According table of randomization patients divided to two groups and patient and the person that do intervention (Yale brown) are blind.
Settings and conduct
Patients who are chosen by random table devided to two group (without know about kind of group) before start intervention done yale brown scale by a staff that don not know about the group of patients. After that one group get pregabalin another group get placebo. After 12 weeks done yale brown scale too.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient with impression of OCD according to DSM V; Yale brown scale>15; without any other psychiatric problem except OCD; without medical problem; do not use any substance
Exclusion criteria: pregnancy; lactation; during psychotherapy
Intervention groups
The patients are divided into two groups that half of them receive pregabalin and the other group take placebo.
Main outcome variables
Assese severity of obsession and compulsion with yale brown scale after get pregabalin.
Patient with impression of OCD according to DSM-V
Yale brown scale>15
Without any other psychiatric problem except OCD
Patient without medical problem
Do not use any substance
Exclusion criteria:
Pregnancy
Lactation
During psychotherapy
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers; according to table of random numbers and number of pationt that come to clinic chose pationt for study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the people that done Yale brown are blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand ave.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2018-12-24, 1397/10/03
Ethics committee reference number
Ir. Sums. Med. Rec. 1397.395
Health conditions studied
1
Description of health condition studied
Obsessive compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Number of yale brown scal
Timepoint
Before give pregabalin and after 12 week done yale brown scale
Method of measurement
Yale brown scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group :continue get serteralin and add pregabalin (start with 75mg and slowly increase to 150mg for 12weeks. We assese numbers of yale brown scale by paired T test.
Category
Treatment - Drugs
2
Description
Control group: Control group :continue get serteraline like first group and (instaed of pregabal) get placebo. Before start study and also the end of study all pationts fill yale brown scale.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Hafez hospital
Full name of responsible person
Dr Arash Mowla
Street address
Hafez hospital, Abiverdi Blvd.
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9366
Email
Mehrghaedsharaf@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad javad Ashraf
Street address
Zand street,shiraz university of medical science
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9366
Email
ashrafm@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mehrnoosh Ghaedsharaf
Position
Resident of psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hafez hospital, Abiverdi Blvd.
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9366
Email
Mehrghaedsharaf@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrnoosh Ghaedsharaf
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hafez hospital, Abiverdi Blvd.
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9366
Email
Mehrghaedsharaf@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Arash Mowla
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ebnesina hospital, Hafez ave.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3228 0236
Email
Mowlaar@gmail.com
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
Yes - There is a plan to make this available
Title and more details about the data/document
Data just available for professor in university
When the data will become available and for how long
Starting 1 year after publication
To whom data/document is available
Reasercher in university
Under which criteria data/document could be used
By e mailing the request data is available for reasercher
From where data/document is obtainable
Mehrghardsharaf@gmail. Com
What processes are involved for a request to access data/document
After evaluate request by authers during 1 month data is available