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Recruiting NCT03649581

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

No phase Interventional Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: compare the two groups of schizophrenic patients, compare the two groups of schizophrenic patients versus volunteers.
Who it may be relevant to
Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

  • Index of affect [Time frame: 6 months after inclusion]
  • Index of psychomotoricity [Time frame: 6 months after inclusion]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Service de Psychiatrie I, Hôpital Civil, Hôpitaux Universitaires de Strasbourg — Strasbourg

Identifiers

NCT: NCT03649581 · 7058

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗