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Source-monitoring & Psychosis (SOURIPSY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236531
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Hôpital le Vinatier

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
Psychosis Other: Cognitive tests and neuroimaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Source-monitoring Processes and Risk for Psychosis
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Source-monitoring performances [ Time Frame: one day ]
    Scores obtained at a source-monitoring task (Brunelin et al., 2006)


Secondary Outcome Measures :
  1. Confidence in source-monitoring judgements [ Time Frame: one day ]
    Confidence in source-monitoring judgements will be measured using a visual analogue scale (0-100)

  2. Grey matter volume [ Time Frame: one day ]
    Grey matter volume will be assessed with a structural MRI scan (3D-T1) followed by morphometry analyses.

  3. Brain gyrification [ Time Frame: one day ]
    Brain gyrification will be assessed with a structural MRI scan (3D-T1) followed by gyrification analyses.

  4. Basic auditory performances [ Time Frame: one day ]
    scores at the Tone Matching Task (Strous et al., 1995)

  5. Working memory performances [ Time Frame: one day ]
    scores at a working memory task (Barrouillet et al., 2004)

  6. Social functioning [ Time Frame: one day ]
    score at the "personal and social performance scale" (0-100)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236531


Contacts
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Contact: Lydie sartelet 0437915531 ext +33 lydie.sartelet@ch-le-vinatier.fr

Locations
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France
Centre Hospitalier le Vinatier
Bron, France, 69678
Contact: Marine Mondino    0437915565 ext +33    marine.mondino@ch-le-vinatier.fr   
Contact: Jérôme Brunelin    0437915297 ext +33    jerome.brunelin@ch-le-vinatier.fr   
Principal Investigator: Marine Mondino         
Sub-Investigator: Hanna Chainay         
Sub-Investigator: Frédéric Haesebaert         
Sub-Investigator: Jerome Brunelin         
Sponsors and Collaborators
Hôpital le Vinatier

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Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT04236531    
Other Study ID Numbers: CSLV22
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hôpital le Vinatier:
source-monitoring
at-risk
MRI
neuroimaging
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders