Open-label, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Aripiprazole vs Paliperidone/Risperidone Using Multi-omics Data in Patients With a First Episode Psychosis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 244
- 主要终点
- Number of patients with a therapeutic response to aripiprazole or paliperidone
研究概览
简要总结
SchizOMICS is a Phase IV, multicenter, dose-flexible, open-label, randomized controlled clinical trial to evaluate the efficacy and safety of aripiprazole versus paliperidone using multi-omics data in patients with a first psychotic episode. The trial will include a total of 244 patients, with two arms of treatment with paliperidone and aripiprazole (1:1).
The main objectives of the study are:
- To compare the efficacy and safety of aripiprazole and paliperidone in the treatment of first episode psychosis (FEP) subjects in real-world clinical settings at 3 months.
- To elucidate whether non-responders after 3 months of adequate treatment may display different molecular signatures at baseline based on multi omics data and systems biology analysis.
- To uncover whether the appearance of side effects after 1 year of adequate treatment may be related to different molecular signatures based on multi-omics data and lifestyle phenotype using systems biology analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •15-40 years;
- •living in the catchment area;
- •experiencing a first episode of psychosis;
- •no prior treatment with antipsychotic medication or, if previously treated, a total lifetime of adequate antipsychotic treatment of less than 6 weeks;
- •Diagnostic and Statistical Manual of Mental Disorders fth Edition (DSM-5) criteria for schizophreniform disorder, schizophrenia, or schizoaffective disorder.
排除标准
- •meeting DSM-5 criteria for drug dependence;
- •meeting DSM-IV criteria for mental retardation;
- •having a history of neurological disease or head injury.
研究组 & 干预措施
First episode of psychosis patients
Operational definition for a "first episode of psychosis" included individuals with a non-affective psychosis who have not received previous antipsychotic treatment regardless of the duration of psychosis.
干预措施: Aripiprazole (Drug)
First episode of psychosis patients
Operational definition for a "first episode of psychosis" included individuals with a non-affective psychosis who have not received previous antipsychotic treatment regardless of the duration of psychosis.
干预措施: Paliperidone (Drug)
结局指标
主要结局
Number of patients with a therapeutic response to aripiprazole or paliperidone
时间窗: 3 months
Considering response as Clinical Global Impression severity scale for schizophrenia (ICG-ESQ-SI) \< 4 points. ICG-ESQ-SI is a test made of 5 items that are scored from 1 (absent) to 7 (extreme).
次要结局
- Number of patients with changes in negative symptoms(12 months)
- Number of patients with changes in depressive symptoms(12 months)
- Number of patients with changes in functionality(12 months)
- Number of patients with changes in quality of life(12 months)
- Number of patients with side effects(12 months)