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Evaluation of the effect of sertraline on functional performance in patients with obsessive-compulsive disorder in two groups of intervention and control

Protocol summary

Summary
This study is a one-way blind clinical trial. Patients with OCD were enrolled and 30 patients were randomly divided into two groups of interventional and control groups.Yale-Brown, demographic, WCST, WMS, and KENT tests are performed on them.In the drug intervention group, patients with drug therapy will receive Certraline 100 mg once daily with control therapy, and before the onset of drug therapy and during pre-test admission, after a 4-month follow-up, a post-test will be performed. In the control group, they will be pre-test and after a one-month post-test, and will not be treated under the medication.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017100826138N1
Registration date: 2017-10-08, 1396/07/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-08, 1396/07/16
Registrant information
Name
Mina Vasebi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 4322 5782
Email address
m.vasebi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardebil Medical University
Expected recruitment start date
2016-04-19, 1395/01/31
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of sertraline on functional performance in patients with obsessive-compulsive disorder in two groups of intervention and control
Public title
The Effectiveness of Medical Treatment on Executive Performance of Patients suffering from Obsessive Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Entry Criteria: Having a diagnosis of OCD disorder Age between 24 to 54 Having a level of education from third guidance to undergraduate Exclusion Criteria: Having an obsessive-compulsive personality disorder and other personality disorders, OCPD Having a psychotic deficiency disorder Being drug addicted Having an IQ of less than 80
Age
From 24 years old to 54 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Ardabil University of Medical Sciences
Street address
Janbazan Square, University Street, Ardabil
City
Ardebil
Postal code
5618985991
Approval date
2015-10-04, 1394/07/12
Ethics committee reference number
ir.arums.rec.1394.30

Health conditions studied

1

Description of health condition studied
obssesive compulsive disorder
ICD-10 code
f42
ICD-10 code description
The essential feature is recurrent obsessional thoughts or compulsive acts.

Primary outcomes

1

Description
Executive performance(behavioral inhibition, cognitive inhibition, flexibility, behavioral organization, semantic memory)
Timepoint
2TIMES, PRE TEST & POST TEST
Method of measurement
WITH WCST

2

Description
short term memory & long term memory
Timepoint
2TIMES, PRE TEST & POST TEST
Method of measurement
With WMS

Secondary outcomes

1

Description
Severity of obsessive-compulsive disorder.
Timepoint
4 TIMES(ONCE IN EVERY VISIT)
Method of measurement
BY Yale- Brown

Intervention groups

1

Description
'Groups: patients will be treated with the drug sertraline 100 mg once a day for 4 months .
Category
Treatment - Drugs

2

Description
Control group: Patients will not receive any medication for one month
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemi Hospital in Ardebil
Full name of responsible person
Mehryar Nadr Mohammadi
Street address
Dr. Fatemi Hospital, not reached to the Shariati square, Imam Khomeini (RA), Sareyn station,
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research of Ardabil University of Medical Sciences
Full name of responsible person
Shahram Habibzadeh
Street address
Ardebil University of Medical Sciences, Janbazan Square, University Street, Ardabil
City
ardebil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Ardabil 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
Ardebil University of Medical sciences
Full name of responsible person
Mina Vasebi
Position
Medical student
Other areas of specialty/work
Street address
Ardebil University of Medical sciences, Janbazan Square, University Street, Ardabil
City
Ardebil
Postal code
5618953141
Phone
+45 33 72 07 71
Fax
Email
vasebi_mina@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardebil University of Medical sciences
Full name of responsible person
Parviz Molavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Ardebil University of Medical sciences, Janbazan Square, University Street, Ardabil
City
Ardebil
Postal code
5618953141
Phone
+98 45 3323 2520
Fax
Email
p.molavi@arums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardebil University of Medical sciences
Full name of responsible person
Mina Vasebi
Position
Medical Student
Other areas of specialty/work
Street address
Ardebil University of Medical sciences, Janbazan Square, University Street, Ardabil
City
Ardebil
Postal code
5618953141
Phone
+98 45 3352 0051
Fax
Email
m.vasebi@arums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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