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;
Parallel
NORSPAN Buprenorphine Transdermal Patchs for Very-low dose group
DrugVery-low dose group will receive medication on arrival before completing the relevant assessment tests; the very-low dose group will be administered 1/9 of a 5mg buprenorphine transdermal patch and replaced with a 0mg patch before returning home from the examination.
NORSPAN Buprenorphine Transdermal Patchs for Lower dose group
DrugThe lower dose group will be administered 1/9 of a 5mg buprenorphine transdermal patch.
NORSPAN Buprenorphine Transdermal Patchs for higher dose group
DrugThe higher dose group will be administered 1/3 of a 5mg buprenorphine transdermal patch.
Social Responsiveness Scale (SRS)
It is a screening tool for the diagnosis and assessment of autism in children aged 4-18 years that recognizes the presence of ASD-related social impairments and quantifies their severity. It identifies ASD-related social impairments and quantifies their severity. The scale consists of 65 questions categorized as Social Self-Consciousness, Social Cognition, Social Communication, and Social Self-Expression. The scale consists of 65 questions divided into five dimensions: social awareness, social cognition, social communication, social motivation, and autistic behavior. There are a total of 65 questions, with a minimum score of 1 and a maximum score of 4 for each question, with a total score range of 65-260. The higher the score, the more significant the condition.
Autism Behavior Checklist （ABC）
It is a behavioral assessment tool for children with autism and is primarily used to assess the outcome of patients with mental retardation and autism. The scale consists of 58 items divided into 5 factors: emotional lability/self-injurious aggression (15 items), social withdrawal/stagnation (16 items), stereotypic behavior (7 items), hyperactivity (16 items), and inappropriate speech (4 items). There are a total of 58 questions, each with a minimum score of 0 and a maximum score of 3, with a total score range of 0-174. The higher the score, the more significant the condition.
Clinical Global Impression (CGI)
It is an overall rating scale that is applicable to any psychiatric treatment and research subject. The comprehensive score is based on the two dimensions of efficacy and adverse reactions. The most effective and least adverse reaction score is 1 point, while the least effective and most adverse reaction score is 16 points. The score range is 1-16.
Treatment Emergent Symptom Scale (TESS)
It is a medication safety evaluation tool used by psychiatrists to assess side effects in patients taking psychotropic medications. There are a total of 29 questions, each with three dimensions: severity, relationship with medication, and treatment. The score range for severity is 0-4, with higher scores indicating greater severity. The score range for the relationship with drugs is 0-4, and the higher the score, the greater the relationship with drugs. The processing range is 0-6, and the higher the score, the greater the degree of processing.
Patient Global Impression (PGI)
There are two questions in total, namely severity and overall evaluation of efficacy. The score range for severity is 0-4, with higher scores indicating greater severity. The score range for the overall efficacy evaluation is 0-7, with higher scores indicating greater deterioration of the condition.
Eye Tracking Test
Subjects will be seated in front of a monitor equipped with eye-tracking equipment. The equipment will be adjusted according to the subject's actual condition before the formal start. After commissioning, a 1-2 minute video will be played and eye movement data will be collected during the video. The eye movement data will be analyzed by quantifying the ratio of the length of time the patient looks at the face of the person appearing in the video to the length of time he/she looks at the geometric figure, the length of time he/she looks at the eye region of the person, and so on.
Click on the lead sponsor to view all of their trials.
Peking University Sixth Hospital
Lead sponsor
Ping An-Shionogi Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
