Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencie… (NCT06036316) | Clinical Trial Compass
RecruitingNot Applicable
Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis
France90 participantsStarted 2024-01-23
Plain-language 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.
Who can participate
Age range
16 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 lif…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.