Effect of propentofylline in children with autism
Phase 3
Recruiting
- Conditions
- Autistic disorder.Autistic disorder
- Registration Number
- IRCT20090117001556N113
- 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 4 and 11 years old
score 12 or more inirritability subscale of ABC-C
Exclusion Criteria
Presence of any active medical problem
Receiving any psychotropic medications except for risperidone during 2 weeks prior 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