Autism Spectrum DisorderPhase 2NCT05934812
Intranasal Oxytocin in Youth With Autism
A Phase 2 study testing Oxytocin nasal spray in people with Autism Spectrum Disorder, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Growing evidence demonstrates the critical contribution of the neuropeptide oxytocin in the development and maintenance of autism, due to its role in social behaviour and learning processes. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Oxytocin nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteNorway
- Study dates
- 18 Sep 2024to 4 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female participants between the ages of 12 and 20, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) diagnosis as per the ADOS/ADI.
- Participants must be in good general physical health, as determined by the investigator.
- Participant's pre-study physical examination and vital signs must not show any clinically significant abnormalities as determined by the investigator.
- Participants and caregivers 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 study information
Who cannot join
- Previous nasal disease, surgery, and dependence on inhaled drugs.
- Current significant nasal congestion due to common colds.
- Clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder.
- Systemic illness requiring treatment within 2 weeks prior to Study Day 1.
- Full scale IQ < 70 (due to the prerequisite ability to complete self-report measures).
- 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.
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- Known allergic reactions or hypersensitivity/intolerance to latex
- Currently breastfeeding
- Pregnancy (self-reported or assessed by pregnancy test prior to the first administration at Experimental session 1 and 2 for all menstruating females)
- 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.
- Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participants unsuitable for enrolment.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Ullevål Hospital
Oslo, N-0424
Daniel S Quintana, PhD, +47 22 84 50 00, daniel.quintana@psykologi.uio.no
Ole A Andreassen, PhD, MD
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, 2-period Cross-over Study in Youth With Autism Spectrum Disorders Evaluating Social and Repetitive Behaviors After Four Weeks of Twice Daily-doses of 24IU of Intranasally Administered Oxytocin
Growing evidence demonstrates the critical contribution of the neuropeptide oxytocin in the development and maintenance of autism, due to its role in social behaviour and learning processes. While some preliminary findings in oxytocin administration trials have been promising, a complete understanding of the effects of long-term oxytocin administration in autism remains elusive, as participant numbers in oxytocin administration studies in autism have been small, most studies exclusively recruit males, and reproducibility has been inconsistent.
To address this critical knowledge gap, this project will include a double-blind, placebo-controlled, randomized controlled crossover trial of a four-week intranasal oxytocin treatment (24 international units, twice-daily) in 128 male and female youth with ASD aged 12-20, with social and repetitive behaviors as primary outcome measures. The investigators predict that intranasal oxytocin treatments will increase performance on social behavior measures and reduce repetitive behaviors using caregiver-reported measures.
Along with the investigation of oxytocin's long-term effects, the investigators will also assess the impact of oxytocin administration on computer-based laboratory tasks that can precisely measure how participants process social cues and disengage with repetitive behaviours. In addition, an electrocardiogram will be collected to evaluate the impact of oxytocin administration on parasympathetic nervous system activity.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Oxytocin nasal spray, Placebo
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
24IU oxytocin liquid delivered with a pump-actuated nasal spray device, administered twice-daily
PlaceboDrug
Placebo liquid nasal spray administered twice-daily
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | 24IU oxytocin liquid delivered with a pump-actuated nasal spray device, administered twice-daily Receives: Drug: Oxytocin nasal spray |
| Placebo | Placebo comparator | Placebo delivered with a pump-actuated nasal spray device, administered twice-daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social behavior
Assessed by the total score of the Social Responsiveness Scale-Second Edition (SRS-2), as completed by caregivers of the participants. Lower scores represent better outcomes.
Measured: Four weeks
Repetitive behaviour
Assessed with the Repetitive Behavior Scale-Revised (RBS-R), as completed by caregivers of the participants. Lower scores represent better outcomes.
Measured: Four weeks
Secondary outcomes (4)
Behavioral inflexibility
Assessed by the Behavioral inflexibility scale (BIS), completed by caregivers of the participants. Lower scores represent better outcomes.
Measured: Four weeks
Social cognition
Assessed by a computerized Emotional body language task completed by the participants. Higher accuracy scores represent better outcomes.
Measured: Four weeks
Repetitive cognition
Assessed by a computerised probabilistic reversal learning task completed by participants. More regressive errors represent worse outcomes (i.e., after initially choosing the new correct response, participants regress back to choosing the previously rewarded response)
Measured: Four weeks
Vagally-mediated heart rate variability
Calculated using electrocardiogram (RMSSD and High Frequency HRV)
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start18 Sep 2024 (estimated)
- Primary completion4 Nov 2025 (estimated)
- Study completion4 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Ole A. Andreassen, Oslo University Hospital
- Investigators
- Ole A Andreassen, PhD, MD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934812
- Sponsor's protocol ID
- 2019-002280-10
- Other IDs
- 2019
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2023
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This needs to confirmed with local data protection authorities
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, 2-period Cross-over Study in Youth With Autism Spectrum Disorders Evaluating Social and Repetitive Behaviors After Four Weeks of Twice Daily-doses of 24IU of Intranasally Administered Oxytocin
- ClinicalTrials.gov ID
- NCT05934812
- Acronym / sponsor ID
- 2019-002280-10
- Conditions
- Autism Spectrum Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 18 Sep 2024 (estimated)
- Primary completion
- 4 Nov 2025 (estimated)
- Study completion
- 4 Nov 2025 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Growing evidence demonstrates the critical contribution of the neuropeptide oxytocin in the development and maintenance of autism, due to its role in social behaviour and learning processes. While some preliminary findings in oxytocin administration trials have been promising, a complete understanding of the effects of long-term oxytocin administration in autism remains elusive, as participant numbers in oxytocin administration studies in autism have been small, most studies exclusively recruit males, and reproducibility has been inconsistent.
To address this critical knowledge gap, this project will include a double-blind, placebo-controlled, randomized controlled crossover trial of a four-week intranasal oxytocin treatment (24 international units, twice-daily) in 128 male and female youth with ASD aged 12-20, with social and repetitive behaviors as primary outcome measures. The investigators predict that intranasal oxytocin treatments will increase performance on social behavior measures and reduce repetitive behaviors using caregiver-reported measures.
Along with the investigation of oxytocin's long-term effects, the investigators will also assess the impact of oxytocin administration on computer-based laboratory tasks that can precisely measure how participants process social cues and disengage with repetitive behaviours. In addition, an electrocardiogram will be collected to evaluate the impact of oxytocin administration on parasympathetic nervous system activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: Oxytocin nasal spray24IU oxytocin liquid delivered with a pump-actuated nasal spray device, administered twice-daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo delivered with a pump-actuated nasal spray device, administered twice-daily |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male and female participants between the ages of 12 and 20, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) diagnosis as per the ADOS/ADI.
- Participants must be in good general physical health, as determined by the investigator.
- Participant's pre-study physical examination and vital signs must not show any clinically significant abnormalities as determined by the investigator.
- Participants and caregivers 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 study information
Key exclusion criteria (12 listed)
- Previous nasal disease, surgery, and dependence on inhaled drugs.
- Current significant nasal congestion due to common colds.
- Clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder.
- Systemic illness requiring treatment within 2 weeks prior to Study Day 1.
- Full scale IQ < 70 (due to the prerequisite ability to complete self-report measures).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin nasal spray24IU oxytocin liquid delivered with a pump-actuated nasal spray device, administered twice-daily | Drug | Oxytocin |
| PlaceboPlacebo liquid nasal spray administered twice-daily | Drug | Placebo |
Primary outcome
Social behavior
Time frame: Four weeks
Assessed by the total score of the Social Responsiveness Scale-Second Edition (SRS-2), as completed by caregivers of the participants. Lower scores represent better outcomes.
Repetitive behaviour
Time frame: Four weeks
Assessed with the Repetitive Behavior Scale-Revised (RBS-R), as completed by caregivers of the participants. Lower scores represent better outcomes.
4 secondary outcomes
Behavioral inflexibility
Time frame: Four weeks
Social cognition
Time frame: Four weeks
Repetitive cognition
Time frame: Four weeks
Vagally-mediated heart rate variability
Time frame: Four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: Undecided. This needs to confirmed with local data protection authorities
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole A Andreassen, PhD, MD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin nasal spray in people with Autism Spectrum Disorder, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel S Quintana, PhD (+47 22 84 50 00, daniel.quintana@psykologi.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social behavior (time frame: Four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.