MDDNCT05976022
pBFS Guided rTMS Therapy Over Different Targets for Treatment-Resistant Depression
A study testing active rTMS in people with MDD and Major Depressive Disorder, run by Changping Laboratory at 1 site in China.
Trial summary
To explore the effectiveness and safety of rTMS intervention with different targets in the left prefrontal cortex defined using the pBFS method, in adult patients with moderate and severe depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- MDD, Major Depressive Disorder, Treatment Resistant Depression
- What is being tested?
- active rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2023to 20 Dec 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
- 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 ≥20 before randomization.
- Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female.
- 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.
- The Maudsley Staging Method (MSM) is used to assess patients as having at least a moderate level of treatment-resistant condition (MSM score ≥ 7 points).
- Voluntarily participate in the trial and sign informed consent. Able to comply with the planned visit, examination and treatment plan, and other study procedures.
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;
- 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 serious heart, liver, kidney diseases, diabetes and other serious physical diseases, causing symptoms and signs of brain abnormalities, or body failure;
- 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;
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- Female of childbearing potential who plans to become pregnant during the trial.
- Female that is pregnant or breastfeeding.
- Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Mental Hospital
Xinxiang, Henan
Yongfeng Yang, M.D, 15836109413
About this study
Official title: Personalized Brain Functional Sector-guided rTMS Therapy Over Different Targets for Treatment-resistant Depression
To explore the effectiveness and safety of rTMS intervention with different targets in the left prefrontal cortex defined using the pBFS method, in adult patients with moderate and severe depressive disorder. Second, investigate the neural circuit that responds to the rTMS intervention using individualized brain image analysis, which may help to establish an effective target for the neuromodulation of patients with major depressive disorder.
Read the detailed description
Stimulation of the dorsolateral prefrontal cortex(DLPFC) and ventromedial prefrontal cortex (DMPFC) as target sites for rTMS intervention in depressive disorders has shown some therapeutic efficacy. However, overall patient response rates remain suboptimal, partly because the prefrontal cortex is a large region encompassing multiple functional networks. Analyses suggest that targeting different targets within the dorsolateral and ventromedial prefrontal cortex for intervention in depressive disorder patients may activate distinct functional networks. Therefore, selecting appropriate targets within the prefrontal cortex that accurately modulate the functional networks involved in depressive disorder patients is crucial for achieving effective clinical outcomes. Fox et al. have demonstrated that clinical response and individualized target sites in the dorsolateral prefrontal cortex are associated with functional connectivity to the subgenual cingulate cortex (sgACC). However, some analyses have indicated that rTMS target sites based solely on minimal sgACC connectivity may not be optimal for all depressive symptoms. Therefore, identifying individualized stimulation targets that improve core symptoms in depressed patients is important for achieving more effective personalized treatment of depressive disorders. This study aims to explore the efficacy and safety of rTMS interventions targeting 40 prefrontal cortex sites in depressive disorder patients and functional imaging-based mechanisms for optimal stimulation targets.
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 assigned a random intervention target from 40 prefrontal cortex sites. Then all participants will undergo a 14-day rTMS modulation and a week follow-up visit. Participants will keep a stable treatment regime during treatment and follow-up.
- Being tested
- active rTMS
- Keywords
- MDD, Major Depressive Disorder, Treatment Resistant Depression
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active rTMSDevice
2 sessions with 1800 pulses per session and 50min inter-session interval of active rTMS will deliver to the assigned target
| Study group | Role | What they receive |
|---|---|---|
| active rTMS | Experimental | 2 sessions with 1800 pulses per session and 50min inter-session interval of active rTMS will deliver to the assigned target Receives: Device: active rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 14(immediate post-treatment)
Secondary outcomes (6)
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 7, Day 14, Day 21
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
Measured: Baseline, Day 7, Day 14, Day 21
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 14(immediate post-treatment)
cognitive change in a continuous performance test (CPT）
CPT from the C-BCT measures a person's sustained and selective attention
Measured: Baseline, Day 14(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 14(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 14(immediate post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start4 Aug 2023
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDDStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changping Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hesheng Liu, Ph.D., Study chair, Changping Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976022
- Sponsor's protocol ID
- CPLMDDdiffTarg_HN
- Status last verified
- Aug 2023
- First submitted
- 14 Jul 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Brain Functional Sector-guided rTMS Therapy Over Different Targets for Treatment-resistant Depression
- ClinicalTrials.gov ID
- NCT05976022
- Acronym / sponsor ID
- CPLMDDdiffTarg_HN
- Keywords
- MDD, Major Depressive Disorder, Treatment Resistant Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 4 Aug 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.
To explore the effectiveness and safety of rTMS intervention with different targets in the left prefrontal cortex defined using the pBFS method, in adult patients with moderate and severe depressive disorder. Second, investigate the neural circuit that responds to the rTMS intervention using individualized brain image analysis, which may help to establish an effective target for the neuromodulation of patients with major depressive disorder.
Detailed description
Stimulation of the dorsolateral prefrontal cortex(DLPFC) and ventromedial prefrontal cortex (DMPFC) as target sites for rTMS intervention in depressive disorders has shown some therapeutic efficacy. However, overall patient response rates remain suboptimal, partly because the prefrontal cortex is a large region encompassing multiple functional networks. Analyses suggest that targeting different targets within the dorsolateral and ventromedial prefrontal cortex for intervention in depressive disorder patients may activate distinct functional networks. Therefore, selecting appropriate targets within the prefrontal cortex that accurately modulate the functional networks involved in depressive disorder patients is crucial for achieving effective clinical outcomes. Fox et al. have demonstrated that clinical response and individualized target sites in the dorsolateral prefrontal cortex are associated with functional connectivity to the subgenual cingulate cortex (sgACC). However, some analyses have indicated that rTMS target sites based solely on minimal sgACC connectivity may not be optimal for all depressive symptoms. Therefore, identifying individualized stimulation targets that improve core symptoms in depressed patients is important for achieving more effective personalized treatment of depressive disorders. This study aims to explore the efficacy and safety of rTMS interventions targeting 40 prefrontal cortex sites in depressive disorder patients and functional imaging-based mechanisms for optimal stimulation targets.
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 assigned a random intervention target from 40 prefrontal cortex sites. Then all participants will undergo a 14-day rTMS modulation and a week follow-up visit. Participants will keep a stable treatment regime during treatment and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active rTMS | Experimental | Device: active rTMS2 sessions with 1800 pulses per session and 50min inter-session interval of active rTMS will deliver to the assigned target |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 ≥20 before randomization.
- Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female.
- 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.
Key exclusion criteria (14 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;
- 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 serious heart, liver, kidney diseases, diabetes and other serious physical diseases, causing symptoms and signs of brain abnormalities, or body failure;
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 rTMS2 sessions with 1800 pulses per session and 50min inter-session interval of active rTMS will deliver to the assigned target | Device | active rTMS |
Primary outcome
change in MADRS
Time frame: Baseline, Day 14(immediate post-treatment)
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
6 secondary outcomes
change in MADRS
Time frame: Baseline, Day 7, Day 14, Day 21
change in HAMD
Time frame: Baseline, Day 7, Day 14, Day 21
cognitive change in Digit Symbol Substitution Test (DSST)
Time frame: Baseline, Day 14(immediate post-treatment)
cognitive change in a continuous performance test (CPT）
Time frame: Baseline, Day 14(immediate post-treatment)
cognitive change in Trail-Making Test (TMT)
Time frame: Baseline, Day 14(immediate post-treatment)
cognitive change in Digit Span Test (DST)
Time frame: Baseline, Day 14(immediate post-treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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, Ph.D. 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 rTMS in people with MDD 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 14 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 6 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. 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, Ph.D. (010-80726688, meilingli@cpl.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in MADRS (time frame: Baseline, Day 14(immediate post-treatment)). 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 6 Feb 2024.