<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/NCT02206776</url>
  </required_header>
  <id_info>
    <org_study_id>#6952</org_study_id>
    <nct_id>NCT02206776</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With OCD</brief_title>
  <official_title>Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With Obsessive Compulsive Disorder (OCD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York State Psychiatric Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obsessive-compulsive disorder (OCD) is a common illness that causes significant distress and&#xD;
      impairment. Currently, serotonin reuptake inhibitors (SRIs) are the only medications that are&#xD;
      FDA-approved to treat OCD. Unfortunately, SRIs can take a long time to work (2-3 months), and&#xD;
      even then they usually only partially reduce OCD symptoms. The present study, will test if&#xD;
      intranasal ketamine is feasible to use and can reduce OCD symptoms significantly more than a&#xD;
      comparison medication called midazolam. Therefore, you may or may not receive ketamine as&#xD;
      part of this study. Results from this study will allow doctors and researchers to better&#xD;
      understand if you and others with OCD may respond to this class of medications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    poor tolerability and low enrollment rate&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.</measure>
    <time_frame>Baseline and 1 Week</time_frame>
    <description>Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>Midazolam</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A single dose of intranasal midazolam up to 4 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of intranasal ketamine up to 50 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intranasal Ketamine</intervention_name>
    <description>A single dose of intranasal ketamine up to 50 mg</description>
    <arm_group_label>Ketamine</arm_group_label>
    <other_name>Ketamine Hydrochloride</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intranasal Midazolam</intervention_name>
    <description>A single dose of intranasal Midazolam up to 4 mg</description>
    <arm_group_label>Midazolam</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-55&#xD;
&#xD;
          -  Physically healthy and not currently pregnant&#xD;
&#xD;
          -  Primary diagnosis of OCD&#xD;
&#xD;
          -  Sufficient severity of symptoms&#xD;
&#xD;
          -  For all patients on medications, medications dose must be stable for at least 6 weeks&#xD;
             prior to enrollment. Must discuss with Dr. current medications and doses.&#xD;
&#xD;
          -  Able to provide consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  First degree relative with schizophrenia&#xD;
&#xD;
          -  Psychiatric conditions that would make participation unsafe determined by study doctor&#xD;
&#xD;
          -  Female patients who are either pregnant or nursing&#xD;
&#xD;
          -  Planning to start EX/RP during the period of the study or those who have completed an&#xD;
             adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks&#xD;
             prior to enrollment.&#xD;
&#xD;
          -  Nasal obstruction or history of nasal surgery&#xD;
&#xD;
          -  Currently on psychotropic medication or other medication likely to interact with the&#xD;
             glutamate system&#xD;
&#xD;
          -  Medical conditions that make participation unsafe&#xD;
&#xD;
          -  Allergy or intolerance to ketamine or midazolam&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carolyn I Rodriguez, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://columbia-ocd.org/</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <results_first_submitted>January 3, 2017</results_first_submitted>
  <results_first_submitted_qc>January 3, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">February 23, 2017</results_first_posted>
  <last_update_submitted>March 30, 2017</last_update_submitted>
  <last_update_submitted_qc>March 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OCD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compulsive Personality Disorder</mesh_term>
    <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
    <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>Midazolam</title>
          <description>A single dose of intranasal midazolam up to 4 mg&#xD;
Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg</description>
        </group>
        <group group_id="P2">
          <title>Ketamine</title>
          <description>A single dose of intranasal ketamine up to 50 mg&#xD;
Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Midazolam</title>
          <description>A single dose of intranasal midazolam up to 4 mg&#xD;
Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg</description>
        </group>
        <group group_id="B2">
          <title>Ketamine</title>
          <description>A single dose of intranasal ketamine up to 50 mg&#xD;
Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg</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="1"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="2"/>
          </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="20" spread="0"/>
                    <measurement group_id="B2" value="36" spread="0"/>
                    <measurement group_id="B3" value="28" spread="11"/>
                  </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="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</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>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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>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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</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>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.</title>
        <description>Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.</description>
        <time_frame>Baseline and 1 Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Midazolam</title>
            <description>A single dose of intranasal midazolam up to 4 mg&#xD;
Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg</description>
          </group>
          <group group_id="O2">
            <title>Ketamine</title>
            <description>A single dose of intranasal ketamine up to 50 mg&#xD;
Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.</title>
          <description>Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Midazolam</title>
          <description>A single dose of intranasal midazolam up to 4 mg&#xD;
Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg</description>
        </group>
        <group group_id="E2">
          <title>Ketamine</title>
          <description>A single dose of intranasal ketamine up to 50 mg&#xD;
Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </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="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>lighheadedness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>perceptual changes (e.g. feeling as if body changed in size)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </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. Carolyn Rodriguez, Assistant Professor</name_or_title>
      <organization>Stanford University</organization>
      <phone>650-723-4095</phone>
      <email>ocdresearch@stanford.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/NCT02206776
org study id: #6952
nct id: NCT02206776
lead sponsor: 
has dmc: Yes
Obsessive-compulsive disorder (OCD) is a common illness that causes significant distress and
      impairment. Currently, serotonin reuptake inhibitors (SRIs) are the only medications that are
      FDA-approved to treat OCD. Unfortunately, SRIs can take a long time to work (2-3 months), and
      even then they usually only partially reduce OCD symptoms. The present study, will test if
      intranasal ketamine is feasible to use and can reduce OCD symptoms significantly more than a
      comparison medication called midazolam. Therefore, you may or may not receive ketamine as
      part of this study. Results from this study will allow doctors and researchers to better
      understand if you and others with OCD may respond to this class of medications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
time frame: Baseline and 1 Week
description: Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.
arm group label: Midazolam
arm group type: Placebo Comparator
description: A single dose of intranasal midazolam up to 4 mg
arm group label: Ketamine
arm group type: Experimental
description: A single dose of intranasal ketamine up to 50 mg
intervention type: Drug
intervention name: Intranasal Ketamine
description: A single dose of intranasal ketamine up to 50 mg
arm group label: Ketamine
other name: Ketamine Hydrochloride
intervention type: Drug
intervention name: Intranasal Midazolam
description: A single dose of intranasal Midazolam up to 4 mg
arm group label: Midazolam
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Carolyn I Rodriguez, M.D., Ph.D.
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
url: http://columbia-ocd.org/
description: Related Info
responsible party type: Sponsor
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder
mesh term: Midazolam
mesh term: Ketamine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 