Source-monitoring & Psychosis

NCT ID: NCT04236531

Last Updated: 2022-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-17

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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Ninety participants will be included in the study: 30 UHR, 30 FEP and 30 healthy controls. All the participants will complete a standardized source-monitoring task, an MRI acquisition (3D-T1 anatomical scan), a tone-matching task as well as a socio-demographic and clinical evaluation including an assessment of the social functioning.

Conditions

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Psychosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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individuals at ultra-high risk for psychosis (UHR)

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

Group Type EXPERIMENTAL

Cognitive tests and neuroimaging

Intervention Type OTHER

comparison of cognitive performances and brain anatomy

patients with first episode psychosis (FEP)

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

Group Type EXPERIMENTAL

Cognitive tests and neuroimaging

Intervention Type OTHER

comparison of cognitive performances and brain anatomy

healthy controls

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

Group Type SHAM_COMPARATOR

Cognitive tests and neuroimaging

Intervention Type OTHER

comparison of cognitive performances and brain anatomy

Interventions

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Cognitive tests and neuroimaging

comparison of cognitive performances and brain anatomy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier le Vinatier

Bron, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier le Vinatier

Bron, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lydie sartelet

Role: CONTACT

0437915531 ext. +33

Facility Contacts

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Marine Mondino

Role: primary

0437915565 ext. +33

Jérôme Brunelin

Role: backup

0437915297 ext. +33

Marine Mondino

Role: primary

0437915565 ext. +33

Jérôme Brunelin

Role: backup

0437915297 ext. +33

Other Identifiers

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2019-A02499-48

Identifier Type: -

Identifier Source: org_study_id

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