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临床试验/NCT05384392
NCT05384392招募中不适用

Biomarkers Predictive of Thymic Evolution and Therapeutic Response at 2 Years in Patients With a First Psychotic Episode

University Hospital, Brest11 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2025年3月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
217
试验地点
11
主要终点
Evaluation of thymic evolution

研究概览

简要总结

Psychosis is a severe, common, and disabling psychological disorder. An epidemiological study conducted in England reported an incidence of 34 new cases per 100,000 person-years, with a peak between 16 and 19 years of age. Following a first psychotic episode, two clinical evolutions are possible: thymic psychosis (17%) and non thymic psychosis (83%). The first includes bipolar disorders with a psychotic component and major depressive disorders with a psychotic component; the second, other psychotic disorders, mainly schizophrenia. One of the major difficulties encountered is the frequent impossibility of specifying the type of psychosis at the beginning of the psychotic episode. However, these disorders require different therapies, particularly medication. This leads to a delay in diagnosis with a high risk of relapse.

The semiological study of these diseases being carried out within the framework of interviews, it seems interesting to be able to record these and to obtain a quantitative and objective measurement through the study of language. The use of machine learning has made it possible to distinguish patients with schizophrenia from those with bipolar disorder by graphical analysis of language in a more efficient way than with clinical scales.Moreover, it is possible to identify linguistic markers: thus, an alteration of syntactic structures and prosody would be more present in non-thymic than in thymic psychoses.

Paraclinical markers are also emerging. In particular, the link between inflammation and mental disorders.For example, an increase in IL-8 has been found only in thymic psychoses.

In this context, it seems essential to be able to distinguish these disorders as early as possible through the combined use of clinical and paraclinical markers, and to be able to better understand their pathophysiology.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
15 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with a first episode of psychosis,
  • Aged between 15 and 30 years,
  • Able to consent and having signed a consent form (parental consent for minors).

排除标准

  • Introduction or increase of antipsychotic and/or antidepressant and/or thymoregulatory treatment in the last month,
  • Mother tongue other than French,
  • Psychotic episode due to an organic disorder,
  • Psychotic episode induced by the use or withdrawal of toxic substances with severe dependence ,
  • Intellectual deficit,
  • Chronic inflammatory disease,
  • Immunomodulatory treatment,
  • Contraindication to MRI,
  • Pregnant or breastfeeding woman,
  • Patient under court protection, guardianship, curatorship or deprived of liberty.

研究组 & 干预措施

Intervention

Experimental

All patients included in the study will be required to complete the examinations specified in the protocol.

干预措施: Recorded interview (Other)

Intervention

Experimental

All patients included in the study will be required to complete the examinations specified in the protocol.

干预措施: Clinical scales (Other)

Intervention

Experimental

All patients included in the study will be required to complete the examinations specified in the protocol.

干预措施: Blood sample (Biological)

结局指标

主要结局

Evaluation of thymic evolution

时间窗: Day 0, Year 2

The primary endpoint is the thymic evolution (yes or no) of the initial psychotic episode The prosodic linguistic markers (fundamental frequency and latency) will be measured at Day 0 during a routine clinical interview and wil enable to build a predictive model to predict the thymic evolution at 2 years in patients with a first psychotic episode. This is main objective of study. The assessment will be measured the answer yes or no, at 2 years, at question, is the psychotic episode a thymic disorder?".

次要结局

  • Evaluation of thymic evolution according syntactic linguistic markers(Day 0)
  • Evaluation of thymic evolution according semantic linguistic markers(Day 0)
  • Inflammatory markers(Day 0)
  • Evaluation of thymic evolution according PANSS(Day 0, Year 1, Year 2)
  • Evaluation of thymic evolution according BPRS(Day 0, Year 1, Year 2)
  • Evaluation of thymic evolution according CDSS(Day 0, Year 1, Year 2)
  • Evaluation of thymic evolution according MADRS(Day 0, Year 1, Year 2)
  • Evaluation of thymic evolution according Altman(Day 0, Year 1, Year 2)
  • Evaluation of thymic evolution according YMRS(Day 0, Year 1, Year 2)
  • Evaluation of thymic evolution according CGI(Day 0, Year 1, Year 2)
  • Evaluation of thymic evolution according GAF(Day 0, Year 1, Year 2)
  • Evaluation of thymic evolution according SF-36(Day 0, Year 1, Year 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (11)

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