Trial · Interventional

CompletedPhase 2Results postedRegistry data

Single Dose Intranasal Oxytocin and Cognitive Effects in Autism

NCTNCT02493426Other idPSYCH-2016-21943

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 27 participants (actual)
Sponsor: University of Minnesota · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: May 2014
Primary completion: 31 Mar 2021
Completion: 31 Mar 2021
First posted: 9 Jul 2015 (estimated)
Last update posted: 23 Jan 2023
Conditions: Autism Spectrum Disorders

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20142016201820202022

Ph 2
Single Dose Intranasal Oxytocin and Cognitive Effects in Autism
NCT02493426
May 2014 to 31 Mar 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Autism spectrum disorder (ASD) is a group of severe, life-long developmental disorders. Oxytocin (OT) is a neurohormone involved in both repetitive/rigid and social behaviors. This study is focusing on how a single dose of intranasal OT (IN-OT) affects cognitive rigidity and social perception tasks. Taking OT as a spray through the nose increases social and decreases repetitive behavior in some adults with ASD, and we are exploring if it helps children with ASD similarly. However, it is unclear whether every person with ASD has an abnormal OT level, and if OT affects restrictive or social behavior differently. Consequently, we aim to study whether OT treatment can be effective in treating subgroups with specific features of ASD. We will use approaches utilizing both behavioral and physiological responses to clarify the role of OT in ASD. We will develop a deeper understanding of the range of social and rigid behaviors and use that information to identify persons with ASD who would benefit from OT treatment. Potential subjects will be asked if they want to participate in two sessions in our clinical laboratory where they will get either single dose IN-OT or placebo. After receiving the substance, they will be asked to do a handful of tasks while we monitor heart rate, eye movements, and collect baseline and post intranasal blood, urine and saliva. The levels of hormones, metabolites and peptides related to or interacting with OT will be measures in the collected samples of blood plasma, urine and saliva. Additionally DNA will be extracted from the blood samples to study genes related to OT and ASD.

Interventions

Intranasal OxytocinDrug
PlaceboDrug

Arms2

Placebo comparator
Placebo
Saline Nasal spray designed to look and feel like the drug intervention
Experimental
Intranasal Oxytocin
Oxytocin nasal spray designed to look as seem exactly like Placebo

Primary outcomes3

Outcomes the sponsor listed as primary.

Reading the Mind in the Eyes Task (RMET)
Time frame · 2 weeks
Registry description
Social Cognition Task-- We are reporting raw score (# of correct responses) Minimum value is 0 and maximum value is 28. A higher score means better performance / outcome.
Rapid Automatized Naming (RAN)
Time frame · 2 weeks
Registry description
Cognitive Rigidity Task for \>10 years old-- Time to name attribute of stimulus requested; minimum time is 0, there is no maximum time. Lower score is better.
Dynamic Affect Recognition Evaluation (DARE)
Time frame · 2 weeks
Registry description
Task Performance with Physiological Data. We reported the raw score - total number correct. Minimum is 0, maximum is 12. Higher score means better performance / outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 2 weeks

Reading the Mind in the Eyes Task (RMET)

Group	Value (total raw score)	Spread
Placebo Then Oxytocin	18.07	4.48
Intranasal Oxytocin Then Placebo	18.08	2.47

Primary outcomeMean· 2 weeks

Rapid Automatized Naming (RAN)

Group	Value (naming time (seconds))	Spread
Placebo Then Oxytocin	18.08	4.69
Intranasal Oxytocin Then Placebo	16.13	6.21

Primary outcomeMean· 2 weeks

Dynamic Affect Recognition Evaluation (DARE)

Group	Value (total raw score)	Spread
Placebo Then Oxytocin	8.5	3.32
Intranasal Oxytocin Then Placebo	8.45	3.67

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PlaceboSaline Nasal spray designed to look and feel like the drug intervention, then Placebo	0 / 27	0 / 27	14 / 27
Intranasal OxytocinOxytocin nasal spray designed to look as seem exactly like Placebo, then Intranasal Oxytocin	0 / 27	0 / 27	13 / 27

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 5 Years up to 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Participants will be between 5 and 40 years of age. * All subjects will have a diagnosis of autistic disorder or ASD that was confirmed by administration of the Autism Diagnostic Observation Schedule-WPS (ADOS-WPS) (30). * Eligible participants must be able to perform the cognitive learning tasks. Exclusion Criteria: * Although we acknowledge that concomitant medications, or other types of intervention, may potentially bias study results, participants will be allowed to stay on concomitant medications and non-pharmacologic treatments, provided that no changes are made within 3 months prior to baseline and that no changes are made during the study. * Individuals that are on antipsychotic drugs will be excluded from participation. All subjects must lack a significant medical history. * Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being will be excluded. * This includes, but is not limited to impairment of renal function, evidence or history of malignancy or any significant hematological, endocrine, respiratory, hepatic, cardiovascular or gastrointestinal disease. * All female subjects of childbearing capacity will have a urine pregnancy test (a positive test will exclude the subject from participation). * A pregnancy test will be conducted at both visits prior to drug administration. Uterine contractions may occur in women and are more likely to occur in pregnant women, especially towards the end of pregnancy. * As a result, we exclude pregnant female patients, sexually active female patients on hormonal birth control and sexually active females who do not use two types of non-hormonal birth control. * All interested potential subjects will be contacted via phone. If they meet eligibility criteria, two sessions that are approximately two weeks apart and approximately the same time of day will be scheduled. At their first visit, we will review the study and undergo informed consent procedures. Overall study procedures per visit are estimated to take approximately 2-3 hours per session, and are detailed in Table 2.

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