Comparison of QEEG(Quantitaive electroencephalography) indices in children with ADHD (Attention deficit hyperactivity disorder)in two groups receiving automoxetine and ritalin
Comparison of the effect of atomoxetine and ritalin on brain wave index changes(QEEG) in ADHD(attention deficit hyperactivity disorder) boy children referred to Tabriz Psychiatric Clinic in the second semester of 1398.
Design
Intervention randomized controlled trial, randomized, without blinding
Settings and conduct
The study is conducted on 7-12 year old boys with severe ADHD (Attention-deficit hyperactivity disorder). These children are referred to the Razi Hospital Psychiatry Clinic. They are divided into two groups. for All children in both groups brainwave indices will be recorded. Then the first group is given Automoxetin for 3 months and the second group is administered Ritalin for 3 months. After 3 months Brainwave indexes are re-recorded for all members of both groups.
Participants/Inclusion and exclusion criteria
inclusion:
1-Obtain informed consent from parents.
2- 12-7 years old.
3. IQ greater than 70.
4- Child and adolescent psychiatrist discusses ADHD
5-Boy children
exclusive:
1. A history of medication for ADHD
2. Other concurrent psychiatric disorder.
3. Concomitant medical illnesses
Intervention groups
drug treatment in the first group with Atomoxetine and in the second group with Ritalin for 3 months.
Main outcome variables
Changes in brainwave indices.(QEEG)
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20140825018927N7
Registration date:2019-12-02, 1398/09/11
Registration timing:prospective
Last update:2019-12-02, 1398/09/11
Update count:0
Registration date
2019-12-02, 1398/09/11
Registrant information
Name
Seyed Gholamreza Noorazar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3382 6512
Email address
noorazars@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-10, 1398/09/19
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of QEEG(Quantitaive electroencephalography) indices in children with ADHD (Attention deficit hyperactivity disorder)in two groups receiving automoxetine and ritalin
Public title
Comparison of brainwave indices in overactive children receiving automoxetine and ritalin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
7-12 years old
Male gender
Parental consent for child participation in research
IQ greater than 70
Diagnosis of ADHD by a child and adolescent psychiatrist
Exclusion criteria:
History of medication for ADHD
Other psychiatric disorders
Existence of medical diseases
Age
From 7 years old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to either the Ritalin and the automoxetin treatment groups according to the National Code Number of Participants.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Children7-12 years old with ADHD diagnosed according to DSM-5 criteria and adolescent psychiatrist enter clinical trial after obtaining informed consent from parents about their children's participation in the study and inclusion criteria.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Central campus of Tabriz university of medical science, Golgasht Avenue, Azadi street, Tabriz, Eastern Azarbayjan, Iran
Children with ADHD, aged 7-12 years, enter the study after obtaining informed consent from parental clinical trial studies and having inclusion and exclusion criteria. Parents' Connors Test is used to determine the severity of the disease.The brain wave markers are recorded for sever disorderes with LORETA QEEG, then the drug treatment with automoxetine at a dose of 0.5-1.8 mg daily is continued for 3 months, then the QEEG is recorded.
Category
Treatment - Drugs
2
Description
Intervention group2: Children with ADHD, aged 7-12 years, enter the study after obtaining informed consent from parental clinical trial studies and having inclusion and exclusion criteria. Parents' Connors Test is used to determine the severity of the disease.The brain wave markers are recorded for sever disorderes with LPRETA QEEG, then the drug treatment with Ritalin at a dose of 0.3-1 mg daily is continued for 3 months, then the QEEG is recorded.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi medical-educational center
Full name of responsible person
Dr Seyed Gholamreza Noorazar
Street address
EL-GOLI
City
Tabriz
Province
East Azarbaijan
Postal code
5173865955
Phone
Email
sahar65salimi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Fakhari
Street address
Central campus of Tabriz university of medical science, Golgasht Avenue, Azadi street, Tabriz, Eastern Azirbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5657894356
Phone
+98 41 3383 1269
Email
sahar65salimi@yahoo.com
Grant name
Tabriz University of Medical Sciences
Grant code / Reference number
3
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
sahar salimi
Position
psychiatry residency
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Clinical psychiatric research center, Razi educational-medical center, Eil goli street, Tabriz, Eastern Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5465433452
Phone
+98 41 3383 1269
Fax
Email
sahar65salimi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Seyed Gholamreza Noorazar
Position
assistant professor of Psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Clinical psychiatric research center, Razi educational-medical center, Eil goli street, Tabriz, Eastern Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5644532341
Phone
+98 41 3383 1269
Fax
Email
s.gh.noorazar@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
sahar salimi
Position
residency of psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Clinical psychiatric research center, Razi educational-medical center, Eil goli street, Tabriz, Eastern Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
567743231
Phone
+98 41 3383 1269
Fax
Email
sahr65salimi@yahoo.om
Web page address
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
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
Will be presented in the article
When the data will become available and for how long
1399
To whom data/document is available
public
Under which criteria data/document could be used
Article and thesis
From where data/document is obtainable
University site
What processes are involved for a request to access data/document