Source-monitoring & Psychosis (SOURIPSY)

March 23, 2022 updated by: Hôpital le Vinatier

Source-monitoring Processes and Risk for Psychosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69678
        • Not yet recruiting
        • Centre Hospitalier Le Vinatier
        • Sub-Investigator:
          • Hanna Chainay
      • Bron, France, 69678
        • Recruiting
        • Centre Hospitalier Le Vinatier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Other: Cognitive tests and neuroimaging
comparison of cognitive performances and brain anatomy
EXPERIMENTAL: patients with first episode psychosis (FEP)
30 patients with first episode psychosis (FEP) will be recruited and will complete cognitive task and MRI scan
Other: Cognitive tests and neuroimaging
comparison of cognitive performances and brain anatomy
SHAM_COMPARATOR: healthy controls
30 healthy individuals will be recruited and will complete cognitive task and MRI scan
Other: Cognitive tests and neuroimaging
comparison of cognitive performances and brain anatomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Source-monitoring performances
Time Frame: one day
Scores obtained at a source-monitoring task (Brunelin et al., 2006)
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confidence in source-monitoring judgements
Time Frame: one day
Confidence in source-monitoring judgements will be measured using a visual analogue scale (0-100)
one day
Grey matter volume
Time Frame: one day
Grey matter volume will be assessed with a structural MRI scan (3D-T1) followed by morphometry analyses.
one day
Brain gyrification
Time Frame: one day
Brain gyrification will be assessed with a structural MRI scan (3D-T1) followed by gyrification analyses.
one day
Basic auditory performances
Time Frame: one day
scores at the Tone Matching Task (Strous et al., 1995)
one day
Working memory performances
Time Frame: one day
scores at a working memory task (Barrouillet et al., 2004)
one day
Social functioning
Time Frame: one day
score at the "personal and social performance scale" (0-100)
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital le Vinatier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 17, 2021

Primary Completion (ANTICIPATED)

October 1, 2023

Study Completion (ANTICIPATED)

January 1, 2024

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (ACTUAL)

January 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A02499-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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