Back to resultsIntranasal Oxytocin in Youth With Autism
Primary Purpose
Autism Spectrum Disorder
Status
Not yet recruiting
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Oxytocin nasal spray
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Sites / Locations
- Ullevål Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oxytocin
Placebo
Arm Description
24IU oxytocin liquid delivered with a pump-actuated nasal spray device, administered twice-daily
Placebo delivered with a pump-actuated nasal spray device, administered twice-daily
Outcomes
Primary Outcome Measures
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.
Repetitive behaviour
Assessed with the Repetitive Behavior Scale-Revised (RBS-R), as completed by caregivers of the participants. Lower scores represent better outcomes.
Secondary Outcome Measures
Behavioral inflexibility
Assessed by the Behavioral inflexibility scale (BIS), completed by caregivers of the participants. Lower scores represent better outcomes.
Social cognition
Assessed by a computerized Emotional body language task completed by the participants. Higher accuracy scores represent better outcomes.
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)
Vagally-mediated heart rate variability
Calculated using electrocardiogram (RMSSD and High Frequency HRV)
Full Information
NCT ID
NCT05934812
First Posted
June 24, 2023
Last Updated
July 6, 2023
Sponsor
Oslo University Hospital
Collaborators
University of Oslo
1. Study Identification
Unique Protocol Identification Number
NCT05934812
Brief Title
Intranasal Oxytocin in Youth With Autism
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 18, 2023 (Anticipated)
Primary Completion Date
November 4, 2025 (Anticipated)
Study Completion Date
November 4, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
University of Oslo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
24IU oxytocin liquid delivered with a pump-actuated nasal spray device, administered twice-daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo delivered with a pump-actuated nasal spray device, administered twice-daily
Intervention Type
Drug
Intervention Name(s)
Oxytocin nasal spray
Intervention Description
24IU oxytocin liquid delivered with a pump-actuated nasal spray device, administered twice-daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo liquid nasal spray administered twice-daily
Primary Outcome Measure Information:
Title
Social behavior
Description
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.
Time Frame
Four weeks
Title
Repetitive behaviour
Description
Assessed with the Repetitive Behavior Scale-Revised (RBS-R), as completed by caregivers of the participants. Lower scores represent better outcomes.
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Behavioral inflexibility
Description
Assessed by the Behavioral inflexibility scale (BIS), completed by caregivers of the participants. Lower scores represent better outcomes.
Time Frame
Four weeks
Title
Social cognition
Description
Assessed by a computerized Emotional body language task completed by the participants. Higher accuracy scores represent better outcomes.
Time Frame
Four weeks
Title
Repetitive cognition
Description
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)
Time Frame
Four weeks
Title
Vagally-mediated heart rate variability
Description
Calculated using electrocardiogram (RMSSD and High Frequency HRV)
Time Frame
Four weeks
Other Pre-specified Outcome Measures:
Title
Participation in social activities
Description
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
Time Frame
Four weeks
Title
Caregiver quality of life
Description
As measured by the Care-related Quality of Life instrument (CarerQol). Higher scores represent better outcomes
Time Frame
Four weeks
Title
Executive function
Description
As measured by the Behavior Rating Inventory of Executive Functions. Lower scores represent better outcomes
Time Frame
Four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel S Quintana, PhD
Phone
+47 22 84 50 00
Email
daniel.quintana@psykologi.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole A Andreassen, PhD, MD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ullevål Hospital
City
Oslo
ZIP/Postal Code
N-0424
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel S Quintana, PhD
Phone
+47 22 84 50 00
Email
daniel.quintana@psykologi.uio.no
First Name & Middle Initial & Last Name & Degree
Ole A Andreassen, PhD, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
This needs to confirmed with local data protection authorities
Learn more about this trial
Intranasal Oxytocin in Youth With Autism
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