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pBFS Guided rTMS Over DMPFC for Treatment-Resistant Depression

Primary Purpose

Treatment Resistant Depression, Major Depressive Disorder

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

About this trial

This is an interventional treatment trial for Treatment Resistant Depression focused on measuring Treatment Resistant Depression, TRD, Moderate Depression, MDD, personalized neuromodulation, Personalized Brain Functional Sectors

Eligibility Criteria

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

Inclusion Criteria: Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female. 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 ≥25 before randomization. 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. 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; Patients with serious or unstable diseases of the cardiovascular, liver, kidney, blood, endocrine, neurological system, and other systems or organs, especially those 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; 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, VNS, DBS, tDCS, light therapy, or other physical therapy related to mental illness within 3 months; Currently receiving or planning to start formal cognitive or behavioral therapy, or systemic psychological therapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy, etc.) during the trial. Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past 1 year; Female of childbearing potential who plans to become pregnant during the trial. Female that is pregnant or breastfeeding. Patients in any clinical trials of other drugs or physical therapy within 1 month before the screening. 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. Investigators think that was inappropriate to participate.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    active rTMS treatment

    sham control

    Arm Description

    3 sessions of active rTMS would be delivered to the left DMPFC daily, with a session of 1800 pulse.

    3 sessions of sham rTMS would be delivered to the left DMPFC daily, with a session of 1800 pulse.

    Outcomes

    Primary Outcome Measures

    Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment
    The Montgomery-Asberg Depression Rating Scale (MADRS) is a validated instrument stratifying the severity of depressive episodes in adults. The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression).

    Secondary Outcome Measures

    Remission and response rates were estimated using Montgomery-Asberg Depression Rating Scale(MADRS)
    The response is defined as a symptom improvement of ≥50% and remission is defined as a score ≤10 on MADRS
    Remission and response rates were estimated using Hamilton Depression Rating Scale (HAMD-17)
    The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The HAMD-17 version consists of 17 items，and has an overall score ranging from 0 (no depression) to 52 (worst depression). Higher scores represent higher depression severity. The response is defined as a symptom improvement of ≥50% and remission is defined as a score ≤7 on HAMD-17
    Changes in the MADRS from baseline to each visit
    The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression). Higher scores represent higher depression severity.
    Changes in the HAMD-17 from baseline to each visit
    The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The HAMD-17 version consists of 17 items，and has an overall score ranging from 0 (no depression) to 52 (worst depression). Higher scores represent higher depression severity.
    cognitive changes from baseline to day 21(Immediate Post-treatment)
    Cognitive scores are measured using Chinese brief cognitive test (C-BCT), including Digit Symbol Substitution Test (DSST), continuous performance test (CPT), Trail-Making Test (TMT), Digit Span Test (DST)

    Full Information

    First Posted
    June 29, 2023
    Last Updated
    July 10, 2023
    Sponsor
    Changping Laboratory
    Collaborators
    Hebei Mental Health Center, Shandong Daizhuang Hospital, West China Hospital, The Second Affiliated Hospital of Xinxiang Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05948839
    Brief Title
    pBFS Guided rTMS Over DMPFC for Treatment-Resistant Depression
    Official Title
    Personalized Brain Functional Sector-guided rTMS Therapy Targeting DMPFC for Treatment-resistant Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 10, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Changping Laboratory
    Collaborators
    Hebei Mental Health Center, Shandong Daizhuang Hospital, West China Hospital, The Second Affiliated Hospital of Xinxiang Medical University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Investigators aim to evaluate the safety and efficacy of pBFS-guided rTMS therapy targeting DMPFC for patients with treatment-resistant depression
    Detailed Description
    Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. The dorsomedial prefrontal cortex (DMPFC), which serves as a connection intermediary of the aberrant functional network in cognitive control and rumination in depression, has been shown to be highly correlated with disease manifestations and post-treatment improvements through several studies involving neuroimaging and brain injury. Research has shown that the response of DMPFC to rTMS is more subject to improving the dimensions of anxiety and insomnia in depression. Therefore, exploring the novel target DMPFC is also beneficial for distinguishing disease dimensions in the future, thereby enabling personalized treatment and improving clinical treatment efficacy. 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 randomized in a double-blind manner in a 2:1 ratio to the active rTMS group, or sham-control group. Then all participants will undergo a 21-day rTMS modulation and a three- and nine-week follow-up visit.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Treatment Resistant Depression, Major Depressive Disorder
    Keywords
    Treatment Resistant Depression, TRD, Moderate Depression, MDD, personalized neuromodulation, Personalized Brain Functional Sectors

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    170 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    active rTMS treatment
    Arm Type
    Experimental
    Arm Description
    3 sessions of active rTMS would be delivered to the left DMPFC daily, with a session of 1800 pulse.
    Arm Title
    sham control
    Arm Type
    Sham Comparator
    Arm Description
    3 sessions of sham rTMS would be delivered to the left DMPFC daily, with a session of 1800 pulse.
    Intervention Type
    Device
    Intervention Name(s)
    active rTMS treatment
    Intervention Description
    Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be generated using the pBFS method.
    Intervention Type
    Device
    Intervention Name(s)
    sham rTMS treatment
    Intervention Description
    The parameters in the sham arms are the same as the active stimulation groups. Stimulation was delivered by the same device as the active group fitted with a sham coil.
    Primary Outcome Measure Information:
    Title
    Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment
    Description
    The Montgomery-Asberg Depression Rating Scale (MADRS) is a validated instrument stratifying the severity of depressive episodes in adults. The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression).
    Time Frame
    Baseline and Day 21(Immediate Post-treatment)]
    Secondary Outcome Measure Information:
    Title
    Remission and response rates were estimated using Montgomery-Asberg Depression Rating Scale(MADRS)
    Description
    The response is defined as a symptom improvement of ≥50% and remission is defined as a score ≤10 on MADRS
    Time Frame
    Baseline, Day 21 (Immediate Post-treatment)
    Title
    Remission and response rates were estimated using Hamilton Depression Rating Scale (HAMD-17)
    Description
    The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The HAMD-17 version consists of 17 items，and has an overall score ranging from 0 (no depression) to 52 (worst depression). Higher scores represent higher depression severity. The response is defined as a symptom improvement of ≥50% and remission is defined as a score ≤7 on HAMD-17
    Time Frame
    Baseline, Day 21 (Immediate Post-treatment)
    Title
    Changes in the MADRS from baseline to each visit
    Description
    The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression). Higher scores represent higher depression severity.
    Time Frame
    Baseline, Day 21 (Immediate Post-treatment), 3-week Post-treatment, 9-week Post-treatment
    Title
    Changes in the HAMD-17 from baseline to each visit
    Description
    The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The HAMD-17 version consists of 17 items，and has an overall score ranging from 0 (no depression) to 52 (worst depression). Higher scores represent higher depression severity.
    Time Frame
    Baseline, Day 21 (Immediate Post-treatment), 3-week Post-treatment, 9-week Post-treatment
    Title
    cognitive changes from baseline to day 21(Immediate Post-treatment)
    Description
    Cognitive scores are measured using Chinese brief cognitive test (C-BCT), including Digit Symbol Substitution Test (DSST), continuous performance test (CPT), Trail-Making Test (TMT), Digit Span Test (DST)
    Time Frame
    Baseline, Day 21 (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: Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female. 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 ≥25 before randomization. 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. 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; Patients with serious or unstable diseases of the cardiovascular, liver, kidney, blood, endocrine, neurological system, and other systems or organs, especially those 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; 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, VNS, DBS, tDCS, light therapy, or other physical therapy related to mental illness within 3 months; Currently receiving or planning to start formal cognitive or behavioral therapy, or systemic psychological therapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy, etc.) during the trial. Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past 1 year; Female of childbearing potential who plans to become pregnant during the trial. Female that is pregnant or breastfeeding. Patients in any clinical trials of other drugs or physical therapy within 1 month before the screening. 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. 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

    Learn more about this trial

    pBFS Guided rTMS Over DMPFC for Treatment-Resistant Depression

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