NCT03525054

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
24mo left

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
May 2018May 2028

First Submitted

Initial submission to the registry

April 26, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

May 18, 2018

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2028

Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

10 years

First QC Date

April 26, 2018

Last Update Submit

September 24, 2024

Conditions

Keywords

Psychotic DisordersDiagnosis, PsychiatricSchizophrenia ProdromalUltra High RiskPrediction Of PsychosisMachine LearningAutomated Language AnalysisSemantic CoherenceSyntaxic Complexity

Outcome Measures

Primary Outcomes (1)

  • Transition to schizophrenia

    Determined from the CAARMS scale (COMPREHENSIVE ASSESSMENT OF AT RISK MENTAL STATES)

    2 years

Secondary Outcomes (1)

  • Identification of patients at "ultra high risk " for developing schizophrenia

    Day 0

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Help-seekers patients are recruited during two years from the early psychosis detection centers in Brest, France (CEVUP), Paris, France (CJAAD) and in Lausanne, Switzerland

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHRU de Brest

Brest, 29609, France

RECRUITING

Meunier Sophie

Caen, France

NOT YET RECRUITING

CH de SAINT ANNE

Paris, 750144, France

RECRUITING

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaSchizotypal Personality DisorderMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersPersonality Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2018

First Posted

May 15, 2018

Study Start

May 18, 2018

Primary Completion (Estimated)

May 2, 2028

Study Completion (Estimated)

May 2, 2028

Last Updated

September 26, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations