Tpoiramate in the treatment of autism
Phase 2
- Conditions
- Childhood autism.Childhood autism
- Registration Number
- IRCT138901141556N9
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Children will be considered for participation in the project if they are between 3 and 11 years of age, meet DSM-IV-TR criteria for diagnosis of autism. Children with concomitant schizophrenia or psychotic disorders were excluded. Children willl be excluded if they have a history of drug or alcohol abuse and tardive dyskinesia. Children will be excluded if they have previously received neuroleptics or any psychotropic drug treatment 6 months prior to recruitment or having significant active medical problem. Children with severe or profound mental retardation in whom a definitive diagnosis of autism could not be made will be excluded.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of Autism based on Aberrant Behavior Check List. Timepoint: weeks 2-4-6-8-10 after begining of trial trial. Method of measurement: Based on Aberrant Behavior Check List.
- Secondary Outcome Measures
Name Time Method Safety. Timepoint: weeks 2, 4, 6, 8, 10 after begining of trial. Method of measurement: based on side effects checklist.