The aim of this study is to evaluate the effects of Transcranial direct current stimulation (TDCS) on reducing depressive symptoms in treatment resistant patients with Major Depressive Disorder (MDD), in a Quasi experimental single group before and after study. 51 patients with MDD will be treated by 10 sessions TDCS (Right Catodal Dorsolateral Prefrontal Cortex (DLPC) and left Anodal Temporal Occipitoparietal Cortex, with 2 MA amplitude and 30 minutes duration). Beck Depression Index (Second Edition) will be used to evaluate interview response on sessions 1 and 5 and 10. Respectively positive response will be considered the 25 percent reduce of baseline Beck Depression Index score.
The patients with (BDI II) score equal or greater than 29 will be included and pregnant women or patients with substance abuse or dependency or any other Major Psychiatric Disorders will be excluded from the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100321965N2
Registration date:2015-12-24, 1394/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-24, 1394/10/03
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
Research and Technology assistance ,Guilan University Of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey of effect of Transcranial direct current stimulation on reduction of symptoms in poor-responder major depression patients
Public title
A survey of effect of Transcranial direct current stimulation on reduction of symptoms in poor-responder major depression patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Non-psychotic major depression treatment-resistant, Test score of 29 or greater on Beck-II Depression Questionnaire, anti depressants
( NSR, SSRI), Benzodiazepines and antipsychotic drugs consumption at least 4 weeks before the study, absence of neurological disease, Without any complication; Exclusion criteria: pregnancy, any kind of drug or substance dependency in the last 6 months, any kind of major co morbidity Psychiatric Disorders(like Schizophrenia, Bipolar and …., any kind of Metal prosthesis in the body.
Age
From 15 years old to 77 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
51
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
Research and Technology assistance ,Ethics committee of Guilan University Of Medical Sciences
Street address
Shahid Beheshti Blvd, Opposite to the Sepah Bank, above Iran Radiator Representation, Research and Technology assistance, Rasht, Iran
City
Rasht
Postal code
41938-93345
Approval date
2015-09-22, 1394/06/31
Ethics committee reference number
IR.GUMS.REC.1394.259
Health conditions studied
1
Description of health condition studied
Major Depression
ICD-10 code
F33.2
ICD-10 code description
A disorder characterized by repeated episodes of depression, the current episode being severe without psychotic symptoms, as in F32.2, and without any history of mania.
Primary outcomes
1
Description
ِDepression
Timepoint
1,5, 10 treatment
Method of measurement
Beck-II Depression Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The method will be designed a Quasi experimental single group (without control group) before and after study. The patients will be treated by 10 sessions with 30 minutes TDCS.
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
Research and Technology assistance(Vice chanceller for research) ,Guilan University Of Medical Scien
Full name of responsible person
Dr Rasool Tabari
Street address
Shahid Beheshti Blvd, Opposite to the Sepah Bank, above Iran Radiator Representation, Research and Technology assistance,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
Research and Technology assistance(Vice chanceller for research) ,Guilan University Of Medical Scien