<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/NCT01680107</url>
  </required_header>
  <id_info>
    <org_study_id>MRC-01</org_study_id>
    <secondary_id>2012-003191-39</secondary_id>
    <nct_id>NCT01680107</nct_id>
  </id_info>
  <brief_title>D-cycloserine Augmented CBT for Panic Disorder</brief_title>
  <official_title>The Effect of a Single-dose of D-cycloserine on the Basic Effects of Cognitive-behaviour Therapy for Panic Disorder - a Randomized Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether d-cycloserine augments the clinical effects&#xD;
      of exposure-based cognitive-behaviour therapy for panic disorder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2017</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>self-reported and clinician-rated anxiety and depression measures</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>emotional information processing</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Panic Disorder</condition>
  <arm_group>
    <arm_group_label>d-cycloserine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral, capsule, 250 mg, once</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sugar pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>oral, capsule, once</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>d-cycloserine</intervention_name>
    <arm_group_label>d-cycloserine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>sugar pill</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cognitive-behaviour therapy</intervention_name>
    <arm_group_label>d-cycloserine</arm_group_label>
    <arm_group_label>sugar pill</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of panic disorder&#xD;
&#xD;
          -  at least moderate agoraphobic avoidance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  psychoactive medication last 6 weeks&#xD;
&#xD;
          -  exposure-based cognitive-behaviour treatment for panic disorder and agoraphobia during&#xD;
             last 3 months&#xD;
&#xD;
          -  female participant who is pregnant or breast-feeding&#xD;
&#xD;
          -  lifetime history of psychosis, bipolar disorder, alcohol, medication or drug abuse or&#xD;
             dependence; current primary depressive disorder&#xD;
&#xD;
          -  lifetime history of epilepsy or other significant disease or disorder&#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>Andrea Reinecke, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oxford</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Catherine Harmer, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Oxford</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Psychiatry, University of Oxford</name>
      <address>
        <city>Oxford</city>
        <zip>OX37JX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>d-cycloserine, cognitive-behaviour therapy, panic disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Panic Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cycloserine</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/NCT01680107
org study id: MRC-01
secondary id: 2012-003191-39
nct id: NCT01680107
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether d-cycloserine augments the clinical effects
      of exposure-based cognitive-behaviour therapy for panic disorder.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: self-reported and clinician-rated anxiety and depression measures
time frame: 6 months
measure: emotional information processing
time frame: 1 day
arm group label: d-cycloserine
arm group type: Experimental
description: oral, capsule, 250 mg, once
arm group label: sugar pill
arm group type: Placebo Comparator
description: oral, capsule, once
intervention type: Drug
intervention name: d-cycloserine
arm group label: d-cycloserine
intervention type: Drug
intervention name: placebo
arm group label: sugar pill
intervention type: Behavioral
intervention name: cognitive-behaviour therapy
arm group label: d-cycloserine
arm group label: sugar pill
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Andrea Reinecke, PhD
role: Principal Investigator
affiliation: University of Oxford
last name: Catherine Harmer, PhD
role: Study Director
affiliation: University of Oxford
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Panic Disorder
mesh term: Cycloserine