Source-monitoring & Psychosis

NCT04236531 | Unknown

• 1 other identifier: 2019-A02499-48
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

Source-monitoring is a cognitive process that refers to the ability to remember the source of an information. Some studies have showed source-monitoring deficits in patients with schizophrenia as well as in individuals at ultra-high risk for psychosis (UHR) and in first-episode psychosis patients (FEP). Source-monitoring deficits have thus been proposed as a potential early risk factor for psychosis. However, further studies are needed to better characterize this deficit. The aim of this project is to investigate source-monitoring performances in UHR, FEP patients and healthy controls (HC) and to characterize these deficits in terms of brain anatomy, basic auditory processes and social functioning.

Conditions

Psychosis

Keywords

source-monitoring; at-risk; MRI; neuroimaging

Outcome Measures

Primary Outcomes (1)

• Source-monitoring performances

  Scores obtained at a source-monitoring task (Brunelin et al., 2006)

  one day

Secondary Outcomes (6)

• Confidence in source-monitoring judgements

  one day

• Grey matter volume

  one day

• Brain gyrification

  one day

• Basic auditory performances

  one day

• Working memory performances

  one day

Study Arms (3)

individuals at ultra-high risk for psychosis (UHR)

EXPERIMENTAL

30 individuals meeting the UHR criteria according to the "Comprehensive Assessment of at-risk mental state" (CAARMS) will be recruited and will complete cognitive task and MRI scan

Other: Cognitive tests and neuroimaging

patients with first episode psychosis (FEP)

EXPERIMENTAL

30 patients with first episode psychosis (FEP) will be recruited and will complete cognitive task and MRI scan

Other: Cognitive tests and neuroimaging

healthy controls

SHAM COMPARATOR

30 healthy individuals will be recruited and will complete cognitive task and MRI scan

Other: Cognitive tests and neuroimaging

Interventions

Cognitive tests and neuroimaging OTHER

comparison of cognitive performances and brain anatomy

healthy controls; individuals at ultra-high risk for psychosis (UHR); patients with first episode psychosis (FEP)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and Women aged between 18 and 30
• Having given their written informed consent
• French speakers and readers
• Absence of hearing impairments (or tinnitus) that could prevent the successful completion of tasks involving listening to sounds or words
• Absence of visual impairments that could prevent the successful completion of tasks involving reading on the screen
• For the healthy control group, no history of previous diagnosed psychiatric disorders (according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - DSM5), absence of relatives diagnosed with spectrum disorder schizophrenia and bipolar disorder (DSM5), absence of psychotic prodromes measured by a score of less than 6 in the "prodromal questionnaire" - PQ-16 (Ising et al., 2012), absence of drug treatments (except oral contraception).
• For the UHR group, meeting the UHR criteria according to the "Comprehensive Assessment of at-risk mental state" (CAARMS).
• For the FEP group, presenting with daily psychotic symptoms for at least a week.

You may not qualify if:

• Do not consent to be included in the study
• Contraindication to MRI scan
• History of neurological disease
• Pregnancy
• Being under tutorship or curatorship
• Having developed musical abilities (that is, regularly practicing a musical instrument)

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (2)

Centre Hospitalier le Vinatier

Bron, 69678, France

NOT YET RECRUITING

Centre Hospitalier le Vinatier

Bron, 69678, France

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Neuropsychological Tests; Neuroimaging

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Central Study Contacts

Lydie sartelet

CONTACT

0437915531; lydie.sartelet@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three groups of participants will be recruited: individuals at ultra-high risk for psychosis, first-episode psychosis patients and healthy controls.

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 22, 2020
• Study Start: May 17, 2021
• Primary Completion: October 1, 2023
• Study Completion: January 1, 2024
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

FR (2)