This study evaluates the safety and efficacy of low-dose buprenorphine in patients with ASD by using standard ASD symptom assessment methods (e.g., SRS-2 and ABC) as well as AI-assisted analyses utilizing exploratory gaze patterns in conjunction with fMRI and electroencephalogram measurements to assess changes in brain functional status.
Sex: male/female;
Age:6-18 years at the time of randomization;
Clinical diagnosis in accordance with the DSM-5 diagnosis of ASD;
Diagnosis of ASD using the K-SADS-PL-C DSM-5 and CARS;
Neurologic/Psychiatric Disorders
Concurrent comorbidity with any other mental disorder (other than ADHD) as diagnosed by the K-SADS-PL-C DSM-5;
Neurologic disorders or prior head trauma resulting in coma;
Unstable or uncontrollable clinically significant psychiatric and/or neurological disorders that may interfere with safety or efficacy outcome;
Peking University Sixth Hospital
Lead sponsor
Ping An-Shionogi Co., Ltd.
Collaborator