The purpose of this trial is to compare the efficacy and side effects of memantine and risperidone in autistic patients. Autistic patients between 4-17 years of age can enter this study. Exclusion criteria includes any history of neuroleptic malignant syndrome and a history of allergic reactions to risperidone or memantine. This study is a randomized, open lable trial that will be done on 30 autistic patients. Starting dose of risperidone will be 0.02 mg/kg/day that rises to 0.04 mg/kg/day after 7 days and ultimately to 0.06 mg/kg/day at the bigining of week 3. Maximum daily dose of risperidoe will be 3 mg/day. Starting dose of memantine will be 0.2 mg/kg/day that rises to 0.3 mg/kg/day after 7 days and ultimately to 0.4 mg/kg/day at the bigining of week 3. Maximum daily dose of memantine will be 20 mg/day. Baseline evaluation will be done by utilizing Aberrant Behavioral Check list and Childhood Autism Rating Scale scales. At the end of the forth week reevaluation with Aberrant Behavioral Check list and at the end of 8th week reevaluation with both scales will be done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204037202N5
Registration date:2012-06-20, 1391/03/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-06-20, 1391/03/31
Registrant information
Name
Padideh Ghaeli
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
pghaeli@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing efficacy and side effects of Memantine and Risperidone in treating autistic
patients
Public title
Comparing efficacy and side effects of Memantine and Risperidone in treating autistic patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age of 4-17 year old; autistic patients not received any drug for treatment in past or not responded adequately to previous drugs; seizure attacks in epileptic patients should be controlled and any change in dose and kind of antiepileptic drugs should not be made from one month before entrance to the study.
exclusion criteria: any neurologic disease except for seizure; substance abuse; pregnancy; any history of neuroleptic malignant syndrom and history of allergic reactions to mementine or risperidone; history of cardiovascular diseases, malignant hematologic diseases, acute kidney or liver failure.
Age
From 4 years old to 17 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Enghelab street
City
Tehran
Postal code
Approval date
2012-05-24, 1391/03/04
Ethics committee reference number
91-01-33-16991-51133
Health conditions studied
1
Description of health condition studied
Autism
ICD-10 code
F84
ICD-10 code description
Pervasive developmental disorders
Primary outcomes
1
Description
autism symptoms
Timepoint
before intervention, four and eight weeks after intervention
Method of measurement
Aberrant Behavioral Check list and Childhood Autism Rating Scale scales
Secondary outcomes
1
Description
Side effects including any side effect that related to the drug
Timepoint
two, four and eight weeks after intervention
Method of measurement
side effects checklist
Intervention groups
1
Description
Risperidone with gradual increasing in dose will be prescribed as bellow: 0.02mg/kg/day at begining, 0.04 mg/kg/day at second week and ultimately will be increased to 0.06 mg/kg/day at third week. Calculated dose based on body weight will be rounded to the nearest dose that according to the available dosage form of risperidone can easily be prescribed. Maximum daily dose of risperidone will be 3 mg.
Category
Treatment - Drugs
2
Description
Memantine with gradual increasing in dose will be prescribed as bellow: 0.2mg/kg/day at begining, 0.3mg/kg/day at second week and ultimately will be rised to 0.4mg/kg/day at third week. Calculated dose based on body weight will be rounded to the nearest dose that according to the available dosage form of memantine can easily be prescribed. Maximum daily dose of memantine will be 20 mg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric and adolescent psychiatrist office
Full name of responsible person
Mehdi Tehranidoost
Street address
Baran Building, Falsafi alley, Shariati avenue
City
Tehran
2
Recruitment center
Name of recruitment center
Clinic of psychiatric diseases in pediatrics and adolescents
Full name of responsible person
Zahra Shahrivar
Street address
Roozbeh hospital, South Kargar avenue
City
Tehran
3
Recruitment center
Name of recruitment center
Pediatric and adolescent psychiatrist office
Full name of responsible person
Javad Alagheband Rad
Street address
Sharifi alley, Behzad street, Mirdamad boulevard
City
Tehran
4
Recruitment center
Name of recruitment center
Psychiatric diseases hospital
Full name of responsible person
Padideh Ghaeli
Street address
Roozbeh hospital, South Kargar avenue
City
Tehran
5
Recruitment center
Name of recruitment center
Psychiatric diseases hospital
Full name of responsible person
Naemeh Nikvarz
Street address
Roozbeh hospital, South Kargar avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central building of Tehran University of Medical Sciences, Ghods street
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
Full name of responsible person
Naemeh Nikvarz
Position
Clinical Pharmacy resident
Other areas of specialty/work
Street address
Faculty of Pharmacy and Pharmaceutical sciences, 16 Azar street
City
Tehran
Postal code
1417614411
Phone
+98 21 6695 4709
Fax
Email
nnikvarz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Padideh Ghaeli
Position
Clinical Pharmacist
Other areas of specialty/work
Street address
Faculty of Pharmacy and Pharmaceutical sciences, 16 Azar street
City
Tehran
Postal code
1417614411
Phone
+98 21 6695 4709
Fax
Email
pghaeli@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Naemeh Nikvarz
Position
Clinical Pharmacy resident
Other areas of specialty/work
Street address
Faculty of Pharmacy and Pharmaceutical sciences, 16 Azar street
City
Tehran
Postal code
1417614411
Phone
+98 21 6695 4709
Fax
+98 21 6695 4709
Email
nnikvarz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)