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/NCT05991232</url>
    </required_header>
    <id_info>
      <org_study_id>2022H0446</org_study_id>
      <nct_id>NCT05991232</nct_id>
    </id_info>
    <brief_title>Repeated Neurocognitive Measurements in Depressed Patients</brief_title>
    <official_title>Repeated Neurocognitive Measurements in Depressed Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jay Fournier</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ohio State 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>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this project, we will A) track the functioning of a collection of potential&#xD;
        neurobiological targets for depression over time, B) examine how fluctuations in the&#xD;
        functioning of those targets relates to real-world functioning, and C) in a subset of the&#xD;
        sample, determine how the functioning in those targets is altered by a single dose of&#xD;
        ketamine.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2025</primary_completion_date>
    <phase>Phase 1/Phase 2</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>fMRI resting state connectivity</measure>
      <time_frame>24hrs post-intervention</time_frame>
      <description>directed connectivity beta weights between default mode, frontoparietal, limbic/affective, and salience networks (larger beta weight = stronger connectivity)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Montgomery-Asberg Depression Rating Scale</measure>
      <time_frame>24hrs post-intervention</time_frame>
      <description>Clinician-rated depression (range: 0-60; higher scores = worse outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montgomery-Asberg Depression Rating Scale</measure>
      <time_frame>5 days post-intervention</time_frame>
      <description>Clinician-rated depression (range: 0-60; higher scores = worse outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montgomery-Asberg Depression Rating Scale</measure>
      <time_frame>12 days post-intervention</time_frame>
      <description>Clinician-rated depression (range: 0-60; higher scores = worse outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hamilton Depression Rating Scale</measure>
      <time_frame>24hrs post-intervention</time_frame>
      <description>Clinician-rated depression (range: 0-52; higher scores = worse outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hamilton Depression Rating Scale</measure>
      <time_frame>5 days post-intervention</time_frame>
      <description>Clinician-rated depression (range: 0-52; higher scores = worse outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hamilton Depression Rating Scale</measure>
      <time_frame>12 days post-intervention</time_frame>
      <description>Clinician-rated depression (range: 0-52; higher scores = worse outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quick Inventory of Depressive Symptoms</measure>
      <time_frame>24hrs post-intervention</time_frame>
      <description>Self-reported depression (range: 0-27; higher scores = worse outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quick Inventory of Depressive Symptoms</measure>
      <time_frame>5 days post-intervention</time_frame>
      <description>Self-reported depression (range: 0-27; higher scores = worse outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quick Inventory of Depressive Symptoms</measure>
      <time_frame>12 days post-intervention</time_frame>
      <description>Self-reported depression (range: 0-27; higher scores = worse outcome)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Depression, Unipolar</condition>
    <arm_group>
      <arm_group_label>Intravenous Ketamine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Open-label ketamine infusion</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Intravenous Ketamine</intervention_name>
      <description>Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)</description>
      <arm_group_label>Intravenous Ketamine</arm_group_label>
      <other_name>Ketalar</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          All participants will:&#xD;
  &#xD;
            1. be between the ages of 18 and 60 years,&#xD;
  &#xD;
            2. score ≥ 14 on the Hamilton Depression Rating Scale (Ham-D)&#xD;
  &#xD;
            3. possess a level of understanding sufficient to agree to all tests and examinations&#xD;
               required by the protocol and must sign an informed consent document&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          All participants:&#xD;
  &#xD;
            1. Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic&#xD;
               substance use (e.g., ongoing moderate-to-severe substance use disorder);&#xD;
  &#xD;
            2. Failure to meet standard MRI inclusion criteria: those who have cardiac pacemakers,&#xD;
               neural pacemakers, cochlear implants, metal braces, or other non-MRI-compatible metal&#xD;
               objects in their body. History of significant injury or surgery to the brain or spinal&#xD;
               cord that would impair interpretation of results.&#xD;
  &#xD;
            3. Acute suicidality or other psychiatric crises requiring treatment escalation. We will&#xD;
               use the Columbia Suicide Severity Rating Scale (CSSRS) as both an initial exclusion&#xD;
               criteria (CSSRS &quot;Baseline/Screening&quot; Version for past 1month period) and as grounds&#xD;
               for rescue/removal (CSSRS &quot;Since Last Visit&quot; form). The CSSRS will be administered&#xD;
               using a paper form by an experienced and thoroughly trained clinical assessor on the&#xD;
               study team. Subjects with CSSRS suicide ideation scores scored &quot;yes&quot; on items 4&#xD;
               (active suicidal ideation with some intent to act) and/or 5 (active suicidal ideation&#xD;
               with specific plan and intent) will be excluded from the study, and if enrolled, will&#xD;
               be exited from the study and referred immediately to the nearest emergency mental&#xD;
               health facility for additional thorough assessment and appropriate treatment referral.&#xD;
  &#xD;
            4. Changes made to treatment regimen within 4 weeks of baseline assessment.&#xD;
  &#xD;
            5. Reading level &lt;6th grade as per patient self-report.&#xD;
  &#xD;
            6. Patients who have received ECT in the past 2 months prior to Screening.&#xD;
  &#xD;
          Ketamine phase subsample additional exclusion criteria:&#xD;
  &#xD;
            1. Patients currently taking any psychotropic medication.&#xD;
  &#xD;
            2. Lifetime recreational ketamine or PCP use&#xD;
  &#xD;
            3. Current pregnancy or breastfeeding&#xD;
  &#xD;
            4. For ketamine phase entry, patients must be reasonable medical candidates for ketamine&#xD;
               infusion, as determined by a physician co-investigator. Serious, unstable medical&#xD;
               illnesses including respiratory [obstructive sleep apnea, or history of difficulty&#xD;
               with airway management during previous anesthetics], cardiovascular [including&#xD;
               ischemic heart disease and uncontrolled hypertension], and neurologic [including&#xD;
               history of severe head injury] will be exclusions.&#xD;
  &#xD;
            5. Clinically significant abnormal findings of laboratory parameters [including urine&#xD;
               toxicology screen for drugs of abuse], physical examination, or ECG.&#xD;
  &#xD;
            6. Uncontrolled or poorly controlled hypertension, as determined by a physician&#xD;
               co-investigator's review of vitals collected during screening and any other relevant&#xD;
               medical history/records.&#xD;
  &#xD;
            7. Patients with one or more seizures without a clear and resolved etiology.&#xD;
  &#xD;
            8. Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to&#xD;
               Screening.&#xD;
  &#xD;
            9. Past intolerance or hypersensitivity to ketamine.&#xD;
  &#xD;
           10. Patients taking medications with known activity at the NMDA or AMPA glutamate receptor&#xD;
               [e.g., riluzole, amantadine, memantine, topiramate, dextromethorphan, Dcycloserine],&#xD;
               or the mu-opioid receptor.&#xD;
  &#xD;
           11. Patients taking any of the following medications: St John's Wort, theophylline,&#xD;
               tramadol, metrizamide.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jay Fournier, PhD</last_name>
      <phone>614-293-9889</phone>
      <email>jay.fournier@osumc.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Ohio State University</investigator_affiliation>
      <investigator_full_name>Jay Fournier</investigator_full_name>
      <investigator_title>Associate Professor, Department of Psychiatry &amp; Behavioral Health</investigator_title>
    </responsible_party>
    <keyword>Depressive Disorder</keyword>
    <keyword>Mood Disorders</keyword>
    <keyword>Mental Disorders</keyword>
    <keyword>Ketamine</keyword>
    <keyword>Analgesics</keyword>
    <keyword>Sensory System Agents</keyword>
    <keyword>Peripheral Nervous System Agents</keyword>
    <keyword>Physiological Effects of Drugs</keyword>
    <keyword>Anesthetics, Dissociative</keyword>
    <keyword>Anesthetics, Intravenous</keyword>
    <keyword>Anesthetics, General</keyword>
    <keyword>Anesthetics</keyword>
    <keyword>Central Nervous System Depressants</keyword>
    <keyword>Excitatory Amino Acid Antagonists</keyword>
    <keyword>Excitatory Amino Acid Agents</keyword>
    <keyword>Neurotransmitter Agents</keyword>
    <keyword>Molecular Mechanisms of Pharmacological Action</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depressive 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>
    <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/NCT05991232
  org study id: 2022H0446
  nct id: NCT05991232
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  In this project, we will A) track the functioning of a collection of potential
        neurobiological targets for depression over time, B) examine how fluctuations in the
        functioning of those targets relates to real-world functioning, and C) in a subset of the
        sample, determine how the functioning in those targets is altered by a single dose of
        ketamine.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: fMRI resting state connectivity
  time frame: 24hrs post-intervention
  description: directed connectivity beta weights between default mode, frontoparietal, limbic/affective, and salience networks (larger beta weight = stronger connectivity)
  measure: Montgomery-Asberg Depression Rating Scale
  time frame: 24hrs post-intervention
  description: Clinician-rated depression (range: 0-60; higher scores = worse outcome)
  measure: Montgomery-Asberg Depression Rating Scale
  time frame: 5 days post-intervention
  description: Clinician-rated depression (range: 0-60; higher scores = worse outcome)
  measure: Montgomery-Asberg Depression Rating Scale
  time frame: 12 days post-intervention
  description: Clinician-rated depression (range: 0-60; higher scores = worse outcome)
  measure: Hamilton Depression Rating Scale
  time frame: 24hrs post-intervention
  description: Clinician-rated depression (range: 0-52; higher scores = worse outcome)
  measure: Hamilton Depression Rating Scale
  time frame: 5 days post-intervention
  description: Clinician-rated depression (range: 0-52; higher scores = worse outcome)
  measure: Hamilton Depression Rating Scale
  time frame: 12 days post-intervention
  description: Clinician-rated depression (range: 0-52; higher scores = worse outcome)
  measure: Quick Inventory of Depressive Symptoms
  time frame: 24hrs post-intervention
  description: Self-reported depression (range: 0-27; higher scores = worse outcome)
  measure: Quick Inventory of Depressive Symptoms
  time frame: 5 days post-intervention
  description: Self-reported depression (range: 0-27; higher scores = worse outcome)
  measure: Quick Inventory of Depressive Symptoms
  time frame: 12 days post-intervention
  description: Self-reported depression (range: 0-27; higher scores = worse outcome)
  arm group label: Intravenous Ketamine
  arm group type: Experimental
  description: Open-label ketamine infusion
  intervention type: Drug
  intervention name: Intravenous Ketamine
  description: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
  arm group label: Intravenous Ketamine
  other name: Ketalar
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Jay Fournier, PhD
  phone: 614-293-9889
  email: jay.fournier@osumc.edu
  responsible party type: Sponsor-Investigator
  investigator affiliation: Ohio State University
  investigator full name: Jay Fournier
  investigator title: Associate Professor, Department of Psychiatry & Behavioral Health
  mesh term: Depressive Disorder
  mesh term: Ketamine
  sharing ipd: No