search
Back to results

pBFS Guided 20min Inter-session Interval rTMS Treatment for MDD

Primary Purpose

Moderate Depression, Major Depressive Disorder, Severe Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
active rTMS: 20min inter-session interval
active rTMS: 50min inter-session interval
sham rTMS: 20min inter-session interval
sham rTMS: 50min inter-session interval
Sponsored by
Changping Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Depression focused on measuring transcranial magnetic stimulation, rTMS, Major Depression, Moderate Depression, MDD, personalized neuromodulation

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 the depression disorder without psychotic symptoms, and currently experiencing recurrence episodes. Hospitalized patients aged 18-65 years (inclusive), male or female. Total HAMD-17 score ≥20 before randomization.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. Exclusion Criteria: Meet diagnostic criteria for other mental disorders (such as schizophrenia, schizoaffective disorder, bipolar disorder, secondary depression, and so on); 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 organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumor, etc.) and a history of severe brain trauma as judged by the researcher; Patients with serious heart, liver, kidney diseases, diabetes, and other serious physical diseases, causing symptoms and signs of brain abnormalities, or body failure; The female of childbearing potential plans to become pregnant during the trial, and the female who is pregnant or breastfeeding. Alcohol abuse or drugs abuse 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 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Sham Comparator

    Sham Comparator

    Arm Label

    active rTMS: 20min inter-session interval

    active rTMS: 50min inter-session interval

    sham rTMS: 20min inter-session interval

    sham rTMS: 50min inter-session interval

    Arm Description

    Three sessions of active rTMS would be delivered, with 1800 pulse/session and 20 min inter-session intervals.

    Three sessions of active rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals.

    Three sessions of sham rTMS would be delivered, with 1800 pulse/session and 20 min inter-session intervals.

    Three sessions of sham rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals.

    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
    change in QID_SR
    A provider-administered questionnaire was used to assess remission and recovery from depression. The 16-item QIDS_SR is a widely used self-report instrument covering depressive symptoms incorporating nine Diagnostic and Statistical Manual of Mental Disorder-IV (DSM-IV) diagnostic criteria for major depressive disorders. Each item is scored on a scale of 0 to 4. Higher scores represent higher depression severity.
    change in HAMA
    The HAMA was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).

    Full Information

    First Posted
    July 14, 2023
    Last Updated
    July 14, 2023
    Sponsor
    Changping Laboratory
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05957341
    Brief Title
    pBFS Guided 20min Inter-session Interval rTMS Treatment for MDD
    Official Title
    Personalized Brain Functional Sectors(pBFS) Guided 20min Inter-session Interval rTMS Treatment for Major Depressive Disorder: a Randomized, Double-Blind, Sham-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 30, 2023 (Anticipated)
    Primary Completion Date
    July 30, 2024 (Anticipated)
    Study Completion Date
    August 30, 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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators aim to explore the efficacy and safety of rTMS therapies with different intervals between sessions for treating patients with moderate to severe depression.
    Detailed Description
    FDA-approved intermittent theta burst stimulation (iTBS) for the treatment of depression disorder, reduces the duration of a single sequence treatment from 37 minutes to 3 minutes with traditional rTMS and gets the same antidepressant effect. Studies have shown that large doses and individualized target stimulation based on iTBS can improve the efficacy of rTMS and greatly save the time spent during patient treatment, but the effect of the interval between iTBS sessions on the efficacy is inconclusive. Previous studies on interval effect in rats based on iTBS have indirectly found that the waiting time between iTBS sessions of 50 to 90 minutes can maximize the cumulative effect of stimulation, so researchers mostly set the iTBS treatment interval to 50 minutes. However, most patients give up treatment because of the long wait time of 50 minutes, so it is urgent to explore the effect of short intervals of iTBS accepted easier by patients. In this study, we examined the intersession interval of 50 min vs. 20 min in the efficacy and safety of pBFS-guided TMS treatment in patients with moderate to severe depression. 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 4:4:1:1 ratio to a 50-minute active rTMS group, a 20-minute active rTMS group, a 50-minute sham-control group, and a 20-minute sham-control group. And then all participants will undergo a 21-day rTMS treatment followed by two-week and four-week follow-up visits.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Moderate Depression, Major Depressive Disorder, Severe Depression
    Keywords
    transcranial magnetic stimulation, rTMS, Major Depression, Moderate Depression, MDD, personalized neuromodulation

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    active rTMS: 20min inter-session interval
    Arm Type
    Experimental
    Arm Description
    Three sessions of active rTMS would be delivered, with 1800 pulse/session and 20 min inter-session intervals.
    Arm Title
    active rTMS: 50min inter-session interval
    Arm Type
    Active Comparator
    Arm Description
    Three sessions of active rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals.
    Arm Title
    sham rTMS: 20min inter-session interval
    Arm Type
    Sham Comparator
    Arm Description
    Three sessions of sham rTMS would be delivered, with 1800 pulse/session and 20 min inter-session intervals.
    Arm Title
    sham rTMS: 50min inter-session interval
    Arm Type
    Sham Comparator
    Arm Description
    Three sessions of sham rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals.
    Intervention Type
    Device
    Intervention Name(s)
    active rTMS: 20min inter-session interval
    Intervention Description
    Participants will receive active TMS, with 3 sessions per day, 1800 pulses/session, and 20 min inter-session intervals, lasting for 21 days. Individualized targets will be generated using the pBFS method.
    Intervention Type
    Device
    Intervention Name(s)
    active rTMS: 50min inter-session interval
    Intervention Description
    Participants will receive active TMS, with 3 sessions per day, 1800 pulses/session, and 50 min inter-session intervals, lasting for 21 days. Individualized targets will be generated using the pBFS method.
    Intervention Type
    Device
    Intervention Name(s)
    sham rTMS: 20min inter-session interval
    Intervention Description
    The parameters in this group are the same as in the active rTMS: 20min inter-session interval group. Stimulation was delivered by the same device as the active group fitted with a sham coil.
    Intervention Type
    Device
    Intervention Name(s)
    sham rTMS: 50min inter-session interval
    Intervention Description
    The parameters in this group are the same as in the active rTMS: 50min inter-session interval group. Stimulation was delivered by the same device as the active group fitted with a sham coil.
    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 and Day 21(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, 2-week post-treatment, 4-week post-treatment
    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, 2-week post-treatment, 4-week post-treatment
    Title
    change in QID_SR
    Description
    A provider-administered questionnaire was used to assess remission and recovery from depression. The 16-item QIDS_SR is a widely used self-report instrument covering depressive symptoms incorporating nine Diagnostic and Statistical Manual of Mental Disorder-IV (DSM-IV) diagnostic criteria for major depressive disorders. Each item is scored on a scale of 0 to 4. Higher scores represent higher depression severity.
    Time Frame
    Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment
    Title
    change in HAMA
    Description
    The HAMA was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
    Time Frame
    Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week 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 the depression disorder without psychotic symptoms, and currently experiencing recurrence episodes. Hospitalized patients aged 18-65 years (inclusive), male or female. Total HAMD-17 score ≥20 before randomization.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. Exclusion Criteria: Meet diagnostic criteria for other mental disorders (such as schizophrenia, schizoaffective disorder, bipolar disorder, secondary depression, and so on); 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 organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumor, etc.) and a history of severe brain trauma as judged by the researcher; Patients with serious heart, liver, kidney diseases, diabetes, and other serious physical diseases, causing symptoms and signs of brain abnormalities, or body failure; The female of childbearing potential plans to become pregnant during the trial, and the female who is pregnant or breastfeeding. Alcohol abuse or drugs abuse 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
    Hesheng Liu, Ph.D.
    Phone
    010-80726688
    Email
    heshengliu@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 20min Inter-session Interval rTMS Treatment for MDD

    We'll reach out to this number within 24 hrs