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临床试验/NCT06036316
NCT06036316招募中不适用

Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients with Psychosis

Centre Psychothérapique de Nancy2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年1月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
2
主要终点
language assessment performance score

研究概览

简要总结

This research concerns the study of language disorders of patients present in the spectrum of psychosis. It is indeed accepted that psychotic disorders are associated with language difficulties, which are only poorly highlighted thanks to reusable tools in clinical practice. These language disorders impact communication, and concern many linguistic domains, thus covering phonology, lexicon, semantics, morphosyntax and pragmatics. It therefore seems relevant to characterize these language disorders and to assess to what extent they interact with the other symptoms of the pathology, in particular the course of the thought disorder and the neuropsychological symptoms. In addition, this study is particularly interested in the interactions between working memory capacities and those related to syntax. It is intended for different patients suffering from psychotic disorders of different intensities, treated in the Psychotherapeutic Center of Nancy. Patients suffering from at-risk mental state (ARMS), first episode of psychosis (FEP) or schizophrenia will benefit from a complete language assessment, evaluating each domain mentioned above, on the expressive and understanding sides. The results of the language assessment will be compared with those of a control group in the same tests. They will also be analyzed with regard to the neuropsychological and psychiatric elements noted in the patient's medical file, in order to highlight possible associations between language skills, neuropsychological and psychiatric symptoms in this patient population.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
16 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All Groups:
  • Patient affiliated or entitled to a social security scheme
  • Patient having received informed information on the study and having co-signed, with the investigator, a consent to participate in the study
  • For minor participants, at least one of the parents or holders of parental authority having been informed of the study, having received the information note relating to it and not having objected to the participation of his or her child
  • Native language: French
  • ARMS and FEP Patient Group:
  • Age between 16 and 35 years old
  • Present the criteria for EMRP or FEP as defined by the Comprehensive Assessment of At Risk Mental State (CAARMS) or present the criteria for Disorders of the course of thought to the items of the Schizophrenia Proneness Instrument (SPI-A)
  • Patients with schizophrenia group:
  • Age between 16 and 55 years old
  • Patient with diagnostic criteria for schizophrenia, as defined by DSM V (American Psychiatric Association, 2015)
  • Present the criteria for Disorganization of Speech and Formal Thought Disorder as defined by the Thinking, Language and Communication (TLC) Rating Scale.
  • Healthy Volunteers Group:
  • Age between 16 and 55 years old
  • Parental authorization (of both parents) to participate in the study for minor patients

排除标准

  • All groups:
  • Pregnant, parturient or nursing mother
  • Person deprived of liberty by a judicial or administrative decision
  • Person in a life-threatening emergency
  • Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
  • Adult person unable to express their consent and who is not the subject of a legal protection measure
  • Impairment of the subject making it difficult, if not impossible, for them to participate in the trial or to understand the information given to them
  • Abuse or dependence of any substance according to DSM V criteria excluding cannabis
  • Healthy Volunteers Group:
  • Evolving psychiatric pathology (axis I of the DSM IV, measured at the MINI) excluding anxiety disorder
  • Presence of developmental disorder of oral language or written language revealed on clinical examination.

结局指标

主要结局

language assessment performance score

时间窗: day 1

complete speech therapy assessment evaluating each language domain. and is based on the completion of a speech therapy assessment test and on the assessment of language abilities by the experimental speech therapist.

次要结局

  • Severity score for the disordered items of the course of thought of the SPI-A(day 1)
  • Severity score for speech disorganization and formal thought disorders on the TLC Scale(day 1)
  • Neuropsychological rating scales scores (CVLT total)(day 1)
  • Neuropsychological rating scales scores (Front and back spans)(day 1)
  • CAARMS Speech Disorganization Severity Score(day 1)
  • Neuropsychological rating scales scores (CVLT)(day 1)
  • Neuropsychological rating scales scores (TAP 2)(day 1)
  • Neuropsychological rating scales scores (TAP 1)(day 1)
  • Neuropsychological rating scales scores (Front and back spans 2)(day 1)
  • Neuropsychological rating scales scores (TAP 3)(day 1)
  • Neuropsychological rating scales scores (TAP 5)(day 1)
  • Cannabis Abuse Screening Test (CAST) score(day 1)
  • Neuropsychological rating scales scores (TAP 4)(day 1)

研究者

发起方
Centre Psychothérapique de Nancy
申办方类型
Other
责任方
Sponsor

研究点 (2)

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