Survey on short-acting methylphenidate (Ritalin) vs. long-acting methylphenidate (Matoride) effectiveness on Attention deficit Hyperactivity Disorder symptom among 6 - 18 year-old children
Comparison of short-acting methylphenidate (Ritalin) vs. long-acting methylphenidate (Matoride) effectiveness on Attention deficit Hyperactivity Disorder symptom among 6 - 18 year-old children
Design
Clinical trial with parallel control group, double blinded and randomization.
Settings and conduct
This is a double-blind clinical trial in which the patient and distributor of the drug will not be aware of the type of medication. The sample size was 75 in each group (Ritalin and Methoroid). Ritalin is given at a dose of 10 mg and metribuide is given at a dose of 18 mg in the morning before going to school, and the child's performance after school hours is assessed by Parents' Conners Questionnaire. In this case, the short acting efficacy of Ritalin is not problematic, and both drugs can be evaluated in their half-life. Also, about the side effects of the drug, at the end of three weeks of treatment, the parents will be asked to complete the questionnaire after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Satisfaction with entering the study by the parent or patient
2. Having a minimum age of 6 and a maximum of 18 years of age
3. Confirm Diagnosis of Hyperactivity Disorder - DSM-5 Hyperactivity by Pediatric Psychiatrist
4. Lack of major psychiatric disorder
Exclusion criteria:
1. Lack of patient and family cooperation to complete the intervention period
2. Receive other medications except matoride and ritalin
3. Having a physical illness that prevents the use of the drug
Intervention groups
For Intervention group 1, will be given a short-acting methylphenidate drug (Ritalin) manufactured by NOVARTIS at a dose of 10 mg per day for 10 days, and intervention group 2 will receive a dose of 18 mg of Matoraid manufactured by SALUTAS PHARMA GMBH per day for 10 days prior to going to school.
Main outcome variables
The child's performance.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181113041638N1
Registration date:2019-02-19, 1397/11/30
Registration timing:prospective
Last update:2019-02-19, 1397/11/30
Update count:0
Registration date
2019-02-19, 1397/11/30
Registrant information
Name
Sahar Saadatmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3265 6159
Email address
saharsaadatmand@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey on short-acting methylphenidate (Ritalin) vs. long-acting methylphenidate (Matoride) effectiveness on Attention deficit Hyperactivity Disorder symptom among 6 - 18 year-old children
Public title
Effectiveness of Matoride in Attention deficit - Hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirm the diagnosis of ADHD based on DSM-5 by pediatric psychiatrist
Abscence of other major psychiatric disorder
Being at least the age of 6 and maximum age of 18 years old
Satisfaction of the inclusion by the parent or guardian of the patient
Exclusion criteria:
The lack of cooperation of the patient and family in order to make the full intervention
Receive other drugs, except Matoride and Ritalin
A medical condition that prevents use of the drugs
Severe hypersensitivity to the drug
Age
From 6 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Randomization block, randomization unit: Individual, Random layer: not done Randomization, tool: Random sequence generation software (Excel), How to create random sequence: Using random blocks, each block contains 4 people And assign a number from 1 to 6 to each block
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients are not aware of the drug and the drug is given to them by the collector in sealed packages. The packets will be properly coded by the researcher before being available to the data collector. The drug distributor will also not be aware of the medication in the package.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Isfahan University of Medical Sciences
Street address
Ethics Commitee of Isfahan University of Medical Sciences, Research Vice Department, Isfahan Medical University, Hezar Jarib university, Isfahan, Iran.
City
Esfahan
Province
Isfehan
Postal code
8145831451
Approval date
2018-10-04, 1397/07/12
Ethics committee reference number
IR.MUI.MED.REC.1397.058
Health conditions studied
1
Description of health condition studied
Attention deficit - Hyperactivity disorder
ICD-10 code
F90.9
ICD-10 code description
Attention-deficit hyperactivity disorder, unspecified type
Primary outcomes
1
Description
The child's performance
Timepoint
every day after school will be evaluate.
Method of measurement
Parents' Conners' questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A group in which patients will receive 10 mg per day of Ritalin Manufactured by NOVARTIS every morning before the school for ten days.
Category
Treatment - Drugs
2
Description
Intervention group 2: A group of patients will receive 18 mg per day of Matoride manufactured by SALUTAS PHARMA GMBH every morning before the school for ten days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Psychology Clinic, Special Clinic of Khorshid Hospital
Full name of responsible person
Sahar Saadatmand
Street address
Pediatric Psychology Clinic, Special Clinic of Khorshid Hospital, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3668 6974
Email
nour@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoe Javanmard
Street address
Vice chancellor for research, Isfahan University of Medical Sciences; Faculty of Medicine; Isfahan University of Medical Sciences; Hezar-Jarib Street; Isfahan; Iran
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2273
Email
h_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Javad Tarahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Behavioral Sciences Resaerch Center, Isfahan University of Medical Sciences, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3792 3071
Email
tarrahi_mj@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Javad Tarahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Behavioral Sciences Resaerch Center, Isfahan University of Medical Sciences, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3792 3071
Email
tarrahi_mh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sahar Saadatmand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Isfahan Medical University, Faculty of Medicine, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3265 6159
Fax
Email
saharsaadatmand@resident.mui.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
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 will be available.
When the data will become available and for how long
The start of the access time is immediately after the relevant article is publish.
To whom data/document is available
All people can access the data.
Under which criteria data/document could be used
All analyzes needed can be done on data, and all individuals can apply for data.
From where data/document is obtainable
Applicants can contact the phone number 09138325471 to receive the data
What processes are involved for a request to access data/document
The data will be available to the applicant as soon as possible.