Psychiatric DisorderNCT03886584
Source Monitoring Déficit in Neuropsychiatric Population
A study testing Monitoring source test in people with Psychiatric Disorder, run by Hôpital le Vinatier at 1 site in France.
Trial summary
the investigators will measure source-monitoring ability in patients with several neuropsychiatric condition and in healthy controls appaired in age, sex and educational level. Source-monitoring will be measured thanks to internal- and reality-monitoring informatic tasks.The investigators hypothesized patients with… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- Monitoring source test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2019to 31 Jul 2026
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who gave their free and informed consent;
- Men and women;
- Aged 18 to 80;
- Having normal or corrected vision;
- Mastering the French language (read and spoken);
- All subjects will not have a working memory deficit preventing the test from being passed (MMSE short version):AM patients should have a score of <MMSE <26; Patients with pre-dementia AD will be diagnosed according to Dubois criteria (Dubois et al., 2016); patients with early FTD will be diagnosed according to Rascovsky's criteria (Rascovsky et al., 2011); Patients with DCL will be diagnosed according to McKeith's criteria (McKeith et al., 2005), TBP patients will be diagnosed using DSM 5 criteria (Arlington VA, 2013).
Who cannot join
- Inadmissibility of the consent or refusal of the subject.
- Patients under guardianship
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, Auvergne-Rhône-Alpes, 69678
VIAL VERONIQUE, 0033437915531, veronique.vial@ch-le-vinatier.fr
About this study
the investigators will measure source-monitoring ability in patients with several neuropsychiatric condition and in healthy controls appaired in age, sex and educational level. Source-monitoring will be measured thanks to internal- and reality-monitoring informatic tasks.The investigators hypothesized patients with fronto-temporal abnormalities would show more marked deficits than patients with only frontal abnormalities.
Read the detailed description
Source-monitoring abilities will be measured thanks to reality-monitoring testing (i.e. the ability to distinguish internal-generated events from external ones) and internal-monitoring testing (i.e. the ability to distinguish an imagined source from a performed one). A source-monitoring deficit have been demonstrated in patients with psychiatric conditions such as schizophrenia and seems linked to frontotemporal abnormalities (frontotemporal dysconnectivity and temporal hypoactivity). With a total of 150 patients, the investigators will include 30 patients per group: patients with pre-dementia stage Alzheimer, Alzheimer, Fronto-Temporal dementia, Lewy Body dementia or Parkinson and Bipolar Disorder, with the hypothesis that Bipolar Disorder patients will present less marked deficit. The investigators will recruit 150 healthy controls.
- Conditions
- Psychiatric Disorder
- Being tested
- Monitoring source test
- Keywords
- Bipolar Disorder, Source-monitoring
- Medical subject headings
- Mental Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring source testOther
Internal- and external-monitoring correct responses and inversions
| Study group | Role | What they receive |
|---|---|---|
| Patients with with neuropsychiatric conditions | Experimental | In this arm, five groups :
* Patients with DFT, diagnosed according Racovsky criteria
* Patients with Lewi Body dementia, diagnosed according McKeith criteria
* Patients with pre-demential Alzheimer, diagnosed according Dubois criteria
* Patients with Alzheimer, diagnosed according MMSE
* Patients with bipolar disorder, diagnosed according DSM 5 Receives: Other: Monitoring source test |
| Healthy subjects | Active comparator | Healthy controls appaired in age, sex and educational level Receives: Other: Monitoring source test |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure source memory performance
in patients with neuropsychiatric disorders with or without temporal involvement (pre-dementia Alzheimer's disease, Alzheimer's disease - AD, fronto-temporal dementia - DFT, Lewy body dementia - DCL and bipolar disorder - TBP) and healthy volunteers matched in age, gender, and level of education.
Measured: one year
Secondary outcomes (1)
measure the recognition of distractors
words not presented during the source monitoring test phase but presented during the recall phase. This measure will allow us to avoid that a disturbance invading the working memory or attentional capacities does not compromise the good realization of the task.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start8 Mar 2019
- Primary completion8 Mar 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies 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
- 2 arms
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JEROME BRUNELIN, PHD, Principal investigator, Centre Hospitalier Le Vinatier - CRNL - INSERM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886584
- Sponsor's protocol ID
- 2018-A00584-51
- Status last verified
- Jul 2025
- First submitted
- 11 Mar 2019
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Source Monitoring Déficit in Neuropsychiatric Population
- ClinicalTrials.gov ID
- NCT03886584
- Acronym / sponsor ID
- 2018-A00584-51
- Conditions
- Psychiatric Disorder
- Keywords
- Bipolar Disorder, Source-monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 8 Mar 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 22 Mar 2019 (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.
the investigators will measure source-monitoring ability in patients with several neuropsychiatric condition and in healthy controls appaired in age, sex and educational level. Source-monitoring will be measured thanks to internal- and reality-monitoring informatic tasks.The investigators hypothesized patients with fronto-temporal abnormalities would show more marked deficits than patients with only frontal abnormalities.
Detailed description
Source-monitoring abilities will be measured thanks to reality-monitoring testing (i.e. the ability to distinguish internal-generated events from external ones) and internal-monitoring testing (i.e. the ability to distinguish an imagined source from a performed one). A source-monitoring deficit have been demonstrated in patients with psychiatric conditions such as schizophrenia and seems linked to frontotemporal abnormalities (frontotemporal dysconnectivity and temporal hypoactivity). With a total of 150 patients, the investigators will include 30 patients per group: patients with pre-dementia stage Alzheimer, Alzheimer, Fronto-Temporal dementia, Lewy Body dementia or Parkinson and Bipolar Disorder, with the hypothesis that Bipolar Disorder patients will present less marked deficit. The investigators will recruit 150 healthy controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arms
| Arm | Type | Receives |
|---|---|---|
| Patients with with neuropsychiatric conditions | Experimental | Other: Monitoring source testIn this arm, five groups : * Patients with DFT, diagnosed according Racovsky criteria * Patients with Lewi Body dementia, diagnosed according McKeith criteria * Patients with pre-demential Alzheimer, diagnosed according Dubois criteria * Patients with Alzheimer, diagnosed according MMSE * Patients with bipolar disorder, diagnosed according DSM 5 |
| Healthy subjects | Active comparator | Other: Monitoring source testHealthy controls appaired in age, sex and educational level |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who gave their free and informed consent;
- Men and women;
- Aged 18 to 80;
- Having normal or corrected vision;
- Mastering the French language (read and spoken);
Key exclusion criteria (2 listed)
- Inadmissibility of the consent or refusal of the subject.
- Patients under guardianship
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 |
|---|---|---|
| Monitoring source testInternal- and external-monitoring correct responses and inversions | Other | Healthy subjects, Patients with with neuropsychiatric conditions |
Primary outcome
measure source memory performance
Time frame: one year
in patients with neuropsychiatric disorders with or without temporal involvement (pre-dementia Alzheimer's disease, Alzheimer's disease - AD, fronto-temporal dementia - DFT, Lewy body dementia - DCL and bipolar disorder - TBP) and healthy volunteers matched in age, gender, and level of education.
1 secondary outcome
measure the recognition of distractors
Time frame: one year
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 31 Jul 2025.
- Individual participant dataSharing planned: No
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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.
JEROME BRUNELIN, PHD principal investigator
Centre Hospitalier Le Vinatier - CRNL - INSERM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring source test in people with Psychiatric Disorder, 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 6 inclusion and 2 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 31 Jul 2025. 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 JEROME BRUNELIN, PHD (00334 37 91 55 65, jerome.brunelin@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure source memory performance (time frame: one year). 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 31 Jul 2025.