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Source-monitoring & Psychosis (SOURIPSY)

H

Hôpital le Vinatier

Status

Unknown

Conditions

Psychosis

Treatments

Other: Cognitive tests and neuroimaging

Study type

Interventional

Funder types

Other

Identifiers

NCT04236531
2019-A02499-48

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 3 patient groups

individuals at ultra-high risk for psychosis (UHR)
Experimental group
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
Treatment:
Other: Cognitive tests and neuroimaging
patients with first episode psychosis (FEP)
Experimental group
Description:
30 patients with first episode psychosis (FEP) will be recruited and will complete cognitive task and MRI scan
Treatment:
Other: Cognitive tests and neuroimaging
healthy controls
Sham Comparator group
Description:
30 healthy individuals will be recruited and will complete cognitive task and MRI scan
Treatment:
Other: Cognitive tests and neuroimaging

Trial contacts and locations

1

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Central trial contact

Lydie sartelet

Data sourced from clinicaltrials.gov

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