NCT05464563Completed
Study by Electroencephalography of the Link Between the Lack of Self-compassion and the Disorder of Empathy in Schizophrenia
Source: ClinicalTrials.gov · Last updated 20 Aug 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 21 Apr 2022
- Start date
- 22 Mar 2022
- Primary completion date
- 1 Jan 2024
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Diseases
- Schizophrenia
- NCT number
- NCT05464563
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 22 Mar 2022 to the primary completion date, 1 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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 not stabilized for their psychotic disorders and with regard to their antipsychotic treatments
- 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
- 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 with a medical condition preventing them from participating in the study
Age
- patients with disease duration \< 2 years or \> 20 years
- patients aged \< 18 years or \> 60 years
- subjects aged \< 18 years or \> 60 years
Other
- patients with an addiction to alcohol or other toxic substances, except tobacco
- patients with suicidal intentionality
- 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 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 mental deficiency
- subjects with neurological pathology
- 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
Who the study is looking for
- 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)
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Henri Laborit Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.