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Accelerated iTBS for Depression and Suicidality (RAPID)

Primary Purpose

Major Depressive Disorder, Suicide

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Accelerated Intermittent Theta Burst (aiTBS)
Electroconvulsive therapy (ECT)
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring transcranial magnetic stimulation, theta burst, accelerated TMS, ECT, electroconvulsive therapy, depression, suicidality

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Ability to provide informed consent

    • Availability for the duration of the study and willingness to comply with all study procedures
    • Age 18 to 90
    • Diagnosis of major depressive disorder by DSM-5 criteria
    • Depressive symptoms are thought to be caused primarily by a major depressive episode and not by some other neurologic or psychiatric illness
    • Failure of or intolerance to at least 2 antidepressant treatments of different therapeutic classes (can include psychotherapy trial or neurostimulation trial)
    • Meets criteria for clinical eligibility for ECT treatment, including optimization of any medical conditions and completion of any medical testing or clearance as clinically indicated
    • Able to consent voluntarily to treatment
    • Score of at least 2 on the MADRS item 10
    • Ability to sit or lie down for an extended period of time and willingness to adhere to the theta burst stimulation protocol

Exclusion Criteria:

  • • Presence of implanted ferromagnetic devices or materials, including cardiac pacemaker, cochlear implant, deep brain stimulation device, vagus nerve stimulation device, shrapnel, facial or scalp piercings that cannot be removed, or metallic face or head tattoos

    • Pregnancy or lactation
    • Previous bad reaction or intolerance to transcranial magnetic stimulation
    • Febrile illness within 1 week
    • Treatment with another investigational drug or other intervention within 30 days
    • Recent substance abuse or use disorder within the past 6 months, excluding tobacco or infrequent cannabis use
    • History of epilepsy or seizure disorder
    • History of penetrating traumatic brain injury, multiple sclerosis, or history of brain surgery or intracranial hemorrhage
    • Primary psychiatric or medical/neurologic illness other than MDD that is more likely to account for depressive symptoms, including severe personality disorder or psychotic illness
    • Severe or moderate intellectual disability
    • Major neurocognitive disorder
    • Involuntary commitment or petition filed for involuntary ECT treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    aiTBS arm

    ECT arm

    Arm Description

    aiTBS treatment as lead-in phase to ECT standard of care treatment.

    ECT as clinically indicated.

    Outcomes

    Primary Outcome Measures

    Retention rate at completion of aiTBS vs the ECT group
    The primary tolerability endpoint is the proportion of aiTBS or ECT patients completing the protocol to a degree thought to be satisfactory for achieving the intended antidepressant effect. Completion for aiTBS arm is defined as completion of at least 60% of the treatment protocol (30 of 50 treatments) with treatments on at least 60% of days (3 of 5 days during the week). Completion for ECT arm is defined as completion of at least 2 of 3 ECT treatments during the first week.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 18, 2020
    Last Updated
    February 15, 2023
    Sponsor
    University of Iowa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04441008
    Brief Title
    Accelerated iTBS for Depression and Suicidality
    Acronym
    RAPID
    Official Title
    Radical aiTBS Protocol for Intractable Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    July 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Iowa

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The overall objective of this current study is to evaluate the feasibility, safety, and tolerability of "high dose" aiTBS in psychiatric inpatient and outpatients with treatment-refractory unipolar, non-psychotic major depressive disorder, using patients receiving ECT as an active comparator. Developing a better understanding of the feasibility and tolerability of adapting this treatment to an acutely ill patient population could lead to huge breakthroughs for clinician decision-making and for the further optimization of brain stimulation depression protocols. The results of this study can help guide future confirmatory efficacy trials of high-dose aiTBS by providing a better understanding of how feasibility, safety and tolerability compare to ECT, as well as unforeseen challenges of its use.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder, Suicide
    Keywords
    transcranial magnetic stimulation, theta burst, accelerated TMS, ECT, electroconvulsive therapy, depression, suicidality

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Single-blind with crossover of experimental (aiTBS) group into standard of care (ECT) group.
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    Investigator and outcomes assessor will be blinded to patient's designation.
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    aiTBS arm
    Arm Type
    Experimental
    Arm Description
    aiTBS treatment as lead-in phase to ECT standard of care treatment.
    Arm Title
    ECT arm
    Arm Type
    Active Comparator
    Arm Description
    ECT as clinically indicated.
    Intervention Type
    Device
    Intervention Name(s)
    Accelerated Intermittent Theta Burst (aiTBS)
    Other Intervention Name(s)
    SAINT Protocol, accelerated TMS
    Intervention Description
    High-dose intermittent theta burst administered at a treatment frequency 10x per day, with each treatment session duration 3x standard TMS (1800 pulses). Delivering 50 sessions in 5 days.
    Intervention Type
    Device
    Intervention Name(s)
    Electroconvulsive therapy (ECT)
    Intervention Description
    ECT as per standard clinical care and management.
    Primary Outcome Measure Information:
    Title
    Retention rate at completion of aiTBS vs the ECT group
    Description
    The primary tolerability endpoint is the proportion of aiTBS or ECT patients completing the protocol to a degree thought to be satisfactory for achieving the intended antidepressant effect. Completion for aiTBS arm is defined as completion of at least 60% of the treatment protocol (30 of 50 treatments) with treatments on at least 60% of days (3 of 5 days during the week). Completion for ECT arm is defined as completion of at least 2 of 3 ECT treatments during the first week.
    Time Frame
    5 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • Ability to provide informed consent Availability for the duration of the study and willingness to comply with all study procedures Age 18 to 90 Diagnosis of major depressive disorder by DSM-5 criteria Depressive symptoms are thought to be caused primarily by a major depressive episode and not by some other neurologic or psychiatric illness Failure of or intolerance to at least 2 antidepressant treatments of different therapeutic classes (can include psychotherapy trial or neurostimulation trial) Meets criteria for clinical eligibility for ECT treatment, including optimization of any medical conditions and completion of any medical testing or clearance as clinically indicated Able to consent voluntarily to treatment Score of at least 2 on the MADRS item 10 Ability to sit or lie down for an extended period of time and willingness to adhere to the theta burst stimulation protocol Exclusion Criteria: • Presence of implanted ferromagnetic devices or materials, including cardiac pacemaker, cochlear implant, deep brain stimulation device, vagus nerve stimulation device, shrapnel, facial or scalp piercings that cannot be removed, or metallic face or head tattoos Pregnancy or lactation Previous bad reaction or intolerance to transcranial magnetic stimulation Febrile illness within 1 week Treatment with another investigational drug or other intervention within 30 days Recent substance abuse or use disorder within the past 6 months, excluding tobacco or infrequent cannabis use History of epilepsy or seizure disorder History of penetrating traumatic brain injury, multiple sclerosis, or history of brain surgery or intracranial hemorrhage Primary psychiatric or medical/neurologic illness other than MDD that is more likely to account for depressive symptoms, including severe personality disorder or psychotic illness Severe or moderate intellectual disability Major neurocognitive disorder Involuntary commitment or petition filed for involuntary ECT treatment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Benjamin Pace, MS
    Phone
    (319) 384-9302
    Email
    benjamin-pace@uiowa.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nicholas Trapp, MD
    Phone
    (319) 467-8188
    Email
    nicholas-trapp@uiowa.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nicholas Trapp, MD
    Organizational Affiliation
    University of Iowa
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    27090022
    Citation
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