Major Depressive DisorderNCT04530942
The Efficacy and Prediction of Deep Brain Stimulation for Treatment-resistant Depression
A study testing Deep brain stimulation(Active) in people with Major Depressive Disorder and Deep Brain Stimulation, run by Ruijin Hospital at 1 site in China.
Trial summary
Several open-label trials have shown the therapeutic promise of deep brain stimulation (DBS) targeted to striatal and surrounding capsular areas in treatment-resistant depression (TRD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Deep Brain Stimulation
- What is being tested?
- Deep brain stimulation(Active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2021to 30 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
- Primary diagnosis: Major Depressive Disorder according to the ICD-10 criteria based on a psychiatric interview
- Age: 18-65 years old
- HAMD-17 total ≥17
- Chronic illness with current episode ≥ 24 months duration and/or Illness with at least a total of 4 lifetime episodes (including current episode≥ 12 months) and a minimum of 5 years since the onset of the first depressive episode
- Treatment refractory defined as failure of: at least 3 adequate treatments from at least two distinctly different classes (SSRI, SNRI, NaSSA, TCA +, lithium-addition) for a period of 6-8 weeks or more weeks. Adequate psychotherapy. At least 1 session of ECT, for which the series of ECT was terminated either due to adverse effects or insufficient response (including at least 6 sessions of bilateral ECT); unavailable, rejective or intolerable to ECT
- remain stable with the current anti-depressive medicine for the last month
- Able and willing to give written informed consent
- Able to fully understand the consequences of the procedure
Who cannot join
- Schizophrenia /history of psychosis unrelated to MDD
- Severe personality disorder (assessed by SCID-II)
- Abnormal brain MRI
- Neurological disease (e.g., Parkinson's disease)
- Previous sterosurgery
- Any medical contraindication to surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Functional neurosurgery of Shanghai Jiaotong University affiliated Ruijin Hospital
Shanghai
About this study
Several open-label trials have shown the therapeutic promise of deep brain stimulation (DBS) targeted to striatal and surrounding capsular areas in treatment-resistant depression (TRD). However, the results of placebo-controlled trials have been mixed, with one showing a large difference between active and sham DBS and another finding no difference.
Main aim of this study is establishing whether active DBS results in more treatment responders than sham DBS. Secondary aims are establishing an adverse events profile, establishing effects on quality of life,neuropsychological and neuroimaging measures, and finding predictors of response.
Read the detailed description
Major Depressive Disorder (MDD) is a highly prevalent psychiatric disorder, with an estimated lifetime prevalence of 14.6% across high-income countries.Effective therapeutic options for MDD include psychotherapy, different classes of antidepressants, and electroconvulsive therapy (ECT). Nevertheless, up to 30% of patients do not respond to four consecutive antidepressant strategies and 52% of pharmacotherapy resistant patients do not respond to ECT.Such patients are designated an advanced stage of Treatment Resistant Depression (TRD), which is associated with more hospitalizations, more suicide attempts, and higher costs than non-TRD patients.
Deep Brain Stimulation (DBS) is a promising therapeutic option for TRD patients. DBS consists of implanting electrodes in specific brain areas and then optimizing stimulation parameters (e.g. voltage, frequency, pulse width) to modulate brain activity of the targeted area. Since 2005, several open label trials have reported promising effects of DBS in TRD, targeting different brain structures involved in the neurobiology of MDD: the Subcallosal Cingulate Gyrus (SCG),Medial Forebrain Bundle (MFB),Ventral Capsule/Ventral Striatum (VC/VS), and Nucleus Accumbens (NAc). Response rates, defined as a symptom decrease of at least 50%, range from 30% to 90% with most studies finding a response rate around 50%.
However, results of the first two randomized trials are mixed. The first randomized, controlled trial (RCT) of VC/VS DBS in TRD did not find differences in response rates following active (3 of 14 patients) or sham stimulation (2 of 15 patients) after four months of stimulation. In contrast, another group found a strong antidepressant effect in 16 patients with TRD following active ventral Anterior Limb of the Internal Capsule (vALIC) DBS compared to sham stimulation in a randomized crossover phase.
Therefore, this trial aims to establishing whether active DBS results in more treatment responders than sham DBS. Secondary aims are establishing an adverse events profile, establishing effects on quality of life,neuropsychological and neuroimaging measures, and finding predictors of response.
- Conditions
- Major Depressive Disorder, Deep Brain Stimulation
- Being tested
- Deep brain stimulation(Active), Deep brain stimulation(Sham)
- Keywords
- Treatment Resistant Depression, Deep Brain Stimulation, Ventral Capsule/Ventral Striatum
- 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.
Deep brain stimulation(Active)Device
Also called DBS On
DBS On with the optiomal parameters
Deep brain stimulation(Sham)Device
Also called DBS Off
DBS On with 0V Amplitude
| Study group | Role | What they receive |
|---|---|---|
| Active DBS then Sham DBS | Experimental | After more than 6 months open-lable period, some patients will take DBS ON for two weeks with the optimal stimulation parameters and then take DBS OFF for two weeks. Receives: Device: Deep brain stimulation(Active); Device: Deep brain stimulation(Sham) |
| Sham DBS then Active DBS | Experimental | After more than 6 months open-lable period, some patients will take DBS OFF for two weeks and then take DBS ON for two weeks with the optimal stimulation parameters. Receives: Device: Deep brain stimulation(Active); Device: Deep brain stimulation(Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the comparison between the Hamilton Depression Scale(HAMD-17) scores after active and sham phase
Effect size of comparison between HAMD-17 scores at two weeks when the active and sham phase end. The score of HAMD-17 ranges from 0 to 50. Higher HAMD-17 score indicates more severe depression.
Measured: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
Secondary outcomes (9)
changes in the Montgomery-Asberg Depression Rating Scale(MADRS)
Effect size of active compared to sham stimulation score before and after the sham and treatment periods. The score of the scale ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Measured: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in the Quick Inventory of Depression Scale(QIDS-SR16)
Effect size of active compared to sham stimulation score before and after the sham and treatment periods. The score of the scale ranges from 0 to 42. Higher QIDS-SR16 score indicates more severe depression.
Measured: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in the Depression and Somatic Symptoms Scale(DSSS)
Effect size of active compared to sham stimulation score before and after the sham and treatment periods. The score of the scale ranges from 0 to 66. Higher DSSS score indicates more severe depression and anxiety.
Measured: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in the Dimensional Anhedonia Rating Scale(DARS)
DARS is a self-reported dynamic scale that measures desire, motivation, effort and consummatory pleasure across hedonic domains. Higher scores indicate lower degrees of anhedonia.
Measured: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in Hamilton Anxiety Scales(HAMA)
Clinician administered assessment.The score of the scale ranges from 0 to 56. The higher scores means more severe anxiety.
Measured: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in World Health Organization Quality of Life-BREF(WHO-BREF)
The World Health Organization Quality of Life - BREF (WHOQOL-BREF) is a self report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment. It contains 26 items which is a 5 points scale. The higher score means better quality of life.
Measured: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in the MOS item short from health survey (SF-36)
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. The higher score means better quality of life.
Measured: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in Sheehan Disability Scale
Self-rating scale. The SDS is a composite of three self-rated items designed to measure the extent to which three major domains in the patient's life are functionally impaired by psychiatric or medical symptoms. The SDS assesses functional impairment in three major life domains: work, social life/leisure activities, and family life/home responsibilities. The higher scores mean more severity of disability.
Measured: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in Neuropsychological measures(Scores of Thinc-it tasks)
Neuropsychological measures contains six domains of cognition which are episodic memory, working memory,attention, executive functions, psychomotor speed and social cognition.
Measured: Baseline (preoperative), 6.25 months, 6.5 months, 18months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start29 Mar 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study starts with a longitudinal open-label phase followed by a randomized, double blind crossover phase. In the crossover phase, patients are randomized to active DBS for 2 weeks, followed by sham DBS for 2 weeks, or vice versa. The patients' post-surgery duration need to be more than 6 months when they entered the randomized cross-over phase.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bomin Sun, Ruijin Hospital
- Investigators
- Bomin Sun, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530942
- Sponsor's protocol ID
- 2020 DBS for TRD
- Status last verified
- Mar 2024
- First submitted
- 25 Aug 2020
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dougherty DD, Rezai AR, Carpenter LL, Howland RH, Bhati MT, O'Reardon JP, Eskandar EN, Baltuch GH, Machado AD, Kondziolka D, Cusin C, Evans KC, Price LH, Jacobs K, Pandya M, Denko T, Tyrka AR, Brelje T, Deckersbach T, Kubu C, Malone DA Jr. A Randomized Sham-Controlled Trial of Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Chronic Treatment-Resistant Depression. Biol Psychiatry. 2015 Aug 15;78(4):240-8. doi: 10.1016/j.biopsych.2014.11.023. Epub 2014 Dec 13.
PubMed 25726497Bergfeld IO, Mantione M, Hoogendoorn ML, Ruhe HG, Notten P, van Laarhoven J, Visser I, Figee M, de Kwaasteniet BP, Horst F, Schene AH, van den Munckhof P, Beute G, Schuurman R, Denys D. Deep Brain Stimulation of the Ventral Anterior Limb of the Internal Capsule for Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2016 May 1;73(5):456-64. doi: 10.1001/jamapsychiatry.2016.0152.
PubMed 27049915Dandekar MP, Fenoy AJ, Carvalho AF, Soares JC, Quevedo J. Deep brain stimulation for treatment-resistant depression: an integrative review of preclinical and clinical findings and translational implications. Mol Psychiatry. 2018 May;23(5):1094-1112. doi: 10.1038/mp.2018.2. Epub 2018 Feb 27.
PubMed 29483673Lai Y, Zhang Y, Wang Y, Wang L, Dai L, Ye K, Lv X, Wang F, Zhang J, Zhao Y, Hu K, Huang P, Zhang X, Qiu X, Pan Y, Liu W, Liu Q, Zhang C, Fang Y, Ye Z, Yuan TF, Li D, Li N, Lozano AM, Voon V, Zhan S, Sun B. Bed nucleus of the stria terminalis-nucleus accumbens stimulation for depression: A randomized, double-blind, crossover trial. Cell Rep Med. 2026 Apr 21;7(4):102711. doi: 10.1016/j.xcrm.2026.102711. Epub 2026 Mar 31.
PubMed 41923626Wang L, Zhang Y, Wang Y, Ding Q, Dai L, Hu K, Ye K, Lv X, Zhang X, Mandali A, Manssuer L, Sonkusare S, Zhao Y, Huang P, Qiu X, Pan Y, Lai Y, Li D, Liu W, Zhan S, Sun B, Voon V. Prefrontal-bed nucleus of the stria terminalis physiological and neuropsychological biomarkers predict therapeutic outcomes in depression. Nat Commun. 2025 Nov 18;16(1):10034. doi: 10.1038/s41467-025-65179-z.
PubMed 41253805
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Prediction of Deep Brain Stimulation for Treatment-resistant Depression
- ClinicalTrials.gov ID
- NCT04530942
- Acronym / sponsor ID
- 2020 DBS for TRD
- Conditions
- Major Depressive Disorder, Deep Brain Stimulation
- Keywords
- Treatment Resistant Depression, Deep Brain Stimulation, Ventral Capsule/Ventral Striatum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 28 Aug 2020 (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.
Several open-label trials have shown the therapeutic promise of deep brain stimulation (DBS) targeted to striatal and surrounding capsular areas in treatment-resistant depression (TRD). However, the results of placebo-controlled trials have been mixed, with one showing a large difference between active and sham DBS and another finding no difference.
Main aim of this study is establishing whether active DBS results in more treatment responders than sham DBS. Secondary aims are establishing an adverse events profile, establishing effects on quality of life,neuropsychological and neuroimaging measures, and finding predictors of response.
Detailed description
Major Depressive Disorder (MDD) is a highly prevalent psychiatric disorder, with an estimated lifetime prevalence of 14.6% across high-income countries.Effective therapeutic options for MDD include psychotherapy, different classes of antidepressants, and electroconvulsive therapy (ECT). Nevertheless, up to 30% of patients do not respond to four consecutive antidepressant strategies and 52% of pharmacotherapy resistant patients do not respond to ECT.Such patients are designated an advanced stage of Treatment Resistant Depression (TRD), which is associated with more hospitalizations, more suicide attempts, and higher costs than non-TRD patients.
Deep Brain Stimulation (DBS) is a promising therapeutic option for TRD patients. DBS consists of implanting electrodes in specific brain areas and then optimizing stimulation parameters (e.g. voltage, frequency, pulse width) to modulate brain activity of the targeted area. Since 2005, several open label trials have reported promising effects of DBS in TRD, targeting different brain structures involved in the neurobiology of MDD: the Subcallosal Cingulate Gyrus (SCG),Medial Forebrain Bundle (MFB),Ventral Capsule/Ventral Striatum (VC/VS), and Nucleus Accumbens (NAc). Response rates, defined as a symptom decrease of at least 50%, range from 30% to 90% with most studies finding a response rate around 50%.
However, results of the first two randomized trials are mixed. The first randomized, controlled trial (RCT) of VC/VS DBS in TRD did not find differences in response rates following active (3 of 14 patients) or sham stimulation (2 of 15 patients) after four months of stimulation. In contrast, another group found a strong antidepressant effect in 16 patients with TRD following active ventral Anterior Limb of the Internal Capsule (vALIC) DBS compared to sham stimulation in a randomized crossover phase.
Therefore, this trial aims to establishing whether active DBS results in more treatment responders than sham DBS. Secondary aims are establishing an adverse events profile, establishing effects on quality of life,neuropsychological and neuroimaging measures, and finding predictors of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study starts with a longitudinal open-label phase followed by a randomized, double blind crossover phase. In the crossover phase, patients are randomized to active DBS for 2 weeks, followed by sham DBS for 2 weeks, or vice versa. The patients' post-surgery duration need to be more than 6 months when they entered the randomized cross-over phase.
| Arm | Type | Receives |
|---|---|---|
| Active DBS then Sham DBS | Experimental | Device: Deep brain stimulation(Active), Device: Deep brain stimulation(Sham)After more than 6 months open-lable period, some patients will take DBS ON for two weeks with the optimal stimulation parameters and then take DBS OFF for two weeks. |
| Sham DBS then Active DBS | Experimental | Device: Deep brain stimulation(Active), Device: Deep brain stimulation(Sham)After more than 6 months open-lable period, some patients will take DBS OFF for two weeks and then take DBS ON for two weeks with the optimal stimulation parameters. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary diagnosis: Major Depressive Disorder according to the ICD-10 criteria based on a psychiatric interview
- Age: 18-65 years old
- HAMD-17 total ≥17
- Chronic illness with current episode ≥ 24 months duration and/or Illness with at least a total of 4 lifetime episodes (including current episode≥ 12 months) and a minimum of 5 years since the onset of the first depressive episode
- Treatment refractory defined as failure of: at least 3 adequate treatments from at least two distinctly different classes (SSRI, SNRI, NaSSA, TCA +, lithium-addition) for a period of 6-8 weeks or more weeks. Adequate psychotherapy. At least 1 session of ECT, for which the series of ECT was terminated either due to adverse effects or insufficient response (including at least 6 sessions of bilateral ECT); unavailable, rejective or intolerable to ECT
Key exclusion criteria (6 listed)
- Schizophrenia /history of psychosis unrelated to MDD
- Severe personality disorder (assessed by SCID-II)
- Abnormal brain MRI
- Neurological disease (e.g., Parkinson's disease)
- Previous sterosurgery
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(Active)Also: DBS OnDBS On with the optiomal parameters | Device | Active DBS then Sham DBS, Sham DBS then Active DBS |
| Deep brain stimulation(Sham)Also: DBS OffDBS On with 0V Amplitude | Device | Active DBS then Sham DBS, Sham DBS then Active DBS |
Primary outcome
the comparison between the Hamilton Depression Scale(HAMD-17) scores after active and sham phase
Time frame: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
Effect size of comparison between HAMD-17 scores at two weeks when the active and sham phase end. The score of HAMD-17 ranges from 0 to 50. Higher HAMD-17 score indicates more severe depression.
9 secondary outcomes
changes in the Montgomery-Asberg Depression Rating Scale(MADRS)
Time frame: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in the Quick Inventory of Depression Scale(QIDS-SR16)
Time frame: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in the Depression and Somatic Symptoms Scale(DSSS)
Time frame: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in the Dimensional Anhedonia Rating Scale(DARS)
Time frame: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in Hamilton Anxiety Scales(HAMA)
Time frame: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in World Health Organization Quality of Life-BREF(WHO-BREF)
Time frame: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in the MOS item short from health survey (SF-36)
Time frame: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in Sheehan Disability Scale
Time frame: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months
changes in Neuropsychological measures(Scores of Thinc-it tasks)
Time frame: Baseline (preoperative), 6.25 months, 6.5 months, 18months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Background: PubMed 25726497Dougherty DD, Rezai AR, Carpenter LL, Howland RH, Bhati MT, O'Reardon JP, Eskandar EN, Baltuch GH, Machado AD, Kondziolka D, Cusin C, Evans KC, Price LH, Jacobs K, Pandya M, Denko T, Tyrka AR, Brelje T, Deckersbach T, Kubu C, Malone DA Jr. A Randomized Sham-Controlled Trial of Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Chronic Treatment-Resistant Depression. Biol Psychiatry. 2015 Aug 15;78(4):240-8. doi: 10.1016/j.biopsych.2014.11.023. Epub 2014 Dec 13.
- Background: PubMed 27049915Bergfeld IO, Mantione M, Hoogendoorn ML, Ruhe HG, Notten P, van Laarhoven J, Visser I, Figee M, de Kwaasteniet BP, Horst F, Schene AH, van den Munckhof P, Beute G, Schuurman R, Denys D. Deep Brain Stimulation of the Ventral Anterior Limb of the Internal Capsule for Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2016 May 1;73(5):456-64. doi: 10.1001/jamapsychiatry.2016.0152.
- Background: PubMed 29483673Dandekar MP, Fenoy AJ, Carvalho AF, Soares JC, Quevedo J. Deep brain stimulation for treatment-resistant depression: an integrative review of preclinical and clinical findings and translational implications. Mol Psychiatry. 2018 May;23(5):1094-1112. doi: 10.1038/mp.2018.2. Epub 2018 Feb 27.
- Derived from this study: PubMed 41923626Lai Y, Zhang Y, Wang Y, Wang L, Dai L, Ye K, Lv X, Wang F, Zhang J, Zhao Y, Hu K, Huang P, Zhang X, Qiu X, Pan Y, Liu W, Liu Q, Zhang C, Fang Y, Ye Z, Yuan TF, Li D, Li N, Lozano AM, Voon V, Zhan S, Sun B. Bed nucleus of the stria terminalis-nucleus accumbens stimulation for depression: A randomized, double-blind, crossover trial. Cell Rep Med. 2026 Apr 21;7(4):102711. doi: 10.1016/j.xcrm.2026.102711. Epub 2026 Mar 31.
- Derived from this study: PubMed 41253805Wang L, Zhang Y, Wang Y, Ding Q, Dai L, Hu K, Ye K, Lv X, Zhang X, Mandali A, Manssuer L, Sonkusare S, Zhao Y, Huang P, Qiu X, Pan Y, Lai Y, Li D, Liu W, Zhan S, Sun B, Voon V. Prefrontal-bed nucleus of the stria terminalis physiological and neuropsychological biomarkers predict therapeutic outcomes in depression. Nat Commun. 2025 Nov 18;16(1):10034. doi: 10.1038/s41467-025-65179-z.
- 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. This study is not recruiting at the moment.
Bomin Sun, PhD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation(Active) in people with Major Depressive Disorder and Deep Brain Stimulation, run by Ruijin Hospital 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 8 inclusion and 6 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 25 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the comparison between the Hamilton Depression Scale(HAMD-17) scores after active and sham phase (time frame: Baseline (preoperative),one month, 3 months, 6 months, 6.25 months, 6.5 months, 9 months, 12 months, 18months). 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 NCT04530942, which also lists 5 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 25 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.