drugset / Trial / NCT03510325
Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments(SMART-CAT)
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
Publications
- Li X, Lu C, Zhai Z, Smith RC, Zhang S, Wang H, Wang C, Yao Z, Chen Z, Xu X, Xie S, Feng T, Gao T, Dong Y, Zhuo K, Xiang Q, Jin H, Davis JM, Jiang K, Xu Y, Leucht S, Liu D. Clozapine After 1 Failed Antipsychotic Drug Trial in First-Episode Psychosis: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Jun 1;83(6):570-580. doi: 10.1001/jamapsychiatry.2026.0086.
- Li X, Guo X, Fan X, Feng T, Wang C, Yao Z, Xu X, Chen Z, Wang H, Xie S, He J, Zhuo K, Xiang Q, Cen H, Wang J, Smith RC, Jin H, Keshavan MS, Marder SR, Davis JM, Jiang K, Xu Y, Liu D. Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments (SMART-CAT) in first-episode schizophrenia patients: Rationale and trial design. Schizophr Res. 2021 Apr;230:87-94. doi: 10.1016/j.schres.2020.11.010. Epub 2020 Dec 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |