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Autism Oxytocin Brain Project

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ClinicalTrials.gov Identifier: NCT03033784
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Elissar Andari, Emory University

Brief Summary:
The main goal of the study is to look at the effects of intranasal oxytocin on the brain in Autism Spectrum Disorder (ASD). Oxytocin is a hormone that exists naturally in the body and the brain. It affects a wide range of social behaviors and emotions. Investigators also seek to study how the effects of oxytocin treatment can be affected by genetic, immune and environmental factors.

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

Detailed Description:

This study consists of investigating the effects of several doses of acute administration of intranasal oxytocin on brain activity in adults with Autism Spectrum Disorder (ASD). There is increasing evidence for the role of intranasal oxytocin (IN-OT) in enhancing social skills in ASD. Nevertheless, there is still a need of determining target engagement for oxytocin's action on brain and behavior. Here, investigators are studying the effects of different doses of IN-OT on the modulation of behavioral outcomes and neural responses in a double blind crossover study in individuals with ASD.

The aims of the research are to:

  1. Study the effects of IN-OT doses on the modulation of brain functional connectivity between key socio-emotional brain regions during resting state in ASD
  2. Study the effects of IN-OT doses on the BOLD activity of key emotional and perceptual brain networks in response to social cues (such as faces)
  3. Study the effects of IN-OT on the BOLD activity of brain regions during an interactive social environment (ball game) in ASD

Investigators will compare the neuroimaging and behavioral results of individuals with ASD to control healthy males who will receive intranasal placebo. Investigators are also investigating the role of genetic factors, behavioral or clinical sub-groups of ASD, immune and environmental factors in modulating the effect of IN-OT on brain and behavior.

Participants will undergo 4 clinical visits during which they receive various randomly assigned doses of intranasal oxytocin and placebo. Both participants and the experimenter will be blind to the type of the treatment administered.

There will be only one visit for healthy controls who will all receive placebo spray. The visit for healthy controls will be conducted in a single-blind design. The experimenter will be aware that the subject is receiving placebo. However, the participant will be told that he might receive oxytocin or placebo.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Target Engagement for Intranasal Oxytocin in Autism Spectrum Disorders, an fMRI Dose Response Study
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Autism Spectrum Disorder (ASD)
Male participants diagnosed with ASD will receive 12 puffs (6 in each nostril) of intranasal oxytocin (syntocinon) and placebo (assigned randomly) during 4 study visits.
Drug: Oxytocin
Participants will receive one dose of intranasal oxytocin at a dose of 8IU.
Other Name: syntocinon

Drug: Oxytocin
Participants will receive one dose of intranasal oxytocin at a dose of 24IU.
Other Name: syntocinon

Drug: Oxytocin
Participants will receive one dose of intranasal oxytocin at a dose of 48IU.
Other Name: syntocinon

Drug: Placebo
Participants will receive one dose of intranasal placebo.

Placebo Comparator: Healthy Control
Age matched healthy controls will receive placebo intranasal spray (12 puffs, 6 per nostril) during one study visit.
Drug: Placebo
Participants will receive one dose of intranasal placebo.




Primary Outcome Measures :
  1. Difference in Resting State Functional Connectivity (rsFC) [ Time Frame: Post Intervention (Up to 40 minutes) ]
    Investigators will study the effects of intranasal oxytocin (IN-OT) on the resting state functional connectivity between key socio-emotional and social salience brain regions using functional magnetic resonance imaging (fMRI).Resting state functional connectivity is a task-independent metric of brain activity that is based on correlations between low-frequency fluctuations of the blood oxygen level-dependent signal between several brain regions. It reflects the strength of a functional connection that is in good agreement with the underlying neuroanatomy and provides a system-level understanding of brain function.

  2. Difference in Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues [ Time Frame: Post Intervention (Up to 50 minutes) ]
    BOLD activity level will be assessed via fMRI during completion of the face perception task of emotional and neutral faces (FPT). Difference is defined as the difference in BOLD activity during the FPT in ASD between the different treatment conditions.

  3. Difference in Blood Oxygen Level Dependent (BOLD) Activity in Response to Dynamic Social Cues [ Time Frame: Post Intervention (Up to 70 minutes) ]
    BOLD activity level and functional connectivity between socio-emotional brain regions during the perception of emotional facial videos will be measured while playing a ball-game. Differences between the different treatment conditions (including placebo and oxytocin doses) will be assessed to study the impact of oxytocin on brain function in ASD.


Secondary Outcome Measures :
  1. Adapted Version of the Global Clinical Interview [ Time Frame: Post Intervention (Up to 180 minutes) ]
    Clinical improvements will be rated by a clinician as based on a videotaped interview conducted after the MRI scanning session. Differences between the different treatment conditions will be assessed to study the effect of IN-OXT on ASD at the clinical level. The improvement will be assessed based on the quality of social interaction between the experimenter and the participant.

  2. Eye Gaze [ Time Frame: Post Intervention (Up to 50 minutes) ]
    Eye gaze will be recorded via an eye tracker inside the MRI scanner during the face perception task (FPT). Differences between different treatment conditions will be assessed in ASD.

  3. Social Learning Test (SLT) Score [ Time Frame: Post Intervention (Up to 130 minutes) ]
    During the SLT, participants are asked to complete an implicit association test that will include the use of faces and words. There are several sessions in this test. The participant is asked to match the face or the word that is presented in the middle of the screen to one of the two categories that is presented to the top left and top right of the screen. Differences between treatment conditions will be assessed in ASD.

  4. Emotion Matching Test (EMT) Score [ Time Frame: Post Intervention (Up to 150 minutes) ]
    During the EMT, participants are asked to identify the emotion that is displayed on a face by matching the emotional face that appears on the left to one of the faces that appears to the right (different faces but same emotion). A higher score indicates more matches.

  5. Toronto Alexithymia Scale (TAS) Score [ Time Frame: Post Intervention (Up to 170 minutes) ]
    The TAS is a 20-item instrument that is one of the most commonly used measures of alexithymia. Alexithymia refers to people who have trouble identifying and describing emotions and who tend to minimise emotional experience and focus attention externally. The TAS-20 is a self-report scale that is comprised of 20 items. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia. Differences between treatment conditions in ASD will be assessed. Correlations between scores in this measure and brain function during resting state and the other social tasks will be also considered.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for ASD Participants:

  • Have an ASD diagnosis based on the Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview (ADI) criteria, gold standards of research-based autism diagnosis
  • IQ>70
  • Normal or corrected-to-normal vision

Exclusion Criteria for ASD Participants:

  • Recent occurrence of seizures (past 5 years)
  • Brain damage or head trauma (can be included at discretion of PI and sponsor)
  • Color blind
  • Cardiovascular disease
  • Presence of a severe medical problem
  • Severe mental retardation
  • Alcoholism or substance abuse
  • Asthma (can be included at the discretion of study physician/nurse practitioner if episodes are infrequent and no active problems at time of the study)
  • Migraine headaches (at the discretion of the nurse practitioner or the study physician)
  • Claustrophobia (at discretion of study physician/designee/PI)
  • Pacemakers, cochlear implants, surgical clips or metal fragments

Inclusion Criteria for Healthy Age-Matched Controls:

  • IQ > 70
  • Normal or corrected-to-normal vision

Exclusion Criteria for Healthy Age-Matched Controls:

  • History of seizures
  • Neurological disorder
  • Current psychiatric disorder
  • Previous psychiatric disorder (can be included at discretion of PI)
  • Current use of psychoactive drugs
  • Previous use of psychoactive drugs (can be included at discretion of PI)
  • Head trauma (can be included at discretion of PI)
  • Alcoholism or substance abuse
  • Cardiovascular disease
  • Color blind
  • Asthma (can be included at the discretion of study physician/nurse practitioner if episodes are infrequent and no active problems at time of the study)
  • Migraine headaches (at the discretion of the nurse practitioner or the study physician)
  • Claustrophobia (at discretion of study physician/designee/PI)
  • Presence of a severe medical problem
  • Severe mental retardation
  • Pacemakers, cochlear implants, surgical clips or metal fragments

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): NCT03033784


Contacts
Contact: Elissar Andari, PhD 404-712 9661 eandari@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Elissar Andari, PhD    404-712-9661    eandari@emory.edu   
Sponsors and Collaborators
Emory University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Elissar Andari, PhD Emory University

Responsible Party: Elissar Andari, Post Doctoral Fellow, Emory University
ClinicalTrials.gov Identifier: NCT03033784     History of Changes
Other Study ID Numbers: IRB00093455
P50MH100023 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elissar Andari, Emory University:
Neuroscience

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs