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The effect of repetitive transcranial magnetic stimulation (rTMS) in reducing severity of the signs and symptoms of depression in patients with recurrent major depression disorder.

Protocol summary

Summary
Abstract : Objectives : The purpose of this study was to investigate the effectiveness of rTMS (repetitive transcranial of magnetic stimulation in reduction the signs and symptoms of recurrent major depression. Method : Using a quasi experimental , pretest – posttest design with control group ,the statistical population were persons with recurrent majer depression and the inclusion critria were:recurrent majer depression,age between 20 to50 , 20 or upper scores in beck scale ,under drug treatment and psychotherapy and exclusion critria were sezieure and brain damage ,bipolar or psychosis,psychothrophic addiction ,pregnancy, having metal in head , dental implant,Heart pacemaker. A sample consisting of 32 patients who had recurrent depression on the basis of SCID & BDI& Hamilton scales and were randomly assigned to two groups. The experimental group underwent 20 sessions of rTMS as the independent factor and both groups (control &experimental ) had 12 session psychotherapy and drugs treatment .Upion the intervention , both groups were tested with triplex tests. To determine the effect of the indepenndnt factor on the dependent factor of rTMS. Results : The comprise between pre &post test of all the tests showed the reduction of signs & symptoms of recurrent depression in participants.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012123111953N1
Registration date: 2013-01-17, 1391/10/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-17, 1391/10/28
Registrant information
Name
Mohammadreza Pirmoradi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1653
Email address
mr-pirmoradi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rehabilitation &Welfare University
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of repetitive transcranial magnetic stimulation (rTMS) in reducing severity of the signs and symptoms of depression in patients with recurrent major depression disorder.
Public title
The effect of repetitive transcranial magnetic stimulation (rTMS) in recurrent major depression disorder.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: recurrent major depression based on psychiatrist visit and SCID; 20 to 50 years old; 20 scour or above in beck scale; They treat with drugs &psychotherapy Exclusion criteria: The history of brain damage or seizure; The history of bipolar or psychosis; Psychotropic drugs addiction; pregnancy; Having metal in the head, Heart pacemaker, dental implant
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
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
Rehabilitation &Welfare University
Street address
koodakyar Str.-Daneshjo Bulvar-Evin
City
Tehran
Postal code
1985713834
Approval date
2011-06-12, 1390/03/22
Ethics committee reference number
6730

Health conditions studied

1

Description of health condition studied
depression
ICD-10 code
F33
ICD-10 code description
Recurrent depressive disorder

Primary outcomes

1

Description
signs and symptoms of depression
Timepoint
before and after intervention,weekly
Method of measurement
beck,hamilton

Secondary outcomes

1

Description
increase social function
Timepoint
before and after intervention
Method of measurement
SASS

Intervention groups

1

Description
TMS,20 sessions+psychotherapy(cognition behaiveral,12 sessions+fix drugs
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Atiyeh center
Full name of responsible person
Khomami- Sanaz-doctoral student
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rehabilitation &Welfare University
Full name of responsible person
Ms. Rajabi
Street address
Koodakyar Str.-Daneshjo Bulvar-Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rehabilitation &Welfare University
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
Tehran University of Medical Sciences
Full name of responsible person
Mommadreza Pirmoradi
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran Psychology Institute-Mansori Str.- Satarkhan Str.
City
Tehran
Postal code
Phone
+98 21 6655 1653
Fax
Email
mr-pirmoradi@razi.tums.ac.irmrpirmoradi47@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Pirmoradi
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran Psychology Institute
City
Tehran
Postal code
Phone
+98 21 6655 1653
Fax
Email
mr-pirmoradi@razi.tums.ac.irmrpirmoradi47@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Pirmoradi
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran Psychology Institute
City
Tehran
Postal code
Phone
+98 21 6655 1653
Fax
Email
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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