<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/NCT01664260</url>
  </required_header>
  <id_info>
    <org_study_id>iklnac</org_study_id>
    <nct_id>NCT01664260</nct_id>
  </id_info>
  <brief_title>Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder</brief_title>
  <official_title>Elucidation of Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder: An 8-week Multimodal Neuroimaging and Neurocognitive Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ewha Womans University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ewha Womans University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It has been suggested that N-acetylcysteine exerts neuroprotective effects by regulating&#xD;
      neurotransmitters and cell signaling pathways. We hypothesize that oral N-acetylcysteine&#xD;
      augmentation will help reduce symptoms in patients with posttraumatic stress disorder as well&#xD;
      as improve cognitive functions. We also expect that the N-acetylcysteine augmentation will&#xD;
      induce change in structural, functional, and neurochemical aspects of the brain.&#xD;
&#xD;
      In this study, we plan to conduct a randomized, double-blind, placebo-controlled augmentation&#xD;
      study with N-acetylcysteine in addition to escitalopram. We will assess the efficacy and&#xD;
      safety of the N-acetylcysteine augmentation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The research project has been cancelled before any participants were enrolled.&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 1, 2012</start_date>
  <completion_date type="Anticipated">December 31, 2016</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2016</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach</measure>
    <time_frame>Baseline, 8th weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Clinician-administered PTSD scale scores at 4th weeks</measure>
    <time_frame>Baseline, 4th weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Clinician-administered PTSD scale scores at 8th weeks</measure>
    <time_frame>Baseline, 8th weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Hamilton depression rating scale scores at 4th weeks</measure>
    <time_frame>Baseline, 4th weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Hamilton depression rating scale scores at 8th weeks</measure>
    <time_frame>Baseline, 8th weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Hamilton anxiety rating scale scores at 4th weeks</measure>
    <time_frame>Baseline, 4th weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Hamilton anxiety rating scale scores at 8th weeks</measure>
    <time_frame>Baseline, 8th weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>4th weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>8th weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>N-acetylcysteine + Escitalopram</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + Escitalopram</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>N-acetylcysteine</intervention_name>
    <description>0 - 8 week: 10 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day</description>
    <arm_group_label>N-acetylcysteine + Escitalopram</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>0 - 8 week: 10 mg escitalopram a day + 1200 mg Placebo twice a day</description>
    <arm_group_label>Placebo + Escitalopram</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20-65 year-old male or female&#xD;
&#xD;
          -  Posttraumatic stress disorder diagnosed by SCID-IV&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medication treatment for posttraumatic stress disorder within 2 weeks&#xD;
&#xD;
          -  Neurologic disease (eg., penetrating or open head injury, epilepsy, multiple&#xD;
             sclerosis, brain tumor, cerebrovascular diseases)&#xD;
&#xD;
          -  Any other axis I psychiatric disorder&#xD;
&#xD;
          -  IQ below 80&#xD;
&#xD;
          -  Contraindications to magnetic resosnance imaging (e.g., pacemaker implantation,&#xD;
             claustrophobia, etc.)&#xD;
&#xD;
          -  Any psychotropic medication within 2 weeks&#xD;
&#xD;
          -  Unstable medical illness or severe abnormality in laboratory test at screening&#xD;
             assessment&#xD;
&#xD;
          -  Women who are pregnant, breastfeeding, or planning pregnancy&#xD;
&#xD;
          -  History of myocardial infarction within 6 months&#xD;
&#xD;
          -  Current diagnosis of duodenal ulcer or asthma&#xD;
&#xD;
          -  Contraindications to drugs used in the study (e.g., epilepsy, uncontrolled&#xD;
             narrow-angle glaucoma, etc.)&#xD;
&#xD;
          -  Allergy or intolerance to the study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Inkyoon Lyoo, MD, PhD, MMS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ewha Womans University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ewha Womans University Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>158-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>February 8, 2018</last_update_submitted>
  <last_update_submitted_qc>February 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ewha Womans University</investigator_affiliation>
    <investigator_full_name>In Kyoon Lyoo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Posttraumatic Stress Disorder</keyword>
  <keyword>N-acetylcysteine</keyword>
  <keyword>Magnetic Resonance Imaging</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>Acetylcysteine</mesh_term>
    <mesh_term>N-monoacetylcystine</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/NCT01664260
org study id: iklnac
nct id: NCT01664260
lead sponsor: 
has dmc: Yes
It has been suggested that N-acetylcysteine exerts neuroprotective effects by regulating
      neurotransmitters and cell signaling pathways. We hypothesize that oral N-acetylcysteine
      augmentation will help reduce symptoms in patients with posttraumatic stress disorder as well
      as improve cognitive functions. We also expect that the N-acetylcysteine augmentation will
      induce change in structural, functional, and neurochemical aspects of the brain.

      In this study, we plan to conduct a randomized, double-blind, placebo-controlled augmentation
      study with N-acetylcysteine in addition to escitalopram. We will assess the efficacy and
      safety of the N-acetylcysteine augmentation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach
time frame: Baseline, 8th weeks
measure: Change from baseline in Clinician-administered PTSD scale scores at 4th weeks
time frame: Baseline, 4th weeks
measure: Change from baseline in Clinician-administered PTSD scale scores at 8th weeks
time frame: Baseline, 8th weeks
measure: Change from baseline in Hamilton depression rating scale scores at 4th weeks
time frame: Baseline, 4th weeks
measure: Change from baseline in Hamilton depression rating scale scores at 8th weeks
time frame: Baseline, 8th weeks
measure: Change from baseline in Hamilton anxiety rating scale scores at 4th weeks
time frame: Baseline, 4th weeks
measure: Change from baseline in Hamilton anxiety rating scale scores at 8th weeks
time frame: Baseline, 8th weeks
measure: Number of participants with adverse events
time frame: 4th weeks
measure: Number of participants with adverse events
time frame: 8th weeks
arm group label: N-acetylcysteine + Escitalopram
arm group type: Experimental
description: The subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram
arm group label: Placebo + Escitalopram
arm group type: Placebo Comparator
description: The subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram
intervention type: Drug
intervention name: N-acetylcysteine
description: 0 - 8 week: 10 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day
arm group label: N-acetylcysteine + Escitalopram
intervention type: Drug
intervention name: Placebo
description: 0 - 8 week: 10 mg escitalopram a day + 1200 mg Placebo twice a day
arm group label: Placebo + Escitalopram
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Inkyoon Lyoo, MD, PhD, MMS
role: Principal Investigator
affiliation: Ewha Womans University
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ewha Womans University
investigator full name: In Kyoon Lyoo
investigator title: Professor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
mesh term: Acetylcysteine
mesh term: N-monoacetylcystine