<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/NCT02234011</url>
  </required_header>
  <id_info>
    <org_study_id>2014P001140</org_study_id>
    <nct_id>NCT02234011</nct_id>
  </id_info>
  <brief_title>A Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder</brief_title>
  <official_title>A Placebo-Controlled Crossover Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mclean Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mclean Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to learn whether administration of intranasal (inhaled through the&#xD;
      nose) ketamine reduces symptoms of obsessive-compulsive disorder (OCD). Ketamine has been&#xD;
      approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent (a medicine to&#xD;
      reduce pain during surgery and other procedures) but ketamine has not been approved by the&#xD;
      FDA as a treatment for OCD.&#xD;
&#xD;
      The investigators believe that ketamine may be effective in reducing symptoms of OCD due to&#xD;
      its ability to decrease the activity of a specific brain chemical called glutamate. Previous&#xD;
      studies have shown that people with OCD can have abnormal levels of glutamate in their&#xD;
      brains. This is the first time that intranasal ketamine is being studied in people with OCD.&#xD;
      However, studies have been done in the past using intravenous (IV; through a needle into a&#xD;
      vein in your arm) ketamine in people with OCD, and intranasal ketamine has been studied in&#xD;
      people with other psychiatric conditions.&#xD;
&#xD;
      This research study will compare ketamine to placebo. The placebo looks exactly like&#xD;
      ketamine, but contains no ketamine. At some time during the study, the investigators will&#xD;
      give you ketamine. At another time, the investigators will give you placebo. Placebos are&#xD;
      used in research studies to see if the results are due to the study drug or due to other&#xD;
      reasons.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Terminated due to difficulty in recruiting participants.&#xD;
  </why_stopped>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Observing if Ketamine May Cause a Decrease in OCD Symptoms</measure>
    <time_frame>Baseline to Week 5</time_frame>
    <description>Examining if ketamine is associated with a decrease in OCD symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at completion of one treatment when compared to placebo (saline solution).&#xD;
The Y-BOCS measures OCD symptoms on a scale of 0-40, with higher numbers indicating greater severity of OCD symptoms. For this study, subjects had to have a Y-BOCS of greater than or equal to 18 in order to participate.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>Ketamine/Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive 5 sprays (10 mg each) of intranasal ketamine for the first treatment visit, then receive 5 sprays of placebo (saline solution) at the second treatment visit two weeks later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo/Ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive 5 sprays of placebo (saline solution) for the first treatment visit, then receive 5 sprays (10 mg each) of intranasal ketamine at the second treatment visit two weeks later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <arm_group_label>Ketamine/Placebo</arm_group_label>
    <arm_group_label>Placebo/Ketamine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Ketamine/Placebo</arm_group_label>
    <arm_group_label>Placebo/Ketamine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female age ≥ 18 and ≤ 55&#xD;
&#xD;
          2. Meets DSM-IV50 criteria for OCD as the primary presenting diagnosis as determined by&#xD;
             the investigator (participants with secondary comorbid dysthymia, major depression,&#xD;
             anxiety disorders, eating disorders, and other obsessive-compulsive spectrum disorders&#xD;
             will still be eligible for enrollment).&#xD;
&#xD;
          3. Score of ≥ 18 on the Y-BOCS at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unwillingness or inability to provide written informed consent.&#xD;
&#xD;
          2. Active suicidal ideation at screening&#xD;
&#xD;
          3. Lifetime history of psychotic disorder or autism spectrum disorder&#xD;
&#xD;
          4. DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine&#xD;
             dependence, within three months prior to screening&#xD;
&#xD;
          5. Any history of intolerance or hypersensitivity to ketamine&#xD;
&#xD;
          6. Any history of nasal/sinus anomalies or dysfunction (e.g., nasal obstruction or&#xD;
             history of nasal surgery)&#xD;
&#xD;
          7. Clinically significant medical disease including, but not limited to, cardiac&#xD;
             (including uncontrolled hypertension or uncontrolled hypotension, arrhythmias,&#xD;
             congestive heart failure, angina), pulmonary, hepatic, renal, or endocrine disorders,&#xD;
             which would increase the risk to the participant or interfere with interpretation of&#xD;
             results as judged by the principal investigator.&#xD;
&#xD;
          8. Clinically significant neurologic disease including, but not limited to, seizure&#xD;
             disorder, neurodegenerative diseases, transient ischemic attacks, neural vascular&#xD;
             disease, stroke, cerebral aneurysms, and history of traumatic brain injury.&#xD;
&#xD;
          9. Female participants with a positive serum or urine pregnancy test at screening&#xD;
&#xD;
         10. Pregnancy. Females of childbearing potential must be using an effective contraceptive&#xD;
             method (e.g., abstinence, prescription oral contraceptives, contraceptive injections,&#xD;
             double-barrier method, male partner sterilization). Women that are not of childbearing&#xD;
             potential are defined as: postmenopausal (&gt;45 years of age with amenorrhea for at&#xD;
             least 12 months, or any age with menorrhea for at least 6 months and a serum follicle&#xD;
             stimulating hormone (FSH) level &gt;40 IU/ml); permanently sterilized (e.g., tubal&#xD;
             occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of&#xD;
             pregnancy.&#xD;
&#xD;
         11. Female participants who are lactating.&#xD;
&#xD;
         12. Any screening laboratory abnormality deemed clinically significant by the investigator&#xD;
&#xD;
         13. Currently taking opiate pain medications, dextromethorphan, St. John's Wort,&#xD;
             theophylline, or tramadol.&#xD;
&#xD;
         14. Any participation in an investigational drug trial within 30 days of enrollment in&#xD;
             study.&#xD;
&#xD;
         15. Contraindication to having an MRI.&#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>Brian P Brennan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mclean Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McLean Hospital</name>
      <address>
        <city>Belmont</city>
        <state>Massachusetts</state>
        <zip>02478</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>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>January 20, 2017</results_first_submitted>
  <results_first_submitted_qc>April 5, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 12, 2017</results_first_posted>
  <last_update_submitted>April 5, 2017</last_update_submitted>
  <last_update_submitted_qc>April 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mclean Hospital</investigator_affiliation>
    <investigator_full_name>Brian P. Brennan, MD</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <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>Ketamine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>One subject completed the screening visit, but chose to withdraw from study due to time commitment required. Because this subject only completed a screening visit, she was never entered into the treatment arm of the study (which begins at the baseline visit).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment</title>
          <description>No participants enrolled in treatment portion of study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment</title>
          <description>No participants enrolled in treatment portion of study, and therefore never completed a baseline visit. One subject completed a screening visit and then withdrew from study due to time commitments.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <class_list>
            <class>
              <title>United States</title>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Observing if Ketamine May Cause a Decrease in OCD Symptoms</title>
        <description>Examining if ketamine is associated with a decrease in OCD symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at completion of one treatment when compared to placebo (saline solution).&#xD;
The Y-BOCS measures OCD symptoms on a scale of 0-40, with higher numbers indicating greater severity of OCD symptoms. For this study, subjects had to have a Y-BOCS of greater than or equal to 18 in order to participate.</description>
        <time_frame>Baseline to Week 5</time_frame>
        <population>One subject had a screening visit, but was never enrolled in the treatment portion and therefore never had any sort of treatment analysis performed on her data.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>No participants enrolled in treatment portion of study.</description>
          </group>
        </group_list>
        <measure>
          <title>Observing if Ketamine May Cause a Decrease in OCD Symptoms</title>
          <description>Examining if ketamine is associated with a decrease in OCD symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at completion of one treatment when compared to placebo (saline solution).&#xD;
The Y-BOCS measures OCD symptoms on a scale of 0-40, with higher numbers indicating greater severity of OCD symptoms. For this study, subjects had to have a Y-BOCS of greater than or equal to 18 in order to participate.</description>
          <population>One subject had a screening visit, but was never enrolled in the treatment portion and therefore never had any sort of treatment analysis performed on her data.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Treatment</title>
          <description>No participants enrolled in treatment portion of study. One subject had a screening visit, but since she never entered the treatment portion of the study and never received the study medication. Because she never had any exposure to the study medication and had no visits other than the initial screening visit, she was never at risk for any adverse events related to study medication.&#xD;
No adverse events related to study medication were collected since no subjects ever entered the treatment phase of this study.</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="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
              </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. Brian Brennan, MD</name_or_title>
      <organization>McLean Hospital, Biological Psychiatry Laboratory</organization>
      <phone>617-855-2911</phone>
      <email>bbrennan@partners.org</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/NCT02234011
org study id: 2014P001140
nct id: NCT02234011
lead sponsor: 
has dmc: Yes
This study is being done to learn whether administration of intranasal (inhaled through the
      nose) ketamine reduces symptoms of obsessive-compulsive disorder (OCD). Ketamine has been
      approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent (a medicine to
      reduce pain during surgery and other procedures) but ketamine has not been approved by the
      FDA as a treatment for OCD.

      The investigators believe that ketamine may be effective in reducing symptoms of OCD due to
      its ability to decrease the activity of a specific brain chemical called glutamate. Previous
      studies have shown that people with OCD can have abnormal levels of glutamate in their
      brains. This is the first time that intranasal ketamine is being studied in people with OCD.
      However, studies have been done in the past using intravenous (IV; through a needle into a
      vein in your arm) ketamine in people with OCD, and intranasal ketamine has been studied in
      people with other psychiatric conditions.

      This research study will compare ketamine to placebo. The placebo looks exactly like
      ketamine, but contains no ketamine. At some time during the study, the investigators will
      give you ketamine. At another time, the investigators will give you placebo. Placebos are
      used in research studies to see if the results are due to the study drug or due to other
      reasons.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Observing if Ketamine May Cause a Decrease in OCD Symptoms
time frame: Baseline to Week 5
description: Examining if ketamine is associated with a decrease in OCD symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at completion of one treatment when compared to placebo (saline solution).
The Y-BOCS measures OCD symptoms on a scale of 0-40, with higher numbers indicating greater severity of OCD symptoms. For this study, subjects had to have a Y-BOCS of greater than or equal to 18 in order to participate.
arm group label: Ketamine/Placebo
arm group type: Experimental
description: Participants in this group will receive 5 sprays (10 mg each) of intranasal ketamine for the first treatment visit, then receive 5 sprays of placebo (saline solution) at the second treatment visit two weeks later.
arm group label: Placebo/Ketamine
arm group type: Experimental
description: Participants in this group will receive 5 sprays of placebo (saline solution) for the first treatment visit, then receive 5 sprays (10 mg each) of intranasal ketamine at the second treatment visit two weeks later.
intervention type: Drug
intervention name: Ketamine
arm group label: Ketamine/Placebo
arm group label: Placebo/Ketamine
intervention type: Drug
intervention name: Placebo
arm group label: Ketamine/Placebo
arm group label: Placebo/Ketamine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Brian P Brennan, M.D.
role: Principal Investigator
affiliation: Mclean Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mclean Hospital
investigator full name: Brian P. Brennan, MD
investigator title: M.D.
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder
mesh term: Ketamine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 