DepressionNCT05964036
pBFS-guided High-dose TMS Over DMPFC for Treatment-resistant Major Depressive Disorder
A study testing active TMS in people with Depression and Major Depressive Disorder, run by Changping Laboratory at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Major Depressive Disorder, Severe Depression
- What is being tested?
- active TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2023to 20 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hebei Mental Health Center
Baoding, Hebei
Bing Li
Keqing Li
About this study
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
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
Read the 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.
- Conditions
- Depression, Major Depressive Disorder, Severe Depression
- Being tested
- active TMS, sham TMS
- Keywords
- transcranial magnetic stimulation, rTMS, DMPFC, pBFS, precision target
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active TMSDevice
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
sham TMSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| active TMS | Experimental | active iTBS coupled with medical therapy Receives: Device: active TMS |
| sham TMS | Sham comparator | Sham iTBS coupled with medical therapy Receives: Device: sham TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Day 5
Secondary outcomes (9)
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
Measured: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
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.
Measured: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
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.
Measured: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
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
Measured: Baseline, Day 5 (Immediate Post-treatment)
cognitive change in continuous performance test (CPT)
CPT from the C-BCT measures a person's sustained and selective attention
Measured: Baseline, Day 5 (Immediate Post-treatment)
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
Measured: Baseline, Day 5 (Immediate Post-treatment)
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
Measured: Baseline, Day 5 (Immediate Post-treatment)
Safety estimated using SSI
Scale for Suicide Ideation (SSI) measures suicide ideation
Measured: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
Safety estimated using YMRS
Young Mania Rating Scale(YMARS) measures mania
Measured: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start21 Jul 2023
- Primary completion20 Apr 2024 (estimated)
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changping Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hesheng Liu, Study chair, Changping Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964036
- Sponsor's protocol ID
- CPLMDDHidoseDM
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05964036
- Acronym / sponsor ID
- CPLMDDHidoseDM
- Conditions
- Depression, Major Depressive Disorder, Severe Depression
- Keywords
- transcranial magnetic stimulation, rTMS, DMPFC, pBFS, precision target
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 20 Apr 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active TMS | Experimental | Device: active TMSactive iTBS coupled with medical therapy |
| sham TMS | Sham comparator | Device: sham TMSSham iTBS coupled with medical therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active TMSParticipants 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 | Device | active TMS |
| sham TMSThe 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 | Device | sham TMS |
Primary outcome
change in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline, Day 5
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).
9 secondary outcomes
Change in MADRS
Time frame: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
Change in Hamilton Depression Scale (HAMD-17)
Time frame: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS_SR)
Time frame: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
cognitive change in Digit Symbol Substitution Test (DSST)
Time frame: Baseline, Day 5 (Immediate Post-treatment)
cognitive change in continuous performance test (CPT)
Time frame: Baseline, Day 5 (Immediate Post-treatment)
cognitive change in Trail-Making Test (TMT)
Time frame: Baseline, Day 5 (Immediate Post-treatment)
cognitive change in Digit Span Test (DST)
Time frame: Baseline, Day 5 (Immediate Post-treatment)
Safety estimated using SSI
Time frame: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
Safety estimated using YMRS
Time frame: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hesheng Liu study chair
Changping Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active TMS in people with Depression and Major Depressive Disorder, run by Changping Laboratory at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meiling Li, phd (13540014981 ext. 86, limeilingcheng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Baseline, Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.