Evaluation of TDCS for augmentation treatment of major depressive disorder with poor treatment response
double blinded randomized clinical trial
patient with MDD that treated by efficient dose of one of the SSRIs for 8 week that have inappropriate responces and need to augmentation treatment refer to emam reza hospital in two case and control group randomizly if they have inclusion criteria .
for cases 10 session of TDCS for 20 minutes by 2mA by stimulatore and for control group 10 inactive session by the same device uses. befor,exactly after the end of sessions and 3 mounth later Hamilton rating scale for depression filled.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012526189N1
Registration date:2016-03-04, 1394/12/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-04, 1394/12/14
Registrant information
Name
Sayedeh Elham Sharafi
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2210
Email address
e-sharafi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of TDCS for augmentation treatment of major depressive disorder with poor treatment response
Public title
Evaluation of TDCS for augmentation treatment of major depressive disorder with poor treatment response
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient with MDD diagnosis due to DSM4 criteria; 20-60 years old; minimum education: 5 class; 8 week treatment by efficient dose of SSRIs and inappropriate response that reffer for TDCs by their psychiatrist plus drug treatment concurrently; probablity of bipolarity and medical problem such as hypothyroidism and acute social problem cause treatment resistance must be evaluate by psychiatrist befor study.
Exclusin criteria: suicidal thought, psychosis, other psychiatric comorbidity except anxiety disorders; personality disorders, substance and alcohol abuse and dependency norologic disease( seizure, stroke, history of traumatic brain injury, life threatening problem in axis 3; metal things in brain or heart; pregnancy; lactation; disagreement to continue the study.
Age
From 20 years old to 60 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Tehran University of Medical Sciencses
Street address
Tehran University of Medical Sciencses, Keshavarz blvd.
City
Tehran
Postal code
Approval date
2015-12-05, 1394/09/14
Ethics committee reference number
IR.TUMS.REC.1394.1339
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32.0
ICD-10 code description
Mild depressive episode
Primary outcomes
1
Description
ِDepression rate
Timepoint
Before, immediately after and 3 months after treatment
Method of measurement
Hamilton depression rating scale
Secondary outcomes
empty
Intervention groups
1
Description
in case group:10 session of 20 minute of trans cranial direct current stimulation by 2 ma
Category
Treatment - Other
2
Description
in control group:10 inactive session of 20 minutes by the same device
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
emam khomeini hospital
Full name of responsible person
Jamshid Ghaderi MD
Street address
ruzbeh hosp
City
Tehran
2
Recruitment center
Name of recruitment center
Ruzbeh hospital
Full name of responsible person
jamshid ghaderi MD
Street address
ghazvin square
City
tehran
3
Recruitment center
Name of recruitment center
emam reza hosoital
Full name of responsible person
mrs afsane dadarkhah
Street address
west fatemi st
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
dr. Masud yunesian.manager of research affairs of Tehran University of Medical Sciencses
Full name of responsible person
Jamshid Ghaderi MD
Street address
Ruzbeh hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
dr. Masud yunesian.manager of research affairs of Tehran University of Medical Sciencses
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
AJA University of Medical Sciences
Full name of responsible person
Afsane Dadarkhah
Position
Faculty member
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Tehran
Postal code
Phone
+98 21 8802 8931
Fax
Email
dadarkhah @yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciencses
Full name of responsible person
Jamshid Ghaderi
Position
MD, Resident of psychiatry
Other areas of specialty/work
Street address
Ruzbeh hospital, South Kargar St.
City
Tehran
Postal code
Phone
+98 21 5541 9151
Fax
Email
drghaderi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyedeh Elham Sharafi
Position
Assistant professor of psychiatry department
Other areas of specialty/work
Street address
Imam Khomeini hospital, Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2421
Fax
Email
esharafi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)