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Prevalence of Sialorrhea in Patients Treated With Clozapine

NCT04197037 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 129

Last updated 2022-09-28

No results posted yet for this study

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.

Conditions

  • Sialorrhea
  • Clozapine Adverse Reaction
  • Quality of Life

Interventions

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)

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2020-03-30
Completion
2021-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04197037 on ClinicalTrials.gov