Intranasal Oxytocin in Youth With Autism

NCT05934812 | Not Yet Recruiting Phase 2

• 1 other identifier: 2019-002280-10
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Behavioral inflexibility

  Four weeks

• Social cognition

  Four weeks

• Repetitive cognition

  Four weeks

• Vagally-mediated heart rate variability

  Four weeks

Other Outcomes (3)

• Participation in social activities

  Four weeks

• Caregiver quality of life

  Four weeks

• Executive function

  Four weeks

Study Arms (2)

Oxytocin

EXPERIMENTAL

24IU oxytocin liquid delivered with a pump-actuated nasal spray device, administered twice-daily

Drug: Oxytocin nasal spray

Placebo

PLACEBO COMPARATOR

Placebo delivered with a pump-actuated nasal spray device, administered twice-daily

Drug: Placebo

Interventions

Oxytocin nasal spray DRUG

24IU oxytocin liquid delivered with a pump-actuated nasal spray device, administered twice-daily

Oxytocin

Placebo DRUG

Placebo liquid nasal spray administered twice-daily

Placebo

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

Ullevål Hospital

Oslo, N-0424, Norway

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ole A Andreassen, PhD, MD

  University of Oslo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel S Quintana, PhD

CONTACT

+47 22 84 50 00; daniel.quintana@psykologi.uio.no

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 7, 2023
• Study Start: September 18, 2024
• Primary Completion: November 4, 2025
• Study Completion: November 4, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

NO (1)