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Evaluation of the effectiveness of oxytocin by placebo nasal spray on symptoms and treatment of adults with autism

Comparison of the effectiveness of oxytocin nasal spray with placebo on symptoms and treatment of adults with autism: a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200404046938N1
Enrollment
40
Registered
2022-02-19
Start date
2022-03-21
Completion date
Unknown
Last updated
2022-03-08

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

Conditions

Autistic Disorder. Autistic disorder

Interventions

Intervention 1: Intervention group: Oxytocin nasal spray, including oxytocin peptide, 25 ml bottle, 2 times a day, two puffs in each nostril, including 48 international units of oxytocin daily, for 8

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 56 Years

Inclusion criteria

Inclusion criteria: Age between 16 years and zero months to 55 years and 11 months Confirmation of diagnosis by a psychiatrist based on dsm5 Complete physical examination and normal laboratory tests Ability to understand and speak Persian fluently Ability to read and understand the consent form in full and if it is not possible for the legal guardian to read and sign the form Clinical global impression-severity CGI-S score above 4 in screening Intelligence score in Stanford test - above 75

Exclusion criteria

Exclusion criteria: Patients with nasal septal deformity and previous epithelial injuries and a history of nasal surgeries with a risk of nasal epithelium damage and people with a history of inhaled substance use Patients with nasal congestion due to colds Patients in the acute phase of psychiatric illness or with thoughts of death and suicide Having a history of neurological diseases, seizures and head injuries People with a history of neurological or metabolic disease that affects their sensory and motor function, etc. Receive stimulant medications History of uncontrolled cardiovascular, renal and hepatic diseases Pregnant women or young women who do not take oral contraceptives People whose type and dose of psychiatric medication have changed in the last 4 weeks People with a history of chronic oxytocin treatment History of allergy to oxytocin and syntocinin and all its compounds asthma

Design outcomes

Primary

MeasureTime frame
Improving the social symptoms of adults with autism. Timepoint: Start of study, 4 weeks later, 8 weeks later. Method of measurement: Social responsiveness scale -social motivation subscale (SRS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaba Faraji Niri

Tehran University of Medical Sciences

S_farajin@razi.tums.ac.ir+98 21 2282 9356

Outcome results

None listed

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