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Effect of intranasal oxytocin on the core social symptoms in children with autism spectrum disorder

Effectiveness of intranasal oxytocin on the core social symptoms in children with autism spectrum disorder

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260324069012N1
Enrollment
60
Registered
2026-03-29
Start date
2026-04-19
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Mental, behavioral, and neurodevelopmental disorders are conditions characterized by clinically significant disturbances in an individual’s cognition, emotional regulation, or behavior. These disorders reflect dysfunction in psychological, biological, or developmental processes, compromising mental and behavioral functioning. They are typically associated with distress or impairment in important areas of functioning, including personal, familial, social, educational, occupational, or other life

Interventions

Intervention 1: Intervention group: In the intervention group, in addition to standard treatment measures, patients will use intranasal oxytocin spray (50 IU/mL) twice daily (one puff in each nostril

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 8 Years

Inclusion criteria

Inclusion criteria: Age between 3 and 8 years Diagnosis of Autism Spectrum Disorder Receiving standard treatment for at least 2 months prior to the start of the intervention No use of pituitary hormones, cortisol, androgens, or estrogens No cardiovascular or respiratory problems No comorbid psychiatric disorders

Exclusion criteria

Exclusion criteria: Occurrence of serious side-effects

Design outcomes

Primary

MeasureTime frame
Assessment of patients’ status in terms of stereotyped behaviors, communication, social interaction, and developmental disorders. Timepoint: before and after the intervention. Method of measurement: Gilliam Autism Rating Scale (GARS).;Assessment of communication and social disorders, restricted and stereotyped interests, and motor and vocal tics. Timepoint: Before and after the intervention. Method of measurement: Autism Spectrum Screening Questionnaire (ASSQ).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAkram Boromand Dizji

Mashhad University of Medical Sciences

akram.boroumand2020@gmail.com+98 51 3711 2701

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026