Evaluation of the effect of adding mementine to educational treatment of learning disorder(dyslexia) in 8-7 years old children admitted in Nour Hospital in 2015-16 years.
The aim of this study is to evaluate the efficacy of memantine in the treatment of learning disorders in 7 to 8 years-old children. Inclusion criteria contains age less than 14 years, definite diagnosis of a learning disability in reading by standardized tests of reading, no other psychiatric disorders such as attention deficit, hyperactivity disorder and no mental retardation. Exclusion criteria includes lack of desire to continue participating in the project or facing to side effects of the medication. The study population is children with learning disabilities in reading. We measure child's learning level in reading by EQ questionnaire. Then, without considering the scores, patients will randomly divided into two groups. Intervention group will take medicine and will be educated (two half of memantine 5 mg per day in the form of tablets in addition to receive training) and the control group will be received placebo plus education (which trained more power for learning to read). In each group children are up to 31 cases. The intervention period will be last for 3 months in each group of patients. One and three months after the intervention, children’s learning to read score will be evaluated by the psychologist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091329807N1
Registration date:2017-02-01, 1395/11/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-01, 1395/11/13
Registrant information
Name
Marzieh Salehi
Name of organization / entity
Isfahan University of Medical Sciences, Faculty of medicine
Country
Iran (Islamic Republic of)
Phone
+98 31 3626 9015
Email address
marziehsalehi@ymail.com
Recruitment status
Recruitment complete
Funding source
Isfahan Univercity of Medical Sciences
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of adding mementine to educational treatment of learning disorder(dyslexia) in 8-7 years old children admitted in Nour Hospital in 2015-16 years.
Public title
Effect of memantine in treatment of dyslexia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age <14 years; diagnosis of dyslexia with standard test; acceptance of parcipitating in study; no any disease in which memantine is contraindicated; no any disease such as ADHD, mental retardation, stuttering and ect.
Exclusion criteria:
Not wanting to continue participating in the project; having special disease; the incidence of side effects related to medication.
Age
From 7 years old to 8 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
62
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
Isfahan University of Medical Sciences
Street address
Hezarjerib street, Isfahan
City
Isfahan
Postal code
Approval date
2015-05-30, 1394/03/09
Ethics committee reference number
IR.MUI.REC.1394.3.538
Health conditions studied
1
Description of health condition studied
dyslexia
ICD-10 code
R48
ICD-10 code description
Dyslexia and other symbolic dysfunctions, not elsewhere classified
Primary outcomes
1
Description
Nama dyslexia test score
Timepoint
Before the study, the first month, third month
Method of measurement
Nama dyslexia test that evaluated by the psychologist
Secondary outcomes
1
Description
don't have
Timepoint
not calculated
Method of measurement
not calculated
Intervention groups
1
Description
Intervention group:
Memantine drug, 5 mg tablets orally, half a pill every 12 hours, for three months; educational intervention, in this tutorial first prerequisite for learning skills such as concentration, visual and auditory short-term memory, immediate memory, visual perception, executive function, attention, according includes a variety of selective attention, perceptual organization and ... . This information is noted in the patient's record. About aspects of the curriculum, the speed and quality of the combination of memory and reading comprehension are recorded and due to the disruption in this sector, training to be given for three months.
Category
Treatment - Drugs
2
Description
Control group:
Placebo pill, 5 mg tablets, half a pill every 12 hours, for three months; educational intervention, in this tutorial first prerequisite for learning skills such as concentration, visual and auditory short-term memory, immediate memory, visual perception, executive function, attention, according includes a variety of selective attention, perceptual organization and ... . This information is noted in the patient's record. About aspects of the curriculum, the speed and quality of the combination of memory and reading comprehension are recorded and due to the disruption in this sector, training to be given for three months.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic and the Center for Psychology in Noor and Ali Asghar hospital
Full name of responsible person
Marzieh Salehi
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, Faculty of medicine
Full name of responsible person
Dr. Mansour Siyavash
Street address
Hezarjerib street, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, Faculty of medicine
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
Isfahan University of Medical Sciences, Faculty of medicine
Full name of responsible person
Marzieh Salehi
Position
Psychiatry assistant
Other areas of specialty/work
Street address
Hezarjerib street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3668 0048
Fax
Email
karahmadi@med.mui.ac.ir, marziehsalehi@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences, Faculty of medicine
Full name of responsible person
Marzieh Salehi
Position
Psychiatry resident
Other areas of specialty/work
Street address
Hezarjerib street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3668 0048
Fax
Email
karahmadi@med.mui.ac.ir,marziehsalehi@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Marzieh Salehi
Position
Other areas of specialty/work
Street address
City
Isfahan
Postal code
Phone
Fax
Email
karahmadi@med.mui.ac.ir, marziehsalehi@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)