Schizophrenia
Conditions
Interventions
Group 1:Deep Brain Stimulation (DBS) of the nucleus accumbens and the anterior limb of the internal capsule is performed: Two weeks after DBS implantation, the device is turned on for monopolar stimul
Group 2:Deep Brain Stimulation (DBS) of the nucleus accumbens and the anterior limb of the internal capsule is performed: Two weeks after DBS implantation, the device is turned on for monopolar stimul
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-55 years (inclusive) at the time of signing the informed consent form, male or non-pregnant female; 2.Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for schizophrenia; 3.Schizophrenia disease course >= 5 years before the screening visit; 4.Meets criteria for refractory and/or ultra-refractory schizophrenia (refer to the 2016 TRRIP criteria for refractory schizophrenia), satisfying the following: a. Previous treatment with >= 2 different antipsychotics (excluding clozapine) at adequate dose (>= 600mg/day chlorpromazine equivalent) and duration (>= 12 weeks) with no response or intolerance; b. Previous treatment with clozapine at adequate dose (>= 300mg/day or plasma concentration >= 350ng/ml) and duration (>= 12 weeks) with no response or intolerance; c. Symptom severity of at least moderate; 5.PANSS total score >= 70 at screening and baseline; 6.No changes in medication treatment in the past 2 months; 7.The patient and their guardian have been fully informed of the study purpose, content, expected treatment, and risks, agree to receive implantable neurostimulation system treatment, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Comorbid with epilepsy, severe cognitive impairment (MMSE score < 10), organic mental disorder, paranoid personality disorder, mental retardation, or addiction (other than nicotine); 2.Has implanted cochlear implants, cardiac pacemakers, implantable cardioverter-defibrillators, unilateral/bilateral similar devices, or undergone surgery within 6 months that the investigator deems may affect the trial; 3.Has contraindications to DBS implantation, deemed unsuitable for surgery by the investigator; 4.Currently participating in or has participated in other drug or medical device clinical trials within 3 months before screening; 5.Confirmed HIV-positive; 6.Pregnant or lactating women; women of childbearing age with positive blood 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; 7.Other conditions deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction rate of the total PANSS score compared with the baseline, where a 20% reduction defines effectiveness or ineffectiveness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impressions Scale - Schizophrenia (CGI) score;Drug dosage; | — |
Countries
China
Contacts
Public ContactKang Dezhi; Lin Yuanxiang
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed