<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/NCT03238924</url>
  </required_header>
  <id_info>
    <org_study_id>36616</org_study_id>
    <nct_id>NCT03238924</nct_id>
  </id_info>
  <brief_title>Prolonged Exposure and Oxytocin</brief_title>
  <official_title>Augmenting Prolonged Exposure Therapy for PTSD With Intranasal Oxytocin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Posttraumatic stress disorder (PTSD) is a chronic, debilitating anxiety disorder that may&#xD;
      develop after direct or indirect exposure to traumatic events. Prolonged Exposure (PE) is a&#xD;
      cognitive-behavioral psychotherapy modality with a wealth of empirical support demonstrating&#xD;
      its efficacy to treat PTSD in a variety of populations. The neuropeptide oxytocin is a&#xD;
      promising new pharmacotherapeutic agent with prominent anxiolytic effects . Despite a strong&#xD;
      biological and theoretical rationale for investigating the potential effectiveness of&#xD;
      augmenting PE with intranasal oxytocin, no studies to date have done so. The current study&#xD;
      aims to address this important gap in the literature by examining changes in PTSD symptoms&#xD;
      following PE treatment combined with a) 40 IU of intranasal oxytocin or b) placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 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>PTSD Symptom Severity</measure>
    <time_frame>Change from Baseline to end of treatment (10 weeks)</time_frame>
    <description>Clinician-Administered PTSD Scale (CAPS-5). CAPS-5 scores range from 0-120. Items are summed to obtain a total score with higher scores reflective of greater symptom severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PTSD Symptom Severity</measure>
    <time_frame>Change from Baseline to end of treatment (10 weeks)</time_frame>
    <description>PTSD Checklist (PCL). The PCL is a self-report measure which uses a 5-point scale to assess the frequency and severity of PTSD symptoms. Item responses are summed to obtain a total score ranging from 17-85 with greater scores reflective of greater symptom severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Symptom Severity</measure>
    <time_frame>Change from Baseline to end of treatment (10 weeks)</time_frame>
    <description>Beck Depression Inventory-II. The BDI-II is a self-report measure where each item is rated on a 0-3 scale and summed to obtain a total score. Greater scores are reflective of greater symptom severity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 IU intranasal oxytocin spray</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo is matching saline nasal spray</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>40 IU oxytocin nasal spray, self-administered</description>
    <arm_group_label>Oxytocin</arm_group_label>
    <other_name>Pitocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Saline nasal spray, self-administered</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female; any race or ethnicity; age 18-75 years.&#xD;
&#xD;
          2. Able to provide informed consent and function at an intellectual level sufficient to&#xD;
             allow accurate completion of the assessment instruments.&#xD;
&#xD;
          3. Participants must be able to comprehend English.&#xD;
&#xD;
          4. Meet DSM-5 criteria for current PTSD (assessed via the Clinician Administered PTSD&#xD;
             Scale; CAPS).&#xD;
&#xD;
          5. A CAPS score of 50 or greater.&#xD;
&#xD;
          6. Participants may also meet criteria for a mood disorder (except bipolar affective&#xD;
             disorder, see Exclusion Criteria) or anxiety disorders (e.g., agoraphobia, social&#xD;
             phobia, generalized anxiety disorder). The inclusion of participants with affective&#xD;
             and anxiety disorders is essential because of the marked frequency of the co-existence&#xD;
             of mood and other anxiety disorders among patients with PTSD.&#xD;
&#xD;
          7. Participants taking psychotropic medications will be required to be maintained on a&#xD;
             stable dose for at least eight weeks before study initiation. Initiation or change of&#xD;
             psychotropic medications during the course of the trial may interfere with&#xD;
             interpretation of results.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participants meeting DSM-5 criteria for a history of or current psychotic or bipolar&#xD;
             affective disorders, or with current suicidal or homicidal ideation and intent. Those&#xD;
             participants will be referred clinically.&#xD;
&#xD;
          2. Participants who would present a serious suicide risk or who are likely to require&#xD;
             hospitalization during the course of the study. Those participants will be referred&#xD;
             clinically.&#xD;
&#xD;
          3. Participants on maintenance anxiolytic, antidepressant, or mood stabilizing&#xD;
             medications, which have been initiated during the past 8 weeks.&#xD;
&#xD;
          4. Participants meeting DSM-5 criteria for a substance use disorder, except caffeine or&#xD;
             nicotine, within the past 12 months.&#xD;
&#xD;
          5. Pregnant women will be excluded from the proposed study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>April 3, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <results_first_submitted>January 29, 2018</results_first_submitted>
  <results_first_submitted_qc>April 26, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">May 25, 2018</results_first_posted>
  <last_update_submitted>April 26, 2018</last_update_submitted>
  <last_update_submitted_qc>April 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Julianne Flanagan</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>posttraumatic stress disorder</keyword>
  <keyword>oxytocin</keyword>
  <keyword>Prolonged Exposure</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Oxytocin</title>
          <description>40 IU intranasal oxytocin spray&#xD;
Oxytocin: 40 IU oxytocin nasal spray, self-administered</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo is matching saline nasal spray&#xD;
Placebos: Saline nasal spray, self-administered</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Oxytocin</title>
          <description>40 IU intranasal oxytocin spray&#xD;
Oxytocin: 40 IU oxytocin nasal spray, self-administered</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo is matching saline nasal spray&#xD;
Placebos: Saline nasal spray, self-administered</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="17"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.63" spread="14.58"/>
                    <measurement group_id="B2" value="45.78" spread="15.09"/>
                    <measurement group_id="B3" value="43.82" spread="14.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>PTSD Symptom Severity</title>
        <description>Clinician-Administered PTSD Scale (CAPS-5). CAPS-5 scores range from 0-120. Items are summed to obtain a total score with higher scores reflective of greater symptom severity.</description>
        <time_frame>Change from Baseline to end of treatment (10 weeks)</time_frame>
        <population>Data belonging to participants who completed the trial were examined.</population>
        <group_list>
          <group group_id="O1">
            <title>Oxytocin</title>
            <description>40 IU intranasal oxytocin spray&#xD;
Oxytocin: 40 IU oxytocin nasal spray, self-administered</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo is matching saline nasal spray&#xD;
Placebos: Saline nasal spray, self-administered</description>
          </group>
        </group_list>
        <measure>
          <title>PTSD Symptom Severity</title>
          <description>Clinician-Administered PTSD Scale (CAPS-5). CAPS-5 scores range from 0-120. Items are summed to obtain a total score with higher scores reflective of greater symptom severity.</description>
          <population>Data belonging to participants who completed the trial were examined.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.00" spread="12.74"/>
                    <measurement group_id="O2" value="17.71" spread="9.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PTSD Symptom Severity</title>
        <description>PTSD Checklist (PCL). The PCL is a self-report measure which uses a 5-point scale to assess the frequency and severity of PTSD symptoms. Item responses are summed to obtain a total score ranging from 17-85 with greater scores reflective of greater symptom severity.</description>
        <time_frame>Change from Baseline to end of treatment (10 weeks)</time_frame>
        <population>Data belonging to participants who completed the trial were examined.</population>
        <group_list>
          <group group_id="O1">
            <title>Oxytocin</title>
            <description>40 IU intranasal oxytocin spray&#xD;
Oxytocin: 40 IU oxytocin nasal spray, self-administered</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo is matching saline nasal spray&#xD;
Placebos: Saline nasal spray, self-administered</description>
          </group>
        </group_list>
        <measure>
          <title>PTSD Symptom Severity</title>
          <description>PTSD Checklist (PCL). The PCL is a self-report measure which uses a 5-point scale to assess the frequency and severity of PTSD symptoms. Item responses are summed to obtain a total score ranging from 17-85 with greater scores reflective of greater symptom severity.</description>
          <population>Data belonging to participants who completed the trial were examined.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.50" spread="19.53"/>
                    <measurement group_id="O2" value="29.71" spread="26.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Symptom Severity</title>
        <description>Beck Depression Inventory-II. The BDI-II is a self-report measure where each item is rated on a 0-3 scale and summed to obtain a total score. Greater scores are reflective of greater symptom severity.</description>
        <time_frame>Change from Baseline to end of treatment (10 weeks)</time_frame>
        <population>Data belonging to participants who completed the trial were examined.</population>
        <group_list>
          <group group_id="O1">
            <title>Oxytocin</title>
            <description>40 IU intranasal oxytocin spray&#xD;
Oxytocin: 40 IU oxytocin nasal spray, self-administered</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo is matching saline nasal spray&#xD;
Placebos: Saline nasal spray, self-administered</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Symptom Severity</title>
          <description>Beck Depression Inventory-II. The BDI-II is a self-report measure where each item is rated on a 0-3 scale and summed to obtain a total score. Greater scores are reflective of greater symptom severity.</description>
          <population>Data belonging to participants who completed the trial were examined.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.67" spread="11.24"/>
                    <measurement group_id="O2" value="17.14" spread="17.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years.</time_frame>
      <desc>All adverse events were recorded.</desc>
      <group_list>
        <group group_id="E1">
          <title>Oxytocin</title>
          <description>40 IU intranasal oxytocin spray&#xD;
Oxytocin: 40 IU oxytocin nasal spray, self-administered</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo is matching saline nasal spray&#xD;
Placebos: Saline nasal spray, self-administered</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Julianne Flanagan</name_or_title>
      <organization>Medical University of South Carolina</organization>
      <phone>843-792-5569</phone>
      <email>Hellmuth@musc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03238924
org study id: 36616
nct id: NCT03238924
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Posttraumatic stress disorder (PTSD) is a chronic, debilitating anxiety disorder that may
      develop after direct or indirect exposure to traumatic events. Prolonged Exposure (PE) is a
      cognitive-behavioral psychotherapy modality with a wealth of empirical support demonstrating
      its efficacy to treat PTSD in a variety of populations. The neuropeptide oxytocin is a
      promising new pharmacotherapeutic agent with prominent anxiolytic effects . Despite a strong
      biological and theoretical rationale for investigating the potential effectiveness of
      augmenting PE with intranasal oxytocin, no studies to date have done so. The current study
      aims to address this important gap in the literature by examining changes in PTSD symptoms
      following PE treatment combined with a) 40 IU of intranasal oxytocin or b) placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: PTSD Symptom Severity
time frame: Change from Baseline to end of treatment (10 weeks)
description: Clinician-Administered PTSD Scale (CAPS-5). CAPS-5 scores range from 0-120. Items are summed to obtain a total score with higher scores reflective of greater symptom severity.
measure: PTSD Symptom Severity
time frame: Change from Baseline to end of treatment (10 weeks)
description: PTSD Checklist (PCL). The PCL is a self-report measure which uses a 5-point scale to assess the frequency and severity of PTSD symptoms. Item responses are summed to obtain a total score ranging from 17-85 with greater scores reflective of greater symptom severity.
measure: Depression Symptom Severity
time frame: Change from Baseline to end of treatment (10 weeks)
description: Beck Depression Inventory-II. The BDI-II is a self-report measure where each item is rated on a 0-3 scale and summed to obtain a total score. Greater scores are reflective of greater symptom severity.
arm group label: Oxytocin
arm group type: Experimental
description: 40 IU intranasal oxytocin spray
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo is matching saline nasal spray
intervention type: Drug
intervention name: Oxytocin
description: 40 IU oxytocin nasal spray, self-administered
arm group label: Oxytocin
other name: Pitocin
intervention type: Drug
intervention name: Placebos
description: Saline nasal spray, self-administered
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Julianne Flanagan
investigator title: Assistant Professor
mesh term: Oxytocin
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 