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

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ClinicalTrials.gov Identifier: NCT03649581
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Other: compare the two groups of schizophrenic patients Other: compare the two groups of schizophrenic patients versus volunteers Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of Clinical, Cognitive and Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : February 2, 2023
Estimated Study Completion Date : February 2, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:

  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).

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:

  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).

Other: compare the two groups of schizophrenic patients versus volunteers
compare the results of the schizophrenic patient group with healthy volunteers

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:

  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).

Other: compare the two groups of schizophrenic patients versus volunteers
compare the results of the schizophrenic patient group with healthy volunteers




Primary Outcome Measures :
  1. Index of affect [ Time Frame: 6 months after inclusion ]
    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

  2. Index of psychomotoricity [ Time Frame: 6 months after inclusion ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649581


Contacts
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Contact: Fabrice BERNA, MD 03 88 11 64 62 fabrice.berna@chru-strasbourg.fr

Locations
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France
Service de Psychiatrie I, Hôpital Civil, Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Fabrice BERNA, MD    33388116462    fabrice.berna@chru-strasbourg.fr   
Principal Investigator: Fabrice BERNA, MD         
Sub-Investigator: Jack FOUCHER, MD         
Sub-Investigator: Julie CLAUSS, MD         
Sub-Investigator: Olivier MAINBERGER, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03649581    
Other Study ID Numbers: 7058
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders