Investigation of Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders
NeuroSplitsz
Investigation of Clinical, Cognitive and Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders
1 other identifier
interventional
84
1 country
1
Brief Summary
The current diagnostic criteria for schizophrenia and other psychotic disorders are relatively broad and lack precision. Therefore, distinct diseases may be grouped together under the same diagnostic category, although these diseases may differ according to their clinical expression, prognosis and perhaps their physiopathological causes. We think that identifying subforms of psychotic disorders that are more homogeneous will better enable to understand their respective physiopathological causes and find personalized treatments. This study will compare two subforms of psychotic disorders that have been clinically distinguished in the 1970s. These phenotypes have however not been validated yet using scientific investigations. Using clinical assessments, cognitive evaluations and neurophysiological measures (fMRI) investigating the domains of affect and psychomotoricity , we expect that these two subforms will differ on their clinical, cognitive and neurophysiological characteristics, namely: hebephrenia will be associated with deficits on the affect markers , and respect psychomotoricity (catatonia scales, tests assessing movement planification) whereas the opposite pattern will be observed for periodic catatonia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable schizophrenia
Started Feb 2019
Longer than P75 for not_applicable schizophrenia
1 active site
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
First Submitted
Initial submission to the registry
August 21, 2018
CompletedFirst Posted
Study publicly available on registry
August 28, 2018
CompletedStudy Start
First participant enrolled
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 2, 2027
August 3, 2025
August 1, 2025
7.9 years
August 21, 2018
August 1, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Index of affect
Compare two groups of markers relating respectively to affectivity in two subforms of schizophrenia: periodic catatonia and hebephrenia in order to highlight a possible double dissociation
6 months after inclusion
Index of psychomotoricity
Compare two groups of markers relating to psychomotricity in two subforms of schizophrenia: periodic catatonia and hebephrenia in order to highlight a possible double dissociation
6 months after inclusion
Study Arms (3)
patient with schizophrenia and periodic catatonia
EXPERIMENTALpatient with schizophrenia and hebephrenia
EXPERIMENTALhealthy volunteers
ACTIVE COMPARATORInterventions
Compare two groups of markers relating respectively to psychomotricity and affectivity in two subforms of schizophrenia: periodic catatonia and hebephrenia in order to highlight a possible double dissociation: 1. abnormalities of markers related to affectivity in Hebephrenia (with preservation of these markers in periodic catatonia), 2. abnormalities of markers related to psychomotricity in periodic catatonia (with markers of these tests in Hebephrenia).
compare the results of the schizophrenic patient group with healthy volunteers
Eligibility Criteria
You may qualify if:
- for both patients and controls
- male or female willing to participate and who have signed up the legal document
- under the protection of health insurance for patients only
- schizophrenia or schizo-affective disorder according to the DSM-5 criteria
- periodic catatonia or hebephrenia accordin to WKL classification
- clinically stable for at least 2 months
- in or out patients for controls only
- no psychiatric history
You may not qualify if:
- for both patients and controls
- current severe or unstable somatic illness
- neurological history (epilepsia, brain injury, brain surgery…)
- current substance use disorder (DSM-5)
- current major depressive disorder (DSM-5)
- mental retardation (IQ \< 70)
- pregnancy, breast feeding
- current legal control
- contra-indication for fMRI for controls only psychotropic intake during the last 3 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Psychiatrie I, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2018
First Posted
August 28, 2018
Study Start
February 28, 2019
Primary Completion (Estimated)
February 2, 2027
Study Completion (Estimated)
February 2, 2027
Last Updated
August 3, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share