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Survey of combination of Memantine and methylphenidate among treatment the children with ADHD(Attention-deficit/hyperactivity disorder)

Protocol summary

Summary
Among patients referred to psychiatric Golestan Hospital, Ahwaz, which have ages 6 to 12 years, 30 children with hyperactivity disorder, who diagnosed by a psychiatrist with clinical interview, based on the parent kind of revised text of the fourth statistical detection guide, was selected and randomly divided into two groups. Companions to all the participants are given sufficient explanation about the plan and then informed consent is obtained. The first group is given Methylphenidate and Memantine with dose of 10 mg per day and the second group is given Methylphenidate and placebo. Methylphenidate, starts to the amount of approximately 0.3 Mg per kg of body weight in both morning and afternoon and increases based on side effects and clinical profile to approximately 1 mg per kg body weight per day. Before treatment and at the end of second and fourth weeks, blood pressure, weight and heart rate in children are also measured and recorded. Before treatment and at the end of 1th,2th,3th,4th weeks, treatment response is measured based on Conners test as well and in this intervals, every side effects is measured based on side effects Check list, And finally the collected data is analyzed statistically.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201208058317N2
Registration date: 2012-12-06, 1391/09/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-12-06, 1391/09/16
Registrant information
Name
Ashraf Tashakori
Name of organization / entity
Jundi Shapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3038
Email address
tashakori-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Ahvaz University of Medical Sciences
Expected recruitment start date
2012-10-21, 1391/07/30
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of combination of Memantine and methylphenidate among treatment the children with ADHD(Attention-deficit/hyperactivity disorder)
Public title
Survey of combination of Memantine and methylphenidate among treatment the children with ADHD(Attention-deficit/hyperactivity disorder)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Having diagnostic criteria based on the revised text of the fourth statistical detection guide to identify mental disorders and tests Conners (Test for diagnosing hyperactivity disorder and it’s grading), In this study, cases of moderate and severe impairment (score greater than or equal to 20 conners) are studied. 2-Age between 6 to 12 years. 3-Obtaining informed consent from parents. Exclusion criteria: 1-Other psychiatric disorder based on a criteria based DSM IV_TR 2-Mental retardation. 3-Having a history of seizures. 4-Any medical problems, including the use of beta blockers and methylphenidate such as asthma, cardiovascular problems, diabetes, history of allergy to drugs, the tic
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Jundi Shapur University of Medical Sciences, Ahwaz
Street address
Ahvaz - City University - Department of Research & Technology Of Medical Sciences, Ahwaz Jondi Shapur - Ground Floor
City
Ahvaz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
ETH-450

Health conditions studied

1

Description of health condition studied
Attention deficit hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention

Primary outcomes

1

Description
The amount of improvement of ADHD symptoms
Timepoint
Before the intervention, 1th, 2th, 3th and 4th weeks after intervention
Method of measurement
Conners test

Secondary outcomes

1

Description
Side effects
Timepoint
Before the intervention, 1th, 2th, 3th and 4th weeks after intervention
Method of measurement
Onset of symptoms based on parents day comment

Intervention groups

1

Description
The first group is given Methylphenidate and Memantine with the dose of 10 mg per day. Methylphenidate, starts to the amount of approximately 0.3 mg per kg of body weight in both morning and afternoon, and increases based on side effects and clinical profile to approximately 1 mg per kg body weight per day.The drug is prescribed for one month.
Category
Treatment - Drugs

2

Description
The second group is given Methylphenidate and placebo . Methylphenidate, starts to the amount of approximately 0.3 mg per kg of body weight in both morning and afternoon, and increases based on side effects and clinical profile to approximately 1 mg per kg body weight per day.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Golestan hospital pediatric psychiatric clinic
Full name of responsible person
Dr. Ashraf Tashakori
Street address
City
Ahvaz

2

Recruitment center
Name of recruitment center
Ahvaz Golestan hospital pediatric psychiatric clinic
Full name of responsible person
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research deputy of Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghi
Street address
Research deputy of Ahvaz University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahwaz Jondi Shapur University of Medical Sciences
Full name of responsible person
Davood mohammadbeigi
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Golestan Hospital, Ahwaz-Department of Psychiatry
City
Ahvaz
Postal code
Phone
+98 85 1334 8261
Fax
Email
Dr.davood.mohammadbeigi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahwaz Jondi Shapur University of Medical Sciences
Full name of responsible person
Ashraf Tashakori
Position
Pediatric subspecialty board(psychiatry)
Other areas of specialty/work
Street address
Golestan Hospital, Ahwaz-Department of Psychiatry
City
ahvaz
Postal code
Phone
+98 61 1374 3038
Fax
Email
Tashakori-a@ajums.ac.irTashakori doctor@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahwaz Jondi Shapur University of Medical Sciences
Full name of responsible person
Davood mohammadbeigi
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Golestan Hospital, Ahwaz-Department of Psychiatry-3743038
City
Ahwaz
Postal code
Phone
+98 61 1372 1409
Fax
Email
Dr.davood.mohammadbeigi363@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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