Health Condition 1: F840- Autistic disorder
Conditions
Interventions
Intervention1: Oral Risperidone tablet: 0.5 mg/day daily for 12 weeks
Control Intervention1: Oral Aripiprazole: 2.5 mg/day daily for 12 weeks
Sponsors
AIIMS Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: 1.Aged 6 to 18 years and weight of at least 15 kg 2. Meet DSM-V criteria for of ASD 3. ABC Irritability subscale score of >18 4. Mental age of at least 18 months 5. If female, not sexually active • Medication free or adequate washout period (2-4 weeks prior to enrollment) of psychoactive drugs (anticonvulsants permitted for seizure management if dosage is stable for 4 weeks) • Parent/guardian able to read and provide informed consent
Exclusion criteria
Exclusion criteria: 1. Prior diagnosis or evidence of genetic or other disorder that may interfere with assessments (e.g. Fragile X syndrome, Rett syndrome, history of very low birth weight) assessed by personal and family history, dysmorphology, and clinical judgment. 2. Prior use of risperidone or aripiprazole for more than 2 weeks 3. Seizure during the past 6 months 4. History or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments during the trial including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, hematologic or immunologic disease as determined by the clinical judgment of the investigator 5. Current suicidal or homicidal risk 6. Dependent on other substances, with the exception of nicotine or caffeine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irritability subscale of autism behavior checklist (ABC)Timepoint: At 0 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of adverse effects in both armsTimepoint: At 4, 8 and 12 weeks | — |
Countries
India
Contacts
Public ContactPrateek Kumar Panda
AIIMS, Rishikesh
Outcome results
None listed