SOURIPSY: Source-monitoring & Psychosis

Sponsor
Hôpital le Vinatier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04236531
Collaborator
(none)
90
2
3
31.5
45
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive tests and neuroimaging
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three groups of participants will be recruited: individuals at ultra-high risk for psychosis, first-episode psychosis patients and healthy controls.Three groups of participants will be recruited: individuals at ultra-high risk for psychosis, first-episode psychosis patients and healthy controls.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Source-monitoring Processes and Risk for Psychosis
Actual Study Start Date :
May 17, 2021
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Source-monitoring performances [one day]

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

Secondary Outcome Measures

  1. Confidence in source-monitoring judgements [one day]

    Confidence in source-monitoring judgements will be measured using a visual analogue scale (0-100)

  2. Grey matter volume [one day]

    Grey matter volume will be assessed with a structural MRI scan (3D-T1) followed by morphometry analyses.

  3. Brain gyrification [one day]

    Brain gyrification will be assessed with a structural MRI scan (3D-T1) followed by gyrification analyses.

  4. Basic auditory performances [one day]

    scores at the Tone Matching Task (Strous et al., 1995)

  5. Working memory performances [one day]

    scores at a working memory task (Barrouillet et al., 2004)

  6. Social functioning [one day]

    score at the "personal and social performance scale" (0-100)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier le Vinatier Bron France 69678
2 Centre Hospitalier le Vinatier Bron France 69678

Sponsors and Collaborators

  • Hôpital le Vinatier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hôpital le Vinatier
ClinicalTrials.gov Identifier:
NCT04236531
Other Study ID Numbers:
  • 2019-A02499-48
First Posted:
Jan 22, 2020
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hôpital le Vinatier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2022