SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Mental Health Center
• Treatments: Amisulpride; Clozapine

Criteria

Inclusion Criteria:

1. meet the DSM-5 diagnostic criteria for schizophrenia,

2. be 18-55 years of age,

3. treatment-resistant schizophrenia:no response to sufficient doses (400-600 mg/ day CPZ equivalent) of at least two antipsychotics in the past 5 years,

4. Informed consent.

Exclusion Criteria:

1. Patients with medical or psychiatric comorbidities and those who require concomitant other medications are excluded.

2. Patients with contraindications to even one of the proposed treatment arms are excluded.

3. Patients with risks such as extreme agitation, stupor or suicide are excluded.

4. Female patients with pregnancy or breast-feeding are also excluded.