Treatment Resistance in Psychiatric Disorders: the Search for Biological Markers Predictive of Response to Treatment

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales: the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin

Study summary

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

Primary outcome measure(s)

• Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3) — 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 disease scale scores at the end of acute phase therapy (V3) — 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.
• Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3) — 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.
• Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3) — 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.
• Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3) — 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.
• Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3) — 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.
• Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3). — 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
• Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3). — 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.
• Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3). — 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.
• Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3). — 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.
• Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3). — 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
• Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3). — 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.
• Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3). — 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.

Trial sites (1)

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