Exploratory study on the efficacy and safety of oxytocin nasal spray in the treatment of autism spectrum disorder

Exploratory study on the efficacy and safety of oxytocin nasal spray in the treatment of autism spectrum disorder - Oxytocin treats autism

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500114162

Enrollment

Unknown

Registered

2025-12-08

Start date

2021-04-01

Completion date

Unknown

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autism spectrum disorder

Interventions

oxytocin group:Oxytocin nasal spray 12IU morning and night

placebo group:Placebo 12IU in the morning and evening

Eligibility

Sex/Gender

All

Age

6 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria for autism spectrum disorder in the American Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5); 2.6 years old <= age <=18 years old; gender is not limited; 3.Not using any psychiatric medication three months before screening; 4. Able to complete all tests; 5.Informed consent of patients and guardians.

Exclusion criteria

Exclusion criteria: 1.Those who have a score reduction rate of >=10% on the SRS-P scale after the introduction period compared with the screening period; 2.Those currently receiving psychiatric medication; 3. Accompanied by psychotic symptoms or severe behavioral disorder; 4. Currently suffering from central nervous system disease or serious physical disease; 5. Meet DSM-5 diagnostic criteria for other diseases; 6. People allergic to oxytocin; 7.Those who fail to take medicine as prescribed by a doctor;

Design outcomes

Primary

Measure	Time frame
Change value of SRS-P scale total score after intervention compared with baseline SRS-P scale total score;	—

Secondary

Measure	Time frame
The change value of ADOS total score after intervention compared with the total score of the scale at baseline;Effectiveness rate between groups: the difference between the groups in the proportion of the total score of the scale reduced by >=50% compared to the baseline;Period of improvement: the difference between groups in the time when the total score of the scale decreases by >= 20% compared to the baseline;Correlation between predose serum oxytocin levels and postintervention efficacy.;	—

Measure

Time frame

The change value of ADOS total score after intervention compared with the total score of the scale at baseline;Effectiveness rate between groups: the difference between the groups in the proportion of the total score of the scale reduced by >=50% compared to the baseline;Period of improvement: the difference between groups in the time when the total score of the scale decreases by >= 20% compared to the baseline;Correlation between predose serum oxytocin levels and postintervention efficacy.;

—

Countries

China

Contacts

Public ContactChen Xu

Beijing Anding Hospital Affiliated to Capital Medical University

yinuo0311@163.com+86 138 1196 5830

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026