First Affiliated Hospital of Fujian Medical University
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
