<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/NCT03031405</url>
  </required_header>
  <id_info>
    <org_study_id>Charite2017-Oxytocin-Study</org_study_id>
    <nct_id>NCT03031405</nct_id>
  </id_info>
  <brief_title>The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories</brief_title>
  <official_title>The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories: A Model to Understand the Development of Posttraumatic Stress Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Central Institute of Mental Health, Mannheim</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <brief_summary>
    <textblock>
      The purpose of the study is to examine whether oxytocin and oxytocin receptor gene&#xD;
      polymorphism affect the development of intrusive memories, a cardinal symptom of PTSD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>Factorial Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intrusive memories</measure>
    <time_frame>four consecutive days</time_frame>
    <description>Influence of oxytocin on the development of intrusive memories measured with an intrusion diary</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Noradrenergic System (measured with salivary alpha-amylase - u/ml)</measure>
    <time_frame>Day 1</time_frame>
    <description>Influence of oxytocin on the noradrenergic system measured with salivary alpha-amylase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genetic polymorphism</measure>
    <time_frame>four consecutive days</time_frame>
    <description>Influence of genetic polymorphism of the oxytocin receptor on intrusive memories measured with an intrusion diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)</measure>
    <time_frame>Day 1</time_frame>
    <description>Influence of oxytocin on the HPA-axis measured with salivary cortisol</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Intrusive Memories</condition>
  <arm_group>
    <arm_group_label>Oxytocin and trauma film paradigm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo and trauma film paradigm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin nasal spray</intervention_name>
    <arm_group_label>Oxytocin and trauma film paradigm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Placebo nasal spray</description>
    <arm_group_label>Placebo and trauma film paradigm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy female volunteers&#xD;
&#xD;
          -  German on a native level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  former or present disorder according to the Diagnostic and Statistical Manual of&#xD;
             Mental Disorders 5 (DSM-5)&#xD;
&#xD;
          -  any physical illnesses&#xD;
&#xD;
          -  any medication intake (except oral contraceptive)&#xD;
&#xD;
          -  history of traumatic experience, e.g. history of sexual abuse or rape&#xD;
&#xD;
          -  pregnancy or lactation period&#xD;
&#xD;
          -  follicular phase of menstrual cycle for all women not using oral contraceptives&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan Roepke, PD Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>August 19, 2018</last_update_submitted>
  <last_update_submitted_qc>August 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Katharina Schultebraucks</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </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/NCT03031405
org study id: Charite2017-Oxytocin-Study
nct id: NCT03031405
lead sponsor: 
collaborator: 
The purpose of the study is to examine whether oxytocin and oxytocin receptor gene
      polymorphism affect the development of intrusive memories, a cardinal symptom of PTSD.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Intrusive memories
time frame: four consecutive days
description: Influence of oxytocin on the development of intrusive memories measured with an intrusion diary
measure: Noradrenergic System (measured with salivary alpha-amylase - u/ml)
time frame: Day 1
description: Influence of oxytocin on the noradrenergic system measured with salivary alpha-amylase
measure: Genetic polymorphism
time frame: four consecutive days
description: Influence of genetic polymorphism of the oxytocin receptor on intrusive memories measured with an intrusion diary
measure: Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)
time frame: Day 1
description: Influence of oxytocin on the HPA-axis measured with salivary cortisol
arm group label: Oxytocin and trauma film paradigm
arm group type: Experimental
arm group label: Placebo and trauma film paradigm
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Oxytocin nasal spray
arm group label: Oxytocin and trauma film paradigm
intervention type: Drug
intervention name: Placebos
description: Placebo nasal spray
arm group label: Placebo and trauma film paradigm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stefan Roepke, PD Dr.
role: Study Director
affiliation: Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Katharina Schultebraucks
investigator title: PhD
mesh term: Oxytocin