Comparing Transcranial direct current stimulation with and without drug therapy on symptoms of patient with obsessive compulsive disorder: a Clinical trial
This study is aimed to compare the effectiveness of the Transcranial direct current stimulation (TDCS) of the brain and medication on symptoms of patients with obsessive compulsive disorder in a pre- and post- tests design. Sample size consists of 40 patients in two groups, 20 patients in each group, one with medication and the other one without medication. Patients will be selected by a psychiatrist based on structured clinical interview according to diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM -5), from Toloo clinic in Rasht. Yale-Brown questionnaire (YBOCS) will be used to assess the seventy of obsessive compulsive symptoms. The minimum score of 16 in required entering the study. After signing the informed consent and considering inclusion and exclusion criteria, treatment resistant obsessive compulsive patients will enter the study. Exclusion criteria is defined as consuming anticonvulsant medication during in the past 6 months, pregnancy, or unwilling to continue the study. Interventions; Intervention in Group 1: Twenty medical treatment - resistant patients suffering from obsessive compulsive disorders will be entered in this group. They will receive brain electrical stimulation (Transcranial direct current stimulation) while getting no medication. Therapy will be carried out in four thirty-minute sessions with one-week interval between each two sessions and music will be played to calm the patients during electrical stimulation.
Intervention Group 2: Twenty medical treatment - resistant patients suffering from obsessive compulsive disorders will be entered in this group. Treatment consists of sufficient dose of Serotonin reuptake inhibitors (SSRI), Fluoxetine 80 mg or Setraline 200 mg, daily in combination with brain electrical stimulation.
In both group, therapy will be carried out in four thirty-minute sessions with one-week interval between each two sessions and a direct continuous electrical stimulation will be sent to the cortex through electrical for a maximum duration of thirty minutes. Music will be played for patients in order to calm them during the sessions. YBOCS will be used to assess the efficacy of treatment one and three month later.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017031121965N6
Registration date:2017-04-21, 1396/02/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-21, 1396/02/01
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
Vice Chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2017-03-11, 1395/12/21
Expected recruitment end date
2017-06-11, 1396/03/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Transcranial direct current stimulation with and without drug therapy on symptoms of patient with obsessive compulsive disorder: a Clinical trial
Public title
The effect of current stimulation and drug therapy on obsessive compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with obsessive compulsive disorder; minimum score of 16 form YBOCS; aged between 18-55 years. Exclusion criteria: Antiepileptic drug therapy in the previous 6 months; neurologic disease; pregnancy; low intelligence quotient; head injury; any metallic instrument in brain or skull.
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Vice chancellor for research of Guilan University of Medical Sciences, the upper floor of Iran Radiator Representation, in front of the Sepah bank, West Shahid Beheshti Blvd.
City
Rasht
Postal code
4193893345
Approval date
2016-10-30, 1395/08/09
Ethics committee reference number
IR.GUMS.REC.1395.271
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
obsessive – compulsive disorder
Timepoint
Measured time intervals will be before the treatment and one and three months after the treatment.
Method of measurement
Yale-Brown test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1: Twenty medical treatment - resistant patients suffering from obsessive compulsive disorders will be entered in this group. They will receive brain electrical stimulation (Transcranial direct current stimulation) while getting no medication. Therapy will be carried out in four thirty-minute sessions with one-week interval between each two sessions and music will be played to calm the patients during electrical stimulation. Follow up visits will be one and three month later. Comparing to the other noninvasive stimulation, TDCS is a new and noninvasive brain electrical stimulation method that is safe, low cost and simply designed in order to use in outpatient settings.
Category
Treatment - Other
2
Description
Intervention Group 2: Twenty medical treatment - resistant patients suffering from obsessive compulsive disorders will be entered in this group. Treatment consists of sufficient dose of Serotonin reuptake inhibitors (SSRI), Fluoxetine 80 mg or Setraline 200 mg, daily in combination with brain electrical stimulation. Therapy will be carried out in four thirty-minute sessions with one-week interval between each two sessions and music will be played to calm the patients during electrical stimulation. Follow up visits will be one and three month later. Comparing to the other noninvasive stimulation, TDCS is a new and noninvasive brain electrical stimulation method that is safe, low cost and simply designed in order to use in outpatient settings
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
Tooloo Specialty and Subspecialty of Psychiatry Clinic ,Shabnam alley, Golsar Crossroads, in front of the Municipality of Area (3), Rasht, Iran.
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Street address
Vice chancellor for research of Guilan University of Medical Sciences, the upper floor of Iran Radiator Representation, in front of the Sepah bank, Shahid Beheshti Blvd.
City
Rasht
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, Guilan 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
Guilan University Of Medical Sciences
Full name of responsible person
Dr Kiomars Najafi
Position
Psychiatrist, Assistant Professor
Other areas of specialty/work
Street address
Shafa educational and remedial center, 15 Khordad avenue, Rasht, Iran
City
Rasht
Postal code
41939-55599
Phone
+98 13 3366 6268
Fax
-
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
Psychiatrist, Assistant Professor
Other areas of specialty/work
Street address
Shafa educational and remedial center, 15 Khordad avenue, Rasht, Iran
City
Rasht
Postal code
41939-55599
Phone
+98 13 3366 6268
Fax
-
Email
Kkiomars@yahoo.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Mona Musaie
Position
Master Of science in Psychology
Other areas of specialty/work
Street address
Shafa educational and remedial center, 15 Khordad avenue, Rasht, Iran
City
Rasht
Postal code
41939-55599
Phone
+98 13 3366 6268
Fax
-
Email
monamusaie@yahoo.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)