Treatment Resistance in Psychiatric Disorders: the Search for Biological Markers Predictive of Response to Treatment (BIO-INM)
27 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
700
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Iolanda PALIMARU, MD
- Número de teléfono: +33145658798
- Correo electrónico: iolanda.palimaru@ghu-paris.fr
Ubicaciones de estudio
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Paris, Francia, 75014
- GHU Paris - Psychiatrie et Neurosciences
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Contacto:
- Cécile MICHEL
- Número de teléfono: +331 80 52 70 19
- Correo electrónico: cecile.bultez@ghu-paris.fr
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: OCD cohort
Patients suffering from OCD resistant to treatments
|
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
|
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Otro: Catatonia cohort
Patients suffering from resistant catatonia
|
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
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Otro: TRD cohort
Patients suffering from treatment resistant depression (TRD)
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the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
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Otro: BD cohort
Patients suffering from treatment resistant bipolar disorders (BD)
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the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
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Otro: Schizophrenia cohort
Patients suffering from schizophrenia resistant to treatments
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the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in CRPus from inclusion (V1) to Day 2 (V2)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
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Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Anne-Cécile PETIT, MD, PhD, GHU Paris Psychiatry & Neurosciences
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de julio de 2026
Finalización primaria (Estimado)
1 de octubre de 2036
Finalización del estudio (Estimado)
1 de agosto de 2038
Fechas de registro del estudio
Enviado por primera vez
29 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de julio de 2026
Publicado por primera vez (Actual)
3 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos bipolares y relacionados
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Espectro de esquizofrenia y otros trastornos psicóticos
- Desordenes mentales
- Síntomas de comportamiento
- Manifestaciones neuroconductuales
- Trastornos del estado de ánimo
- Desórdenes de ansiedad
- Desorden depresivo
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Esquizofrenia
- Trastorno bipolar
- Trastorno depresivo, resistente al tratamiento
- Catatonia
- Desorden obsesivo compulsivo
- Técnicas de investigación
- Terapéutica
- Manejo de muestras
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Puntas
- Procedimientos quirúrgicos, operativo
- Biopsia
- Técnicas de diagnóstico, neurológico
- Punzonado
- Recolección de muestras de sangre
Otros números de identificación del estudio
- D25-P041
- N°ID-RCB: 2026-A00433-48 (Otro identificador: ANSM)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .