Autism Spectrum Disorder
Conditions
Interventions
Subgroup 1:Placebo followed by oxytocin 24IU
Subgroup 2:Oxytocin 24IU followed by placebo
Sponsors
University of Electronic Science and Technology of China
Eligibility
Sex/Gender
All
Age
3 Years to 8 Years
Inclusion criteria
Inclusion criteria: 1. Meet criteria for DSM-5 Autism Spectrum Disorders (ASD);Meet criteria for ADOS-2 on Autism Spectrum Disorders; 2. Aged 3 to 8 years; 3. Gender not limited; 4. Did not receive any kinds of psychotic medications in the last 3 months; Did not receive TMS treatment within 6 months; 5. Capable of accomplishing assessments; 6. Consent of patient and his/her parents.
Exclusion criteria
Exclusion criteria: 1. previous or current use of Oxytocin; 2. Meet the criteria for other mental disorders according to DSM-5; 3. ASD accompanied with psychotic symptoms (such as delusions or hallucinations) or severe behavior disorders; 4. Patients currently with central nervous system illness (such as epilepsy or infection), except for febrile seizures of pediatric patients; 5. 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; 6. Patients with chronic nasal diseases, such as cystic fibrosis, polyposis, Kartageners disease or sicca syndrome who can not use nasal spray; regular nasal obstruction or nosebleeds; 7. Abnormality in laboratory examinations, such as abnormal liver or renal function; 8. EEG abnormality with potential clinical significance therefore researchers consider not suitable recruiting; 9. Patients allergic to oxytocin, or patients with severe allergy; 10. Evidence of a genetic mutation known to cause ASD (e.g., fragile X syndrome); 11. Unable to medicate following prescription; 12. Hearing or vision impairments; 13. Habitually drinks large volumes of water; 14. Patients considered not eligible for the trials by investigators.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Social communication questionnaire;Repetitive behavior scale - revised;Caregiver strain questionnaire;Adaptive behavior assessment system - 2;Eyetracking paradigm 1;Eyetracking paradigm 2;Oxytocin concentration in saliva samples; | — |
Primary
| Measure | Time frame |
|---|---|
| ADOS-2;Social responsibility scale - 2; | — |
Countries
China
Contacts
Public ContactKeith M. Kendrick
University of Electronic Science and Technology of China
Outcome results
None listed