SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia

August 22, 2020 updated by: Shanghai Mental Health Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

162

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clozapine
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml
Drug: Clozapine
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d
Other Names:
  • Clozapine+Amisulpride
  • Clozapine+Gingke biloba
Experimental: Clozapine+Amisulpride
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Amisulpride 200-800mg/d
Drug: Clozapine
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d
Other Names:
  • Clozapine+Amisulpride
  • Clozapine+Gingke biloba
Experimental: Clozapine+Gingke biloba
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Gingke biloba 120-360mg/d
Drug: Clozapine
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d
Other Names:
  • Clozapine+Amisulpride
  • Clozapine+Gingke biloba
Experimental: MECT
MECT:The treatment lasted for 4 months,16 times in total
Device: MECT
MECT:The treatment lasted for 4 months,16 times in total MST:The treatment lasted for 4 months,16 times in total
Other Names:
  • MST
Experimental: MST
MST:The treatment lasted for 4 months,16 times in total
Device: MECT
MECT:The treatment lasted for 4 months,16 times in total MST:The treatment lasted for 4 months,16 times in total
Other Names:
  • MST
Experimental: DBS
Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)
Device: DBS
Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: Change from baseline PANSS score at 12 weeks
25% or greater change in Positive and Negative Syndrome Scale (PANSS)
Change from baseline PANSS score at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse reactions
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
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
Adverse reactions
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
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
Adverse reactions
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
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
Neurocognitive assessments and social function
Time Frame: baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months
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
Neurocognitive assessments and social function
Time Frame: baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months
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
Clinical assessements
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
PANSS (30,210,higher scores mean a worse outcome),
baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Clinical assessements
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
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
Clinical assessements
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
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
Clinical assessements
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Investigators

  • Study Chair: Dengtang Liu, MD, Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

August 12, 2020

First Submitted That Met QC Criteria

August 22, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Actual)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 22, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRS-SMART

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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