<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/NCT01715519</url>
  </required_header>
  <id_info>
    <org_study_id>VII-IT-05</org_study_id>
    <nct_id>NCT01715519</nct_id>
  </id_info>
  <brief_title>Vilazodone for the Treatment of Posttraumatic Stress Disorder</brief_title>
  <official_title>A Double-blind, Placebo-controlled Randomized Trial of Vilazodone in the Treatment of Posttraumatic Stress Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southern California Institute for Research and Education</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Forest Laboratories</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Southern California Institute for Research and Education</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether vilazodone is effective in the treatmen of&#xD;
      Posttraumatic Stress Disorder (PTSD)and co-morbid mild or more depression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 4</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>PTSD symptoms</measure>
    <time_frame>four months</time_frame>
    <description>PCL-C</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PTSD Diagnosis</measure>
    <time_frame>4 months</time_frame>
    <description>CAPS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>four months</time_frame>
    <description>BDI-II</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep</measure>
    <time_frame>4 months</time_frame>
    <description>PSQI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>4 months</time_frame>
    <description>HSCL-25</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Biomarkers</measure>
    <time_frame>four months</time_frame>
    <description>serum</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>PTSD</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Treatment (Viibryd)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 mg/day 1 to 7; 20 mg/day 8 to 14; 40 mg/day week 3 to end week 12. Subjects will then be tapered off vilazodone as follows: 20 mg/day week 13, 10 mg/day, week 14 and no medication during week 15.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>will be compared to the treatment group (viibryd)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment (Viibryd)</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Treatment (Viibryd)</arm_group_label>
    <other_name>Vilazodone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must satisfy DSM-IV diagnostic criteria for chronic PTSD&#xD;
&#xD;
          -  Evidence of PTSD disease base upon one or more of the following:&#xD;
&#xD;
          -  Mild or greater depression on the Beck Depression Inventory -II (BDI-II, score&gt; 12).&#xD;
&#xD;
          -  May have other symptom co-morbid with PTSD (e.g., anxiety or somatic pain)&#xD;
&#xD;
          -  Ability to comprehend and satisfactorily comply with protocol required and signed&#xD;
             written informed consent prior to entering study procedure&#xD;
&#xD;
          -  May be in psychotherapy if initiated at least three months prior to the screening&#xD;
             visit. Subject must not discontinue or otherwise alter therapy during the study.&#xD;
&#xD;
          -  Subject may not have taken any psychopharmacological medications within 7 days prior&#xD;
             to Baseline visit.&#xD;
&#xD;
          -  Negative urine pregnancy test at screening visit and for the duration of the study for&#xD;
             women of childbearing potential.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a concurrent DSM-IV Axis I diagnosis in any of the following categories:&#xD;
&#xD;
               1. Delirium, Dementia, Amnestic and other Cognitive disorders&#xD;
&#xD;
               2. Lifetime Schizophrenia and other Psychotic Disorders&#xD;
&#xD;
               3. lifetime Bipolar I Disorder&#xD;
&#xD;
               4. Bipolar-II Disorder with an episode of hypomania within the last year&#xD;
&#xD;
               5. Alcohol or Substance Dependence or Abuse (excluding nicotine) in one month prior&#xD;
                  to the Screening Visit&#xD;
&#xD;
               6. Any other concurrent Axis I Disorder (including Major Depressive Disorder) must&#xD;
                  be secondary to the primary diagnosis of PTSD.&#xD;
&#xD;
          -  Decisional incapacity (dementia)&#xD;
&#xD;
          -  Use of centrally acting medications that potentially have an effect on biological&#xD;
             expression&#xD;
&#xD;
          -  Chronic pain levels requiring use of any opiate medications&#xD;
&#xD;
          -  Known exposure to chemicals of physical traumas that cause neuropsychiatric sequelae&#xD;
&#xD;
          -  Past chronic PTSD&#xD;
&#xD;
          -  History of 2 or more treatment failures on SSRIs given primarily for the treatment of&#xD;
             PTSD, in adequate does at the Investigator's opinion, for at least 8 weeks&#xD;
&#xD;
          -  History of intolerance or hypersensitivity to SSRI's&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  Significant risk of committing suicide, or are homicidal or violent and in the&#xD;
             Investigator's opinion in significant imminent risk of hurting others&#xD;
&#xD;
          -  Treated with depot-neuroleptic within 3 months or MAO inhibitors within 30 day prior&#xD;
             to Baseline visit&#xD;
&#xD;
          -  Received ECT within 3 months prior to Screening visit&#xD;
&#xD;
          -  Pregnant or nursing, women of childbearing potential who are sexually active and do&#xD;
             not use adequate contraception, or who are judged to be unreliable in their use of&#xD;
             contraception&#xD;
&#xD;
          -  Positive urine drug screen, unless proven to be prescribed for a short-term course of&#xD;
             treatment. Drug screen must be repeated at least 7 days after the last dose of&#xD;
             prescription medication containing narcotics&#xD;
&#xD;
          -  A medical condition, in the Investigator's opinion, would expose them to an increased&#xD;
             risk of a significant adverse event or interfere with assessments of safety and&#xD;
             efficacy during the course of the trial&#xD;
&#xD;
          -  Requiring concomitant treatment with any psychotropic drug (except zolpidem for sleep)&#xD;
&#xD;
          -  Plans to initiate or terminate any form of psychotherapy or behavior therapy during&#xD;
             the study&#xD;
&#xD;
          -  Receiving disability payments (&gt; 50 % service connections or total Social Security) or&#xD;
             who are involved in litigation for PTSD or other psychiatric illnesses.&#xD;
&#xD;
          -  Unable to speak, read, and understand English or are judged by the investigator to be&#xD;
             unable or unlikely to follow the study protocol and complete all scheduled visits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Veterans Affairs Long Beach Healthcare System</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Nebraska Western-Iowa Healthcare Systems</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>April 24, 2017</last_update_submitted>
  <last_update_submitted_qc>April 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southern California Institute for Research and Education</investigator_affiliation>
    <investigator_full_name>Michael Hollifield, MD</investigator_full_name>
    <investigator_title>Director of Program for Traumatic Stress</investigator_title>
  </responsible_party>
  <keyword>Vilazodone</keyword>
  <keyword>PTSD</keyword>
  <keyword>Depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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>Vilazodone Hydrochloride</mesh_term>
  </intervention_browse>
  <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/NCT01715519
org study id: VII-IT-05
nct id: NCT01715519
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether vilazodone is effective in the treatmen of
      Posttraumatic Stress Disorder (PTSD)and co-morbid mild or more depression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: PTSD symptoms
time frame: four months
description: PCL-C
measure: PTSD Diagnosis
time frame: 4 months
description: CAPS
measure: Depression
time frame: four months
description: BDI-II
measure: Sleep
time frame: 4 months
description: PSQI
measure: Anxiety
time frame: 4 months
description: HSCL-25
measure: Biomarkers
time frame: four months
description: serum
arm group label: Treatment (Viibryd)
arm group type: Experimental
description: 10 mg/day 1 to 7; 20 mg/day 8 to 14; 40 mg/day week 3 to end week 12. Subjects will then be tapered off vilazodone as follows: 20 mg/day week 13, 10 mg/day, week 14 and no medication during week 15.
arm group label: Placebo
arm group type: Placebo Comparator
description: will be compared to the treatment group (viibryd)
intervention type: Drug
intervention name: Treatment (Viibryd)
arm group label: Placebo
arm group label: Treatment (Viibryd)
other name: Vilazodone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Southern California Institute for Research and Education
investigator full name: Michael Hollifield, MD
investigator title: Director of Program for Traumatic Stress
mesh term: Depression
mesh term: Stress Disorders, Post-Traumatic
mesh term: Vilazodone Hydrochloride
sharing ipd: No