SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000036891

Enrollment

Unknown

Registered

2020-08-25

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

Clozapine:Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d

Clozapine+Amisulpride:Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Amisulpride 200-800mg/d

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Meet the DSM-5 diagnostic criteria for schizophrenia; 2. Aged 18 to 55 years; 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

Exclusion criteria: 1. Patients with medical or psychiatric comorbidities and those who require concomitant other medications; 2. Patients with contraindications to even one of the proposed treatment arms; 3. Patients with risks such as extreme agitation, stupor or suicide; 4. Female patients with pregnancy or breast-feeding.

Design outcomes

Primary

Measure	Time frame
Response rate;	—

Secondary

Measure	Time frame
Clinical assessements;Neurocognitive assessments and social function ;	—

Countries

China

Contacts

Public ContactDengTang Liu

Shanghai Mental Health Mental

erliu110@163.com+86 18017311138

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026