- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02493426
Single Dose Intranasal Oxytocin and Cognitive Effects in Autism
January 4, 2023 updated by: University of Minnesota
Single Dose Intranasal Oxytocin (IN-OT) Versus Placebo in Autism: Examining Cognitive Effects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55414
- Center for Neurobehavioral Development
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 40 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reading the Mind in the Eyes Task (RMET)
Time Frame: 2 weeks
|
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.
|
2 weeks
|
Rapid Automatized Naming (RAN)
Time Frame: 2 weeks
|
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.
|
2 weeks
|
Dynamic Affect Recognition Evaluation (DARE)
Time Frame: 2 weeks
|
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.
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Suma Jacob, MD/PhD, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2014
Primary Completion (Actual)
March 31, 2021
Study Completion (Actual)
March 31, 2021
Study Registration Dates
First Submitted
July 6, 2015
First Submitted That Met QC Criteria
July 8, 2015
First Posted (Estimate)
July 9, 2015
Study Record Updates
Last Update Posted (Actual)
January 23, 2023
Last Update Submitted That Met QC Criteria
January 4, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSYCH-2016-21943
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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