<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/NCT03829839</url>
  </required_header>
  <id_info>
    <org_study_id>LOXY</org_study_id>
    <nct_id>NCT03829839</nct_id>
  </id_info>
  <brief_title>Effects of Oxytocin and Lorazepam on Fear-related Intra-amygdalar Activity</brief_title>
  <official_title>Common and Dissociable Effects of Oxytocin and Lorazepam on the Neurocircuitry of Fear - an Ultra-high Field Imaging Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bonn</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bonn</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      High-potency benzodiazepines have strong anxiolytic effects accompanied by significant&#xD;
      adverse effects including impaired cognitive function, drowsiness, dizziness and impaired&#xD;
      motoric abilities. Importantly, the long-term use of benzodiazepines may produce dependence&#xD;
      and withdrawal. Therefore, there is considerable scientific and public interest in&#xD;
      identifying new anxiolytic agents.&#xD;
&#xD;
      The hypothalamic peptide oxytocin (OXT) has anxiolytic effects both in healthy participants&#xD;
      and patients with anxiety disorders by decreasing fear-associated amygdala activity. However,&#xD;
      so far no human study has directly compared the underlying anxiolytic mechanisms of OXT and&#xD;
      established anxiolytic agents on amygdala activity. Importantly, the amygdala is not a&#xD;
      homogenous structure but rather consists of several subdivisions with structural and&#xD;
      functional differences.&#xD;
&#xD;
      Therefore, the rationale of the present project is to determine the effects of intranasal OXT&#xD;
      and the high-potency benzodiazepine lorazepam on fear-associated responses in intra-amygdalar&#xD;
      subregions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2016</start_date>
  <completion_date type="Actual">August 16, 2017</completion_date>
  <primary_completion_date type="Actual">August 16, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neural responses to emotional faces in the amygdala subregions</measure>
    <time_frame>Neural activations with be measured with 7 Tesla fMRI in an emotional face matching task that lasts 20 mins</time_frame>
    <description>Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate amygdala subregion responses to emotional faces.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Oxytocin, Lorazepam, Anti-Anxiety Agents, Physiological Effects of Drugs</condition>
  <arm_group>
    <arm_group_label>Oxytocin or PLC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose of intranasal oxytocin (24 international units) or PLC.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lorazepam or PLC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose of lorazepam (1mg) or PLC</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>Intranasal administration, 24 international units (IU) oxytocin</description>
    <arm_group_label>Oxytocin or PLC</arm_group_label>
    <other_name>syntocinon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lorazepam 1 mg</intervention_name>
    <description>Oral administration of 1mg lorazepam</description>
    <arm_group_label>Lorazepam or PLC</arm_group_label>
    <other_name>Tavor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo nasalspray</intervention_name>
    <description>The placebo nasalspray contain identical ingredients except for the active agent itself.</description>
    <arm_group_label>Oxytocin or PLC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>The placebo pill contain identical ingredients except for the active agent itself.</description>
    <arm_group_label>Lorazepam or PLC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy male volunteers&#xD;
&#xD;
          -  right-handed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or past psychiatric illness&#xD;
&#xD;
          -  Current or past physical illness&#xD;
&#xD;
          -  Psychoactive medication&#xD;
&#xD;
          -  Sedative medication&#xD;
&#xD;
          -  MRI contraindication (e.g. metal in body, claustrophobia)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Psychiatry, University of Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>53105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://renehurlemann.squarespace.com/welcome/</url>
    <description>Related Info</description>
  </link>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Bonn</investigator_affiliation>
    <investigator_full_name>Rene Hurlemann</investigator_full_name>
    <investigator_title>Vice Chair of the Department of Psychiatry and Chair of the Medical Psychology Division</investigator_title>
  </responsible_party>
  <keyword>Amygdala, anxiety, benzodiazepines, fear, fMRI, lorazepam, oxytocin, 7 Tesla</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lorazepam</mesh_term>
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03829839
org study id: LOXY
nct id: NCT03829839
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
High-potency benzodiazepines have strong anxiolytic effects accompanied by significant
      adverse effects including impaired cognitive function, drowsiness, dizziness and impaired
      motoric abilities. Importantly, the long-term use of benzodiazepines may produce dependence
      and withdrawal. Therefore, there is considerable scientific and public interest in
      identifying new anxiolytic agents.

      The hypothalamic peptide oxytocin (OXT) has anxiolytic effects both in healthy participants
      and patients with anxiety disorders by decreasing fear-associated amygdala activity. However,
      so far no human study has directly compared the underlying anxiolytic mechanisms of OXT and
      established anxiolytic agents on amygdala activity. Importantly, the amygdala is not a
      homogenous structure but rather consists of several subdivisions with structural and
      functional differences.

      Therefore, the rationale of the present project is to determine the effects of intranasal OXT
      and the high-potency benzodiazepine lorazepam on fear-associated responses in intra-amygdalar
      subregions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Neural responses to emotional faces in the amygdala subregions
time frame: Neural activations with be measured with 7 Tesla fMRI in an emotional face matching task that lasts 20 mins
description: Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate amygdala subregion responses to emotional faces.
arm group label: Oxytocin or PLC
arm group type: Active Comparator
description: Single dose of intranasal oxytocin (24 international units) or PLC.
arm group label: Lorazepam or PLC
arm group type: Active Comparator
description: Single dose of lorazepam (1mg) or PLC
intervention type: Drug
intervention name: Oxytocin
description: Intranasal administration, 24 international units (IU) oxytocin
arm group label: Oxytocin or PLC
other name: syntocinon
intervention type: Drug
intervention name: Lorazepam 1 mg
description: Oral administration of 1mg lorazepam
arm group label: Lorazepam or PLC
other name: Tavor
intervention type: Drug
intervention name: Placebo nasalspray
description: The placebo nasalspray contain identical ingredients except for the active agent itself.
arm group label: Oxytocin or PLC
intervention type: Drug
intervention name: Placebo Oral Tablet
description: The placebo pill contain identical ingredients except for the active agent itself.
arm group label: Lorazepam or PLC
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
url: http://renehurlemann.squarespace.com/welcome/
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Bonn
investigator full name: Rene Hurlemann
investigator title: Vice Chair of the Department of Psychiatry and Chair of the Medical Psychology Division
mesh term: Lorazepam
mesh term: Oxytocin
sharing ipd: No