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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
700
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
GHU Paris - Psychiatrie et Neurosciences
Paris, France
RECRUITINGChanges 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.
Time frame: Up to 10 weeks
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.
Time frame: Up to 10 weeks
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.
Time frame: Up to 10 weeks
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.
Time frame: Up to 10 weeks
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
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.
Time frame: Up to 10 weeks
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
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.
Time frame: Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
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
Time frame: Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
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.
Time frame: Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
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.
Time frame: Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
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.
Time frame: Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3). The dosages are : TSH, prolactin in mUI/L
Time frame: Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
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.
Time frame: Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
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.
Time frame: Up to 10 weeks
Changes in CRPus from inclusion (V1) to Day 2 (V2)
Variation in CRPus between inclusion (V1) and Day 2 (V2) in mg/L.
Time frame: From enrollment to Day 2
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.
Time frame: From enrollment to Day 2
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.
Time frame: From enrollment to Day 2
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.
Time frame: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
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.
Time frame: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
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.
Time frame: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
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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.
Time frame: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
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.
Time frame: From enrollment to Day 2
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
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.
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
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.
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
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.
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
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.
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
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.
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
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.
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in CBC components
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.
Time frame: 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
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.
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in Vitamin B12
Changes in Vitamin B12 measured between inclusion (V1) and the End Of Study (M24) in pg/mL.
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in TSH, prolactin
Changes in biological parameters measured between inclusion (V1) and End Of Study (M24). The dosages are : TSH, prolactin in mUI/L
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in drug dosage
Variation in drug dosage between inclusion (V1) and End Of Study (M24). Unit could be different according to the drug.
Time frame: 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)
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.
Time frame: 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)
Variation in Clinical Global Impression (CGI-S and CGI-I) questionnaire scores between inclusion (V1) and end of acute treatment (V3): * CGI-Severity (CGI-S) assess global disease severity. The Score min is 1 and Score max is 7. * CGI-Improvement (CGI-I) : assess the improvement or deterioration of the disease compared to initial state. The Score min is 1 (highly improved). The Score max is 7 (Highly deteriorated).
Time frame: Up to 10 weeks
Changes from inclusion (V1) in quality of life (by WHOQOL-BREF questionnaire) scores to end of acute treatment (V3)
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.
Time frame: Up to 10 weeks
Changes from inclusion in quality of life (by WHOQOL-BREF scores), to End Of Study (M24)
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.
Time frame: through study completion, an average of 2 years
Changes from inclusion in functional score (by Clinical Global Impression scale), to End Of Study (M24)
Variation in Clinical Global Impression (CGI-S and CGI-I) questionnaire scores between inclusion (V1) and end of study (M24): * CGI-Severity (CGI-S) assess global disease severity. The Score min is 1 and Score max is 7. * CGI-Improvement (CGI-I) : assess the improvement or deterioration of the disease compared to initial state. The Score min is 1 (highly improved). The Score max is 7 (Highly deteriorated).
Time frame: 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)
Side-effects (type, intensity, severity) in total population and by cohort between study inclusion and End Of Study (M24)
Time frame: through study completion, an average of 2 years
Number and characteristics of biomarkers identified in the retrospectively and prospectively included populations
The number and characteristics of biomarkers identified in the retrospectively and prospectively included populations throughout the study
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) in fibrinogen, C3, C4 to End Of Study (M24)
Changes in biological parameters measured between inclusion (V1) and the end of study (M24). The dosages are : C3, C4, fibrinogen in g/L.
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in IL-1β, IL-6, IL-18
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.
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in cortisol dosage
Changes in cortisol measured between inclusion (V1) and the end of study (M24) in nmol/L.
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in CRPus, β2 microglobulin, C1q
Changes in biological parameters measured between inclusion (V1) and End Of Study (M24). The dosages are : CRPus, β2 microglobulin, C1q in mg/L.
Time frame: 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
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.
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in anti-TRAK Ab
Variation in anti TSH receptor specific Antibodies (anti-TRAK Ab) between inclusion (V1) and End Of Study (M24)
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in neuronal Ab
Number of positive neuronal antibodies between inclusion (V1) and End Of Study (M24)
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in interferon signature score
Variation in interferon signature score between inclusion (V1) and End Of Study (M24)
Time frame: through study completion, an average of 2 years