NCT03649581 Investigation of Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders
| NCT ID | NCT03649581 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2019-02-28 |
| Primary Completion | 2027-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2019-02-28 with a primary completion date of 2027-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03649581 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03649581 currently recruiting?
Yes, NCT03649581 is actively recruiting participants. Contact the research team at fabrice.berna@chru-strasbourg.fr for enrollment information.
Where is the NCT03649581 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT03649581 clinical trial?
NCT03649581 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 84 participants.
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