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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

Tracking Information
First Submitted Date  ICMJE July 6, 2015
First Posted Date  ICMJE July 9, 2015
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE May 2014
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
  • 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
  • Cognitive Rigidity Tasks [ Time Frame: 2 weeks ]
    Probabilistic Reversal Learning (PRL) Task, Includes Rapid Automatized Naming (RAN) , Stop Signal Task
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2015)
  • 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
  • Cognitive Rigidity Tasks [ Time Frame: 2 weeks ]
    Probabilistic Reversal Learning (PRL) Task, Includes Rapid Automatized Naming (RAN) , Stop Signal Task
  • 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 recognitional task images.
Change History Complete list of historical versions of study NCT02493426 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Dose Intranasal Oxytocin and Cognitive Effects in Autism
Official Title  ICMJE Single Dose Intranasal Oxytocin (IN-OT) Versus Placebo in Autism: Examining Cognitive Effects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Autism Spectrum Disorders
Intervention  ICMJE
  • Drug: Intranasal Oxytocin
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Saline Nasal spray designed to look and feel like the drug intervention
    Intervention: Drug: Placebo
  • Experimental: Intranasal Oxytocin
    Oxytocin nasal spray designed to look as seem exactly like Placebo
    Intervention: Drug: Intranasal Oxytocin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 28, 2016)
30
Original Actual Enrollment  ICMJE
 (submitted: July 8, 2015)
60
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Suma Jacob, MD/PhD 612-625-8448 sjacob@umn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02493426
Other Study ID Numbers  ICMJE INOT Challenge
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota - Clinical and Translational Science Institute
Study Sponsor  ICMJE University of Minnesota - Clinical and Translational Science Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Suma Jacob, MD/PhD University of Minnesota - Clinical and Translational Science Institute
PRS Account University of Minnesota - Clinical and Translational Science Institute
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP