A randomized, placebo-controlled, double-blind, 3-period cross-over study in youth with autism spectrum disorders evaluating neural plasticity and learning after a single administration of intranasal oxytocin
Key facts
- Where
- Oslo, NorvégiaSee the site
- Phase
- 2. fázis
Where in Norvégia
- Oslo University Hospital HFOslo, NorvégiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oslo University Hospital HF
- Trial code
- EU 2023-506826-36-00
- Record updated
- 2026. szeptember 23.
- Original description
Identify effects of oxytocin delivered intranasally (8 IU and 24 IU) on neural plasticity and learning compared to placebo in youth diagnosed with ASDRead full original descriptionShow less
Identify effects of oxytocin delivered intranasally (8 IU and 24 IU) on neural plasticity and learning compared to placebo in youth diagnosed with ASD
Inclusion: Male and female participant between the ages of 12 and 25, both inclusive; Participants and their caregivers (if applicable) must be able to communicate with the Investigator, to understand and comply with the requirements of the study, and to understand the oral and written patient information; Participants must have a confirmed diagnosis of autism spectrum disorder (ASD).
Exclusion: Previous nasal disease, surgery, and dependence on inhaled drugs; Pregnancy (self-reported or assessed by pregnancy test prior to the first administration at the experimental sessions for all menstruating individuals); Epilepsy and previous history of photosensitive seizures; Systemic illness requiring treatment within 2 weeks prior to Study Day 1; New concomitant medications or formal cognitive/behavioural therapies. If a participant has been taking any medications or receiving formal cognitive/behavioural therapies for at least 4 weeks, then this is not considered a new therapy; Participation in any (other) clinical trial with an investigational medicinal product or medical device within 1 month prior to randomization; 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; Full scale IQ below 70 (due to the prerequisite ability to complete self-report measures); Currently breastfeeding; Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participants unsuitable for enrolment; Current significant nasal congestion due to common colds.