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CompletedNCT02634671FaSchi22Updated Feb 8, 2018

Perception of Facial Emotions in Schizophrenia and 22q11 Deletion Syndrome

An interventional study of schizophrenia and the 22q11 deletion syndrome in Schizophrenia, sponsored by Hôpital le Vinatier. Completed. Open to participants aged 15 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-08.

Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
15 Years to 50 Years
Sex
All
01

Study summary

Background:

The present study aims to identify the mechanisms underlying the deficit in facial emotion recognition reported both in schizophrenia and the 22q11.2 deletion syndrome, and thus, reveal a distinction between the two disorders. Indeed, despite the clinical overlap between the two syndromes, some of the symptoms appear to be specific to only one of them. In particular, the disturbance of visual functions is specifically observed in the 22q11.2DS. Hence, the difficulties in facial emotion recognition in schizophrenia and in the 22q11.DS are likely accounted by different cognitive impairments. Investigating which mechanisms are disturbed would allow a specialized support for patients.

Our main hypothesis is that the deficit in facial emotion recognition is more related to visual impairments in the 22q11.2DS than in schizophrenia. This hypothesis will be tested in two groups of patients (22q11.2DS and schizophrenic patients) and a control group (healthy subjects) using an experimental paradigm based on electroencephalography (EEG).

A second aim of this study is to determine whether the severity of the two disorders' symptoms is correlated with the cerebral response to facial expressions. To answer this question, a set of clinical and neuropsychological tests will be conducted for each patient.

Read the detailed description

Methods:

This study will be conducted using visual steady-state visual evoked potentials (SSVEPs). Visual SSVEPs are periodic neural electrophysiological activities that arise in response to fast periodic visual stimulation (FPVS). They will be recorded in response to the periodic presentation of faces, according to an oddball paradigm. While pictures of faces will appear at a 6 Hz rate, only 1 out of 5 will display an emotion, corresponding to a 1.2 Hz oddball frequency. Different emotions will be tested (happiness, sadness, anger, fear and disgust), displayed with different intensities (20%, 60%, 100%). SSVEPs at 6 Hz will reflect general visual mechanisms (in response to a mixture of low-level (i.e., contrast coding) and high-level (i.e., face detection) processes). Importantly, SSVEPs at 1.2 Hz will index the visual mechanisms specifically involved in facial expression perception and their sensitivity to emotion intensity. Both measures will help determine the underlying brain topographies.

Alongside, clinical and neuropsychological tests will be conducted. While the clinical tests will evaluate the severity of the symptoms, the neuropsychological tests will assess different features such as attention, memory, verbal and visuo-spatial abilities. The patients' scores will be linked with their cerebral activity in response to facial expressions.

Outcomes:

To better understand the impairment of facial emotion recognition in schizophrenia and 22q11.2DS and to improve its care.

02

Conditions studied

  • Schizophrenia

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Keywords

  • schizophrenia
  • Facial emotions
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 70 is close to the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged 15-50 years old
  • No psychiatric conditions or comorbidity
  • Agreement from parents if participant is underage
  • Patients with schizophrenia: diagnosis assessed with DSM5 criteria
  • Patients with 22q11.2 DS: diagnosis assessed by genetic tests (CGH- array or FISH)
  • No mental delay (IQ>70 according to the fNART)
  • No modification of psychotropic treatment during the month before inclusion

Exclusion criteria

Exclusion Criteria:

  • Involvement in a current program of social cognition remediation
  • Pregnancy
  • Substance use disorder (criteria of DSM-5), except for caffeine and tobacco
  • Neurologic disorders (vascular, infectious or neurodegenerative)
  • Uncorrected visual deficit
  • Guardianship
  • Medical drugs with cerebral or psychological effect (e.g, corticosteroids)
  • Resistance to antipsychotics
  • Electroconvulsive therapy in the previous two months
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Other
    22Q11

    24 patients with 22Q11DS to determine whether the severity of the two disorders' symptoms is correlated with the cerebral response to facial expressions. To answer this question, a set of clinical and neuropsychological tests will be conducted for each patient.

    Other: schizophrenia · Other: control group

  • Other
    SCHIZOPHRENIA

    24 patients with schizophrenia to determine whether the severity of the two disorders' symptoms is correlated with the cerebral response to facial expressions. To answer this question, a set of clinical and neuropsychological tests will be conducted for each patient.

    Other: the 22q11 deletion syndrome · Other: control group

Interventions

  • Otherschizophrenia

    The present study aims to identify the mechanisms underlying the deficit in facial emotion recognition reported both in schizophrenia with a control group using an experimental paradigm based on electroencephalography (EEG)

  • Otherthe 22q11 deletion syndrome

    The present study aims to identify the mechanisms underlying the deficit in facial emotion recognition reported both in the 22q11.2 deletion syndrome with a control group using an experimental paradigm based on electroencephalography (EEG)

  • Othercontrol group

    The present study aims to identify the mechanisms underlying the deficit in facial emotion recognition reported both in the schizophrenia and 22q11.2 deletion syndrome with a control group using an experimental paradigm based on electroencephalography (EEG)

06

What researchers measure

Primary outcomes

  1. Steady-state visual evoked potentials (SSVEP) recorded during fast periodic visual stimulation (FPVS).

    SSVEPs arise in response to the periodic presentation of emotional faces. They are analyzed in the frequency domain. Two types of responses are expected: the general visual response (6 Hz and its harmonics) and the expression-specific response (1.2 Hz and its harmonics). Both responses will be compared across the different groups.

    Time frame: SSVEPs will be recorded during 20 sequences of emotional faces pictures. As each sequence lasts 80s, the EEG recording will be approximately 30-minutes-long.

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02634671
Lead sponsor
Hôpital le Vinatier
Responsible party
Sponsor
First posted
Dec 18, 2015
Start date
Nov 2015
Primary completion
Oct 20, 2017
Completion
Dec 30, 2017
Last update
Feb 8, 2018

Study contacts

DEMILY CAROLINE, PH
principal investigator · Centre régional de dépistage et de prises en charge des troubles psychiatriques d'origine génétique Pôle Ouest LE VINATIER HOSPITAL

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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