This study done on 35 patients with schizophrenia refer to shahid Mofateh clinic that visit, interview, MSE and physical exam by psychiatrist. The age of patients are between 10 and 65 years old. the female patients are not pregnant. The PANSS done at the start of study. The CGI, SAS, interview, MSE and physical exam done by psychiatrist on 2nd and 3rd months of treatment. This study is triple blind: patient, psychiatry, pharmacist in drug store
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201709285147N3
Registration date:2017-10-03, 1396/07/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-03, 1396/07/11
Registrant information
Name
Nazir Hashemi Mohammad Abad
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 1222 4696
Email address
n-hashemi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of medical sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Risperidone versus olanzapine for treatment of patients with schizophrenia
Public title
Risperidone versus olanzapine for treatment of patients with schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
The patients with schizophrenia are based on history, MSE, physical exam and DSMIV criteria. PANSS done at the first day of study. Before the starts of study the patients do not have to receive any drug, no pregnant and full cooperation until end of study. The patients exclude if have no any of above condition, or the existence of any side effect.
Age
From 10 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Based on arrangement of entrance to psychiatry clinic: first patient on risperidone, 2nd patient on olanzapine, 3rd patient on risperidone, 4th patient on olanzapine ...
Secondary Ids
1
Registry name
Iran
Secondary trial Id
IR.YUMS.REC.1392.31
Registration date
2013-07-24, 1392/05/02
Ethics committees
1
Ethics committee
Name of ethics committee
Medical ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj, Motahari BvL
City
Yasuj
Postal code
Approval date
2013-07-24, 1392/05/02
Ethics committee reference number
ir.yums.rec.1392.31
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Interview- MSE-PANSS-CGI-SAS
Timepoint
Start day of study-1 month after start- 2 months after start
Method of measurement
Interview based on DSMIV- MSE-PANSS-CGI-SAS
Secondary outcomes
1
Description
Interview-PANSS-CGI-SAS
Timepoint
start day-1 mont dayh after start day-2 month after start
Method of measurement
interview based on DSMIV-PANSS-CGI-SAS
Intervention groups
1
Description
The patients divide to 2groups 1- the patients on Risperidone 4 mg t0 24 mg p.o. 2- patients on Olanzapine 10 mg t0 45mg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yasuj University of medical sciences, Shahid Mofateh Clinic
Full name of responsible person
Nazir Hashemi Mohammad Abad
Street address
Yasuj University of medical sciences, Shahid Mofateh Clinic, Motahari Bulvard
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chanseller of Yasuj University of medical sciences
Full name of responsible person
investigator
Street address
Yasuj University of medical sciences
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chanseller of Yasuj 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
Yasuj University of Medical Sciences
Full name of responsible person
Nazir Hashemi Mohammad Abad
Position
Associated Prof of psychiatry
Other areas of specialty/work
Street address
Yasuj, Shahid Rajaiee Hospital
City
Yasuj
Postal code
Phone
+98 74133222291
Fax
Email
nazir.hashemi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Nazir Hashemi Mohammad Abad
Position
Associated prof of psychiatry
Other areas of specialty/work
Street address
Yasuj, Rajaiee Hospital
City
Yasuj
Postal code
Phone
+98 74133222291
Fax
Email
nazir.hashemi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of medical sciences
Full name of responsible person
Nazir hashemi Mohammad Abad
Position
Associated Pro of psychiatry
Other areas of specialty/work
Street address
Yasuj, Rajaiee Hospital
City
Yasuj
Postal code
Phone
+98 74133222291
Fax
Email
nazir.hashemi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)