Psychotic Disorder Clinical Trial
— ALTER-EGOOfficial title:
Study of Self-Recognition and Self/Other Distinction Disorders in Patients With Psychological Vulnerability (ALTER EGO)
The main objective of this study is to establish whether there are differences in self-recognition and self/other distinction in subjects with psychological vulnerability compared to healthy volunteer controls.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | July 31, 2027 |
Est. primary completion date | July 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 25 Years |
Eligibility | Inclusion criteria for patients: - Aged from 15 to 25 years - Subject meeting the Ultra High Risk criteria at CAARMS and / or SPI-A - Signature of the consent (participants and parents for minors) - Subject affiliated to the social security scheme or benefiting from such a scheme Inclusion criteria for healthy volunteers: - Aged from 15 to 25 years - Subject not familiar to the patient to whom it is matched - Signature of the consent (participants and parents for minors) - Subject affiliated to the social security scheme or benefiting from such a scheme Exclusion Criteria for both patients and healthy volunteers: - History of epilepsy and / or migraine (due to the epileptogenic potential of light stimuli) - Refusal of participation of the minor even if the legal representatives want the subject to participate in the study - Claustrophobia - Wearing glasses - Abnormal right and left visual acuity without contact lenses - Distinctive signs on the face which cannot be temporarily removed - Subject under legal protection (curators / guardianship) or deprived of liberty |
Country | Name | City | State |
---|---|---|---|
France | CHRU BREST Hôpital de Bohars | Bohars |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average of the three M1 | Average of the three M1 thresholds obtained from the "round trip" manipulation repeated three times, the M1 threshold corresponding to the level of luminosity from which a subject begins to recognize himself when his own image gradually appears (during the passage of the condition glass in mirror condition). | Inclusion | |
Secondary | The average of the three M2 | The average of the three M2 thresholds obtained from the "round trip" manipulation repeated three times, the M2 threshold corresponding to the level of brightness from which a subject ceases to recognize himself to recognize the other (passage of the mirror mode to window mode). | Inclusion | |
Secondary | Results to tests for early prodromal symptoms assessed by SPI-A (Schizophrenia Prediction Instrument for Adults) | • Hetero-questionnaire of SPI-A : intensity, type and frequency of symptoms : The answer "yes" to the COPER (Cognitive-Perceptive Basic Symptoms) and / or COGDIS (Cognitive Disturbances) criteria points to at risk mental state. | Inclusion | |
Secondary | Results to tests for early prodromal symptoms assessed by PQ16 (Prodromal Questionnaire - 16) | • Self-administered questionnaire PQ16 : intensity, type and frequency of symptoms : The minimum score is 0 and maximum 16 meaning a higher state of risk. | Inclusion | |
Secondary | Results to tests for early prodromal symptoms assessed by EASE(xamination of Anomalous Self-Experience) | • Self-experience anomalies evaluation scale : EASE, Parnas, 2003), until now not carried out as part of the routine monitoring of CEVUP (Consultation d'Evaluation de la VUlnérabilité Psychique = Psychic Vulnerability Assessment Consultation) patients : score between 0 and 57, the higher the score, the greater the risk of psychosis | Inclusion | |
Secondary | Results to tests for later prodromal symptoms | CAARMS (Comprehensive Assessment of At-Risk Mental States) and its sub-assemblies : if the patient is at risk of psychosis, the test will classify this risk into one of the three following categories : group of trait and state risk factor, group of attenuated psychotic symptoms, group of BLIPS (Brief, Limited or Intermittent Psychotic Symptoms) | Inclusion | |
Secondary | Results to tests concerning the peculiarities of cognitive functioning (neuropsychological assessment) assessed by Wechsler scale | • Wechsler scale : neurocognitive assessment : Total intelligence quotient (between 60 and 140 approximately) Verbal comprehension index: 50 to 160 Perceptual reasoning index: 50 to 160 Working memory index: 50 to 160 Processing speed index: 50 to 160 | Inclusion | |
Secondary | Results to social functioning test: | • Alterations in social functioning at SOFAS : Social and Occupational Functioning Assessment Scale : score theoretically between 0 and 100%. The lower the score, the worse the subject's functioning and therefore the higher the vulnerability. | Inclusion |
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