Effect of sublingual atropine on sialorrhea induced by Clozapine in patients with schizophrenia
Design
A clinical trial with a control group, parallel groups, double-blind, randomized, phase 3 per 62 patients. Computer-generated random numbers will be used for randomization.
Settings and conduct
This study was designed to investigate the effect of sublingual atropine administration on sialorrhea caused by clozapine in patients with schizophrenia who referred to Qods Hospital in Sanandaj. After dividing the patients into two intervention and control groups two drops of atropine sulfate 1% It will be administered under the tongue in the intervention group or placebo in the control group.
In order to blind the study, the patients, the physician and the evaluator of the patients are not aware of the grouping of the studied patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 60 years; Diagnosed schizophrenia; Current use of Clozapine for treatment; Presence of drooling. Exclusion criteria: Pregnancy and breastfeeding; Cardiovascular problems (arrhythmia, blood pressure, etc.); History of taking other anticholinergics.
Intervention groups
After washing and cleaning the mouth, two drops of atropine sulfate 1% in the intervention group or placebo in the control group will be administered under the tongue, for 4 weeks and every night 1 hour before going to sleep.
Main outcome variables
sialorrhea (drooling)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221101056373N1
Registration date:2022-11-12, 1401/08/21
Registration timing:prospective
Last update:2022-11-12, 1401/08/21
Update count:0
Registration date
2022-11-12, 1401/08/21
Registrant information
Name
Sima Sardari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 0025
Email address
sima_sardari83@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Sublingual Atropine on Sialorrhea Induced by Clozapine in Patients with Schizophrenia
Public title
Effect of Sublingual Atropine on Sialorrhea Induced by Clozapine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Diagnosed schizophrenia
Current use of Clozapine for treatment
Presence of drooling
Exclusion criteria:
Pregnancy and breastfeeding
Cardiovascular problems (arrhythmia, blood pressure, etc.)
History of taking other anticholinergics
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done randomly using computer generated random numbers. Thus, each "odd number" produced belongs to group 1 ( intervention group) and each randomly generated "even number" belongs to group 2 (patient placement in the control group)
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the study, patients and their families do not know which of the intervention or control groups they are in. Also, the medicine and placebo are prepared in similar containers and in the same quantity, appearance and taste, and after coding by a psychiatric assistant, who does not know about the grouping, the drugs are prescribed. The final evaluation and summarization of the patients' findings will also be done by a psychiatric assistant who is not part of the group of study patients
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Kurdistan University of Medical Sciences
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617913446
Approval date
2022-09-21, 1401/06/30
Ethics committee reference number
IR.MUK.REC.1401.226
Health conditions studied
1
Description of health condition studied
Clozapin induced sialorrhea
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sialorrhea
Timepoint
For 4 weeks and every night 1 hour before sleep
Method of measurement
Visual analogue scale and Drooling Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After washing and cleaning the mouth, for 4 weeks and every night 1% hour before sleeping, two drops of atropine sulfate will be administered under the tongue.
Category
Treatment - Drugs
2
Description
Control group: After washing and cleaning the mouth, for 4 weeks and every night 1 hour before sleeping, two drops of placebo will be administered under the tongue.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods Hospital
Full name of responsible person
Sima Sardari
Street address
Entezam Blvd, Pasdaran blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713141
Phone
+98 87 3366 0025
Email
qodshospital.sanandaj@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4643
Fax
Email
Research@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Narges Shams alizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Qods hospital, Entezam Blvd. pasdaran blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713141
Phone
+98 87 3366 0026
Email
n.shamsalizadeh@muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Narges Shams alizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Qods hospital, Entezam Blvd. pasdaran blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713141
Phone
+98 87 3366 0026
Email
n.shamsalizadeh@muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Sima Sardari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Medicine school, Kurdisatn university of medical sciences, Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617713141
Phone
+98 87 3366 0025
Fax
Email
sima_sardari83@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available