NCT03649581

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
9mo left

Started Feb 2019

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Feb 2019Feb 2027

First Submitted

Initial submission to the registry

August 21, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

February 28, 2019

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2027

Last Updated

August 3, 2025

Status Verified

August 1, 2025

Enrollment Period

7.9 years

First QC Date

August 21, 2018

Last Update Submit

August 1, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

patient with schizophrenia and periodic catatonia

EXPERIMENTAL
Other: compare the two groups of schizophrenic patientsOther: compare the two groups of schizophrenic patients versus volunteers

patient with schizophrenia and hebephrenia

EXPERIMENTAL
Other: compare the two groups of schizophrenic patientsOther: compare the two groups of schizophrenic patients versus volunteers

healthy volunteers

ACTIVE COMPARATOR
Other: compare the two groups of schizophrenic patientsOther: compare the two groups of schizophrenic patients versus volunteers

Interventions

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).

healthy volunteerspatient with schizophrenia and hebephreniapatient with schizophrenia and periodic catatonia

compare the results of the schizophrenic patient group with healthy volunteers

healthy volunteerspatient with schizophrenia and hebephreniapatient with schizophrenia and periodic catatonia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 28, 2018

Study Start

February 28, 2019

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Last Updated

August 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations