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SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia

Primary Purpose

Treatment-resistant Schizophrenia

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Clozapine
MECT
DBS
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment-resistant Schizophrenia focused on measuring Schizophrenia, Treatment-resistant, Antipsychotics, Combination

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Clozapine

Clozapine+Amisulpride

Clozapine+Gingke biloba

MECT

MST

DBS

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Response rate
25% or greater change in Positive and Negative Syndrome Scale (PANSS)

Secondary Outcome Measures

Adverse reactions
The Barnes Akathisia Scale (BAS) (0,14,higher scores mean a worse outcome),
Adverse reactions
Simpson-Angus Extrapyramidal Side Effects Scale (SAS) (0,40,higher scores mean a worse outcome)
Adverse reactions
Abnormal Involuntary Movement Scale (AIMS) (0,42,higher scores mean a worse outcome)
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,
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)
Clinical assessements
PANSS (30,210,higher scores mean a worse outcome),
Clinical assessements
Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPS) (0,32,higher scores mean a worse outcome),
Clinical assessements
Calgary Depression Scale for Schizophrenia (CDSS) (0,27,higher scores mean a worse outcome)
Clinical assessements
Clinical Global Impression Scale-Severity (CGI-S) (0,7,higher scores mean a worse outcome)

Full Information

First Posted
August 12, 2020
Last Updated
August 22, 2020
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT04528095
Brief Title
SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia
Official Title
Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment-resistant Schizophrenia
Keywords
Schizophrenia, Treatment-resistant, Antipsychotics, Combination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clozapine
Arm Type
Experimental
Arm Description
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml
Arm Title
Clozapine+Amisulpride
Arm Type
Experimental
Arm Description
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Amisulpride 200-800mg/d
Arm Title
Clozapine+Gingke biloba
Arm Type
Experimental
Arm Description
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Gingke biloba 120-360mg/d
Arm Title
MECT
Arm Type
Experimental
Arm Description
MECT:The treatment lasted for 4 months,16 times in total
Arm Title
MST
Arm Type
Experimental
Arm Description
MST:The treatment lasted for 4 months,16 times in total
Arm Title
DBS
Arm Type
Experimental
Arm Description
Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)
Intervention Type
Drug
Intervention Name(s)
Clozapine
Other Intervention Name(s)
Clozapine+Amisulpride, Clozapine+Gingke biloba
Intervention Description
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d
Intervention Type
Device
Intervention Name(s)
MECT
Other Intervention Name(s)
MST
Intervention Description
MECT:The treatment lasted for 4 months,16 times in total MST:The treatment lasted for 4 months,16 times in total
Intervention Type
Device
Intervention Name(s)
DBS
Intervention Description
Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)
Primary Outcome Measure Information:
Title
Response rate
Description
25% or greater change in Positive and Negative Syndrome Scale (PANSS)
Time Frame
Change from baseline PANSS score at 12 weeks
Secondary Outcome Measure Information:
Title
Adverse reactions
Description
The Barnes Akathisia Scale (BAS) (0,14,higher scores mean a worse outcome),
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Title
Adverse reactions
Description
Simpson-Angus Extrapyramidal Side Effects Scale (SAS) (0,40,higher scores mean a worse outcome)
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Title
Adverse reactions
Description
Abnormal Involuntary Movement Scale (AIMS) (0,42,higher scores mean a worse outcome)
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Title
Neurocognitive assessments and social function
Description
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,
Time Frame
baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months
Title
Neurocognitive assessments and social function
Description
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)
Time Frame
baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months
Title
Clinical assessements
Description
PANSS (30,210,higher scores mean a worse outcome),
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Title
Clinical assessements
Description
Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPS) (0,32,higher scores mean a worse outcome),
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Title
Clinical assessements
Description
Calgary Depression Scale for Schizophrenia (CDSS) (0,27,higher scores mean a worse outcome)
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Title
Clinical assessements
Description
Clinical Global Impression Scale-Severity (CGI-S) (0,7,higher scores mean a worse outcome)
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: meet the DSM-5 diagnostic criteria for schizophrenia, be 18-55 years of age, treatment-resistant schizophrenia:no response to sufficient doses (400-600 mg/ day CPZ equivalent) of at least two antipsychotics in the past 5 years, Informed consent. Exclusion Criteria: Patients with medical or psychiatric comorbidities and those who require concomitant other medications are excluded. Patients with contraindications to even one of the proposed treatment arms are excluded. Patients with risks such as extreme agitation, stupor or suicide are excluded. Female patients with pregnancy or breast-feeding are also excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dengtang Liu, MD
Phone
18017311138
Email
erliu110@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dengtang Liu, MD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

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SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia

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