Treatment-Resistant Schizophrenia
Conditions
Interventions
TIS treatment group :TIS treatment
Sham stimulation control group :Sham stimulation
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Meets the DSM-5 diagnostic criteria for schizophrenia; 2. Aged 18-55, right-handed, with an education level of junior high school or higher (>=9 years); 3. According to the attending physician's judgment, and based on past medical history and detailed follow-up of the patient's antipsychotic treatment records, meets the treatment-resistant criteria established by the American Psychiatric Association Treatment Response and Resistance in Psychosis (TRRIP) working group: after receiving >=2 different non-clozapine antipsychotic drugs at adequate doses (>=600 mg/day chlorpromazine equivalent), for an adequate duration (>=6 weeks at continuous therapeutic doses), and with good adherence (>=80% medication intake), the Clinical Global Impression - Severity scale (CGI-S) score is >=4 (indicating moderate or greater functional impairment), and >=2 items on the positive subscale of the Positive and Negative Syndrome Scale (PANSS) score >=4 (indicating moderate or greater severity of symptoms), with no symptom remission; 4. Exhibits moderate or greater disorganized symptoms, with a PANSS disorganized symptom score >=21; 5. The attending physician, together with the patient and family, decide to receive TIS treatment on the basis of existing medication. Patients currently using clozapine are allowed to enroll, provided the dose is stable (>=4 weeks) and there are no serious side effects.
Exclusion criteria
Exclusion criteria: 1. Presence of any contraindications for MRI scans; 2. History of ECT treatment (ECT induces seizures through electrical currents in the brain, which can have significant and potentially lasting effects on brain function and structure); 3. Received any neurostimulation treatments in the past 6 months (including rTMS, tDCS, tACS); 4. Comorbid other types of mental disorders (such as intellectual disability, obsessive-compulsive disorder, personality disorders, etc.); 5. Comorbid history of alcohol or drug abuse or dependence on psychoactive substances; 6. Presence of organic brain diseases or other unstable or severe physical illnesses; 7. Patients who are planning pregnancy, currently pregnant, or breastfeeding; 8. Patients who are extremely agitated, catatonic, passive suicidal, uncooperative, or at significant risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| E/I balance (Glx/GABA), ;gamma oscillations;DMN function; | — |
Countries
China
Contacts
Public ContactHuan Huang
Renmin Hospital of Wuhan University
Outcome results
None listed