Evaluation of the effects of transcranial direct current stimulation on geriatric depression
Design
Two arm parallel group randomized trial with blinded tdcs effect. group of 90 patients. 45 case and 45 control
Settings and conduct
geriatric patients who referred to geriatric clinic of psychiatry institute will be tested with geriatric depression scale. and the positive ones will be chosen.
after registration of demographic data, based on entrance and exit criteria 90 patients will enter the trial. they will be divided in two equal groups based on block randomization. all the patients will receive sertraline with initial dose of 25 mg and increase dose up to 50mg. and 5 period of electrical stimulation, 2 milliampere currents in 20 minutes, with protocol of anode in f3 and supraorbital cathode will be perform in case group,withoff tdcs stimulation in control group. GDS will perform after the third session one time and 1 month after the end of the intervention for the third time. and the result will be comprise between tow groups.
Participants/Inclusion and exclusion criteria
entrance criteria: geriatric more than 60 years old with depression diagnosis in geriatric depression scale
exit criteria: metal in skull area
Intervention groups
Intervention group: 45 geriatric patient with positive geriatric depression scale test which recessive combination therapy with serteraline 50 mg daily and transcranial direct current stimulation 1-2 mA in 5 sessions of 20 minutes period . control group: 45 geriatric patient with positive geriatric depression scale test which recessive just serteraline 50 mg daily.
Main outcome variables
GDS score after third session of TDCS
GDS score after fifth session of TDCS
GDS score one month after completion of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181215041976N1
Registration date:2019-03-10, 1397/12/19
Registration timing:registered_while_recruiting
Last update:2019-03-10, 1397/12/19
Update count:0
Registration date
2019-03-10, 1397/12/19
Registrant information
Name
Mahsa Zareie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 0200
Email address
zareii.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of transcranial direct current stimulation on geriatric depression
Public title
effects of transcranial direct current stimulation on geriatric depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
geriatric older than 60 with depression in geriatric depression scale
Exclusion criteria:
metal skull area
seizure history
history of allergy with TDCS
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
OFF TDCS in control group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of IRAN University of Medical Science
Street address
No. 1, Mansouri St., Niyayesh St. , Sattarkhan St., Tehran, Tehran Institute of Psychiatry
City
Tehran
Province
Tehran
Postal code
1
Approval date
2019-01-17, 1397/10/27
Ethics committee reference number
IR.IUMS.REC.1397.574
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
F32.9
ICD-10 code description
Depressive episode, unspecifiedDepression NOSDepressive disorder NOS
Primary outcomes
1
Description
geriatric depression score
Timepoint
before tdcs and 3, 5 and 30 days after first tdcs
Method of measurement
geriatric depression scale test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 45 geriatric patient with positive geriatric depression scale test which recessive combination therapy with serteraline 50 mg daily and transcranial direct current stimulation 1-2 mA in 5 sessions of 20 minutes period .
Category
Rehabilitation
2
Description
Control group: 45 geriatric patient with positive geriatric depression scale test which recessive serteraline 50 mg daily and the same pattern of tDCS but off mode.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Geriatric clinic
Full name of responsible person
Dr. Mahsa Zareie
Street address
No.1, Mansouri St., Niyayesh St., Sattarkhan St., Tehran, Tehran institute of psychiatry
City
Tehran
Province
Tehran
Postal code
1
Phone
+98 21 6655 1515
Email
zareii.m@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. seyyed Kazem Malakouti
Street address
No. 1, Mansouri St., Niyayesh St. , Sattarkhan St., Tehran, Tehran Institute of Psychiatry
City
Tehran
Province
Tehran
Postal code
1
Phone
+98 21 6655 1515
Email
zareii.m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahsa Zareie
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Geriatrics
Street address
No. 1, Mansouri St., Niyayesh St. , Sattarkhan St., Tehran, Tehran Institute of Psychiatry
City
Tehran
Province
Tehran
Postal code
1
Phone
+98 21 6655 1515
Email
zareii.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahsa Zareie
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Geriatrics
Street address
No. 1, Mansouri St., Niyayesh St. , Sattarkhan St., Tehran, Tehran Institute of Psychiatry
City
Tehran
Province
Tehran
Postal code
1
Phone
+98 21 6655 1515
Email
zareii.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahsa Zareie
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Geriatrition
Street address
No. 1, Mansouri St., Niyayesh St. , Sattarkhan St., Tehran, Tehran Institute of Psychiatry
City
Tehran
Province
Tehran
Postal code
1
Phone
+98 21 6655 1515
Email
zareii.m@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available