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/NCT06034821</url>
    </required_header>
    <id_info>
      <org_study_id>2023P001429</org_study_id>
      <nct_id>NCT06034821</nct_id>
    </id_info>
    <brief_title>Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan</brief_title>
    <acronym>REaKT-SD</acronym>
    <official_title>Rapid Reversal of Suicidal Depression: Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan (REaKT-SD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Brigham and Women's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Johns Hopkins University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Pittsburgh</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Baylor College of Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Arizona</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Cleveland Clinic</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Icahn School of Medicine at Mount Sinai</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Washington University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Toronto</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The University of Texas Health Science Center, Houston</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Brigham and Women's Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a randomized open-label single-blind non-inferiority comparative effectiveness&#xD;
        study of ECT vs. KET for the treatment of Acute Suicidal Depression (ASD).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There is a crisis in the treatment of the imminently suicidal patient. Acute Suicidal&#xD;
        Depression (ASD) is a life-threatening illness which requires rapid relief. A number of&#xD;
        behavioral programs with varying efficacy are available for prevention of suicide. However,&#xD;
        once acute suicidal depression has set in, its treatment is woefully inadequate in the&#xD;
        current health system despite availability of efficacious treatments. Patients suffering from&#xD;
        ASD are usually admitted as inpatients for safety and started on oral antidepressants (which&#xD;
        can take 6 - 12 weeks to have an effect) and given nursing care. They are then discharged&#xD;
        from the hospital, usually within 4 -5 days, as soon as immediate safety concerns are&#xD;
        ameliorated. Essentially, patients do not receive any specific rapidly acting treatment for&#xD;
        their suicidal depression. As The immediate post-discharge period has been shown to be of the&#xD;
        highest risk for repeat suicide attempts and completed suicides. One important reason for the&#xD;
        inadequate treatment of ASD is the lack of large-scale comparative studies of efficacious&#xD;
        treatments such as electroconvulsive therapy (ECT) and subanesthetic dose intravenous&#xD;
        ketamine (KET). In the absence of data to guide rational treatment choice, neither treatment&#xD;
        is being used adequately. Clinicians are less likely to recommend these treatments in the&#xD;
        absence of evidence to base their decision regarding which treatment to give first and under&#xD;
        what circumstances. Patients are reluctant to choose between these treatments due to&#xD;
        uncertainty regarding efficacy and apprehension regarding side effects and social stigma.&#xD;
        Finally, in the absence of effectiveness data, hospital administrators and third-party payers&#xD;
        are reticent about committing material and financial resources for these services leading to&#xD;
        inaccessibility. Hence, there is a critical need for a large-scale comparative effectiveness&#xD;
        trial of ECT vs. intravenous ketamine for rapid reversal of ASD to provide rational guidance&#xD;
        for all stakeholders.&#xD;
  &#xD;
        This study will address this significant clinical dilemma by conducting a large scale (N =&#xD;
        1500) non-inferiority randomized comparative effectiveness trial of ECT vs. KET for rapid&#xD;
        treatment of acute suicidal major depression (ASD) across the lifespan.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2030</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2030</primary_completion_date>
    <phase>Phase 4</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Scale for Suicidal Ideation (SSI)</measure>
      <time_frame>Six weeks</time_frame>
      <description>The Scale for Suicidal Ideation (SSI is excellent in terms of test construction and psychometrics (validity and reliability). It has been shown that a SSI score &gt;6 has been found to be predictive of suicide within 6 months of discharge from hospital. At the end of treatment, patients will be assessed for remission of suicidality which is defined as a SSI score &lt;4 i.e. no clinically significant suicidal ideation70. A stringent criterion for remission was chosen as ASD is a life-threatening illness and full remission should be the treatment goal.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quick Inventory of Depressive Symptoms Self Report QIDS-SR</measure>
      <time_frame>Six weeks</time_frame>
      <description>Self-reported questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Columbia Suicide Severity Rating Scale (CSSR-S)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Clinician rated scales for suicidality and depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montgomery Asberg Depression Rating Scale (MADRS)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Clinician rated scales</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Working Alliance Inventory (WAI-SR)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>National Alcohol and Drug Institute (NIDA) Questionnaire</measure>
      <time_frame>6 weeks</time_frame>
      <description>Substance use questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self and clinician rated scales</measure>
      <time_frame>6 weeks</time_frame>
      <description>Measuring length of hospital stay, memory, side effects and quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brief Psychiatric Rating Scale 4 items (BPRS)</measure>
      <time_frame>6 weeks</time_frame>
      <description>4 items for psychosis, higher scores indicate worse outcomes. Range 4-28.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinician Administered Dissociative Symptoms Scale (CADSS)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Range 0-80, higher scores indicate worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CGI-S</measure>
      <time_frame>6 weeks</time_frame>
      <description>Range 1-7, higher scores indicate worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CGI-I</measure>
      <time_frame>6 weeks</time_frame>
      <description>Range 1-7, higher scores indicate worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Young Mania Rating Scale (YMRS)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Range 0-60, higher scores indicate worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MOCA</measure>
      <time_frame>6 weeks</time_frame>
      <description>Range 0-30, higher scores indicate better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>COWAT (Total words T-score)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Range 0-30, higher scores indicate better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HVLT-R (Total T-score)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Range 0-100, higher scores indicate better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>IAT</measure>
      <time_frame>6 weeks</time_frame>
      <description>Range scores -2-+2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Suicidal Behavior Questionnaire-Revised (SBQ-R)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Range 3-18, higher scores indicate worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Global Self Evaluation of Memory (GSE-My)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Range 1-7, higher scores indicate worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-rated global assessment of severity and improvement (PGI-S/PGI-I)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Range 1-7, higher scores indicate worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Rated Inventory of Side Effects (PRISE)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Not scored</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life Scale (QOLS)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Range 16-112, higher scores indicate better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Likert Scale Treatment Preference Questionnaire</measure>
      <time_frame>6 weeks</time_frame>
      <description>Range 0-7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>National Alcohol and Drug Institute (NIDA) substance use questionnaire (TAPS-I and II)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Substance specific scores 0-3, higher scores indicate worse outcomes.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Acute Suicidal Depression (ASD)</condition>
    <arm_group>
      <arm_group_label>Subanesthetic dose intravenous ketamine (KET)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This trial will use standard dose of ketamine (0.5mg/kg infusion over 40 min period) in accordance with research studies that have used ketamine as an antidepressant.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Electroconvulsive therapy (ECT)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>ECT will be given in a standard manner 3 times a week for 4 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Subanesthetic dose intravenous ketamine (KET)</intervention_name>
      <description>This trial will use standard dose of ketamine (0.5mg/kg infusion over 40 min period) in accordance with research studies that have used ketamine as an antidepressant. Treatments will be given two times a week for a maximum of 8 treatments during the acute arm of the study. The investigators will be able to modify dose and number of treatments as indicated clinically per pragmatic clinical trials procedures. Patients will be clinically assessed prior to each treatment to evaluate response and appropriateness of continuation of treatment. Per FDA guidelines a maximum 60mg/dose will be given regardless of body weight.</description>
      <arm_group_label>Subanesthetic dose intravenous ketamine (KET)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Electroconvulsive therapy (ECT)</intervention_name>
      <description>ECT will be given in a standard manner 3 times a week for 4 weeks. The Initial ECT treatment will be Right Unilateral (RUL) ultra-brief pulse at 6x seizure threshold determined during titration at first visit. If there is not satisfactory improvement with RUL the investigator may change to Bilateral (BL) utilizing brief pulse using 0.5 modified half-age method to determine stimulus intensity. The seizure threshold may increase during the course of treatment and the dose of the electric stimulus may need to be increased incrementally. It is suggested to change to bilateral after three to five RUL treatments if response to treatment is not satisfactory. Treatments will be given three times a week for up to 4 weeks.</description>
      <arm_group_label>Electroconvulsive therapy (ECT)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Referred to ECT service as a candidate for ECT treatment as assessed by treating&#xD;
               clinician.&#xD;
  &#xD;
            -  Males/females 18 - 90 years of age.&#xD;
  &#xD;
            -  Meet DSM-5 criteria for Major Depressive Episode (MDE) as determined by Mini&#xD;
               International Neuropsychiatric Interview (MINI PLUS 5.0.0).&#xD;
  &#xD;
            -  Expressing suicidal intent (thinking or behavior suggesting harming or hurting oneself&#xD;
               with intent that death may result) or attempt (any intentional, non-fatal self-injury&#xD;
               regardless of medical lethality, if intent to die was indicated).&#xD;
  &#xD;
            -  Continue to express suicidal ideation since referral as evidenced by Scale for&#xD;
               Suicidal Ideation (SSI) ≥6)&#xD;
  &#xD;
            -  Meet the following criteria on symptom rating scales at screening: Hamilton Depression&#xD;
               Scale (HAM-D 17) &gt;15 and Montreal Cognitive Assessment (MoCA) of ≥23(to rule out&#xD;
               baseline significant cognitive impairment)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Meeting DSM-5 criteria for schizophrenia, schizophreniform disorder, schizoaffective&#xD;
               disorder.&#xD;
  &#xD;
            -  Not able to give informed consent to receive ECT or KET treatment.&#xD;
  &#xD;
            -  Not able to give informed consent to participate in the study.&#xD;
  &#xD;
            -  Meet exclusion criteria for ECT treatment as described in guidelines.&#xD;
  &#xD;
            -  Meet exclusion criteria for KET treatment such as:&#xD;
  &#xD;
            -  Pregnant or breast feeding&#xD;
  &#xD;
            -  Psychosis&#xD;
  &#xD;
            -  Severe uncontrolled medical illness&#xD;
  &#xD;
            -  Ketamine allergy&#xD;
  &#xD;
            -  Intellectual disability and unable to provide consent or follow study procedures.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amit Anand, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Brigham and Woman's Hospital, Harvard Medical School</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Amit Anand, MD</last_name>
      <phone>6175236060</phone>
      <email>aanand7@bwh.harvard.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Odeta Dyrmishi</last_name>
      <email>odeta_dyrmishi@meei.harvard.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
      <investigator_full_name>Amit Anand</investigator_full_name>
      <investigator_title>Professor of Psychiatry</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</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/NCT06034821
  org study id: 2023P001429
  nct id: NCT06034821
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: Yes
  is us export: No
  This study is a randomized open-label single-blind non-inferiority comparative effectiveness
        study of ECT vs. KET for the treatment of Acute Suicidal Depression (ASD).
  There is a crisis in the treatment of the imminently suicidal patient. Acute Suicidal
        Depression (ASD) is a life-threatening illness which requires rapid relief. A number of
        behavioral programs with varying efficacy are available for prevention of suicide. However,
        once acute suicidal depression has set in, its treatment is woefully inadequate in the
        current health system despite availability of efficacious treatments. Patients suffering from
        ASD are usually admitted as inpatients for safety and started on oral antidepressants (which
        can take 6 - 12 weeks to have an effect) and given nursing care. They are then discharged
        from the hospital, usually within 4 -5 days, as soon as immediate safety concerns are
        ameliorated. Essentially, patients do not receive any specific rapidly acting treatment for
        their suicidal depression. As The immediate post-discharge period has been shown to be of the
        highest risk for repeat suicide attempts and completed suicides. One important reason for the
        inadequate treatment of ASD is the lack of large-scale comparative studies of efficacious
        treatments such as electroconvulsive therapy (ECT) and subanesthetic dose intravenous
        ketamine (KET). In the absence of data to guide rational treatment choice, neither treatment
        is being used adequately. Clinicians are less likely to recommend these treatments in the
        absence of evidence to base their decision regarding which treatment to give first and under
        what circumstances. Patients are reluctant to choose between these treatments due to
        uncertainty regarding efficacy and apprehension regarding side effects and social stigma.
        Finally, in the absence of effectiveness data, hospital administrators and third-party payers
        are reticent about committing material and financial resources for these services leading to
        inaccessibility. Hence, there is a critical need for a large-scale comparative effectiveness
        trial of ECT vs. intravenous ketamine for rapid reversal of ASD to provide rational guidance
        for all stakeholders.
  
        This study will address this significant clinical dilemma by conducting a large scale (N =
        1500) non-inferiority randomized comparative effectiveness trial of ECT vs. KET for rapid
        treatment of acute suicidal major depression (ASD) across the lifespan.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Scale for Suicidal Ideation (SSI)
  time frame: Six weeks
  description: The Scale for Suicidal Ideation (SSI is excellent in terms of test construction and psychometrics (validity and reliability). It has been shown that a SSI score >6 has been found to be predictive of suicide within 6 months of discharge from hospital. At the end of treatment, patients will be assessed for remission of suicidality which is defined as a SSI score <4 i.e. no clinically significant suicidal ideation70. A stringent criterion for remission was chosen as ASD is a life-threatening illness and full remission should be the treatment goal.
  measure: Quick Inventory of Depressive Symptoms Self Report QIDS-SR
  time frame: Six weeks
  description: Self-reported questionnaire
  measure: Columbia Suicide Severity Rating Scale (CSSR-S)
  time frame: 6 weeks
  description: Clinician rated scales for suicidality and depression
  measure: Montgomery Asberg Depression Rating Scale (MADRS)
  time frame: 6 weeks
  description: Clinician rated scales
  measure: Working Alliance Inventory (WAI-SR)
  time frame: 6 weeks
  description: Questionnaire
  measure: National Alcohol and Drug Institute (NIDA) Questionnaire
  time frame: 6 weeks
  description: Substance use questionnaire
  measure: Self and clinician rated scales
  time frame: 6 weeks
  description: Measuring length of hospital stay, memory, side effects and quality of life
  measure: Brief Psychiatric Rating Scale 4 items (BPRS)
  time frame: 6 weeks
  description: 4 items for psychosis, higher scores indicate worse outcomes. Range 4-28.
  measure: Clinician Administered Dissociative Symptoms Scale (CADSS)
  time frame: 6 weeks
  description: Range 0-80, higher scores indicate worse outcomes.
  measure: CGI-S
  time frame: 6 weeks
  description: Range 1-7, higher scores indicate worse outcomes.
  measure: CGI-I
  time frame: 6 weeks
  description: Range 1-7, higher scores indicate worse outcomes.
  measure: Young Mania Rating Scale (YMRS)
  time frame: 6 weeks
  description: Range 0-60, higher scores indicate worse outcomes.
  measure: MOCA
  time frame: 6 weeks
  description: Range 0-30, higher scores indicate better outcomes.
  measure: COWAT (Total words T-score)
  time frame: 6 weeks
  description: Range 0-30, higher scores indicate better outcomes.
  measure: HVLT-R (Total T-score)
  time frame: 6 weeks
  description: Range 0-100, higher scores indicate better outcomes.
  measure: IAT
  time frame: 6 weeks
  description: Range scores -2-+2
  measure: Suicidal Behavior Questionnaire-Revised (SBQ-R)
  time frame: 6 weeks
  description: Range 3-18, higher scores indicate worse outcomes.
  measure: Global Self Evaluation of Memory (GSE-My)
  time frame: 6 weeks
  description: Range 1-7, higher scores indicate worse outcomes.
  measure: Patient-rated global assessment of severity and improvement (PGI-S/PGI-I)
  time frame: 6 weeks
  description: Range 1-7, higher scores indicate worse outcomes.
  measure: Patient Rated Inventory of Side Effects (PRISE)
  time frame: 6 weeks
  description: Not scored
  measure: Quality of Life Scale (QOLS)
  time frame: 6 weeks
  description: Range 16-112, higher scores indicate better outcomes.
  measure: Likert Scale Treatment Preference Questionnaire
  time frame: 6 weeks
  description: Range 0-7
  measure: National Alcohol and Drug Institute (NIDA) substance use questionnaire (TAPS-I and II)
  time frame: 6 weeks
  description: Substance specific scores 0-3, higher scores indicate worse outcomes.
  arm group label: Subanesthetic dose intravenous ketamine (KET)
  arm group type: Active Comparator
  description: This trial will use standard dose of ketamine (0.5mg/kg infusion over 40 min period) in accordance with research studies that have used ketamine as an antidepressant.
  arm group label: Electroconvulsive therapy (ECT)
  arm group type: Active Comparator
  description: ECT will be given in a standard manner 3 times a week for 4 weeks.
  intervention type: Drug
  intervention name: Subanesthetic dose intravenous ketamine (KET)
  description: This trial will use standard dose of ketamine (0.5mg/kg infusion over 40 min period) in accordance with research studies that have used ketamine as an antidepressant. Treatments will be given two times a week for a maximum of 8 treatments during the acute arm of the study. The investigators will be able to modify dose and number of treatments as indicated clinically per pragmatic clinical trials procedures. Patients will be clinically assessed prior to each treatment to evaluate response and appropriateness of continuation of treatment. Per FDA guidelines a maximum 60mg/dose will be given regardless of body weight.
  arm group label: Subanesthetic dose intravenous ketamine (KET)
  intervention type: Device
  intervention name: Electroconvulsive therapy (ECT)
  description: ECT will be given in a standard manner 3 times a week for 4 weeks. The Initial ECT treatment will be Right Unilateral (RUL) ultra-brief pulse at 6x seizure threshold determined during titration at first visit. If there is not satisfactory improvement with RUL the investigator may change to Bilateral (BL) utilizing brief pulse using 0.5 modified half-age method to determine stimulus intensity. The seizure threshold may increase during the course of treatment and the dose of the electric stimulus may need to be increased incrementally. It is suggested to change to bilateral after three to five RUL treatments if response to treatment is not satisfactory. Treatments will be given three times a week for up to 4 weeks.
  arm group label: Electroconvulsive therapy (ECT)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Amit Anand, MD
  role: Principal Investigator
  affiliation: Brigham and Woman's Hospital, Harvard Medical School
  last name: Amit Anand, MD
  phone: 6175236060
  email: aanand7@bwh.harvard.edu
  last name: Odeta Dyrmishi
  email: odeta_dyrmishi@meei.harvard.edu
  responsible party type: Principal Investigator
  investigator affiliation: Brigham and Women's Hospital
  investigator full name: Amit Anand
  investigator title: Professor of Psychiatry
  mesh term: Depression
  mesh term: Ketamine
  sharing ipd: No