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Single Dose Intranasal Oxytocin and Cognitive Effects in Autism

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ClinicalTrials.gov Identifier: NCT02493426
Recruitment Status : Recruiting
First Posted : July 9, 2015
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Drug: Intranasal Oxytocin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Single Dose Intranasal Oxytocin (IN-OT) Versus Placebo in Autism: Examining Cognitive Effects
Actual Study Start Date : May 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Placebo Comparator: Placebo
Saline Nasal spray designed to look and feel like the drug intervention
Drug: Placebo
Experimental: Intranasal Oxytocin
Oxytocin nasal spray designed to look as seem exactly like Placebo
Drug: Intranasal Oxytocin



Primary Outcome Measures :
  1. Social Cognition Tasks [ Time Frame: 2 weeks ]
    Reading the Mind in the Eyes Task (RMET)Includes computerized & photo tasks such as Diagnostic Analysis of Nonverbal Accuracy (DANVA2; has auditory emotion ID component) , an updated version of Lets Face IT! computer task

  2. Cognitive Rigidity Tasks [ Time Frame: 2 weeks ]
    Probabilistic Reversal Learning (PRL) Task, Includes Rapid Automatized Naming (RAN) , Stop Signal Task

  3. Brain Body Physiology measures [ Time Frame: 2 weeks ]
    Data will be collected continuously during the session to examine if specific tasks require more emotion regulation. Blood pressure will be collected twice during the session, once pre challenge and once post challenge.Eye tracking paired with Dynamic Affect Recognition Evaluation (DARE) and facial/video recognition task images.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493426


Contacts
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Contact: Suma Jacob, MD/PhD 612-625-8448 sjacob@umn.edu

Locations
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United States, Minnesota
Center for Neurobehavioral Development Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Emma Shankland, B.S.    612-625-8448    shank092@umn.edu   
Principal Investigator: Suma Jacob, MD, PhD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Suma Jacob, MD/PhD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02493426     History of Changes
Other Study ID Numbers: INOT Challenge
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs