SchizophreniaSHALLNCT03188133
Visual Information Processing in Schizophrenia Patients With Visual Hallucinations
A study testing behavioral task : emotional priming in people with Schizophrenia and Visual Hallucination, run by Central Hospital, Nancy, France.
Trial summary
Occurrence of visual hallucinations (VHs) in schizophrenia depend in part on disorders in the processing of late visual information (Top-Down). The broader question of how these top-down mechanisms (cognitive and / or emotional mechanisms) are involved in the occurrence of VHs remains to be specified and very few… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Visual Hallucination, Auditory Hallucination
- What is being tested?
- behavioral task : emotional priming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2017to 31 Oct 2020
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
All Groups:
- Age between 18 and 55 years
- Affiliation to or benefiting from a social security
- Visual acuity normal or corrected to normal
- Person who received and understood the complete information about the organization of the research and gave written and free informed consent before participating in the study
Group of patients with schizophrenia with visual hallucination (HV) with or without auditory hallucination (HA) (HV group):
- Schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders IV criteria
- Presence of a hallucinatory visual symptomatology (HV) in the history of the disease measured by the Psychosensory hallucination scale (PSAS).
- The presence of a hallucinatory symptomatology in auditory mode (HA) in addition to the HV is not a criterion of non-inclusion.
Group of patients with schizophrenia either with auditory hallucination (HA) but without visual hallucination (HV) or no hallucination, auditory or visual (NH) (HA / NH group)
- Schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders IV criteria
- Presence of a hallucinatory symptomatology in auditory mode (HA) in the history of the disease measured by the PSAS or absence of any hallucinatory manifestations in the history of the disease
- Absence of visual hallucinatory symptomatology (HV) in the history of the disease as measured by PSAS
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Top Down Visual Information Processing in Schizophrenia Patients With Visual Hallucinations
Occurrence of visual hallucinations (VHs) in schizophrenia depend in part on disorders in the processing of late visual information (Top-Down). The broader question of how these top-down mechanisms (cognitive and / or emotional mechanisms) are involved in the occurrence of VHs remains to be specified and very few behavioral studies have so far been interested. The investigators propose to study the implication of Top-Down mechanisms in the visual hallucinatory manifestations, more specifically in the processing of ambiguous stimuli during an emotional priming task. Schizophrenia patients with VHs would have more false visual perceptions in the treatment of ambiguous stimuli than schizophrenia patients with auditory hallucinations or no hallucinations (AH/NH) and healthy controls.
Read the detailed description
In schizophrenia patients with auditory hallucinations, top-down mechanism on perceptual processing could be illustrated by tasks of listening to white noise. These studies show that psychotic subjects detect more words and phrases when exposed to these stimuli. In schizophrenia patients with VHs, to our knowledge no study have explored the mechanism of false perception. Thus, we propose to experimentally manipulate the implication of Top-Down mechanisms on visual perception using an emotional priming task. This paradigm has already been used in this population to explain the mechanisms underlying productive symptoms. For example, in an emotional priming task authors have shown that a negative valence primer contributes to the implementation of an interpretive bias in a confidence judgment task.
The aim of the present study is to explore the implication of these Top-Down mechanisms in hallucinatory manifestations, more specifically on the treatment of ambiguous visual stimuli during an emotional priming task by manipulating the emotional valence of the primer. The goal is to determine how emotional environmental elements contribute to the formation of erroneous perceptions in patients with schizophrenia with VHs.
- Being tested
- behavioral task : emotional priming
- Keywords
- Schizophrenia, Visual Hallucination, False Perception, emotional priming
- Medical subject headings
- Schizophrenia, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral task : emotional primingOther
emotional priming task on ambiguous visual stimuli
| Study group | Role | What they receive |
|---|---|---|
| VH | Experimental | schizophrenia patients with visual hallucinations Receives: Other: behavioral task : emotional priming |
| AH/NH | Active comparator | schizophrenia patients with auditory hallucinations or no hallucinations Receives: Other: behavioral task : emotional priming |
| C | Active comparator | healthy controls Receives: Other: behavioral task : emotional priming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of false visual perception on the emotional priming task
Number of false perception made by participants on an ambiguous visual stimulus i.e when a participant identifies incorrectly an ambiguous stimulus as a genuine percept (for example a participant sees a face in a noisy grey pattern)
Measured: through study completion an average of 6 months
Secondary outcomes (3)
number of false visual perception on the emotional priming task depending of the emotional valence manipulated
The investigators will investigate if the manipulated valence of the emotional priming task influences the number of false visual perceptions of ambiguous stimuli
Measured: through study completion an average of 6 months
Cognitive performances at the neuropsychological assessment
Cognitive performances at the neuropsychological assessment conducted for both groups of schizophrenia patients. Neuropsychological assessment will provide performance scores on different cognitive functions : episodic memory (California Verbal Learning Test), visual memory (delayed match to sample task), working memory (forward and backward digit span, n-back task), sustained attention (test of attentional performance battery), divided attention (test of attentional performance battery), inhibition (test of attentional performance battery), processing speed (coding) and visual perception and processing (visual object space perception task).
Measured: through study completion an average of 6 months
Psychosensory hallucinations scale scores
scores on the Psychosensory hallucinations scale conducted for both schizophrenia patients groups. This scale provides a complete evaluation of hallucinations in all modalities as well as the impact of these symptoms on daily life.
Measured: through study completion an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start17 Oct 2017 (estimated)
- Primary completion1 May 2018 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent LAPREVOTE, Principal investigator, Central hospital Nancy, Centre Psychothérapique de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188133
- Sponsor's protocol ID
- ID-RCB/2017-A01058-45
- Acronym
- SHALL
- Status last verified
- Oct 2017
- First submitted
- 9 Jun 2017
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Catalan A, Simons CJ, Bustamante S, Drukker M, Madrazo A, de Artaza MG, Gorostiza I, van Os J, Gonzalez-Torres MA. Novel evidence that attributing affectively salient signal to random noise is associated with psychosis. PLoS One. 2014 Jul 14;9(7):e102520. doi: 10.1371/journal.pone.0102520. eCollection 2014.
PubMed 25020079Hoffman RE, Woods SW, Hawkins KA, Pittman B, Tohen M, Preda A, Breier A, Glist J, Addington J, Perkins DO, McGlashan TH. Extracting spurious messages from noise and risk of schizophrenia-spectrum disorders in a prodromal population. Br J Psychiatry. 2007 Oct;191:355-6. doi: 10.1192/bjp.bp.106.031195.
PubMed 17906248Galdos M, Simons C, Fernandez-Rivas A, Wichers M, Peralta C, Lataster T, Amer G, Myin-Germeys I, Allardyce J, Gonzalez-Torres MA, van Os J. Affectively salient meaning in random noise: a task sensitive to psychosis liability. Schizophr Bull. 2011 Nov;37(6):1179-86. doi: 10.1093/schbul/sbq029. Epub 2010 Apr 1.
PubMed 20360211Hooker CI, Tully LM, Verosky SC, Fisher M, Holland C, Vinogradov S. Can I trust you? Negative affective priming influences social judgments in schizophrenia. J Abnorm Psychol. 2011 Feb;120(1):98-107. doi: 10.1037/a0020630.
PubMed 20919787
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Top Down Visual Information Processing in Schizophrenia Patients With Visual Hallucinations
- ClinicalTrials.gov ID
- NCT03188133
- Acronym / sponsor ID
- SHALL / ID-RCB/2017-A01058-45
- Keywords
- Schizophrenia, Visual Hallucination, False Perception, emotional priming
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 17 Oct 2017 (estimated)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 15 Jun 2017 (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.
Occurrence of visual hallucinations (VHs) in schizophrenia depend in part on disorders in the processing of late visual information (Top-Down). The broader question of how these top-down mechanisms (cognitive and / or emotional mechanisms) are involved in the occurrence of VHs remains to be specified and very few behavioral studies have so far been interested. The investigators propose to study the implication of Top-Down mechanisms in the visual hallucinatory manifestations, more specifically in the processing of ambiguous stimuli during an emotional priming task. Schizophrenia patients with VHs would have more false visual perceptions in the treatment of ambiguous stimuli than schizophrenia patients with auditory hallucinations or no hallucinations (AH/NH) and healthy controls.
Detailed description
In schizophrenia patients with auditory hallucinations, top-down mechanism on perceptual processing could be illustrated by tasks of listening to white noise. These studies show that psychotic subjects detect more words and phrases when exposed to these stimuli. In schizophrenia patients with VHs, to our knowledge no study have explored the mechanism of false perception. Thus, we propose to experimentally manipulate the implication of Top-Down mechanisms on visual perception using an emotional priming task. This paradigm has already been used in this population to explain the mechanisms underlying productive symptoms. For example, in an emotional priming task authors have shown that a negative valence primer contributes to the implementation of an interpretive bias in a confidence judgment task.
The aim of the present study is to explore the implication of these Top-Down mechanisms in hallucinatory manifestations, more specifically on the treatment of ambiguous visual stimuli during an emotional priming task by manipulating the emotional valence of the primer. The goal is to determine how emotional environmental elements contribute to the formation of erroneous perceptions in patients with schizophrenia with VHs.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VH | Experimental | Other: behavioral task : emotional primingschizophrenia patients with visual hallucinations |
| AH/NH | Active comparator | Other: behavioral task : emotional primingschizophrenia patients with auditory hallucinations or no hallucinations |
| C | Active comparator | Other: behavioral task : emotional priminghealthy controls |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| behavioral task : emotional primingemotional priming task on ambiguous visual stimuli | Other | AH/NH, C, VH |
Primary outcome
Number of false visual perception on the emotional priming task
Time frame: through study completion an average of 6 months
Number of false perception made by participants on an ambiguous visual stimulus i.e when a participant identifies incorrectly an ambiguous stimulus as a genuine percept (for example a participant sees a face in a noisy grey pattern)
3 secondary outcomes
number of false visual perception on the emotional priming task depending of the emotional valence manipulated
Time frame: through study completion an average of 6 months
Cognitive performances at the neuropsychological assessment
Time frame: through study completion an average of 6 months
Psychosensory hallucinations scale scores
Time frame: through study completion an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Background: PubMed 25020079Catalan A, Simons CJ, Bustamante S, Drukker M, Madrazo A, de Artaza MG, Gorostiza I, van Os J, Gonzalez-Torres MA. Novel evidence that attributing affectively salient signal to random noise is associated with psychosis. PLoS One. 2014 Jul 14;9(7):e102520. doi: 10.1371/journal.pone.0102520. eCollection 2014.
- Background: PubMed 17906248Hoffman RE, Woods SW, Hawkins KA, Pittman B, Tohen M, Preda A, Breier A, Glist J, Addington J, Perkins DO, McGlashan TH. Extracting spurious messages from noise and risk of schizophrenia-spectrum disorders in a prodromal population. Br J Psychiatry. 2007 Oct;191:355-6. doi: 10.1192/bjp.bp.106.031195.
- Background: PubMed 20360211Galdos M, Simons C, Fernandez-Rivas A, Wichers M, Peralta C, Lataster T, Amer G, Myin-Germeys I, Allardyce J, Gonzalez-Torres MA, van Os J. Affectively salient meaning in random noise: a task sensitive to psychosis liability. Schizophr Bull. 2011 Nov;37(6):1179-86. doi: 10.1093/schbul/sbq029. Epub 2010 Apr 1.
- Background: PubMed 20919787Hooker CI, Tully LM, Verosky SC, Fisher M, Holland C, Vinogradov S. Can I trust you? Negative affective priming influences social judgments in schizophrenia. J Abnorm Psychol. 2011 Feb;120(1):98-107. doi: 10.1037/a0020630.
- 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.
Vincent LAPREVOTE principal investigator
Central hospital Nancy, Centre Psychothérapique de Nancy
Questions about this trial
What is this clinical trial studying?
A study testing behavioral task : emotional priming in people with Schizophrenia and Visual Hallucination, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent LAPREVOTE (0033+383926822, vincent.laprevote@cpn-laxou.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of false visual perception on the emotional priming task (time frame: through study completion an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188133, which also lists 4 linked publications.
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 9 Oct 2017; AzTrials last refreshed its copy on 27 Oct 2026.