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IRCT20210715051901N1 IRCT 2021-09-07 Ahvaz University of Medical Sciences The effect of Atomoxetine on Cognitive Function of Multiple Sclerosis The effect of Atomoxetine on Cognitive Function of Inpatient and Outpatient Multiple Sclerosis 2021-10-07 anticipated 52 Complete https://irct.ir/trial/58215 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a randomized controlled clinical trial. In this study, patients will be assigned to each of the treatment groups by a randomized block method using 4 blocks Which are selected from patients referring to the clinic or outpatient or inpatient clinics of Golestan Hospital in Ahvaz after reviewing the inclusion and exclusion criteria Exits are selected. At the beginning of the study, patients are tested with McFimes. Randomization or random assignment of patients to each treatment group will be done by randomized block method using 4 blocks by winpepi 11.4 software. Subjects were randomly divided into two groups based on the method of quadruple random blocks. The study is a double-blind study in the sense that the patient and the medical staff are unaware of the type of treatment assigned to each person. The number of each patient is placed on the drug package based on the software randomization list. Also, two placebo and Atomoxetine drugs are packaged in such a way that the patient does not know the name of the drug and is given to patients by a nurse not related to the research. In such a way that the attending physician is not aware of the medication provided to each patient. The Beck test is used to check for depression, and people who score 9 on this test are excluded from the study. Patients who will not be able to continue their study due to intolerance to Atomoxetine will be excluded from the study, Blinding description: The study is a double-blind study in the sense that the patient and the medical staff are unaware of the type of treatment assigned to each person. In this study, patients will be assigned to each treatment group using a randomized block method using 4 blocks. The number of each patient is placed on the drug package based on the software randomization list. Also, two placebo and Atomoxetine drugs are packaged in such a way that the patient does not know the name of the drug and is given to patients by a nurse not related to the research. In such a way that the attending physician is not aware of the medication provided to each patient. 3 Multiple Sclerosis. Intervention 1: Intervention group: The intervention group consisted of 26 patients who will be treated with Atomoxetine capsules at a dose of 40 mg daily for 2 weeks and then increased to 80 mg daily to 40 mg twice daily for It will take three months. Intervention 2: The control group consisted of 26 patients who will be treated with placebo-like Atomoxetine capsules once daily for 2 weeks and then increased twice daily for three months. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 3 months after the results are published To whom: It will be available to researchers working in academic and scientific institutions Conditions: The use of documentation is permitted for non academic neurologists and other specialist physicians Where to obtain: Effat Amouzadeh, contact number 09106530322, email effatamouzadeh@gmail.com, address of residence unit 11, Mohammad 5 Residential complex, Between Eghbal st and Nosrat st, Isfahan Ave, Golestan District, Postal Code 6136913847 How to obtain: Sending an email or letter to Effat Amouzadeh's mailing address, will be responsive within a week Comments:
public Effat Amouzadeh
unit 11, Mohammad 5 Residential complex, Between Eghbal st and Nosrat st, Isfahan Ave, Golestan District
ahvaz Iran (Islamic Republic of) 6136913847 +98 61 3374 3001 effatamouzadeh@gmail.com Ahvaz University of Medical Sciences scientific Effat Amouzadeh
unit 11, Mohammad 5 Residential complex, Between Eghbal st and Nosrat st, Isfahan Ave, Golestan District
Ahvaz Iran (Islamic Republic of) 6136913847 +98 61 3374 3001 effatamouzadeh@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of Multiple Sclerosis based on McDonald's criteria Age between 18 to 55 years Testable Measurable Cognitive impairment (MACFIMS) attributed to Multiple Sclerosis 18 years 55 years Both Continued use of Stimulant Clinical relapse of Multiple Sclerosis with in 60 days of screening Changes in the treatment of Multiple Sclerosis within 90 days of screening Existence of any underlying factor and disease that causes dementia and cognitive impairment Proof of moderate to severe depression with a Beck's test Contraindications to the use of Atomoxetine Confirmation of cognitive impairment related to Multiple Sclerosis with McFimes test G37.9 Demyelinating disease of central nervous system, unspecified Treatment - Drugs Placebo Intervention group: The intervention group consisted of 26 patients who will be treated with Atomoxetine capsules at a dose of 40 mg daily for 2 weeks and then increased to 80 mg daily to 40 mg twice daily for It will take three months The control group consisted of 26 patients who will be treated with placebo-like Atomoxetine capsules once daily for 2 weeks and then increased twice daily for three months Cognitive Disorder Score in MacFims Questionnaire. Timepoint: Perform MacFims test at the beginning of the study and three months after the start of the study. Method of measurement: MacFims Questionnaire. Accompanying depression score. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Beck Questionnaire. Ahvaz University of Medical Sciences Approved 2021-02-25 Ethics committee of Ahvaz University of Medical Sciences unit 11, Mohammad 5 Residential complex, Between Eghbal st and Nosrat st, Isfahan Ave, Golestan District Ahvaz Khouzestan Iran (Islamic Republic of)