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Life sciences · Observational Study
ClinicalTrials.gov · September 14, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT06337539). This is a study registration, not published results. Lead sponsor: Germans Trias i Pujol Hospital. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 50 participants (ACTUAL). Conditions: Depression, Inflammation, Antidepressants, Immunity. Interventions: DRUG: SSRI. Primary outcome measures: Treatment Response , 3 months. Brief summary: 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.