we try to discover the efficacy of treatment of ADHD with long acting Methylphenidate (Matoride) on internet addiction in children.
Design
clinical trial without control group
Settings and conduct
20 children, aged 7-14, with ADHD and internet addiction were treated with Matoride in two months. We used interview, Young’s internet addiction scale, Conner’s parent rating scale and KSAD to collect information.
Participants/Inclusion and exclusion criteria
1- 7- 18 years old 2- no use of Methylphenidate or other psychoactive agent at last month 3- roll out of other psychiatric disorders ( like schizophrenia, bipolar, autism and OCD with K_SAD scale ) 4- no use of other drug 5- no use of any other therapy 6- getting more than 50 points in Young’s Internet Addiction Scale.
Intervention groups
children with ADHD
Main outcome variables
In this study we try to understand the effectiveness of treatment of ADHD with extended released Methylphenidate in children Internet Addiction. Our first hypothesis is that extended released Methylphenidate can improve Internet Addiction in children with ADHD.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210929052634N1
Registration date:2021-10-10, 1400/07/18
Registration timing:retrospective
Last update:2021-10-10, 1400/07/18
Update count:0
Registration date
2021-10-10, 1400/07/18
Registrant information
Name
Mahla Cheraghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3335 4572
Email address
mahlacha@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
2019-07-23, 1398/05/01
Actual recruitment end date
2020-12-20, 1399/09/30
Trial completion date
2020-12-20, 1399/09/30
Scientific title
the efficacy of treatment of ADHD with long acting Methylphenidate (Matoride) on internet addiction in children.
Public title
the efficacy of treatment of ADHD with long acting Methylphenidate (Matoride) on internet addiction in children.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- 7- 18 years old 2- no use of Methylphenidate or other psychoactive agent at last month 3- roll out of other psychiatric disorders ( like schizophrenia, bipolar, autism and OCD with K_SAD scale ) 4- no use of other drug 5- no use of any other therapy 6- getting more than 50 points in Young’s Internet Addiction Scale.
Exclusion criteria:
Age
From 7 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
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 shahid beheshti university of medical science
Street address
pooriya apa, Mahtab Ave, Flestin Blvd, Sari Town
City
Sari
Province
Mazandaran
Postal code
4815679016
Approval date
2019-06-18, 1398/03/28
Ethics committee reference number
IR.SBMU.MSP.REC.1398.241
Health conditions studied
1
Description of health condition studied
children with ADHD and Internet Addiction
ICD-10 code
ADHD
ICD-10 code description
ADHD
Primary outcomes
1
Description
internet addiction
Timepoint
at first day and 60 days after drug taking
Method of measurement
Young’s internet addiction scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: children with ADHD
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hosein Hospital
Full name of responsible person
Mahla cheraghi
Street address
Emam Hosein Hospital, Madani Blve, Tehran Town
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
info@ehmc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ali Ziyaii
Street address
Tehran Province, Tehran, Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Av
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
Email
Dean.medicalschool@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahla Chraghi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
pooriya ap, Mahtab Ave, Felestin Blve, Sari
City
Sari
Province
Mazandaran
Postal code
4815679016
Phone
009811333454572
Email
Mahlacha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahla Cheraghi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Pooriya Ap, Mahtab Ave, Felesstin Blve, Sari
City
Sari
Province
Mazandaran
Postal code
4815679016
Phone
+98 11 3335 4572
Email
Mahlacha@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahla Cheraghi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Mahtab Ave, Felestin Blve, Sari
City
Sari
Province
Mazandaran
Postal code
4815679016
Phone
+98 11 3335 4572
Email
Mahlacha@gmail.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
results are available
When the data will become available and for how long
6 months after release article
To whom data/document is available
just researchers
Under which criteria data/document could be used
after release article
From where data/document is obtainable
sending e-mail
What processes are involved for a request to access data/document