Comparison of the effectiveness of rTMS device with drug therapy on the improvement of cognitive impairment in patients with generalized anxiety disorder
Overall Objective: To evaluate the effect of rTMS device(repetitive Transcranial Magnetic Stimulation) on recovery of patients with generalized anxiety disorder in Yazd
Design
Clinical trial with control group, with parallel groups, without blinding, on 60 patients
Settings and conduct
Patients in the intervention group will receive medication and rTMS, and patients in the control group will receive medication alone. The number of rTMS sessions is ten sessions that will be performed during 2 weeks and the patients in both groups will be treated with two drugs, paroxetine 20 and trimipramine (a drug from the TCA class). This study will be performed in Bahman psychiatric hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients in the age range of 15-55 years with generalized anxiety disorder, without previous treatment history
Exclusion criteria: under 15 years old or over 55 years old, presence of metal accessories or prostheses in the body, traditional or industrial drug addiction, having underlying diseases such as diabetes and hypertension, drug use, anxiety and severe restlessness or Severe insomnia, having dementia
Intervention groups
The intervention group includes 30 patients using rTMS and drug therapy and the control group includes 30 patients undergoing drug treatment alone.
Main outcome variables
Cognitive Disorder Score on Cognitive Disorder Test (MMSE)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210328050785N1
Registration date:2021-08-02, 1400/05/11
Registration timing:registered_while_recruiting
Last update:2021-08-02, 1400/05/11
Update count:0
Registration date
2021-08-02, 1400/05/11
Registrant information
Name
Mahtab Meydani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3725 1785
Email address
mahtabmeydani2014@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-18, 1400/04/27
Expected recruitment end date
2021-08-18, 1400/05/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of rTMS device with drug therapy on the improvement of cognitive impairment in patients with generalized anxiety disorder
Public title
Effect of rTMS in treatment of generalized anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with generalized anxiety disorder in the age range of 15-55 years
Patients agree to enter the study
The first action of patients in the treatment of their disease
Exclusion criteria:
Age under 15 or over 55 years
Existence of metal accessories or prostheses in the body
Traditional or industrial drug addiction
Having comorbid disease such as diabetes and high blood pressure
Severe anxiety and restlessness or severe insomnia
Taking any medication in the patient's history
Age
From 15 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups by simple random sampling. The selection of individuals and their placement in dual groups will be random, so that after confirming the necessary conditions to enter the study, patients are selected sequentially, the first patient in the first group, the second patient in the second group, and Likewise, patients will be placed in separate groups. The number of patients in the two groups will be equal.
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
Ethics committee of Yazd Islamic Azad University
Street address
No. 2, Rose Alley., Imam Hossein Square
City
Yazd
Province
Yazd
Postal code
8916184719
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.IAU.YAZD.REC.1400.003
Health conditions studied
1
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Cognitive impairment score in ( MMSE) Mini-Mental State Exam, cognitive impairment test
Timepoint
Measurement of cognitive impairment score (before the start of the study) and 2 and 4 weeks after the end of the study
Method of measurement
MMSE Cognitive Disorder Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 sessions of treatment with repetitive transcranial magnetic stimulation (rTMS) over 2 weeks (5 days per week). Each treatment session will last about 45 minutes.
Category
Treatment - Devices
2
Description
Control group: Common drug treatment of the disease includes the use of 2 drugs paroxetine 20 mg (Paroxetine) and trimipramine 25 mg (Trimipramine), which will be done in the same way in the intervention group. Paroxetine 20 once a night and trimipramine 25 in case of insomnia One will be used each night. Both drugs will be prescribed to patients in pill form.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahman Psychiatric Hospital
Full name of responsible person
Mojtaba Yassini
Street address
Bahman Psychiatric Hospital, Kashani St, Yazd Town
City
Yazd
Province
Yazd
Postal code
8913783111
Phone
+98 35 3629 2300
Fax
+98 35 3623 8080
Email
admin@bahmanclinic.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
احمد شجری
Street address
Unknown Martyrs Blvd, Safaieh Area, Yazd Town
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3187 1000
Email
info@iauyazd.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mahtab Meydani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 2, Rose Alley., Imam Hossein Square
City
Yazd
Province
Yazd
Postal code
8916184719
Phone
+98 35 3725 1785
Email
mahtabmeydani2014@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Afshin Ataeian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Taleghani Blvd
City
Yazd
Province
Yazd
Postal code
8913835699
Phone
+98 35 3626 2889
Email
dr.ataeiyan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahtab Meydani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 2, Rose Alley., Imam Hossein Square
City
Yazd
Province
Yazd
Postal code
8916184719
Phone
+98 35 3725 1785
Email
mahtabmeydani2014@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information about the main outcome (MMSE cognitive impairment score), can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
One must be a member and researcher of a study organization and be employed in that center. The purpose of accessing the data should be to find a new treatment or to better understand the disease and help improve the quality of life of patients. It should not be just for the benefit and use of study information. Provide the necessary evidence that indicates the conduct of the research process.
From where data/document is obtainable
Mahtab Meydani
mahtabmeydani2014@gmail.com
What processes are involved for a request to access data/document
Contact the person holding the research work (Afshin Ataeian or Mahtab meydani) and fully state their purpose and characteristics and provide sufficient evidence to prove the status of being a researcher and working in a study center.