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Chinese First Episode Schizophrenia's Optimal Dynamic Antipsychotic Treatment Regime

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Olanzapine
Risperidone
Aripiprazole
Amisulpride
Paliperidone long-acting injection
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia; Antipsychotics；Cost-Effectiveness Analyses

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meet the diagnostic criteria of Diagnostic and Statistical Manual Diploma in Social Medicine(DSM-V) schizophrenia or schizophreniform psychosis
  • Patient interview using the MINI-International Neuropsychiatric Interview(MINI 7.0)
  • 18 to 40 years of age
  • First episode, disease course less than 3 years
  • Antipsychotic naïve, or the time of taking the same type of antipsychotic <2 weeks (2 weeks is a time criterion to determine the efficacy in lots of studies), and cumulative antipsychotic drug exposure time <6 weeks Informed consent.

In addition, the severity of psychiatric symptoms is moderate or above, the specific criteria are:

  • All patients have a score ≥4 on at least one Positive and Negative Syndrome Scale (PANSS; 17) psychosis item (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, or suspiciousness/persecution)
  • All patients have a score ≥4 (moderately ill) on the severity item of the Clinical Global Impression scale (CGI; 19) at the point of maximum severity of illness to date

Exclusion Criteria:

  • organic disease
  • severe physical illness
  • psychoactive substance dependence
  • mental retardation
  • pregnancy or breast-feeding patients
  • extreme agitation, stupor, negative suicide
  • other non-cooperation or risk patients

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 Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Olanzapine

Risperidone

Amisulpride

Aripiprazole

Paliperidone long-acting injection

Arm Description

dosage form:po dosage:5-20mg frequency:qn duration:If the drug is effective, it can be taken for a long time. If the drug is ineffective or the side effect is too difficult to tolerate, the drug should be changed according to the treatment stage.

dosage form:po dosage:4-6mg frequency:2 doses duration:If the drug is effective, it can be taken for a long time. If the drug is ineffective or the side effect is too difficult to tolerate, the drug should be changed according to the treatment stage.

dosage form:po dosage:0.4-1.2g frequency:2 doses duration:If the drug is effective, it can be taken for a long time. If the drug is ineffective or the side effect is too difficult to tolerate, the drug should be changed according to the treatment stage.

dosage form:po dosage:15-30mg frequency:qd duration:If the drug is effective, it can be taken for a long time. If the drug is ineffective or the side effect is too difficult to tolerate, the drug should be changed according to the treatment stage.

dosage form:im dosage:75-150mg frequency:once a month duration:If the drug is effective, it can be taken for a long time. If the drug is ineffective or the side effect is too difficult to tolerate, the drug should be changed according to the treatment stage.

Outcomes

Primary Outcome Measures

Change from baseline in Positive and Negative Syndrome Scale [PANSS]
Reduction to the PANSS total score≥50%

Secondary Outcome Measures

Change from baseline in Psychiatric Symptom severity scale (CRDPSS)
Psychiatric Symptom severity scale (CRDPSS)
Change from baseline in the Cost inventory
Cost inventory
Change from baseline in overall clinical impression Scale (CGI)
overall clinical impression Scale (CGI)

Full Information

First Posted
February 12, 2018
Last Updated
July 30, 2018
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT03510325
Brief Title
Chinese First Episode Schizophrenia's Optimal Dynamic Antipsychotic Treatment Regime
Official Title
Estimating the Optimal Dynamic Antipsychotic Treatment Regime: Sequential Multiple-assignment Randomized Clinical Antipsychotic Trials in Chinese Patients With First-episode Psychosis.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Anticipated)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
September 1, 2021 (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
Yes

5. Study Description

Brief Summary
This project is mainly to clarify the optimal treatment plan and the treatment recommendation sequence of different drugs in Chinese first-episode schizophrenia patients,to identify the optimized sequential treatment regimen for the treatment of resistance patients and provide new evidence for the revision of the guidelines for the treatment of schizophrenia.
Detailed Description
This project will be a large sample, multi-center clinical trials for first episode schizophrenia. We plan to get a clear initial regimen and the drug recommendation in the treatment of first episode schizophrenia in China, based on the efficacy, adverse effect and pharmacoeconomics evaluation for the most widely used antipsychotic drugs (amisulpride, risperidone, olanzapine, aripiprazole ) and paliperidone injection. We will carry out sequential treatment trials in first-episode treatment resistant patients (Phase 2: Randomized controlled trials of other antipsychotic drugs that are not used in Phase 1 and paliperidone injection; Phase 3: Clozapine monotherapy, oral administration of other drugs or long-acting injection in treatment; Phase 4: Clozapine combination therapy or any combination of two other antipsychotics), so that we could get a better sequential treatment protocol based on the therapeutic outcome. The current project has great clinical significance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia; Antipsychotics；Cost-Effectiveness Analyses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Model Description
"Real-World" Study Based on SMART Design: Subjects were arranged according to patient's wishes and randomized allocation. Next phase of treatment was determined based on the patient's response (efficacy and adverse reactions). We could not achieve double blind designed protocol; however, assessor's blindness could be achieved in the design.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Olanzapine
Arm Type
Experimental
Arm Description
dosage form:po dosage:5-20mg frequency:qn duration:If the drug is effective, it can be taken for a long time. If the drug is ineffective or the side effect is too difficult to tolerate, the drug should be changed according to the treatment stage.
Arm Title
Risperidone
Arm Type
Experimental
Arm Description
dosage form:po dosage:4-6mg frequency:2 doses duration:If the drug is effective, it can be taken for a long time. If the drug is ineffective or the side effect is too difficult to tolerate, the drug should be changed according to the treatment stage.
Arm Title
Amisulpride
Arm Type
Experimental
Arm Description
dosage form:po dosage:0.4-1.2g frequency:2 doses duration:If the drug is effective, it can be taken for a long time. If the drug is ineffective or the side effect is too difficult to tolerate, the drug should be changed according to the treatment stage.
Arm Title
Aripiprazole
Arm Type
Experimental
Arm Description
dosage form:po dosage:15-30mg frequency:qd duration:If the drug is effective, it can be taken for a long time. If the drug is ineffective or the side effect is too difficult to tolerate, the drug should be changed according to the treatment stage.
Arm Title
Paliperidone long-acting injection
Arm Type
Experimental
Arm Description
dosage form:im dosage:75-150mg frequency:once a month duration:If the drug is effective, it can be taken for a long time. If the drug is ineffective or the side effect is too difficult to tolerate, the drug should be changed according to the treatment stage.
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
Commonly used oral antipsychotics intervention therapy.
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
Commonly used oral antipsychotics intervention therapy.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
Commonly used oral antipsychotics intervention therapy.
Intervention Type
Drug
Intervention Name(s)
Amisulpride
Intervention Description
Commonly used oral antipsychotics intervention therapy.
Intervention Type
Drug
Intervention Name(s)
Paliperidone long-acting injection
Intervention Description
long-acting injection
Primary Outcome Measure Information:
Title
Change from baseline in Positive and Negative Syndrome Scale [PANSS]
Description
Reduction to the PANSS total score≥50%
Time Frame
baseline,2 months,4 months and 6 months and 12 months
Secondary Outcome Measure Information:
Title
Change from baseline in Psychiatric Symptom severity scale (CRDPSS)
Description
Psychiatric Symptom severity scale (CRDPSS)
Time Frame
baseline,2 months,4 months and 6 months and 12 months
Title
Change from baseline in the Cost inventory
Description
Cost inventory
Time Frame
baseline,2 months,4 months and 6 months and 12 months
Title
Change from baseline in overall clinical impression Scale (CGI)
Description
overall clinical impression Scale (CGI)
Time Frame
baseline,2 months,4 months and 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet the diagnostic criteria of Diagnostic and Statistical Manual Diploma in Social Medicine(DSM-V) schizophrenia or schizophreniform psychosis Patient interview using the MINI-International Neuropsychiatric Interview(MINI 7.0) 18 to 40 years of age First episode, disease course less than 3 years Antipsychotic naïve, or the time of taking the same type of antipsychotic <2 weeks (2 weeks is a time criterion to determine the efficacy in lots of studies), and cumulative antipsychotic drug exposure time <6 weeks Informed consent. In addition, the severity of psychiatric symptoms is moderate or above, the specific criteria are: All patients have a score ≥4 on at least one Positive and Negative Syndrome Scale (PANSS; 17) psychosis item (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, or suspiciousness/persecution) All patients have a score ≥4 (moderately ill) on the severity item of the Clinical Global Impression scale (CGI; 19) at the point of maximum severity of illness to date Exclusion Criteria: organic disease severe physical illness psychoactive substance dependence mental retardation pregnancy or breast-feeding patients extreme agitation, stupor, negative suicide other non-cooperation or risk patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dengtang Liu, M.d.
Phone
+8618017311138
Email
erliu110@126.com
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

Plan to Share IPD
No
Citations:
PubMed Identifier
33279374
Citation
Li X, Guo X, Fan X, Feng T, Wang C, Yao Z, Xu X, Chen Z, Wang H, Xie S, He J, Zhuo K, Xiang Q, Cen H, Wang J, Smith RC, Jin H, Keshavan MS, Marder SR, Davis JM, Jiang K, Xu Y, Liu D. Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments (SMART-CAT) in first-episode schizophrenia patients: Rationale and trial design. Schizophr Res. 2021 Apr;230:87-94. doi: 10.1016/j.schres.2020.11.010. Epub 2020 Dec 2.
Results Reference
derived

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Chinese First Episode Schizophrenia's Optimal Dynamic Antipsychotic Treatment Regime

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