Treatment Resistance in Psychiatric Disorders: the Search for Biological Markers Predictive of Response to Treatment (BIO-INM)
2026年7月27日 更新者：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.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
700
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Iolanda PALIMARU, MD
- 电话号码：+33145658798
- 邮箱：iolanda.palimaru@ghu-paris.fr
学习地点
-
-
-
Paris、法国、75014
- GHU Paris - Psychiatrie et Neurosciences
-
接触：
- Cécile MICHEL
- 电话号码：+331 80 52 70 19
- 邮箱：cecile.bultez@ghu-paris.fr
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：OCD cohort
Patients suffering from OCD resistant to treatments
|
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
|
|
其他：Catatonia cohort
Patients suffering from resistant catatonia
|
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
|
|
其他：TRD cohort
Patients suffering from treatment resistant depression (TRD)
|
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
|
|
其他：BD cohort
Patients suffering from treatment resistant bipolar disorders (BD)
|
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
|
|
其他：Schizophrenia cohort
Patients suffering from schizophrenia resistant to treatments
|
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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).
大体时间：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).
大体时间：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).
大体时间：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).
大体时间：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).
大体时间：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).
大体时间：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).
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in CRPus from inclusion (V1) to Day 2 (V2)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Anne-Cécile PETIT, MD, PhD、GHU Paris Psychiatry & Neurosciences
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月15日
初级完成 (估计的)
2036年10月1日
研究完成 (估计的)
2038年8月1日
研究注册日期
首次提交
2026年6月29日
首先提交符合 QC 标准的
2026年7月27日
首次发布 (实际的)
2026年8月3日
研究记录更新
最后更新发布 (实际的)
2026年8月3日
上次提交的符合 QC 标准的更新
2026年7月27日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- D25-P041
- N°ID-RCB: 2026-A00433-48 (其他标识符：ANSM)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.