Other Childhood Disintegrative disorder. Other childhood disintegrative disorder
Conditions
Interventions
Intervention 1: Intervention group: Tablet Prednisolone( 1mg/kg per day) plus Risperidone ( 1 to 3.5 mg per day) for 12 weeks. Intervention 2: Control group: Tablet placebo plus Risperidone( 1 to 3.5
Treatment - Drugs
Placebo
Intervention group: Tablet Prednisolone( 1mg/kg per day) plus Risperidone ( 1 to 3.5 mg per day) for 12 weeks
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: clinical diagnosis of autistic Disorder according to DSM-5 criteria Children between ages of 3 and 12 years Regressive subtype according to ADI-R Presence of behavioral problems such as aggression, overactivity, or repetitive behaviors(indication of treatment with Risperidone)
Exclusion criteria
Exclusion criteria: presence of any active medical problem Any other psychiatric diagnosis except for Intellectual disability History of intolerance and allergy to corticosteroids History of Catarct History of peptic ulcer or Gastrointestinal bleeding Raise of ICP Hypertension Presence of neurological diseases including Fragile X syndrome, Angelman syndrome, Tuberous sclerosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| IFN-?, IL-1ß, IL-8, IL-6, MCP-1, TGF-ß1. Timepoint: Baseline and week 12. Method of measurement: By ELISA. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShahin Akhondzadeh
Tehran University of Medical Sciences
Outcome results
None listed