SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia

Shanghai Mental Health Center

Status and phase: Unknown; Phase 3

Conditions: Treatment-resistant Schizophrenia

Treatments: Device: DBS; Drug: Clozapine; Device: MECT

Study type: Interventional

Funder types: Other

Identifiers

NCT04528095

TRS-SMART

Details and patient eligibility

About

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.

Full description

This trial is a sequential multiple-assignment RCT design of antipsychotic drugs, planning to recruit 162 people with treatment-resistant schizophrenia followed for 12 months. The study includes three treatment phases and a naturalistic follow-up phase. Participants who meet the response criteria remain on that treatment for the duration of 12-month treatment. If the participants fail the treatment or can't tolerant the side effects, the patient moves to the next phase of the study to receive a new treatment.

Enrollment: 162 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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162 participants in 6 patient groups

Clozapine

Experimental group

Description:

Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml

Treatment:

Drug: Clozapine

Clozapine+Amisulpride

Experimental group

Description:

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

Treatment:

Drug: Clozapine

Clozapine+Gingke biloba

Experimental group

Description:

Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml Gingke biloba 120-360mg/d

Treatment:

Drug: Clozapine

MECT

Experimental group

Description:

MECT:The treatment lasted for 4 months,16 times in total

Treatment:

Device: MECT

MST

Experimental group

Description:

MST:The treatment lasted for 4 months,16 times in total

Treatment:

Device: MECT

DBS

Experimental group

Description:

Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)

Treatment:

Device: DBS