Childhood autism. Childhood autism
Conditions
Interventions
Intervention 1: Intervention: Tablet Topiramate 200 mg/day +Tablet Risperidone 2-3mg/day for 10 weeks. Intervention 2: Control: Tablet Risperidone 2-3mg/day + Tablet placebo for 10 weeks.
Treatment - Drugs
Intervention: Tablet Topiramate 200 mg/day +Tablet Risperidone 2-3mg/day for 10 weeks
Control: Tablet Risperidone 2-3mg/day + Tablet placebo for 10 weeks
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
3 Years to 11 Years
Inclusion criteria
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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety. Timepoint: weeks 2, 4, 6, 8, 10 after begining of trial. Method of measurement: based on side effects checklist. | — |
Countries
Iran (Islamic Republic of)
Outcome results
None listed