|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
IRCT |
|
Last refreshed on:
|
22 February 2018 |
|
Main ID: |
IRCT2017031121965N6 |
|
Date of registration:
|
2017-04-21 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The effect of current stimulation and drug therapy on obsessive compulsive disorder
|
|
Scientific title:
|
Comparing Transcranial direct current stimulation with and without drug therapy on symptoms of patient with obsessive compulsive disorder: a Clinical trial |
|
Date of first enrolment:
|
2017-03-11 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Complete |
|
URL:
|
http://en.irct.ir/trial/19079 |
|
Study type:
|
interventional |
|
Study design:
|
Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -.
|
|
Phase:
|
3
|
|
|
Countries of recruitment
|
|
Iran (Islamic Republic of)
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr Kiomars Najafi
|
|
Address:
|
Shafa educational and remedial center, 15 Khordad avenue, Rasht, Iran
41939-55599
Rasht
Iran (Islamic Republic of) |
|
Telephone:
|
+98 13 3366 6268 |
|
Email:
|
Kkiomars@yahoo.com |
|
Affiliation:
|
Guilan University Of Medical Sciences |
|
|
Name:
|
Dr Kiomars Najafi
|
|
Address:
|
Shafa educational and remedial center, 15 Khordad avenue, Rasht, Iran
41939-55599
Rasht
Iran (Islamic Republic of) |
|
Telephone:
|
+98 13 3366 6268 |
|
Email:
|
Kkiomars@yahoo.com |
|
Affiliation:
|
Guilan University Of Medical Sciences |
| |
|
Key inclusion & exclusion criteria
|
Inclusion 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.
Exclusion criteria:
Age minimum:
18 years
Age maximum:
55 years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
obsessive – compulsive disorder.
Obsessive-compulsive disorder
|
|
Obsessive-compulsive disorder
|
|
Intervention(s)
|
|
Intervention 1: 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. Intervention 2: 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.
|
|
Treatment - Other
|
|
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
|
|
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.
|
|
Primary Outcome(s)
|
|
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.
|
|
Source(s) of Monetary Support
|
|
Vice chancellor for research, Guilan University of Medical Sciences
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Ethics committee of Guilan University of Medical Sciences
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|