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Investigation of Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders (NeuroSplitsz)

Primary Purpose

Schizophrenia

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

compare the two groups of schizophrenic patients

compare the two groups of schizophrenic patients versus volunteers

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Service de Psychiatrie I, Hôpital Civil, Hôpitaux Universitaires de StrasbourgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

patient with schizophrenia and periodic catatonia

patient with schizophrenia and hebephrenia

healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03649581

First Posted

August 21, 2018

Last Updated

August 18, 2023

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT03649581

Brief Title

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

Acronym

NeuroSplitsz

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 28, 2019 (Actual)

Primary Completion Date

February 2, 2027 (Anticipated)

Study Completion Date

February 2, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patient with schizophrenia and periodic catatonia

Arm Type

Experimental

Arm Title

patient with schizophrenia and hebephrenia

Arm Type

Experimental

Arm Title

healthy volunteers

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

compare the two groups of schizophrenic patients

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

compare the two groups of schizophrenic patients versus volunteers

Intervention Description

compare the results of the schizophrenic patient group with healthy volunteers

Primary Outcome Measure Information:

Title

Index of affect

Description

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

Time Frame

6 months after inclusion

Title

Index of psychomotoricity

Description

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

Time Frame

6 months after inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fabrice BERNA, MD

Phone

03 88 11 64 62

fabrice.berna@chru-strasbourg.fr

Facility Information:

Facility Name

Service de Psychiatrie I, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Individual Site Status

Recruiting

Facility Contact: