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The Dosage Effect of pBFS Guided rTMS Treatment for MDD

Primary Purpose

Moderate Depression, Major Depressive Disorder, Severe Depression

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
4 session rTMS
6 session rTMS
8 session rTMS
10 session rTMS
sham rTMS
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: 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 before randomization. Total MADRS score of ≥25 before randomization. Inadequate response to at least one antidepressant trial of adequate doses and duration. Participants currently are on a stable or no-drug use for at least 4 weeks before randomization. The type and dose of antidepressant drugs remained unchanged throughout the intervention period. Voluntarily participate in the trial and able to provide 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 plan 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. Investigators think that was inappropriate to participate.

Sites / Locations

  • Beijing HuiLongGuan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Sham Comparator

Arm Label

4 session rTMS

6 session rTMS

8 session rTMS

10 session rTMS

sham rTMS

Arm Description

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

Six sessions of active TMS would be delivered to the left DLPFC daily, with a session of 1800 pulse.

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

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

Subjects were randomized to receive 4 sessions or 6 sessions or 8 sessions or 10 sessions of sham rTMS to the left DLPFC daily in a 1:1:1:1 ratio.

Outcomes

Primary Outcome Measures

Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment
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 (HDRS, or Ham-D) 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 HAM-17 there can be a total score of 22. 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.
Safety estimated using SSI, YMRS
Scale for Suicide Ideation (SSI) measures suicide ideation, Young Mania Rating Scale(YMARS) measures mania

Full Information

First Posted
April 24, 2023
Last Updated
July 12, 2023
Sponsor
Changping Laboratory
Collaborators
Beijing HuiLongGuan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05842278
Brief Title
The Dosage Effect of pBFS Guided rTMS Treatment for MDD
Official Title
The Dosage Effect of Personalized Brain Functional Sectors(pBFS) Guided 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
Recruiting
Study Start Date
July 7, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changping Laboratory
Collaborators
Beijing HuiLongGuan Hospital

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
The investigators aim to find the optimal dosage of the pBFS-guided rTMS treatment for patients with moderate to severe depression.
Detailed Description
In 2022, the FDA cleared a large dosage of repetitive transcranial magnetic stimulation for treatment-resistant depression (TRD), which requires 10 sessions per day of 1,800 pulses per session for a total of 18,000 pulses per day. The inter-session interval is 50 min, and it costs patients 9 hours for the intervention. The investigators assume that patients with moderate to severe depression may not need 10 sessions per day, patients may achieve response or remission with a less amount of dosage, which will save the cost of treatment. Hence, the investigators try to find the optimal treatment dosage for 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 1:1:1:1:1 ratio to each active rTMS group with different pulses (4×1800 pulses, 6×1800 pulses, 8×1800 pulses, 10×1800 pulses) and sham-control group. And then all participants will undergo a 5-day rTMS treatment followed by four- and eight weeks 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
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
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4 session rTMS
Arm Type
Active Comparator
Arm Description
Four sessions of active rTMS would be delivered to the left DLPFC daily, with a session of 1800 pulse.
Arm Title
6 session rTMS
Arm Type
Active Comparator
Arm Description
Six sessions of active TMS would be delivered to the left DLPFC daily, with a session of 1800 pulse.
Arm Title
8 session rTMS
Arm Type
Active Comparator
Arm Description
Eight sessions of active rTMS would be delivered to the left DLPFC daily, with a session of 1800 pulse.
Arm Title
10 session rTMS
Arm Type
Active Comparator
Arm Description
Ten sessions of active rTMS would be delivered to the left DLPFC daily, with a session of 1800 pulse.
Arm Title
sham rTMS
Arm Type
Sham Comparator
Arm Description
Subjects were randomized to receive 4 sessions or 6 sessions or 8 sessions or 10 sessions of sham rTMS to the left DLPFC daily in a 1:1:1:1 ratio.
Intervention Type
Device
Intervention Name(s)
4 session rTMS
Intervention Description
Participants will receive 4 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.
Intervention Type
Device
Intervention Name(s)
6 session rTMS
Intervention Description
Participants will receive 6 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.
Intervention Type
Device
Intervention Name(s)
8 session rTMS
Intervention Description
Participants will receive 8 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.
Intervention Type
Device
Intervention Name(s)
10 session rTMS
Intervention Description
Participants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.
Intervention Type
Device
Intervention Name(s)
sham rTMS
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 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(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 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment, 56 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 (HDRS, or Ham-D) 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 HAM-17 there can be a total score of 22. Higher scores represent higher depression severity.
Time Frame
Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment, 56 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, 56 days Post-treatment
Title
Safety estimated using SSI, YMRS
Description
Scale for Suicide Ideation (SSI) measures suicide ideation, Young Mania Rating Scale(YMARS) measures mania
Time Frame
Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment, 56 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: 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 before randomization. Total MADRS score of ≥25 before randomization. Inadequate response to at least one antidepressant trial of adequate doses and duration. Participants currently are on a stable or no-drug use for at least 4 weeks before randomization. The type and dose of antidepressant drugs remained unchanged throughout the intervention period. Voluntarily participate in the trial and able to provide 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 plan 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. 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
Facility Information:
Facility Name
Beijing HuiLongGuan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100096
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song Chen, MD

12. IPD Sharing Statement

Learn more about this trial

The Dosage Effect of pBFS Guided rTMS Treatment for MDD

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