Intranasal oxytocin in youth with autism

Prior treatment

• Previous nasal disease, surgery, and dependence on inhaled drugs.
• Participation in any (other) clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation.
• New concomitant medications or formal cognitive/behavioral therapies. If a participant has been taking any medications or receiving formal cognitive/behavioral therapies for at least 4 weeks, then this is not considered a new therapy.
• Systemic illness requiring treatment within 2 weeks prior to Study Day 1.
• Pregnancy (self-reported or assessed by pregnancy test prior to the first administration at Experimental session 1 and 3 for all menstruating females).

Other illness

• Clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder.
• Known allergic reactions or hypersensitivity to any component of the study medication in the nasal spray, such as propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218) and chlorobutanol hemihydrate.
• Known allergic reactions or hypersensitivity/intolerance to latex.

Other

• Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participants unsuitable for enrollment.
• Current significant nasal congestion due to common colds.
• Full scale IQ < 70 (due to the prerequisite ability to complete self-report measures).
• Currently breastfeeding.

• Male and female participant between the ages of 12 and 20, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) using the Autism Diagnostic Observation Schedule (ADOS).
• Participants must be in good general physical health, as determined by the investigator.
• Participants must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and to understand the oral and written patient information.
• Provision of a signed, written informed consent, if 16 years and older. Participants between the ages of 12 and 15 (inclusive) will provide assent, with caregivers providing consent. Caregivers will also provide consent for research participation.