compare Efficacy and adverse drug reaction between Risperidone solution local made and original drug in treatment of autism spectrum disorders Efficacy adverse drug reaction Risperidone local made original drug autism spectrum disorders
Conditions
Interventions
rispel solution is risperidone solution local made ,risperidal solution is original drug
Active Comparator Drug,Placebo Comparator Drug
rispel solution,risperidal solution
Sponsors
No
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1.diagnostic Autism spectrum disorders by ICD 10 2.age between 3-12 years old 3.never treated with antipsychotic drug 4.no history with seizure 4.not treated with CYP2D6 inhibitor or inducer
Exclusion criteria
Exclusion criteria: 1.serious adverse drug reaction during treat with Risperidone solution 2. non compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| compare efficacy between Risperidone solution local made and original dru 1 2 3 6 month ater take medication Aberrant Behavior Checklist- Community (ABC) | — |
Secondary
| Measure | Time frame |
|---|---|
| compare adverse drug reaction between Risperidone solution local made and original dru 1 2 3 6 month ater take medication adverse drug reaction form | — |
Countries
Thailand
Contacts
Public ContactJinatana Mongkolpitaksuk
Rajanukul Institute
Outcome results
None listed