Precision Psychiatry for Depression: Immune Response and Affective Symptoms as Predictors of Response to Antidepressants

PI-23-185

Objectives: To identify in patients with major depression different peripheral markers of neuroinflammation in relation to affective symptoms (anxiety, depression, irritability), fatigue and cognitive symptoms; and its relationship with the response to antidepressant treatment with selective serotonin reuptake inhibitors (SSRIs). Methodology: This is a prospective observational cohort study in patients with major depression naturally subjected to treatment with SSRIs. For this, 30 patients with major depression attended in the Outpatient Psychiatry Consultations will be selected. All of them will be evaluated at baseline and after 3 months of treatment, collecting demographic and clinical variables, Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) psychiatric diagnoses, psychopathological scales and immunological and biochemical variables. The correlation between immunological markers and affective and cognitive symptoms at baseline, as well as their variation with treatment, will be analyzed. A group of 20 healthy subjects will be used as a control group. Subsequently, a bivariate comparative analysis will be carried out, where the statistically significant or marginally significant variables associated with psychopathological variables will be used to build a multivariate binary logistic regression model.

2024-04-01

2026-12-31

2027-07-31

Not yet recruiting

50

Inclusion Criteria: * Age between 18 and 65 years * Clinical diagnosis of major depression according to DSM-5 criteria made by a psychiatrist applying the Structured Clinical Interview for DSM-5 (SCID-5). * Eligible for receiving antidepressant treatment for major depression. Exclusion Criteria: * Who have received antidepressant, antipsychotic or euthymizer treatments in the 6 weeks prior to inclusion in the study. * Who present concurrent psychotic symptoms. * Who present disorders due to alcohol or drug use, with active consumption during the last 3 months. * Pregnant women. * Who have serious or unstable medical disorders, Addison's or Cushing's disease, systemic inflammatory or autoimmune diseases, or primary or secondary immunodeficiencies.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Immunological and biochemical variables:\n\n* Acute phase biomarkers: CRP\n* Proinflammatory cytokines: IL-1, IL-6, TNF-α, IL-12, IL-23, IL-17, IL-22\n* Anti-inflammatory cytokines: IL-10, IL-4, tumor growth factor (TGF) -β\n* Cortisol\n* Oxidative and nitrosative stress: Zinc, Glutathione, Albumin, Uric Acid, Bilirubin, Vitamin C and Vitamin E\n* Microglia activation: microRNA (miR)-155, miR-126, miR-223, miR-146a, miR-21, miR-124\n* Neurogenesis and neuroinflammation: BDNF, VILIP-1, CC chemokine ligand 2 (MCP-1), sTREM-2, vascular endothelial growth factor (VEGF), sTREM-1, β-NGF, sRAGE, CX3CL1\n* Lymphocyte subpopulations in peripheral blood (Th1, Th2, Th17, Th1/17, Treg, naive cells, total Tfh, Tγδ1, Tγδ2, Tγδ17, Tγδ1/17, monocytes)\n* Transcriptomic and proteomic lymphocyte study at the single-cell level'}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2024-03-29