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NCT Number: NCT06036316

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

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.

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Key information

Conditions

Psychosis At-risk Mental State Communication Disorders Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Psychothérapeutique de Nancy

Laxou, France, 54520

Location status: Recruiting

Location contact

Anaëlle PAJAUD

CONTACT

[email protected]

Anaëlle PAJAUD, PhD Student

SUB_INVESTIGATOR

Florent BERNARDIN, PhD psy

PRINCIPAL_INVESTIGATOR

Florent M Bernardin

CONTACT

[email protected]

Vincent LAPRÉVOTE, Pr.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Language assessment

Behavioral

The proposed speech and language therapy assessment will consist of a battery of standardized tests that speech and language therapists can use to assess the language skills in reception and expression of adult patients.

Concerning the assessment of the interactions between working memory and semantic abilities, a complete protocol has been developed.

Other names: Speech and language therapy assessment

TLC - Scale for the Assessment of Thought, Language, and Communication

Behavioral

This scale is frequently used in psychiatry and is used to measure formal thought disorders in patients suffering from psychosis. As part of this study, it will be intended for patients suffering from schizophrenia

MINI - Mini International Neuropsychiatric Interview

Behavioral

This scale corresponds to a rapid assessment of the psychiatric and psychological state of patients. It helps detect any psychiatric disorders. Here, it will be offered to volunteers who are part of the control group.

CAST - Cannabis Abuse Screening Test

Combination Product

The purpose of this questionnaire is to approximate participants' cannabis consumption and to assess any disorders associated with cannabis consumption. It will be offered to all participants, patients and healthy controls

Primary outcomes

  1. language assessment performance score

    Time frame: 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.

Secondary outcomes

  1. CAARMS Speech Disorganization Severity Score

    Time frame: day 1

    CAARMS: Comprehensive Assessment of At Risk Mental State

  2. Severity score for the disordered items of the course of thought of the SPI-A

    Time frame: day 1

    SPI-A:Schizophrenia Proneness Instrument

  3. Severity score for speech disorganization and formal thought disorders on the TLC Scale

    Time frame: day 1

    TLC: Thinking, Language and Communication Rating Scale

  4. Neuropsychological rating scales scores (CVLT)

    Time frame: day 1

    CVLT (California Verbal Learning test) (quantitative variable):

    CVLT: number of correct recognitions

  5. Neuropsychological rating scales scores (CVLT total)

    Time frame: day 1

    CVLT (California Verbal Learning test) (quantitative variable):

    CVLT total: total number of words recalled during the test Recognition

  6. Neuropsychological rating scales scores (Front and back spans)

    Time frame: day 1

    Front and back spans (quantitative variable) Front span size (number of digits recalled in front order)

  7. Neuropsychological rating scales scores (Front and back spans 2)

    Time frame: day 1

    Front and back spans (quantitative variable) Reverse span size (number of digits recalled in reverse order)

  8. Neuropsychological rating scales scores (TAP 1)

    Time frame: day 1

    TAP- Working Memory :Number of omissions TAP(Test of Attentional Performance) (quantitative variable)

  9. Neuropsychological rating scales scores (TAP 2)

    Time frame: day 1

    TAP- Sustained attention :Number of omissions TAP(Test of Attentional Performance) (quantitative variable)

  10. Neuropsychological rating scales scores (TAP 3)

    Time frame: day 1

    TAP- Flexibility :Number of errors TAP(Test of Attentional Performance) (quantitative variable)

  11. Neuropsychological rating scales scores (TAP 4)

    Time frame: day 1

    TAP- Incompatibility TAP(Test of Attentional Performance) (quantitative variable)

  12. Neuropsychological rating scales scores (TAP 5)

    Time frame: day 1

    TAP- Divided attention

  13. Cannabis Abuse Screening Test (CAST) score

    Time frame: day 1

    CAST: Cannabis Abuse Screening Test

Study contacts

Contact information is provided by the study sponsor or research team.

Anaëlle PAJAUD

CONTACT

[email protected]

0383260863

Naoual MELLOUKI, PhD

CONTACT

[email protected]

0383925267

Sponsors and collaborators

Lead sponsor

Centre Psychothérapique de Nancy

Other

Registry information

Acronym: TDLRipsy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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