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Clinical Trials in France / NCT06539611
Active, not recruiting Observational

Prospective Cohort Study of a Population at Risk of Psychotic Transition

NCT06539611 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-11-18
Last updated
2025-12-19

Condition(s) studied

At-risk Mental States

Investigational drug(s) / intervention(s)

Observational

Observational: This study is observationnal: Questionnaires to assess the endpoint

Study summary

In psychiatry, insight is the patient's awareness of his or her disorder or symptom. Lack of insight also seems to be associated with the presence of anxiety-depressive symptoms.

There are several forms of insight:

* clinical" insight, which is the perception of suffering from a given pathology or symptoms
* cognitive insight (CI), which is the ability to analyse or judge one's own thoughts, beliefs and judgements
* and the insight of cognitive disorders or the subjective perception of the cognitive alterations (or cognitive symptoms) presented. In this study, the investigators will refer to this dimension as 'subjective cognitive complaint' (SCP), in order to differentiate it from cognitive insight, the name of which may lead to confusion.

In schizophrenic disorders, there is a positive correlation between the subjective cognitive complaint SCC, and certain alterations in the neurocognitive assessment, including the attentional dimension. There are scales for collecting SCC in psychotic disorders, such as the SSTICS. To date, there is no scale validated specifically for the UHR population. Thus, the scales used (STICSS, SCoRS, etc.) are validated in populations presenting a characterised psychotic state. Objective impairment is measured during a neurocognitive assessment carried out by a specialised professional: a clinical psychologist specialised in neuropsychology. The cognitive performance of UHR patients is impaired, particularly in terms of cognitive flexibility and self-perception of cognitive disorders, and there may be a discrepancy between the complaint, the objective disorders and their identification as "disorders" by the patient.

Despite this discrepancy, to the investigators knowledge no study to date has investigated a possible link between SCC and psychotic transition in this population. Thus, it is not known whether social class may be a factor in exposure to transition, or whether there is a link at all between social class and risk of transition. The aim of this study is to determine psychotic transition in UHR in a 30 months follow-up, and to determine whether there is a link between SCC and transition.

Eligibility

Sex
ALL
Min age
15 Years
Max age
30 Years
Healthy volunteers
No
Inclusion Criteria: * Male or female ; * Be aged between 15 and 30 ; * Being assessed by the eDIP (early intervention team "équipe de détection et d'intervention précoce") ; * Sufficient level of French to understand and express yourself orally and in writing; * For adults: Patients who have received informed information about the study and who have signed a consent to participate in the study; \- For minors: Patient who has received informed information about the study and who has signed, as well as the holders of parental authority the minor's consent to participate in the study. Exclusion Criteria: * Have already presented a First Psychotic Episode; * Previous diagnosis of schizophrenia, psychotic disorder or bipolar disorder; * Being on antipsychotic treatment at the time of inclusion ; * Known intellectual disability ; * Pregnant or breast-feeding woman; * Minors and adults under legal protection.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Mirvat B HAMDAN-DUMONT Limoges France

More Centre Hospitalier Esquirol trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06539611 on ClinicalTrials.gov ↗ ← All trials in France