Comprative effectiveness of transcranial Direct Current Stimulation (tDCS) in both PreSMA and LOF inhibition and comparing them with placebo in reducing symptoms in nonresponsive OCD patients
Obsessive-Compulsive Disorder (OCD) is the fourth most common psychiatric disorder after phobias, substance abuse and Major Depressive Disorder (MDD). The lifetime prevalence of OCD is 2-3% in general population. About 10–40% of patients do not respond to routine treatments. tDCS or transcranial direct current stimulation is a new non-invasive brain stimulation compared with other non-invasive stimulation is a safe, low cost, simple design, deployment is easy and can be done in an outpatient clinic. This study is designed to study the effects of TDCS on reducing OCD symptoms in these patients. The target population are the outpatients with treatment-resistant OCD who will be chosen by a psychiatrist in Zare Hospital of Sari and based on the results drown from the Yale-Brown Obsessive Compulsive Questionnaire (YBOCS). These patients between 18-60 years of age and at least 16 must be their test score and if they have other psychiatric illness, or not satisfactory they are excluded. In this study that designed double-blinded, 51 patients with treatment-resistant obsessive-compulsive disorder in three groups (two experimental groups and one placebo group) are matched for age and sex. And the severity of obsessive-compulsive symptoms before and after treatment and one month after treatment is evaluated on the basis of the questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701095138N3
Registration date:2017-02-14, 1395/11/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-14, 1395/11/26
Registrant information
Name
Abbas Masoudzadeh
Name of organization / entity
Mazandaran Uiversity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15133241889
Email address
amasoudzadeh@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Assistance of Mazandaran University of Medical Sciences
Dr. Ahmad Ali Enayati
2th BLD. Moallem SQ. Sari. Mazandaran IRAN
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comprative effectiveness of transcranial Direct Current Stimulation (tDCS) in both PreSMA and LOF inhibition and comparing them with placebo in reducing symptoms in nonresponsive OCD patients
Public title
Effectiveness of transcranial Direct Current Stimulation (tDCS) in Obsessive-Compulsive Disorder patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of OCD according to DSMV ; Lack of response to treatment with 2 drugs with sufficient dose and time (equal 80 mg Fluoxetine) ; Only this diagnosis in axis I and not have diagnosis in axis II ; Lack of drug dependence and lack of major neurological complications in terms of history; Written consent to participate in the study ; Right-handed ; Unchanged drug in the last month and the lack of psychotherapy in 8 weeks
Exclusion criteria:Other disorders in axis I and II ; Having implant or prosthesis or metal in skull ; Patient satisfaction or waiver of him; Pregnancy
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
51
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
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Moallem Sq.
City
Sari
Postal code
Approval date
2017-01-17, 1395/10/28
Ethics committee reference number
IR.MAZUMS.REC.95.1780
Health conditions studied
1
Description of health condition studied
Obsessive-Compulsive Disorder
ICD-10 code
F 42.0
ICD-10 code description
These may take the form of ideas, mental images, or impulses to act, which are nearly always distressing to the subject. Sometimes the ideas are an indecisive, endless consideration of alternatives, associated with an inability to make trivial but necessa
Primary outcomes
1
Description
Intensity of Obsession Compulsion Symptoms
Timepoint
Before intervention- after last intervention and 1 month after last intervention
Method of measurement
YALE-BROWN (Y-BOCS) Test
Secondary outcomes
empty
Intervention groups
1
Description
17 patient in 10 days and every day 20 min treated with tDCS that cathode on left orbitofrontal region and anode on contralateral region with intensity 2mA
Category
Treatment - Devices
2
Description
17 patient in 10 days and every day 20 min treated with tDCS that cathode on left presupplementary motor area and anode on contralateral region with intensity 2mA
Category
Treatment - Devices
3
Description
17 patient in 10 days and every day 20 second treated with tDCS that cathode on left orbitofrontal region and anode on contralateral region with intensity 2mA
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zare Hospital
Full name of responsible person
Dr. Abbas Masoudzadeh
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ahmad Ali Enayati
Street address
Moallem Sq.
City
Sari
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 of Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Rezaei
Position
Psychiatry Assistant
Other areas of specialty/work
Street address
Zare Hospital Sari-Neka Road
City
Sari
Postal code
Phone
+98 11 3328 3886
Fax
Email
drrezaei@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Scienses
Full name of responsible person
Dr. Abbas Masoudzadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Zare Hospital Sari-Neka Road
City
Sari
Postal code
Phone
+98 11 3328 3886
Fax
Email
amasoudzadeh@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Rezaei
Position
MD , Psychiatry assistant
Other areas of specialty/work
Street address
Zare Hospital Sari-Neka Road
City
Sari
Postal code
Phone
+98 91133283886
Fax
Email
drrezaei@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)