<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/NCT01713556</url>
  </required_header>
  <id_info>
    <org_study_id>09 106 01</org_study_id>
    <nct_id>NCT01713556</nct_id>
  </id_info>
  <brief_title>Treatment of PTSD by Reduction of Traumatic Memory Reconsolidation by Propranolol : a Multisite Trial</brief_title>
  <acronym>REDUCTRAUMA2</acronym>
  <official_title>Treatment of PTSD by Reduction of Traumatic Memory Reconsolidation by Propranolol : a Multisite Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test whether propranolol, when given during a re-evocation of&#xD;
      a traumatic memory, is capable of reducing subsequent PTSD symptoms associated with that&#xD;
      memory.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-traumatic stress disorder (PTSD) develops following an exposure to a life threatening&#xD;
      event. One of the characteristic features of PTSD is the recurrence of intrusive memories of&#xD;
      an experienced trauma. The persistence of disturbing traumatic memories in PTSD is often&#xD;
      explained in terms of a trauma-induced enhancement of memory encoding. Several studies&#xD;
      indicate that an increased noradrenergic activity during trauma enhances the encoding of&#xD;
      memory. Elevated levels of norepinephrine in the cerebrospinal fluid of individuals with PTSD&#xD;
      and the correlation of this elevation with the severity of PTSD symptoms suggest that&#xD;
      increased noradrenergic activity is also involved in the maintenance of PTSD symptoms.&#xD;
      Reactivation of memory by retrieval also renders the memory labile and susceptible to&#xD;
      treatments. This latter process is referred to as memory reconsolidation. Consolidation and&#xD;
      reconsolidation both occur within a distinct time window following new learning (in&#xD;
      consolidation) and/or retrieval (in reconsolidation). Even well-consolidated old fear&#xD;
      memories undergo reconsolidation and may be disrupted by means of pharmacological&#xD;
      manipulation. Propranolol may be effective in treating PTSD long after symptoms have been&#xD;
      consolidated. Propranolol given after reactivation of the memory of a past traumatic event&#xD;
      reduces physiologic responding during subsequent mental imagery of the event.&#xD;
&#xD;
      HYPOTHESE: Subjects with chronic PTSD who receive propranolol before trauma evocation will&#xD;
      subsequently show decreased PTSD symptoms, compared to subjects who receive a placebo.&#xD;
&#xD;
      METHOD: 56 participants with chronic PTSD will be recruited for participation. On Week 1, the&#xD;
      subjects will complete a standardized measure of PTSD symptoms. Next, 90 minutes after the&#xD;
      administration of the study medication (either propranolol or placebo), participants will&#xD;
      undergo a script preparation procedure, during which they will disclose details of their&#xD;
      traumatic event. Scripts portraying this event will be prepared for subsequent replay.&#xD;
&#xD;
      On Week 2, after the administration of the study medication (either propranolol or placebo),&#xD;
      participants will be asked (reading the script) to engaged in a script-driven mental imagery&#xD;
      of the traumatic event. Following this procedure, PTSD symptoms will be assessed.&#xD;
&#xD;
      The same procedure will be repeated on Weeks 3, 4, 5 and 6. On Weeks 7 and 18, the&#xD;
      standardized measure of PTSD symptoms will be repeated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PTCD CheckList (PCL) total score.</measure>
    <time_frame>difference between week 1 (before administration of the study medication) and week 7 (one week after the last intake of study medication)</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Post-traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Propranolol + reactivation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>they have a script-driven mental imagery of the traumatic event white drug</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + reactivation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>They have a script-driven mental imagery of the traumatic event with placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propranolol</intervention_name>
    <arm_group_label>Propranolol + reactivation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trauma reactivation</intervention_name>
    <description>Trauma reactivation: script-driven mental imagery of the traumatic event</description>
    <arm_group_label>Placebo + reactivation</arm_group_label>
    <arm_group_label>Propranolol + reactivation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Placebo + reactivation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of chronic PTSD&#xD;
&#xD;
          -  PTSD CheckList total score &gt;44&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systolic blood pressure &lt; 100 mmHg&#xD;
&#xD;
          -  Contraindication to Propranolol&#xD;
&#xD;
          -  Previous adverse reaction to a β-blocker&#xD;
&#xD;
          -  Use of another β-blocker&#xD;
&#xD;
          -  Use of medication that could involve potentially dangerous interactions with&#xD;
             propranolol&#xD;
&#xD;
          -  Psychotherapy or treatment with any pharmacologic PTSD medication within the 2 weeks&#xD;
             prior to inclusion (6 weeks for fluoxetine)&#xD;
&#xD;
          -  Female with reproductive potential without reliable means of contraception&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Alcohol or drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe BIRMES, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Charles Perrens</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chru Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>November 6, 2020</last_update_submitted>
  <last_update_submitted_qc>November 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PTSD, Propranolol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propranolol</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/NCT01713556
org study id: 09 106 01
nct id: NCT01713556
lead sponsor: 
has dmc: No
The purpose of this study is to test whether propranolol, when given during a re-evocation of
      a traumatic memory, is capable of reducing subsequent PTSD symptoms associated with that
      memory.
Post-traumatic stress disorder (PTSD) develops following an exposure to a life threatening
      event. One of the characteristic features of PTSD is the recurrence of intrusive memories of
      an experienced trauma. The persistence of disturbing traumatic memories in PTSD is often
      explained in terms of a trauma-induced enhancement of memory encoding. Several studies
      indicate that an increased noradrenergic activity during trauma enhances the encoding of
      memory. Elevated levels of norepinephrine in the cerebrospinal fluid of individuals with PTSD
      and the correlation of this elevation with the severity of PTSD symptoms suggest that
      increased noradrenergic activity is also involved in the maintenance of PTSD symptoms.
      Reactivation of memory by retrieval also renders the memory labile and susceptible to
      treatments. This latter process is referred to as memory reconsolidation. Consolidation and
      reconsolidation both occur within a distinct time window following new learning (in
      consolidation) and/or retrieval (in reconsolidation). Even well-consolidated old fear
      memories undergo reconsolidation and may be disrupted by means of pharmacological
      manipulation. Propranolol may be effective in treating PTSD long after symptoms have been
      consolidated. Propranolol given after reactivation of the memory of a past traumatic event
      reduces physiologic responding during subsequent mental imagery of the event.

      HYPOTHESE: Subjects with chronic PTSD who receive propranolol before trauma evocation will
      subsequently show decreased PTSD symptoms, compared to subjects who receive a placebo.

      METHOD: 56 participants with chronic PTSD will be recruited for participation. On Week 1, the
      subjects will complete a standardized measure of PTSD symptoms. Next, 90 minutes after the
      administration of the study medication (either propranolol or placebo), participants will
      undergo a script preparation procedure, during which they will disclose details of their
      traumatic event. Scripts portraying this event will be prepared for subsequent replay.

      On Week 2, after the administration of the study medication (either propranolol or placebo),
      participants will be asked (reading the script) to engaged in a script-driven mental imagery
      of the traumatic event. Following this procedure, PTSD symptoms will be assessed.

      The same procedure will be repeated on Weeks 3, 4, 5 and 6. On Weeks 7 and 18, the
      standardized measure of PTSD symptoms will be repeated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: PTCD CheckList (PCL) total score.
time frame: difference between week 1 (before administration of the study medication) and week 7 (one week after the last intake of study medication)
arm group label: Propranolol + reactivation
arm group type: Experimental
description: they have a script-driven mental imagery of the traumatic event white drug
arm group label: Placebo + reactivation
arm group type: Placebo Comparator
description: They have a script-driven mental imagery of the traumatic event with placebo
intervention type: Drug
intervention name: Propranolol
arm group label: Propranolol + reactivation
intervention type: Other
intervention name: Trauma reactivation
description: Trauma reactivation: script-driven mental imagery of the traumatic event
arm group label: Placebo + reactivation
arm group label: Propranolol + reactivation
intervention type: Drug
intervention name: placebo
arm group label: Placebo + reactivation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Philippe BIRMES, MD
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
mesh term: Propranolol