SchizophreniaNeuroSplitszNCT03649581
Investigation of Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders
A study testing compare the two groups of schizophrenic patients and compare the two groups of schizophrenic patients versus volunteers in people with Schizophrenia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- compare the two groups of schizophrenic patients and compare the two groups of schizophrenic patients versus volunteers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2019to 2 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- pregnancy, breast feeding
- current legal control
- contra-indication for fMRI for controls only psychotropic intake during the last 3 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Psychiatrie I, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Fabrice BERNA, MD, 33388116462, fabrice.berna@chru-strasbourg.fr
Fabrice BERNA, MD
About this study
Official title: Investigation of Clinical, Cognitive and Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders
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.
Read more
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.
- Conditions
- Schizophrenia
- Being tested
- compare the two groups of schizophrenic patients, compare the two groups of schizophrenic patients versus volunteers
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compare the two groups of schizophrenic patientsOther
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).
compare the two groups of schizophrenic patients versus volunteersOther
compare the results of the schizophrenic patient group with healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| patient with schizophrenia and periodic catatonia | Experimental | Not described Receives: Other: compare the two groups of schizophrenic patients; Other: compare the two groups of schizophrenic patients versus volunteers |
| patient with schizophrenia and hebephrenia | Experimental | Not described Receives: Other: compare the two groups of schizophrenic patients; Other: compare the two groups of schizophrenic patients versus volunteers |
| healthy volunteers | Active comparator | Not described Receives: Other: compare the two groups of schizophrenic patients; Other: compare the two groups of schizophrenic patients versus volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start28 Feb 2019
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649581
- Sponsor's protocol ID
- 7058
- Acronym
- NeuroSplitsz
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2018
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Clinical, Cognitive and Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders
- ClinicalTrials.gov ID
- NCT03649581
- Acronym / sponsor ID
- NeuroSplitsz / 7058
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patient with schizophrenia and periodic catatonia | Experimental | Other: compare the two groups of schizophrenic patients, Other: compare the two groups of schizophrenic patients versus volunteers |
| patient with schizophrenia and hebephrenia | Experimental | Other: compare the two groups of schizophrenic patients, Other: compare the two groups of schizophrenic patients versus volunteers |
| healthy volunteers | Active comparator | Other: compare the two groups of schizophrenic patients, Other: compare the two groups of schizophrenic patients versus volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| compare the two groups of schizophrenic patientsCompare 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 | healthy volunteers, patient with schizophrenia and hebephrenia, patient with schizophrenia and periodic catatonia |
| compare the two groups of schizophrenic patients versus volunteerscompare the results of the schizophrenic patient group with healthy volunteers | Other | healthy volunteers, patient with schizophrenia and hebephrenia, patient with schizophrenia and periodic catatonia |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compare the two groups of schizophrenic patients and compare the two groups of schizophrenic patients versus volunteers in people with Schizophrenia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrice BERNA, MD (03 88 11 64 62, fabrice.berna@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index of affect (time frame: 6 months after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.