<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01712464</url>
  </required_header>
  <id_info>
    <org_study_id>12-033</org_study_id>
    <nct_id>NCT01712464</nct_id>
  </id_info>
  <brief_title>Modulation of Reinforcement Learning</brief_title>
  <official_title>Modulation of Reinforcement Learning and Neuronal Activation in Ventral Stratum by Oxytocin - a Pilot Study at Autism Spectrum Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RWTH Aachen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RWTH Aachen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to examine the modulation of neuronal and behavioural parameters of social&#xD;
      reinforcement learning.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2013</start_date>
  <completion_date type="Actual">August 7, 2016</completion_date>
  <primary_completion_date type="Actual">August 7, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bold Signal in nucleus accumbens</measure>
    <time_frame>1 Day</time_frame>
    <description>during social learning at one treatment with oxytocin vs placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bold signal in ventral tegmental areal</measure>
    <time_frame>1 Day</time_frame>
    <description>during social learning at one treatment with oxytocin vs placebo</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Impact of Oxytocin on Social Learning</condition>
  <arm_group>
    <arm_group_label>Cross over Oxytocin and Placebo</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cross over Placebo and Oxytocin</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin vs. Placebo</intervention_name>
    <description>FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days</description>
    <arm_group_label>Cross over Oxytocin and Placebo</arm_group_label>
    <arm_group_label>Cross over Placebo and Oxytocin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 26 years&#xD;
&#xD;
          -  male&#xD;
&#xD;
          -  IQ&gt;80&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  proband understands character, extent and individual consequences of the study&#xD;
&#xD;
          -  competent persons who are able to follow the instructions of the study personnel&#xD;
&#xD;
          -  for ASD patients: assured ASD diagnosis, comply of the ASD criteria ADI-R/ADOS-G&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prosopagnosia&#xD;
&#xD;
          -  anaphylaxis of oxytocin or other chemical substances&#xD;
&#xD;
          -  metal inside the body or other contraindications of mri scan&#xD;
&#xD;
          -  physical illness which can affect the examinations or endanger the proband&#xD;
&#xD;
          -  actual or assumed drug or alcohol abuse&#xD;
&#xD;
          -  persons who are accommodated in an institution because of court or administrative&#xD;
             order&#xD;
&#xD;
          -  persons with a relationship of dependence to the sponsor or investigator&#xD;
&#xD;
          -  healthy probands: psychiatric disorder according to ICD-10-WHO F at the moment and in&#xD;
             history, continuous drug-intake at time of measurements&#xD;
&#xD;
          -  patients with ASD: psychiatric disorder according to ICD-10-WHO F (except ASD disorder&#xD;
             in patient group) during the last 12 month being not treated, continuous drug-intake&#xD;
             at time of measurements (psychotropic medication), exception: stimulants used for&#xD;
             treatment of attention disorders, if they can come off for the measurements&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Schulte-Rüther, Dr. rer. nat</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Aachen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universtiy Hospital Aachen</name>
      <address>
        <city>Aachen</city>
        <state>Northrhine-Westfalia</state>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>April 30, 2018</last_update_submitted>
  <last_update_submitted_qc>April 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01712464
org study id: 12-033
nct id: NCT01712464
lead sponsor: 
has dmc: No
This study aims to examine the modulation of neuronal and behavioural parameters of social
      reinforcement learning.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
measure: Bold Signal in nucleus accumbens
time frame: 1 Day
description: during social learning at one treatment with oxytocin vs placebo
measure: Bold signal in ventral tegmental areal
time frame: 1 Day
description: during social learning at one treatment with oxytocin vs placebo
arm group label: Cross over Oxytocin and Placebo
arm group type: Other
description: FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days
arm group label: Cross over Placebo and Oxytocin
arm group type: Other
description: FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days
intervention type: Drug
intervention name: Oxytocin vs. Placebo
description: FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days
arm group label: Cross over Oxytocin and Placebo
arm group label: Cross over Placebo and Oxytocin
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Martin Schulte-Rüther, Dr. rer. nat
role: Study Director
affiliation: University Hospital, Aachen
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Oxytocin