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Low-Intensity Focused Ultrasound for Treatment-Resistant Depression

Primary Purpose

Major Depressive Disorder, Treatment Resistant Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low-Intensity Focused Ultrasound Pulsation
Sham Low-Intensity Focused Ultrasound Pulsation
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring focused ultrasound, neuromodulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Male or female Age 18-70 Normal or corrected-to normal vision and hearing Primary diagnosis of major depressive disorder, moderate/severe per DSM-5 (MADRS >20) The duration of the illness must exceed one year Must be medically stable as determined by investigator Patient must have attempted and failed treatment with at least 2 SSRI and 1 augmentation History of rTMS is permitted, but not required Exclusionary criteria: Diagnosis of primary DSM-5 depressive disorder other than MDD Anxiety disorders such as GAD are permitted as long as MDD is primary Diagnosis of schizophrenia or bipolar disorder Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of MDD) Contraindication to enter the MRI environment. Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term). Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precaution should be taken. Examples of acceptable methods of birth control for participants involved in the study includes: birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant. Inability to adhere to treatment schedule. Initiation of new antidepressant treatment at the time of study randomization.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Active/Active Group

    Sham/Active Group

    Arm Description

    This group will receive eight total treatments of LIFUP across two days one week apart (four treatments each day).

    This group will receive sham LIFUP for four treatments over one day, followed by four total treatments of active LIFUP across one day one week after sham.

    Outcomes

    Primary Outcome Measures

    Montgomery-Asberg Depression Rating Scale (MADRS) Score Change
    Change in the MADRS score, which ranges from 0-60, with 0-8 = no depression; 9-17 = mild; 18-34 = moderate; and >35 = severe

    Secondary Outcome Measures

    Patient Health Questionnaire (PHQ-9) Score Change
    Change in PHQ-9 Score, which ranges from 0-27, with 0-4 = no depression; 5-9 = mild; 10-14 = moderate; and >15 = severe
    General Anxiety Disorder (GAD-7) Score Change
    Change in GAD-7 Score, which ranges from 0-21, with 0-4 = no anxiety; 5-9 = mild; 10-14 = moderate; and >15 = severe

    Full Information

    First Posted
    August 22, 2023
    Last Updated
    September 5, 2023
    Sponsor
    Medical University of South Carolina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06013384
    Brief Title
    Low-Intensity Focused Ultrasound for Treatment-Resistant Depression
    Official Title
    Clinical Feasibility of Low Intensity Focused Ultrasound Pulsation for the Treatment of Treatment Resistant Major Depressive Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of South Carolina

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes

    5. Study Description

    Brief Summary
    The Investigators are proposing to demonstrate safety and efficacy of LIFUP for treatment resistant major depressive disorder in a ten-patient pilot study. LIFUP is an emerging treatment with the advantage of being able to target subcortical transcranial targets, which may have superior efficacy or a shorter treatment course compared to other available treatments such as transcranial magnetic stimulation. This study will investigate the effect of this stimulation on the left subgenual cingulate cortex, a highly connected node in the depression network that is correlated with clinical symptomatology.
    Detailed Description
    The purpose of this pilot study is to evaluate safety and efficacy of a novel treatment, low intensity focused ultrasound pulsation (LIFUP) for treatment resistant depression (TRD). Participants will receive either LIFUP or sham stimulation with crossover of sham participants into the treatment group halfway through the treatment course. The initial visit will involve consent and an MRI scan, followed by several more either active or sham treatments outside of the MRI environment delivered over the course of two days over one week. Response and potential side effects will be monitored pre- and post- each treatment along with one week and one month follow-up assessments.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder, Treatment Resistant Depression
    Keywords
    focused ultrasound, neuromodulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active/Active Group
    Arm Type
    Experimental
    Arm Description
    This group will receive eight total treatments of LIFUP across two days one week apart (four treatments each day).
    Arm Title
    Sham/Active Group
    Arm Type
    Other
    Arm Description
    This group will receive sham LIFUP for four treatments over one day, followed by four total treatments of active LIFUP across one day one week after sham.
    Intervention Type
    Device
    Intervention Name(s)
    Low-Intensity Focused Ultrasound Pulsation
    Intervention Description
    Low-intensity focused ultrasound pulsation will be directed towards the target region at FDA-approved intensity levels in treatment sessions one and two.
    Intervention Type
    Device
    Intervention Name(s)
    Sham Low-Intensity Focused Ultrasound Pulsation
    Intervention Description
    Sham low-intensity focused ultrasound pulsation will be given.
    Primary Outcome Measure Information:
    Title
    Montgomery-Asberg Depression Rating Scale (MADRS) Score Change
    Description
    Change in the MADRS score, which ranges from 0-60, with 0-8 = no depression; 9-17 = mild; 18-34 = moderate; and >35 = severe
    Time Frame
    One week post-treatment
    Secondary Outcome Measure Information:
    Title
    Patient Health Questionnaire (PHQ-9) Score Change
    Description
    Change in PHQ-9 Score, which ranges from 0-27, with 0-4 = no depression; 5-9 = mild; 10-14 = moderate; and >15 = severe
    Time Frame
    One week post-treatment
    Title
    General Anxiety Disorder (GAD-7) Score Change
    Description
    Change in GAD-7 Score, which ranges from 0-21, with 0-4 = no anxiety; 5-9 = mild; 10-14 = moderate; and >15 = severe
    Time Frame
    One week post-treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Male or female Age 18-70 Normal or corrected-to normal vision and hearing Primary diagnosis of major depressive disorder, moderate/severe per DSM-5 (MADRS >20) The duration of the illness must exceed one year Must be medically stable as determined by investigator Patient must have attempted and failed treatment with at least 2 SSRI and 1 augmentation History of rTMS is permitted, but not required Exclusionary criteria: Diagnosis of primary DSM-5 depressive disorder other than MDD Anxiety disorders such as GAD are permitted as long as MDD is primary Diagnosis of schizophrenia or bipolar disorder Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of MDD) Contraindication to enter the MRI environment. Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term). Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precaution should be taken. Examples of acceptable methods of birth control for participants involved in the study includes: birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant. Inability to adhere to treatment schedule. Initiation of new antidepressant treatment at the time of study randomization.

    12. IPD Sharing Statement

    Learn more about this trial

    Low-Intensity Focused Ultrasound for Treatment-Resistant Depression

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