NCT02874482

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2019

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

5.4 years

First QC Date

August 17, 2016

Last Update Submit

August 25, 2020

Conditions

Keywords

SchizophreniaChange blindnessEye trackingImplicit response

Outcome Measures

Primary Outcomes (1)

  • response time

    The explicit response of the participants will be measure behaviourally by response time before the detection of neutral stimuli.

    42 months

Secondary Outcomes (3)

  • sensitivity index

    42 months

  • implicit response

    42 months

  • emotional response

    42 months

Study Arms (2)

Patients with schizophrenia

30 patients with schizophrenia (diagnosis based on the standard DSM criteria)

Controls

30 healthy controls without any psychiatric or neurological diagnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 patients with schizophrenia and 30 healthy controls

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Guillaume VAIVA

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 22, 2016

Study Start

July 1, 2014

Primary Completion

November 17, 2019

Study Completion

November 17, 2019

Last Updated

August 26, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations