Prospective Cohort Study of a Population at Risk of Psychotic Transition

NCT ID: NCT06539611

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-18

Study Completion Date

2030-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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At-risk Mental States

Keywords

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at-risk mental states early intervention psychotic transition subjective cognitive complaint

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Observational

This study is observationnal: Questionnaires to assess the endpoint

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Esquirol

OTHER

Sponsor Role lead

Responsible Party

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Dr Mirvat HAMDAN-DUMONT

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mirvat B HAMDAN-DUMONT, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Esquirol Center

Locations

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Mirvat B HAMDAN-DUMONT

Limoges, , France

Site Status

Countries

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France

Other Identifiers

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2024-A00720-47

Identifier Type: -

Identifier Source: org_study_id