- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03188133
Visual Information Processing in Schizophrenia Patients With Visual Hallucinations (SHALL)
Top Down Visual Information Processing in Schizophrenia Patients With Visual Hallucinations
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vincent LAPREVOTE
- Phone Number: 0033+383926822
- Email: vincent.laprevote@cpn-laxou.com
Study Contact Backup
- Name: Florent BERNARDIN
- Phone Number: 0033+383925034
- Email: florent.bernardin@cpn-laxou.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VH
schizophrenia patients with visual hallucinations
|
emotional priming task on ambiguous visual stimuli
|
Active Comparator: AH/NH
schizophrenia patients with auditory hallucinations or no hallucinations
|
emotional priming task on ambiguous visual stimuli
|
Active Comparator: C
healthy controls
|
emotional priming task on ambiguous visual stimuli
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
through study completion an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
The investigators will investigate if the manipulated valence of the emotional priming task influences the number of false visual perceptions of ambiguous stimuli
|
through study completion an average of 6 months
|
Cognitive performances at the neuropsychological assessment
Time Frame: through study completion an average of 6 months
|
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).
|
through study completion an average of 6 months
|
Psychosensory hallucinations scale scores
Time Frame: through study completion an average of 6 months
|
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.
|
through study completion an average of 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincent LAPREVOTE, Central hospital Nancy, Centre Psychothérapique de Nancy
Publications and helpful links
General 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.
- Hoffman 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.
- Galdos 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.
- Hooker 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID-RCB/2017-A01058-45
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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