard" antipsychotic drug for the treatment of resistant schizophrenia or resistant psychosis. Despite the high rates of good clinical response, the potential side effects can limit its use. Sialorrhea or excessive salivation is a side effect that occurs in 30-80% of people who receive this treatment and it can cause a decrease in self-esteem and feeling of security, greater social isolation and increase stigma.

The main objective of this study is to measure the prevalence of sialorrhea in inpatients and outpatients treated with clozapine and its consequences on the quality of life of people who are receiving this treatment.

A total of 129 patients over 18 years of age in treatment with clozapine will be recruited from different units of the Institute of Neuropsychiatry and Addictions (INAD) of the Parc de Salut Mar.

Sialorrhea will be evaluated by the nursing team with the Nocturnal Hypersalivation Rating Scale (NHRS), the Scale of Frequency and severity of salivation and the scale of impact on the quality of life. Also sociodemographic variables such as age, date of birth, race, date of diagnosis and clinical variables such as diagnosis, dose of clozapine and other treatments prescribed will be collected.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

Clozapine is an atypical antipsychotic drug considered the "gold standard" in the treatment of resistant psychosis and also in patients who have had adverse effects with others drugs previously indicated as first line. It has been described that almost two thirds of patients who do not respond to first and second generation antipsychotics respond to clozapine treatment. Despite its effectiveness in positive, negative symptoms and the risk of suicide, clozapine presents a risk of adverse effects ranging from potentially dangerous ones. such as agranulocytosis or myocarditis, to others that are considered mild but that they can compromise the quality of life of patients and non-compliance. One of these mild, but extremely annoying, side effects is sialorrhea. The prevalence of sialorrhea secondary to clozapine reported by different studies range from 30% to 80% and it seems to be a dose-dependent relationship. This great variability observed in the studies probably has to do with the tendency that clinicians have to underestimate this side effect. In addition, the presence of sialorrhea can impact negatively in the subject causing a decrease in self-esteem and feeling of security, greater social isolation and an increase in stigma.

JUSTIFICATION OF THE STUDY:

Due to the consequences that sialorrhea has on the quality of life perceived by people in Clozapine treatment and the relationship with possible therapeutic abandonment, in addition to the low systematic evaluation of this side effect, it is considered relevant to establish a systematic evaluation of clozapine induced sialorrhea in the different mental health devices of our center.

OBJECTIVES:

To measure the prevalence of sialorrhea in patients treated with clozapine and its impact on subjective perception of quality of life. The possible relationship between the Clozapine dose and sialorrhea severity, as well as severity prediction will be evaluated based on the clinical and sociodemographic variables collected.

HYPOTHESIS:

  1. The prevalence of sialorrhea in people treated with clozapine is at least 30% of patients receiving this antipsychotic treatment.
  2. The presence of sialorrhea is directly related to a worse perception of the perceived quality of life in patients treated with clozapine.
  3. The presence of sialorrhea is directly related to the prescribed dose of clozapine, presenting a dose-dependence relationship.
  4. There is an association between the total daily dose of clozapine and the severity of sialorrhea in patients treated with clozapine.

MATERIAL AND METHODS:

Study design:

A quasi-experimental study will be carried out to measure the prevalence of sialorrhea in patients treated with clozapine in different Units of the INAD.

To estimate the sample size, people with the diagnosis of schizophrenia or schizoaffective disorder will be collected in the Units above mentioned in 2018, it was a sample size of 250.

Based on that the incidence of refractory schizophrenia is around 30% to 50% of cases, the number of patients potentially candidates to be treated with clozapine would be 125.

The final sample size has been calculated with the following tool available on the web http://.fisterra.com/mbe/investia/9samples/9samples.asp, with a 95% confidence interval and an accuracy of 3%, expecting sialorrhea in 30% of the cases and including a proportion of losses around 15%. The final sample will be 129 patients.

Methodology:

Nursing team will be responsible to inform the patients about the study, to enroll them and to obtain informed consent. Also they will administer 3 clinical scales previously used in hypersalivation studies (Maher et al. 2016; Wai Hong Man, Jantine Colen-de Koning, Peter Schulte and Ingrid van Haelst 2017) through the direct observation of the sialorrhea presented by the patient with stable treatment with clozapine. The scales will be administered only once and there won't be any longitudinal follow-up.

The scales are:

  1. The Nocturnal Hypersalivation Rating Scale (NHRS): A validated scale of 5 items used to assess the severity of nocturnal salivation. Scores range from the non-presence of nocturnal salivation to wake up a minimum of 3 times during the night due to hypersalivation (Spivak et al. 1997).

  2. Drooling Severity and Frequency Scale (DSFS): A validated scale to evaluate the severity of daytime sialorrhea (Rashnoo and Daniel 2015). Scores range from no presence of sialorrhea to a profuse sialorrhea where saliva wets the body or even objects and furniture (saliva falls on the table when the person is sitting) based on a 5-point scale.

    Both severity and frequency scores are added to give a final score of the daytime sialorrhea.

  3. Impact on the quality of life scale: It is a 5-point scale that range from no impact on quality of life to a major problem.

In addition, sociodemographic variables such as age, date of birth, race, date of diagnosis, as well as variables clinics such as diagnosis, years of disease evolution, total daily dose of Clozapine treatment and other prescribed treatments.

All this information will be included in an anonymous database (subjects will be identified by a study code and the database will not include personal data).

Statistic analysis:

The data analysis will be carried out using the Statistical Package for the Social Sciences (SPSS statistical program), version 25.0. The distribution of the sociodemographic and clinical characteristics of the sample will be analyzed using descriptive statistics. Likewise, to describe the possible linear associations between quantitative variables related to clozapine and sialorrhea will use the coefficient of correlation. Finally, an exploratory regression analysis will be done to predict the severity of the sialorrhea based on clinical and sociodemographic variables. The limitations of the study will be the foreseeable studies of quasi-experimental studies: that do not allow establishing cause-effect relationships between variables or calculate incidence.

Study Type

Observational

Enrollment (Actual)

129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08019
        • Centre Forum Parc de Salut Mar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A sample of 129 patients over 18 years, treated with a stable dose of clozapine, will be selected through different units of the Institute of Neuropsychiatry and Addictions (INAD) of the Parc de Salut Mar.

Description

Inclusion Criteria:

  • People over 18 years
  • In- and outpatients from different INAD Units
  • Clozapine treatment with a stable dose (minimum one month without dose changes)

Exclusion Criteria:

  • People under 18 years
  • People receiving antipsychotic treatment other than clozapine (even though they present sialorrhea due to this treatment).
  • It will not be exclusion criteria to be in treatment with other antipsychotics in conjunction with clozapine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People with schizophrenia treated with clozapine
People more than 18 with diagnosis of schizophrenia and treated with clozapine in a stable dose and stable status of the disease (at least 2-3 weeks).
Procedure: Evaluation of sialorrhea through questionnaires that measure daytime and nighttime sialorrhea and the impact on quality of life.
Sialorrhea will be evaluated by the Nocturnal hypersalivation rating scale (NHRS) and Drooling Severity and Frequency Scale (DSFS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of nocturnal sialorrhea in patients treated with clozapine
Time Frame: 1 week
Prevalence of sialorrhea measured by Nocturnal hypersalivation rating scale. The values range from 0 to 4, the higher the score the greater the severity.
1 week
Prevalence of sialorrhea in patients treated with clozapine
Time Frame: 1 week
Prevalence of daytime sialorrhea measured by Drooling Severity and Frequency Scale. The scale has two parts: one measures severity between 0-5 and the other measure frequency between 1-4. The higher the score, the more severe it is.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in quality of life due to hypersalivation
Time Frame: 1 week
Negative impact on quality of life due to hypersalivation measured by quality of life rating scale.The scale range is between 0 and 4, the higher the score the more severe it is.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2018

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

December 11, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/8197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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