Determination of the effects of adding endonestrone to the treatment of negative symptoms of schizophernia
Design
Clinical trial with control group, with parallel, double- blind, randomized and outcome assessment
Settings and conduct
All admission and outpatient patient referred to the emergency department and psychiatric clinics of 5 azar hospital in Gorgan, which are approved for schizophernia. Then, all coded patient (blind) and randomly assigned to two groups of control and intervention are divided
Participants/Inclusion and exclusion criteria
All admission and outpatient patient referred to the emergency department and psychiatric clinics of 5 azar hospital in Gorgan, which are approved for schizophernia
Intervention groups
Patients are randomly assigned to either the ondanestron or placebo groups. Both groups receive risperidone as an antipsychotics. The control group also receives placebo and the case group.
Main outcome variables
Negative symptoms of schizophrenia
Positive symptoms of schizophrenia
Side effects of medication
General information
Reason for update
Acronym
بررسی تأثیر اندانسترون بعنوان داروی کمکی در اختلال اسکیزوفرنیا
IRCT registration information
IRCT registration number:IRCT20190321043096N1
Registration date:2019-04-23, 1398/02/03
Registration timing:registered_while_recruiting
Last update:2019-04-23, 1398/02/03
Update count:0
Registration date
2019-04-23, 1398/02/03
Registrant information
Name
Hedye Mohmoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3605 7872
Email address
mitrajudy@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-04-30, 1398/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Ondansetron as Additional Drug on Reducing Negative Symptoms in Hospitalized and Outpatient with Schizophrenia Disorders
Public title
Evaluation of the Effect of Ondansetron as Additional Drug on Reducing Negative Symptoms in Hospitalized and Outpatient with Schizophrenia Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age of 18-65
No physical illness
No alcohol or drug abuse
The absence of pregnancy and lactation in women
PANSS score of more than 15
Acceptance of written consent
Exclusion criteria:
Drug abuse or alcohol abuse
Breastfeeding and pregnancy women
The need for other psychotropic drugs during the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Use random number tables
At the beginning of the study, each patient was assigned a code that was recorded on the patient's questionnaire. Then, using the random numbers table and the registered codes, the patients in the intervention group were selected and the remaining patients were assigned to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
1- subject coding
2- use of placebo is similar to the original medicine
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan Golestan University of Medical Sciences
Street address
Moslem 19
City
Mashhad
Province
Razavi Khorasan
Postal code
۴۴۸۱۶۵۶۷۶۱
Approval date
2018-09-22, 1397/06/31
Ethics committee reference number
IR.GOUMS.REC.1397.105
Health conditions studied
1
Description of health condition studied
Schizophernia
ICD-10 code
F20.9
ICD-10 code description
Schizophrenia, unspecified
Primary outcomes
1
Description
Earn score 7-49 in the test of N-PANSs
Timepoint
Before starting the study and 6, 8 and 12 weeks after starting the study
Method of measurement
Based on DSM-5
Secondary outcomes
1
Description
Negative symptoms of schizophrenia
Timepoint
Weeks of 0, 6, 8 and 12
Method of measurement
Evaluation Scale of PANSS
Intervention groups
1
Description
Intervention group: This group receive risperidone as an antipsychotics. Besides that intervention group will receive andonestrone. The dose of ondansetron is 4 mg in the first week and will reach 8 mg in the coming weeks. All subjects at the onset of the study, at weeks 0, 6, 8 and 12, will be evaluated for negative symptoms of schizophrenia by the PANSS scoring scale.
Category
Treatment - Drugs
2
Description
Control group: this group receive risperidone as an antipsychotics. The control group will receive the placebo. The dose of placebo is 4 mg in the first week and will reach 8 mg in the coming weeks. All subjects at the onset of the study, at weeks 0, 6, 8 and 12, will be evaluated for negative symptoms of schizophrenia by the PANSS scoring scale.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
5 Azar Hospital in Gorgan
Full name of responsible person
Hedge Mahmoudi
Street address
Moalem19
City
Mashhad
Province
Razavi Khorasan
Postal code
4481656761
Phone
+98 51 3605 7872
Email
mitrajudy@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Masome Mirkarimi
Street address
Km 2 Gorgan-Sari Road
City
Gorgan
Province
Golestan
Postal code
۵۶۷۵۸
Phone
+98 17 3245 2658
Email
C_t@goums.ac.ir
Web page address
http://goums.ac.ir/page/2704
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
70
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
Gorgan University of Medical Sciences
Full name of responsible person
Hedye Mahmodi
Position
Resident Psychiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Moslem 19
City
Mashhad
Province
Razavi Khorasan
Postal code
۴۴۸۱۶۵۶۷۶۱
Phone
+98 51 3605 7872
Email
mitrajudy@goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Hedye Mahmoudi
Position
Resident Psychiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Moalen19
City
Mashhad
Province
Razavi Khorasan
Postal code
۴۴۸۱۶۵۶۷۶۱
Phone
+98 51 3605 7872
Email
Pazohesh.3397@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Hedge mahmoudi
Position
Resident psychiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Moalem19
City
Mashhad
Province
Razavi Khorasan
Postal code
4481656761
Phone
+98 51 3605 7872
Email
mitrajudy@goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The main consequence of the study is the ability to share
When the data will become available and for how long
Two month
To whom data/document is available
Academic Institutions and Psychiatric Clinics
Under which criteria data/document could be used
Improvement in the treatment of schizophrenia
From where data/document is obtainable
Gorgan University of Medical Sciences
What processes are involved for a request to access data/document