SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia
Treatment-resistant Schizophrenia
About this trial
This is an interventional treatment trial for Treatment-resistant Schizophrenia focused on measuring Schizophrenia, Treatment-resistant, Antipsychotics, Combination
Eligibility Criteria
Inclusion Criteria:
- meet the DSM-5 diagnostic criteria for schizophrenia,
- be 18-55 years of age,
- treatment-resistant schizophrenia:no response to sufficient doses (400-600 mg/ day CPZ equivalent) of at least two antipsychotics in the past 5 years,
- Informed consent.
Exclusion Criteria:
- Patients with medical or psychiatric comorbidities and those who require concomitant other medications are excluded.
- Patients with contraindications to even one of the proposed treatment arms are excluded.
- Patients with risks such as extreme agitation, stupor or suicide are excluded.
- Female patients with pregnancy or breast-feeding are also excluded.
Sites / Locations
- Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Clozapine
Clozapine+Amisulpride
Clozapine+Gingke biloba
MECT
MST
DBS
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Amisulpride 200-800mg/d
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Gingke biloba 120-360mg/d
MECT:The treatment lasted for 4 months,16 times in total
MST:The treatment lasted for 4 months,16 times in total
Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)