Memantine versus pelacebo as an adjunct in the treatment of children with Attention Deficit Hyperactivity Disorder: a double-blind randomized, placebo-controlled study
This study investigates the effect of combined administration of memantine and methylphenidate in the treatment of children with attention deficit hyperactivity disorder.
Design
This study is a randomized double‐blind placebo‐controlled trial
Settings and conduct
200 Children with ADHD aged between 6 and 12 years, referred to the Child and Adolescent Psychiatric Clinic of Shahid Beheshti Hospital and the Child and Adolescent Psychiatric Clinic of Shafieieh Clinic in Zanjan, will randomly be divided into two groups.The first group will receive methylphenidate and memantine and the second group will receive methylphenidate and placebo.The response to treatment will be assessed.This will be a double-blind study
Participants/Inclusion and exclusion criteria
Admission requirements:
6 to 12 years old
Lack of other accompanying psychiatric disorders
No mental retardation
No neurological diseases, especially seizures
Exclusion criteria:
Concomitant treatment with lamotrigine, amantadine, acetylcysteine, dicyclo-serine
Concomitant use of hydrochlorothiazide, triamterene, metformin, cimetidine, ranitidine, quinidine
Starting a new psychological intervention thirty days before the start of the study
History of non-febrile seizures without a definite etiology
Simultaneous kidney or liver disease
Urinary-genital disorders that increase urinary pH (infections and RTA)
No further referral to the clinic
Intervention groups
This study is a double-blind clinical trial. 200 Children with Attention Deficit Hyperactivity Disorder are randomly divided into two groups. The first group receives methylphenidate and memantine and the second group receives methylphenidate and placebo. The response to treatment is assessed based on the Conners scale and the side effects of the drugs at the beginning of the study and at weeks 1, 2 and 4.
Main outcome variables
Coners scale for Attention Deficit Hyperactivity Disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200427047221N1
Registration date:2021-04-19, 1400/01/30
Registration timing:retrospective
Last update:2021-04-19, 1400/01/30
Update count:0
Registration date
2021-04-19, 1400/01/30
Registrant information
Name
Seyed Yaser Mousavi Nodoushan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6147 9000
Email address
mousavinodoushan@zanjan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-04, 1399/03/15
Expected recruitment end date
2020-10-06, 1399/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Memantine versus pelacebo as an adjunct in the treatment of children with Attention Deficit Hyperactivity Disorder: a double-blind randomized, placebo-controlled study
Public title
Memantine versus pelacebo as an adjunct in the treatment of children with Attention Deficit Hyperactivity Disorder: a double-blind randomized, placebo-controlled study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
6 -12 years old
ADHD
No other psychiatric disorders
No mental retardation
No neurological disorders
Not using other medications
Exclusion criteria:
Concomitant treatment with lamotrigine, amantadine, acetylcysteine, dicyclo-serine
Concomitant use of hydrochlorothiazide, triamterene, metformin, cimetidine, ranitidine, quinidine
Starting a new psychological intervention thirty days before the start of the study
History of non-febrile seizures without a definite etiology
Simultaneous kidney or liver disease
Urinary-genital disorders that increase urinary pH (infections and RTA)
No further referral to the clinic
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
a double-blind randomized, placebo-controlled study
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
mahdavi blvd , Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513914500
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.ZUMS.REC.1398.406
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
Conner tests scores
Timepoint
1th, 2th, 4th month
Method of measurement
Conner test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The amount of prescription methylphenidate in the group receiving memantine is at least 10 mg and at most 50 mg, and the amount of prescription memantine in the group receiving memantine is at least 2.5 mg and at most 5 mg.
Category
Treatment - Drugs
2
Description
Control group:The prescription drug methylphenidate in the placebo group is at least 10 mg and at most 50 mg.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
Moein Kiani
Street address
Beheshti hospital, Sadi Intersection
City
Zanjan
Province
Zanjan
Postal code
4513914500
Phone
+98 21 6147 9000
Email
drsymousavi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyd Yaser Mousavi Nodoushan
Street address
No.1074, East Karmandan Ave, Mahdavi Blvd
City
Zanjan
Province
Zanjan
Postal code
4513914500
Phone
+98 21 6147 9000
Email
drsymousavi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Seyed Yaser Mousavi Nodoushan
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No.1074, East Karmandan Ave, Mahdavi Blvd
City
Zanjan
Province
Zanjan
Postal code
4513914500
Phone
+98 24 3345 4594
Email
drsymousavi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyed Yaser Mousavi Nodoushan
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No.1074, East Karmandan Ave, Mahdavi Blvd
City
Zanjan
Province
Zanjan
Postal code
4513914500
Phone
+98 24 3345 4594
Email
drsymousavi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyed Yaser Mousavi Nodoushan
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No.1074, East Karmandan Ave, Mahdavi Blvd
City
Zanjan
Province
Zanjan
Postal code
4513914500
Phone
+98 24 3345 4594
Email
drsymousavi@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
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
full content
When the data will become available and for how long
6 month after publication
To whom data/document is available
university researchers
Under which criteria data/document could be used
same subject
From where data/document is obtainable
seyd yaser mousavi nodoushan
What processes are involved for a request to access data/document