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SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia

NCT04528095 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2020-08-27

No results posted yet for this study

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.

Conditions

  • Treatment-resistant Schizophrenia

Interventions

DRUG

Clozapine

Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d

DEVICE

MECT

MECT:The treatment lasted for 4 months,16 times in total MST:The treatment lasted for 4 months,16 times in total

DEVICE

DBS

Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)

Sponsors & Collaborators

  • Shanghai Mental Health Center

    lead OTHER

Principal Investigators

  • Dengtang Liu, MD · Shanghai Mental Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04528095 on ClinicalTrials.gov