NCT02634671

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Nov 2015

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

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

December 16, 2015

Last Update Submit

February 7, 2018

Conditions

Keywords

schizophreniaFacial emotions

Outcome Measures

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.

    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.

Study Arms (2)

22Q11

OTHER

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: schizophreniaOther: control group

SCHIZOPHRENIA

OTHER

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 syndromeOther: control group

Interventions

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)

22Q11

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)

SCHIZOPHRENIA

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)

22Q11SCHIZOPHRENIA

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • DEMILY CAROLINE, PH

    Centre régional de dépistage et de prises en charge des troubles psychiatriques d'origine génétique Pôle Ouest LE VINATIER HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 18, 2015

Study Start

November 1, 2015

Primary Completion

October 20, 2017

Study Completion

December 30, 2017

Last Updated

February 8, 2018

Record last verified: 2018-02