Treatment-resistant Schizophrenia
Conditions
Keywords
Schizophrenia, Treatment-resistant, Antipsychotics, Combination
Brief summary
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.
Detailed description
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.
Interventions
DRUGClozapine
Clozapine 400 \ 600mg/d or plasma concentration \>350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d
DEVICEMECT
MECT:The treatment lasted for 4 months,16 times in total MST:The treatment lasted for 4 months,16 times in total
DEVICEDBS
Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. meet the DSM-5 diagnostic criteria for schizophrenia, 2. be 18-55 years of age, 3. treatment-resistant schizophrenia:no response to sufficient doses (400-600 mg/ day CPZ equivalent) of at least two antipsychotics in the past 5 years, 4. Informed consent.
Exclusion criteria
1. Patients with medical or psychiatric comorbidities and those who require concomitant other medications are excluded. 2. Patients with contraindications to even one of the proposed treatment arms are excluded. 3. Patients with risks such as extreme agitation, stupor or suicide are excluded. 4. Female patients with pregnancy or breast-feeding are also excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | Change from baseline PANSS score at 12 weeks | 25% or greater change in Positive and Negative Syndrome Scale (PANSS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse reactions | baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks | The Barnes Akathisia Scale (BAS) (0,14,higher scores mean a worse outcome), |
| Neurocognitive assessments and social function | baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months | 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, |
| Clinical assessements | baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks | PANSS (30,210,higher scores mean a worse outcome), |
Countries
China
Contacts
Primary ContactDengtang Liu, MD
Outcome results
None listed