xml: <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/NCT05962424</url>
    </required_header>
    <id_info>
      <org_study_id>70198</org_study_id>
      <nct_id>NCT05962424</nct_id>
    </id_info>
    <brief_title>HNC: Human Neural Circuits Electrophysiology During Cognition</brief_title>
    <official_title>HNC: Human Neural Circuits Electrophysiology During Cognition</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Stanford University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to understand how ketamine brings about dissociative symptoms.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this proposed research is to record the effects of ketamine on brain activity to&#xD;
        understand the changes that occur during antidepressant therapy and the side effect of&#xD;
        dissociation. This research is designed to probe altered cognitive states associated with&#xD;
        dissociation, depression, and other neuropsychiatric conditions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
    <phase>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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with dissociative events during ketamine infusion as assessed by CADSS (Clinician-Administered Dissociative State Scale)</measure>
      <time_frame>up to 1 week</time_frame>
      <description>The CADSS is an instrument for the measurement of dissociative symptoms. The CADSS comprises 23 subjective items and participant's responses are coded on a 5-point scale (0 = Not at all; 4 = Extreme). The higher the number on the CADSS, the more severe the symptoms.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Psychiatric Disorder</condition>
    <arm_group>
      <arm_group_label>Ketamine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Study participants will receive 0.5mg/kg of ketamine - one single infusion</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ketamine Hydrochloride</intervention_name>
      <description>Ketamine is an FDA-approved dissociative anesthetic.</description>
      <arm_group_label>Ketamine</arm_group_label>
      <other_name>Ketalar</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient in clinical neuro inpatient units at Stanford Medical Center&#xD;
  &#xD;
            -  Age &gt;18 years old&#xD;
  &#xD;
            -  Female participants are expected to use an effective method of birth control&#xD;
               throughout the study which includes: hormonal methods (birth control pills, patches,&#xD;
               injections, vaginal ring or implants), barrier methods (condom or diaphragm) used with&#xD;
               spermicide, intrauterine device (IUD), or abstinence (no sex)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lifetime psychotic disorder&#xD;
  &#xD;
            -  Pregnant or nursing females&#xD;
  &#xD;
            -  Prior adverse ketamine response&#xD;
  &#xD;
            -  Use of ketamine in past 7 days&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Karl Deisseroth, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dariana Gil-Hernandez, BA</last_name>
      <phone>650-724-8902</phone>
      <email>dariana@stanford.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Karl Deisseroth</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mental Disorders</mesh_term>
      <mesh_term>Problem Behavior</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>
  
  
text: 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/NCT05962424
  org study id: 70198
  nct id: NCT05962424
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The purpose of this study is to understand how ketamine brings about dissociative symptoms.
  The goal of this proposed research is to record the effects of ketamine on brain activity to
        understand the changes that occur during antidepressant therapy and the side effect of
        dissociation. This research is designed to probe altered cognitive states associated with
        dissociation, depression, and other neuropsychiatric conditions.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Number of participants with dissociative events during ketamine infusion as assessed by CADSS (Clinician-Administered Dissociative State Scale)
  time frame: up to 1 week
  description: The CADSS is an instrument for the measurement of dissociative symptoms. The CADSS comprises 23 subjective items and participant's responses are coded on a 5-point scale (0 = Not at all; 4 = Extreme). The higher the number on the CADSS, the more severe the symptoms.
  arm group label: Ketamine
  arm group type: Experimental
  description: Study participants will receive 0.5mg/kg of ketamine - one single infusion
  intervention type: Drug
  intervention name: Ketamine Hydrochloride
  description: Ketamine is an FDA-approved dissociative anesthetic.
  arm group label: Ketamine
  other name: Ketalar
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Karl Deisseroth, MD, PhD
  role: Principal Investigator
  affiliation: Stanford University
  last name: Dariana Gil-Hernandez, BA
  phone: 650-724-8902
  email: dariana@stanford.edu
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: Karl Deisseroth
  investigator title: Professor
  mesh term: Mental Disorders
  mesh term: Problem Behavior
  mesh term: Ketamine
  sharing ipd: No