Clinical trial NCT04236531: Source-monitoring & Psychosis
Official title: Source-monitoring Processes and Risk for Psychosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychosis
Keywords: source-monitoring
at-risk
MRI
neuroimaging
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups of participants will be recruited: individuals at ultra-high risk for psychosis, first-episode psychosis patients and healthy controls.
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Source-monitoring performances
timeFrame: one day
Secondary outcomes:
measure: Confidence in source-monitoring judgements
timeFrame: one day
measure: Grey matter volume
timeFrame: one day
measure: Brain gyrification
timeFrame: one day
measure: Basic auditory performances
timeFrame: one day
measure: Working memory performances
timeFrame: one day
measure: Social functioning
timeFrame: one day
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre Hospitalier le Vinatier
city: Bron
country: France
facility: Centre Hospitalier le Vinatier
Study officials:
References: