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Source-monitoring & Psychosis (SOURIPSY)

Primary Purpose

Psychosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive tests and neuroimaging
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psychosis focused on measuring source-monitoring, at-risk, MRI, neuroimaging

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Centre Hospitalier le Vinatier
  • Centre Hospitalier le VinatierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

individuals at ultra-high risk for psychosis (UHR)

patients with first episode psychosis (FEP)

healthy controls

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 6, 2020
Last Updated
March 23, 2022
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT04236531
Brief Title
Source-monitoring & Psychosis
Acronym
SOURIPSY
Official Title
Source-monitoring Processes and Risk for Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
source-monitoring, at-risk, MRI, neuroimaging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
individuals at ultra-high risk for psychosis (UHR)
Arm Type
Experimental
Arm Description
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
Arm Title
patients with first episode psychosis (FEP)
Arm Type
Experimental
Arm Description
30 patients with first episode psychosis (FEP) will be recruited and will complete cognitive task and MRI scan
Arm Title
healthy controls
Arm Type
Sham Comparator
Arm Description
30 healthy individuals will be recruited and will complete cognitive task and MRI scan
Intervention Type
Other
Intervention Name(s)
Cognitive tests and neuroimaging
Intervention Description
comparison of cognitive performances and brain anatomy
Primary Outcome Measure Information:
Title
Source-monitoring performances
Description
Scores obtained at a source-monitoring task (Brunelin et al., 2006)
Time Frame
one day
Secondary Outcome Measure Information:
Title
Confidence in source-monitoring judgements
Description
Confidence in source-monitoring judgements will be measured using a visual analogue scale (0-100)
Time Frame
one day
Title
Grey matter volume
Description
Grey matter volume will be assessed with a structural MRI scan (3D-T1) followed by morphometry analyses.
Time Frame
one day
Title
Brain gyrification
Description
Brain gyrification will be assessed with a structural MRI scan (3D-T1) followed by gyrification analyses.
Time Frame
one day
Title
Basic auditory performances
Description
scores at the Tone Matching Task (Strous et al., 1995)
Time Frame
one day
Title
Working memory performances
Description
scores at a working memory task (Barrouillet et al., 2004)
Time Frame
one day
Title
Social functioning
Description
score at the "personal and social performance scale" (0-100)
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lydie sartelet
Phone
0437915531
Ext
+33
Email
lydie.sartelet@ch-le-vinatier.fr
Facility Information:
Facility Name
Centre Hospitalier le Vinatier
City
Bron
ZIP/Postal Code
69678
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marine Mondino
Phone
0437915565
Ext
+33
Email
marine.mondino@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Jérôme Brunelin
Phone
0437915297
Ext
+33
Email
jerome.brunelin@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Marine Mondino
First Name & Middle Initial & Last Name & Degree
Hanna Chainay
First Name & Middle Initial & Last Name & Degree
Frédéric Haesebaert
First Name & Middle Initial & Last Name & Degree
Jerome Brunelin
Facility Name
Centre Hospitalier le Vinatier
City
Bron
ZIP/Postal Code
69678
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marine Mondino
Phone
0437915565
Ext
+33
Email
marine.mondino@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Jérôme Brunelin
Phone
0437915297
Ext
+33
Email
jerome.brunelin@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Marine Mondino
First Name & Middle Initial & Last Name & Degree
Frédéric Haesebaert
First Name & Middle Initial & Last Name & Degree
Jerome Brunelin

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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