Sulforaphane as adjunctive treatment of irritability in children with Autism spectrum disorder
Phase 3
Recruiting
- Conditions
- Autistic disorder.Autistic disorder
- Registration Number
- IRCT20090117001556N107
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
DSM-5 clinical diagnosis of autistic disorder
Children between the ages of 3 and 12 years old
Presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone)
Exclusion Criteria
Presence of any active medical problem
Other psychiatric diagnosis except for mild to moderate Intellectual disability
Receiving any antipsychotic medications during past monthprior to the trial
Severe hepatic disease
History of allergy to risperidone and intolerance of it
History of seizure requiring change of antiepileptic dose during the last month
Seizure during the last 6 months
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of autism. Timepoint: Baseline and weeks 4, 8 and 12. Method of measurement: By Aberrant Behavior Checklist-Community( ABC-C) and Childhood Autism Rating scale( CARS).
- Secondary Outcome Measures
Name Time Method