Effect of trance cranial direct current electrical stimulation plus cranial electrothrapy stimulation rather than trance cranial direct current stimulation in treatment of major depression disorder.
Comparison of two methods of trance cranial direct electrical stimulation plus cranial electrotherapy stimulation rather than trance cranial direct electrical stimulation lonely in the treatment of major depression, it is a double-blind randomized clinical trial study with a control group (sham) as a placebo on 30 patients with major depression, the 30 patients after semi-structured interviews with the consent of a study by a psychiatrist, patients with chronic physical illness or mental disorders or defects of the skull. The numbers are in three groups: in control group to eliminate placebo effect of TDCS we use active cs device with inactive tdcs(sham) in group B we use active TDCS device and inactive CES as sham.) Group C (both devices (tDCS) and (CES)are active, each device are used for patient separately for 20 minutes and frequency of devices are adjust upon of QEG has been taken from each patient before the intervention. Before and after the last session patient fill Beck questioner of depression t, not the patient nor the analyst is not aware of the type of treatment effectiveness of treatments carried out on the basis of changes in Depression Inventory scores before and after treatment are calculated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051122176N2
Registration date:2015-06-22, 1394/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-22, 1394/04/01
Registrant information
Name
Ehsan Mohammadi
Name of organization / entity
Joundishapoor University of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 71 3830 0623
Email address
mohammadi.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoghi University of Medical Sciences, Yazd
Expected recruitment start date
2014-12-24, 1393/10/03
Expected recruitment end date
2015-04-30, 1394/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of trance cranial direct current electrical stimulation plus cranial electrothrapy stimulation rather than trance cranial direct current stimulation in treatment of major depression disorder.
Public title
Trance cranial direct current electrical stimulation plus cranial electrothrapy stimulation rather than trance cranial direct current stimulation in treatment of major depression disorder.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: major depression that diagnosed during a semi-structured interviews by psychiatrists on DSMIV-TR and having ultimately up to the age and sign a consent. Exclusion criteria: other major psychiatric disorders such as active psychosis; suicidal thoughts and suicide; abusie or dependency on any substance (except caffeine); other anxiety disorders except mild to moderate anxiety followed by depression (Beck Anxiety Inventory score under 21); lack of physical illness itself as a chronic stressor act during illness the lack of a defect in the skull, scalp; foreign bodies in the brain; lack of grief or mourning the loss of a close relationship between the patient; there is no criteria for personality disorder as a disease in a patient during an interview on DSMIV-TR; the absence of disease; neurological especially active seizure and pregnancy.
Age
From 18 years old to 55 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
Shahid Sadoghi University of Medical Sciences, Yazd
Street address
Pardise Medical University of Yazd
City
Yazd
Postal code
Approval date
2015-04-23, 1394/02/03
Ethics committee reference number
ir.ssu.medicine.rec. 1393.127
Health conditions studied
1
Description of health condition studied
Major deppresion disorder
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
depression
Timepoint
9 days
Method of measurement
beck depression questionary
Secondary outcomes
1
Description
side effectes of intervenion devices
Timepoint
after the last session
Method of measurement
examination by medical doctor
Intervention groups
1
Description
IN FIRST international group 10 patients who has chosen double blined randomised recive both devices (tDCS) AND (CES ) IN ACTIVE form for 6 sessions that first three sessions are daily and the three other are with 1day interval
Category
Treatment - Devices
2
Description
In group B of intervention 10 patients in double blind randomised clincal traial recived (tDCS ) in sctive way and (Ces) in actively as (sham) in 6 sessions that first 3 sessions are daily and the 3 others are with one day interval, an each devices are used 20 minutes separately
Category
Treatment - Devices
3
Description
Group c , is control group that used for vanished the placebo effect of (tDCS),fore that reason 10 patients that chosen randomly in double blinde clincal traial, eith the active form of(CES ) and in active form of ( tDCS)for 6 sessions that first 3 sessions are daily and the other 3 sessions are with 1 day interval, each device is use d separately for 20 minutes
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Baghaeipour Clinical Centre
Full name of responsible person
Dr. Ghasem Dastjerdi
Street address
Shahid Sadoughi hospital
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoghi University of Medical Sciences, Yazd
Full name of responsible person
Dr. Ghasem Dastjerdi
Street address
Psychiatry Research Center, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoghi University of Medical Sciences, Yazd
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
Jundishapoor University of Medical Sciences
Full name of responsible person
Dr. Ehsan Mohammadi
Position
MD, resistant of psychology
Other areas of specialty/work
Street address
No. 241, Eslahnejad avenue, Shiraz
City
Ahvaz
Postal code
Phone
+98 917 305 1609
Fax
Email
ehsanmdi10@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoghi University of Medical Sciences, Yazd
Full name of responsible person
Dr. Ghasem Dastjerdi
Position
Assistant professor
Other areas of specialty/work
Street address
Psychiatry treatment and research center of yazd
City
Taft
Postal code
00987138300623
Phone
+98 913 359 2916
Fax
Email
Drgdastjerdi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jundishapoor University of Medical Sciences
Full name of responsible person
Ehsan Mohammadi
Position
MD, resident of psychiatry
Other areas of specialty/work
Street address
No. 241, Eslahnejad avenue, Shiraz
City
Shiraz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)