CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 129 enrolled
Drug / intervention
Evaluation of sialorrhea through questionnaires that measure daytime and nighttime sialorrhea and the impact on quality of life.procedure
Likely dose
Not stated in record
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Search/NCT04197037
NCT04197037N/ACompleted

Prevalence Study of Sialorrhea in Inpatients and Outpatients Treated With Clozapine

Parc de Salut Mar·observational·Posted Dec 12, 2019·Updated Sep 28, 2022

In Brief

An observational study evaluating Evaluation of sialorrhea through questionnaires that measure daytime and nighttime sialorrhea and the impact on quality of life. for Sialorrhea and 2 related conditions. Completed, enrolled 129 participants across 1 site.

Detailed Summary

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 Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 12, 2019
Enrollment StartMar 20, 2018
Primary CompletionMar 30, 2020
Study CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.6 years ago

Interventions

Evaluation of sialorrhea through questionnaires that measure daytime and nighttime sialorrhea and the impact on quality of life.procedure

Sialorrhea will be evaluated by the Nocturnal hypersalivation rating scale (NHRS) and Drooling Severity and Frequency Scale (DSFS)