Refractory SchizophreniaNCT07369401
Deep Brain Stimulation of the Nucleus Accumbens and Anterior Limb of the Internal Capsule in the Treatment of Refractory Schizophrenia
A study testing Deep Brain Stimulation in people with Refractory Schizophrenia, run by First Affiliated Hospital of Fujian Medical University.
Trial summary
Schizophrenia is a lifelong psychiatric disorder with a prevalence rate of 0.559% and a lifetime prevalence rate of 0.588% among Chinese adults. It often causes social dysfunction and psychiatric disability, shortening patients' life expectancy by 10-25 years compared to the general population. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Refractory Schizophrenia
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-55 years (inclusive) at the time of signing the informed consent form, male or non-pregnant female;
- Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for schizophrenia;
- Schizophrenia disease course ≥ 5 years before screening;
- Meets the 2016 TRRIP criteria for refractory/ultra-refractory schizophrenia: previous treatment with ≥ 2 non-clozapine antipsychotics at adequate dose (≥ 600mg/day chlorpromazine equivalent) and duration (≥ 12 weeks) with no response or intolerance, or clozapine at adequate dose (≥ 300mg/day or plasma concentration ≥ 350ng/ml) and duration (≥ 12 weeks) with no response or intolerance, plus moderate or greater symptom severity;
- PANSS total score ≥ 70 at screening and baseline;
- No changes in medication regimen in the past 2 months;
- The patient and their guardian have been fully informed and signed the informed consent form.
Who cannot join
- Comorbid with epilepsy, severe cognitive impairment (Mini-Mental State Examination [MMSE] score < 10), organic mental disorder, paranoid personality disorder, mental retardation, or addiction (other than nicotine);
- Has implanted devices such as cochlear implants or cardiac pacemakers, or has undergone surgery that may affect the trial within 6 months;
- Has contraindications to DBS implantation and is deemed unsuitable for surgery by the investigator;
- Has participated in other drug/medical device clinical trials within 3 months before screening;
- Confirmed HIV-positive;
- Pregnant/lactating women, women of childbearing age with positive HCG/urine pregnancy test at screening, those unable to use effective contraception during the trial, or those planning to conceive within 3 months after trial initiation;
- Other conditions deemed unsuitable for participation by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yao Peisen, professor of medicine contact
About this study
Official title: Efficacy and Safety of Deep Brain Stimulation of the Nucleus Accumbens and Anterior Limb of the Internal Capsule in the Treatment of Refractory Schizophrenia: A Prospective, Single-Center, Double-Blind, Randomized Controlled Study
Schizophrenia is a lifelong psychiatric disorder with a prevalence rate of 0.559% and a lifetime prevalence rate of 0.588% among Chinese adults. It often causes social dysfunction and psychiatric disability, shortening patients' life expectancy by 10-25 years compared to the general population. Approximately 30% of patients are resistant to antipsychotic medications, and 60% of these do not respond to clozapine (ultra-refractory). DBS has shown definite efficacy in movement disorders and refractory obsessive-compulsive disorder (OCD) as well as major depressive disorder (MDD). Preliminary studies have indicated that DBS targeting sites such as the NAcc can improve symptoms in some schizophrenia patients. Additionally, abnormal white matter in the anterior limb of the internal capsule has been identified in refractory patients, providing a basis for exploring combined target stimulation.
This study aims to investigate the efficacy and safety of deep brain stimulation of the Nucleus Accumbens and Anterior Limb of the Internal Capsule in the treatment of refractory schizophrenia. A randomized controlled (self-controlled) design is adopted. The statistical analysis unit generates a random allocation table using SAS software, and groups are assigned via central randomization. Both groups undergo three stimulation phases: DBS activation 2 weeks after surgery, 6 weeks of single-target stimulation followed by 2 weeks of shutdown, another 6 weeks of alternate single-target stimulation followed by 2 weeks of shutdown, and finally 6 weeks of combined dual-target stimulation. Trial Group 1 is stimulated sequentially at NAcc, Anterior Limb of the Internal Capsule, and dual targets; Trial Group 2 follows the reverse order for single-target stimulation before combined stimulation. Surgery is performed under general anesthesia by neurosurgeons with associate senior titles or above and extensive experience. After head frame placement, CT and MRI images are fused for targeting. Electrodes are implanted into the NAcc via the Anterior Limb of the Internal Capsule, and a pulse generator is placed under the clavicle and connected to the electrodes. Postoperative CT confirms electrode position. Trial devices are provided by Jingyu Medical Technology (Suzhou) Co., Ltd., including implantable neurostimulation systems, electrode leads, extension leads, and programming equipment. On-site follow-up is conducted at key time points: screening, baseline, 2 weeks postoperatively (DBS activation), 6 weeks after stimulation, 16 weeks postoperatively, and 24 weeks postoperatively, including scale assessments, physical examinations, and laboratory/imaging tests. The primary outcome measure was the reduction rate of the total PANSS score at 24 weeks after DBS implantation compared to baseline, with a 20% reduction defined as effective, assessed by independent psychiatric evaluators.
- Conditions
- Refractory Schizophrenia
- Being tested
- Deep Brain Stimulation
- Keywords
- Deep Brain Stimulation, Refractory Schizophrenia, Nucleus Accumbens, Anterior Limb
- Medical subject headings
- Schizophrenia, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
An assessment is conducted 7 days postoperatively. DBS is activated 2 weeks after implantation for NAcc-only stimulation. Stimulation is maintained for 6 weeks (until week 8 postoperatively), then shut down. Stimulation is reactivated at week 10 for anterior limb of the internal capsule-only stimulation, maintained for 6 weeks (until week 16 postoperatively), then shut down. Based on the participant's vital signs and motor responses to stimulation, initial parameters are set as: 2.5-7.5 V, pulse width 60-210 µs, frequency 80-210 Hz. During the stabilization phase, an independent clinical programmer adjusts parameters individually for each patient based on clinical status and provides guidance according to symptom changes. Patients are not informed of any adjustments. To maximize therapeutic efficacy, the adjustment sequence is: (1) increase voltage up to 7.5 V; (2) increase pulse width or frequency up to 210 µs/Hz; (3) change contacts or modes (monopolar negative or bipolar negative).
Deep Brain StimulationDevice
An assessment is conducted 7 days postoperatively. DBS is activated 2 weeks after implantation for anterior limb of the internal capsule-only stimulation. Stimulation is maintained for 6 weeks (until week 8 postoperatively), then shut down. Stimulation is reactivated at week 10 for NAcc-only stimulation, maintained for 6 weeks (until week 16 postoperatively), then shut down.Based on the participant's vital signs and motor responses to stimulation, initial parameters are set as: 2.5-7.5 V, pulse width 60-210 µs, frequency 80-210 Hz. During the stabilization phase, an independent clinical programmer adjusts parameters individually for each patient based on clinical status and provides guidance according to symptom changes. Patients are not informed of any adjustments. To maximize therapeutic efficacy, the adjustment sequence is: (1) increase voltage up to 7.5 V; (2) increase pulse width or frequency up to 210 µs/Hz; (3) change contacts or modes (monopolar negative or bipolar negative).
| Study group | Role | What they receive |
|---|---|---|
| Trial Group 1 | Experimental | DBS is activated 2 weeks after implantation for NAcc-only stimulation. Stimulation is maintained for 6 weeks (until week 8 postoperatively), then shut down. Stimulation is reactivated at week 10 for anterior limb of the internal capsule-only stimulation, maintained for 6 weeks (until week 16 postoperatively), then shut down. Combined stimulation of the NAcc and anterior limb of the internal capsule is initiated at week 18 postoperatively, maintained for 6 weeks, followed by efficacy assessment. Receives: Device: Deep Brain Stimulation |
| Trial Group 2 | Experimental | DBS is activated 2 weeks after implantation for anterior limb of the internal capsule-only stimulation. Stimulation is maintained for 6 weeks (until week 8 postoperatively), then shut down. Stimulation is reactivated at week 10 for NAcc-only stimulation, maintained for 6 weeks (until week 16 postoperatively), then shut down. Combined stimulation of the NAcc and anterior limb of the internal capsule is initiated at week 18 postoperatively, maintained for 6 weeks, followed by efficacy assessment. Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reduction rate of the total PANSS score at 24 weeks
The reduction rate of the total PANSS score at 24 weeks after DBS implantation compared to baseline. The reduction rate is (PANSS score at baseline - PANSS score at 24-weeks) / PANSS score at baseline. PANSS score was assessed by independent psychiatric evaluators.
Measured: 24 weeks after treatment
Secondary outcomes (2)
The proportion of effective treatment
Compared with the baseline, a reduction of ≥ 20% in the total PANSS score is defined as effective treatment. The reduction rate is (PANSS score at baseline - PANSS score at 24-weeks) / PANSS score at baseline. PANSS score was assessed by independent psychiatric evaluators.
Measured: 24 weeks after treatment
The change value of the Clinical Global Impression (CGI) scale score at 24 weeks
Changes in the Clinical Global Impression (CGI) scale score at 24 weeks postoperatively compared to baseline. The change value is the CGI score at 24 weeks minus the CGI score at baseline.
Measured: 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory SchizophreniaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, De-zhi Kang, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369401
- Sponsor's protocol ID
- MRCTA,ECFAH of FMU [2025]637
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Deep Brain Stimulation of the Nucleus Accumbens and Anterior Limb of the Internal Capsule in the Treatment of Refractory Schizophrenia: A Prospective, Single-Center, Double-Blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07369401
- Acronym / sponsor ID
- MRCTA,ECFAH of FMU [2025]637
- Conditions
- Refractory Schizophrenia
- Keywords
- Deep Brain Stimulation, Refractory Schizophrenia, Nucleus Accumbens, Anterior Limb
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jan 2026 (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.
Schizophrenia is a lifelong psychiatric disorder with a prevalence rate of 0.559% and a lifetime prevalence rate of 0.588% among Chinese adults. It often causes social dysfunction and psychiatric disability, shortening patients' life expectancy by 10-25 years compared to the general population. Approximately 30% of patients are resistant to antipsychotic medications, and 60% of these do not respond to clozapine (ultra-refractory). DBS has shown definite efficacy in movement disorders and refractory obsessive-compulsive disorder (OCD) as well as major depressive disorder (MDD). Preliminary studies have indicated that DBS targeting sites such as the NAcc can improve symptoms in some schizophrenia patients. Additionally, abnormal white matter in the anterior limb of the internal capsule has been identified in refractory patients, providing a basis for exploring combined target stimulation.
This study aims to investigate the efficacy and safety of deep brain stimulation of the Nucleus Accumbens and Anterior Limb of the Internal Capsule in the treatment of refractory schizophrenia. A randomized controlled (self-controlled) design is adopted. The statistical analysis unit generates a random allocation table using SAS software, and groups are assigned via central randomization. Both groups undergo three stimulation phases: DBS activation 2 weeks after surgery, 6 weeks of single-target stimulation followed by 2 weeks of shutdown, another 6 weeks of alternate single-target stimulation followed by 2 weeks of shutdown, and finally 6 weeks of combined dual-target stimulation. Trial Group 1 is stimulated sequentially at NAcc, Anterior Limb of the Internal Capsule, and dual targets; Trial Group 2 follows the reverse order for single-target stimulation before combined stimulation. Surgery is performed under general anesthesia by neurosurgeons with associate senior titles or above and extensive experience. After head frame placement, CT and MRI images are fused for targeting. Electrodes are implanted into the NAcc via the Anterior Limb of the Internal Capsule, and a pulse generator is placed under the clavicle and connected to the electrodes. Postoperative CT confirms electrode position. Trial devices are provided by Jingyu Medical Technology (Suzhou) Co., Ltd., including implantable neurostimulation systems, electrode leads, extension leads, and programming equipment. On-site follow-up is conducted at key time points: screening, baseline, 2 weeks postoperatively (DBS activation), 6 weeks after stimulation, 16 weeks postoperatively, and 24 weeks postoperatively, including scale assessments, physical examinations, and laboratory/imaging tests. The primary outcome measure was the reduction rate of the total PANSS score at 24 weeks after DBS implantation compared to baseline, with a 20% reduction defined as effective, assessed by independent psychiatric evaluators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial Group 1 | Experimental | Device: Deep Brain StimulationDBS is activated 2 weeks after implantation for NAcc-only stimulation. Stimulation is maintained for 6 weeks (until week 8 postoperatively), then shut down. Stimulation is reactivated at week 10 for anterior limb of the internal capsule-only stimulation, maintained for 6 weeks (until week 16 postoperatively), then shut down. Combined stimulation of the NAcc and anterior limb of the internal capsule is initiated at week 18 postoperatively, maintained for 6 weeks, followed by efficacy assessment. |
| Trial Group 2 | Experimental | Device: Deep Brain StimulationDBS is activated 2 weeks after implantation for anterior limb of the internal capsule-only stimulation. Stimulation is maintained for 6 weeks (until week 8 postoperatively), then shut down. Stimulation is reactivated at week 10 for NAcc-only stimulation, maintained for 6 weeks (until week 16 postoperatively), then shut down. Combined stimulation of the NAcc and anterior limb of the internal capsule is initiated at week 18 postoperatively, maintained for 6 weeks, followed by efficacy assessment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 18-55 years (inclusive) at the time of signing the informed consent form, male or non-pregnant female;
- Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for schizophrenia;
- Schizophrenia disease course ≥ 5 years before screening;
- Meets the 2016 TRRIP criteria for refractory/ultra-refractory schizophrenia: previous treatment with ≥ 2 non-clozapine antipsychotics at adequate dose (≥ 600mg/day chlorpromazine equivalent) and duration (≥ 12 weeks) with no response or intolerance, or clozapine at adequate dose (≥ 300mg/day or plasma concentration ≥ 350ng/ml) and duration (≥ 12 weeks) with no response or intolerance, plus moderate or greater symptom severity;
- PANSS total score ≥ 70 at screening and baseline;
Key exclusion criteria (7 listed)
- Comorbid with epilepsy, severe cognitive impairment (Mini-Mental State Examination [MMSE] score < 10), organic mental disorder, paranoid personality disorder, mental retardation, or addiction (other than nicotine);
- Has implanted devices such as cochlear implants or cardiac pacemakers, or has undergone surgery that may affect the trial within 6 months;
- Has contraindications to DBS implantation and is deemed unsuitable for surgery by the investigator;
- Has participated in other drug/medical device clinical trials within 3 months before screening;
- Confirmed HIV-positive;
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 StimulationAn assessment is conducted 7 days postoperatively. DBS is activated 2 weeks after implantation for NAcc-only stimulation. Stimulation is maintained for 6 weeks (until week 8 postoperatively), then shut down. Stimulation is reactivated at week 10 for anterior limb of the internal capsule-only stimulation, maintained for 6 weeks (until week 16 postoperatively), then shut down. Based on the participant's vital signs and motor responses to stimulation, initial parameters are set as: 2.5-7.5 V, pulse width 60-210 µs, frequency 80-210 Hz. During the stabilization phase, an independent clinical programmer adjusts parameters individually for each patient based on clinical status and provides guidance according to symptom changes. Patients are not informed of any adjustments. To maximize therapeutic efficacy, the adjustment sequence is: (1) increase voltage up to 7.5 V; (2) increase pulse width or frequency up to 210 µs/Hz; (3) change contacts or modes (monopolar negative or bipolar negative). | Device | Trial Group 1 |
| Deep Brain StimulationAn assessment is conducted 7 days postoperatively. DBS is activated 2 weeks after implantation for anterior limb of the internal capsule-only stimulation. Stimulation is maintained for 6 weeks (until week 8 postoperatively), then shut down. Stimulation is reactivated at week 10 for NAcc-only stimulation, maintained for 6 weeks (until week 16 postoperatively), then shut down.Based on the participant's vital signs and motor responses to stimulation, initial parameters are set as: 2.5-7.5 V, pulse width 60-210 µs, frequency 80-210 Hz. During the stabilization phase, an independent clinical programmer adjusts parameters individually for each patient based on clinical status and provides guidance according to symptom changes. Patients are not informed of any adjustments. To maximize therapeutic efficacy, the adjustment sequence is: (1) increase voltage up to 7.5 V; (2) increase pulse width or frequency up to 210 µs/Hz; (3) change contacts or modes (monopolar negative or bipolar negative). | Device | Trial Group 2 |
Primary outcome
The reduction rate of the total PANSS score at 24 weeks
Time frame: 24 weeks after treatment
The reduction rate of the total PANSS score at 24 weeks after DBS implantation compared to baseline. The reduction rate is (PANSS score at baseline - PANSS score at 24-weeks) / PANSS score at baseline. PANSS score was assessed by independent psychiatric evaluators.
2 secondary outcomes
The proportion of effective treatment
Time frame: 24 weeks after treatment
The change value of the Clinical Global Impression (CGI) scale score at 24 weeks
Time frame: 24 weeks after treatment
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 Jan 2026.
- 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.
Yao Peisen, professor of medicine contact
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Refractory Schizophrenia, run by First Affiliated Hospital of Fujian Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Kang Dezhi, Professor (0591-87982798, kdz99988@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reduction rate of the total PANSS score at 24 weeks (time frame: 24 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.