Source-monitoring & Psychosis

Psychosis Clinical Trial

— SOURIPSY  

Official title:

Source-monitoring Processes and Risk for Psychosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04236531
• Other study ID #: 2019-A02499-48
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: January 2024

Study information

• Verified date: March 2022
• Source: Hôpital le Vinatier
• Contact: Lydie sartelet
• Phone: 0437915531
• Email: lydie.sartelet[@]ch-le-vinatier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Other:
• Cognitive tests and neuroimaging
comparison of cognitive performances and brain anatomy

Locations

Country	Name	City	State
France	Centre Hospitalier le Vinatier	Bron
France	Centre Hospitalier le Vinatier	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Source-monitoring performances	Scores obtained at a source-monitoring task (Brunelin et al., 2006)	one day
Secondary	Confidence in source-monitoring judgements	Confidence in source-monitoring judgements will be measured using a visual analogue scale (0-100)	one day
Secondary	Grey matter volume	Grey matter volume will be assessed with a structural MRI scan (3D-T1) followed by morphometry analyses.	one day
Secondary	Brain gyrification	Brain gyrification will be assessed with a structural MRI scan (3D-T1) followed by gyrification analyses.	one day
Secondary	Basic auditory performances	scores at the Tone Matching Task (Strous et al., 1995)	one day
Secondary	Working memory performances	scores at a working memory task (Barrouillet et al., 2004)	one day
Secondary	Social functioning	score at the "personal and social performance scale" (0-100)	one day