The aim of this before after study was to determine the prevalence of side effect of Risperidone in the patients with schizophrenia. A total of 50 patients with schizophrenia referred to Shahid Mofateh psychiatry Clinic of Yasouj city, aged 15-60 years old, without any other diseases and no drug consumption in 6 months prior to the study first visit were recruited and received Risperidone for 1 month duration with dosage between 1 and 10 mg per day; prescribed by a psychiatrist based on the patient’s condition. The patients were visited by a psychiatrist every 15 days and interview, MSE, and physical examination was done to determine if any adverse effect occurred.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011225147N2
Registration date:2011-02-16, 1389/11/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-16, 1389/11/27
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
Yasouj University of Medical Sciences
Expected recruitment start date
2010-04-04, 1389/01/15
Expected recruitment end date
2010-09-06, 1389/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The prevalence of side effect of Risperidone drug in patient with schizophrenia
Public title
The prevalence of side effect of Risperidone drug in patient with schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the diagnosis of schizophrenia by a psychiatrist based on DSMIV-TR criteria, age 15 – 60 years, no history of use of any other drug over 6 months prior to the study, no history of any other systemic diseases such as epilepsy, hematological diseases, CVD, glaucoma
Exclusion criteria: poor cooperation, not coming for visits, incidence of serious side effects
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasouj University of Medical sciences
Street address
Yasouj University of Medical Sciences, Jomhoori Islami Boulevard, Yasouj
City
Yasouj
Postal code
Approval date
2009-03-09, 1387/12/19
Ethics committee reference number
871219
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Incidence of adverse effects
Timepoint
two times: 15 days and 30 days after intervention
Method of measurement
Visiting by psychiatrist based on interview, mental status examination,filling questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Risperidone, with dosage between 1 and 10 mg per day; prescribed by a psychiatrist based on the patient’s condition, for 1 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofateh Clinic of Yasouj
Full name of responsible person
Nazir Hashemi Mohammad Abad
Street address
No 19, Bahonar 5 St., Oghab square
City
Yasouj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Nazir Hashemi Mohammad Abad
Street address
No 19, Bahonar 5 St., Oghab square
City
Yasouj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical sciences
Full name of responsible person
Nazir Hashemi Mohammad Abad
Position
Assistant professor of Yasouj University of Medical sciences- psychiatrist
Other areas of specialty/work
Street address
No 19, Bahonar 5 St., Oghab square
City
Yasouj
Postal code
Phone
+98 74 1222 4696
Fax
Email
nazir.hashemi@gmail.comn-hashemi@yums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical sciences
Full name of responsible person
Nazir Hashemi Mohammad Abad
Position
Assistant professor of Yasouj University of Medical sciences- psychiatrist
Other areas of specialty/work
Street address
No 19, Bahonar 5 St., Oghab square
City
Yasouj
Postal code
Phone
+98 74 1222 4696
Fax
Email
nazir.hashemi@gmail.comn-hashemi@yums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical sciences
Full name of responsible person
Nazir Hashemi Mohammad Abad
Position
Assistant professor of Yasouj University of Medical sciences- psychiatrist
Other areas of specialty/work
Street address
No 19, Bahonar 5 St., Oghab square
City
Yasouj
Postal code
Phone
+98 74 1222 4696
Fax
Email
nazir.hashemi@gmail.comn-hashemi@yums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)