SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia

Treatment-resistant Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04528095
• Other study ID #: TRS-SMART
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2020
• Est. completion date: December 2022

Study information

• Verified date: August 2020
• Source: Shanghai Mental Health Center
• Contact: Dengtang Liu, MD
• Phone: 18017311138
• Email: erliu110[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia
• Treatment-resistant Schizophrenia

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	25% or greater change in Positive and Negative Syndrome Scale (PANSS)	Change from baseline PANSS score at 12 weeks
Secondary	Adverse reactions	The Barnes Akathisia Scale (BAS) (0,14,higher scores mean a worse outcome),	baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Secondary	Adverse reactions	Simpson-Angus Extrapyramidal Side Effects Scale (SAS) (0,40,higher scores mean a worse outcome)	baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Secondary	Adverse reactions	Abnormal Involuntary Movement Scale (AIMS) (0,42,higher scores mean a worse outcome)	baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Secondary	Neurocognitive assessments and social function	The University of California, San Diego (UCSD) Performance- based Skills Assessment-Brief (UPSA-B) (0,100,higher scores mean a better outcome) is used to evaluate the social function,	baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months
Secondary	Neurocognitive assessments and social function	The MATRICS consensus cognitive battery (MCCB) has been widely used to evaluate cognitive deficits in schizophrenia patients(0%,100%,higher scores mean a better outcome)	baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months
Secondary	Clinical assessements	PANSS (30,210,higher scores mean a worse outcome),	baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Secondary	Clinical assessements	Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPS) (0,32,higher scores mean a worse outcome),	baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Secondary	Clinical assessements	Calgary Depression Scale for Schizophrenia (CDSS) (0,27,higher scores mean a worse outcome)	baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Secondary	Clinical assessements	Clinical Global Impression Scale-Severity (CGI-S) (0,7,higher scores mean a worse outcome)	baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks