Chinese First Episode Schizophrenia's Optimal Dynamic Antipsychotic Treatment Regime

July 30, 2018 updated by: Shanghai Mental Health Center

Estimating the Optimal Dynamic Antipsychotic Treatment Regime: Sequential Multiple-assignment Randomized Clinical Antipsychotic Trials in Chinese Patients With First-episode Psychosis.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1260

Phase

  • Phase 4

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

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olanzapine
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.
Drug: Olanzapine
Commonly used oral antipsychotics intervention therapy.
Experimental: Risperidone
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.
Drug: Risperidone
Commonly used oral antipsychotics intervention therapy.
Experimental: Amisulpride
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.
Drug: Aripiprazole
Commonly used oral antipsychotics intervention therapy.
Experimental: Aripiprazole
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.
Drug: Amisulpride
Commonly used oral antipsychotics intervention therapy.
Experimental: Paliperidone long-acting injection
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.
Drug: Paliperidone long-acting injection
long-acting injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Positive and Negative Syndrome Scale [PANSS]
Time Frame: baseline,2 months,4 months and 6 months and 12 months
Reduction to the PANSS total score≥50%
baseline,2 months,4 months and 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Psychiatric Symptom severity scale (CRDPSS)
Time Frame: baseline,2 months,4 months and 6 months and 12 months
Psychiatric Symptom severity scale (CRDPSS)
baseline,2 months,4 months and 6 months and 12 months
Change from baseline in the Cost inventory
Time Frame: baseline,2 months,4 months and 6 months and 12 months
Cost inventory
baseline,2 months,4 months and 6 months and 12 months
Change from baseline in overall clinical impression Scale (CGI)
Time Frame: baseline,2 months,4 months and 6 months and 12 months
overall clinical impression Scale (CGI)
baseline,2 months,4 months and 6 months and 12 months

Collaborators and Investigators

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

Sponsor

Shanghai Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2018

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

February 12, 2018

First Submitted That Met QC Criteria

April 17, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC2017ZD03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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