Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies: A Multicentric Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Score of the predictive value of the imagery markers.
研究概览
简要总结
Researchers propose in this project to evaluate predictive factors of non response. It is defined by the lack of symptomatic remission at month 3, for patients presenting a first episode of psychosis. It will be performed on objective markers taken from imagery techniques. The link between evolution of these markers and clinical measures will be studied.
详细描述
Recently, radiological markers demonstrated a good capacity to discriminate first episode of psychosis patients, that will show a bad response to treatment. Furthermore, automatic learning methods were recently successfully applied to neurological data, but never for the first episode psychosis patients. These powerful methods are based on multivariate analyses allowing the prediction at an individual stage. The possibility to identify more precisely the population of non-answering patients would allow the adaptation of the support in first attention for these patients, and consequently to perform appropriate cares.
Researchers propose in this project to evaluate predictive factors of non response. It is defined by the lack of symptomatic remission at month 3, for patients presenting a first episode of psychosis. It will be performed on objective markers taken from imagery techniques. The link between evolution of these markers and clinical measures will be studied.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women aged 18-35 years
- •member or beneficiary of a social security scheme,
- •for women, appropriate contraception will be mandatory, as well as a negative pregnancy test,
- •patients with a diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder according to the DMS V
- •having never received anti-psychotic treatment,
- •followed in the hospital or outpatient,
- •having given their written informed consent,
- •that the physical examination revealed no significant clinical abnormalities
排除标准
- •Female patients of childbearing period without effective contraception (oral, intramuscular hormonal, intrauterine device, or surgical);
- •Patients pregnant or nursing;
- •Presenting a serious somatic or neurological disease, especially Parkinson's disease, epilepsy, debilitating tardive dyskinesia, cardiovascular disease, severe liver or kidney;
- •Featuring against-indication for an MRI; including: metallic foreign body eye or intracranial, pacemaker, heart valve, surgical clips, claustrophobia, large tattoo in the upper part of the body, not compatible with 3T MRI
- •Having a history of alcohol or drug abuse in the past year;
- •Participating in another clinical trial or being in an exclusion period of the previous protocol;
- •Patients likely to exhibit aggressive behavior self according to the judgment of the investigators.
研究组 & 干预措施
First episode of psychosis patients
Patients with schizophrenia will be studied in this clinical trial, and that have never received anti-psychotic treatment. They will perform an MRI.
干预措施: MRI (Procedure)
结局指标
主要结局
Score of the predictive value of the imagery markers.
时间窗: Month 3
To evaluate the predictive value of imaging markers (morphological and structural connectivity imaging) for the absence of remission at 3 months in patients with PEP.
次要结局
未报告次要终点