Autistic Disorder. Childhood autism
Conditions
Interventions
Intervention 1: Tablet simvastatin 20 to 40 mg/day+ Tablet Risperidon 1-3.5 mg/day as intervention 10 for 10 weeks. Intervention 2: Tablet Risperidone 1-3.5 mg/day + Placebo as control for 10 weeks.
Treatment - Drugs
Placebo
Tablet simvastatin 20 to 40 mg/day+ Tablet Risperidon 1-3.5 mg/day as intervention 10 for 10 weeks
Tablet Risperidone 1-3.5 mg/day + Placebo as control 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: DSM-5 clinical diagnosis of autistic disorder; children between the ages of 4 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; any other psychiatric diagnosis except for mild mental retardation; receiving any psychotropic medications during past two weeks prior to the trial; presence of hepatic disease; history of seizure; history of allergy to simvastatin or intolerance of it; neutropenia, anemia or thrombocytopenia and renal disease.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of Autism. Timepoint: Baseline and weeks 5 and 10 after beginning of treatment. Method of measurement: Aberrant Behavior Checklist-Community (ABC-C) Rating Scale (Irritability subscale ). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactProf. Shahin Akhondzadeh
Tehran University of Medical Sciences
Outcome results
None listed