The Effect of Methylphenidate and Atomoxetine Combination Therapy in the Treatment of Children with Hyperactivity Disorder - Attention Deficit with Relative Response to Single Medicinal Therapy
Comparison of the effect of Ritalin and Atomoxetine therapy and Ritalin-Atomoxetine combination in the treatment of hyperactivity-disordered children
Design
A randomized, concealed, double blinded, without control, without parallel
Settings and conduct
double blinded, Children with ADHD in Ibn-e-Sina Hospital of Mashhad, at 1397
Participants/Inclusion and exclusion criteria
1. Children with ADHD based on DSM5
2. Age of 6-17 years
3. People who are not under any medication or non-pharmacological treatment of any other concomitant mental illness.
4. People who do not have chronic medical conditions, such as cardiovascular disease.
5. IQ more than 70
6. Lack of organic brain dysfunction
7. If having a seizure disorder, be treated and controlled.
8. Lack of previous diagnosis of mental illness such as psychosis, bipolar disorder, schizoaffective, schizophrenia, unipolar depression, panic or GAD
9. No Tourette Disorder
Intervention groups
ADHD children with CGI score of 3, 4 and 5
Main outcome variables
Progress in social and home functions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190526043708N1
Registration date:2019-12-23, 1398/10/02
Registration timing:retrospective
Last update:2019-12-23, 1398/10/02
Update count:0
Registration date
2019-12-23, 1398/10/02
Registrant information
Name
mahdi pourmahmoudian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3700 2202
Email address
pourmahmoudianm941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-21, 1397/04/30
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2018-07-21, 1397/04/30
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-05-20, 1398/02/30
Scientific title
The Effect of Methylphenidate and Atomoxetine Combination Therapy in the Treatment of Children with Hyperactivity Disorder - Attention Deficit with Relative Response to Single Medicinal Therapy
Public title
The effect of combination therapy of methylphenidate and Atomoxetine in the treatment of hyperactivity-disordered children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ADHD
aged 6-17 years
patients who are not treated concurrently with medicinal or non-drug therapy
IQ of more than 70
Exclusion criteria:
Family dissatisfaction with continued treatment
Incidence of side effects
Age
From 6 years old to 17 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
24
Actual sample size reached:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, main researcher
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mashad University of Medical Sciences
Street address
At the beginning of Hore Amali Street, Avicenna Hospital
City
mashad
Province
Razavi Khorasan
Postal code
9196634539
Approval date
2018-07-18, 1397/04/27
Ethics committee reference number
ir.mums.fm.rec.1396.237
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Parents' ADHD/RS Score
Timepoint
0 and 4 weeks later
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with attention deficit hyperactivity disorder were divided into two groups, half of them were treated with 4 weeks of atomoxetine and the other half were treated with 4 weeks of ritalin. The dose of atomoxetine was started 0.5 mg / kg daily before bedtime with snacks and then up to 1.4 mg / kg daily - the maximum dose was 100 mg twice daily, depending on patient tolerance. The dose of ritalin was increased to 0.5 mg / kg up to a maximum of 1 mg / kg daily divided by patient tolerance. Patients with partial response were subsequently treated with combination ritalin and atomoxetine for 4 weeks at the same dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn-e-Sina Hospital
Full name of responsible person
Paria Hebrani
Street address
Hor-e Ameli Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9196634539
Phone
+98 51 3700 2202
Email
HebraniP@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Azadi Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9196634539
Phone
+98 51 3700 2202
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Pourmahmoudian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hor-e Ameli Ave.
City
Mshhad
Province
Razavi Khorasan
Postal code
9196634539
Phone
+98 51 3700 2202
Email
pourmahmoodian.m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Pourmahmoudian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hor-e Ameli Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9196634539
Phone
+98 51 3700 2202
Email
pourmahmoodian.m@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Pourmahmoodian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hor-e Ameli Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9196634539
Phone
+98 51 3700 2202
Email
pourmahmoodian.m@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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Age distribution, Sex distributions, Education Grade, ADHD/RS score, CGI score
When the data will become available and for how long
Summer 2019
To whom data/document is available
Researchers
Under which criteria data/document could be used
Advanced studies, use in treatment
From where data/document is obtainable
Mahdi Pourmahmoodian
pourmahmoodian.m@gmail.com
What processes are involved for a request to access data/document