<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/NCT04427137</url>
  </required_header>
  <id_info>
    <org_study_id>071-2020</org_study_id>
    <nct_id>NCT04427137</nct_id>
  </id_info>
  <brief_title>Accelerated LFR for Bipolar Patients During the COVID-19 Pandemic</brief_title>
  <official_title>A Novel and Practical Accelerated Low-frequency Right-sided Stimulation Protocol as a Substitute for Patients With Bipolar Depression Needing Electroconvulsive Therapy During the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre for Addiction and Mental Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study aims to assess the feasibility, acceptance and clinical outcomes of a&#xD;
      practical high-dose LFR protocol, including tapering treatments and symptom-based relapse&#xD;
      prevention treatments, in patients with bipolar depression previously responsive to ECT and&#xD;
      patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment resistant bipolar depression is a leading cause of disability and socioeconomic&#xD;
      burden of disease, and current treatment options all suffer from critical deficiencies of&#xD;
      efficacy, capacity, or tolerability, especially given the current COVID-19 pandemic. rTMS and&#xD;
      aLFR in particular has the potential to overcome many of these deficiencies, and is safe and&#xD;
      well-tolerated. Taken together with the reported findings of other groups, aLFR may be&#xD;
      feasible, tolerable, and capable of achieving comparable and potentially better remission&#xD;
      rates than longer 20 to 30-day courses and it may also be beneficial to taper treatments and&#xD;
      use symptom-based relapse prevention treatments in an aLFR protocol. Importantly, our pilot&#xD;
      data in two patients previously responsive to ECT and data from the Cole et al. study suggest&#xD;
      that accelerated rTMS may be a potential substitute for ECT as it may be possible to achieve&#xD;
      remission in patients with severe depressive symptoms who would otherwise receive ECT.&#xD;
      Furthermore, there is a burden of being able to provide care to as many people as possible&#xD;
      based on severity of illness during the pandemic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 9, 2020</start_date>
  <completion_date type="Anticipated">November 9, 2022</completion_date>
  <primary_completion_date type="Actual">January 9, 2022</primary_completion_date>
  <phase>N/A</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>Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>Less than or equal to 10&#xD;
This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Hamilton Rating Scale for Depresion 24-it (HRSD-24)</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>changes in scores&#xD;
This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response on Hamilton Rating Scale for Depresion 24-it (HRSD-24)</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>50% Reduction in score&#xD;
This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Young Mania Rating Scale (YMRS)</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>changes in scores&#xD;
This scale is used to quantify the severity of symptoms of mania Scale range: 0-60 (total score) Lower scores indicate lower severity of manic symptoms (i.e., better outcome) Higher scores indicate higher severity of manic symptoms (i.e., worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission on Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>Less than or equal to 4&#xD;
This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response on Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>50% Reduction in score&#xD;
This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>changes in scores&#xD;
This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission on General Anxiety Disorder 7 item (GAD-7)</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>Less than or equal to 4&#xD;
This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response on General Anxiety Disorder 7 item (GAD-7)</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>50% Reduction in score&#xD;
This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in General Anxiety Disorder 7 item (GAD-7)</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>changes in scores&#xD;
This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission on Beck Depression Inventory (BDI-II)</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>Less than or equal to 12&#xD;
This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response on Beck Depression Inventory (BDI-II)</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>50% Reduction in Score&#xD;
This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on Beck Depression Inventory (BDI-II)</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>changes in scores&#xD;
This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission on Beck Scale for Suicidal Ideation (SSI)</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>Score of 0&#xD;
This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas Scale range: 0 - 38 (total score) Lower scores indicate lower severity of suicidal ideation (i.e., better outcome) Higher scores indicate higher severity of suicidal ideation (i.e., worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on Beck Scale for Suicidal Ideation (SSI)</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>changes in scores&#xD;
This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas Scale range: 0 - 38 (total score) Lower scores indicate lower severity of suicidal ideation (i.e., better outcome) Higher scores indicate higher severity of suicidal ideation (i.e., worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in WHO Disability Assessment Schedule (WHODAS) Range 0-38</measure>
    <time_frame>Up to 10 days (From screening/baseline to end of the acute treatment)</time_frame>
    <description>changes in scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Maintaining Response During Relapse Prevention</measure>
    <time_frame>24 weeks (Tapering and Relapse prevention phase)</time_frame>
    <description>Includes number of treatment days needed and number going on to receive ECT</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Bipolar Depression</condition>
  <arm_group>
    <arm_group_label>Accelerated LFR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the acute treatment phase, treatment will occur 8 times daily (50 min pause between treatments) on weekdays, until symptom remission is achieved (HRSD-24 score &lt; to 10) or a maximum of 10 working days of daily treatment. In the tapering phase, treatments will be reduced to 2 treatment days per week for 2 weeks and then 1 treatment day per week for 2 weeks (4 weeks total). Patients that have responded to treatment will then enter the symptom-based relapse prevention phase including virtual check-in with study staff and a treatment schedule based on symptom level according to a modified relapse prevention algorithm that has been developed to prevent relapse after a successful course of ECT (known as the STABLE algorithm). The relapse prevention phase will last a maximum of 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MagPro X100 Stimulator, B70 Fluid-Cooled Coil</intervention_name>
    <description>Treatment will occur 8 times per treatment day (50 min pause between treatments). Each treatment session will consist of a single LFR treatment, with 360 pulses of LFR delivered in one continuous train of 6 minutes at 1Hz at 120% of the patient's resting motor threshold.</description>
    <arm_group_label>Accelerated LFR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently are experiencing a bipolar depressive episode (bipolar disorder type 1 or 2)&#xD;
             based on the MINI with or without psychotic symptoms&#xD;
&#xD;
          -  Have previous response to ECT or high symptom severity warranting acute ECT in the&#xD;
             opinion of one of the brain stimulation psychiatrists&#xD;
&#xD;
          -  Are over the age of 18&#xD;
&#xD;
          -  Pass the TMS adult safety screening (TASS) questionnaire&#xD;
&#xD;
          -  Are voluntary and competent to consent to treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of&#xD;
             substance dependence or abuse within the last 1 month&#xD;
&#xD;
          -  Currently experiencing a mixed or manic episode (YMRS &gt;12)&#xD;
&#xD;
          -  have a concomitant major unstable medical illness, cardiac pacemaker or implanted&#xD;
             medication pump&#xD;
&#xD;
          -  have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of&#xD;
             schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional&#xD;
             disorder&#xD;
&#xD;
          -  have any significant neurological disorder or insult including, but not limited to:&#xD;
             any condition likely to be associated with increased intracranial pressure, space&#xD;
             occupying brain lesion, any history of seizure except those therapeutically induced by&#xD;
             ECT or a febrile seizure of infancy or single seizure related to a known drug related&#xD;
             event, cerebral aneurysm, significant head trauma with loss of consciousness for&#xD;
             greater than 5 minutes&#xD;
&#xD;
          -  have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear&#xD;
             implants, or electrodes) or any other metal object within or near the head, excluding&#xD;
             the mouth, that cannot be safely removed&#xD;
&#xD;
          -  currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an&#xD;
             anticonvulsant due to the potential to limit rTMS efficacy&#xD;
&#xD;
          -  Lack of response to accelerated course of rTMS in the past&#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>Daniel Blumberger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CAMH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CAMH</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6H3J7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 22, 2022</last_update_submitted>
  <last_update_submitted_qc>July 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Addiction and Mental Health</investigator_affiliation>
    <investigator_full_name>Daniel Blumberger</investigator_full_name>
    <investigator_title>Medical Head and Co-Director, Temerty Centre for Therapeutic Brain Intervention</investigator_title>
  </responsible_party>
  <keyword>bipolar depression</keyword>
  <keyword>transcranial magnetic stimulation</keyword>
  <keyword>treatment resistance</keyword>
  <keyword>low-frequency right-side stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT04427137
org study id: 071-2020
nct id: NCT04427137
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current study aims to assess the feasibility, acceptance and clinical outcomes of a
      practical high-dose LFR protocol, including tapering treatments and symptom-based relapse
      prevention treatments, in patients with bipolar depression previously responsive to ECT and
      patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.
Treatment resistant bipolar depression is a leading cause of disability and socioeconomic
      burden of disease, and current treatment options all suffer from critical deficiencies of
      efficacy, capacity, or tolerability, especially given the current COVID-19 pandemic. rTMS and
      aLFR in particular has the potential to overcome many of these deficiencies, and is safe and
      well-tolerated. Taken together with the reported findings of other groups, aLFR may be
      feasible, tolerable, and capable of achieving comparable and potentially better remission
      rates than longer 20 to 30-day courses and it may also be beneficial to taper treatments and
      use symptom-based relapse prevention treatments in an aLFR protocol. Importantly, our pilot
      data in two patients previously responsive to ECT and data from the Cole et al. study suggest
      that accelerated rTMS may be a potential substitute for ECT as it may be possible to achieve
      remission in patients with severe depressive symptoms who would otherwise receive ECT.
      Furthermore, there is a burden of being able to provide care to as many people as possible
      based on severity of illness during the pandemic.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: Less than or equal to 10
This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
measure: Change in Hamilton Rating Scale for Depresion 24-it (HRSD-24)
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: changes in scores
This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
measure: Response on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: 50% Reduction in score
This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
measure: Change in Young Mania Rating Scale (YMRS)
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: changes in scores
This scale is used to quantify the severity of symptoms of mania Scale range: 0-60 (total score) Lower scores indicate lower severity of manic symptoms (i.e., better outcome) Higher scores indicate higher severity of manic symptoms (i.e., worse outcome)
measure: Remission on Patient Health Questionnaire (PHQ-9)
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: Less than or equal to 4
This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
measure: Response on Patient Health Questionnaire (PHQ-9)
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: 50% Reduction in score
This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
measure: Change in Patient Health Questionnaire (PHQ-9)
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: changes in scores
This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
measure: Remission on General Anxiety Disorder 7 item (GAD-7)
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: Less than or equal to 4
This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)
measure: Response on General Anxiety Disorder 7 item (GAD-7)
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: 50% Reduction in score
This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)
measure: Change in General Anxiety Disorder 7 item (GAD-7)
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: changes in scores
This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)
measure: Remission on Beck Depression Inventory (BDI-II)
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: Less than or equal to 12
This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
measure: Response on Beck Depression Inventory (BDI-II)
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: 50% Reduction in Score
This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
measure: Change on Beck Depression Inventory (BDI-II)
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: changes in scores
This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
measure: Remission on Beck Scale for Suicidal Ideation (SSI)
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: Score of 0
This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas Scale range: 0 - 38 (total score) Lower scores indicate lower severity of suicidal ideation (i.e., better outcome) Higher scores indicate higher severity of suicidal ideation (i.e., worse outcome)
measure: Change on Beck Scale for Suicidal Ideation (SSI)
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: changes in scores
This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas Scale range: 0 - 38 (total score) Lower scores indicate lower severity of suicidal ideation (i.e., better outcome) Higher scores indicate higher severity of suicidal ideation (i.e., worse outcome)
measure: Change in WHO Disability Assessment Schedule (WHODAS) Range 0-38
time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
description: changes in scores
measure: Proportion of Patients Maintaining Response During Relapse Prevention
time frame: 24 weeks (Tapering and Relapse prevention phase)
description: Includes number of treatment days needed and number going on to receive ECT
arm group label: Accelerated LFR
arm group type: Experimental
description: In the acute treatment phase, treatment will occur 8 times daily (50 min pause between treatments) on weekdays, until symptom remission is achieved (HRSD-24 score < to 10) or a maximum of 10 working days of daily treatment. In the tapering phase, treatments will be reduced to 2 treatment days per week for 2 weeks and then 1 treatment day per week for 2 weeks (4 weeks total). Patients that have responded to treatment will then enter the symptom-based relapse prevention phase including virtual check-in with study staff and a treatment schedule based on symptom level according to a modified relapse prevention algorithm that has been developed to prevent relapse after a successful course of ECT (known as the STABLE algorithm). The relapse prevention phase will last a maximum of 6 months.
intervention type: Device
intervention name: MagPro X100 Stimulator, B70 Fluid-Cooled Coil
description: Treatment will occur 8 times per treatment day (50 min pause between treatments). Each treatment session will consist of a single LFR treatment, with 360 pulses of LFR delivered in one continuous train of 6 minutes at 1Hz at 120% of the patient's resting motor threshold.
arm group label: Accelerated LFR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Blumberger, MD
role: Principal Investigator
affiliation: CAMH
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Centre for Addiction and Mental Health
investigator full name: Daniel Blumberger
investigator title: Medical Head and Co-Director, Temerty Centre for Therapeutic Brain Intervention
mesh term: COVID-19
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Bipolar Disorder