SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia

Sponsor
Shanghai Mental Health Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04528095
Collaborator
(none)
162
1
6
24
6.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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)

    Outcome Measures

    Primary Outcome Measures

    1. Response rate [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200030

    Sponsors and Collaborators

    • Shanghai Mental Health Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Mental Health Center
    ClinicalTrials.gov Identifier:
    NCT04528095
    Other Study ID Numbers:
    • TRS-SMART
    First Posted:
    Aug 27, 2020
    Last Update Posted:
    Aug 27, 2020
    Last Verified:
    Aug 1, 2020
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 27, 2020