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.
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Mental Health Center |
China,
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 |
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