Back to resultspBFS-guided High-dose TMS Over DMPFC for Treatment-resistant Major Depressive Disorder
Primary Purpose
Depression, Major Depressive Disorder, Severe Depression
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
active TMS
sham TMS
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring transcranial magnetic stimulation, rTMS, DMPFC, pBFS, precision target
Eligibility Criteria
Inclusion Criteria: DSM-5 diagnosis of depressive disorder, recurrent episodes; A total score of at least 20 on the HAMD-17 and Montgomery-Asberg Depression Rating Scale; Aged 18-65 years, female or male; Inadequate response to at least one antidepressant trial of adequate doses and duration; The MSM (Maudsley Staging Method) score ≥ 7; Stable antidepressant regimen for at least 4 weeks before treatment; Understand the trial and sign the informed consent. 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; The female of childbearing potential who plans to become pregnant during the trial, and 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. 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 TMS
sham TMS
Arm Description
active iTBS coupled with medical therapy
Sham iTBS coupled with medical therapy
Outcomes
Primary Outcome Measures
change in Montgomery-Asberg Depression Rating Scale (MADRS)
The 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
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 Hamilton Depression Scale (HAMD-17)
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 Quick Inventory of Depressive Symptomatology Self-Report (QIDS_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.
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 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
Safety estimated using SSI
Scale for Suicide Ideation (SSI) measures suicide ideation
Safety estimated using YMRS
Young Mania Rating Scale(YMARS) measures mania
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05964036
Brief Title
pBFS-guided High-dose TMS Over DMPFC for Treatment-resistant Major Depressive Disorder
Official Title
Personalized Brain Functional Sectors (pBFS)-Guided DMPFC With High-dose rTMS for Treatment-resistant 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 20, 2023 (Anticipated)
Primary Completion Date
April 20, 2024 (Anticipated)
Study Completion Date
July 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators aim to evaluate the safety and efficacy of pBFS-guided DMPFC target and high-dose rTMS therapy for the treatment of patients with treatment-resistant depression
Detailed Description
Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. Currently, the FDA cleared the SAINT Neuromodulation System for the treatment of Treatment-Resistant Depression(TRD) over the left dorsolateral prefrontal cortex (DLPFC). This methodology has been effective in a short period of time for treatment-resistant depression. However, some patients may not be able to persist in completing the treatment because they cannot bear the pain during treatment. The dorsomedial prefrontal cortex (DMPFC) region is relatively posterior, and DMPFC as an intervention target has been proven to have antidepressant effects, and patients have better pain tolerance during treatment, which can be used as an alternative to DLPFC target, so it is urgent to explore the effectiveness and safety of high-dose iTBS targeting DMPFC in the treatment of 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 blind manner in a 2:1 ratio to the active-rTMS group, and sham-rTMS group. Then all participants will undergo a 5-day rTMS modulation followed by two-week and four-week follow-up visits. Participants will keep a stable treatment regime during treatment and the four-week follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Major Depressive Disorder, Severe Depression
Keywords
transcranial magnetic stimulation, rTMS, DMPFC, pBFS, precision target
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active TMS
Arm Type
Experimental
Arm Description
active iTBS coupled with medical therapy
Arm Title
sham TMS
Arm Type
Sham Comparator
Arm Description
Sham iTBS coupled with medical therapy
Intervention Type
Device
Intervention Name(s)
active TMS
Intervention Description
Participants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized target in the DMPFC will be generated using the pBFS method
Intervention Type
Device
Intervention Name(s)
sham TMS
Intervention Description
The parameters in the sham arm are the same as in the active stimulation group. 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)
Description
The 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, Day 5
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 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
Title
Change in Hamilton Depression Scale (HAMD-17)
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 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
Title
Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS_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 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
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 5 (Immediate Post-treatment)
Title
cognitive change in continuous performance test (CPT)
Description
CPT from the C-BCT measures a person's sustained and selective attention
Time Frame
Baseline, Day 5 (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 5 (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 5 (Immediate Post-treatment)
Title
Safety estimated using SSI
Description
Scale for Suicide Ideation (SSI) measures suicide ideation
Time Frame
Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
Title
Safety estimated using YMRS
Description
Young Mania Rating Scale(YMARS) measures mania
Time Frame
Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days 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:
DSM-5 diagnosis of depressive disorder, recurrent episodes;
A total score of at least 20 on the HAMD-17 and Montgomery-Asberg Depression Rating Scale;
Aged 18-65 years, female or male;
Inadequate response to at least one antidepressant trial of adequate doses and duration;
The MSM (Maudsley Staging Method) score ≥ 7;
Stable antidepressant regimen for at least 4 weeks before treatment;
Understand the trial and sign the informed consent.
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;
The female of childbearing potential who plans to become pregnant during the trial, and 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.
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, phd
Phone
13540014981
Ext
86
Email
limeilingcheng@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hesheng Liu
Organizational Affiliation
Changping Laboratory
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
pBFS-guided High-dose TMS Over DMPFC for Treatment-resistant Major Depressive Disorder
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