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The effect of trans cranial direct current stimulation of the brain (TDCS) in patients with major depressive disorder referring

Protocol summary

Summary
The aim of this study was to investigate the effect of direct brain electrical stimulation (TDCS) in patients with major depressive disorder based on the criteria for entering the age of 18 to 65, both sexes have male and female, sixth grade primary education, no physical illness, other psychiatric disorders, family history of bipolar disorder, mental retardation, pregnancy after a clinical interview by psychologist and psychiatrist. The DSM-IV-TR diagnostic criteria and the score of over 18 in the Hamilton test are performed. Patients are randomly divided into case and control groups. In the control group, the SSRI drug is used and the electrodes are attached, but no electrical stimulation is performed. In the case group, in addition to the use of SSRI, electrodes are attached after preparing the subject, with the declaration of his readiness, a direct electric stimulation with a tDCS device with an intensity of 2 milliamperes is performed for 20 minutes per day during the week for 20 sessions. Hamilton test is repeated once before tDCS and then 4 weeks, 8 weeks, and 12 weeks after tDCS.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017101436756N1
Registration date: 2017-11-19, 1396/08/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Bahman Salehi
Name of organization / entity
Arak University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3465 5314
Email address
dr.basalehi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research of Arak University of Medical Sciences
Expected recruitment start date
2016-06-26, 1395/04/06
Expected recruitment end date
2017-06-27, 1396/04/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of trans cranial direct current stimulation of the brain (TDCS) in patients with major depressive disorder referring
Public title
The effect of trans cranial direct current stimulation of the brain (TDCS) in patients with major depressive disorder referringl
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: aged 18 to 65 years; lack of psychotic diseases and synchronization with other disorders; lack of use; diagnosis of major depression based on clinical interview and diagnostic criteria of DSM IV Exclusion criteria: Severe psychiatric disorders; Personality disorders; Consumption of multiple medications simultaneously; Severe physical illnesses; Recent use of warfarin, amoxicillin, ampicillin, theophylline, mycophenolate mofetil; Use of antidepressants in the last month; Pregnancy and lactation; Thoughts Suicide or harm to others; substance abuse and alcohol consumption
Age
From 18 years old to 65 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
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
Arak University of Medical Sciences
Street address
Arak, Sardasht, School of Medicine
City
Araj
Postal code
3819838453
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.ARAKMU.REC.1395.53

Health conditions studied

1

Description of health condition studied
depressive disorder
ICD-10 code
F33
ICD-10 code description
F33.0 , F33.1

Primary outcomes

1

Description
depression
Timepoint
Before tDCS and 4 weeks, 8 weeks and 12 weeks after tDCS
Method of measurement
Hamilton questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Case group: In addition to using the SSRI drug, the electrodes are connected. After preparing the subject, he / she is prepared to direct the electric stimulation with a tDCS device with an intensity of 2 milliamperes for 20 minutes, one day per week for 20 sessions.
Category
Treatment - Other

2

Description
Control group: SSRI is consumed and electrodes are connected but no electrical stimulation is performed.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Dr. Farid Modirpoor
Street address
Amir Kabir Hospital, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Farid Modirpoor
Street address
Amir Kabir Hospital, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Farid Modirpoor
Position
Resident psychiatrist
Other areas of specialty/work
Street address
Amir Kabir Hospital, Arak
City
Arak
Postal code
Phone
+98 86 3465 5314
Fax
Email
rahenorayaneh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Farid Modirpoor
Position
Resident psychiatrist
Other areas of specialty/work
Street address
Amir Kabir Hospital, Arak
City
Arak
Postal code
Phone
+98 86 3465 5314
Fax
Email
rahenorayaneh@yhaoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical sciences
Full name of responsible person
Dr. Farid Modirpoor
Position
Resident psychiatrist
Other areas of specialty/work
Street address
medical School
City
Arak
Postal code
Phone
+98 86 3465 5314
Fax
Email
rahenorayaneh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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