<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/NCT02183272</url>
  </required_header>
  <id_info>
    <org_study_id>Ketamine IIT</org_study_id>
    <nct_id>NCT02183272</nct_id>
  </id_info>
  <brief_title>Emergency Ketamine Treatment of Suicidal Ideation</brief_title>
  <official_title>Ketamine as an Adjunctive Treatment of Acute Suicidal Ideation in the Emergency Setting.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the current program of research will be to test whether intranasal ketamine&#xD;
      treatment is more effective than placebo in reducing suicidal ideation in suicidal patients&#xD;
      presenting for acute treatment in emergency department settings. Secondary objectives will&#xD;
      test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine&#xD;
      and the correlation of speech patterns and facial movement patterns with subjective&#xD;
      reductions in suicidal ideation after ketamine treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the current program of research will be to test whether intranasal ketamine&#xD;
      treatment is more effective than placebo in reducing suicidal ideation in suicidal patients&#xD;
      presenting for acute treatment in emergency department settings. Secondary objectives will&#xD;
      test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine&#xD;
      and the correlation of speech patterns and facial movement patterns with subjective&#xD;
      reductions in suicidal ideation after ketamine treatment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ketamine effect on Suicidal Ideation and Depression.</measure>
    <time_frame>4 weeks</time_frame>
    <description>To assess the acute efficacy and durability of effect over a 4 week time period of single dose of 0.2 mg/kg intranasal ketamine treatment on suicidal ideation and depression in individuals with acute suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS) and the Montgomery-Asberg Depression Rating Scale (MADRS)as compared to placebo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of Role of Mu Opioid Receptor</measure>
    <time_frame>4 weeks</time_frame>
    <description>To assess the role of specific mu opioid receptor genetic variants in prediction of response to ketamine to alleviate suicidal ideation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Assessment of Changes of Biological Markers</measure>
    <time_frame>4 weeks</time_frame>
    <description>To assess the changes in biological markers of suicide risk such as linguistic patterns, voice and facial movements after ketamine treatment compared to baseline.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Depression</condition>
  <condition>Suicidal Ideation</condition>
  <condition>Suicidal Impulses</condition>
  <arm_group>
    <arm_group_label>Intranasal Ketamine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.2 mg / kg dose of intranasal ketamine for treatment of suicidality will be given in two separate doses on the day of admission to the hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intranasal Saline Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intranasal Ketamine</intervention_name>
    <description>Ketamine in liquid form to be distributed nasally by a board-certified physician while the subject is already in the hospital for suicidal ideation.</description>
    <arm_group_label>Intranasal Ketamine</arm_group_label>
    <other_name>ketamine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intranasal Saline Placebo</intervention_name>
    <description>Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.</description>
    <arm_group_label>Intranasal Saline Placebo</arm_group_label>
    <other_name>saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females&#xD;
&#xD;
          2. Ages 18-65&#xD;
&#xD;
          3. All races and ethnicities&#xD;
&#xD;
          4. Willing and able to provide informed consent&#xD;
&#xD;
          5. A cutoff score of &gt;3 on the Beck Scale for Suicidal Ideation&#xD;
&#xD;
          6. &gt;2 on the Columbia Scale for Suicide Severity Rating&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or lactation; women of reproductive potential must have a negative urine&#xD;
             pregnancy test&#xD;
&#xD;
          2. Post-partum state (within 2 months of delivery)&#xD;
&#xD;
          3. Homicide risk as determined by clinical interview&#xD;
&#xD;
          4. Any of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)&#xD;
             diagnoses:&#xD;
&#xD;
               1. Any current primary psychotic disorder&#xD;
&#xD;
               2. Acute intoxication or withdrawal from alcohol or any other substance of abuse, as&#xD;
                  determined by clinical interview and urine drug screen except opioids&#xD;
&#xD;
               3. use of any hallucinogen (except cannabis), in the last month&#xD;
&#xD;
               4. Any dissociative disorder&#xD;
&#xD;
               5. Pervasive developmental disorder&#xD;
&#xD;
               6. Cognitive disorder&#xD;
&#xD;
               7. Cluster A personality disorder&#xD;
&#xD;
               8. Anorexia nervosa.&#xD;
&#xD;
          5. Treatment with any medication known to affect the N-methyl-D-aspartate (NMDA) receptor&#xD;
             system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium)&#xD;
&#xD;
          6. Any known hypersensitivity or serious adverse effect with ketamine&#xD;
&#xD;
          7. Any clinically-significant medication or condition that would preclude the use of&#xD;
             ketamine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cheryl McCullumsmith, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Faryal Mallick</last_name>
    <phone>513-558-4997</phone>
    <email>mallicfl@ucmail.uc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Faryal Mallick, MD</last_name>
      <phone>513-558-4997</phone>
      <email>mallicfl@ucmail.uc.edu</email>
    </contact>
    <investigator>
      <last_name>Cheryl McCullumsmith, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>August 3, 2016</last_update_submitted>
  <last_update_submitted_qc>August 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cincinnati</investigator_affiliation>
    <investigator_full_name>Cheryl McCullumsmith</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Suicidal Ideation</keyword>
  <keyword>Ketamine</keyword>
  <keyword>Emergency Department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Suicidal Ideation</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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02183272
org study id: Ketamine IIT
nct id: NCT02183272
lead sponsor: 
has dmc: Yes
The objective of the current program of research will be to test whether intranasal ketamine
      treatment is more effective than placebo in reducing suicidal ideation in suicidal patients
      presenting for acute treatment in emergency department settings. Secondary objectives will
      test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine
      and the correlation of speech patterns and facial movement patterns with subjective
      reductions in suicidal ideation after ketamine treatment.
The objective of the current program of research will be to test whether intranasal ketamine
      treatment is more effective than placebo in reducing suicidal ideation in suicidal patients
      presenting for acute treatment in emergency department settings. Secondary objectives will
      test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine
      and the correlation of speech patterns and facial movement patterns with subjective
      reductions in suicidal ideation after ketamine treatment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Ketamine effect on Suicidal Ideation and Depression.
time frame: 4 weeks
description: To assess the acute efficacy and durability of effect over a 4 week time period of single dose of 0.2 mg/kg intranasal ketamine treatment on suicidal ideation and depression in individuals with acute suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS) and the Montgomery-Asberg Depression Rating Scale (MADRS)as compared to placebo.
measure: Assessment of Role of Mu Opioid Receptor
time frame: 4 weeks
description: To assess the role of specific mu opioid receptor genetic variants in prediction of response to ketamine to alleviate suicidal ideation.
measure: Assessment of Changes of Biological Markers
time frame: 4 weeks
description: To assess the changes in biological markers of suicide risk such as linguistic patterns, voice and facial movements after ketamine treatment compared to baseline.
arm group label: Intranasal Ketamine
arm group type: Active Comparator
description: 0.2 mg / kg dose of intranasal ketamine for treatment of suicidality will be given in two separate doses on the day of admission to the hospital.
arm group label: Intranasal Saline Placebo
arm group type: Placebo Comparator
description: 0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission.
intervention type: Drug
intervention name: Intranasal Ketamine
description: Ketamine in liquid form to be distributed nasally by a board-certified physician while the subject is already in the hospital for suicidal ideation.
arm group label: Intranasal Ketamine
other name: ketamine
intervention type: Drug
intervention name: Intranasal Saline Placebo
description: Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.
arm group label: Intranasal Saline Placebo
other name: saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Cheryl McCullumsmith, MD PhD
role: Principal Investigator
affiliation: University of Cincinnati
last name: Faryal Mallick
phone: 513-558-4997
email: mallicfl@ucmail.uc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Cincinnati
investigator full name: Cheryl McCullumsmith
investigator title: Principal Investigator
mesh term: Emergencies
mesh term: Depression
mesh term: Suicidal Ideation
mesh term: Ketamine
sharing ipd: No