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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Mental Health Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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