NCT04528095

SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia

Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Treatment-resistant Schizophrenia

Interventions

Type	Name	Description
DRUG	Clozapine	Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d
DEVICE	MECT	MECT:The treatment lasted for 4 months,16 times in total MST:The treatment lasted for 4 months,16 times in total
DEVICE	DBS	Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-08-27
• Last updated: 2020-08-27

Locations

1 site across 1 country: China