Chinese First Episode Schizophrenia's Optimal Dynamic Antipsychotic Treatment Regime

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03510325
• Other study ID #: CRC2017ZD03
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: February 2018
• Source: Shanghai Mental Health Center
• Contact: Dengtang Liu, M.d.
• Phone: +8618017311138
• Email: erliu110[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1260
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Olanzapine
Commonly used oral antipsychotics intervention therapy.
• Risperidone
Commonly used oral antipsychotics intervention therapy.
• Aripiprazole
Commonly used oral antipsychotics intervention therapy.
• Amisulpride
Commonly used oral antipsychotics intervention therapy.
• Paliperidone long-acting injection
long-acting injection

Locations

Country	Name	City	State
China	Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Positive and Negative Syndrome Scale [PANSS]	Reduction to the PANSS total score=50%	baseline,2 months,4 months and 6 months and 12 months
Secondary	Change from baseline in Psychiatric Symptom severity scale (CRDPSS)	Psychiatric Symptom severity scale (CRDPSS)	baseline,2 months,4 months and 6 months and 12 months
Secondary	Change from baseline in the Cost inventory	Cost inventory	baseline,2 months,4 months and 6 months and 12 months
Secondary	Change from baseline in overall clinical impression Scale (CGI)	overall clinical impression Scale (CGI)	baseline,2 months,4 months and 6 months and 12 months