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Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia
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.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
No
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Start Date
December 1, 2020
Primary Completion Date
December 1, 2022
Completion Date
December 1, 2022
Last Updated
August 27, 2020
162
ESTIMATED participants
Clozapine
DRUG
MECT
DEVICE
DBS
DEVICE
Lead Sponsor
Shanghai Mental Health Center
NCT03868839
NCT03230864
Data Source & Attribution
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