Evaluation of the effect of Methylphenidate on neural correlate of understanding intentionality in children with attention-deficit hyperactivity disorder {ADHD)
Evaluation of the effect of Methylphenidate on neural correlate of understanding intentionality in children with
attention-deficit hyperactivity disorder(ADHD)
Design
The before-after study without a control group and the study' phase is 4 with the participation of twenty patients. In the present study, convenience sampling is used. All children and adolescence with ADHD are selected according to inclusion criteria from those who refer to the Psychiatric Clinic of Tehran Roozbeh hospital.
Settings and conduct
Neuroimaging (fMRI) will be performed at the National Brain Mapping Laboratory. Other stages of the study will be performed at Roozbeh Psychiatric Hospital in Tehran.The patients will be selected based on the psychiatrist's diagnosis. The intelligence quotient (IQ) will be performed by a clinical psychologist. For all the subjects, baseline assessment of disorder severity and dimensions, clinical interview, neurocognitive assessments will be done. Neurocognitive assessment and fMRI will be reoperate six-weeks after starting the treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ADHD diagnosis; Male sex; Age 8 to12 years; IQ more than 90 according to Wechsler Intelligence Scale,
Exclusion criteria: Major psychiatric disorders; Neurologic disorders;
Major medical disorders; Taking medications that affect the central nervous system; substance abuse
Intervention groups
This study has an intervention group without a control group. Intervention group have ADHD and receive six weeks of medication with Methylphenidate 0.5 -1mg/kg/day divided into three daily doses. Magnetic resonance brain imaging (fMRI) and cognitive assessments (cognitive Tasks and questionnaires) will be performed before and six weeks after the start of treatment.
Main outcome variables
Neural correlate of understanding intentionality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201103049254N1
Registration date:2020-12-28, 1399/10/08
Registration timing:registered_while_recruiting
Last update:2020-12-28, 1399/10/08
Update count:0
Registration date
2020-12-28, 1399/10/08
Registrant information
Name
Shahrbanoo Ghodrati-Jaldbakhan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4305 2000
Email address
sh-ghodrati@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-03, 1399/07/12
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Methylphenidate on neural correlate of understanding intentionality in children with attention-deficit hyperactivity disorder {ADHD)
Public title
Effect of Methylphenidate on understanding intentionality in ADHD children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
ADHD diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition
Male sex
Age 8-12 years
IQ more than 90 according to Wechsler Intelligence Scale
Exclusion criteria:
Major psychiatric disorders
Neurologic disorders
Major medical disorders
Taking medications that affect the central nervous system
substance abuse
Age
From 8 years old to 12 years old
Gender
Male
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
N0. 88, Department of Neurosciences and Addiction Studies, Ninth floor, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417755469
Approval date
2019-12-22, 1398/10/01
Ethics committee reference number
IR.TUMS.VCR.REC.1398.735
Health conditions studied
1
Description of health condition studied
Attention-deficit hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
Changes in the activity of brain regions related to the undrestanding intentionality
Timepoint
Before, and six weeks after starting the treatment with Methylphenidate
Method of measurement
Fanctional magnetic resonance brain imaging (fMRI)
Secondary outcomes
1
Description
Ability of response inhibition
Timepoint
Before and six weeks after starting the treatment with Methylphenidate
Method of measurement
Stop-Signal task by Cambridge Neuropsychological Test Automated Battery (CANTAB)
2
Description
Severity of core symptoms of attention deficit-hyperactivity disorder
Timepoint
Before and six weeks after starting the treatment with Methylphenidate
Method of measurement
Conners’ Parent Rating Scale (Questionnaire)
3
Description
The effects of symptoms on behavior in terms of family, education, social and psychological
Timepoint
Before and six weeks after starting the treatment with Methylphenidate
Method of measurement
Children’s Global Assessment Scale
Intervention groups
1
Description
Intervention group: participants have ADHD and receive six weeks of medication with Methylphenidate 0.5 -1mg/kg/day divided into three daily doses (1mg per kg maximum dosage). In this study Methylphenidate tablets (Novartis company) are used. To evaluate the effect of Methylphenidate on neural correlate of understanding intentionality, magnetic resonance brain imaging (fMRI) and cognitive assessments (cognitive Tasks and questionnaires) will be performed before and six weeks after the start of treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Mehdi Tehrani-Doost
Street address
Roozbeh hospital, South Kargar Street, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Fax
+98 21 5541 2756
Email
hosp_roozbeh@tums.ac.ir
Web page address
http://roozbehhospital.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Sixth Floor, Central Organization of Tehran University of Medical Science, Qods Street
City
Tehran
Province
Tehran
Postal code
3439123900
Phone
+98 21 8889 3978
Email
tums_edu@tums.ac.ir
Web page address
http://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
Dr. Mehdi Tehrani-Doost
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Roozbeh Hospital, South Kargar Street, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Fax
+98 21 5541 2756
Email
Tehranid@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mehdi Tehrani-Doost
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Roozbeh Hospital, South Kargar Street, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Fax
+98 21 5541 2756
Email
Tehranid@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahrbanoo Ghodrati-Jaldbakhan
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
N0. 88, Department of Neurosciences and Addiction Studies, Ninth floor, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Fax
Email
sh-ghodrati@farabi.tums.ac.ir
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
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
Not applicable
Title and more details about the data/document
Information of the main (primary outcome) and the secondary outcomes like neuronal networks reorganization outcome and cognitive assessments can be shared.
When the data will become available and for how long
6 months after publication of results
To whom data/document is available
Research data will be available for the researchers of universities and scientific institutes.
Under which criteria data/document could be used
The data will be available when the samples are taken out, all the stages of the project are completed and finalized, and the results are published.
From where data/document is obtainable
Dr. Mehdi Tehrani-Doost Tehranid@tums.ac.ir
What processes are involved for a request to access data/document
In order to receive the information, firstly the applicants send the
formal application to the correspondent of the present proposal, Dr. Mehdi Tehrani-Doost, and then they will be informed of the details of the data reception (including timing and the way of addressing the available data like email or in-person).