Chinese First Episode Schizophrenia's Optimal Dynamic Antipsychotic Treatment Regime
关键词
抽象
描述
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.
日期
| 最后验证: | 01/31/2018 |
| 首次提交: | 02/11/2018 |
| 提交的预估入学人数: | 04/16/2018 |
| 首次发布: | 04/26/2018 |
| 上次提交的更新: | 07/29/2018 |
| 最近更新发布: | 07/31/2018 |
| 实际学习开始日期: | 09/30/2018 |
| 预计主要完成日期: | 08/31/2020 |
| 预计完成日期: | 08/31/2021 |
状况或疾病
干预/治疗
Drug: Olanzapine
Drug: Risperidone
Drug: Amisulpride
Drug: Aripiprazole
Drug: Paliperidone long-acting injection
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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: Amisulpride 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: Aripiprazole 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 |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Change from baseline in Positive and Negative Syndrome Scale [PANSS] [baseline,2 months,4 months and 6 months and 12 months]
次要成果指标
1. Change from baseline in Psychiatric Symptom severity scale (CRDPSS) [baseline,2 months,4 months and 6 months and 12 months]
2. Change from baseline in the Cost inventory [baseline,2 months,4 months and 6 months and 12 months]
3. Change from baseline in overall clinical impression Scale (CGI) [baseline,2 months,4 months and 6 months and 12 months]
