Intranasal Oxytocin in Youth With Autism

Autism Spectrum Disorder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05934812
• Other study ID #: 2019-002280-10
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 18, 2023
• Est. completion date: November 4, 2025

Study information

• Verified date: July 2023
• Source: Oslo University Hospital
• Contact: Daniel S Quintana, PhD
• Phone: +47 22 84 50 00
• Email: daniel.quintana[@]psykologi.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: November 4, 2025
• Est. primary completion date: November 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Participants must be in good general physical health, as determined by the investigator.

3. Participant's pre-study physical examination and vital signs must not show any clinically significant abnormalities as determined by the investigator.

4. 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

Exclusion Criteria:

1. Previous nasal disease, surgery, and dependence on inhaled drugs.

2. Current significant nasal congestion due to common colds.

3. Clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder.

4. Systemic illness requiring treatment within 2 weeks prior to Study Day 1.

5. Full scale IQ < 70 (due to the prerequisite ability to complete self-report measures).

6. 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.

7. Known allergic reactions or hypersensitivity/intolerance to latex

8. Currently breastfeeding

9. Pregnancy (self-reported or assessed by pregnancy test prior to the first administration at Experimental session 1 and 2 for all menstruating females)

10. Participation in any (other) clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation.

11. 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.

12. Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participants unsuitable for enrolment.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Drug:
• Oxytocin nasal spray
24IU oxytocin liquid delivered with a pump-actuated nasal spray device, administered twice-daily
• Placebo
Placebo liquid nasal spray administered twice-daily

Locations

Country	Name	City	State
Norway	Ullevål Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participation in social activities	As measured by the Participation and Environment measure-Child and Youth scale. Higher scores on the "participation frequency", "level of involvement", and "Percent total environmental supportiveness" subscores represent better outcomes, and lower scores on the "Percent never participates" and "Percent that parents desired change" represent better outcomes	Four weeks
Other	Caregiver quality of life	As measured by the Care-related Quality of Life instrument (CarerQol). Higher scores represent better outcomes	Four weeks
Other	Executive function	As measured by the Behavior Rating Inventory of Executive Functions. Lower scores represent better outcomes	Four weeks
Primary	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.	Four weeks
Primary	Repetitive behaviour	Assessed with the Repetitive Behavior Scale-Revised (RBS-R), as completed by caregivers of the participants. Lower scores represent better outcomes.	Four weeks
Secondary	Behavioral inflexibility	Assessed by the Behavioral inflexibility scale (BIS), completed by caregivers of the participants. Lower scores represent better outcomes.	Four weeks
Secondary	Social cognition	Assessed by a computerized Emotional body language task completed by the participants. Higher accuracy scores represent better outcomes.	Four weeks
Secondary	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)	Four weeks
Secondary	Vagally-mediated heart rate variability	Calculated using electrocardiogram (RMSSD and High Frequency HRV)	Four weeks