Prevalence of Sialorrhea in Patients Treated With Clozapine
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|ClinicalTrials.gov Identifier: NCT04197037|
Recruitment Status : Completed
First Posted : December 12, 2019
Last Update Posted : September 28, 2022
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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.
|Condition or disease||Intervention/treatment|
|Sialorrhea Clozapine Adverse Reaction Quality of Life||Procedure: Evaluation of sialorrhea through questionnaires that measure daytime and nighttime sialorrhea and the impact on quality of life.|
|Study Type :||Observational|
|Actual Enrollment :||129 participants|
|Official Title:||Prevalence Study of Sialorrhea in Inpatients and Outpatients Treated With Clozapine|
|Actual Study Start Date :||March 20, 2018|
|Actual Primary Completion Date :||March 30, 2020|
|Actual Study Completion Date :||December 31, 2021|
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)
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- People over 18 years
- In- and outpatients from different INAD Units
- Clozapine treatment with a stable dose (minimum one month without dose changes)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197037
|Centre Forum Parc de Salut Mar|
|Barcelona, Spain, 08019|
|Responsible Party:||Alicia Valiente, Professor, Parc de Salut Mar|
|Other Study ID Numbers:||
|First Posted:||December 12, 2019 Key Record Dates|
|Last Update Posted:||September 28, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Quality of life
Salivary Gland Diseases