SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia
NCT ID: NCT04528095
Last Updated: 2020-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
162 participants
INTERVENTIONAL
2020-12-31
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Clozapine
Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml
Clozapine
Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d
Clozapine+Amisulpride
Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml Amisulpride 200-800mg/d
Clozapine
Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d
Clozapine+Gingke biloba
Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml Gingke biloba 120-360mg/d
Clozapine
Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d
MECT
MECT:The treatment lasted for 4 months,16 times in total
MECT
MECT:The treatment lasted for 4 months,16 times in total MST:The treatment lasted for 4 months,16 times in total
MST
MST:The treatment lasted for 4 months,16 times in total
MECT
MECT:The treatment lasted for 4 months,16 times in total MST:The treatment lasted for 4 months,16 times in total
DBS
Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)
DBS
Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)
Interventions
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Clozapine
Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d
MECT
MECT:The treatment lasted for 4 months,16 times in total MST:The treatment lasted for 4 months,16 times in total
DBS
Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
ALL
No
Sponsors
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Shanghai Mental Health Center
OTHER
Responsible Party
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Principal Investigators
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Dengtang Liu, MD
Role: STUDY_CHAIR
Shanghai Mental Health Center
Locations
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Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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TRS-SMART
Identifier Type: -
Identifier Source: org_study_id
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