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Evaluation the effects of atomoxetine on the improvement of cognitive impairment in Behcet’s disease patients

Protocol summary

Study aim
Evaluation the effects of atomoxetine on the improvement of cognitive impairment in Behcet’s disease patients
Design
parallel group, double blind, randomized controlled trial
Settings and conduct
In this double blind, randomized placebo controlled clinical trial, 40 eligible individual, at Rheumatology clinic of Shariati hospital (Tehran University of Medical Sciences), will be randomized between two groups. In the intervention group, Atomoxetine capsule (Amin pharmaceutical company) will be administered 40mg/day. After 3 days will be increased to 40mg, twice a day and then continued for 10 weeks. In the control group, Patients take placebo which is completely the same with Atomoxetine capsule for 10 weeks. Dosing will be the same with intervention group too. Before and after Atomoxetine and placebo administration, participant's cognitive function will be assessed by following tests: Forward digit span, Backward digit span, Trail making A, Trail making B, Verbal fluency; and results will be compared. Blinding of participants, investigators and outcome assessors will be done.
Participants/Inclusion and exclusion criteria
inclusion criteria: Individuals diagnosed with Behcet's disease based on international criteria for Behcet's disease (ICBD) Presence of cognitive impairment exclusion criteria: History of cognitive impairment before being affected by Behcet's disease Substance use
Intervention groups
Intervention group: initially, Atomoxetine capsule (Amin pharmaceutical company) will be administered 40mg/day. After 3 days will be increased to 40mg, twice a day and then continued for 10 weeks. Control group: Patients take placebo which is completely the same with Atomoxetine capsule for 10 weeks. Dosing will be the same with intervention group too.
Main outcome variables
change in following test scores: Forward digit span Backward digit span Trail making A Trail making B Verbal fluency

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211206053288N1
Registration date: 2022-02-20, 1400/12/01
Registration timing: prospective

Last update: 2022-02-20, 1400/12/01
Update count: 0
Registration date
2022-02-20, 1400/12/01
Registrant information
Name
malekfarhad malek
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 9151
Email address
malekmf@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2023-12-25, 1402/10/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of atomoxetine on the improvement of cognitive impairment in Behcet’s disease patients
Public title
Atomoxetine for cognitive impairment in Behcet's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals diagnosed with Behcet's disease according to ICBD (International Criteria for Behcet's Disease) criteria Presence of cognitive impairment detected by following tests: Forward digit span, Backward digit span, Trail making A, Trail making B, Verbal fluency
Exclusion criteria:
History of cognitive impairment before affected by Behcet's disease Substance use History of adverse reactions to Atomoxetine
Age
From 17 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple method with Computer-generated randomization schedule with allocation concealment
Blinding (investigator's opinion)
Double blinded
Blinding description
participants investigators healthcare providers data collectors outcome assessors
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Room 605, 6th Floor, Central organization of Tehran University of Medical Sciences, Corner of Qods street, Keshavarz boulevard, Tehran, Irand
City
Tehran
Province
Tehran
Postal code
1416634793
Approval date
2021-07-18, 1400/04/27
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.462

Health conditions studied

1

Description of health condition studied
Behcet's disease
ICD-10 code
M35.2
ICD-10 code description
Behcet's disease

2

Description of health condition studied
Cognitive impairment
ICD-10 code
G31.84
ICD-10 code description
Mild cognitive impairment, so stated

Primary outcomes

1

Description
score of following cognitive tests: Forward digit span, Backward digit span, Trail making A, Trail making B, Verbal fluency
Timepoint
before intervention and 10 weeks after intervention
Method of measurement
cognitive tests: Forward digit span, Backward digit span, Trail making A, Trail making B, Verbal fluency

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: initially, Atomoxetine capsule (Amin pharmaceutical company) will be administered 40mg/day. After 3 days will be increased to 40mg, twice a day and then continued for 10 weeks.
Category
Treatment - Drugs

2

Description
Control group: Patients take placebo which is completely the same with Atomoxetine capsule for 10 weeks. Dosing will be the same with intervention group too.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Malekfarhad Malek
Street address
Shariati hospital, North Kargar street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Web page address
http://shariati.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
6th floor of central organization of Tehran University of Medical Sciences, Corner of Qods street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Malekfarhad Malek
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Rouzbeh hospital, south Kargar St.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Fax
Email
malekmf@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Malekfarhad Malek
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Rouzbeh hospital, south Kargar St.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Fax
Email
malekmf@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Malekfarhad Malek
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Rouzbeh hospital, south Kargar St.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Fax
Email
malekmf@sina.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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