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IRCT20210328050785N1 IRCT 2021-08-02 Islamic Azad University Effect of rTMS in treatment of generalized anxiety disorder Comparison of the effectiveness of rTMS device with drug therapy on the improvement of cognitive impairment in patients with generalized anxiety disorder 2021-07-18 anticipated 60 Complete https://irct.ir/trial/55221 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Generalized anxiety disorder. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main outcome (MMSE cognitive impairment score), can be shared. When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: 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. Where to obtain: Mahtab Meydani mahtabmeydani2014@gmail.com How to obtain: 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. Comments:
public Mahtab Meydani
No. 2, Rose Alley., Imam Hossein Square
Yazd Iran (Islamic Republic of) 8916184719 +98 35 3725 1785 mahtabmeydani2014@gmail.com Islamic Azad University scientific Afshin Ataeian
Taleghani Blvd
Yazd Iran (Islamic Republic of) 8913835699 +98 35 3626 2889 dr.ataeiyan@yahoo.com Islamic Azad University Iran (Islamic Republic of) 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 15 years 55 years Both 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 F41.1 Generalized anxiety disorder Treatment - Devices Treatment - Drugs 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. 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. 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. Islamic Azad University Approved 2021-05-31 Ethics committee of Yazd Islamic Azad University No. 2, Rose Alley., Imam Hossein Square Yazd Yazd Iran (Islamic Republic of)