Autism spectrum disorders
Conditions
Interventions
Group 1:Oxytocin nasal spray 12IU bid
Group 2:Placebo 12IU bid
Sponsors
Beijing Anding Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Meet criteria for DSM-5 Autism Spectrum Disorders (ASD); 2. Aged 6 to 12 years; 3. Gender not limited; 4. Didnt receive any kinds of psychotic medications in the last 3 months; 5. Capable of accomplshing assessments; 6. Consent of patient and his/her parents.
Exclusion criteria
Exclusion criteria: 1. Meet the criteria for other mental disorders according to DSM-5; 2. ASD accompanied with psychotic symptoms (such as delusions or hallucinations) or severe behavior disorders; 3. Patients currently with central nervous system illness (such as epilepsy or infection) , except for febrile seizures of pediatric patients; 4. Patients with severe or unstable physical problems, including cardiovascular diseases, tumors, renal diseases, endocrine diseases (including thyroid function abnormality), gastrointestinal diseases, hemopathy and nervous system diseases; 5. Female patient with a positive result in pregnancy test; 6. Patients with chronic nasal diseases, such as cystic fibrosis, polyposis, Kartageners disease or sicca syndrome who can not use nasal spray; 7. Abnormality in laboratory examinations, such as abnormal liver or renal function; 8. ECG abnormality with potential clinical significance therefore researchers consider not suitable recruiting; 9. Patients allergic to oxytocin, or patients with severe allergy; 10. Currently receiving psychotic medications and still using in 5 half-time periods; 11. Unable to medicate following prescription; 12. Have been clinical medication trials in the last 3 months; 13. Patients considered not eligible for the trials by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Social responsiveness scale, SRS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Repetitive behavior scale-revised, RBS-R;Caregiver strain questionnaire, CSQ; | — |
Countries
China
Contacts
Public ContactXu Chen
Beijing Anding Hospital Capital Medical University
Outcome results
None listed