The objective of this study is to assess the efficacy of Galantamine 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 Galantamine (2-24 mg/day ) + Risperidone (1-2mg/day) or Placebo + Risperidone (1-2mg/day) for a 10-week, double-blind, placebo-controlled study. The initial dose of Galantamine will be 2 mg per day and after one week the dose will be increased to 4 mg twice daily .If tolerated, the dose will be gradually increased to 24 mg per day. Patients will be assessed at baseline and after 5 and 10 weeks of starting medication. The primary outcome measure is the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale (Irritability subscale).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204081556N40
Registration date:2012-04-14, 1391/01/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-04-14, 1391/01/26
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
2012-04-20, 1391/02/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Galantamine added to risperidone in the treatment of Autism: A double blind and placebo controlled trial
Public title
Galantamine 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 Galantamine,4- receiving any psychotropic medications during past two 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:
50
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 Tehran University of Medical Sciences
Street address
Keshvarz Blvd
City
Tehran
Postal code
Approval date
2011-12-22, 1390/10/01
Ethics committee reference number
13216
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 begining of treatment