The objective of this study is to assess the efficacy of Amantadine 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 Amantadine (100-150 mg/day ) + Risperidone (1-3 mg/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:IRCT201106101556N25
Registration date:2011-06-12, 1390/03/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-06-12, 1390/03/22
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
2011-07-06, 1390/04/15
Expected recruitment end date
2012-07-06, 1391/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A double - blind placebo controlled traial of Amantadine added to risperidone in patint with autistic disorder
Public title
Amantadine 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 11 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 Amantadine,4- receiving any psychotropic medications during past six weeks prior to the trial, 5-presence of hepatic disease, 6-history of seizure