SchizophreniaSOUMONCT04237155
French Source-monitoring Task
A study testing Questionnaire and Cognitive tests in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
Trial summary
Source-monitoring is a cognitive process that refers to the ability to remember the source of an information. Source-monitoring processes are usually studied using experimental behavioral tasks. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Questionnaire and Cognitive tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2020to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and Women aged between 18 and 45
- Having given their written informed consent
- Native French speakers
- Normal or corrected-to-normal vision
- Education level greater than or equal to 8 (in years)
- 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 first-degree relatives diagnosed with spectrum disorder schizophrenia and bipolar disorder (DSM).
- For the schizophrenia patients group, meeting the DSM5 criteria for schizophrenia.
Who cannot join
- Do not consent to be included in the study
- History of hearing impairments
- People who cannot read
- Presence of neurological or somatic diseases
- Being under tutorship or curatorship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- 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: Development of a Source-monitoring Task in French Adapted to Neuroimaging Protocols
Source-monitoring is a cognitive process that refers to the ability to remember the source of an information. Source-monitoring processes are usually studied using experimental behavioral tasks. These tasks, which are very heterogeneous, are not all available in French and, for the most part, cannot be used in neuroimaging protocols.
The aim of this project is to develop an experimental task which allows the measurement of source-monitoring performances, and which is adapted to neuroimaging protocols in a French-speaking population.
Read the detailed description
The study will include 2 steps: 1) validation of the verbal material necessary for the creation of the source-monitoring task and 2) testing the task.
- Conditions
- Schizophrenia
- Being tested
- Questionnaire, Cognitive tests
- Keywords
- Sorce-monitoring
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Subjects will complete a verbal material scoring questionnaire
Cognitive testsOther
Subjects will complete two source-monitoring tasks: the source-monitoring task which will be created from step 1 as well as the task of reference
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls involved in step 1 | Other | 30 healthy individuals will complete a verbal material scoring questionnaire Receives: Other: Questionnaire |
| Patients with schizophrenia involved in step 1 | Other | 30 patients with schizophrenia will complete a verbal material scoring questionnaire Receives: Other: Questionnaire |
| Healthy controls involved in step 2 | Other | 30 healthy individuals will complete the source-monitoring task which will be created from step 1 as well as the task of reference Receives: Other: Cognitive tests |
| Patients with schizophrenia involved in step 2 | Other | 30 patients with schizophrenia will complete the source-monitoring task which will be created from step 1 as well as the task of reference Receives: Other: Cognitive tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Source-monitoring performances
Performances (calculated as the number of accurate source responses and the number of errors) obtained at the new source-monitoring task and at the source-monitoring task of reference (Brunelin et al., 2006).
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 posted23 Jan 2020
- Study start7 Feb 2020
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- For step 1, two populations of participants: 30 healthy volunteers and 30 patients with schizophrenia will have to complete a verbal material scoring questionnaire. For step 2, two populations of participants: 30 healthy volunteers and 30 patients with schizophrenia will have to complete the source-monitoring task which will be created from step 1 as well as the task of reference (Brunelin et al., 2008).
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT04237155
- Sponsor's protocol ID
- 2019-A02549-48
- Acronym
- SOUMO
- Status last verified
- Jun 2026
- First submitted
- 17 Jan 2020
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Source-monitoring Task in French Adapted to Neuroimaging Protocols
- ClinicalTrials.gov ID
- NCT04237155
- Acronym / sponsor ID
- SOUMO / 2019-A02549-48
- Conditions
- Schizophrenia
- Keywords
- Sorce-monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 23 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. Source-monitoring processes are usually studied using experimental behavioral tasks. These tasks, which are very heterogeneous, are not all available in French and, for the most part, cannot be used in neuroimaging protocols.
The aim of this project is to develop an experimental task which allows the measurement of source-monitoring performances, and which is adapted to neuroimaging protocols in a French-speaking population.
Detailed description
The study will include 2 steps: 1) validation of the verbal material necessary for the creation of the source-monitoring task and 2) testing the task.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- For step 1, two populations of participants: 30 healthy volunteers and 30 patients with schizophrenia will have to complete a verbal material scoring questionnaire. For step 2, two populations of participants: 30 healthy volunteers and 30 patients with schizophrenia will have to complete the source-monitoring task which will be created from step 1 as well as the task of reference (Brunelin et al., 2008).
| Arm | Type | Receives |
|---|---|---|
| Healthy controls involved in step 1 | Other | Other: Questionnaire30 healthy individuals will complete a verbal material scoring questionnaire |
| Patients with schizophrenia involved in step 1 | Other | Other: Questionnaire30 patients with schizophrenia will complete a verbal material scoring questionnaire |
| Healthy controls involved in step 2 | Other | Other: Cognitive tests30 healthy individuals will complete the source-monitoring task which will be created from step 1 as well as the task of reference |
| Patients with schizophrenia involved in step 2 | Other | Other: Cognitive tests30 patients with schizophrenia will complete the source-monitoring task which will be created from step 1 as well as the task of reference |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Men and Women aged between 18 and 45
- Having given their written informed consent
- Native French speakers
- Normal or corrected-to-normal vision
- Education level greater than or equal to 8 (in years)
Key exclusion criteria (5 listed)
- Do not consent to be included in the study
- History of hearing impairments
- People who cannot read
- Presence of neurological or somatic diseases
- 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 |
|---|---|---|
| QuestionnaireSubjects will complete a verbal material scoring questionnaire | Other | Healthy controls involved in step 1, Patients with schizophrenia involved in step 1 |
| Cognitive testsSubjects will complete two source-monitoring tasks: the source-monitoring task which will be created from step 1 as well as the task of reference | Other | Healthy controls involved in step 2, Patients with schizophrenia involved in step 2 |
Primary outcome
Source-monitoring performances
Time frame: one day
Performances (calculated as the number of accurate source responses and the number of errors) obtained at the new source-monitoring task and at the source-monitoring task of reference (Brunelin et al., 2006).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire and Cognitive tests in people with Schizophrenia, run by Hôpital le Vinatier at 1 site 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
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 11 Jun 2026.