Autism Oxytocin Brain Project
Condition: Autism; Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

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, affecting a wide range of social behaviors and emotions. The investigators will
      study the effects of different treatments (3 doses of oxytocin and one dose of placebo) on
      brain functional connectivity at rest in patients with ASD, using functional magnetic
      resonance imaging (fMRI). Investigators also seek to study how the effects of oxytocin
      treatment can be affected by genetic, immune and environmental factors.
    

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 blood-oxygen-level dependent (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 with ASD 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.
    

Intervention name(s): 8 International Units (IU) of Oxytocin; 24IU of Oxytocin; 48IU of Oxytocin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive one dose of intranasal oxytocin at a dose of 8IU.; Participants will receive one dose of intranasal oxytocin at a dose of 24IU.; Participants will receive one dose of intranasal oxytocin at a dose of 48IU.; Participants will receive an intranasal placebo to match the oxytocin doses.
Other intervention name(s): syntocinon; syntocinon; syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Neuroscience