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Recruiting NCT06036316

NCT06036316 Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis

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Clinical Trial Summary
NCT ID NCT06036316
Status Recruiting
Phase —
Sponsor Centre Psychothérapique de Nancy
Condition Psychosis
Study Type INTERVENTIONAL
Enrollment 90 participants
Start Date 2024-01-23
Primary Completion 2026-01-23

Eligibility & Interventions

Sex All sexes
Min Age 16 Years
Max Age 55 Years
Study Type INTERVENTIONAL
Interventions
Language assessmentTLC - Scale for the Assessment of Thought, Language, and CommunicationMINI - Mini International Neuropsychiatric Interview

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 90 participants in total. It began in 2024-01-23 with a primary completion date of 2026-01-23.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Contact & Investigator

Central Contact

Anaëlle PAJAUD

✉ Anaelle.PAJAUD@cpn-laxou.com

📞 0383260863

Principal Investigator

Florent Bernardin, PhD

PRINCIPAL INVESTIGATOR

Centre psychothérapeutique de Nancy

Frequently Asked Questions

Who can join the NCT06036316 clinical trial?

This trial is open to participants of all sexes, aged 16 Years or older, up to 55 Years, studying Psychosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06036316 currently recruiting?

Yes, NCT06036316 is actively recruiting participants. Contact the research team at Anaelle.PAJAUD@cpn-laxou.com for enrollment information.

Where is the NCT06036316 trial being conducted?

This trial is being conducted at Laxou, France.

Who is sponsoring the NCT06036316 clinical trial?

NCT06036316 is sponsored by Centre Psychothérapique de Nancy. The principal investigator is Florent Bernardin, PhD at Centre psychothérapeutique de Nancy. The trial plans to enroll 90 participants.

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