DepressionPhase 4NCT06417437
Non-invasive BCI and Application Verification for Depressed People
A Phase 4 study testing SSRI, rTMS and Neuro-Feedback in people with Depression and Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Major Depressive Disorder (MDD) is a serious mental illness and public health problem that poses threat to both physical and mental health. According to statistics from WHO, it is estimated that more than 350 million people worldwide suffer from depression, with a prevalence rate of 2.1% in China, which is… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Major Depressive Disorder, Bipolar Depression
- What is being tested?
- SSRI, rTMS and Neuro-Feedback
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ≥ 12 years old, male or female, right-handed, Han ethnicity
- Meets the DSM-5 diagnostic criteria for depression, with HAMD-17 scores greater than 17 and YMRS scores less than 6;
- Primary school education or above, able to understand the research content, willing to participate in this study and sign an informed consent form
Who cannot join
- Concomitant or previous history of organic brain disease or severe traumatic brain injury, personal or family history of epilepsy;
- Severe abnormalities in heart, liver, and kidney function;
- Patients with severe physical illnesses;
- History of substance dependence or abuse (alcohol, cocaine, drugs, etc.);
- Patients with mental disorders caused by organic diseases, drug or alcohol induced mental disorders, and other mental disorders;
- Pregnancy or lactation period;
Show all 10Show fewer
- Within six months, physical therapy such as MECT and TMS should be used;
- Implants of vegetative nerve stimulation;
- Individuals who have implanted electronic or metal instruments (such as pacemakers, defibrillators, stents, orthopedic plates, etc.) and undergo ventriculoperitoneal shunt surgery;
- Obvious visual and auditory impairment, unable to cooperate in completing neuropsychological and scale assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Min Zhao, chief physician, 34773231
About this study
Official title: New Non-invasive Brain-computer Interface: Theory, Technology and Application Demonstration - Studies on and Intervention for Depressed People Based on Non-invasive BCI and Application Verification
Major Depressive Disorder (MDD) is a serious mental illness and public health problem that poses threat to both physical and mental health. According to statistics from WHO, it is estimated that more than 350 million people worldwide suffer from depression, with a prevalence rate of 2.1% in China, which is approximately 30 million people.
At present, due to the lack of neurobiological markers for screening and diagnosing depression, the identification and diagnosis of MDD are based on the judgment of professional doctors, and the treatment mostly relies on clinical symptoms.
Read more
In terms of treatment, medication remains the main stream for MDD. Although current methods have certain therapeutic effects, patients still suffer from various side effects and poor cognitive function.In current clinical practice, relying purely on symptomatic diagnosis and treatment is difficult to meet the needs of clinical practice, so there is an urgent need to search for neurobiological markers in depression and develop targeted non-invasive intervention technologies.
This study aims to combine advanced brain imaging technology, digital twin-brain models, multi-source information decoding technology, integrated detection and intervention technology. The target is to create two new types of non-invasive BCI systems that can regulate emotions. One is a intervention BCI system for MDD that is suitable for hospital settings with the purpose of precise physical stimulation, and the other one is an ecological BCI system that regulate emotions and intervene with depression which is suitable for both hospital settings and future family environments.
This study will collect a comprehensive collection of physiological and biochemical indicators from patients with depression and from healthy control groups, as well as multimodal information such as head surface electroencephalography, MRI, and eye movements under different brain states, to personalize the available BCI information of depression related brain regions, circuits, and networks. The study also tries to explore emotional-interactive games that can intervene with depression and build a game data base that is dedicated to MDD. Other goals include designing and establishing two new types of emotional regulation systems, which are precise external physical stimulation intervention and ecological intervention, constructing a BCI regulation system, and conducting application verification to evaluate the regulation effect.
Read the detailed description
This study aims to establish a BCI regulation scheme and system for individuals with mdd, and to conduct validation for this application. Four more detailed contents are being designed, including 1. providing biological markers in brain regions, circuits, and networks that are probably related to MDD, 2. assessment models of the state of brain and multivariate signal mapping models, 3. virtual regulation paradigms, evaluations on the effect of the regulation , and 4. multimodal information collection and regulation software and hardware technologies.
Shanghai Mental Health Center, as the sponsor institution, tends to recruit MDD patients from daily outpatient service. The paticipants' personal information will be noted and then the patients will undergo different assessment on their level of depression, anxiety, anhedonia, manic state, cognitive status, effect and side effects of the current treatment, and their biological rhythm, sleep, quality of life, etc. Peripheral blood will be drawn for different potential biomarkers, as well as multimodal information such as EEG, eye movement, magnetic resonance imaging, magnetoencephalogram, fNIRS, and etc. Then compare the following laboratory indicators between depressed patients and healthy individuals such as differences in the concentration and gene expression of peripheral blood inflammatory factors, oxidative stress indicators, brain-derived neurotrophic factors, brain imaging, electrophysiology, blood oxygen and etc. The work above is to obtain specific neurobiological markers of MDD.
Intervention measures are as follows:
- Traditional medication with SSRIs. MDD patients will be give different SSRIs medication and undergo a two-week treatment, after which the above assessments will be done again to evaluation the efficacy and side effects of the current treatment. For MDD patients with anhedonia, other medication can be considered such as Voxetine and Bupropion.
- rTMS combined with traditional SSRIs medication. The current brain regions chosen for rTMS include dorsolateral pre-frontal cortex. In this part, the study tends to find out new potential brain regions suitable for physical treatment in MDD patients. The considered brain regions include orbitofrontal cortex, cerebellum and others. It uses a classic 8-shaped coils, butterfly coils, deep coils, etc., neural navigation to locate stimulation targets.
- Treatment based on neurobiological feedback. In this kind of treatment, MDD patients are treated with neurobiological feedback and will be monitored by EGG to catch unique and specific brain waves that may considered only found in MDD patients. This treatment involves using different psychological paradigms including classic cognitive research paradigms to evaluate the outcome of neuron-training and cognitive function after treatment.
Other technologies used in this study includes:
- Functional Magnetic Resonance Imaging. Brain images will be captures during different functional tasks such as emotional matching, Monetary Incentive Delay Task ( MID ). These images will be further analyzed to figure out the neuro-mechanism of MDD. We will be using 3T Siemens PRISMA, collecting data of rs-fMRI、DTI、T1、T2 and fMRI.
- Electroencephalography. In this part, the investigators will be using the DSI-24 wireless dry electrode EEG system. Each subject will undergo EEG collection experiments, at least collecting EEG data in a resting state (with eyes closed and open).
- Eye movement detection. Eye movement will be traced using Tobii Pro Spectrum.
- Functional Near-Infrared Spectroscopy. Patients will perform different tasks under the monitoring of a portable fNIRS device called Nirsport2 wireless wearable NIRS imaging system. It consists of a 8-channel LED illuminator and 8-channel active sensor for fiberless optical detection. During the tasks, the device will provide the value and changes in the level of oxyhemoglobin and deoxygenated hemoglobin observed in the subjects.
- Magnetoencephalogram. MEG is a completely non-invasive function detection technique, widely used in the development and research of brain function and the clinical diagnosis of brain diseases. MEG uses a sensitive magnetic sensor SQUID (Superconducting Quantum Interferometer), which is placed around the head to measure the abnormally weak magnetic field generated by neuronal activity. The detected magnetic signal data will then be analyzed and processed by a computer and superimposed on magnetic resonance imaging (MRI). Through software 3D imaging, the results can be more intuitive, making the MEG have extremely high temporal and spatial resolution.
MDD patients will be divided into different treatment gourds based on theirs condition and whether the chosen treatment would be the most suitable for them. All individuals will undergo the above assessments to establish a comprehensive, multimodal information data base, and finally after comparing the outcome before and after the treatment, the study tries to find out new and effective measures and validate their feasibility.
- Conditions
- Depression, Major Depressive Disorder, Bipolar Depression
- Being tested
- SSRI, rTMS, Neuro-Feedback, Game Regulation
- Medical subject headings
- Depression, Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSRIDrug
Patients are not masked from the types of intervention they receive. Assessment will be done before and after each intervention. Each group is independent from other groups.
rTMSDevice
Patients will be treated targeting either the traditional brain region or new region.
Neuro-FeedbackBehavioural
Patients under 18 years old will first be considered this treatment before other methods.
Game RegulationBehavioural
Patients will learn how to play several games that can supposedly regulate or affect negative emotions.
| Study group | Role | What they receive |
|---|---|---|
| Medication Group | Active comparator | Patients with anhedonia will be using either Bupropion or Voxetine. Patients without anhedonia will be given SSRIs. Frequency and dosage will be guided by psychiatrist. Treatment will last 4 weeks. Receives: Drug: SSRI |
| Traditional rTMs Group | Experimental | In addition to medication using SSRIs, patients will be also treated with rTMS. The stimulated brain region has decided to be dlpfc. Treatment will last 4 weeks. Receives: Drug: SSRI; Device: rTMS |
| New rTMS Group | Experimental | In addition to medication using SSRIs, patients will be also treated with rTMS. The stimulated brain region has not been decided, but rbitofrontal cortex, cerebellum and others are considered. Treatment will last 4 weeks. Receives: Drug: SSRI; Device: rTMS |
| Neuro-Feedback Group | Experimental | In addition to medication using SSRIs, patients will be also treated with Neuro-Training. The process will be guided under fNIRS and monitored by EGG. Treatment will last 4 weeks. Receives: Drug: SSRI; Behavioral: Neuro-Feedback |
| Game-regulation Group | Experimental | In addition to medication using SSRIs, patients will be also treated with games that can regulate emotions. Details are not yet decided. Treatment will last 4 weeks. Receives: Drug: SSRI; Behavioral: Game Regulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG power in alpha band between the depression patient group and healthy controls.
Changes from baseline in multimodal emotional data as assessed by EEG at 2 weeks.
Measured: 2 weeks
EEG power in beta band between the depression patient group and healthy controls.
Changes from baseline in multimodal emotional data as assessed by EEG at 2 weeks.
Measured: 2 weeks
MRI imaging of DLPFC between the depression patient group and healthy controls.
Changes in brain imaging from baseline in multimodal emotional data as assessed by MRI at 2 weeks.
Measured: 2 weeks
HbO in fNIRS between the depression patient group and healthy controls.
Changes from baseline in multimodal emotional data as assessed by fNIRS at 2 weeks.
Measured: 2 weeks
Hb in fNIRS between the depression patient group and healthy controls.
Changes from baseline in multimodal emotional data as assessed by fNIRS at 2 weeks.
Measured: 2 weeks
EEG power in alpha band between the depression patient group and healthy controls.
Changes from baseline in multimodal emotional data as assessed by EEG at 4 weeks.
Measured: 4 weeks
EEG power in beta band between the depression patient group and healthy controls.
Changes from baseline in multimodal emotional data as assessed by EEG at 4 weeks.
Measured: 4 weeks
MRI imaging of DLPFC between the depression patient group and healthy controls.
Changes in brain imaging from baseline in multimodal emotional data as assessed by MRI at 4 weeks.
Measured: 4 weeks
HbO in fNIRS between the depression patient group and healthy controls.
Changes from baseline in multimodal emotional data as assessed by fNIRS at 4 weeks.
Measured: 4 weeks
Hb in fNIRS between the depression patient group and healthy controls.
Changes from baseline in multimodal emotional data as assessed by fNIRS at 4 weeks.
Measured: 4 weeks
EEG power in alpha band between the depression patient group and healthy controls.
Changes from baseline in multimodal emotional data as assessed by EEG at 8 weeks.
Measured: 8 weeks
EEG power in beta band between the depression patient group and healthy controls.
Changes from baseline in multimodal emotional data as assessed by EEG at 8 weeks.
Measured: 8 weeks
MRI imaging of DLPFC between the depression patient group and healthy controls.
Changes in brain imaging from baseline in multimodal emotional data as assessed by MRI at 8 weeks.
Measured: 8 weeks
HbO in fNIRS between the depression patient group and healthy controls.
Changes from baseline in multimodal emotional data as assessed by fNIRS at 8 weeks.
Measured: 8 weeks
Hb in fNIRS between the depression patient group and healthy controls.
Changes from baseline in multimodal emotional data as assessed by fNIRS at 8 weeks.
Measured: 8 weeks
The score of HAMD-17 in depression patient group and healthy controls.
Changes from baseline in the score of HAMD-17 at 2 weeks
Measured: 2 weeks
The score of HAMD-17 in depression patient group and healthy controls.
Changes from baseline in depression patient group in the score of HAMD-17 at 4 weeks
Measured: 4 weeks
The score of HAMD-17 in depression patient group and healthy controls.
Changes from baseline in depression patient group in the score of HAMD-17 at 8 weeks
Measured: 8 weeks
Secondary outcomes (15)
The change in the state of depression in depression patient groups
The state of depression in patient group measured by SDS(0-80) at 2 weeks.
Measured: 2 weeks
The change in the state of agitation in depression patient groups
The state of depression in patient group measured by HCL-32(0-32) at 2 weeks.
Measured: 2 weeks
The change in the state of depression in depression patient groups
The state of depression in patient group measured by SDS(0-80) at 4 weeks.
Measured: 4 weeks
The change in the state of agitation in depression patient groups
The state of depression in patient group measured by HCL-32(0-32) at 4 weeks.
Measured: 4 weeks
The change in the state of depression in depression patient groups
The state of depression in patient group measured by SDS(0-80) at 8 weeks.
Measured: 8 weeks
The change in the state of agitation in depression patient groups
The state of depression in patient group measured by HCL-32(0-32) at 8 weeks.
Measured: 8 weeks
The change in the state of anhedonia in depression patient groups
The state of depression in patient group measured by SHAPS(0-64) at 2 weeks.
Measured: 2 weeks
The change in the state of anhedonia in depression patient groups
The state of depression in patient group measured by SHAPS(0-64) at 4 weeks.
Measured: 4 weeks
The change in the state of anhedonia in depression patient groups
The state of depression in patient group measured by SHAPS(0-64) at 8 weeks.
Measured: 8 weeks
The change in the state of anxiety in depression patient groups
The state of anxiety in patient group measured by different scales including GAD-7(0-56) at 2 weeks.
Measured: 2 weeks
The change in the state of anxiety in depression patient groups
The state of anxiety in patient group measured by different scales including GAD-7(0-56) at 4 weeks.
Measured: 4 weeks
The change in the state of anxiety in depression patient groups
The state of anxiety in patient group measured by different scales including GAD-7(0-56) at 8 weeks.
Measured: 8 weeks
The change in the level of cognitive function in depression patient group
The level of cognitive function in patient group measured by RBANS at 2 weeks.
Measured: 2 weeks
The change in the level of cognitive function in depression patient group
The level of cognitive function in patient group measured by RBANS at 4 weeks.
Measured: 4 weeks
The change in the level of cognitive function in depression patient group
The level of cognitive function in patient group measured by RBANS at 8 weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jul 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Fourth People's Hospital of Chengdu, Shanghai Jiao Tong University School of Medicine, University of Electronic Science and Technology of China, East China Normal University
- Responsible party
- Sponsor
- Investigators
- Zhenghui Yi, chief physician, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417437
- Sponsor's protocol ID
- 2022ZD0208505
- Status last verified
- May 2024
- First submitted
- 23 Apr 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pu L, Wang Y, Deng Z, Wu J, Chen Z, Fu R, Yao D, Yu S, Yan G, Yan H. Effect of iTBS on suicidal ideation and emotion regulation in major depressive disorder: a randomized clinical trial. BMC Psychiatry. 2026 Jun 12. doi: 10.1186/s12888-026-08283-8. Online ahead of print.
PubMed 42286600
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Non-invasive Brain-computer Interface: Theory, Technology and Application Demonstration - Studies on and Intervention for Depressed People Based on Non-invasive BCI and Application Verification
- ClinicalTrials.gov ID
- NCT06417437
- Acronym / sponsor ID
- 2022ZD0208505
- Conditions
- Depression, Major Depressive Disorder, Bipolar Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- The Fourth People's Hospital of Chengdu, Shanghai Jiao Tong University School of Medicine, University of Electronic Science and Technology of China, East China Normal University
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 16 May 2024 (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.
Major Depressive Disorder (MDD) is a serious mental illness and public health problem that poses threat to both physical and mental health. According to statistics from WHO, it is estimated that more than 350 million people worldwide suffer from depression, with a prevalence rate of 2.1% in China, which is approximately 30 million people.
At present, due to the lack of neurobiological markers for screening and diagnosing depression, the identification and diagnosis of MDD are based on the judgment of professional doctors, and the treatment mostly relies on clinical symptoms.
In terms of treatment, medication remains the main stream for MDD. Although current methods have certain therapeutic effects, patients still suffer from various side effects and poor cognitive function.In current clinical practice, relying purely on symptomatic diagnosis and treatment is difficult to meet the needs of clinical practice, so there is an urgent need to search for neurobiological markers in depression and develop targeted non-invasive intervention technologies.
This study aims to combine advanced brain imaging technology, digital twin-brain models, multi-source information decoding technology, integrated detection and intervention technology. The target is to create two new types of non-invasive BCI systems that can regulate emotions. One is a intervention BCI system for MDD that is suitable for hospital settings with the purpose of precise physical stimulation, and the other one is an ecological BCI system that regulate emotions and intervene with depression which is suitable for both hospital settings and future family environments.
This study will collect a comprehensive collection of physiological and biochemical indicators from patients with depression and from healthy control groups, as well as multimodal information such as head surface electroencephalography, MRI, and eye movements under different brain states, to personalize the available BCI information of depression related brain regions, circuits, and networks. The study also tries to explore emotional-interactive games that can intervene with depression and build a game data base that is dedicated to MDD. Other goals include designing and establishing two new types of emotional regulation systems, which are precise external physical stimulation intervention and ecological intervention, constructing a BCI regulation system, and conducting application verification to evaluate the regulation effect.
Detailed description
This study aims to establish a BCI regulation scheme and system for individuals with mdd, and to conduct validation for this application. Four more detailed contents are being designed, including 1. providing biological markers in brain regions, circuits, and networks that are probably related to MDD, 2. assessment models of the state of brain and multivariate signal mapping models, 3. virtual regulation paradigms, evaluations on the effect of the regulation , and 4. multimodal information collection and regulation software and hardware technologies.
Shanghai Mental Health Center, as the sponsor institution, tends to recruit MDD patients from daily outpatient service. The paticipants' personal information will be noted and then the patients will undergo different assessment on their level of depression, anxiety, anhedonia, manic state, cognitive status, effect and side effects of the current treatment, and their biological rhythm, sleep, quality of life, etc. Peripheral blood will be drawn for different potential biomarkers, as well as multimodal information such as EEG, eye movement, magnetic resonance imaging, magnetoencephalogram, fNIRS, and etc. Then compare the following laboratory indicators between depressed patients and healthy individuals such as differences in the concentration and gene expression of peripheral blood inflammatory factors, oxidative stress indicators, brain-derived neurotrophic factors, brain imaging, electrophysiology, blood oxygen and etc. The work above is to obtain specific neurobiological markers of MDD.
Intervention measures are as follows:
- Traditional medication with SSRIs. MDD patients will be give different SSRIs medication and undergo a two-week treatment, after which the above assessments will be done again to evaluation the efficacy and side effects of the current treatment. For MDD patients with anhedonia, other medication can be considered such as Voxetine and Bupropion.
- rTMS combined with traditional SSRIs medication. The current brain regions chosen for rTMS include dorsolateral pre-frontal cortex. In this part, the study tends to find out new potential brain regions suitable for physical treatment in MDD patients. The considered brain regions include orbitofrontal cortex, cerebellum and others. It uses a classic 8-shaped coils, butterfly coils, deep coils, etc., neural navigation to locate stimulation targets.
- Treatment based on neurobiological feedback. In this kind of treatment, MDD patients are treated with neurobiological feedback and will be monitored by EGG to catch unique and specific brain waves that may considered only found in MDD patients. This treatment involves using different psychological paradigms including classic cognitive research paradigms to evaluate the outcome of neuron-training and cognitive function after treatment.
Other technologies used in this study includes:
- Functional Magnetic Resonance Imaging. Brain images will be captures during different functional tasks such as emotional matching, Monetary Incentive Delay Task ( MID ). These images will be further analyzed to figure out the neuro-mechanism of MDD. We will be using 3T Siemens PRISMA, collecting data of rs-fMRI、DTI、T1、T2 and fMRI.
- Electroencephalography. In this part, the investigators will be using the DSI-24 wireless dry electrode EEG system. Each subject will undergo EEG collection experiments, at least collecting EEG data in a resting state (with eyes closed and open).
- Eye movement detection. Eye movement will be traced using Tobii Pro Spectrum.
- Functional Near-Infrared Spectroscopy. Patients will perform different tasks under the monitoring of a portable fNIRS device called Nirsport2 wireless wearable NIRS imaging system. It consists of a 8-channel LED illuminator and 8-channel active sensor for fiberless optical detection. During the tasks, the device will provide the value and changes in the level of oxyhemoglobin and deoxygenated hemoglobin observed in the subjects.
- Magnetoencephalogram. MEG is a completely non-invasive function detection technique, widely used in the development and research of brain function and the clinical diagnosis of brain diseases. MEG uses a sensitive magnetic sensor SQUID (Superconducting Quantum Interferometer), which is placed around the head to measure the abnormally weak magnetic field generated by neuronal activity. The detected magnetic signal data will then be analyzed and processed by a computer and superimposed on magnetic resonance imaging (MRI). Through software 3D imaging, the results can be more intuitive, making the MEG have extremely high temporal and spatial resolution.
MDD patients will be divided into different treatment gourds based on theirs condition and whether the chosen treatment would be the most suitable for them. All individuals will undergo the above assessments to establish a comprehensive, multimodal information data base, and finally after comparing the outcome before and after the treatment, the study tries to find out new and effective measures and validate their feasibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Medication Group | Active comparator | Drug: SSRIPatients with anhedonia will be using either Bupropion or Voxetine. Patients without anhedonia will be given SSRIs. Frequency and dosage will be guided by psychiatrist. Treatment will last 4 weeks. |
| Traditional rTMs Group | Experimental | Drug: SSRI, Device: rTMSIn addition to medication using SSRIs, patients will be also treated with rTMS. The stimulated brain region has decided to be dlpfc. Treatment will last 4 weeks. |
| New rTMS Group | Experimental | Drug: SSRI, Device: rTMSIn addition to medication using SSRIs, patients will be also treated with rTMS. The stimulated brain region has not been decided, but rbitofrontal cortex, cerebellum and others are considered. Treatment will last 4 weeks. |
| Neuro-Feedback Group | Experimental | Drug: SSRI, Behavioral: Neuro-FeedbackIn addition to medication using SSRIs, patients will be also treated with Neuro-Training. The process will be guided under fNIRS and monitored by EGG. Treatment will last 4 weeks. |
| Game-regulation Group | Experimental | Drug: SSRI, Behavioral: Game RegulationIn addition to medication using SSRIs, patients will be also treated with games that can regulate emotions. Details are not yet decided. Treatment will last 4 weeks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 12 years old, male or female, right-handed, Han ethnicity
- Meets the DSM-5 diagnostic criteria for depression, with HAMD-17 scores greater than 17 and YMRS scores less than 6;
- Primary school education or above, able to understand the research content, willing to participate in this study and sign an informed consent form
Key exclusion criteria (10 listed)
- Concomitant or previous history of organic brain disease or severe traumatic brain injury, personal or family history of epilepsy;
- Severe abnormalities in heart, liver, and kidney function;
- Patients with severe physical illnesses;
- History of substance dependence or abuse (alcohol, cocaine, drugs, etc.);
- Patients with mental disorders caused by organic diseases, drug or alcohol induced mental disorders, and other mental disorders;
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 |
|---|---|---|
| SSRIPatients are not masked from the types of intervention they receive. Assessment will be done before and after each intervention. Each group is independent from other groups. | Drug | Game-regulation Group, Medication Group, Neuro-Feedback Group, New rTMS Group, Traditional rTMs Group |
| rTMSPatients will be treated targeting either the traditional brain region or new region. | Device | New rTMS Group, Traditional rTMs Group |
| Neuro-FeedbackPatients under 18 years old will first be considered this treatment before other methods. | Behavioural | Neuro-Feedback Group |
| Game RegulationPatients will learn how to play several games that can supposedly regulate or affect negative emotions. | Behavioural | Game-regulation Group |
Primary outcome
EEG power in alpha band between the depression patient group and healthy controls.
Time frame: 2 weeks
Changes from baseline in multimodal emotional data as assessed by EEG at 2 weeks.
EEG power in beta band between the depression patient group and healthy controls.
Time frame: 2 weeks
Changes from baseline in multimodal emotional data as assessed by EEG at 2 weeks.
MRI imaging of DLPFC between the depression patient group and healthy controls.
Time frame: 2 weeks
Changes in brain imaging from baseline in multimodal emotional data as assessed by MRI at 2 weeks.
HbO in fNIRS between the depression patient group and healthy controls.
Time frame: 2 weeks
Changes from baseline in multimodal emotional data as assessed by fNIRS at 2 weeks.
Hb in fNIRS between the depression patient group and healthy controls.
Time frame: 2 weeks
Changes from baseline in multimodal emotional data as assessed by fNIRS at 2 weeks.
EEG power in alpha band between the depression patient group and healthy controls.
Time frame: 4 weeks
Changes from baseline in multimodal emotional data as assessed by EEG at 4 weeks.
EEG power in beta band between the depression patient group and healthy controls.
Time frame: 4 weeks
Changes from baseline in multimodal emotional data as assessed by EEG at 4 weeks.
MRI imaging of DLPFC between the depression patient group and healthy controls.
Time frame: 4 weeks
Changes in brain imaging from baseline in multimodal emotional data as assessed by MRI at 4 weeks.
HbO in fNIRS between the depression patient group and healthy controls.
Time frame: 4 weeks
Changes from baseline in multimodal emotional data as assessed by fNIRS at 4 weeks.
Hb in fNIRS between the depression patient group and healthy controls.
Time frame: 4 weeks
Changes from baseline in multimodal emotional data as assessed by fNIRS at 4 weeks.
EEG power in alpha band between the depression patient group and healthy controls.
Time frame: 8 weeks
Changes from baseline in multimodal emotional data as assessed by EEG at 8 weeks.
EEG power in beta band between the depression patient group and healthy controls.
Time frame: 8 weeks
Changes from baseline in multimodal emotional data as assessed by EEG at 8 weeks.
MRI imaging of DLPFC between the depression patient group and healthy controls.
Time frame: 8 weeks
Changes in brain imaging from baseline in multimodal emotional data as assessed by MRI at 8 weeks.
HbO in fNIRS between the depression patient group and healthy controls.
Time frame: 8 weeks
Changes from baseline in multimodal emotional data as assessed by fNIRS at 8 weeks.
Hb in fNIRS between the depression patient group and healthy controls.
Time frame: 8 weeks
Changes from baseline in multimodal emotional data as assessed by fNIRS at 8 weeks.
The score of HAMD-17 in depression patient group and healthy controls.
Time frame: 2 weeks
Changes from baseline in the score of HAMD-17 at 2 weeks
The score of HAMD-17 in depression patient group and healthy controls.
Time frame: 4 weeks
Changes from baseline in depression patient group in the score of HAMD-17 at 4 weeks
The score of HAMD-17 in depression patient group and healthy controls.
Time frame: 8 weeks
Changes from baseline in depression patient group in the score of HAMD-17 at 8 weeks
15 secondary outcomes
The change in the state of depression in depression patient groups
Time frame: 2 weeks
The change in the state of agitation in depression patient groups
Time frame: 2 weeks
The change in the state of depression in depression patient groups
Time frame: 4 weeks
The change in the state of agitation in depression patient groups
Time frame: 4 weeks
The change in the state of depression in depression patient groups
Time frame: 8 weeks
The change in the state of agitation in depression patient groups
Time frame: 8 weeks
The change in the state of anhedonia in depression patient groups
Time frame: 2 weeks
The change in the state of anhedonia in depression patient groups
Time frame: 4 weeks
The change in the state of anhedonia in depression patient groups
Time frame: 8 weeks
The change in the state of anxiety in depression patient groups
Time frame: 2 weeks
The change in the state of anxiety in depression patient groups
Time frame: 4 weeks
The change in the state of anxiety in depression patient groups
Time frame: 8 weeks
The change in the level of cognitive function in depression patient group
Time frame: 2 weeks
The change in the level of cognitive function in depression patient group
Time frame: 4 weeks
The change in the level of cognitive function in depression patient group
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 42286600Pu L, Wang Y, Deng Z, Wu J, Chen Z, Fu R, Yao D, Yu S, Yan G, Yan H. Effect of iTBS on suicidal ideation and emotion regulation in major depressive disorder: a randomized clinical trial. BMC Psychiatry. 2026 Jun 12. doi: 10.1186/s12888-026-08283-8. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Zhenghui Yi, chief physician study chair
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SSRI, rTMS and Neuro-Feedback in people with Depression and Major Depressive Disorder, run by Shanghai Mental Health Center 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 16 May 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenghui Yi, chief physician (18017311007, yizhenghui1971@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG power in alpha band between the depression patient group and healthy controls. (time frame: 2 weeks). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06417437, which also lists 1 linked publication.
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 16 May 2024.