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Single Dose Intranasal Oxytocin and Cognitive Effects in Autism

NCT02493426 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-01-23

Study results available
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Summary

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.

Conditions

  • Autism Spectrum Disorders

Interventions

DRUG

Intranasal Oxytocin

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Suma Jacob, MD/PhD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02493426 on ClinicalTrials.gov