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

PHASE3CompletedINTERVENTIONAL
Enrollment

762

Participants

Timeline

Start Date

February 12, 2019

Primary Completion Date

September 27, 2023

Study Completion Date

September 27, 2023

Conditions
Schizophrenia
Interventions
DRUG

Phase 1: Olanzapine

Initial dosage: 5-10 mg; recommended dosage: 5-20 mg/d; dosage form: po. duration: 8 weeks

DRUG

Phase 1: Risperidone

Initial dosage: 1-2 mg; recommended dosage: 2-6 mg/d; dosage form: po. duration: 8 weeks

DRUG

Phase 1: Amisulpride

Initial dosage: 200-400 mg; recommended dosage: 400-1200 mg/d; dosage form: po. duration: 8 weeks

DRUG

Phase 1: Aripiprazole

Initial dosage: 5-10 mg; recommended dosage: 10-30 mg/d; dosage form: po. duration: 8 weeks

DRUG

Phase 1: Perphenazine

Initial dosage: 2-4 mg; recommended dosage: 6-36 mg/d; dosage form: po. duration: 8 weeks

DRUG

Phase 2: Olanzapine

Initial dosage: 5-10 mg; recommended dosage: 5-20 mg/d; dosage form: po. duration: 8 weeks

DRUG

Phase 2: Amisulpride

Initial dosage: 200-400 mg; recommended dosage: 400-1200 mg/d; dosage form: po. duration: 8 weeks

DRUG

Phase 2: Clozapine

Initial dosage: 25-50 mg; recommended dosage: 200-400 mg/d; dosage form: po. duration: 8 weeks

OTHER

Phase 3A: Clozapine extended treatment or Combined clozapine-MECT therapy

"Clozapine extended treatment:~dosage: 200-600 mg/d; dosage form: po.~Combined clozapine-MECT therapy:~Dosage of clozapine: 200-600 mg/d; The modified electroconvulsive therapy (MECT) will be administered three times per week for the first 2 weeks, then twice a week for the next 2 weeks. The total treatment duration is about one month."

DRUG

Phase 3B: Clozapine or another SGAs

"Clozapine:~Initial dosage: 25-50 mg; recommended dosage: 200-600 mg/d; duration: 8 weeks~Another Second generation antipsychotics (SGAs) (not previously used in phase 1 and 2): Olanzapine, risperidone, amisulpride, or aripiprazole The dosage of each drug is the same as that of phase 1 and phase 2."

Trial Locations (7)

100000

Beijing Anding Hospital of Capital Medical University, Beijing

116000

Dalian Seventh People's Hospital, Dalian

200030

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai

210000

Nanjing Brain Hospital Affiliated to Nanjing Medical University, Nanjing

310000

Hangzhou Seventh People's Hospital, Hangzhou

430000

Renmin Hospital of Wuhan University, Wuhan

650000

First Affiliated Hospital of Kunming Medical University, Kunming

All Listed Sponsors
lead

Shanghai Mental Health Center

OTHER

NCT03510325 - Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments(SMART-CAT) | Biotech Hunter | Biotech Hunter