Treatment-resistant Depression (TRD)Early Phase 1NCT06784388
Personalized DBS Targeting for Treating Depression
A Early Phase 1 study testing Deep Brain Stimulation(DBS) and Esketamine in people with Treatment-resistant Depression (TRD), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to optimize the target brain areas for deep brain stimulation (DBS) for depression based on personalized brain imaging and stereo-electroencephalography(SEEG), to administer long-term DBS treatment in the target brain areas, to assess the effectiveness and safety of DBS for… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Treatment-resistant Depression (TRD)
- What is being tested?
- Deep Brain Stimulation(DBS) and Esketamine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2025to 30 Dec 2028
- Phase
- Early Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A psychiatrist-confirmed diagnosis of major depressive disorder in accordance with the Diagnostic And Statistical Manual Of Mental Disorders.5th Ed (DSM-V);
- A psychiatric examination by two trained psychiatrists and a diagnosis consistent with the DSM-V;
- A history of depression of at least 12 months duration in depressed patients (including MECT) who have failed to respond to a full dose and course of treatment with 2 or more antidepressants of different mechanisms;
- A 17-item score on the HAMD scale ⩾ 20 at initial screening;
- A score of ≤ 50 on the Gross Assessment of Functioning (GAF) scale;
- The patient himself/herself or legal guardian was able to fully understand the therapy and agreed to enroll after signing an informed consent form.
Who cannot join
- Persons with severe or unstable cardiac, hepatic, renal, endocrine, hematologic, and other medical disorders and co-morbidities with psychotic symptoms, including personality disorders diagnosed by history, questioning, and clinical examination;
- Persons with psychiatric disorders other than depression (except generalized anxiety);
- Persons with a history of substance abuse within 12 months; persons with a previous history of epilepsy, and persons with febrile convulsions in childhood;
- Patients with a history of suicide attempts within the past 6 months or more than 2 suicide attempts within the past 2 years;
- Women who are breastfeeding, pregnant, and patients who are pregnant or intend to become pregnant during the clinical study;
- Contraindications to DBS surgery and MRI;
- Years of education less than or equal to 9 years;
- Patients who are involuntarily hospitalized.
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
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Yuxiao Yang, Ph.D., +86 15088771810, yuxiao.yang@zju.edu.cn
About this study
Official title: Clinical Application of Personalized DBS Target Optimization for Treating Depression
The goal of this clinical trial is to optimize the target brain areas for deep brain stimulation (DBS) for depression based on personalized brain imaging and stereo-electroencephalography(SEEG), to administer long-term DBS treatment in the target brain areas, to assess the effectiveness and safety of DBS for refractory depression and to validate the method of personalized optimization of DBS targets. The main questions it aims to answer are:
- Where is the optimal DBS target brain region for each patient?
- What are the optimal DBS parameters for each patient ?
- What are the neural biomarkers of depression symptoms for each patient?
- Are the optimized DBS strategies effective in treating refractory depression?
Read the detailed description
This clinical study is a prospective clinical trial focused on the personalized optimization methods and applications of DBS targets for depression.
The study is divided into 4 phases and in each phase and participants will complete different tasks:
- The preoperative assessment phase:Lasting 7 days, participants will be required to complete preoperative symptom assessments, brain imaging, and task-state functional magnetic resonance imaging(fMRI) assessment.
- The SEEG assessment phase: Lasting 14 days, participants will be implanted SEEG electrodes and complete a series of SEEG assessments.
- The DBS treatment phase: Lasting 421 days, participants will be implanted a DBS device and treated with the DBS. During this period, participants will be required to complete the appropriate depressive symptom assessment tasks, as well as follow-up visits every 2 weeks.
- The efficacy observation phase after DBS shutdown: Lasting 2 months, if the participant has a good outcome at the DBS for depression phase, the electrical stimulation will be shut down for 2 months to observe the maintenance of the efficacy of the treatment, during which time, if the symptoms rebound, the DBS treatment will be restarted until the completion of the study at the end of the 2-month period. During this time participants will be required to complete the appropriate depressive symptom assessment tasks, and follow-up visits every 2 weeks.
- Conditions
- Treatment-resistant Depression (TRD)
- Being tested
- Deep Brain Stimulation(DBS), Esketamine
- Keywords
- Treatment-resistant depression (TRD), DBS, stimulation target, stimulation parameters, neural biomarker
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation(DBS)Device
During the DBS treatment phase, the DBS device will apply electrical stimulation to the patient's target brain regions using a specific strategy, and if the efficacy of this phase is not satisfactory, electrical stimulation will continue to be applied during the efficacy observation phase after DBS shutdown.
EsketamineDrug
SEEG intraoperative experiment: patients will be implanted with microelectrodes and connected to an electrophysiological recorder under local anesthesia. Intraoperative neurophysiological baseline will be recorded for 5 minutes, and esketamine will be injected intravenously at a dose of 0.5 mg/kg, and neurophysiological recordings will be continued for 15 minutes to observe the neuronal electrophysiological changes in various brain regions and target points.
| Study group | Role | What they receive |
|---|---|---|
| Depression | Experimental | Not described Receives: Device: Deep Brain Stimulation(DBS); Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Rating Scale for Depression (HAMD) score during the DBS treatment phase relative to preoperative baseline
Improvement is defined as a 25-49% reduction in Hamilton Rating Scale for Depression (HAMD) score relative to the preoperative baseline; response is defined as a ≥50% reduction in HAMD score relative to the preoperative baseline; and remission is defined as a HAMD score ≤8.
Measured: at baseline and after 442 day
Changes in HAMD scores during the efficacy observation phase after DBS shutdown
Rebound is defined as a HAMD ≥18 in the subsequent follow-up period if the patient has an initial assessment of HAMD ≤8 in the efficacy observation phase after DBS shutdown, and rebound is defined as a HAMD score more than 2 times the initial assessment or 20 in the subsequent follow-up period if the patient has an initial assessment of HAMD >8 in that phase.
Measured: Two months after 442 days
Secondary outcomes (15)
the score of Montgomery-Asberg Depression Rating Scale (MADRS)
The score of the scale ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Measured: Every 2 weeks between day 21 and day 442
the score of multi-lingual Hypomania Check List(C-SSRS)
The Multi-Lingual Hypomania Check List (C-SSRS) is a self-report questionnaire used to assess hypomanic symptoms and suicide risk. This tool includes multiple items designed to identify emotional and behavioral changes based on patient feedback. The results of the C-SSRS assist professionals in developing treatment plans, with higher scores typically indicating more severe symptoms, thereby facilitating timely intervention and support.
Measured: Every 2 weeks between day 21 and day 442
the score of Hamilton Anxiety Scale(HAMA)
The score of the scale ranges from 0 to 56. The higher scores means more severe anxiety.
Measured: Every 2 weeks between day 21 and day 442
the score of the Oxford Depression Questionnaire(ODQ)
The Oxford Depression Questionnaire (ODQ) is a self-report instrument designed to assess the presence and severity of depressive symptoms. It evaluates various aspects of mood, motivation, and behavior related to depression. The questionnaire consists of multiple items scored on a scale, where higher scores indicate greater levels of depressive symptoms, facilitating effective monitoring and intervention by healthcare professionals.
Measured: Every 2 weeks between day 21 and day 442
the score of THINC-integrated tool(THINC-it)
Neuropsychological measures contains six domains of cognition which are episodic memory, working memory,attention, executive functions, psychomotor speed and social cognition.
Measured: Every 2 weeks between day 21 and day 442
the score of Visual Analogue Scale-Depression(VAS-D)
The Visual Analogue Scale for Depression (VAS-D) is a self-report tool used to assess the severity of depressive symptoms. It consists of a single continuous line, where respondents indicate their level of depression by marking a point on the line. The scale ranges from "no depression" to "worst possible depression," allowing for a visual representation of the individual's emotional state. Higher marks on the scale correspond to greater levels of depressive symptoms, aiding healthcare providers in monitoring and addressing the patient's condition.
Measured: Every 2 weeks between day 21 and day 442
the score of HAMD-6 item(HAMD-6)
The Hamilton Depression Rating Scale-6 Item (HAMD-6) is a self-report questionnaire designed to assess the severity of depression. It focuses on six key symptoms, including mood, feelings of guilt, insomnia, work and activities, psychomotor agitation or retardation, and anxiety. Each item is rated on a scale, with higher scores indicating more severe depressive symptoms. This concise tool facilitates quick evaluation and monitoring of depression in clinical settings.
Measured: Every 2 weeks between day 21 and day 442
the score of Patient Health Questionnaire-9( PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a self-report tool used to assess the presence and severity of depressive symptoms. It consists of nine items that correspond to the diagnostic criteria for major depressive disorder. Respondents rate the frequency of their symptoms over the past two weeks on a 4-point scale. Higher scores indicate more severe depressive symptoms, helping healthcare providers to evaluate, monitor, and guide treatment decisions for patients.
Measured: Every 2 weeks between day 21 and day 442
the score of Beck Depression Inventory(BDI)
The Beck Depression Inventory (BDI) is a self-report questionnaire designed to measure the severity of depressive symptoms. It consists of 21 items that assess various aspects of depression, including mood, hopelessness, and physical symptoms. Respondents rate each item on a scale, with higher scores indicating greater levels of depression. The BDI is widely used in clinical and research settings to evaluate depression and monitor treatment progress.
Measured: Every 2 weeks between day 21 and day 442
the score of Visual Analogue Scale-Anxiety(VAS-A)
The Visual Analogue Scale for Anxiety (VAS-A) is a self-report tool used to measure the level of anxiety experienced by individuals. It consists of a continuous line, where respondents indicate their anxiety level by marking a point on the line. The scale ranges from "no anxiety" to "worst possible anxiety," providing a visual representation of the individual's emotional state. Higher marks on the scale correspond to greater levels of anxiety, assisting healthcare providers in assessing and addressing the patient's anxiety levels.
Measured: Every 2 weeks between day 21 and day 442
the score of General Anxiety Disorder-7(GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a self-report questionnaire designed to assess the severity of generalized anxiety disorder symptoms. It consists of seven items that evaluate various aspects of anxiety, including feelings of nervousness, worry, and difficulty relaxing. Respondents rate the frequency of their symptoms over the past two weeks on a 4-point scale. Higher scores indicate more severe anxiety symptoms, helping healthcare providers to identify and monitor anxiety levels in patients effectively.
Measured: Every 2 weeks between day 21 and day 442
the score of Beck Anxiety Inventory(BAI)
The Beck Anxiety Inventory (BAI) is a self-report questionnaire designed to measure the severity of anxiety symptoms. It consists of 21 items that assess various aspects of anxiety, such as physiological symptoms and cognitive disturbances. Respondents rate the intensity of their anxiety over the past week on a 4-point scale. Higher scores indicate greater levels of anxiety, providing valuable information for healthcare providers in evaluating and managing anxiety disorders.
Measured: Every 2 weeks between day 21 and day 442
the score of Immediate Mood Scale(IMS)
The Immediate Mood Scale (IMS) is a self-report questionnaire designed to assess an individual's current mood state. It includes a series of items that evaluate various emotional dimensions, such as happiness, sadness, anxiety, and anger. Respondents rate their mood on a scale, providing a snapshot of their emotional well-being at the moment. Higher scores on specific mood dimensions indicate a more positive emotional state, assisting healthcare providers in understanding and addressing the individual's immediate emotional needs.
Measured: Every 2 weeks between day 21 and day 442
the score of Quick Inventory of Depressive Symptomatology, Self-Rated(QIDS-SR)
The score of the scale ranges from 0 to 42. Higher QIDS-SR16 score indicates more severe depression.
Measured: Every 2 weeks between day 21 and day 442
Adverse events
Record: Adverse events during the "perioperative period" of SEEG and DBS implantation, during the DBS treatment phase, and during the follow-up period of the efficacy observation phase after DBS shutdown , including abnormalities in laboratory tests as judged necessary by the investigator.
Measured: Perioperative and every 2 weeks between day 21 and day 442
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start5 Jan 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Treatment-resistant Depression (TRD)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuxiao Yang, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784388
- Sponsor's protocol ID
- IR2024292
- Status last verified
- Apr 2026
- First submitted
- 14 Jan 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Scangos KW, Khambhati AN, Daly PM, Makhoul GS, Sugrue LP, Zamanian H, Liu TX, Rao VR, Sellers KK, Dawes HE, Starr PA, Krystal AD, Chang EF. Closed-loop neuromodulation in an individual with treatment-resistant depression. Nat Med. 2021 Oct;27(10):1696-1700. doi: 10.1038/s41591-021-01480-w. Epub 2021 Oct 4.
PubMed 34608328Alagapan S, Choi KS, Heisig S, Riva-Posse P, Crowell A, Tiruvadi V, Obatusin M, Veerakumar A, Waters AC, Gross RE, Quinn S, Denison L, O'Shaughnessy M, Connor M, Canal G, Cha J, Hershenberg R, Nauvel T, Isbaine F, Afzal MF, Figee M, Kopell BH, Butera R, Mayberg HS, Rozell CJ. Cingulate dynamics track depression recovery with deep brain stimulation. Nature. 2023 Oct;622(7981):130-138. doi: 10.1038/s41586-023-06541-3. Epub 2023 Sep 20.
PubMed 37730990
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Personalized DBS Target Optimization for Treating Depression
- ClinicalTrials.gov ID
- NCT06784388
- Acronym / sponsor ID
- IR2024292
- Conditions
- Treatment-resistant Depression (TRD)
- Keywords
- Treatment-resistant depression (TRD), DBS, stimulation target, stimulation parameters, neural biomarker
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 20 Jan 2025 (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 goal of this clinical trial is to optimize the target brain areas for deep brain stimulation (DBS) for depression based on personalized brain imaging and stereo-electroencephalography(SEEG), to administer long-term DBS treatment in the target brain areas, to assess the effectiveness and safety of DBS for refractory depression and to validate the method of personalized optimization of DBS targets. The main questions it aims to answer are:
- Where is the optimal DBS target brain region for each patient?
- What are the optimal DBS parameters for each patient ?
- What are the neural biomarkers of depression symptoms for each patient?
- Are the optimized DBS strategies effective in treating refractory depression?
Detailed description
This clinical study is a prospective clinical trial focused on the personalized optimization methods and applications of DBS targets for depression.
The study is divided into 4 phases and in each phase and participants will complete different tasks:
- The preoperative assessment phase:Lasting 7 days, participants will be required to complete preoperative symptom assessments, brain imaging, and task-state functional magnetic resonance imaging(fMRI) assessment.
- The SEEG assessment phase: Lasting 14 days, participants will be implanted SEEG electrodes and complete a series of SEEG assessments.
- The DBS treatment phase: Lasting 421 days, participants will be implanted a DBS device and treated with the DBS. During this period, participants will be required to complete the appropriate depressive symptom assessment tasks, as well as follow-up visits every 2 weeks.
- The efficacy observation phase after DBS shutdown: Lasting 2 months, if the participant has a good outcome at the DBS for depression phase, the electrical stimulation will be shut down for 2 months to observe the maintenance of the efficacy of the treatment, during which time, if the symptoms rebound, the DBS treatment will be restarted until the completion of the study at the end of the 2-month period. During this time participants will be required to complete the appropriate depressive symptom assessment tasks, and follow-up visits every 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depression | Experimental | Device: Deep Brain Stimulation(DBS), Drug: Esketamine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A psychiatrist-confirmed diagnosis of major depressive disorder in accordance with the Diagnostic And Statistical Manual Of Mental Disorders.5th Ed (DSM-V);
- A psychiatric examination by two trained psychiatrists and a diagnosis consistent with the DSM-V;
- A history of depression of at least 12 months duration in depressed patients (including MECT) who have failed to respond to a full dose and course of treatment with 2 or more antidepressants of different mechanisms;
- A 17-item score on the HAMD scale ⩾ 20 at initial screening;
- A score of ≤ 50 on the Gross Assessment of Functioning (GAF) scale;
Key exclusion criteria (8 listed)
- Persons with severe or unstable cardiac, hepatic, renal, endocrine, hematologic, and other medical disorders and co-morbidities with psychotic symptoms, including personality disorders diagnosed by history, questioning, and clinical examination;
- Persons with psychiatric disorders other than depression (except generalized anxiety);
- Persons with a history of substance abuse within 12 months; persons with a previous history of epilepsy, and persons with febrile convulsions in childhood;
- Patients with a history of suicide attempts within the past 6 months or more than 2 suicide attempts within the past 2 years;
- Women who are breastfeeding, pregnant, and patients who are pregnant or intend to become pregnant during the clinical study;
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 |
|---|---|---|
| Deep Brain Stimulation(DBS)During the DBS treatment phase, the DBS device will apply electrical stimulation to the patient's target brain regions using a specific strategy, and if the efficacy of this phase is not satisfactory, electrical stimulation will continue to be applied during the efficacy observation phase after DBS shutdown. | Device | Depression |
| EsketamineSEEG intraoperative experiment: patients will be implanted with microelectrodes and connected to an electrophysiological recorder under local anesthesia. Intraoperative neurophysiological baseline will be recorded for 5 minutes, and esketamine will be injected intravenously at a dose of 0.5 mg/kg, and neurophysiological recordings will be continued for 15 minutes to observe the neuronal electrophysiological changes in various brain regions and target points. | Drug | Depression |
Primary outcome
Change in Hamilton Rating Scale for Depression (HAMD) score during the DBS treatment phase relative to preoperative baseline
Time frame: at baseline and after 442 day
Improvement is defined as a 25-49% reduction in Hamilton Rating Scale for Depression (HAMD) score relative to the preoperative baseline; response is defined as a ≥50% reduction in HAMD score relative to the preoperative baseline; and remission is defined as a HAMD score ≤8.
Changes in HAMD scores during the efficacy observation phase after DBS shutdown
Time frame: Two months after 442 days
Rebound is defined as a HAMD ≥18 in the subsequent follow-up period if the patient has an initial assessment of HAMD ≤8 in the efficacy observation phase after DBS shutdown, and rebound is defined as a HAMD score more than 2 times the initial assessment or 20 in the subsequent follow-up period if the patient has an initial assessment of HAMD >8 in that phase.
15 secondary outcomes
the score of Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Every 2 weeks between day 21 and day 442
the score of multi-lingual Hypomania Check List(C-SSRS)
Time frame: Every 2 weeks between day 21 and day 442
the score of Hamilton Anxiety Scale(HAMA)
Time frame: Every 2 weeks between day 21 and day 442
the score of the Oxford Depression Questionnaire(ODQ)
Time frame: Every 2 weeks between day 21 and day 442
the score of THINC-integrated tool(THINC-it)
Time frame: Every 2 weeks between day 21 and day 442
the score of Visual Analogue Scale-Depression(VAS-D)
Time frame: Every 2 weeks between day 21 and day 442
the score of HAMD-6 item(HAMD-6)
Time frame: Every 2 weeks between day 21 and day 442
the score of Patient Health Questionnaire-9( PHQ-9)
Time frame: Every 2 weeks between day 21 and day 442
the score of Beck Depression Inventory(BDI)
Time frame: Every 2 weeks between day 21 and day 442
the score of Visual Analogue Scale-Anxiety(VAS-A)
Time frame: Every 2 weeks between day 21 and day 442
the score of General Anxiety Disorder-7(GAD-7)
Time frame: Every 2 weeks between day 21 and day 442
the score of Beck Anxiety Inventory(BAI)
Time frame: Every 2 weeks between day 21 and day 442
the score of Immediate Mood Scale(IMS)
Time frame: Every 2 weeks between day 21 and day 442
the score of Quick Inventory of Depressive Symptomatology, Self-Rated(QIDS-SR)
Time frame: Every 2 weeks between day 21 and day 442
Adverse events
Time frame: Perioperative and every 2 weeks between day 21 and day 442
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 27 Apr 2026.
- Results publication: PubMed 34608328Scangos KW, Khambhati AN, Daly PM, Makhoul GS, Sugrue LP, Zamanian H, Liu TX, Rao VR, Sellers KK, Dawes HE, Starr PA, Krystal AD, Chang EF. Closed-loop neuromodulation in an individual with treatment-resistant depression. Nat Med. 2021 Oct;27(10):1696-1700. doi: 10.1038/s41591-021-01480-w. Epub 2021 Oct 4.
- Results publication: PubMed 37730990Alagapan S, Choi KS, Heisig S, Riva-Posse P, Crowell A, Tiruvadi V, Obatusin M, Veerakumar A, Waters AC, Gross RE, Quinn S, Denison L, O'Shaughnessy M, Connor M, Canal G, Cha J, Hershenberg R, Nauvel T, Isbaine F, Afzal MF, Figee M, Kopell BH, Butera R, Mayberg HS, Rozell CJ. Cingulate dynamics track depression recovery with deep brain stimulation. Nature. 2023 Oct;622(7981):130-138. doi: 10.1038/s41586-023-06541-3. Epub 2023 Sep 20.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Deep Brain Stimulation(DBS) and Esketamine in people with Treatment-resistant Depression (TRD), run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 6 inclusion and 8 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 27 Apr 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Junming Zhu, Ph.D. (+86 13968055768, dr.zhujunming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Rating Scale for Depression (HAMD) score during the DBS treatment phase relative to preoperative baseline (time frame: at baseline and after 442 day). The study lists 2 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 NCT06784388, which also lists 2 linked publications.
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 27 Apr 2026.