Efficacy and adverse drug reaction between Risperidone solution local made and original drug in treatment of autism spectrum disorders
Not Applicable
- Conditions
- compare Efficacy and adverse drug reaction between Risperidone solution local made and original drug in treatment of autism spectrum disordersEfficacyadverse drug reactionRisperidonelocal madeoriginal drugautism spectrum disorders
- Registration Number
- TCTR20180414001
- Lead Sponsor
- o
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 60
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
1.serious adverse drug reaction during treat with Risperidone solution
2. non compliance
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method compare efficacy between Risperidone solution local made and original dru 1 2 3 6 month ater take medication Aberrant Behavior Checklist- Community (ABC)
- Secondary Outcome Measures
Name Time Method compare adverse drug reaction between Risperidone solution local made and original dru 1 2 3 6 month ater take medication adverse drug reaction form