An interventional study of blood sample taken in Schizophrenia, Bipolar Disorder and Alzheimer Disease, sponsored by Hôpital le Vinatier. Recruiting at 2 sites in France. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Diagnostic
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Among 32 studies in Schizophrenia by Hôpital le Vinatier — 6 open to participants now, 6 under way, none of them phase 3. Schizophrenia · Hôpital le Vinatier.
Among the 32 studies in Schizophrenia by Hôpital le Vinatier, this one is the 7th largest by planned enrollment of the 31 interventional ones that give a count, is one of 2 that started in 2021, is one of 31 with no phase, and was the 28th registered.
3,567 studies on the registry are indexed under Schizophrenia; 493 are open to participants now.
Browse Schizophrenia studies →6 of the 32 studies in Schizophrenia by Hôpital le Vinatier are open now, in 1 country. Recruiting first, the newest first:
Hôpital le Vinatier · Sites in France
Ages 18+
Hôpital le Vinatier · Sites in France
Ages 18–45 · Healthy volunteers
Hôpital le Vinatier · Sites in France
Ages 18–40
Hôpital le Vinatier
Ages 18–65 · Healthy volunteers
Hôpital le Vinatier · Sites in France
Ages 18–50
By country, each count listing its studies:
Of the 332 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 258 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 45 Years to 80 Years · all sexes · no healthy volunteers.
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32 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2021.
This study's planned enrollment of 120 is above the median of 71 across 2,947 interventional studies indexed under Schizophrenia.
Median enrollment 60 across the 31 interventional studies, 515 across the 1 observational. Of the 24 that completed or were terminated, 0 (0%) have results posted.
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Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.
2 of the studies in Schizophrenia by Hôpital le Vinatier that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04237155Hôpital le VinatierFrench Source-monitoring Task | 2027-02-01 |
| NCT04946916Hôpital le VinatierNeurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease | 2027-03-22 |
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Among the 32 studies in Schizophrenia by Hôpital le Vinatier, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The validation of biomarkers allowing the discrimination of cognitive and behavioral disorders of psychiatric origin from those of neurodegenerative origin would facilitate diagnosis and improve patient management. Neurofilaments, which are markers of neuronal lysis, appear to be a promising biomarker. In a previous preliminary study, the investigators demonstrated significantly lower concentrations of neurofilaments in CSF of psychiatric patients compared to neurodegenerative diseases.
The main objective of this study is to validate the plasma assay of neurofilament light chain as a biomarker for the differential diagnosis of psychiatric or neurodegenerative cognitive impairment. Other biomarkers of interest (Tau, TDP-43, GFAP and UCH-L1) will also be analyzed.
A sub-part of this study will also focus on the retrospective analysis of the CSF/Plasma correlations of the different biomarkers mentioned above from tube bottom samples taken in routine care.
One hundred twenty participants will be included in this study
All the participants will perform cognitive, behavioral, and psychiatric evaluation and will be have blood sample taken.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with psychiatric conditions:
Participants with neurodegenerative disease:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the psychiatric condition group without cognitive impairment will be included participants with schizophrenia or bipolar disorder according to DSM V criteria.
Diagnostic Test: blood sample taken
In the psychiatric condition group with cognitive impairment will be included participants with schizophrenia or bipolar disorder according to DSM V criteria. To date, there are no clinical criteria for defining the dementia evolution of psychiatric disorders. The diagnosis of psychiatric disorder with cognitive involution is often made on the basis of subjective criteria or on the appreciation of health care teams. In the present study, cognitive involution will be defined by the occurrence of cognitive deterioration objectified by disturbed neuropsychological tests and the occurrence of progressive behavioral changes contrasting with the person's previous state and reported by the care team, a member of the family or by the patient himself. Cognitive involution must be accompanied by a decrease in autonomy with respect to the person's previous abilities.
Diagnostic Test: blood sample taken
Alzheimer's disease with frontal, amnestic, language, and visual presentation with typical Alzheimer CSF according to the 2011 NIA-AA diagnostic criteria.
Diagnostic Test: blood sample taken
Probable or definite Fronto-temporal dementia, mostly behavioral variant of FTD (according to the diagnostic criteria for FTDb of Rascovsky, 2011) but Semantic Disease, Primary Progressive Non-Fluent Aphasia, Progressive Supra-Nuclear Palsy-DFT will be accepted if behavioral onset.
Diagnostic Test: blood sample taken
Comparaison of Neurofilament light chain serum concentration between the arms
Also known as: Cognitive tests and psychiatric questionnaires
neurofilament light chain
serum neurofilament light chain concentration
Time frame: two months
Total tau
serum tau protein concentration
Time frame: two months
GFAP Glial fibrillary acidic protein
Serum GFAP concentration
Time frame: two months
neurofilament heavy chain (pNF-h)
Serum neurofilament heavy chain (pNF-h) concentration
Time frame: two months
Plan to share: Yes — Clinical and biological IPD
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 4 years
Access criteria: all criterias
No publications or documents are linked to this record.
Started Oct 2021 (actual). Primary completion is estimated for Mar 2027, 65 months after the start.
Of 756 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 65 months is above that.
Counting every sponsor, half of 769 studies reached it within 32 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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