Clinical trial NCT06036316: Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis
Official title: Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Schizophrenia
At-risk Mental State
Language Disorders
Lead sponsor: Centre Psychothérapique de Nancy
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: language assessment performance score
timeFrame: day 1
Secondary outcomes:
measure: CAARMS Speech Disorganization Severity Score
timeFrame: day 1
measure: Severity score for the disordered items of the course of thought of the SPI-A
timeFrame: day 1
measure: Severity score for speech disorganization and formal thought disorders on the TLC Scale
timeFrame: day 1
measure: Neuropsychological rating scales scores (CVLT)
timeFrame: day 1
measure: Neuropsychological rating scales scores (CVLT total)
timeFrame: day 1
measure: Neuropsychological rating scales scores (Front and back spans)
timeFrame: day 1
measure: Neuropsychological rating scales scores (Front and back spans 2)
timeFrame: day 1
measure: Neuropsychological rating scales scores (TAP 1)
timeFrame: day 1
measure: Neuropsychological rating scales scores (TAP 2)
timeFrame: day 1
measure: Neuropsychological rating scales scores (TAP 3)
timeFrame: day 1
measure: Neuropsychological rating scales scores (TAP 4)
timeFrame: day 1
measure: Neuropsychological rating scales scores (TAP 5)
timeFrame: day 1
measure: Cannabis Abuse Screening Test (CAST) score
timeFrame: day 1
Other outcomes:
Locations:
city: Laxou
country: France
facility: Centre Psychothérapeutique de Nancy
Study officials:
affiliation: Centre psychothérapeutique de Nancy
name: Florent Bernardin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Majerus S. Language repetition and short-term memory: an integrative framework. Front Hum Neurosci. 2013 Jul 12;7:357. doi: 10.3389/fnhum.2013.00357. eCollection 2013.