SchizophreniaFaSchi22NCT02634671
Perception of Facial Emotions in Schizophrenia and 22q11 Deletion Syndrome
A study testing schizophrenia and the 22q11 deletion syndrome in people with Schizophrenia, run by Hôpital le Vinatier.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- schizophrenia and the 22q11 deletion syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Medical drugs with cerebral or psychological effect (e.g, corticosteroids)
- Resistance to antipsychotics
- Electroconvulsive therapy in the previous two months
About this study
Official title: Facial Expression Perception by Intensity in Schizophrenia and 22q11.2 Deletion Syndrome: Neural Electrophysiological Evidence by Means of Fast Periodic Visual Stimulation
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.
Read more
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.
- Conditions
- Schizophrenia
- Being tested
- schizophrenia, the 22q11 deletion syndrome, control group
- Keywords
- schizophrenia, Facial emotions
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
schizophreniaOther
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)
the 22q11 deletion syndromeOther
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)
control groupOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: schizophrenia; Other: 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. Receives: Other: the 22q11 deletion syndrome; Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startNov 2015
- Primary completion20 Oct 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634671
- Sponsor's protocol ID
- 2015-A01247- 42
- Acronym
- FaSchi22
- Status last verified
- Feb 2018
- First submitted
- 16 Dec 2015
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Expression Perception by Intensity in Schizophrenia and 22q11.2 Deletion Syndrome: Neural Electrophysiological Evidence by Means of Fast Periodic Visual Stimulation
- ClinicalTrials.gov ID
- NCT02634671
- Acronym / sponsor ID
- FaSchi22 / 2015-A01247- 42
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, Facial emotions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 22Q11 | Other | Other: schizophrenia, Other: control group24 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. |
| SCHIZOPHRENIA | Other | Other: the 22q11 deletion syndrome, Other: control group24 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. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| schizophreniaThe 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) | Other | 22Q11 |
| the 22q11 deletion syndromeThe 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) | Other | SCHIZOPHRENIA |
| control groupThe 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) | Other | 22Q11, SCHIZOPHRENIA |
Primary outcome
Steady-state visual evoked potentials (SSVEP) recorded during fast periodic visual stimulation (FPVS).
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
A study testing schizophrenia and the 22q11 deletion syndrome in people with Schizophrenia, run by Hôpital le Vinatier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steady-state visual evoked potentials (SSVEP) recorded during fast periodic visual stimulation (FPVS). (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.