Investigation of Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders

Schizophrenia Clinical Trial

— NeuroSplitsz  

Official title:

Investigation of Clinical, Cognitive and Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03649581
• Other study ID #: 7058
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2019
• Est. completion date: February 2, 2027

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Fabrice BERNA, MD
• Phone: 03 88 11 64 62
• Email: fabrice.berna[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Other:
• compare the two groups of schizophrenic patients
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: abnormalities of markers related to affectivity in Hebephrenia (with preservation of these markers in periodic catatonia), abnormalities of markers related to psychomotricity in periodic catatonia (with markers of these tests in Hebephrenia).
• compare the two groups of schizophrenic patients versus volunteers
compare the results of the schizophrenic patient group with healthy volunteers

Locations

Country	Name	City	State
France	Service de Psychiatrie I, Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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