Childhood autism. Childhood autism
Conditions
Interventions
Intervention 1: Capsule palmitoylethanolamide600 mg BID+ Tablet Risperidon 1-3.5 mg/day as intervention for 10 weeks. Intervention 2: Tablet Risperidone 1-3.5 mg/day +Capsule Placebo as control for 10
Treatment - Drugs
Placebo
Capsule palmitoylethanolamide600 mg BID+ Tablet Risperidon 1-3.5 mg/day as intervention for 10 weeks
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
4 Years to 12 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1-DSM 5 clinical diagnosis of autistic disorder; 2-children between the ages of 4 and 11 years old; 3- presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone). Exclusion Criteria: 1- Presence of any active medical problem; 2-any other psychiatric diagnosis except for Intellectual disability; 3-history of allergy or intolerance to Risperidone; 4- receiving any psychotropic medications during past two weeks prior to the trial; 5-presence of hepatic disease resulting impairment of liver function or rising hepatic enzymes; 6-history of seizure during the last 6 months.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of Autism. Timepoint: Baseline and weerks 5 and 10. Method of measurement: Aberrant Behavior Checklist-Community (ABC-C) Rating Scale (irritibility subscale) and Childhood autism rating scale(CARS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactProf. Shahin Akhondzadeh
Tehran University of Medical Sciences
Outcome results
None listed