<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/NCT03237286</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19040414</org_study_id>
    <secondary_id>1R01MH113857</secondary_id>
    <nct_id>NCT03237286</nct_id>
  </id_info>
  <brief_title>Intravenous Ketamine Plus Neurocognitive Training for Depression</brief_title>
  <official_title>Testing a Synergistic, Neuroplasticity-Based Intervention for Depressive Neurocognition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rebecca Price</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</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>
      This study has two aims: 1) to characterize the effects of intravenous ketamine on&#xD;
      neurocognitive markers in depressed patients; 2) to test the efficacy of a synergistic&#xD;
      intervention for depression combining intravenous ketamine with neurocognitive training.&#xD;
      Three of the primary outcomes listed (fMRI functional connectivity; Implicit Association&#xD;
      Test; cognitive flexibility testing) pertain to Aim 1. For Aim 2, one primary clinical&#xD;
      outcome (MADRS, a clinician-administered measure of depression severity) pertains to the&#xD;
      acute (30-day) phase, while the QIDS (a self-report measure of depression severity) becomes&#xD;
      the primary clinical outcome during the 12-month naturalistic follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      NOTE: Corrections have been made to the &quot;Time Frame&quot; entries for all primary/secondary&#xD;
      outcomes after identifying errors stemming from the study team's misunderstanding of the&#xD;
      &quot;Time Frame&quot; query. Initially, the &quot;Time Frame&quot; query was misinterpreted to mean the range&#xD;
      (minimum to maximum) length of the time interval over which any given assessment visit might&#xD;
      query symptoms, and were therefore assigned erroneous values (&quot;1 day to 2 weeks&quot;; &quot;1 day to&#xD;
      lifetime&quot;) reflecting the time interval(s) queried by the instrument (e.g. at the +24 hours&#xD;
      timepoint, symptoms are queried over a 1-day interval; at other assessment points, they could&#xD;
      be queried over a 2-week interval for some measures, or over the entire lifetime for other&#xD;
      measures). After recognizing this misinterpretation, the values have been adjusted to&#xD;
      accurately reflect the a priori analytic plan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">October 18, 2022</completion_date>
  <primary_completion_date type="Actual">October 18, 2022</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Montgomery Asberg Depression Scale</measure>
    <time_frame>Trajectories from 24 hours through Day 30 post-infusion</time_frame>
    <description>Clinician-rated depression (range: 0-60; higher scores = worse outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Executive-salience network functional connectivity</measure>
    <time_frame>Trajectories from 24 hours through Day 30 post-infusion</time_frame>
    <description>fMRI measure (beta weights where larger beta weight = stronger connectivity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implicit self-representations</measure>
    <time_frame>Trajectories from 24 hours through Day 30 post-infusion</time_frame>
    <description>Implicit Association Test &quot;D-score&quot; (performance-based measure; range = -inf-inf; high score=worse outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive Flexibility</measure>
    <time_frame>Trajectories from 24 hours through Day 30 post-infusion</time_frame>
    <description>Neurocognitive testing via NIH Toolbox DCCS fully-corrected T-scores (range = 0-100; high score=better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quick Inventory of Depressive Symptoms</measure>
    <time_frame>Trajectories from Day 30 through 12 months post-infusion (naturalistic follow-up)</time_frame>
    <description>Self-reported depression (range: 0-27; higher scores = worse outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neural activation and connectivity patterns</measure>
    <time_frame>Trajectories from 24 hours through Day 30 post-infusion</time_frame>
    <description>MRI measures in prefrontal cortex, hippocampus, amygdala (range: -inf-inf; high score=greater connectivity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Affective flexibility/inhibition</measure>
    <time_frame>Trajectories from 24 hours through Day 30 post-infusion</time_frame>
    <description>Neurocognitive testing via Affective Go/No-Go task (range: -inf-inf; high score=better performance)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS measures-depression</measure>
    <time_frame>Trajectories from 24 hours through Month 12 post-infusion</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported depression T-score range: 0-100 (higher score = worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS measures-anxiety</measure>
    <time_frame>Trajectories from 24 hours through Month 12 post-infusion</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anxiety T-score range: 0-100 (higher score = worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS measures-anger</measure>
    <time_frame>Trajectories from 24 hours through Month 12 post-infusion</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anger T-score range: 0-100 (higher score = worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS measures-positive affect</measure>
    <time_frame>Trajectories from 24 hours through Month 12 post-infusion</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported positive affect/well-being T-score range: 0-100 (higher score = better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS measures-sleep disturbance</measure>
    <time_frame>Trajectories from 24 hours through Month 12 post-infusion</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported sleep disturbance T-score range: 0-100 (higher score = worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS measures-cognitive function</measure>
    <time_frame>Trajectories from 24 hours through Month 12 post-infusion</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported cognitive function T-score range: 0-100 (higher score = better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS measures-substance use</measure>
    <time_frame>Trajectories from 24 hours through Month 12 post-infusion</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported substance use T-score range: 0-100 (higher score = worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS measures-alcohol</measure>
    <time_frame>Trajectories from 24 hours through Month 12 post-infusion</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported alcohol use T-score range: 0-100 (higher score = worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Triad Inventory</measure>
    <time_frame>Trajectories from 24 hours through Month 12 post-infusion</time_frame>
    <description>Negative perceptions of self, future, &amp; world (range=12-84; higher score = better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Columbia-Suicide Severity Rating Scale</measure>
    <time_frame>Trajectories from 24 hours through Month 12 post-infusion</time_frame>
    <description>Suicidality and patient safety (most severe ideation score, range=0-5; higher score = worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHO Disability Assessment Scale (SR)</measure>
    <time_frame>Trajectories from 24 hours through Month 12 post-infusion</time_frame>
    <description>Global functioning (range=0-48; higher score = better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Flexibility Scale</measure>
    <time_frame>Trajectories from 24 hours through Month 12 post-infusion</time_frame>
    <description>Self-reported cognitive flexibility (range=12-72; higher score = better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuroplasticity-related markers in blood</measure>
    <time_frame>Trajectories from 40min through Day 5 post-infusion</time_frame>
    <description>ketamine, ketamine metabolites, BDNF, inflammatory markers (range=0-inf; higher score = greater concentration in blood)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Ketamine + Cognitive Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketamine + Sham Training</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline + Cognitive Training</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous ketamine</intervention_name>
    <description>Intravenous ketamine is given at a subanesthetic dose, which previous research suggests is safe and efficacious for rapid relief from depression.</description>
    <arm_group_label>Ketamine + Cognitive Training</arm_group_label>
    <arm_group_label>Ketamine + Sham Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computer-based Cognitive Training</intervention_name>
    <description>Computer-based Cognitive Training will be delivered following intravenous ketamine to test whether learning during a post-ketamine &quot;window of opportunity&quot; might extend relief from depression.</description>
    <arm_group_label>Ketamine + Cognitive Training</arm_group_label>
    <arm_group_label>Saline + Cognitive Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants will:&#xD;
&#xD;
          1. be between the ages of 18 and 60 years,&#xD;
&#xD;
          2. have not responded to one or more adequate trials of FDA-approved antidepressants&#xD;
             within the current depressive episode, determined by Antidepressant Treatment History&#xD;
             Form&#xD;
&#xD;
          3. score ≥ 25 on the Montgomery Asberg Depression Rating Scale (MADRS)&#xD;
&#xD;
          4. score &gt;1SD above the normative mean on the Cognitive Triad Inventory &quot;self&quot; subscale&#xD;
             *OR* &lt;1SD below the normative mean on the Rosenberg self-esteem scale&#xD;
&#xD;
          5. 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;
          6. agree to sign a release of information (ROI), identifying another individual [friend,&#xD;
             family member, etc.] as a contact person while the patient is enrolled in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic&#xD;
             substance use (e.g., substance use disorder); or lifetime recreational ketamine or PCP&#xD;
             use&#xD;
&#xD;
          2. Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks&#xD;
&#xD;
          3. 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, especially in the eye. Dental fillings do not present a&#xD;
             problem. Plastic or removable dental appliances do not require exclusion. History of&#xD;
             significant injury or surgery to the brain or spinal cord that would impair&#xD;
             interpretation of results.&#xD;
&#xD;
          4. Current pregnancy or breastfeeding, or failure to engage in an effective birth control&#xD;
             strategy throughout the duration of the study&#xD;
&#xD;
          5. Acute suicidality or other psychiatric crises requiring treatment escalation.&#xD;
&#xD;
          6. Changes made to treatment regimen within 4 weeks of baseline assessment&#xD;
&#xD;
          7. Reading level &lt;6th grade&#xD;
&#xD;
          8. For study entry, patients must be reasonable medical candidates for ketamine infusion,&#xD;
             as determined by a board-certified physician co-investigator during study screening.&#xD;
             Serious, unstable medical illnesses including respiratory [obstructive sleep apnea, or&#xD;
             history of difficulty with airway management during previous anesthetics],&#xD;
             cardiovascular [including ischemic heart disease and uncontrolled hypertension], and&#xD;
             neurologic [including history of severe head injury] will be exclusions.&#xD;
&#xD;
          9. Clinically significant abnormal findings of laboratory parameters [including urine&#xD;
             toxicology screen for drugs of abuse], physical examination, or ECG.&#xD;
&#xD;
         10. Uncontrolled or poorly controlled hypertension, as determined by a board-certified&#xD;
             physician co-investigator's review of vitals collected during screening and any other&#xD;
             relevant medical history/records.&#xD;
&#xD;
         11. Patients with one or more seizures without a clear and resolved etiology.&#xD;
&#xD;
         12. Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to&#xD;
             Screening. Birth control is not an exclusion.&#xD;
&#xD;
         13. Past intolerance or hypersensitivity to ketamine or midazolam.&#xD;
&#xD;
         14. Patients taking medications with known activity at the NMDA or AMPA glutamate receptor&#xD;
             [e.g., riluzole, amantadine, lamotrigine, memantine, topiramate, dextromethorphan,&#xD;
             D-cycloserine], or the muopioid receptor.&#xD;
&#xD;
         15. Patients taking any of the following medications: St John's Wort, theophylline,&#xD;
             tramadol, metrizamide&#xD;
&#xD;
         16. Patients who have received ECT in the past 6 months prior to Screening.&#xD;
&#xD;
         17. Patients currently receiving treatment with vagus nerve stimulation (VNS) or&#xD;
             repetitive transcranial stimulation (rTMS).&#xD;
&#xD;
         18. Patients taking benzodiazepines (within 8 hours of infusion) or GABA agonists&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Western Psychiatric Institute and Clinic</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>December 7, 2022</last_update_submitted>
  <last_update_submitted_qc>December 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Rebecca Price</investigator_full_name>
    <investigator_title>Assistant Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>depression</keyword>
  <keyword>ketamine</keyword>
  <keyword>neurocognitive</keyword>
  <keyword>fMRI</keyword>
  <keyword>cognitive training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <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>Yes</sharing_ipd>
    <ipd_description>We will comply with all NIMH guidelines regarding data repository/sharing.</ipd_description>
    <ipd_time_frame>We will comply with all NIMH guidelines regarding data repository/sharing.</ipd_time_frame>
  </patient_data>
  <pending_results>
    <submitted>September 12, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03237286
org study id: STUDY19040414
secondary id: 1R01MH113857
nct id: NCT03237286
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study has two aims: 1) to characterize the effects of intravenous ketamine on
      neurocognitive markers in depressed patients; 2) to test the efficacy of a synergistic
      intervention for depression combining intravenous ketamine with neurocognitive training.
      Three of the primary outcomes listed (fMRI functional connectivity; Implicit Association
      Test; cognitive flexibility testing) pertain to Aim 1. For Aim 2, one primary clinical
      outcome (MADRS, a clinician-administered measure of depression severity) pertains to the
      acute (30-day) phase, while the QIDS (a self-report measure of depression severity) becomes
      the primary clinical outcome during the 12-month naturalistic follow-up.
NOTE: Corrections have been made to the "Time Frame" entries for all primary/secondary
      outcomes after identifying errors stemming from the study team's misunderstanding of the
      "Time Frame" query. Initially, the "Time Frame" query was misinterpreted to mean the range
      (minimum to maximum) length of the time interval over which any given assessment visit might
      query symptoms, and were therefore assigned erroneous values ("1 day to 2 weeks"; "1 day to
      lifetime") reflecting the time interval(s) queried by the instrument (e.g. at the +24 hours
      timepoint, symptoms are queried over a 1-day interval; at other assessment points, they could
      be queried over a 2-week interval for some measures, or over the entire lifetime for other
      measures). After recognizing this misinterpretation, the values have been adjusted to
      accurately reflect the a priori analytic plan.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Montgomery Asberg Depression Scale
time frame: Trajectories from 24 hours through Day 30 post-infusion
description: Clinician-rated depression (range: 0-60; higher scores = worse outcome)
measure: Executive-salience network functional connectivity
time frame: Trajectories from 24 hours through Day 30 post-infusion
description: fMRI measure (beta weights where larger beta weight = stronger connectivity
measure: Implicit self-representations
time frame: Trajectories from 24 hours through Day 30 post-infusion
description: Implicit Association Test "D-score" (performance-based measure; range = -inf-inf; high score=worse outcome)
measure: Cognitive Flexibility
time frame: Trajectories from 24 hours through Day 30 post-infusion
description: Neurocognitive testing via NIH Toolbox DCCS fully-corrected T-scores (range = 0-100; high score=better outcome)
measure: Quick Inventory of Depressive Symptoms
time frame: Trajectories from Day 30 through 12 months post-infusion (naturalistic follow-up)
description: Self-reported depression (range: 0-27; higher scores = worse outcome)
measure: Neural activation and connectivity patterns
time frame: Trajectories from 24 hours through Day 30 post-infusion
description: MRI measures in prefrontal cortex, hippocampus, amygdala (range: -inf-inf; high score=greater connectivity)
measure: Affective flexibility/inhibition
time frame: Trajectories from 24 hours through Day 30 post-infusion
description: Neurocognitive testing via Affective Go/No-Go task (range: -inf-inf; high score=better performance)
measure: PROMIS measures-depression
time frame: Trajectories from 24 hours through Month 12 post-infusion
description: Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported depression T-score range: 0-100 (higher score = worse outcome)
measure: PROMIS measures-anxiety
time frame: Trajectories from 24 hours through Month 12 post-infusion
description: Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anxiety T-score range: 0-100 (higher score = worse outcome)
measure: PROMIS measures-anger
time frame: Trajectories from 24 hours through Month 12 post-infusion
description: Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anger T-score range: 0-100 (higher score = worse outcome)
measure: PROMIS measures-positive affect
time frame: Trajectories from 24 hours through Month 12 post-infusion
description: Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported positive affect/well-being T-score range: 0-100 (higher score = better outcome)
measure: PROMIS measures-sleep disturbance
time frame: Trajectories from 24 hours through Month 12 post-infusion
description: Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported sleep disturbance T-score range: 0-100 (higher score = worse outcome)
measure: PROMIS measures-cognitive function
time frame: Trajectories from 24 hours through Month 12 post-infusion
description: Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported cognitive function T-score range: 0-100 (higher score = better outcome)
measure: PROMIS measures-substance use
time frame: Trajectories from 24 hours through Month 12 post-infusion
description: Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported substance use T-score range: 0-100 (higher score = worse outcome)
measure: PROMIS measures-alcohol
time frame: Trajectories from 24 hours through Month 12 post-infusion
description: Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported alcohol use T-score range: 0-100 (higher score = worse outcome)
measure: Cognitive Triad Inventory
time frame: Trajectories from 24 hours through Month 12 post-infusion
description: Negative perceptions of self, future, & world (range=12-84; higher score = better outcome)
measure: Columbia-Suicide Severity Rating Scale
time frame: Trajectories from 24 hours through Month 12 post-infusion
description: Suicidality and patient safety (most severe ideation score, range=0-5; higher score = worse outcome)
measure: WHO Disability Assessment Scale (SR)
time frame: Trajectories from 24 hours through Month 12 post-infusion
description: Global functioning (range=0-48; higher score = better outcome)
measure: Cognitive Flexibility Scale
time frame: Trajectories from 24 hours through Month 12 post-infusion
description: Self-reported cognitive flexibility (range=12-72; higher score = better outcome)
measure: Neuroplasticity-related markers in blood
time frame: Trajectories from 40min through Day 5 post-infusion
description: ketamine, ketamine metabolites, BDNF, inflammatory markers (range=0-inf; higher score = greater concentration in blood)
arm group label: Ketamine + Cognitive Training
arm group type: Experimental
arm group label: Ketamine + Sham Training
arm group type: Sham Comparator
arm group label: Saline + Cognitive Training
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Intravenous ketamine
description: Intravenous ketamine is given at a subanesthetic dose, which previous research suggests is safe and efficacious for rapid relief from depression.
arm group label: Ketamine + Cognitive Training
arm group label: Ketamine + Sham Training
intervention type: Behavioral
intervention name: Computer-based Cognitive Training
description: Computer-based Cognitive Training will be delivered following intravenous ketamine to test whether learning during a post-ketamine "window of opportunity" might extend relief from depression.
arm group label: Ketamine + Cognitive Training
arm group label: Saline + Cognitive Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Rebecca Price
investigator title: Assistant Professor of Psychiatry
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Ketamine
sharing ipd: Yes
ipd description: We will comply with all NIMH guidelines regarding data repository/sharing.
ipd time frame: We will comply with all NIMH guidelines regarding data repository/sharing.
submitted: September 12, 2023