The objective of this study is to assess the efficacy of Riluzole in the treatment of autism. Fifty children between the ages 3 and 12 years with a DSM IV clinical diagnosis of autistic disorder and who will be outpatients from a specialty clinic for children will be recruited. The children should present with a chief complaint of severely disruptive symptoms related to autistic disorder. Patients will be randomly allocated into Riluzole (50-100 mg/day ) + Risperidone (1-3mg/day) or Placebo + Risperidone (1-3 mg/day) for a 10-week, double-blind, placebo-controlled study. Patients will be assessed at baseline and after 5,10 weeks of starting medication. The primary outcome measure is the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale and CGI
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107281556N27
Registration date:2011-07-30, 1390/05/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-07-30, 1390/05/08
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-09-23, 1391/07/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Riluzole added to risperidone in the treatment of Autism: A double blind and placebo controlled trial
Public title
Riluzole in the treatment of autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 1-DSM IV clinical diagnosis of autistic disorder, 2-children between the ages of 3 and 12 years ,3- presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone) Exclusion Criteria:1- Presence of any active medical problem, 2-any diagnosis in Axis I and II except for mental retardation, 3-history of allergy to Riluzole,4- receiving any psychotropic medications during past six weeks prior to the trial, 5-presence of hepatic disease, 6-history of seizure
Age
From 3 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Postal code
Approval date
2011-07-17, 1390/04/26
Ethics committee reference number
14009
Health conditions studied
1
Description of health condition studied
Childhood autism
ICD-10 code
F84.0
ICD-10 code description
Childhood autism
Primary outcomes
1
Description
Severity of Autism
Timepoint
Baseline and weeks 5, and 10 after the begining of the treatment