The project intends to take treatment-resistant schizophrenia as the research object and uses sequential multiple assignment randomized trial(SMART) design to define the treatment recommendations of different drug regimen for treatment resistant schizophrenia and to determine the physical enhancement regimen for clozapine-resistant schizophrenia and to explore targeted regulation scheme for ultra-resistant schizophrenia.
This trial is a sequential multiple-assignment RCT design of antipsychotic drugs, planning to recruit 162 people with treatment-resistant schizophrenia followed for 12 months. The study includes three treatment phases and a naturalistic follow-up phase. Participants who meet the response criteria remain on that treatment for the duration of 12-month treatment. If the participants fail the treatment or can't tolerant the side effects, the patient moves to the next phase of the study to receive a new treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
162
Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml Amisulpride 200-800mg/d 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)
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Response rate
25% or greater change in Positive and Negative Syndrome Scale (PANSS)
Time frame: Change from baseline PANSS score at 12 weeks
Adverse reactions
The Barnes Akathisia Scale (BAS) (0,14,higher scores mean a worse outcome),
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Adverse reactions
Simpson-Angus Extrapyramidal Side Effects Scale (SAS) (0,40,higher scores mean a worse outcome)
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Adverse reactions
Abnormal Involuntary Movement Scale (AIMS) (0,42,higher scores mean a worse outcome)
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Neurocognitive assessments and social function
The University of California, San Diego (UCSD) Performance- based Skills Assessment-Brief (UPSA-B) (0,100,higher scores mean a better outcome) is used to evaluate the social function,
Time frame: baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months
Neurocognitive assessments and social function
The MATRICS consensus cognitive battery (MCCB) has been widely used to evaluate cognitive deficits in schizophrenia patients(0%,100%,higher scores mean a better outcome)
Time frame: baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months
Clinical assessements
PANSS (30,210,higher scores mean a worse outcome),
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Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Clinical assessements
Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPS) (0,32,higher scores mean a worse outcome),
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Clinical assessements
Calgary Depression Scale for Schizophrenia (CDSS) (0,27,higher scores mean a worse outcome)
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Clinical assessements
Clinical Global Impression Scale-Severity (CGI-S) (0,7,higher scores mean a worse outcome)
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks