Comparison of the effects of different doses of memantine in combination with methylphenidate in children affected by attention deficit hyperactivity disorder
Effect of different amounts of memantine with methylphenidate in children with ADHD
Design
This clinical trial has two intervention groups of 69 people, community based and pragmatic with parallel, blind, and randomized groups. The random method is the permutation block and Phase 2 is a clinical trial.
Settings and conduct
his study will be done at Ahvaz Golestan Hospital. The two-blind study will be that the patient, nurse and assessor are unaware of how the medication is given and the dose administered.
Participants/Inclusion and exclusion criteria
inclusion criteria: Age of children aged 6 to 12 years, Having diagnostic criteria based on IV-IRDSM and Conners test
exclusion criteria: the presence of other serious psychiatric disorders, History of Complications of Ritalin, memantine allergy history
Intervention groups
Intervention group 1: This memantine group will be given at a dose of 0.1 to 0.25 milligrams per kilogram. In this group, the minimum dose of memantine, 0.1, will begin with ritalin and will increase to a maximum dose within two weeks. Ritalin is used at a constant dose.
Intervention group 2: This memantine group will be given at a dose of 0.25 to 0.50 milligrams per kilogram. In this group, the minimum dose of memantine, 0.25, will begin with ritalin and will increase to a maximum dose within two weeks. Ritalin is used at a constant dose. This drug is prescribed to patients in the form of placebo with the same form, color, smell and taste.
Main outcome variables
ADHD
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100520003979N8
Registration date:2018-09-22, 1397/06/31
Registration timing:prospective
Last update:2018-09-22, 1397/06/31
Update count:0
Registration date
2018-09-22, 1397/06/31
Registrant information
Name
Forugh Riahi
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
riahi-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of different doses of memantine in combination with methylphenidate in children affected by attention deficit hyperactivity disorder
Public title
Effecting the combination of memantine and methylphenidate in children affected by attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of children aged 6 to 12 years
Having diagnostic criteria based on IV-IRDSM and Conners test
Exclusion criteria:
Another serious psychiatric disorder, such as schizophrenia, bipolar disorder
A history of seizure and medical conditions such as cardiovascular problems and diabetes
History of allergy for Memantine
Failure to respond to Memantine
Severe ritalin complications
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
69
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the method of the permutation 4blocks, individuals are randomly divided into two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient, nurse, and evaluator did not know how much memantine was taken by each patient. each group did not have any information that another group exists and receive a different dose. Because medicines are packaged in the form of one and two, and delivered to the patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd, Ahvaz, Khoozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2017-05-20, 1396/02/30
Ethics committee reference number
IR.AJUMS.REC.1396.543
Health conditions studied
1
Description of health condition studied
attention deficit hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
Attention-deficit hyperactivity disorder, predominantly inattentive type
Primary outcomes
1
Description
Attention Deficit Hyperactivity Disorder.
Timepoint
Befor intervention- the end of second, fourth and sixth,eighth, tenth,twelfth weeks of the study
Method of measurement
The Conner's parent rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, memantine is given at a dose of 0.1 to 0.25 mg / kg. In this group, with a minimum dose of memantine 0.1, it starts with ritalin, and gradually we increase and maximize the dose within two weeks. Ritalin is given at a fixed dose. In the first week, one fourth of the pill is taken twice daily, the second week, the second one, twice a day, the third week, three quarters of the pill twice daily, and the fourth week, once a pill twice a day, and until the end of the study, the dose remains constant.
Category
Treatment - Drugs
2
Description
Intervention group 2: In this group, memantine is given at a dose of 0.25 to 0.50mg / kg. In this group, with a minimum dose of memantine 0.25, it starts with ritalin, and gradually we increase and maximize the dose within two weeks. Ritalin is given at a fixed dose. In the first week, one fourth of the pill is taken twice daily, the second week, the second one, twice a day, the third week, three quarters of the pill twice daily, and the fourth week, once a pill twice a day, and until the end of the study, the dose remains constant.This drug is prescribed to patients in the form of placebo with the same form, color, smell and taste.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Adolecent and child Psychiatry Clinic, Golestan Hospital
Full name of responsible person
Forugh Riahi
Street address
Ahvaz Golestan Hospital, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Riahi13@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz Junishapur University of Medical Science,Farvardin Blvd,Ahvaz ,Khoozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
badavi.m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Forough Riahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychology
Street address
Golestan hospital,Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Riahi13@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Enayatollahi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Golestan hospital,Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Mary208067@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Enayatollahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Golestan hospital,Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Mary208067@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available