<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/NCT03011970</url>
  </required_header>
  <id_info>
    <org_study_id>OXT_KINO</org_study_id>
    <nct_id>NCT03011970</nct_id>
  </id_info>
  <brief_title>Temporal Dynamics and Pharmacokinetics of Intranasally Administered Oxytocin</brief_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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala&#xD;
      response vary as a function of treatment dose and dose-test latency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the present study is to determine whether intranasal oxytocin (IN-OXT)&#xD;
      effects on blood oxygenation level-dependent functional magnetic resonance imaging (BOLD&#xD;
      fMRI) in the amygdala vary as a function of dose and latency. In particular, the&#xD;
      investigators plan to compare effects of three different IN-OXT doses (12, 24, and 48&#xD;
      international units, IU) and three different dose-test latencies of IN-OXT administration&#xD;
      (task starting at 15, 45 and 75min after administration) on established neural and&#xD;
      behavioural correlates of emotion processing. As effects of OXT are particularly promising in&#xD;
      autism, the investigators further want to investigate how autistic-like traits influence the&#xD;
      OXT effects in exploratory post-hoc analyses&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala</measure>
    <time_frame>45min after nasal spray administration</time_frame>
    <description>Magnetic resonance imaging (MRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli of varying intensity. The investigators specifically plan to investigate amygdala response to fearful faces, as this subcortical region has repeatedly been reported to show activation changes after OXT treatment.&#xD;
Dose-test latency varies between the different treatment arms (i.e. imaging starts 15min [arm 1], 45min [arm 2,4 and 5] or 75min [arm 3] after nasal spray administration).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ratings of emotional faces</measure>
    <time_frame>45min after nasal spray administration</time_frame>
    <description>During each trial, subjects are asked to use a button response grip to indicate whether they perceived the depicted face as neutral, fearful or happy.&#xD;
Depending on the treatment arm, ratings are recorded 15min (arm 1), 45min (arm 2,4 and 5) or 75min (arm 3) after nasal spray administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire measurement of mood (PANAS)</measure>
    <time_frame>10 min before and 105 min after nasal spray administration</time_frame>
    <description>Positive and negative affect is assessed via self-rating questionnaire 'The Positive and Negative Affect Schedule' using a categorical 5 point scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire measurement of anxiety (STAI).</measure>
    <time_frame>10 min before and 105 min after nasal spray administration</time_frame>
    <description>State anxiety is assessed via self-rating questionnaire 'and State Trait Anxiety Inventory' using a categorical 4 point scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saliva oxytocin concentrations</measure>
    <time_frame>immediately before the nasal spray administration and (on average) 15,40,80 and 105 min after administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma oxytocin concentrations</measure>
    <time_frame>immediately before the nasal spray administration and immediately after the fMRI experiment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modulatory effects of autistic like traits on neural and behavioral outcome measures</measure>
    <time_frame>screening session, ~7days prior to imaging session</time_frame>
    <description>Autistic like traits are assessed via Autism Spectrum quotient in a screening session, preceding the testing sessions. The investigators expect pronounced OXT effects in subjects with high autistic-like traits.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Oxytocin; 24IU, 15min</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intranasal administration, 24 international units (IU) oxytocin. Imaging starting 15min after nasal spray administration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxytocin; 24IU, 45min</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intranasal administration, 24 IU oxytocin. Imaging starting 45min after nasal spray administration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxytocin; 24IU, 75min</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intranasal administration, 24 IU oxytocin. Imaging starting 75min after nasal spray administration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxytocin; 12IU, 45min</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intranasal administration, 12 IU oxytocin. Imaging starting 45min after nasal spray administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxytocin; 48IU, 45min</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intranasal administration, 48 IU oxytocin. Imaging starting 45min after nasal spray administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo nasal spray.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <arm_group_label>Oxytocin; 12IU, 45min</arm_group_label>
    <arm_group_label>Oxytocin; 24IU, 15min</arm_group_label>
    <arm_group_label>Oxytocin; 24IU, 45min</arm_group_label>
    <arm_group_label>Oxytocin; 24IU, 75min</arm_group_label>
    <arm_group_label>Oxytocin; 48IU, 45min</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</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 disease&#xD;
&#xD;
          -  Current or past physical illness&#xD;
&#xD;
          -  Psychoactive medication&#xD;
&#xD;
          -  Tobacco smokers&#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>
        <state>North Rhine-Westphalia</state>
        <zip>53105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</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>Professor</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/NCT03011970
org study id: OXT_KINO
nct id: NCT03011970
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala
      response vary as a function of treatment dose and dose-test latency.
The objective of the present study is to determine whether intranasal oxytocin (IN-OXT)
      effects on blood oxygenation level-dependent functional magnetic resonance imaging (BOLD
      fMRI) in the amygdala vary as a function of dose and latency. In particular, the
      investigators plan to compare effects of three different IN-OXT doses (12, 24, and 48
      international units, IU) and three different dose-test latencies of IN-OXT administration
      (task starting at 15, 45 and 75min after administration) on established neural and
      behavioural correlates of emotion processing. As effects of OXT are particularly promising in
      autism, the investigators further want to investigate how autistic-like traits influence the
      OXT effects in exploratory post-hoc analyses
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala
time frame: 45min after nasal spray administration
description: Magnetic resonance imaging (MRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli of varying intensity. The investigators specifically plan to investigate amygdala response to fearful faces, as this subcortical region has repeatedly been reported to show activation changes after OXT treatment.
Dose-test latency varies between the different treatment arms (i.e. imaging starts 15min [arm 1], 45min [arm 2,4 and 5] or 75min [arm 3] after nasal spray administration).
measure: Ratings of emotional faces
time frame: 45min after nasal spray administration
description: During each trial, subjects are asked to use a button response grip to indicate whether they perceived the depicted face as neutral, fearful or happy.
Depending on the treatment arm, ratings are recorded 15min (arm 1), 45min (arm 2,4 and 5) or 75min (arm 3) after nasal spray administration.
measure: Questionnaire measurement of mood (PANAS)
time frame: 10 min before and 105 min after nasal spray administration
description: Positive and negative affect is assessed via self-rating questionnaire 'The Positive and Negative Affect Schedule' using a categorical 5 point scale.
measure: Questionnaire measurement of anxiety (STAI).
time frame: 10 min before and 105 min after nasal spray administration
description: State anxiety is assessed via self-rating questionnaire 'and State Trait Anxiety Inventory' using a categorical 4 point scale.
measure: Saliva oxytocin concentrations
time frame: immediately before the nasal spray administration and (on average) 15,40,80 and 105 min after administration
measure: Plasma oxytocin concentrations
time frame: immediately before the nasal spray administration and immediately after the fMRI experiment
measure: Modulatory effects of autistic like traits on neural and behavioral outcome measures
time frame: screening session, ~7days prior to imaging session
description: Autistic like traits are assessed via Autism Spectrum quotient in a screening session, preceding the testing sessions. The investigators expect pronounced OXT effects in subjects with high autistic-like traits.
arm group label: Oxytocin; 24IU, 15min
arm group type: Active Comparator
description: Intranasal administration, 24 international units (IU) oxytocin. Imaging starting 15min after nasal spray administration.
arm group label: Oxytocin; 24IU, 45min
arm group type: Active Comparator
description: Intranasal administration, 24 IU oxytocin. Imaging starting 45min after nasal spray administration.
arm group label: Oxytocin; 24IU, 75min
arm group type: Active Comparator
description: Intranasal administration, 24 IU oxytocin. Imaging starting 75min after nasal spray administration.
arm group label: Oxytocin; 12IU, 45min
arm group type: Active Comparator
description: Intranasal administration, 12 IU oxytocin. Imaging starting 45min after nasal spray administration
arm group label: Oxytocin; 48IU, 45min
arm group type: Active Comparator
description: Intranasal administration, 48 IU oxytocin. Imaging starting 45min after nasal spray administration
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo nasal spray.
intervention type: Drug
intervention name: Oxytocin
arm group label: Oxytocin; 12IU, 45min
arm group label: Oxytocin; 24IU, 15min
arm group label: Oxytocin; 24IU, 45min
arm group label: Oxytocin; 24IU, 75min
arm group label: Oxytocin; 48IU, 45min
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Bonn
investigator full name: Rene Hurlemann
investigator title: Professor
mesh term: Oxytocin