SchizophreniaSAILLANCE1NCT02874482
Cognitive and Emotional Factors in Visual Exploration Among Patients With Schizophrenia
An observational study of Schizophrenia, run by University Hospital, Lille at 1 site in France.
Trial summary
Background: Patients with schizophrenia are abnormally disturbed by information onsets, which may result in a disadvantage in filtering relevant information. It seems that they accord the same importance to all objects in a scene without taking into account the relevance of objects (cognitive salience) or their… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to 17 Nov 2019
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 patients with schizophrenia and 30 healthy controls
Who may be able to join
- Normal or corrected vision
- Affiliate to a social security system
- For group of patients with schizophrenia : diagnosis of schizophrenia based on the standard DSM-IV criteria and patients will be clinically stable at the testing time
Who cannot join
- History of neurological illness
- Pregnant and nursing women
- Drugs use in the last 24 hours
- Acute ocular disorder
- Under tutorship, curatorship or deprived of liberty
- For controls group : be free DSM-IV axis-I diagnoses according the MINI test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Cognitive and Emotional Factors Influencing the Visual Exploration Among Patients With Schizophrenia
Background:
Patients with schizophrenia are abnormally disturbed by information onsets, which may result in a disadvantage in filtering relevant information. It seems that they accord the same importance to all objects in a scene without taking into account the relevance of objects (cognitive salience) or their emotional charge (salience emotional).
Read more
The paradigm of change blindness offers the interesting possibility of studying sensitivity to the sudden irruption of visual information with ecological stimuli in schizophrenia. An increased attentional capture by the irruption of visual information would suggest better performance in patients than in healthy controls. Moreover, patients are disturbed to processing of emotional information, in this way we would like to measure the impact of emotional salience on the visual exploration.
Main aim:
The main objective is to evaluate, if patients with schizophrenia quickly detect changes occurring on irrelevant objects in the understanding of the scene.
Secondary objectives:
To evaluate in patients with schizophrenia the impact of emotional salience using the same paradigm.
To separate an explicit response (motors responses) with an implicit response (eye tracking measures).
Methodology:
30 patients with schizophrenia and 30 healthy controls were asked to detect changes in 96 scenes with 0 or 1 change (neutral or emotional changes). We will measure the participants' speed and accuracy in explicitly reporting the changes via motor responses and their capacity to implicitly detect changes via eye movements.
Read the detailed description
This study will include one visit:
- Written consent will be obtained from all participants
- Inclusion and exclusion criteria will be checked
- An ophthalmologic test, a pregnancy test, a alcohol test and a salivary test will be realized
- Various symptoms will be assessed with the PANSS (Positive And Negative Syndrome Scale for schizophrenia) and the UPDRS (Unified Parkinson Disease Rating Scale for patients, the MOCA (Montreal Cognitive Assessment), The HAD (Hospital Anxiety and Depression Scale) and the MINI (Mini International Neuropsychiatric Interview) for all participants.
- The task will be divided in two parts:
A visuo-spatial task allowing to record saccadic eye movements (approximately 10 min).
The change blindness session lasted approximately 20 min.
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Change blindness, Eye tracking, Implicit response
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with schizophrenia | 30 patients with schizophrenia (diagnosis based on the standard DSM criteria) | |
| Controls | 30 healthy controls without any psychiatric or neurological diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
response time
The explicit response of the participants will be measure behaviourally by response time before the detection of neutral stimuli.
Measured: 42 months
Secondary outcomes (3)
sensitivity index
Performances will be measure by a sensitivity index (D prime) which considers the number of correct detections compared with the missed detections and false alarms; thus it evaluates the capacity to discriminate the signal against a background noise.
Measured: 42 months
implicit response
The implicit response will be measure by the localization and duration of fixations
Measured: 42 months
emotional response
The emotional response will be measure by the localization, duration of fixations and performances for the detection of emotional stimuli
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startJul 2014
- Primary completion17 Nov 2019
- Study completion17 Nov 2019
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 University Hospital, LilleThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume VAIVA, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874482
- Sponsor's protocol ID
- 2013_19.1
- Other IDs
- 2013-A01497-38
- Acronym
- SAILLANCE1
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2016
- Last updated
- 26 Aug 2020
- 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 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cognitive and Emotional Factors Influencing the Visual Exploration Among Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02874482
- Acronym / sponsor ID
- SAILLANCE1 / 2013_19.1
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Change blindness, Eye tracking, Implicit response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- 17 Nov 2019 (actual)
- Study completion
- 17 Nov 2019 (actual)
- First posted
- 22 Aug 2016 (estimated)
- 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.
Background:
Patients with schizophrenia are abnormally disturbed by information onsets, which may result in a disadvantage in filtering relevant information. It seems that they accord the same importance to all objects in a scene without taking into account the relevance of objects (cognitive salience) or their emotional charge (salience emotional).
The paradigm of change blindness offers the interesting possibility of studying sensitivity to the sudden irruption of visual information with ecological stimuli in schizophrenia. An increased attentional capture by the irruption of visual information would suggest better performance in patients than in healthy controls. Moreover, patients are disturbed to processing of emotional information, in this way we would like to measure the impact of emotional salience on the visual exploration.
Main aim:
The main objective is to evaluate, if patients with schizophrenia quickly detect changes occurring on irrelevant objects in the understanding of the scene.
Secondary objectives:
To evaluate in patients with schizophrenia the impact of emotional salience using the same paradigm.
To separate an explicit response (motors responses) with an implicit response (eye tracking measures).
Methodology:
30 patients with schizophrenia and 30 healthy controls were asked to detect changes in 96 scenes with 0 or 1 change (neutral or emotional changes). We will measure the participants' speed and accuracy in explicitly reporting the changes via motor responses and their capacity to implicitly detect changes via eye movements.
Detailed description
This study will include one visit:
- Written consent will be obtained from all participants
- Inclusion and exclusion criteria will be checked
- An ophthalmologic test, a pregnancy test, a alcohol test and a salivary test will be realized
- Various symptoms will be assessed with the PANSS (Positive And Negative Syndrome Scale for schizophrenia) and the UPDRS (Unified Parkinson Disease Rating Scale for patients, the MOCA (Montreal Cognitive Assessment), The HAD (Hospital Anxiety and Depression Scale) and the MINI (Mini International Neuropsychiatric Interview) for all participants.
- The task will be divided in two parts:
A visuo-spatial task allowing to record saccadic eye movements (approximately 10 min).
The change blindness session lasted approximately 20 min.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with schizophrenia | – | –30 patients with schizophrenia (diagnosis based on the standard DSM criteria) |
| Controls | – | –30 healthy controls without any psychiatric or neurological diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients with schizophrenia and 30 healthy controls
Key inclusion criteria (3 listed)
- Normal or corrected vision
- Affiliate to a social security system
- For group of patients with schizophrenia : diagnosis of schizophrenia based on the standard DSM-IV criteria and patients will be clinically stable at the testing time
Key exclusion criteria (6 listed)
- History of neurological illness
- Pregnant and nursing women
- Drugs use in the last 24 hours
- Acute ocular disorder
- Under tutorship, curatorship or deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
response time
Time frame: 42 months
The explicit response of the participants will be measure behaviourally by response time before the detection of neutral stimuli.
3 secondary outcomes
sensitivity index
Time frame: 42 months
implicit response
Time frame: 42 months
emotional response
Time frame: 42 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- 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. This study is not recruiting at the moment.
Guillaume VAIVA principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by University Hospital, Lille 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 3 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: finished, as of the sponsor's last update on 26 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response time (time frame: 42 months). 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 26 Aug 2020.