NCT05742893

Brief Summary

The scientific literature has largely objectified language disorders in schizophrenia. And more precisely, the impairment of pragmatic and discursive language skills. Currently, there is no standardized language assessment tool specific to these patients. The aim of this study is to compare the effectiveness of a newly developed speech-language assessment tool for pragmatic and discourse skills for patients suffering from schizophrenia .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 2, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

Same day

First QC Date

February 2, 2023

Last Update Submit

April 10, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • assess of pragmatic skills

    The patients is evaluated by means of a semi-directed interview

    day 0

  • assess discourse skills

    he patient is evaluated through two image description tasks

    day 0

  • assess narrative skills

    the patients is evaluated through the oral restitution of two heard texts.

    day 0

Study Arms (1)

diagnostic

EXPERIMENTAL

all patients have the study test

Diagnostic Test: Measurement of pragmatic and discourse test scores in the two scales.

Interventions

The aim of this study is to compare the effectiveness of a newly developed speech-language assessment tool for pragmatic and discourse skills for patients suffering from schizophrenia .

diagnostic

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female between the ages of 18 and 60
  • Patient with a diagnosis of schizophrenic spectrum disorder and other psychotic disorders meeting DSM V criteria
  • Patient who has been clinically and treatment stable for at least three months
  • Patient who can read and write French
  • Patient who is a beneficiary of a social security plan or similar
  • Patient with ability to sign free and informed consent

You may not qualify if:

  • \- Patient hospitalized under restraint
  • Patient under guardianship
  • Patient who has stopped taking his or her treatment
  • Patient who had a change in treatment in the period of less than three months prior to the pass

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Nice

Nice, 06003, France

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Benoit Michel

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 24, 2023

Study Start

March 6, 2023

Primary Completion

March 6, 2023

Study Completion

February 13, 2024

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations