drugset / Trial / NCT03510325

Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments(SMART-CAT)

NCT03510325

Phase 3 Completed 762 enrolled Shanghai Mental Health Center
RandomizedSequentialSingle-blindTreatment

Summary

This study is a sequential multiple-assignment randomized trial (RCT) of antipsychotic medication treatment in first-episode schizophrenia patients in the real-world settings.Through analysis of treatment efficacy rate and adverse reactions and pharmacoeconomic evaluation, this project intends to provide evidence for the selection of antipsychotics in FES patients as well as the efficacy and safety of using clozapine in the early phase of schizophrenia treatment by comparing with other SGAs.

Timeline

Start
2019-02-12
Primary completion
2023-09-27
Completion
2023-09-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Amisulpride Small molecule 400 mg
Subject Amisulpride Small molecule 1200 mg
Subject Aripiprazole Other / unclassified 10 mg
Subject Aripiprazole Other / unclassified 30 mg
Subject Clozapine Other / unclassified 200 mg Oral
Subject Clozapine Other / unclassified 400 mg Oral
Subject Clozapine Other / unclassified 600 mg Oral
Subject Olanzapine Small molecule 5 mg Oral
Subject Olanzapine Small molecule 20 mg Oral
Subject Perphenazine Small molecule 6 mg
Subject Perphenazine Small molecule 36 mg
Subject Risperidone Other / unclassified 2 mg
Subject Risperidone Other / unclassified 6 mg

Indications