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

Phase 3

Not yet recruiting

• Conditions: Autistic Disorder.; Autistic disorder; F84.0

• Registration Number: IRCT20200404046938N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 March 2022

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).