Protocol summary

Summary
This clinical trial to determine the efficacy of memantine to improve cognitive deficits specific learning disorders among 94 children 12-8 years referred to Amir Kabir hospital psychiatric diagnostic criteria for disorders that have specific learning methods available (easy) through diagnostic interview based on V MSD is performed by physician specialty. Patients assigned to two groups, Mma Ntyn observations and placebo are randomly like blocks instead of patrol. Two tablets of memantine daily for three months in 47 patients in the first group and so on placebo in 47 patients in the second group will be given daily for three months. To measure cognitive deficits in patients both before and after treatment, outcome measures, including sustained attention and working memory selective attention by the continuous performance test, Stroop Test and Digit Span forward and reverse and Kessler and seats cubes measuring and Similarly, following treatment, both of these variables will be measured. Inclusion criteria: age 8-12 years diagnosed patients by physician specialty pure LD; no organic disorders, psychotic, mood, anxiety and combined, have normal intelligence More than 85 Exclusion criteria: mental retardation, organic problems (auditory, visual, etc.); psychotic problems, a disorder ADHD; a Pervasive Developmental Disorder, not wanting to continue treatment

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015102124633N1
Registration date: 2016-03-03, 1394/12/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-03-03, 1394/12/13
Registrant information
Name
Elham Ahmadi Zahrani
Name of organization / entity
Arak University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 86334172517
Email address
e.ahmadizahrani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor Arak University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Memantine in improvement of cognitive deficits in specific learning disorder
Public title
Effectiveness of Memantine in improvement of cognitive deficits in specific learning disorder
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 8-12 years diagnosed patients by physician specialty pure LD; no organic disorders, psychotic, mood, anxiety and combined, have normal intelligence More than 85 Exclusion criteria: mental retardation, organic problems (auditory, visual, etc.); psychotic problems, a disorder ADHD; a Pervasive Developmental Disorder, not wanting to continue treatment
Age
From 8 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 94
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
Ethics committee of Arak University of Medical Sciences
Street address
Alamolhoda, Maskan, Arak
City
Arak
Postal code
Approval date
2014-10-20, 1393/07/28
Ethics committee reference number
93-169-15

Health conditions studied

1

Description of health condition studied
specific learning disorder
ICD-10 code
F81.9
ICD-10 code description
Developmental disorder of scholastic skills, unspecified

Primary outcomes

1

Description
Sustained attention
Timepoint
Before treatment and after treatment
Method of measurement
Continuous Performance Test

Secondary outcomes

1

Description
Working memory
Timepoint
Before treatment and after treatment
Method of measurement
Stroop test

Intervention groups

1

Description
group 1 : The two tablets of memantine daily for three months
Category
Treatment - Drugs

2

Description
group 2 : received placebo daily for three months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Amir Kabir Hospital psychiatric clinic
Full name of responsible person
Dr. Ahmadizahrani Elham
Street address
Amir Kabir Hospital Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rafiee
Street address
School of Medicine, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Arak 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
Arak University of Medical sceinces
Full name of responsible person
Dr. Ahmadizaharani Elham
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Amirkabir Hospital Arak
City
Arak
Postal code
Phone
+98 913 313 9554
Fax
Email
e.ahmadizahrani@arakmu.ac.ir;rahenorayaneh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Ahmadi Elham
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
AmirKabir Hospital, Arak
City
Arak
Postal code
Phone
+98 86 3312 4922
Fax
Email
e.ahmadizahrani@arakmu.ac.ir; rahenorayaneh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
dr. Ahmadi Elham
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
AmirKabir Hospital,St. Rahahan, Arak
City
Arak
Postal code
Phone
+98 86 3313 7550
Fax
Email
rahenorayaneh@yahoo.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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