The aim of this randomized double blind clinical trial is comparison of Memantine and Methylphenidate in the treatment of children with ADHD. In this study, 40 patients with attention deficit disorder - hyperactivity that are having inclusion criteria such as diagnostic criteria, age range and not using any psychiatric drugs and exclusion criteria such as having mental retardation; having any psychiatric disorders, Seizure, heart disease, allergic history to Memantine and etc, were randomly divided into intervention or control groups. Patients in the intervention group will receive Memantine and in the control group will receive Methylphenidate. In this study, we compare the effectiveness of Memantine and Methylphenidate drugs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205157462N7
Registration date:2012-06-01, 1391/03/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-01, 1391/03/12
Registrant information
Name
Mohammad Reza Mohammadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 3540
Email address
pprc@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of memantine and ritalin in the treatment of children with ADHD
Public title
comparison of Memantine and Methylphenidate in the treatment of children with ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: receiving DSM-IV-TR diagnostic criteria for ADHD; the age range of 6 to 11 years old; not using any psychiatric drugs at least 2 weeks before the research.
Exclusion criteria: having mental retardation; having any psychiatric disorders except ODD; allergic history to Memantine; having serious disorder like heart disease; uncontrolled Seizure disorder; individuals with Systolic blood pressure above 125 mmHg or resting pulse under 60 or having above 115 beats per minute.
Age
From 6 years old to 11 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Qods street, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Approval date
2012-04-08, 1391/01/20
Ethics committee reference number
17262
Health conditions studied
1
Description of health condition studied
attention deficiency hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
the ADHD symptoms
Timepoint
Baseline, third and sixth weeks after intervention
Method of measurement
ADHD Rating Scale, Clinical Global Impressions Severity
Secondary outcomes
1
Description
Side effects
Timepoint
Baseline, third and sixth weeks after intervention
Method of measurement
Side effects quesionnaire
Intervention groups
1
Description
One group of patients are randomly assigned to the intervention group are treated with Memantine 10 mg. Therapeutic dosage of Memantine 10 mg is prescribed a tablet daily for the first week (half tablet in the morning at 8 o'clock, and half tablet at 14 o'clock) and 2 tablets are daily prescribed in the second week (one tablet in the morning at 8 o'clock, one tablet at 14 o'clock).
Category
Treatment - Drugs
2
Description
One group of patients are randomly assigned to receive methylphenidate in the control group. Methylphenidate 10 mg is prescribed for the first week, a daily tablet (half tablet in morning at 8 o'clock and half tablet at 14 o'clock); in the second week, two tablets are daily prescribed (one in the morning at 8 o'clock, one at 14 o'clock); if the weight is above 30 pounds, 3 tablets will be daily prescribed in the second week (one and a half tablet each morning at 8 o'clock, one and a half tablet at 14 o'clock)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Soleiman Mohammadzadeh
Street address
Roozbeh Hospital, South Kargar Avenue, after the Lashkar crossroads, Tehran, IRAN.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mrs karimi
Street address
Fifth floor, Qods street, Keshavarz Blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences, Psychiatry research center
Full name of responsible person
Soleiman Mohammadzadeh, MD
Position
Assistant specialist child and adolescent psychiatry
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Avenue, after the Lashkar crossroads, Tehran, IRAN
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
dr.mohammadzadeh86@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, Psychiatry and Psychology Research Center
Full name of responsible person
Mohammad Reza Mohammadi
Position
MD
Other areas of specialty/work
Street address
Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Avenue, after the Lashkar crossroads, Tehran, IRAN.
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
mohammadimr@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Psychiatry and Psychology Research Center
Full name of responsible person
Maryam Salmanian
Position
MS/Researcher
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 5541 3540
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)