Antipsychotic drug for autism
- Conditions
- Health Condition 1: F840- Autistic disorder
- Registration Number
- CTRI/2021/12/038721
- Lead Sponsor
- AIIMS Rishikesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Irritability subscale of autism behavior checklist (ABC)Timepoint: At 0 weeks and 12 weeks
- Secondary Outcome Measures
Name Time Method Frequency of adverse effects in both armsTimepoint: At 4, 8 and 12 weeks