Treatment Resistance in Psychiatric Disorders: the Search for Biological Markers Predictive of Response to Treatment (BIO-INM)
27 juli 2026 bijgewerkt door: Centre Hospitalier St Anne
The disruption of immune system is a key candidate in the pathogenesis of psychiatric disorders, especially those resistant to traditional treatments. Involving complex processes within the brain and peripheral immune system, inflammation may lead to imbalance of neurotransmitter systems and synaptic plasticity and directly contribute to the psychiatric symptoms observed in conditions such as depression, bipolar disorder (BD) and schizophrenia (SCZ).
Studies show that treatment-resistant depression (TRD) is associated with elevated levels of inflammatory markers in the blood, which are linked to a lower response to conventional antidepressants. Interventions that modulate this inflammatory response, such as immunomodulatory treatments or therapies targeting pro-inflammatory cytokines, have demonstrated beneficial effects by reducing symptoms and improving patients' quality of life.
A thorough understanding of the links between inflammation and treatment resistance therefore paves the way for innovative therapeutic strategies. These approaches could transform current practices by offering more personalized and effective solutions for patients suffering from chronic and resistant psychiatric disorders.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
700
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Iolanda PALIMARU, MD
- Telefoonnummer: +33145658798
- E-mail: iolanda.palimaru@ghu-paris.fr
Studie Locaties
-
-
-
Paris, Frankrijk, 75014
- GHU Paris - Psychiatrie et Neurosciences
-
Contact:
- Cécile MICHEL
- Telefoonnummer: +331 80 52 70 19
- E-mail: cecile.bultez@ghu-paris.fr
-
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Patient aged ≥ 18 years old;
- Patient suffering from a psychiatric disorder according to DSM-5 criteria;
- Patient with drug-resistant disease according to the definition of the protocol
- Patient starting a new treatment for his pathology;
- Patient informed and having signed an informed consent;
- Patient covered by the social security system.
Exclusion Criteria:
- Patient with major neurocognitive disorder diagnosed (dementia syndrome)
- Pregnant, laboring, or breastfeeding female patients
- Patient deprived of liberty by judicial or administrative decision. Patient in psychiatric care under constraints may be included.
- For patients accepting the lumbar punction: patients who are unable to control themselves and are likely to engage in physical or violent behavior.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: OCD cohort
Patients suffering from OCD resistant to treatments
|
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
|
|
Ander: Catatonia cohort
Patients suffering from resistant catatonia
|
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
|
|
Ander: TRD cohort
Patients suffering from treatment resistant depression (TRD)
|
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
|
|
Ander: BD cohort
Patients suffering from treatment resistant bipolar disorders (BD)
|
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
|
|
Ander: Schizophrenia cohort
Patients suffering from schizophrenia resistant to treatments
|
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Tijdsspanne: Up to 10 weeks
|
Changes in Positive and Negative Syndrome Scale (PANSS) scores between inclusion (V1) and the end of acute phase therapy (V3).
The scale will be used to assess disease severity for Schizophrenia patients.
The minimal score is 30.
The maximal score is 210.
|
Up to 10 weeks
|
|
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Tijdsspanne: Up to 10 weeks
|
Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) scores between inclusion (V1) and the end of acute phase therapy (V3).
The scale will be used to assess disease severity for depression.
The minimal score is 0. The maximal score is 60.
|
Up to 10 weeks
|
|
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Tijdsspanne: Up to 10 weeks
|
Changes in Young Mania Rating Scale (YMRS) scores between inclusion (V1) and the end of acute phase therapy (V3).
The scale will be used to assess disease severity for bipolar troubles.
The minimal score is 0. The maximal score is 60.
|
Up to 10 weeks
|
|
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Tijdsspanne: Up to 10 weeks
|
Changes in Obsessive-Compulsive Inventory-Revised (OCI-R) scores between inclusion (V1) and the end of acute phase therapy (V3).
The scale will be used to assess disease severity for obsessive compulsive disorder.
The minimal score is 0. The maximal score is 72.
|
Up to 10 weeks
|
|
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Tijdsspanne: Up to 10 weeks
|
Changes in Visual analogic scale for obsessive compulsive disorder (VAS-OCD) scores between inclusion (V1) and the end of acute phase therapy (V3).
The scale will be used to assess disease severity for obsessive compulsive disorder.
The minimal score is 0 mm.
The maximal score is 100 mm.
|
Up to 10 weeks
|
|
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Tijdsspanne: Up to 10 weeks
|
Changes in Bush-Francis Catatonia Rating Scale (BFCRS) scores between inclusion (V1) and the end of acute phase therapy (V3).
The scale will be used to assess disease severity for catatonia.
The minimal score is 0 mm.
The maximal score is 69.
|
Up to 10 weeks
|
|
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Tijdsspanne: Up to 10 weeks
|
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3).
The dosages are : White blood cells, neutrophils, eosinophils, basophils, lymphocytes, monocytes, platelets in G/L
|
Up to 10 weeks
|
|
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Tijdsspanne: Up to 10 weeks
|
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3).
The dosages are : C3, C4, fibrinogen in g/L.
|
Up to 10 weeks
|
|
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Tijdsspanne: Up to 10 weeks
|
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3).
The dosages are : Vitamin B12, IL-1β, IL-6, IL-18 in pg/mL.
|
Up to 10 weeks
|
|
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Tijdsspanne: Up to 10 weeks
|
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3).
The dosages are : Folate, Vitamin B1, B6, D, cortisol in nmol/L.
|
Up to 10 weeks
|
|
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Tijdsspanne: Up to 10 weeks
|
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3).
The dosages are : TSH, prolactin in mUI/L
|
Up to 10 weeks
|
|
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Tijdsspanne: Up to 10 weeks
|
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3).
The dosages are : CRPus, β2 microglobulin, C1q in mg/L.
|
Up to 10 weeks
|
|
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Tijdsspanne: Up to 10 weeks
|
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3).
The dosages are : anti-TPO Ab, anti-TG Ab, CH50 in UI/mL.
|
Up to 10 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in CRPus from inclusion (V1) to Day 2 (V2)
Tijdsspanne: From enrollment to Day 2
|
Variation in CRPus between inclusion (V1) and Day 2 (V2) in mg/L.
|
From enrollment to Day 2
|
|
Changes in immunity markers from inclusion (V1) to Day 2 (V2)
Tijdsspanne: From enrollment to Day 2
|
Variation in IL-1β, IL-6, and IL-18 between inclusion (V1) and Day 2 (V2) in pg/mL.
|
From enrollment to Day 2
|
|
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Tijdsspanne: From enrollment to Day 2
|
Changes in Bush-Francis Catatonia Rating Scale (BFCRS) scores between inclusion (V1) and Day 2 (V2).
The scale will be used to assess disease severity for catatonia.
The minimal score is 0 mm.
The maximal score is 69.
|
From enrollment to Day 2
|
|
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Tijdsspanne: From enrollment to Day 2
|
Changes in Positive and Negative Syndrome Scale (PANSS) scores between inclusion (V1) and Day 2 (V2).
The scale will be used to assess disease severity for Schizophrenia patients.
The minimal score is 30.
The maximal score is 210.
|
From enrollment to Day 2
|
|
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Tijdsspanne: From enrollment to Day 2
|
Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) scores between inclusion (V1) and day 2 (V2).
The scale will be used to assess disease severity for depression.
The minimal score is 0. The maximal score is 60.
|
From enrollment to Day 2
|
|
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Tijdsspanne: From enrollment to Day 2
|
Changes in Young Mania Rating Scale (YMRS) scores between inclusion (V1) and Day 2 (V2).
The scale will be used to assess disease severity for bipolar troubles.
The minimal score is 0. The maximal score is 60.
|
From enrollment to Day 2
|
|
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Tijdsspanne: From enrollment to Day 2
|
Changes in Visual analogic scale for obsessive compulsive disorder (VAS-OCD) scores between inclusion (V1) and Day 2 (V2).
The scale will be used to assess disease severity for obsessive compulsive disorder.
The minimal score is 0 mm.
The maximal score is 100 mm.
|
From enrollment to Day 2
|
|
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Tijdsspanne: From enrollment to Day 2
|
Changes in Obsessive-Compulsive Inventory-Revised (OCI-R) scores between inclusion (V1) and Day 2 (V2).
The scale will be used to assess disease severity for obsessive compulsive disorder.
The minimal score is 0. The maximal score is 72.
|
From enrollment to Day 2
|
|
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Tijdsspanne: through study completion, an average of 2 years
|
Changes in Positive and Negative Syndrome Scale (PANSS) scores between inclusion (V1) and the end of study EOS (M24).
The scale will be used to assess disease severity for Schizophrenia patients.
The minimal score is 30.
The maximal score is 210.
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Tijdsspanne: through study completion, an average of 2 years
|
Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) scores between inclusion (V1) and the end of study (M24).
The scale will be used to assess disease severity for depression.
The minimal score is 0. The maximal score is 60.
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Tijdsspanne: through study completion, an average of 2 years
|
Variation in standardized clinical disease scale scores between inclusion (V1) and EOS (M24). Changes in Young Mania Rating Scale (YMRS) scores between inclusion (V1) and the end of study (M24). The scale will be used to assess disease severity for bipolar troubles. The minimal score is 0. The maximal score is 60. |
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Tijdsspanne: through study completion, an average of 2 years
|
Changes in Obsessive-Compulsive Inventory-Revised (OCI-R) scores between inclusion (V1) and the end of study (M24).
The scale will be used to assess disease severity for obsessive compulsive disorder.
The minimal score is 0. The maximal score is 72.
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Tijdsspanne: through study completion, an average of 2 years
|
Variation in standardized clinical disease scale scores between inclusion (V1) and EOS (M24). Changes in Visual analogic scale for obsessive compulsive disorder (VAS-OCD) scores between inclusion (V1) and the end of study (M24). The scale will be used to assess disease severity for obsessive compulsive disorder. The minimal score is 0 mm. The maximal score is 100 mm. |
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Tijdsspanne: through study completion, an average of 2 years
|
Changes in Bush-Francis Catatonia Rating Scale (BFCRS) scores between inclusion (V1) and the end of study (M24).
The scale will be used to assess disease severity for catatonia.
The minimal score is 0 mm.
The maximal score is 69.
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to end of study (M24) in CBC components
Tijdsspanne: through study completion, an average of 2 years
|
Variation in Complete Blood Count components between inclusion (V1) and End Of Study (M24) : White blood cells, neutrophils, eosinophils, basophils, lymphocytes, monocytes, platelets in G/L.
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to end of study (M24) in Folates, Vitamin B6, Vitamin B1, Vitamin D
Tijdsspanne: through study completion, an average of 2 years
|
Changes in biological parameters measured between inclusion (V1) and the End Of Study (M24).
The dosages are : Folates, Vitamins B1, B6, D in nmol/L.
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to end of study (M24) in Vitamin B12
Tijdsspanne: through study completion, an average of 2 years
|
Changes in Vitamin B12 measured between inclusion (V1) and the End Of Study (M24) in pg/mL.
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to end of study (M24) in TSH, prolactin
Tijdsspanne: through study completion, an average of 2 years
|
Changes in biological parameters measured between inclusion (V1) and End Of Study (M24).
The dosages are : TSH, prolactin in mUI/L
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to end of study (M24) in drug dosage
Tijdsspanne: through study completion, an average of 2 years
|
Variation in drug dosage between inclusion (V1) and End Of Study (M24).
Unit could be different according to the drug.
|
through study completion, an average of 2 years
|
|
Changes from inclusion in levels of pro-inflammatory cytokines and other immune biomarkers in cerebrospinal fluid, skin biopsies and/or stool, at end of acute treatment (V3), 6-month follow-up (V4), 12-month follow-up (V5) and 24-month follow-up (V6)
Tijdsspanne: At inclusion (V1), 10 weeks, 6 months-, 12 months- and 24 months after end of acute treatment
|
Change in levels of pro-inflammatory cytokines and other immune biomarkers in other biological samples (cerebrospinal fluid (CSF), skin biopsies, stool) between inclusion (V1) , end of acute treatment (V3), 6-month follow-up (V4), 12-month follow-up (V5) and 24-month follow-up (V6).
This will enable direct assessment of the efficacy of interventions on immune processes.
|
At inclusion (V1), 10 weeks, 6 months-, 12 months- and 24 months after end of acute treatment
|
|
Changes from inclusion (V1) in functional (Clinical Global Impression, CGI-S and CGI-I) scores to end of acute treatment (V3)
Tijdsspanne: Up to 10 weeks
|
Variation in Clinical Global Impression (CGI-S and CGI-I) questionnaire scores between inclusion (V1) and end of acute treatment (V3):
|
Up to 10 weeks
|
|
Changes from inclusion (V1) in quality of life (by WHOQOL-BREF questionnaire) scores to end of acute treatment (V3)
Tijdsspanne: Up to 10 weeks
|
Variation in WHOQOL-BREF questionnaire scores between inclusion (V1) and end of acute treatment (V3).
The minimum score is 16 and the maximum is 80.
The higher the score, the better the perceived quality of life in the relevant area.
|
Up to 10 weeks
|
|
Changes from inclusion in quality of life (by WHOQOL-BREF scores), to End Of Study (M24)
Tijdsspanne: through study completion, an average of 2 years
|
Variation in quality-of-life questionnaire scores (WHOQOL-BREF) between inclusion (V1) and End Of Study (M24).
The minimal score is 16 and the maximal is 80.
The higher the score, the better the perceived quality of life in the relevant area.
|
through study completion, an average of 2 years
|
|
Changes from inclusion in functional score (by Clinical Global Impression scale), to End Of Study (M24)
Tijdsspanne: through study completion, an average of 2 years
|
Variation in Clinical Global Impression (CGI-S and CGI-I) questionnaire scores between inclusion (V1) and end of study (M24):
|
through study completion, an average of 2 years
|
|
Number of side-effects (type, intensity, severity) in total population and by cohort between study inclusion (V1) and end of study (M24)
Tijdsspanne: through study completion, an average of 2 years
|
Side-effects (type, intensity, severity) in total population and by cohort between study inclusion and End Of Study (M24)
|
through study completion, an average of 2 years
|
|
Number and characteristics of biomarkers identified in the retrospectively and prospectively included populations
Tijdsspanne: through study completion, an average of 2 years
|
The number and characteristics of biomarkers identified in the retrospectively and prospectively included populations throughout the study
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) in fibrinogen, C3, C4 to End Of Study (M24)
Tijdsspanne: through study completion, an average of 2 years
|
Changes in biological parameters measured between inclusion (V1) and the end of study (M24).
The dosages are : C3, C4, fibrinogen in g/L.
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to End Of Study (M24) in IL-1β, IL-6, IL-18
Tijdsspanne: through study completion, an average of 2 years
|
Changes in biological parameters measured between inclusion (V1) and the End Of Study (M24).
The dosages are : IL-1β, IL-6, IL-18 in pg/mL.
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to End Of Study (M24) in cortisol dosage
Tijdsspanne: through study completion, an average of 2 years
|
Changes in cortisol measured between inclusion (V1) and the end of study (M24) in nmol/L.
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to End Of Study (M24) in CRPus, β2 microglobulin, C1q
Tijdsspanne: through study completion, an average of 2 years
|
Changes in biological parameters measured between inclusion (V1) and End Of Study (M24).
The dosages are : CRPus, β2 microglobulin, C1q in mg/L.
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to End Of Study (M24) in anti-TPO Ab, anti-TG Ab, CH50
Tijdsspanne: through study completion, an average of 2 years
|
Changes in biological parameters measured between inclusion (V1) and the End Of Study (M24).
The dosages are : anti-Peroxidase Antibodies, anti-thyroglobulin Antibodies, Hemolytic Complement 50 in UI/mL.
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to End Of Study (M24) in anti-TRAK Ab
Tijdsspanne: through study completion, an average of 2 years
|
Variation in anti TSH receptor specific Antibodies (anti-TRAK Ab) between inclusion (V1) and End Of Study (M24)
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to End Of Study (M24) in neuronal Ab
Tijdsspanne: through study completion, an average of 2 years
|
Number of positive neuronal antibodies between inclusion (V1) and End Of Study (M24)
|
through study completion, an average of 2 years
|
|
Changes from inclusion (V1) to End Of Study (M24) in interferon signature score
Tijdsspanne: through study completion, an average of 2 years
|
Variation in interferon signature score between inclusion (V1) and End Of Study (M24)
|
through study completion, an average of 2 years
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Anne-Cécile PETIT, MD, PhD, GHU Paris Psychiatry & Neurosciences
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
15 juli 2026
Primaire voltooiing (Geschat)
1 oktober 2036
Studie voltooiing (Geschat)
1 augustus 2038
Studieregistratiedata
Eerst ingediend
29 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
27 juli 2026
Eerst geplaatst (Werkelijk)
3 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
27 juli 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Bipolaire en aanverwante stoornissen
- Neurologische manifestaties
- Ziekten van het zenuwstelsel
- Schizofreniespectrum en andere psychotische stoornissen
- Psychische aandoening
- Gedragssymptomen
- Neurologische gedragsmanifestaties
- Stemmingsstoornissen
- Angst stoornissen
- Depressieve stoornis
- Pathologische aandoeningen, tekenen en symptomen
- Gedrag
- Tekenen en symptomen
- Schizofrenie
- Bipolaire stoornis
- Depressieve stoornis, therapieresistent
- Catatonie
- Obsessief-compulsieve stoornis
- Onderzoekstechnieken
- Therapeutica
- Exemplaarbehandeling
- Klinische laboratoriumtechnieken
- Diagnostische technieken en procedures
- Diagnose
- Buren
- Chirurgische procedures, operatief
- Biopsie
- Diagnostische technieken, neurologisch
- Spinale punctie
- Bloedspecimenverzameling
Andere studie-ID-nummers
- D25-P041
- N°ID-RCB: 2026-A00433-48 (Andere identificatie: ANSM)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .