About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales
Biological/Vaccinethe biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
Treatment groups
Trial outcomes
Primary outcomes
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
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 disease scale scores at the end of acute phase therapy (V3)
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.
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
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.
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
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.
Secondary outcomes
Changes in CRPus from inclusion (V1) to Day 2 (V2)
Variation in CRPus between inclusion (V1) and Day 2 (V2) in mg/L.
Changes in immunity markers from inclusion (V1) to Day 2 (V2)
Variation in IL-1β, IL-6, and IL-18 between inclusion (V1) and Day 2 (V2) in pg/mL.
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
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.
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
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.
Sponsors and contacts
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Centre Hospitalier St Anne
Lead sponsor
GHU Paris Psychiatry & Neurosciences
Collaborator