Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 29 for:    Developmental Disabilities | ( Map: Minnesota, United States )

Intranasal Oxytocin and Learning in Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02090829
Recruitment Status : Withdrawn (Low recruitment)
First Posted : March 18, 2014
Last Update Posted : November 1, 2019
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE February 28, 2014
First Posted Date  ICMJE March 18, 2014
Last Update Posted Date November 1, 2019
Actual Study Start Date  ICMJE March 2014
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2014)
  • Change from Baseline to Post-testing on the The Part/Whole Identity Test [ Time Frame: Baseline/Follow-up post testing (max 12 days) ]
    4) Part/Whole Identity Test measures the extent to which the participant employed a featural or holistic face recognition strategy. In this task, a sample face is presented for 4 sec, followed by a test face composed of either two whole faces or two face parts. As expected in Part/Whole Identity, effect sizes ranged from a low 0.30 for the part mouth condition to a high of 0.81 for the whole eye condition, such that the condition measuring holistic processing in the eye region was most sensitive to group differences. This measure was also most sensitive to behavioral changes with the LFI intervention trial.
  • Change from Baseline to Post-testing on the Reading the Mind in the Eyes Task [ Time Frame: Baseline to Post-testing (max. 12 days) ]
    Reading the Mind in the Eyes Test (child version) (Baron-Cohen, et al., 2001) is a test of emotion recognition. This test asks children to pick the best word out of four options to describe the mental state of a set of eyes. The test includes 28 photographs of eyes with both affective (e.g., upset) and cognitive (e.g., thoughtful) mental state words as choices.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2014)
Change from Baseline to Post-testing on measures of social attention, reward/motivation, perception and cognition [ Time Frame: Baseline/follow-up (after max 12 days) ]
Behavioral tasks: watching social interactions eye tracking-task, happy faces eye-tracking tasks, signal detection social task, discrimination task
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Oxytocin and Learning in Autism
Official Title  ICMJE Promoting Social Perceptual Learning With Oxytocin in Autism
Brief Summary : The objective of this study is to determine the tolerability and therapeutic potential of oxytocin in children and adolescents with Autism Spectrum Disorders (ASD) when paired with a computer game intervention that is designed to enhance face perception skills. We designate two measures as our primary outcomes, based on prior published work with these interventions, and we propose a sample based on power analyses from these prior results. A second objective of this study is to learn about the breadth of possible positive effects that this combination therapy might have for children with ASD. To this end, we include a host of other exploratory measures that assess aspects of social motivation and attention, social perception, and social cognition. Thus, a second objective is to conduct a "signal finding" study - to gather outcome data on a range of dependent variables that theoretically should be related to oxytocin's effects on social processes, but for which there are no prior data. The signal finding aspect of this study will provide the preliminary data needed to design a more targeted follow up study.
Detailed Description

This is a double-blind placebo-controlled trial of intranasal oxytocin in 52 children and adolescents with ASD. Diagnosis will be confirmed using Diagnostic and Statistical Manual (DSM) criteria, supported by the Autism Diagnostic Interview and the Autism Diagnostic Observation Schedule. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of the FaceStation computer games, developed at CHOP. Measures of social function and cognition will be administered before and after the game play period. Two measures of social functioning will serve as our primary endpoints; all other measures will be treated as exploratory variables, with significance testing corrected for multiple comparisons.

Recognizing faces is critical to social functioning, and can be improved for individuals with ASD by using intervention software in the form of appropriately designed computer games. The effects of this type of social intervention may be amplified with the concurrent use of oxytocin. Furthermore, these learning effects may impact social skills in general and translate to the level of the individual's everyday social behavior. Thus, the objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with ASD when paired with a computer game intervention that is designed to enhance face perception skills.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorders
Intervention  ICMJE
  • Drug: Syntocinon (synthetic oxytocin)
    Syntocinon is a nine residue cyclic peptide; the hormone is prepared synthetically to avoid possible contamination with vasopressin and other small polypeptides with biologic activity.
    Other Name: Syntocinon
  • Other: Placebo

    Placebo Comparator: Intranasal Placebo Intranasal placebo The placebo is identical to the oxytocin formulation with the exception of the active compound.

    Route of administration: Intranasal Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.

    One dose equals 6 spray puffs (3 puffs in each nostril).

Study Arms  ICMJE
  • Placebo Comparator: Placebo Group

    Placebo Comparator: Intranasal Placebo Intranasal placebo The placebo is identical to the oxytocin formulation with the exception of the active compound.

    Route of administration: Intranasal Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.

    One dose equals 6 spray puffs (3 puffs in each nostril).

    Intervention: Other: Placebo
  • Active Comparator: Experimental Group

    Intranasal oxytocin (Trade name: Syntocinon) Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.

    Route of administration: Intranasal Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.

    One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril). Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.

    Intervention: Drug: Syntocinon (synthetic 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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 20, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2014)
52
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects aged 12-17 years, Mental age ≥ 7 (as measured by an IQ test such as the Differential Ability Scales II).
  2. Gender: males
  3. Diagnosis of an ASD
  4. Consent: parent/guardian permission and child assent.
  5. Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in English
  6. Study participant needs to be on clinically stable, in the opinion of the study clinicians. Stability will be assessed by the clinicians based on information from and conversations with the parent, if necessary. The parent needs to commit verbally to not making any changes to his or her child's current treatments for the duration of this study.

Exclusion Criteria:

  1. History of traumatic brain injury, epilepsy/seizure disorder (except febrile seizures), or other significant medical, genetic, or acquired neurological abnormality affecting brain function and motor, sensory or higher cognitive functioning.
  2. Patients with one or more of the following: HIV, HBV, HCV, hemophilia (bleeding problems, recent nose and brain injuries), abnormal blood pressure (hypotension or hypertension), drug abuse, immunity disorder, or severe depression.
  3. Sensory impairments (e.g., significant vision/hearing loss).
  4. Gestational age below 35 weeks and/or perinatal injury.
  5. Profound mental retardation (e.g., IQ < 45) or sensory-motor difficulties that would preclude valid use of diagnostic instruments
  6. Lack of impairment in face recognition as determined by average or above average performance on the Benton Face Recognition Task.
  7. Female participants.
  8. Patients who are sensitive to Syntocinon or any components of its formulation.
  9. Fever at the time of the baseline visit, defined as temperature above 37.5 degrees Celsius or 99.5 degrees Fahrenheit.
  10. Judgment by the study physician/P.I. (Suma Jacob, M.D,) that the patient is not suitable for the study due to unforeseeable safety issues.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02090829
Other Study ID Numbers  ICMJE 1402M48250
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Children's Hospital of Philadelphia
Investigators  ICMJE
Principal Investigator: Suma Jacob, M.D. Ph.D University of Minnesota Department of Psychiatry
PRS Account University of Minnesota
Verification Date October 2019

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