<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/NCT03041870</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL16_0014</org_study_id>
    <secondary_id>2016-A01588-43</secondary_id>
    <nct_id>NCT03041870</nct_id>
  </id_info>
  <brief_title>Relationship Between Serotonin and Brain Response to Social Dominance and Emotion Perception.</brief_title>
  <acronym>SERODOM</acronym>
  <official_title>Relationship Between Serotonin and Brain Response to Social Dominance Perception and Emotion: a Combined [11C]DASB-PET/fMRI Study in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies have already revealed the involvement of the serotoninergic system in the&#xD;
      social behavior process. For example, more serotonin (5HT) was found in dominant male adult&#xD;
      monkeys. Little is known about the serotoninergic implication in human's social behavior. The&#xD;
      project aims to clarify the role of the serotoninergic system in social behavior in relation&#xD;
      to the process of social hierarchical information. In order to determine how serotoninergic&#xD;
      system is involved, the investigator will use a new technic TEP-fMRI. This technic allows us&#xD;
      to measure the brain activity and the serotoninergic transporter occupancy (using the&#xD;
      [C11]-DASB) at the same time. The current study aims to investigate whether serotonin&#xD;
      transporter (5-HTT) activity correlates with the neural response (BOLD) during the detection&#xD;
      of social dominance in facial expressions or other measures of social information processing.&#xD;
      Blood sample, SLC6A4 (allele coding for the 5HT transporter) genotyping and&#xD;
      neuropsychological questionnaires will give at the investigator more information and allow to&#xD;
      investigate whether performance on social information processing is modulated by personality&#xD;
      trait and genotype.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2017</start_date>
  <completion_date type="Actual">June 21, 2019</completion_date>
  <primary_completion_date type="Actual">June 21, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>level of Blood-Oxygen-Level Dependent (BOLD) signal</measure>
    <time_frame>at day 0</time_frame>
    <description>The BOLD signal will be measured using a MRI scanner, and simultaneously we will record the level of serotonin transporter with [11C]DASB marker of the serotonin transmission, using a PET signal. We will use the Scatchard method in order to determine the level of [11C]DASB bonded to the transporter. Our reference region will be the cerebellum.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>level of serotonin transporter</measure>
    <time_frame>at day 0</time_frame>
    <description>The BOLD signal will be measured using a MRI scanner, and simultaneously we will record the level of serotonin transporter with [11C]DASB marker of the serotonin transmission, using a PET signal. We will use the Scatchard method in order to determine the level of [11C]DASB bonded to the transporter. Our reference region will be the cerebellum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Behavioral assessment</measure>
    <time_frame>at day 0</time_frame>
    <description>During the entire scanner, subjects will be ask to perform a behavioral task. Their responses will be analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Testosterone Blood level</measure>
    <time_frame>after the scan session at day 0</time_frame>
    <description>The testosterone will be measured on a blood sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortisol Blood level</measure>
    <time_frame>after the scan session at day 0</time_frame>
    <description>The cortisol will be measured on a blood sample (prelevated at same time than testosterone).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SLC6A4 genotyping</measure>
    <time_frame>at day 0</time_frame>
    <description>The genotyping of this gene (SLC6A4) will be realized on a sample of saliva.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Dominance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PET-fMRI scan</intervention_name>
    <description>fMRI scan include MR sequences: BOLD and fMRI. The PET acquisition will be carried out in dynamic for 90 consecutive minutes following intravenous administration of 4 MBq / kg dose of [11C]DASB bolus.</description>
    <arm_group_label>Dominance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  French speaking&#xD;
&#xD;
          -  Normal vision&#xD;
&#xD;
          -  Age from 18 to 45&#xD;
&#xD;
          -  Without psychiatric antecedent&#xD;
&#xD;
          -  Without any neurologic antecedent&#xD;
&#xD;
          -  Not taking psychotropic or anxiolytic drugs&#xD;
&#xD;
          -  Having health insurance coverage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject does not wish to be notified of any anomalies detected during MRI&#xD;
&#xD;
          -  Subjects suffering from claustrophobia&#xD;
&#xD;
          -  Subjects carrying magnetic metal objects that cannot be removed as cochlear implant,&#xD;
             surgical clips, piercings, pacemakers, mechanical valves&#xD;
&#xD;
          -  Subjects participating in a clinical trial or being in a period of exclusion from a&#xD;
             previous clinical trial&#xD;
&#xD;
          -  Person under guardianship or curatorship or deprived of liberty or in emergencies&#xD;
&#xD;
          -  Taking unauthorized treatment in the month before the completion of the review&#xD;
&#xD;
          -  Person whose physical or mental condition does not allow him to pass the test study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian SCHEIBER</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon - CNRS UMR 5229</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>July 15, 2019</last_update_submitted>
  <last_update_submitted_qc>July 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PET-fMRI</keyword>
  <keyword>dominance</keyword>
  <keyword>5HT transporter</keyword>
  <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/NCT03041870
org study id: 69HCL16_0014
secondary id: 2016-A01588-43
nct id: NCT03041870
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Previous studies have already revealed the involvement of the serotoninergic system in the
      social behavior process. For example, more serotonin (5HT) was found in dominant male adult
      monkeys. Little is known about the serotoninergic implication in human's social behavior. The
      project aims to clarify the role of the serotoninergic system in social behavior in relation
      to the process of social hierarchical information. In order to determine how serotoninergic
      system is involved, the investigator will use a new technic TEP-fMRI. This technic allows us
      to measure the brain activity and the serotoninergic transporter occupancy (using the
      [C11]-DASB) at the same time. The current study aims to investigate whether serotonin
      transporter (5-HTT) activity correlates with the neural response (BOLD) during the detection
      of social dominance in facial expressions or other measures of social information processing.
      Blood sample, SLC6A4 (allele coding for the 5HT transporter) genotyping and
      neuropsychological questionnaires will give at the investigator more information and allow to
      investigate whether performance on social information processing is modulated by personality
      trait and genotype.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: level of Blood-Oxygen-Level Dependent (BOLD) signal
time frame: at day 0
description: The BOLD signal will be measured using a MRI scanner, and simultaneously we will record the level of serotonin transporter with [11C]DASB marker of the serotonin transmission, using a PET signal. We will use the Scatchard method in order to determine the level of [11C]DASB bonded to the transporter. Our reference region will be the cerebellum.
measure: level of serotonin transporter
time frame: at day 0
description: The BOLD signal will be measured using a MRI scanner, and simultaneously we will record the level of serotonin transporter with [11C]DASB marker of the serotonin transmission, using a PET signal. We will use the Scatchard method in order to determine the level of [11C]DASB bonded to the transporter. Our reference region will be the cerebellum.
measure: Behavioral assessment
time frame: at day 0
description: During the entire scanner, subjects will be ask to perform a behavioral task. Their responses will be analyzed.
measure: Testosterone Blood level
time frame: after the scan session at day 0
description: The testosterone will be measured on a blood sample.
measure: Cortisol Blood level
time frame: after the scan session at day 0
description: The cortisol will be measured on a blood sample (prelevated at same time than testosterone).
measure: SLC6A4 genotyping
time frame: at day 0
description: The genotyping of this gene (SLC6A4) will be realized on a sample of saliva.
arm group label: Dominance
arm group type: Experimental
description: Healthy subjects
intervention type: Device
intervention name: PET-fMRI scan
description: fMRI scan include MR sequences: BOLD and fMRI. The PET acquisition will be carried out in dynamic for 90 consecutive minutes following intravenous administration of 4 MBq / kg dose of [11C]DASB bolus.
arm group label: Dominance
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christian SCHEIBER
role: Principal Investigator
affiliation: Hospices Civils de Lyon - CNRS UMR 5229
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No