2023-506826-36-00RecruitingPhase 2
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Sept 2026
Brief summary (registry, in English)
Identify effects of oxytocin delivered intranasally (8 IU and 24 IU) on neural plasticity and learning compared to placebo in youth diagnosed with ASD
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 98 (estimated)
- First submitted
- 15 Feb 2024
- Start date
- 26 Jan 2026
- Lead sponsor
- Oslo University Hospital HF
- Diseases
- Autism
- EU CT number
- 2023-506826-36-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 98
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for young people with a confirmed diagnosis of autism spectrum disorder. Each person gets oxytocin nasal spray and placebo in turn.
- Age
- 12 to 25 years, both included
- Sex
- Males and females can join.
- Disease stage
- Confirmed diagnosis of autism spectrum disorder (ASD).
- Earlier treatment
- People cannot join if they started a new medicine or formal cognitive/behavioural therapy. Therapy taken for at least 4 weeks is not counted as new.
Main reasons for not taking part
- Full scale IQ below 70
- Previous nasal disease, surgery, or dependence on inhaled drugs
- Pregnancy or currently breastfeeding
- Epilepsy or past photosensitive seizures
- Significant liver, kidney, hormone, heart, nerve, lung, blood or metabolic disorder in the history
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
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
- 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
Who the study is looking for
- 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)
Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital HF | Oslo | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.