Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03188133
Other study ID # ID-RCB/2017-A01058-45
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 9, 2017
Last updated October 6, 2017
Start date October 17, 2017
Est. completion date October 31, 2020

Study information

Verified date October 2017
Source Central Hospital, Nancy, France
Contact Vincent LAPREVOTE
Phone 0033+383926822
Email vincent.laprevote@cpn-laxou.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date October 31, 2020
Est. primary completion date May 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Intervention

Other:
behavioral task : emotional priming
emotional priming task on ambiguous visual stimuli

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) through study completion an average of 6 months
Secondary 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 through study completion an average of 6 months
Secondary 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). through study completion an average of 6 months
Secondary 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. through study completion an average of 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A