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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03525054
Other study ID # ASESID (29BRC17.0198)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 18, 2018
Est. completion date June 30, 2024

Study information

Verified date July 2023
Source University Hospital, Brest
Contact Michel WALTER
Phone 02-98-01-51-57
Email michel.walter@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Subtle speech disorganization could be predictive of a transition to schizophrenia of ultra-high-risk patients. The aim of our longitudinal multicenter cohort study is to identify specific linguistic markers of the psychotic transition to validate a french predictive model of this transition using computerized speech analysis techniques


Description:

Different scales allow identification of patients at ultra-high-risk to develop psychosis. The current challenge is to identify a predictive marker of transition to schizophrenia. Language disorders, which reflect psyche, could be one of these markers. Computerized speech analysis techniques such as Latent Semantic Analysis (LSA) have already proven their reliability in schizophrenia. These techniques reveal subtle speech disorganization that would be predictive of a clinical transition of ultra-high-risk psychotic patients. A combination of semantic and syntactic analysis could accurately predict the psychotic transition. The aim of our longitudinal multicenter cohort study is to validate this predicitve model in french language as well as identifying specific linguistic markers of the psychotic transition. The initial report including the CAARMS is completed with an audio recording from the initial medical interview. The recording will be transcribed and analyzed by computer following the method of lemmatization and vectorial analysis (LSA). An analysis of the grammatical function (number of words, rate of the various grammatical functions) will also be performed. This first analysis will emerge linguistic markers correlated to transition to psychosis that we will use to construct a predictive model for transition to schizophrenia.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 15 Years to 30 Years
Eligibility Inclusion Criteria: - Major and/or minor from 15 to 30 years old - Who alleged a suicidal gesture or idea or behavior that has repercussions in their emotional, social or professional life - If patients receive neuroleptic treatment that impairs cognitive abilities, a one-week wash-out period will be scheduled prior to assessment. Exclusion Criteria: - History of psychosis - Risk of self-harm or violence not compatible with outpatient treatment - QI<70 (WAIS) - Neurological disorder or major health problem - Impossibility to interrupt neuroleptic treatment for one week - Refusal to participate

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU de Brest Brest
France Meunier Sophie Caen
France CH de SAINT ANNE Paris

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Transition to schizophrenia Determined from the CAARMS scale (COMPREHENSIVE ASSESSMENT OF AT RISK MENTAL STATES) 2 years
Secondary Identification of patients at "ultra high risk " for developing schizophrenia Determined from the CAARMS scale ( COMPREHENSIVE ASSESSMENT OF AT RISK MENTAL STATES) Day 0
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