<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/NCT01691092</url>
  </required_header>
  <id_info>
    <org_study_id>1111009365</org_study_id>
    <nct_id>NCT01691092</nct_id>
  </id_info>
  <brief_title>PET Imaging of mGLuR5 With Drug Challenge</brief_title>
  <official_title>PET Imaging of mGluR5 With Drug Challenge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to look at that involvement of a process in the brain called the&#xD;
      glutamate system in depression. Participants will undergo a screening session, up to two&#xD;
      functional Magnetic Resonance Imaging (fMRI) scans, and up to three Positron Emission&#xD;
      Tomography (PET) scans, as well as cognitive testing at each scan session. For one of the PET&#xD;
      scans, a drug (either ketamine or n-acetyl cysteine) will be administered.&#xD;
&#xD;
      Hypothesis 1: The investigators hypothesize administration of ketamine or n-acetylcysteine&#xD;
      (NAC) will lead to a decrease in mGluR5.&#xD;
&#xD;
      Hypothesis 2: The investigators hypothesize an improvement in memory and attentional skills&#xD;
      after drug challenge.&#xD;
&#xD;
      Hypothesis 3: The investigators hypothesize an increase in mGluR5 availability and change in&#xD;
      MRI measures post drug challenge as compared to baseline, signifying synaptogenesis.&#xD;
&#xD;
      Hypothesis 4: We expect there should not be a significant difference in reduction in mGluR5&#xD;
      availability due to differences in ABP688 radiotracer infusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1: To determine the acute effect of medication-induced glutamate release on mGluR5&#xD;
      availability in human subjects. Hypothesis 1: We hypothesize administration of ketamine or&#xD;
      n-acetylcysteine (NAC) will lead to a decrease in mGluR5 availability.&#xD;
&#xD;
      Aim 2: To determine if glutamate release via administration of ketamine or NAC has pro&#xD;
      cognitive benefits.&#xD;
&#xD;
      Hypothesis 2: We hypothesize an improvement in memory and attentional skills after drug&#xD;
      challenge.&#xD;
&#xD;
      Aim 3: To determine if there is synaptogenesis detectable by PET and MRI post ketamine or NAC&#xD;
      within a week of drug challenge (at the time of greatest antidepressant response). Hypothesis&#xD;
      3: We hypothesize an increase in mGluR5 availability and change in MRI measures, post drug&#xD;
      challenge as compared to baseline, signifying synaptogenesis.&#xD;
&#xD;
      Aim 4: To determine if there is a difference in reduction of mGluR5 availability after&#xD;
      ketamine administration when radiotracer is administered bolus as compared to bolus to&#xD;
      constant infusion in the same subjects (ABP688 radiotracer only).&#xD;
&#xD;
      Hypothesis 4: We expect there should not be a significant difference in reduction in mGluR5&#xD;
      availability due to differences in ABP688 radiotracer infusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Glutamate Levels at Baseline and After Ketamine Administration as Confirmed by Positron Emission Tomography (PET) Imaging</measure>
    <time_frame>1st scan: 90 minute baseline scan; 2nd scan: 90 minutes, ketamine administration at start of scan; scan 3: 90 minute scan 24 hours post ketamine</time_frame>
    <description>PET imaging obtained in healthy and Major Depressive Disorder (MDD) subjects. Glutamate levels determined by radiotracer uptake in PET images.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Major Depressive Disorder</condition>
  <condition>Post-Traumatic Stress Disorder (PTSD)</condition>
  <arm_group>
    <arm_group_label>Ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will receive ketamine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>All subjects will receive ketamine to induce glutamate release in the brain</description>
    <arm_group_label>Ketamine</arm_group_label>
    <other_name>ketamine IV</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years old&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  No other Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)&#xD;
             diagnosis present, besides required as below.&#xD;
&#xD;
        Inclusion criteria for depressed subjects&#xD;
&#xD;
          -  clinical diagnosis of a current or past depressive episode&#xD;
&#xD;
          -  medication free for at least 2 weeks&#xD;
&#xD;
          -  Score &gt;16 on Hamilton Depression Rating Scale (HDRS) if currently depressed or &lt;11 if&#xD;
             not currently depressed&#xD;
&#xD;
          -  treatment or non-treatment seeking who understand that this study is for research&#xD;
             purposes only&#xD;
&#xD;
        Inclusion criteria for healthy controls&#xD;
&#xD;
          -  no current, or history of, any DSM-IV diagnosis&#xD;
&#xD;
          -  no first-degree relative with history of psychotic, mood, or anxiety disorder&#xD;
&#xD;
        Inclusion criteria for PTSD subjects&#xD;
&#xD;
          -  current Post-Traumatic Stress Disorder, as determined by the Structured Clinical&#xD;
             Interview for DSM-IV-Text Revision (TR) (SCID) patient research edition&#xD;
&#xD;
          -  Clinician Administered PTSD Scale for DSM-IV-TR (CAPS) score of 50 or higher&#xD;
&#xD;
        Inclusion criteria for trauma control subjects&#xD;
&#xD;
        -history of trauma (meeting the criterion A of PTSD but not a full diagnosis of PTSD)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or past significant medical, neurological, or metabolic disorder or loss of&#xD;
             consciousness for 5 minutes or more&#xD;
&#xD;
          -  active, significant suicidal ideation&#xD;
&#xD;
          -  implanted metallic devices or any Magnetic Resonance (MR) contraindications&#xD;
&#xD;
          -  women who are pregnant or breastfeeding&#xD;
&#xD;
          -  met DSM-IV criteria for alcohol/illicit substance dependence in their life-time or met&#xD;
             alcohol/illicit substance abuse within past year&#xD;
&#xD;
          -  history of prior radiation exposure for research purposes within the past year such&#xD;
             that participation in this study would place them over FDA limits for annual radiation&#xD;
             exposure. This guideline is an effective dose of 5 rem received per year&#xD;
&#xD;
          -  blood donation within eight weeks of the start of the study&#xD;
&#xD;
          -  radiation exposure at work that precludes study participation&#xD;
&#xD;
          -  blood pressure &gt;140/80&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irina Esterlis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Connecticut Mental Health Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University Magnetic Resonance Research Center (MRRC)</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University PET Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <results_first_submitted>December 21, 2016</results_first_submitted>
  <results_first_submitted_qc>March 10, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 21, 2017</results_first_posted>
  <last_update_submitted>March 10, 2017</last_update_submitted>
  <last_update_submitted_qc>March 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Ketamine</keyword>
  <keyword>PET</keyword>
  <keyword>PTSD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
    <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>Ketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ketamine</title>
          <description>All subjects will receive ketamine&#xD;
Ketamine: All subjects will receive ketamine to induce glutamate release in the brain</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>used for different study</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>screen fail</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>reason for discrepancy: some subjects completed baseline scan but did not continue with ketamine administration and subsequent scans.</population>
      <group_list>
        <group group_id="B1">
          <title>Ketamine</title>
          <description>All subjects will receive ketamine&#xD;
Ketamine: All subjects will receive ketamine to induce glutamate release in the brain</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="42"/>
          </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="34.07143" spread="12.12615"/>
                  </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="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Healthy Control (HC)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Major Depressive Disorder (MDD)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Post-Traumatic Stress Disorder (PTSD)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Comorbid MDD &amp; PTSD</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Glutamate Levels at Baseline and After Ketamine Administration as Confirmed by Positron Emission Tomography (PET) Imaging</title>
        <description>PET imaging obtained in healthy and Major Depressive Disorder (MDD) subjects. Glutamate levels determined by radiotracer uptake in PET images.</description>
        <time_frame>1st scan: 90 minute baseline scan; 2nd scan: 90 minutes, ketamine administration at start of scan; scan 3: 90 minute scan 24 hours post ketamine</time_frame>
        <population>13 healthy (6 males, 7 females) and 14 MDD non-smokers (4 males, 10 females) Mean age: 33.5 ± 13.2 yrs reasons for discrepancy (participant flow module): some data was not able to be analyzed due to elevated metabolites; some subject did not tolerate ketamine and had to be pulled out of scanner so we could not obtain data.</population>
        <group_list>
          <group group_id="O1">
            <title>Ketamine</title>
            <description>All subjects will receive ketamine&#xD;
Ketamine: All subjects will receive ketamine to induce glutamate release in the brain</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Glutamate Levels at Baseline and After Ketamine Administration as Confirmed by Positron Emission Tomography (PET) Imaging</title>
          <description>PET imaging obtained in healthy and Major Depressive Disorder (MDD) subjects. Glutamate levels determined by radiotracer uptake in PET images.</description>
          <population>13 healthy (6 males, 7 females) and 14 MDD non-smokers (4 males, 10 females) Mean age: 33.5 ± 13.2 yrs reasons for discrepancy (participant flow module): some data was not able to be analyzed due to elevated metabolites; some subject did not tolerate ketamine and had to be pulled out of scanner so we could not obtain data.</population>
          <units>percentage reduction</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HC % reduction from baseline immediately post ket</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MDD % reduction from baseline immediately post ket</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HC % reduction from baseline 24 hrs post ket</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31" spread="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MDD % reduction from baseline 24 hrs post ket</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 years</time_frame>
      <desc>Standard assessments and regular observations are used to determine whether or not certain adverse events have occurred.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ketamine</title>
          <description>All subjects will receive ketamine&#xD;
Ketamine: All subjects will receive ketamine to induce glutamate release in the brain</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>post-ketamine non-responsiveness</sub_title>
                <description>Post-ketamine subject was non-responsive to questions- did not respond to verbal arousal. Subject was clinically stable. Sent to ER where it was believed the experience was dissociative event due to ketamine.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="38"/>
              </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>
    <limitations_and_caveats>Study lacks placebo control group Hemodynamic effects of ketamine may alter tracer delivery and washout Study lacks long-term follow up Only non-smokers studied Ketamine dose administered is higher than typical dose used for clinical purposes</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Irina Esterlis, Ph.D.</name_or_title>
      <organization>Yale University - Psychiatry Department</organization>
      <phone>(203)737-6820</phone>
      <email>irina.esterlis@yale.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/NCT01691092
org study id: 1111009365
nct id: NCT01691092
lead sponsor: 
has dmc: No
This study is designed to look at that involvement of a process in the brain called the
      glutamate system in depression. Participants will undergo a screening session, up to two
      functional Magnetic Resonance Imaging (fMRI) scans, and up to three Positron Emission
      Tomography (PET) scans, as well as cognitive testing at each scan session. For one of the PET
      scans, a drug (either ketamine or n-acetyl cysteine) will be administered.

      Hypothesis 1: The investigators hypothesize administration of ketamine or n-acetylcysteine
      (NAC) will lead to a decrease in mGluR5.

      Hypothesis 2: The investigators hypothesize an improvement in memory and attentional skills
      after drug challenge.

      Hypothesis 3: The investigators hypothesize an increase in mGluR5 availability and change in
      MRI measures post drug challenge as compared to baseline, signifying synaptogenesis.

      Hypothesis 4: We expect there should not be a significant difference in reduction in mGluR5
      availability due to differences in ABP688 radiotracer infusion.
Aim 1: To determine the acute effect of medication-induced glutamate release on mGluR5
      availability in human subjects. Hypothesis 1: We hypothesize administration of ketamine or
      n-acetylcysteine (NAC) will lead to a decrease in mGluR5 availability.

      Aim 2: To determine if glutamate release via administration of ketamine or NAC has pro
      cognitive benefits.

      Hypothesis 2: We hypothesize an improvement in memory and attentional skills after drug
      challenge.

      Aim 3: To determine if there is synaptogenesis detectable by PET and MRI post ketamine or NAC
      within a week of drug challenge (at the time of greatest antidepressant response). Hypothesis
      3: We hypothesize an increase in mGluR5 availability and change in MRI measures, post drug
      challenge as compared to baseline, signifying synaptogenesis.

      Aim 4: To determine if there is a difference in reduction of mGluR5 availability after
      ketamine administration when radiotracer is administered bolus as compared to bolus to
      constant infusion in the same subjects (ABP688 radiotracer only).

      Hypothesis 4: We expect there should not be a significant difference in reduction in mGluR5
      availability due to differences in ABP688 radiotracer infusion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Glutamate Levels at Baseline and After Ketamine Administration as Confirmed by Positron Emission Tomography (PET) Imaging
time frame: 1st scan: 90 minute baseline scan; 2nd scan: 90 minutes, ketamine administration at start of scan; scan 3: 90 minute scan 24 hours post ketamine
description: PET imaging obtained in healthy and Major Depressive Disorder (MDD) subjects. Glutamate levels determined by radiotracer uptake in PET images.
arm group label: Ketamine
arm group type: Experimental
description: All subjects will receive ketamine
intervention type: Drug
intervention name: Ketamine
description: All subjects will receive ketamine to induce glutamate release in the brain
arm group label: Ketamine
other name: ketamine IV
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Irina Esterlis, PhD
role: Principal Investigator
affiliation: Yale University
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
mesh term: Ketamine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study lacks placebo control group Hemodynamic effects of ketamine may alter tracer delivery and washout Study lacks long-term follow up Only non-smokers studied Ketamine dose administered is higher than typical dose used for clinical purposes
point of contact: 