Treatment Resistance in Psychiatric Disorders: the Search for Biological Markers Predictive of Response to Treatment (BIO-INM)
2026년 7월 27일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
700
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Iolanda PALIMARU, MD
- 전화번호: +33145658798
- 이메일: iolanda.palimaru@ghu-paris.fr
연구 장소
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Paris, 프랑스, 75014
- GHU Paris - Psychiatrie et Neurosciences
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연락하다:
- Cécile MICHEL
- 전화번호: +331 80 52 70 19
- 이메일: cecile.bultez@ghu-paris.fr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
5
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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다른: OCD cohort
Patients suffering from OCD resistant to treatments
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the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
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다른: Catatonia cohort
Patients suffering from resistant catatonia
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the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
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다른: 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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다른: 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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다른: 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
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
기간: 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.
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Up to 10 weeks
|
|
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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).
기간: 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).
기간: 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).
기간: 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).
기간: 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
|
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Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
기간: 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).
기간: 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).
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in CRPus from inclusion (V1) to Day 2 (V2)
기간: From enrollment to Day 2
|
Variation in CRPus between inclusion (V1) and Day 2 (V2) in mg/L.
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From enrollment to Day 2
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Changes in immunity markers from inclusion (V1) to Day 2 (V2)
기간: From enrollment to Day 2
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Variation in IL-1β, IL-6, and IL-18 between inclusion (V1) and Day 2 (V2) in pg/mL.
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From enrollment to Day 2
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Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
기간: 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
|
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Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
기간: 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
|
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Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
기간: 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
|
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Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
기간: 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)
기간: 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)
기간: 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
|
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Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 연구 책임자: Anne-Cécile PETIT, MD, PhD, GHU Paris Psychiatry & Neurosciences
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 7월 15일
기본 완료 (추정된)
기본 완료
2036년 10월 1일
연구 완료 (추정된)
연구 완료
2038년 8월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 29일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 27일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 3일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 27일
마지막으로 확인됨
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- D25-P041
- N°ID-RCB: 2026-A00433-48 (기타 식별자: ANSM)
개별 참가자 데이터(IPD) 계획
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