PsychosisTDLRipsyNCT06036316
Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis
A study testing Language assessment, TLC - Scale for the Assessment of Thought, Language, and Communication and MINI - Mini International Neuropsychiatric Interview in people with Psychosis and Schizophrenia, run by Centre Psychothérapique de Nancy at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosis, Schizophrenia, At-risk Mental State
- What is being tested?
- Language assessment, TLC - Scale for the Assessment of Thought, Language, and Communication and MINI - Mini International Neuropsychiatric Interview
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Psychothérapeutique de Nancy
Laxou, France, 54520
Florent M Bernardin, Florent.BERNARDIN@cpn-laxou.com
Anaëlle PAJAUD, Anaelle.PAJAUD@cpn-laxou.com
About this study
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.
- Conditions
- Psychosis, Schizophrenia, At-risk Mental State, Language Disorders
- Being tested
- Language assessment, TLC - Scale for the Assessment of Thought, Language, and Communication, MINI - Mini International Neuropsychiatric Interview, CAST - Cannabis Abuse Screening Test
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Language assessmentBehavioural
Also called Speech and language therapy 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.
TLC - Scale for the Assessment of Thought, Language, and CommunicationBehavioural
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 InterviewBehavioural
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 TestCombination 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
| Study group | Role | What they receive |
|---|---|---|
| early psychotic symptoms | Experimental | 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. Receives: Behavioral: Language assessment; Combination Product: CAST - Cannabis Abuse Screening Test |
| patients with schizophrenia | Experimental | 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. Receives: Behavioral: Language assessment; Behavioral: TLC - Scale for the Assessment of Thought, Language, and Communication; Combination Product: CAST - Cannabis Abuse Screening Test |
| healthy controls | Experimental | 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. Receives: Behavioral: Language assessment; Behavioral: MINI - Mini International Neuropsychiatric Interview; Combination Product: CAST - Cannabis Abuse Screening Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1
Secondary outcomes (13)
CAARMS Speech Disorganization Severity Score
CAARMS: Comprehensive Assessment of At Risk Mental State
Measured: day 1
Severity score for the disordered items of the course of thought of the SPI-A
SPI-A:Schizophrenia Proneness Instrument
Measured: day 1
Severity score for speech disorganization and formal thought disorders on the TLC Scale
TLC: Thinking, Language and Communication Rating Scale
Measured: day 1
Neuropsychological rating scales scores (CVLT)
CVLT (California Verbal Learning test) (quantitative variable):
CVLT: number of correct recognitions
Measured: day 1
Neuropsychological rating scales scores (CVLT total)
CVLT (California Verbal Learning test) (quantitative variable):
CVLT total: total number of words recalled during the test Recognition
Measured: day 1
Neuropsychological rating scales scores (Front and back spans)
Front and back spans (quantitative variable) Front span size (number of digits recalled in front order)
Measured: day 1
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)
Measured: day 1
Neuropsychological rating scales scores (TAP 1)
TAP- Working Memory :Number of omissions TAP(Test of Attentional Performance) (quantitative variable)
Measured: day 1
Neuropsychological rating scales scores (TAP 2)
TAP- Sustained attention :Number of omissions TAP(Test of Attentional Performance) (quantitative variable)
Measured: day 1
Neuropsychological rating scales scores (TAP 3)
TAP- Flexibility :Number of errors TAP(Test of Attentional Performance) (quantitative variable)
Measured: day 1
Neuropsychological rating scales scores (TAP 4)
TAP- Incompatibility TAP(Test of Attentional Performance) (quantitative variable)
Measured: day 1
Neuropsychological rating scales scores (TAP 5)
TAP- Divided attention
Measured: day 1
Cannabis Abuse Screening Test (CAST) score
CAST: Cannabis Abuse Screening Test
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start23 Jan 2024
- Primary completion23 Jan 2026
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Psychothérapique de Nancy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent Bernardin, PhD, Principal investigator, Centre psychothérapeutique de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036316
- Sponsor's protocol ID
- 2023-A00949-36
- Acronym
- TDLRipsy
- Status last verified
- Mar 2026
- First submitted
- 1 Sep 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis
- ClinicalTrials.gov ID
- NCT06036316
- Acronym / sponsor ID
- TDLRipsy / 2023-A00949-36
- Conditions
- Psychosis, Schizophrenia, At-risk Mental State, Language Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Psychothérapique de NancyUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| early psychotic symptoms | Experimental | Behavioral: Language assessment, Combination Product: CAST - Cannabis Abuse Screening TestThis 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. |
| patients with schizophrenia | Experimental | Behavioral: Language assessment, Behavioral: TLC - Scale for the Assessment of Thought, Language, and Communication, Combination Product: CAST - Cannabis Abuse Screening TestThe 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. |
| healthy controls | Experimental | Behavioral: Language assessment, Behavioral: MINI - Mini International Neuropsychiatric Interview, Combination Product: CAST - Cannabis Abuse Screening TestThe 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. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- All Groups:
- ARMS and FEP Patient Group:
- Patients with schizophrenia group:
- Healthy Volunteers Group:
Key exclusion criteria (11 listed)
- All groups:
- Healthy Volunteers Group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Language assessmentAlso: Speech and language therapy assessmentThe 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. | Behavioural | early psychotic symptoms, healthy controls, patients with schizophrenia |
| TLC - Scale for the Assessment of Thought, Language, and CommunicationThis 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 | Behavioural | patients with schizophrenia |
| MINI - Mini International Neuropsychiatric InterviewThis 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. | Behavioural | healthy controls |
| CAST - Cannabis Abuse Screening TestThe 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 | Combination product | early psychotic symptoms, healthy controls, patients with schizophrenia |
Primary outcome
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.
13 secondary outcomes
CAARMS Speech Disorganization Severity Score
Time frame: day 1
Severity score for the disordered items of the course of thought of the SPI-A
Time frame: day 1
Severity score for speech disorganization and formal thought disorders on the TLC Scale
Time frame: day 1
Neuropsychological rating scales scores (CVLT)
Time frame: day 1
Neuropsychological rating scales scores (CVLT total)
Time frame: day 1
Neuropsychological rating scales scores (Front and back spans)
Time frame: day 1
Neuropsychological rating scales scores (Front and back spans 2)
Time frame: day 1
Neuropsychological rating scales scores (TAP 1)
Time frame: day 1
Neuropsychological rating scales scores (TAP 2)
Time frame: day 1
Neuropsychological rating scales scores (TAP 3)
Time frame: day 1
Neuropsychological rating scales scores (TAP 4)
Time frame: day 1
Neuropsychological rating scales scores (TAP 5)
Time frame: day 1
Cannabis Abuse Screening Test (CAST) score
Time frame: day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 23874280Majerus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florent Bernardin, PhD principal investigator
Centre psychothérapeutique de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Language assessment, TLC - Scale for the Assessment of Thought, Language, and Communication and MINI - Mini International Neuropsychiatric Interview in people with Psychosis and Schizophrenia, run by Centre Psychothérapique de Nancy at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anaëlle PAJAUD (0383260863, Anaelle.PAJAUD@cpn-laxou.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
language assessment performance score (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06036316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.