SchizophreniaSCE-SCHIZONCT05464563
Study by Electroencephalography of the Link Between the Lack of Self-compassion and the Disorder of Empathy in Schizophrenia
A study testing Electroencephalogram in people with Schizophrenia and Schizoaffective Disorder, run by Centre Hospitalier Henri Laborit at 1 site in France.
Trial summary
This research project focuses on a fundamental element of the psychopathology of schizophrenia, that is to say, the disorders of self-awareness and on the functional alterations associated with it, that is to say, self-compassion deficit and empathy disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Electroencephalogram
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2022to 1 Jan 2024
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with a schizophrenic or schizoaffective disorder according to the DSM-5 criteria (axis 1), with no other pathology of axis 1, except addiction to tobacco
- patients stabilized for at least 3 months for their psychotic disorders
- patients with disease duration > 2 years but < 20 years
- patients whose treatment has not been changed or modified in the previous month
- patients on stable treatments who should not change treatment during the study (good compliance, good tolerance)
- patients who do not benefit from a neuromodulation protocol for their symptoms (rTMS, TDCS)
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- patients who do not benefit from a cognitive remediation program
- patients between the ages of 18 and 60
- men and women
- patients with normal or corrected vision
- patients without mental impairment
- patients without neurological impairment (epilepsy, encephalopathy, head trauma)
- patients with a sufficient command of French
- patients free or under protective measures
- patients benefiting from coverage by a social security scheme or benefiting from it through a third party
- Having given their consent to participate in the study after having received written, clear and fair information (and after obtaining the consent of the tutor/curator if applicable)
- healthy volunteers without schizophrenic or schizoaffective disorder and without other psychiatric pathologies as defined by the DSM 5 (axis 1) (in particular, absence of psychic trauma revealed by the MINI and of PTSD (current as whole life))
- subjects aged 18 to 60
- men and women
- subjects with normal or corrected vision
- subjects without mental impairment
- subjects without neurological impairment (epilepsy, encephalopathy, head trauma)
- free subjects, without guardianship or curatorship or subordination
- subjects benefiting from coverage by a social security scheme or benefiting from it through a third party
- Having given their consent to participate in the study after having received written, clear and honest information.
Who cannot join
- patients with an axis 1 pathology other than a schizophrenic or schizoaffective disorder (in particular, psychic trauma revealed by MINI and symptoms of PTSD (current as lifetime))
- patients with an addiction to alcohol or other toxic substances, except tobacco
- patients with suicidal intentionality
- patients not stabilized for their psychotic disorders and with regard to their antipsychotic treatments
- patients receiving antiepileptic treatment with mood-regulating, antidepressant and anxiolytic properties
- patients receiving benzodiazepine treatment that they could not stop 72 hours before the EEG
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- patients with disease duration < 2 years or > 20 years
- patients with an IQ < 70
- patients benefiting from a neuromodulation protocol (rTMS, TDCS)
- patients benefiting from a cognitive remediation program
- patients with a PANSS > or = 5 for items G8 (hostility) and P7 (non-cooperation)
- patients aged < 18 years or > 60 years
- patients with mental impairment
- patients with neurological impairment (epilepsy, encephalopathy, head trauma)
- patients with documented neurological pathology or medical condition that may explain the psychotic manifestations
- patients who do not speak French well enough
- subjects residing within a radius greater than 50 km from the hospital
- patients hospitalized under duress
- patients without social security
- subjects with a psychiatric pathology as defined in the DSM-5 (axis 1) (in particular, psychic trauma revealed by the MINI and symptoms of PTSD (current as lifetime))
- subjects aged < 18 years or > 60 years
- subjects with a mental deficiency
- subjects with neurological pathology
- subjects with a medical condition preventing them from participating in the study
- subjects residing within a radius greater than 50 km from the hospital
- subjects under guardianship or curatorship
- subjects not benefiting from a Social Security scheme or not benefiting from it through a third party
Trial locations and contacts
1 site in 1 country.
About this study
This research project focuses on a fundamental element of the psychopathology of schizophrenia, that is to say, the disorders of self-awareness and on the functional alterations associated with it, that is to say, self-compassion deficit and empathy disorder.
It will be a question of better understanding the neuro-functional mechanisms which underlie the lack of self-compassion and the disorder of empathy in schizophrenia, the relationship that these disorders maintain between them but also the relationship that they maintain with the general psychopathology of schizophrenia and, in particular, with the abnormalities of the self. In other words, the overall framework of this project is that of the link between the psychopathology of schizophrenia and the functional impairment associated with it. Its specific field of application is that of the link between self-awareness disorders, self-compassion deficit and empathy disorder. For this, this project proposes a methodological approach combining the recording of intrinsic and extrinsic brain activity using high-density electroencephalography (EEG).
Read the detailed description
This study includes patients (n=30) and healthy volunteers (n=30).
At inclusion visit, participants have:
- a psychiatric evaluation;
- self evaluation of: empathy, self-compassion, émotionnel processing, anxiety, insight, perceptual aberration and quality of life;
- training to practise of self-compassion and empathy (for patients only).
During the phase of experimentation, the participants have electroencephalogram exams during a rest phase, a self-compasion task and an empathy task.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Electroencephalogram
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalogramDevice
An electroencephalogram is recorded during a task of rest then self-compassion and then empathy.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | Patients have electroencephalogram records during :
* a phase of rest;
* a task of self-compassion
* a task of empathy. Receives: Device: Electroencephalogram |
| Control group | Experimental | Healthy volunteers have electroencephalogram records during :
* a phase of rest;
* a task of self-compassion
* a task of empathy. Receives: Device: Electroencephalogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the temporal parameters of the EEG microstates C, D, E and F (duration, contribution, occurrence) and the inter-subject correlation index during the practice of self-compassion and the practice of empathy.
Correlation between the temporal parameters of the EEG microstates C, D, E and F (duration, contribution, occurrence) and the inter-subject correlation index during the practice of self-compassion and the practice of empathy.
Measured: through study completion, an average of 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start22 Mar 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
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.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464563
- Sponsor's protocol ID
- 2021-A01913-38
- Acronym
- SCE-SCHIZO
- Status last verified
- Aug 2024
- First submitted
- 21 Apr 2022
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study by Electroencephalography of the Link Between the Lack of Self-compassion and the Disorder of Empathy in Schizophrenia
- ClinicalTrials.gov ID
- NCT05464563
- Acronym / sponsor ID
- SCE-SCHIZO / 2021-A01913-38
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Henri LaboritUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 19 Jul 2022 (actual)
- 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.
This research project focuses on a fundamental element of the psychopathology of schizophrenia, that is to say, the disorders of self-awareness and on the functional alterations associated with it, that is to say, self-compassion deficit and empathy disorder.
It will be a question of better understanding the neuro-functional mechanisms which underlie the lack of self-compassion and the disorder of empathy in schizophrenia, the relationship that these disorders maintain between them but also the relationship that they maintain with the general psychopathology of schizophrenia and, in particular, with the abnormalities of the self. In other words, the overall framework of this project is that of the link between the psychopathology of schizophrenia and the functional impairment associated with it. Its specific field of application is that of the link between self-awareness disorders, self-compassion deficit and empathy disorder. For this, this project proposes a methodological approach combining the recording of intrinsic and extrinsic brain activity using high-density electroencephalography (EEG).
Detailed description
This study includes patients (n=30) and healthy volunteers (n=30).
At inclusion visit, participants have:
- a psychiatric evaluation;
- self evaluation of: empathy, self-compassion, émotionnel processing, anxiety, insight, perceptual aberration and quality of life;
- training to practise of self-compassion and empathy (for patients only).
During the phase of experimentation, the participants have electroencephalogram exams during a rest phase, a self-compasion task and an empathy task.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | Experimental | Device: ElectroencephalogramPatients have electroencephalogram records during : * a phase of rest; * a task of self-compassion * a task of empathy. |
| Control group | Experimental | Device: ElectroencephalogramHealthy volunteers have electroencephalogram records during : * a phase of rest; * a task of self-compassion * a task of empathy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- patients with a schizophrenic or schizoaffective disorder according to the DSM-5 criteria (axis 1), with no other pathology of axis 1, except addiction to tobacco
- patients stabilized for at least 3 months for their psychotic disorders
- patients with disease duration > 2 years but < 20 years
- patients whose treatment has not been changed or modified in the previous month
- patients on stable treatments who should not change treatment during the study (good compliance, good tolerance)
Key exclusion criteria (27 listed)
- patients with an axis 1 pathology other than a schizophrenic or schizoaffective disorder (in particular, psychic trauma revealed by MINI and symptoms of PTSD (current as lifetime))
- patients with an addiction to alcohol or other toxic substances, except tobacco
- patients with suicidal intentionality
- patients not stabilized for their psychotic disorders and with regard to their antipsychotic treatments
- patients receiving antiepileptic treatment with mood-regulating, antidepressant and anxiolytic properties
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 |
|---|---|---|
| ElectroencephalogramAn electroencephalogram is recorded during a task of rest then self-compassion and then empathy. | Device | Control group, Patient group |
Primary outcome
Correlation between the temporal parameters of the EEG microstates C, D, E and F (duration, contribution, occurrence) and the inter-subject correlation index during the practice of self-compassion and the practice of empathy.
Time frame: through study completion, an average of 36 months.
Correlation between the temporal parameters of the EEG microstates C, D, E and F (duration, contribution, occurrence) and the inter-subject correlation index during the practice of self-compassion and the practice of empathy.
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 20 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalogram in people with Schizophrenia and Schizoaffective Disorder, run by Centre Hospitalier Henri Laborit at 1 site in France.
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 25 inclusion and 27 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 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Correlation between the temporal parameters of the EEG microstates C, D, E and F (duration, contribution, occurrence) and the inter-subject correlation index during the practice of self-compassion and the practice of empathy. (time frame: through study completion, an average of 36 months.). 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 20 Aug 2024.