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Prospective Cohort Study of a Population at Risk of Psychotic Transition

Study acronym: EPEDIP
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Primary completion date changed from estimate of Sep 1, 2024 to Nov 18, 2024
    • Start date changed from estimate of Sep 1, 2024 to Nov 18, 2024
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06539611
Lead Sponsor Centre Hospitalier Esquirol
Conditions
(from sponsor)
At-risk Mental States
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov