<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/NCT03788694</url>
  </required_header>
  <id_info>
    <org_study_id>GOO-17-048</org_study_id>
    <nct_id>NCT03788694</nct_id>
  </id_info>
  <brief_title>Intranasal Ketamine for Suicidal Ideation in Veterans</brief_title>
  <official_title>Pilot Study of Open Label, Intranasal Ketamine for Suicidal Ideation in Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bronx Veterans Medical Research Foundation, Inc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bronx Veterans Medical Research Foundation, Inc</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The objective of the current study is to investigate the safety, efficacy, and feasibility of&#xD;
      multiple doses of intranasal (IN) ketamine for suicidal ideation Veterans.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To address the significant need for effective treatment of suicidal ideation in Veterans,&#xD;
      this trial is designed as an open label pilot study of intranasal ketamine in 15 people.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was never funded nor started, no participants were enrolled&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2020</primary_completion_date>
  <phase>Early Phase 1</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Beck Scale for Suicidal Ideation (BSSI)</measure>
    <time_frame>Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks</time_frame>
    <description>Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Montgomery-Asberg Depression Rating Scale (MADRS)</measure>
    <time_frame>Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks</time_frame>
    <description>The MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR)</measure>
    <time_frame>Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks</time_frame>
    <description>QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al. 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Suicidal Ideation</condition>
  <arm_group>
    <arm_group_label>Intranasal Ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive study medication, intranasal ketamine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>8 doses of intranasal ketamine; 40 mg per dose.</description>
    <arm_group_label>Intranasal Ketamine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients, 21-70 years of age&#xD;
&#xD;
          2. Female individuals who are not of childbearing potential (i.e., surgically sterile,&#xD;
             postmenopausal for at least one year) or using a medically accepted reliable means of&#xD;
             contraception. Women using oral contraceptive medication for birth control must also&#xD;
             be using a barrier contraceptive. Women of childbearing potential must also have a&#xD;
             negative pregnancy test at screening and at pre-administration&#xD;
&#xD;
          3. Any non-psychotic disorder diagnosis&#xD;
&#xD;
          4. Score &gt;4 on the suicide item of the Montgomery-Asberg Depression Rating Scale&#xD;
             (MADRS-SI; range 0-6)for clinically significant suicidal ideation or past suicide&#xD;
             attempts&#xD;
&#xD;
          5. Each participant must have a level of understanding sufficient to agree to all tests&#xD;
             and examinations required by the protocol and must sign an informed consent document&#xD;
&#xD;
          6. Each participant must agree to avoid future enrollment in ketamine trials.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. current psychotic symptoms or lifetime history of primary psychotic disorder&#xD;
&#xD;
          2. active substance use in the preceding two weeks or needing medical attention for&#xD;
             withdrawal&#xD;
&#xD;
          3. neurodevelopmental disorder (e.g., ASD)&#xD;
&#xD;
          4. major neurocognitive disorder (e.g., Alzheimer's type dementia)&#xD;
&#xD;
          5. serious cardiac disease&#xD;
&#xD;
          6. suicide attempt precipitating current admission requiring medical stabilization&#xD;
&#xD;
          7. Lifetime histories of autism, mental retardation, pervasive developmental disorders,&#xD;
             or Tourette's syndrome&#xD;
&#xD;
          8. Women who are either pregnant or nursing&#xD;
&#xD;
          9. Hypertension (systolic BP &gt;160 mm Hg or diastolic BP &gt;90 mm Hg) at screening or&#xD;
             immediately prior to treatment with study drug&#xD;
&#xD;
         10. Previously received ketamine for refractory depression.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>James J. Peters VA Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10468</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>James J. Peters Veterans Affairs Medical Center</investigator_affiliation>
    <investigator_full_name>Marianne Goodman</investigator_full_name>
    <investigator_title>Associate Director, VISN 2 Mental Illness, Reseach, Education, Clinical Center (MIRECC) Director, Suicide Prevention and Treatment Research Program</investigator_title>
  </responsible_party>
  <keyword>Ketamine</keyword>
  <keyword>Veteran</keyword>
  <keyword>Suicide</keyword>
  <keyword>Suicidal Ideation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Yes</sharing_ipd>
    <ipd_description>All IPD that underlie results in publications as well as study protocol, statistical analysis plan, informed consent form.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>6 months after publication and will remain available for 5 years.</ipd_time_frame>
  </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/NCT03788694
org study id: GOO-17-048
nct id: NCT03788694
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The objective of the current study is to investigate the safety, efficacy, and feasibility of
      multiple doses of intranasal (IN) ketamine for suicidal ideation Veterans.
To address the significant need for effective treatment of suicidal ideation in Veterans,
      this trial is designed as an open label pilot study of intranasal ketamine in 15 people.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Beck Scale for Suicidal Ideation (BSSI)
time frame: Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks
description: Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
time frame: Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks
description: The MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
measure: The Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR)
time frame: Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks
description: QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al. 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3.
arm group label: Intranasal Ketamine
arm group type: Experimental
description: Subjects will receive study medication, intranasal ketamine.
intervention type: Drug
intervention name: Ketamine
description: 8 doses of intranasal ketamine; 40 mg per dose.
arm group label: Intranasal Ketamine
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: James J. Peters Veterans Affairs Medical Center
investigator full name: Marianne Goodman
investigator title: Associate Director, VISN 2 Mental Illness, Reseach, Education, Clinical Center (MIRECC) Director, Suicide Prevention and Treatment Research Program
mesh term: Suicidal Ideation
mesh term: Ketamine
sharing ipd: Yes
ipd description: All IPD that underlie results in publications as well as study protocol, statistical analysis plan, informed consent form.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: 6 months after publication and will remain available for 5 years.