Prevalence of Sialorrhea in Patients Treated With Clozapine

NCT04197037 | Completed

• 1 other identifier: 2019/8197
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Schizophrenia; Sialorrhea; Quality of life; Prevalence

Outcome Measures

Primary Outcomes (2)

• Prevalence of nocturnal sialorrhea in patients treated with clozapine

  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

  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 Outcomes (1)

• Decrease in quality of life due to hypersalivation

  1 week

Study Arms (1)

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.

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)

People with schizophrenia treated with clozapine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• People under 18 years
• People receiving antipsychotic treatment other than clozapine (even though they present sialorrhea due to this treatment).

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Centre Forum Parc de Salut Mar

Barcelona, 08019, Spain

Location

Related Publications (10)

• Essali A, Al-Haj Haasan N, Li C, Rathbone J. Clozapine versus typical neuroleptic medication for schizophrenia. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD000059. doi: 10.1002/14651858.CD000059.pub2.

  PMID: 19160174 BACKGROUND

• Maher S, Cunningham A, O'Callaghan N, Byrne F, Mc Donald C, McInerney S, Hallahan B. Clozapine-induced hypersalivation: an estimate of prevalence, severity and impact on quality of life. Ther Adv Psychopharmacol. 2016 Jun;6(3):178-84. doi: 10.1177/2045125316641019. Epub 2016 Mar 30.

  PMID: 27354906 BACKGROUND

• Rashnoo P, Daniel SJ. Drooling quantification: Correlation of different techniques. Int J Pediatr Otorhinolaryngol. 2015 Aug;79(8):1201-5. doi: 10.1016/j.ijporl.2015.05.010. Epub 2015 May 18.

  PMID: 26092552 BACKGROUND

• Remington G, Lee J, Agid O, Takeuchi H, Foussias G, Hahn M, Fervaha G, Burton L, Powell V. Clozapine's critical role in treatment resistant schizophrenia: ensuring both safety and use. Expert Opin Drug Saf. 2016 Sep;15(9):1193-203. doi: 10.1080/14740338.2016.1191468. Epub 2016 Jun 1.

  PMID: 27207070 BACKGROUND

• Sockalingam S, Shammi C, Remington G. Clozapine-induced hypersalivation: a review of treatment strategies. Can J Psychiatry. 2007 Jun;52(6):377-84. doi: 10.1177/070674370705200607.

  PMID: 17696024 BACKGROUND

• Spivak B, Adlersberg S, Rosen L, Gonen N, Mester R, Weizman A. Trihexyphenidyl treatment of clozapine-induced hypersalivation. Int Clin Psychopharmacol. 1997 Jul;12(4):213-5. doi: 10.1097/00004850-199707000-00005.

  PMID: 9347382 BACKGROUND

• Syed R, Au K, Cahill C, Duggan L, He Y, Udu V, Xia J. Pharmacological interventions for clozapine-induced hypersalivation. Cochrane Database Syst Rev. 2008 Jul 16;2008(3):CD005579. doi: 10.1002/14651858.CD005579.pub2.

  PMID: 18646130 BACKGROUND

• Man WH, Colen-de Koning J, Schulte P, Cahn W, van Haelst I, Heerdink E, Wilting I. Clozapine-induced hypersalivation: the association between quantification, perceived burden and treatment satisfaction reported by patients. Ther Adv Psychopharmacol. 2017 Sep;7(8-9):209-210. doi: 10.1177/2045125317707746. Epub 2017 May 1. No abstract available.

  PMID: 28959433 BACKGROUND

• Yusufi B, Mukherjee S, Flanagan R, Paton C, Dunn G, Page E, Barnes TR. Prevalence and nature of side effects during clozapine maintenance treatment and the relationship with clozapine dose and plasma concentration. Int Clin Psychopharmacol. 2007 Jul;22(4):238-43. doi: 10.1097/YIC.0b013e32819f8f17.

  PMID: 17519648 BACKGROUND

• Sanagustin D, Martin-Subero M, Hogg B, Fortea L, Gardoki I, Guinart D, Roldan M, Angelats M, Cerro L, Navas D, Jimenez JD, Ortiz L, Ros R, Polo X, Ventura Y, Contreras J, Moreno-Alcazar A, Perez-Sola V, Amann BL, Valiente-Gomez A. Prevalence of clozapine-induced sialorrhea and its effect on quality of life. Psychopharmacology (Berl). 2023 Jan;240(1):203-211. doi: 10.1007/s00213-022-06294-3. Epub 2022 Dec 20.

  PMID: 36538098 DERIVED

Related Links

• National Institute of Health and Clinical Excellence (NICE). 2014. "Psychosis and Schizophrenia in Adults." The NICE guidelines on treatment and management (February): 74-80.

MeSH Terms

Conditions

Sialorrhea; Schizophrenia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 12, 2019
• Study Start: March 20, 2018
• Primary Completion: March 30, 2020
• Study Completion: December 31, 2021
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

ES (1)