There are contradictory reports regarding the antidepressant effects of repetitive transcranial magnetic stimulation. This study is a randomized, electroconvulsive therapy controlled, parallel group clinical trial comparing antidepressant effects of electroconvulsive therapy and repetitive transcranial magnetic stimulation in patients with major depressive disorder diagnosed according to clinical interview using DSM-IV criteria. Patients with each of the following items will be excluded: bipolar mood disorder, serious medical conditions, suicidal attempt, and the lack of patients’ consent. Beck depression inventory and Hamilton depression rating scales are used to measure depression score as the main outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902253930N1
Registration date:2010-11-24, 1389/09/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-11-24, 1389/09/03
Registrant information
Name
Ahmad Ghanizadeh
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 3070
Email address
ghanizad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences.
Expected recruitment start date
2010-06-02, 1389/03/12
Expected recruitment end date
2010-12-03, 1389/09/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of electroconvulsive therapy and repetitive transcranial magnetic stimulation
Public title
Comparison of the efficacy of electroconvulsive therapy and repetitive transcranial magnetic stimulation
on Major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: 1- major depressive disorder, 2- age>20, 3- voluntary participation.
Exclusion: 1-bipolar mood disorder, 2- serious medical conditions, 3- suicidal attempt, 4- lack of consent.
Age
From 19 years old to 65 years old
Gender
Both
Phase
1
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
Shiraz University of Medical Sciences
Street address
Shiraz- Chamran street- Hafez hospital
City
Shiraz
Postal code
--
Approval date
2010-06-02, 1389/03/12
Ethics committee reference number
CT-89-5091
Health conditions studied
1
Description of health condition studied
major depressive Disorder
ICD-10 code
F32
ICD-10 code description
Depressive episode
2
Description of health condition studied
Recurrent depressive disorder
ICD-10 code
F33
ICD-10 code description
Recurrent depressive disorder
Primary outcomes
1
Description
Depression score
Timepoint
before and after 10 sessions of intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The patients in electroconvulsive therapy group receive 10 sessions (3 days per week). There are 3 sessions of electroconvulsive therapy in each week for each patient
Category
Treatment - Other
2
Description
The patients in repetitive transcranial magnetic stimulation group receive repetitive transcranial magnetic stimulation daily for 10 days (Saturday to Wednesday). Each session is 10 minutes with a large figure of eight coil
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Psychiatry and behavioral sciences
Full name of responsible person
Mitra Keshtkar
Street address
Shiraz- Chamran Street- Hafez hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hossien Dabbaghmanesh
Street address
Zand Street- Shiraz University of Medical sciences- Vice-chancellery of Research Affairs
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
MD
Other areas of specialty/work
Street address
Shiraz- Chamran street- Hafez Hospital
City
Shiraz
Postal code
--
Phone
+98 71 1627 3070
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)