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SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia

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ClinicalTrials.gov Identifier: NCT04528095
Recruitment Status : Not yet recruiting
First Posted : August 27, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Mental Health Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Treatment-resistant Schizophrenia Drug: Clozapine Device: MECT Device: DBS Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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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 Name: 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 Name: 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)


Outcome Measures
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Primary Outcome Measures :
  1. Response rate [ Time Frame: Change from baseline PANSS score at 12 weeks ]
    25% or greater change in Positive and Negative Syndrome Scale (PANSS)


Secondary Outcome Measures :
  1. 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),

  2. 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)

  3. 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)

  4. 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,

  5. 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)

  6. 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),

  7. 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),

  8. 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)

  9. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528095


Contacts
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Contact: Dengtang Liu, MD 18017311138 erliu110@163.com

Locations
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China, Shanghai
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200030
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
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Study Chair: Dengtang Liu, MD Shanghai Mental Health Center
More Information
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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT04528095    
Other Study ID Numbers: TRS-SMART
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Mental Health Center:
Schizophrenia
Treatment-resistant
Antipsychotics
Combination
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Clozapine
Amisulpride
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents