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

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Other: compare the two groups of schizophrenic patients; Other: compare the two groups of schizophrenic patients versus volunteers

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabrice BERNA, MD; Phone Number: 03 88 11 64 62; Email: fabrice.berna@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service de Psychiatrie I, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
    • Sub-Investigator: Jack FOUCHER, MD
    • Sub-Investigator: Olivier MAINBERGER, MD
    • Contact: Fabrice BERNA, MD; Phone Number: 33388116462; Email: fabrice.berna@chru-strasbourg.fr
    • Principal Investigator: Fabrice BERNA, MD
    • Sub-Investigator: Julie CLAUSS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: healthy volunteers	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).; Other: compare the two groups of schizophrenic patients versus volunteers; compare the results of the schizophrenic patient group with healthy volunteers
Experimental: patient with schizophrenia and periodic catatonia	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).; Other: compare the two groups of schizophrenic patients versus volunteers; compare the results of the schizophrenic patient group with healthy volunteers
Experimental: patient with schizophrenia and hebephrenia	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).; Other: compare the two groups of schizophrenic patients versus volunteers; compare the results of the schizophrenic patient group with healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 7058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No