ClinicalTrials.gg
RecruitingNCT06036316TDLRipsyUpdated Mar 27, 2026

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

An interventional study of Language assessment and TLC - Scale for the Assessment of Thought, Language, and Communication in Psychosis, Schizophrenia and At-risk Mental State, sponsored by Centre Psychothérapique de Nancy. Recruiting at 1 site in France. Open to participants aged 16 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Centre Psychothérapique de Nancy · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
16 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psychosis
  • Schizophrenia
  • At-risk Mental State
  • Language Disorders
03

In context

Psychotic Disorders

1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.

This study's planned enrollment of 90 is above the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.

Browse Psychotic Disorders studies →

Lead sponsor

Centre Psychothérapique de Nancy is the lead sponsor of 19 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • 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 · Combination Product: CAST - Cannabis Abuse Screening Test

  • 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 · Behavioral: TLC - Scale for the Assessment of Thought, Language, and Communication · Combination Product: CAST - Cannabis Abuse Screening Test

  • 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 · Behavioral: MINI - Mini International Neuropsychiatric Interview · Combination Product: CAST - Cannabis Abuse Screening Test

Interventions

  • BehavioralLanguage 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.

    Also known as: Speech and language therapy assessment

  • BehavioralTLC - 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

  • BehavioralMINI - 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 productCAST - 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

06

What researchers measure

Primary outcomes

  1. language assessment performance score

    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.

    Time frame: day 1

Secondary outcomes

  1. CAARMS Speech Disorganization Severity Score

    CAARMS: Comprehensive Assessment of At Risk Mental State

    Time frame: day 1

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

    SPI-A:Schizophrenia Proneness Instrument

    Time frame: day 1

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

    TLC: Thinking, Language and Communication Rating Scale

    Time frame: day 1

  4. Neuropsychological rating scales scores (CVLT)

    CVLT (California Verbal Learning test) (quantitative variable): CVLT: number of correct recognitions

    Time frame: day 1

  5. Neuropsychological rating scales scores (CVLT total)

    CVLT (California Verbal Learning test) (quantitative variable): CVLT total: total number of words recalled during the test Recognition

    Time frame: day 1

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

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

    Time frame: day 1

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

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

    Time frame: day 1

  8. Neuropsychological rating scales scores (TAP 1)

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

    Time frame: day 1

  9. Neuropsychological rating scales scores (TAP 2)

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

    Time frame: day 1

  10. Neuropsychological rating scales scores (TAP 3)

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

    Time frame: day 1

  11. Neuropsychological rating scales scores (TAP 4)

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

    Time frame: day 1

  12. Neuropsychological rating scales scores (TAP 5)

    TAP- Divided attention

    Time frame: day 1

  13. Cannabis Abuse Screening Test (CAST) score

    CAST: Cannabis Abuse Screening Test

    Time frame: day 1

07

Study locations

1 of 1 sites recruiting
  • Centre Psychothérapeutique de Nancy
    Laxou, France 54520, France
    Recruiting
08

References and documents

Publications

  • 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. PubMed 23874280 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06036316
Lead sponsor
Centre Psychothérapique de Nancy
Responsible party
Sponsor
First posted
Sep 13, 2023
Start date
Jan 23, 2024
Primary completion
Jan 23, 2026
Completion
Jun 1, 2026 (estimated)
Last update
Mar 27, 2026

Study contacts

Anaëlle PAJAUD
Contact
Anaelle.PAJAUD@cpn-laxou.com
0383260863
Naoual MELLOUKI, PhD
Contact
Naoual.MELLOUKIBENDIMRED@cpn-laxou.com
0383925267
Florent Bernardin, PhD
principal investigator · Centre psychothérapeutique de Nancy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion