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

NCT06337539 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-03-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SSRI

Outpatients with a diagnosis of major depression in the Psychiatry Outpatient Clinics will be evaluated for recruitment. * Recruitment visit: It will be carried out by one of the psychiatrists participating in the study. The patient will be informed about the study and written consent will be requested. Subsequently, the inclusion and exclusion criteria will be reviewed, and all demographic and clinical variables will be collected. * Baseline visit: One of the psychiatrists will interview the patient and apply the semi-structured clinical interview and the psychopathological evaluation questionnaires. In addition, a blood draw will be performed for serum collection, spectral cytometric analysis of lymphocyte subpopulations and obtaining peripheral blood mononuclear cells (PBMCs). * Follow-up visit after 3 months of treatment: Clinical variables will be collected and the same procedures will be performed as during the baseline visit. Not in the control group.

Sponsors & Collaborators

  • Germans Trias i Pujol Hospital

    lead OTHER

Principal Investigators

  • Maria Iglesias-González, PhD · Germans Trias i Pujol University Hospital

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2026-12-31
Completion
2027-07-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06337539 on ClinicalTrials.gov