To study the efficacy of addition of risperidone to fluoxetine in obsessive compulsive disorder, we will choose 60 subjects among outpatient clients seeking help in our psychiatric clinic who according to DSM-IV-TR meet the criteria for obsessive compulsive disorder and on Yale Brown rating scale (YBOCS) score at least 16. The subjects will be randomly divided into two groups: one group will be treated with fluoxetine-risperidone and the other with fluoxetine –placebo. Each group consists of 30 subjects in whom psychotic disorders, substance abuse and suicidal ideation have been ruled out and age between 18-65 years. The YBOCS questionnaire will be filled for each patient at the beginning of the study and after 6-12 weeks from treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103083010N2
Registration date:2011-04-18, 1390/01/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-04-18, 1390/01/29
Registrant information
Name
Faeze Tatari
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 4618
Email address
ftatari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences and Health Servises
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of efficacy of risperidone addition to fluoxetine in obsessive compulsive patients
Public title
The efficacy of combination of risperidone and fluoxetine in obsessive compulsive patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: obsessive compulsive disorder, New case , age>18, age<65, Yale Brown rating scale >16. Exclusion criteria: substance abuse, comorbid of psychotic disorder, suicidal ideation, Yale Brown rating.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethical Comitte of Kermanshah University of Medical Sciences and Health Servises
Street address
Shahid Beheshti Blvd, 2th Building of Kermanshah University
City
Kermanshah
Postal code
6714673159
Approval date
2010-11-09, 1389/08/18
Ethics committee reference number
9881/420/7/پ
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42.8
ICD-10 code description
Anxiety disorder
Primary outcomes
1
Description
Response to treatment
Timepoint
Before treatment, 6weeks after treatment , 12weeks after treatment
Method of measurement
Obsessive compulsive qustioner (Y-Bocs)
Secondary outcomes
1
Description
Clinical side effects
Timepoint
6 and 12 weeks after treatment
Method of measurement
According to patients report
Intervention groups
1
Description
Intervention group: risperidone is started at 0.5 mg/d in the first week and then is elevated to 1 mg/d in the second week and is continued until the end of the third month.
Category
Treatment - Drugs
2
Description
Control group: identical to that of risperidone.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital clinic
Full name of responsible person
Dr. Tatari
Street address
Farabi Hospital of Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Dr. Farid Najafi
Street address
Shahid Beheshti boulevard
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
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
Farabi Hospital of Kermanshah
Full name of responsible person
Dr. Fahimeh Jahandar Lashaki
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Ashayer Boulevard, Dolat Abad
City
Kermanshah
Postal code
Phone
+98 83 1826 1046
Fax
Email
fh.jahandar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences and Health Servises
Full name of responsible person
Dr. Faeze Tatari
Position
Psychiatrist
Other areas of specialty/work
Street address
Ashayer Boulevard, Dolat Abad
City
Kermanshah
Postal code
Phone
+98 83 1826 1046
Fax
Email
ftatari@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences and Health Servises
Full name of responsible person
Dr. Fahimeh Jahandar Lashaki
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Ashayer Boulevard, Dolat Abad
City
Kermanshah
Postal code
Phone
+98 83 1826 1046
Fax
Email
fh.jhandar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)