1.Determining the frequency of cognitive disorders in the study population in the group of Atomoxetine and Placebo
2.Comparison of changes in cognitive impairment before and after drug administration between Placebo and Atomoxetine
Design
Clinical trial with control group,double blind, randomized, phase 3 ,with a parallel group design of 52 patients. For randomization, a randomized block method with 4 blocks was used
Settings and conduct
.Patients referred to outpatient or inpatient clinics of Golestan Hospital in Ahvaz are selected after reviewing the inclusion and exclusion criteria. Initially, McFims test patients are taken in a double-blind study. 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.Group A, which consists of 26 patients selected by an uninformed person, will be treated with Atomoxetine for three months, and group B, which includes 26 patients, will be treated by an uninformed person. Will be selected and treated with placebo. At the beginning and end of 3 months, McFims test is performed for patients.
Participants/Inclusion and exclusion criteria
Entry requirements; Age between 18 and 55 years; Testable measurable cognitive impairment McFims attributed to multiple sclerosis; Diagnosis of multiple sclerosis based on McDonald's criteria
No entry conditions; Continuous use of stimulants; Contraindications to the use of Atomoxetine
Intervention groups
Group A will be treated with Atomoxetine and group B will be treated with Placebo
Main outcome variables
Language; executive function; processing speed ; functional memory; new learning power
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210715051901N1
Registration date:2021-09-07, 1400/06/16
Registration timing:prospective
Last update:2021-09-07, 1400/06/16
Update count:0
Registration date
2021-09-07, 1400/06/16
Registrant information
Name
Effat Amouzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3522 7599
Email address
effatamouzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-07, 1400/07/15
Expected recruitment end date
2021-11-06, 1400/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Atomoxetine on Cognitive Function of Inpatient and Outpatient Multiple Sclerosis
Public title
The effect of Atomoxetine on Cognitive Function of Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Multiple Sclerosis based on McDonald's criteria
Age between 18 to 55 years
Testable Measurable Cognitive impairment (MACFIMS) attributed to Multiple Sclerosis
Exclusion criteria:
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
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
unit 11, Mohammad 5 Residential complex, Between Eghbal st and Nosrat st, Isfahan Ave, Golestan District
City
Ahvaz
Province
Khouzestan
Postal code
6136913847
Approval date
2021-02-25, 1399/12/07
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.148
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G37.9
ICD-10 code description
Demyelinating disease of central nervous system, unspecified
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
Accompanying depression score
Timepoint
At the beginning of the study and 3 months later
Method of measurement
Beck Questionnaire
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Ehsan Mohammadian negad
Street address
Neurology Department, next to Farvardin Boulevard, Golestan Hospital, Golestan Alley
City
Ahvaz
Province
Khouzestan
Postal code
6136835685
Phone
+98 61 3374 3001
Fax
+98 21 8289 7694
Email
effatamouzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahdi Ahmadimoghadam
Street address
Ground Floor ,Vice Chancellor for Research and Technology Ahvaz Jundishapur University of Medical Sciences and Health Services, University City
City
Ahvaz
Province
Khouzestan
Postal code
6136913847
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
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
Ahvaz University of Medical Sciences
Full name of responsible person
Effat Amouzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
unit 11, Mohammad 5 Residential complex, Between Eghbal st and Nosrat st, Isfahan Ave, Golestan District
City
ahvaz
Province
Khouzestan
Postal code
6136913847
Phone
+98 61 3374 3001
Email
effatamouzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Effat Amouzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
unit 11, Mohammad 5 Residential complex, Between Eghbal st and Nosrat st, Isfahan Ave, Golestan District
City
Ahvaz
Province
Khouzestan
Postal code
6136913847
Phone
+98 61 3374 3001
Email
effatamouzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Effat Amouzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
unit 11, Mohammad 5 Residential complex, Between Eghbal st and Nosrat st, Isfahan Ave, Golestan District
City
Ahvaz
Province
Khouzestan
Postal code
6136913847
Phone
+98 61 3374 3001
Email
effatamouzadeh@gamil.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 3 months after the results are published
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of documentation is permitted for non academic neurologists and other specialist physicians
From where data/document is obtainable
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
What processes are involved for a request to access data/document
Sending an email or letter to Effat Amouzadeh's mailing address, will be responsive within a week