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

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ClinicalTrials.gov Identifier: NCT06036316
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : February 8, 2024
Sponsor:
Information provided by (Responsible Party):
Centre Psychothérapique de Nancy

Study Description
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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.

Condition or disease Intervention/treatment Phase
Psychosis Schizophrenia At-risk Mental State Language Disorders Behavioral: Language assessment Behavioral: TLC - Scale for the Assessment of Thought, Language, and Communication Behavioral: MINI - Mini International Neuropsychiatric Interview Combination Product: CAST - Cannabis Abuse Screening Test Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis
Actual Study Start Date : January 23, 2024
Estimated Primary Completion Date : January 23, 2025
Estimated Study Completion Date : January 23, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: early psychotic symptoms
This group includes patients with ARMS and those with FEP. Although they are not in the same place in the continuum of psychosis, these patients benefit from the same language assessment and CAST, do not benefit from the TLC or the MINI, and the data from their neuropsychological and psychiatric assessment will be used , which is why we have chosen to bring them together in the same arm. They are between 16 and 35 years old and are cared for as part of their usual follow-up at the CPN (Nancy Psychotherapeutic Center). They must have received the diagnosis of ARMS and FEP according to the criteria of CAARMS and SPI-A.
 Behavioral: Language assessment

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 Name: Speech and language therapy assessment

Combination Product: CAST - Cannabis Abuse Screening Test
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
Experimental: patients with schizophrenia
The schizophrenic patients group will benefit from language assessment, TLC and CAST. They are between 18 and 55 years old and are cared for as part of their usual follow-up at the CPN. They must have been diagnosed with schizophrenia according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria.
 Behavioral: Language assessment

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 Name: Speech and language therapy assessment

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

Combination Product: CAST - Cannabis Abuse Screening Test
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
Experimental: healthy controls
The control group for this study will be made up of volunteers between the ages of 16 and 55, not suffering from any mental disorder detected on the MINI or from a developmental disorder of oral or written language. They will also benefit from an assessment of cannabis use using the CAST.
 Behavioral: Language assessment

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 Name: Speech and language therapy assessment

Behavioral: MINI - Mini International Neuropsychiatric Interview
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.

Combination Product: CAST - Cannabis Abuse Screening Test
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06036316


Contacts
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Contact: Anaëlle PAJAUD 0383260863 Anaelle.PAJAUD@cpn-laxou.com
Contact: Naoual MELLOUKI, PhD 0383925267 Naoual.MELLOUKIBENDIMRED@cpn-laxou.com

Locations
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France
Centre Psychothérapeutique de Nancy Recruiting
Laxou, France, 54520
Contact: Florent M Bernardin       Florent.BERNARDIN@cpn-laxou.com   
Contact: Anaëlle PAJAUD       Anaelle.PAJAUD@cpn-laxou.com   
Principal Investigator: Florent BERNARDIN, PhD psy         
Sub-Investigator: Vincent LAPRÉVOTE, Pr.         
Sub-Investigator: Anaëlle PAJAUD, PhD Student         
Sponsors and Collaborators
Centre Psychothérapique de Nancy
Investigators
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Principal Investigator: Florent Bernardin, PhD Centre psychothérapeutique de Nancy
More Information
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Publications:

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Responsible Party: Centre Psychothérapique de Nancy
ClinicalTrials.gov Identifier: NCT06036316    
Other Study ID Numbers: 2023-A00949-36
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: February 8, 2024
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Language Disorders
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
 Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases