PsychosisSOURIPSYNCT04236531
Source-monitoring & Psychosis
A study testing Cognitive tests and neuroimaging in people with Psychosis, run by Hôpital le Vinatier at 2 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosis
- What is being tested?
- Cognitive tests and neuroimaging
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- 17 May 2021to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Not yet recruiting
Centre Hospitalier le Vinatier
Bron, 69678
Marine Mondino, 0437915565 ext. +33, marine.mondino@ch-le-vinatier.fr
Jérôme Brunelin, 0437915297 ext. +33, jerome.brunelin@ch-le-vinatier.fr
- Recruiting
Centre Hospitalier le Vinatier
Bron, 69678
Marine Mondino, 0437915565 ext. +33, marine.mondino@ch-le-vinatier.fr
Jérôme Brunelin, 0437915297 ext. +33, jerome.brunelin@ch-le-vinatier.fr
About this study
Official title: Source-monitoring Processes and Risk for Psychosis
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.
Read the 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.
- Conditions
- Psychosis
- Being tested
- Cognitive tests and neuroimaging
- Keywords
- source-monitoring, at-risk, MRI, neuroimaging
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive tests and neuroimagingOther
comparison of cognitive performances and brain anatomy
| Study group | Role | What they receive |
|---|---|---|
| individuals at ultra-high risk for psychosis (UHR) | Experimental | 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 Receives: Other: Cognitive tests and neuroimaging |
| patients with first episode psychosis (FEP) | Experimental | 30 patients with first episode psychosis (FEP) will be recruited and will complete cognitive task and MRI scan Receives: Other: Cognitive tests and neuroimaging |
| healthy controls | Sham comparator | 30 healthy individuals will be recruited and will complete cognitive task and MRI scan Receives: Other: Cognitive tests and neuroimaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Source-monitoring performances
Scores obtained at a source-monitoring task (Brunelin et al., 2006)
Measured: one day
Secondary outcomes (6)
Confidence in source-monitoring judgements
Confidence in source-monitoring judgements will be measured using a visual analogue scale (0-100)
Measured: one day
Grey matter volume
Grey matter volume will be assessed with a structural MRI scan (3D-T1) followed by morphometry analyses.
Measured: one day
Brain gyrification
Brain gyrification will be assessed with a structural MRI scan (3D-T1) followed by gyrification analyses.
Measured: one day
Basic auditory performances
scores at the Tone Matching Task (Strous et al., 1995)
Measured: one day
Working memory performances
scores at a working memory task (Barrouillet et al., 2004)
Measured: one day
Social functioning
score at the "personal and social performance scale" (0-100)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start17 May 2021
- Primary completionOct 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236531
- Sponsor's protocol ID
- 2019-A02499-48
- Acronym
- SOURIPSY
- Status last verified
- Mar 2022
- First submitted
- 6 Jan 2020
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Source-monitoring Processes and Risk for Psychosis
- ClinicalTrials.gov ID
- NCT04236531
- Acronym / sponsor ID
- SOURIPSY / 2019-A02499-48
- Conditions
- Psychosis
- Keywords
- source-monitoring, at-risk, MRI, neuroimaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three groups of participants will be recruited: individuals at ultra-high risk for psychosis, first-episode psychosis patients and healthy controls.
| Arm | Type | Receives |
|---|---|---|
| individuals at ultra-high risk for psychosis (UHR) | Experimental | Other: Cognitive tests and neuroimaging30 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 |
| patients with first episode psychosis (FEP) | Experimental | Other: Cognitive tests and neuroimaging30 patients with first episode psychosis (FEP) will be recruited and will complete cognitive task and MRI scan |
| healthy controls | Sham comparator | Other: Cognitive tests and neuroimaging30 healthy individuals will be recruited and will complete cognitive task and MRI scan |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- Do not consent to be included in the study
- Contraindication to MRI scan
- History of neurological disease
- Pregnancy
- Being under tutorship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive tests and neuroimagingcomparison of cognitive performances and brain anatomy | Other | healthy controls, individuals at ultra-high risk for psychosis (UHR), patients with first episode psychosis (FEP) |
Primary outcome
Source-monitoring performances
Time frame: one day
Scores obtained at a source-monitoring task (Brunelin et al., 2006)
6 secondary outcomes
Confidence in source-monitoring judgements
Time frame: one day
Grey matter volume
Time frame: one day
Brain gyrification
Time frame: one day
Basic auditory performances
Time frame: one day
Working memory performances
Time frame: one day
Social functioning
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive tests and neuroimaging in people with Psychosis, run by Hôpital le Vinatier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lydie sartelet (0437915531 ext. +33, lydie.sartelet@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Source-monitoring performances (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.