The aim of study is to evaluate the efficacy of ondansetron in treating schizophrenia
Design
In this research, 50 eligible patients with schizophrenia diagnosis according to DSM-IV criteria are enrolled and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
50 eligible patients with schizophrenia diagnosis referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: is based on DSM-IV diagnosis of schizophrenia; ages of subjects were between 25 to 65 years and Exclusion Criteria: patients treated with clozapine; any serious medical or neurological problem; pregnancy and breast feeding.
Intervention groups
The intervention group will receive ondansetron 8 mg daily for 12 months. The control group will receive placebo for 12 months.
Main outcome variables
Severity of schizophrenia use is evaluated with Positive and Negative Syndrome Scale (PANSS) in the beginning of the study and 4, 8, 12 months after beginning of treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180505039530N1
Registration date:2018-05-29, 1397/03/08
Registration timing:registered_while_recruiting
Last update:2018-05-29, 1397/03/08
Update count:0
Registration date
2018-05-29, 1397/03/08
Registrant information
Name
Alireza Moteshaker arani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3323 5427
Email address
moteshakerarani-a@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-18, 1396/11/29
Expected recruitment end date
2019-02-18, 1397/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effect of ondansetron on Negative Symptoms in Schizophrenia
Public title
Efficacy of ondanstron in the treatment of schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages of subjects were between 25 to 65 years
Is based on DSM-IV diagnosis of schizophrenia
The patient or patient's guardian consent to participate.
PANSS score at the beginning of the project is more than 55.
Exclusion criteria:
Patients treated with clozapine
Pregnancy and breast feeding
Any serious medical or neurological problem
Hypersensitivity to ondansetron
Substance abuse and alcohol
Patients who choose to be excluded.
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment will be done by the use of computer-generated random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind (both patients and researchers) in your study are blinded
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973446
Approval date
2018-02-12, 1396/11/23
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.110
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Severity of schizophrenia
Timepoint
The beginning of the study and 4, 8, 12 months after beginning of treatment
Method of measurement
Positive and Negative Syndrome Scale (PANSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 8 mg/day of Tablets ondansetron as intervention group for 12 months.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive placebo for 12 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gholabchi Clinic
Full name of responsible person
Zahra Sepehrmanesh
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
z.sepehrmanesh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 2999
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Alireza Moteshakerarani
Position
Assistant Psychiatrist
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 2999
Email
moteshakerarani-a@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Sepehrmanesh
Position
Neuropsychiatrist
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8713783981
Phone
+98 31 5554 0021
Email
z.sepehrmanesh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Alireza Moteshakerarani
Position
Assistant Psychiatrist
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 2999
Email
moteshakerarani-a@kaums.ac.ir
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
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available