Asperger's syndrome
Conditions
Interventions
Oxytocin group :AS patients in the oxytocin group were treated with oxytocin for 6 weeks at a daily dose of 48IU (24IU BID), and nasal spray was given to the patients twice a day in the morning and ev
Placebo group:AS patients in the placebo group were treated with placebo for 6 weeks at a daily dose of 48IU (24IU BID) and nasal spray twice a day in the morning and evening.
Sponsors
Beijing Anding Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for Asperger's syndrome in the American Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV); 2. 18 years old=85; 3. Gender is not limited; 4. Have not used any psychiatric medication in the three months prior to screening; 5. Able to complete all tests; 6. Informed consent of patients and guardians.
Exclusion criteria
Exclusion criteria: 1. Currently receiving psychiatric medication; 2. Subjects with a current or prior diagnosis of other disorders other than autism according to DSM-5 diagnostic criteria; 3. According to the clinical judgment of the investigator, subjects with severe impulsive aggression or self-injurious behavior, suicidal ideation and behavior; 4. Subject has a current or previous history of convulsive seizures (except for simple febrile seizures in childhood without sequelae); 5. Subjects with unstable physical illnesses requiring medical or surgical treatment; 6. Subjects with any anatomical or medical condition that may preclude intranasal administration or absorption of the study drug, as judged by the investigator clinically; 7. Subjects with abnormal clinical laboratory tests or electrocardiogram examinations and clinical significance during the screening period; 8. Subjects with known allergies to oxytocin or the main components of oxytocin nasal spray.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SRS scale total score change value;Change in total score of CSQ scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change value of the total score of RBS scale;1. Brain activation: fMRI data under the task were detected and analyzed to determine the similarities and differences of brain activation patterns between the two groups of patients under the empathy-systematization task. ;2. Brain functional connectivity: psychophysiological interaction analysis was used to study whether the functional interaction between the interested brain area and other brain areas in the whole brain found in the empathy-systematization level task was regulated by the task state;3. Brain effect linkage: Based on the previous analysis results, a dynamic causal model was used to establish a directed interaction model of brain function under the empathic-systematic level task, and the differences in effect linkage patterns between the two groups were compared.; | — |
Countries
China
Contacts
Public ContactTian Yin
Beijing Anding Hospital Affiliated to Capital Medical University
Outcome results
None listed