Treatment Resistance in Psychiatric Disorders: the Search for Biological Markers Predictive of Response to Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
时间窗: 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.
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
时间窗: 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
次要结局
- Changes in immunity markers from inclusion (V1) to Day 2 (V2)(From enrollment to Day 2)
- Changes in CRPus from inclusion (V1) to Day 2 (V2)(From enrollment to Day 2)
- Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)(From enrollment to Day 2)
- Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores(through study completion, an average of 2 years)
- Changes from inclusion (V1) to end of study (M24) in CBC components(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(through study completion, an average of 2 years)
- Changes from inclusion (V1) to end of study (M24) in Vitamin B12(through study completion, an average of 2 years)
- Changes from inclusion (V1) to end of study (M24) in TSH, prolactin(through study completion, an average of 2 years)
- Changes from inclusion (V1) to end of study (M24) in drug dosage(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)(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)(Up to 10 weeks)
- Changes from inclusion (V1) to End Of Study (M24) in anti-TRAK Ab(through study completion, an average of 2 years)
- Changes from inclusion (V1) in quality of life (by WHOQOL-BREF questionnaire) scores to end of acute treatment (V3)(Up to 10 weeks)
- Changes from inclusion in quality of life (by WHOQOL-BREF scores), to End Of Study (M24)(through study completion, an average of 2 years)
- Changes from inclusion in functional score (by Clinical Global Impression scale), to 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)(through study completion, an average of 2 years)
- Number and characteristics of biomarkers identified in the retrospectively and prospectively included populations(through study completion, an average of 2 years)
- Changes from inclusion (V1) in fibrinogen, C3, C4 to End Of Study (M24)(through study completion, an average of 2 years)
- Changes from inclusion (V1) to End Of Study (M24) in IL-1β, IL-6, IL-18(through study completion, an average of 2 years)
- Changes from inclusion (V1) to End Of Study (M24) in cortisol dosage(through study completion, an average of 2 years)
- Changes from inclusion (V1) to End Of Study (M24) in CRPus, β2 microglobulin, C1q(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(through study completion, an average of 2 years)
- Changes from inclusion (V1) to End Of Study (M24) in neuronal Ab(through study completion, an average of 2 years)
- Changes from inclusion (V1) to End Of Study (M24) in interferon signature score(through study completion, an average of 2 years)