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rTMS Therapy for Treatment-Resistant Depression With Different Targets Guided by pBFS

Primary Purpose

MDD, Major Depressive Disorder, Treatment Resistant Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
active rTMS
Sponsored by
Changping Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MDD focused on measuring MDD, Major Depressive Disorder, Treatment Resistant Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for depression disorder without psychotic symptoms, and currently experiencing a recurrence episode. Total HAMD17 score ≥20 and total MADRS score ≥20 before randomization. Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female. Inadequate response to at least one antidepressant trial of adequate doses and duration. A stable antidepressant regimen for at least 4 weeks at a dose not lower than the prescribed range of drug use before randomization. The Maudsley Staging Method (MSM) is used to assess patients as having at least a moderate level of treatment-resistant condition (MSM score ≥ 7 points). Voluntarily participate in the trial and sign informed consent. Able to comply with the planned visit, examination and treatment plan, and other study procedures. Exclusion Criteria: Meet DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depressive disorders due to substances and/or medications, depressive disorders due to other medical problems, etc.); Patients with a cardiac pacemaker, cochlear implant, or other metal foreign body and any electronic equipment implanted in the body, patients with claustrophobia and other contraindications to magnetic resonance scanning, and patients with contraindications to rTMS treatment; History of epilepsy (presence of at least 2 uninduced seizures more than 24 hours apart, or diagnosis of the epileptic syndrome, or seizures within the past 12 months); Or currently received medications or other treatments that will lower the seizure threshold; History of ECT, rTMS, and light therapy within 3 months; Patients with serious heart, liver, kidney diseases, diabetes and other serious physical diseases, causing symptoms and signs of brain abnormalities, or body failure; Patients with organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumor, etc.) and a history of severe brain trauma as judged by the researcher; Female of childbearing potential who plans to become pregnant during the trial. Female that is pregnant or breastfeeding. Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past 1 year; First-degree relatives have bipolar affective disorder. There is a significant risk of suicide (MADRS item 10 ≥ 5). Difficulty or inability to engage in normal communication, understand or follow instructions, and cooperate with treatment and evaluators. Currently participating in clinical trials of other drugs or physical therapy (e.g. deep brain stimulation (DBS), electroconvulsive therapy (ECT), rTMS). Investigators think that was inappropriate to participate.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    active rTMS

    Arm Description

    2 sessions with 1800 pulses per session and 50min inter-session interval of active rTMS will deliver to the assigned target

    Outcomes

    Primary Outcome Measures

    change in MADRS
    A provider-administered questionnaire was used to assess remission and recovery from depression. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression

    Secondary Outcome Measures

    change in MADRS
    A provider-administered questionnaire was used to assess remission and recovery from depression. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression
    change in HAMD
    A provider-administered questionnaire was used to assess remission and recovery from depression. The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The Ham-17 version consists of 17 items assessing mood, guilt, general somatic symptoms, work and activities, anxiety, and slowness of thought and speech. Each item is scored on a scale of 0 to 4, except for the somatic, sleep, and insight items which are scored 0 to 2. On the HAMD-17 there can be a total score of 52. Higher scores represent higher depression severity
    cognitive change in Digit Symbol Substitution Test (DSST)
    Cognitive scores are measured using Chinese brief cognitive test (C-BCT), the DSST equires a subject to match symbols to numbers according to a key located on the top of the page
    cognitive change in a continuous performance test (CPT）
    CPT from the C-BCT measures a person's sustained and selective attention
    cognitive change in Trail-Making Test (TMT)
    The TMT test from the C-BCT can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning
    cognitive change in Digit Span Test (DST)
    DST from the C-BCT is a measure of verbal short term and working memory that can be used in two formats, Forward Digit Span and Reverse Digit Span

    Full Information

    First Posted
    October 18, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Changping Laboratory
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06095778
    Brief Title
    rTMS Therapy for Treatment-Resistant Depression With Different Targets Guided by pBFS
    Official Title
    Personalized Brain Functional Sector-guided rTMS Therapy Over Different Targets for Treatment-resistant Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 20, 2023 (Anticipated)
    Primary Completion Date
    July 20, 2024 (Anticipated)
    Study Completion Date
    October 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Changping Laboratory

    4. Oversight

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

    5. Study Description

    Brief Summary
    To explore the effectiveness and safety of rTMS intervention with different targets in the left prefrontal cortex defined using the pBFS method, in adult patients with moderate and severe depressive disorder. Second, investigate the neural circuit that responds to the rTMS intervention using individualized brain image analysis, which may help to establish an effective target for the neuromodulation of patients with major depressive disorder.
    Detailed Description
    Stimulation of the dorsolateral prefrontal cortex(DLPFC) and ventromedial prefrontal cortex (DMPFC) as target sites for rTMS intervention in depressive disorders has shown some therapeutic efficacy. However, overall patient response rates remain suboptimal, partly because the prefrontal cortex is a large region encompassing multiple functional networks. Analyses suggest that targeting different targets within the dorsolateral and ventromedial prefrontal cortex for intervention in depressive disorder patients may activate distinct functional networks. Therefore, selecting appropriate targets within the prefrontal cortex that accurately modulate the functional networks involved in depressive disorder patients is crucial for achieving effective clinical outcomes. Fox et al. have demonstrated that clinical response and individualized target sites in the dorsolateral prefrontal cortex are associated with functional connectivity to the subgenual cingulate cortex (sgACC). However, some analyses have indicated that rTMS target sites based solely on minimal sgACC connectivity may not be optimal for all depressive symptoms. Therefore, identifying individualized stimulation targets that improve core symptoms in depressed patients is important for achieving more effective personalized treatment of depressive disorders. This study aims to explore the efficacy and safety of rTMS interventions targeting 40 prefrontal cortex sites in depressive disorder patients and functional imaging-based mechanisms for optimal stimulation targets. After being informed about the study and potential risks. All patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be assigned a random intervention target from 40 prefrontal cortex sites. Then all participants will undergo a 14-day rTMS modulation and a week follow-up visit. Participants will keep a stable treatment regime during treatment and follow-up.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    active rTMS
    Arm Type
    Experimental
    Arm Description
    2 sessions with 1800 pulses per session and 50min inter-session interval of active rTMS will deliver to the assigned target
    Intervention Type
    Device
    Intervention Name(s)
    active rTMS
    Intervention Description
    2 sessions with 1800 pulses per session and 50min inter-session interval of active rTMS will deliver to the assigned target
    Primary Outcome Measure Information:
    Title
    change in MADRS
    Description
    A provider-administered questionnaire was used to assess remission and recovery from depression. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression
    Time Frame
    Baseline, Day 14(immediate post-treatment)
    Secondary Outcome Measure Information:
    Title
    change in MADRS
    Description
    A provider-administered questionnaire was used to assess remission and recovery from depression. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression
    Time Frame
    Baseline, Day 7, Day 14, Day 21
    Title
    change in HAMD
    Description
    A provider-administered questionnaire was used to assess remission and recovery from depression. The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The Ham-17 version consists of 17 items assessing mood, guilt, general somatic symptoms, work and activities, anxiety, and slowness of thought and speech. Each item is scored on a scale of 0 to 4, except for the somatic, sleep, and insight items which are scored 0 to 2. On the HAMD-17 there can be a total score of 52. Higher scores represent higher depression severity
    Time Frame
    Baseline, Day 7, Day 14, Day 21
    Title
    cognitive change in Digit Symbol Substitution Test (DSST)
    Description
    Cognitive scores are measured using Chinese brief cognitive test (C-BCT), the DSST equires a subject to match symbols to numbers according to a key located on the top of the page
    Time Frame
    Baseline, Day 14(immediate post-treatment)
    Title
    cognitive change in a continuous performance test (CPT）
    Description
    CPT from the C-BCT measures a person's sustained and selective attention
    Time Frame
    Baseline, Day 14(immediate post-treatment)
    Title
    cognitive change in Trail-Making Test (TMT)
    Description
    The TMT test from the C-BCT can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning
    Time Frame
    Baseline, Day 14(immediate post-treatment)
    Title
    cognitive change in Digit Span Test (DST)
    Description
    DST from the C-BCT is a measure of verbal short term and working memory that can be used in two formats, Forward Digit Span and Reverse Digit Span
    Time Frame
    Baseline, Day 14(immediate post-treatment)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for depression disorder without psychotic symptoms, and currently experiencing a recurrence episode. Total HAMD17 score ≥20 and total MADRS score ≥20 before randomization. Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female. Inadequate response to at least one antidepressant trial of adequate doses and duration. A stable antidepressant regimen for at least 4 weeks at a dose not lower than the prescribed range of drug use before randomization. The Maudsley Staging Method (MSM) is used to assess patients as having at least a moderate level of treatment-resistant condition (MSM score ≥ 7 points). Voluntarily participate in the trial and sign informed consent. Able to comply with the planned visit, examination and treatment plan, and other study procedures. Exclusion Criteria: Meet DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depressive disorders due to substances and/or medications, depressive disorders due to other medical problems, etc.); Patients with a cardiac pacemaker, cochlear implant, or other metal foreign body and any electronic equipment implanted in the body, patients with claustrophobia and other contraindications to magnetic resonance scanning, and patients with contraindications to rTMS treatment; History of epilepsy (presence of at least 2 uninduced seizures more than 24 hours apart, or diagnosis of the epileptic syndrome, or seizures within the past 12 months); Or currently received medications or other treatments that will lower the seizure threshold; History of ECT, rTMS, and light therapy within 3 months; Patients with serious heart, liver, kidney diseases, diabetes and other serious physical diseases, causing symptoms and signs of brain abnormalities, or body failure; Patients with organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumor, etc.) and a history of severe brain trauma as judged by the researcher; Female of childbearing potential who plans to become pregnant during the trial. Female that is pregnant or breastfeeding. Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past 1 year; First-degree relatives have bipolar affective disorder. There is a significant risk of suicide (MADRS item 10 ≥ 5). Difficulty or inability to engage in normal communication, understand or follow instructions, and cooperate with treatment and evaluators. Currently participating in clinical trials of other drugs or physical therapy (e.g. deep brain stimulation (DBS), electroconvulsive therapy (ECT), rTMS). Investigators think that was inappropriate to participate.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Meiling Li, Ph.D.
    Phone
    010-80726688
    Email
    meilingli@cpl.ac.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hesheng Liu, Ph.D.
    Organizational Affiliation
    Changping Laboratory
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    rTMS Therapy for Treatment-Resistant Depression With Different Targets Guided by pBFS

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