Schizophrenia
Conditions
Interventions
Treatment-Resistant Schizophrenia Group:Implantable Neurostimulation System Treatment
Sponsors
Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–65 years (inclusive) at the time of signing the informed consent form, outpatient or inpatient, male or female; 2. Meets DSM-5 diagnostic criteria for schizophrenia; 3. Duration of illness >=5 years; 4. Meets the criteria for treatment-resistant and/or ultra-resistant schizophrenia, satisfying one of the following conditions: a) Previous treatment failure or intolerance to =2 different antipsychotic medications (excluding clozapine) at adequate dose (>=600 mg/day chlorpromazine equivalent) and duration (>=12 weeks); b) Treatment failure or intolerance to clozapine at adequate dose (>=300 mg/day or blood concentration >=350 ng/ml) and duration (>=12 weeks); 5. PANSS total score >=70 during both screening and baseline periods, with at least one item on the PANSS positive symptom subscale (P1, P2, P3, P5, P6, G9) scoring >=4; or at least three items on the PANSS negative symptom subscale (N1–N7) scoring >=4, or at least two items scoring >=5; 6. CGI-S score >=4 during both screening and baseline periods; 7. After being fully informed about the study’s purpose, content, expected treatment, and associated risks, the patient and their guardian consent to receive treatment with the implantable neurostimulation system and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with organic mental disorders, paranoid personality disorder, mental retardation, or other psychiatric disorders; 2. Individuals who, based on the clinical assessment of the researcher, are currently at significant risk of suicidal behavior; 3. Individuals whose PANSS total score decreases (improves) by >=20% from the screening period to the baseline period; 4. Individuals with severe or unstable cardiovascular, respiratory, hepatic, renal, hematological, endocrine, neurological, or other systemic diseases; 5. Individuals with neurological disorders such as organic brain diseases, traumatic brain injury, or refractory epilepsy; 6. Individuals with clinically significant abnormalities in physical examination, laboratory tests, ECG, or imaging during the screening or baseline period, deemed unsuitable for inclusion by the researcher; 7. Individuals who have had cochlear implants, cardiac pacemakers, cardiac defibrillators, have previously had unilateral or bilateral similar products implanted, or have undergone other surgeries within six months that the researcher believes may affect this trial; 8. Individuals with contraindications for DBS implantation surgery, deemed unsuitable for surgery by the researcher; 9. Individuals diagnosed as HIV positive; 10. Pregnant or breastfeeding women, or women of childbearing potential with positive blood HCG/urine pregnancy test results during the screening period; or those unable to use effective contraception during the trial; or those planning to conceive within three months after the trial begins; 11. Individuals currently participating in or who have participated in other drug or medical device clinical trials within three months prior to screening; 12. Individuals deemed unsuitable for participation in this clinical study by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction rate in PANSS total score compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| At weeks 8, 12, and 24 after activation, the treatment efficacy rate (defined as a reduction rate in PANSS total score of =20% compared to baseline);Reduction rate in PANSS total score compared to baseline at weeks 8 and 24 after activation;Reduction rate in PANSS positive symptom subscale score compared to baseline at weeks 8, 12, and 24 after activation;Reduction rate in PANSS negative symptom subscale score compared to baseline at weeks 8, 12, and 24 after activation.;Change in Global Assessment of Functioning (GAF) score compared to baseline at weeks 8, 12, and 24 after activation.;Change in Clinical Global Impression-Schizophrenia (CGI-S) score compared to baseline at weeks 8, 12, and 24 after activation.;Change in Clinical Global Impression-Improvement (CGI-I) score compared to baseline at weeks 8, 12, and 24 after activation.; | — |
Countries
China
Contacts
Public ContactXiaoping Wang /Yu Mengqiang
Second Xiangya Hospital of Central South University
Outcome results
None listed