Protocol summary

Summary
Obsessive-Compulsive Disorder (OCD) is the fourth most common psychiatric disorder after phobias, substance abuse and Major Depressive Disorder (MDD). The main feature of this disorder severe obsessions or compulsions cause charge considerable suffering for the individual. The prevalence of this disorder is estimated 2-3% of the population. TDCS is a new Nero-stimulation (electrical stimulation) non-invasive method. In comparison to other non-invasive stimulators, This is a safe, low cost, simply designed, easy to use, and practical method for a specialized Clinic. This study is designed to study the effects of TDCS on reducing OCD symptoms in these patients. It is Quasi-experimental, while designing one group before and after the test which started in Summer 2015 and will be fulfilled in a year. The target population are the outpatients with OCD who are resistant to the drug therapy who will be chosen by a psychiatrist in Tooloo Clinic of Rasht and based on the results drown from the Obsessive Compulsive Questionnaire(YBOCS). The minimum test score to be considered is 16. respect to inclusion and exclusion criteria of the study after obtaining informed consent convenience were 50 people are to be chosen study, will observing the inclusion and exclusion criteria of the study as an easy sampling and also after receiving the letters of consent. Based on the average volume of the previous studies, this sample volume has been considered .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015042721965N1
Registration date: 2015-09-12, 1394/06/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-12, 1394/06/21
Registrant information
Name
Homa Zarrabi
Name of organization / entity
Guilan University of Medical Sceinces,«Kavosh » Cognitive Behaviour Sciences and Addiction Researc
Country
Iran (Islamic Republic of)
Phone
+98 13 3366 6268
Email address
shafakavosh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University Of Medical Sciences
Expected recruitment start date
2015-08-11, 1394/05/20
Expected recruitment end date
2015-12-11, 1394/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey of effect of TDCS on reduction of symptoms in poor-responder OCD pationts
Public title
A survey of effect of tdcs on reduction of symptoms in poor-responder ocd pationts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: OCD diagnosis on Axis I in order to DSM IV IR criteria; Test score of at least 16 YBOCS; Age range 16 to 65 years; Fixed patient medication at least 2 months before entering the study. Exclusion criteria: Both serious medical illnesses; Patients organic brain; History of seizures; mental retardation; Alcohol and drug use in the last 6 months; Psychotic disorders such as schizophrenia active phase, bipolar disorder and depression; During treatment, psychotherapy; Pregnancy and lactation; Patients with OCD who have never been under medical treatment.
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
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
Guilan University Of Medical Sciences
Street address
Shahid Beheshti Blvd,Opposite to the Sepah bank, Above Iran Radiator Representation. Building Of Assistance Research and Technology, Rasht, Iran
City
Rasht
Postal code
4193893345
Approval date
2014-12-09, 1393/09/18
Ethics committee reference number
1930373601

Health conditions studied

1

Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42.0
ICD-10 code description
The essential feature is recurrent obsessional thoughts or compulsive acts. Obsessional thoughts are ideas, images, or impulses that enter the patient's mind again and again in a stereotyped form. They are almost invariably distressing and the patient oft

Primary outcomes

1

Description
Obsessive-compulsive disorder Intensity
Timepoint
1,5,10 and 15 Sessions
Method of measurement
in order to Ybocs Questionnaire score

Secondary outcomes

empty

Intervention groups

1

Description
This quasi-experimental study of the implementation of the Quasi-Exprimental is design with a before and after test One group: Pretest-Posttest design .
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tooloo Specialty and subspecialty of psychiatry Clinic of Rasht
Full name of responsible person
Dr kiomars Najafi
Street address
Shabnam alley, Golsar Crossroads, Opposite to the Municipal of Area (3),Rasht, Iran
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University Of Medical Sceinces,Research and Technology assistance
Full name of responsible person
Dr Rasool Tabari
Street address
Shahid Beheshti Blvd, Opposite to the Sepah Bank, above Iran Radiator Representation، Rasht, Iran
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University Of Medical Sceinces,Research and Technology assistance
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
Guilan University Of Medical Sciences
Full name of responsible person
Dr kiomars Najafi
Position
Psychiatrist, Assistance of Professor
Other areas of specialty/work
Street address
15 khordad avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Postal code
4193955599
Phone
+98 13 3366 6268
Fax
+98 13336662689
Email
kkiomars@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Dr Kiomars Najafi
Position
Assistance of Professor
Other areas of specialty/work
Street address
15 Kordad Avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Postal code
4193955599
Phone
+98 13 3366 6268
Fax
Email
kkiomars@yahoo.com / K-nagafi@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Mahdiyeh Pakdaman
Position
Master Of Science in Clinincal Psychology
Other areas of specialty/work
Street address
15 Kordad Avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Postal code
4193955599
Phone
+98 13 3366 6268
Fax
+98 13 3366 6268
Email
m.pakdaman1981@gmail.com
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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