The object of this randomized, placebo controlled, double blind study is Comparison of effect of atropine drops and Amitriptyline tablet in clozapine-induced hypersalivation in psychotic patients.
40 patients with ages between 18-65 years who have no other medical conditions, with DSMIV-TR diagnosed Schizophrenia and other psychotic disorders will receive Amitryptiline tablet and Placebo drop(n=20) and other group will receive Atropine drop and Placebo tablet for 4 weeks.The amount of sialorrhea in patient will measure daily in first week and then weekly until 4 weeks based on TNHS and Drooling scale.Side effects will be evaluated at baseline and then weekly with CGI scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701136691N3
Registration date:2017-02-15, 1395/11/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-15, 1395/11/27
Registrant information
Name
Fatemeh Sheikhmoonesi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1328 5109
Email address
fmoonesi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-02-28, 1395/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of atropine drops and Amitriptyline tablets in clozapine-induced hypersalivation
Public title
Comparison of effect of atropine drops and Amitriptyline tablet in clozapine-induced hypersalivation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Every hospitalized patient taking Clozapine and recieved diagnosis of Schizophrenia, Schizoaffective or other psychiatric disorders according to DSM-IV ; Age between 18-65 year old ; Having nacturnal sialorrhea more than 2 scores based on TNHS ; Agreement and optional participation of patients is necessary.
Exclusion criteria: Sensitivity to Atropine and Amitriptyline ; Comorbidity with other diseases produce sialorrhea like Parkinson dx and Cerebral palsy ;Affliction with untreated constipation, Bladder outlet obsrtuction and urinary retention; Co-consumption of anticholinergic drugs ; Lactation &Pregnancy ; past positive history of myasthenia gravis, Cardiac arrythmia, Glucoma, Pyloric obsrtruction,Paralytic ileus, Prostatic hypertrophia and Renal dysfunction ; Sever dysoutonomy 8. Mental retardation 9. Bipolar schizoaffective and Bipolar mood disorder
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Central building of Mazandaran University of Medical Scienses and Health Service, Daneshgah Blvd, Emam Square
City
sari
Postal code
48154
Approval date
2016-11-26, 1395/09/06
Ethics committee reference number
IR.MAZUMS.REC.95.1747
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Severity and Frequency of sialorhea
Timepoint
Daily in first week and then weekly until4 weeks
Method of measurement
Toronto Nacturnal Hypersalivation Scale,Drooling scale
Secondary outcomes
1
Description
Palpitation
Timepoint
Baseline and weeks 1-2-3-4 after begining of treatment
Method of measurement
puise rate measuring at Baseline and weeks 1-2-3-4 after begining of treatment
2
Description
Hypertension
Timepoint
Baseline and weeks 1-2-3-4 after begining of treatment
Method of measurement
Blood pressure measuring at Baseline and weeks 1-2-3-4 after begining of treatment
Intervention groups
1
Description
Within 4 weeks 1 group of patient will recieve Amytriptiline tablet and Placebo drop .
Category
Treatment - Drugs
2
Description
within 4 weeks other group will recieve Atropine drop and placebo tablet.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Sheikhmoonesi
Street address
Zare Psychiatry Hospital
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmadali Enayati
Street address
Vice Chancellor for Research and Technology, Building N.2, Moallem Square, Moallem Street
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Sheikhmoonesi
Position
Assistant Prof. of Psychiatry, Psychiatrist,Fellowship of psychotherapy
Other areas of specialty/work
Street address
Zare Psychiatry Hospital
City
sari
Postal code
4815466848
Phone
+98 11 3328 5109
Fax
+98 11 3328 5109
Email
fmoonesi@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Sheikhmoonesi
Position
Assistant Prof. of Psychiatry, Psychiatrist,Fellowship of psychotherapy
Other areas of specialty/work
Street address
Zare Psychiatry Hospital
City
Sari
Postal code
4815466848
Phone
+98 11 3328 5109
Fax
+98 11 3328 5109
Email
fmoonesi@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Sheikhmoonesi
Position
Assistant Prof. of Psychiatry, Psychiatrist,Fellowship of psychotherapy
Other areas of specialty/work
Street address
Zare Psychiatry Hospital
City
sari
Postal code
4815466848
Phone
+98 11 3328 5109
Fax
+98 11 3328 5109
Email
fmoonesi@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)