Comparison of the efficacy of oral Risperidone and Aripiprazole in children with Autism Spectrum disorders (ASDs) aged 6-18 years: a double blind randomized controlled trial - RAAT

AIIMS Rishikesh0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年2月21日

试验速览

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•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

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