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

NCT06337539 | Not Yet Recruiting DMC

• 1 other identifier: PI-23-185
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Inflammation; Antidepressants; Immunity

Keywords

Selective serotonin reuptake inhibitors; Depression; Inflammation; Immunity

Outcome Measures

Primary Outcomes (1)

• Treatment Response

  The response to treatment will be assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS) scale scores. The MADRS scoring instructions indicate that a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression), a score ranging from 7 to 19 indicates "mild depression", 20 to 34 indicates "moderate depression", a score of 35 and greater indicates "severe depression", and a total score of 60 or greater indicates "very severe depression".

  3 months

Secondary Outcomes (3)

• Lymphocyte subpopulations

  3 years

• Biochemical variables

  3 years

• Single-cell CITEseq

  3 years

Study Arms (1)

SSRI treatment

The subjects who will participate in this study will be outpatients seen in the Psychiatry Outpatient Clinics of the Germans Trias i Pujol University Hospital (Badalona, Spain) clinically diagnosed with major depression and eligible to receive antidepressant treatment with SSRIs. The control group will be made up of healthy subjects, using the same inclusion and exclusion criteria except for the psychiatric diagnosis.

Drug: SSRI

Interventions

SSRI DRUG

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.

Also known as: Sertraline, Citalopram, Escitalopram, Fluoxetine, Paroxetine, Fluvoxamine

SSRI treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects that will participate in this study will be outpatients attended in the Outpatient Psychiatry Consultations of the Hospital Universitari Germans Trias i Pujol (Badalona, Spain) clinically diagnosed with major depression and eligible to receive antidepressant treatment with SSRIs. The control group will be made up of healthy subjects, using the same inclusion and exclusion criteria except for the psychiatric diagnosis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Catalonia, 08916, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Immunological and biochemical variables: * Acute phase biomarkers: CRP * Proinflammatory cytokines: IL-1, IL-6, TNF-α, IL-12, IL-23, IL-17, IL-22 * Anti-inflammatory cytokines: IL-10, IL-4, tumor growth factor (TGF) -β * Cortisol * Oxidative and nitrosative stress: Zinc, Glutathione, Albumin, Uric Acid, Bilirubin, Vitamin C and Vitamin E * Microglia activation: microRNA (miR)-155, miR-126, miR-223, miR-146a, miR-21, miR-124 * 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 * Lymphocyte subpopulations in peripheral blood (Th1, Th2, Th17, Th1/17, Treg, naive cells, total Tfh, Tγδ1, Tγδ2, Tγδ17, Tγδ1/17, monocytes) * Transcriptomic and proteomic lymphocyte study at the single-cell level

MeSH Terms

Conditions

Depression; Inflammation

Interventions

Sertraline; Citalopram; Escitalopram; Fluoxetine; Paroxetine; Fluvoxamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Oximes; Hydroxylamines

Study Officials

• Maria Iglesias-González, PhD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Iglesias-González, PhD

CONTACT

+34934651200; maiglesias.germanstrias@gencat.cat

Crisanto Díez-Quevedo, PhD

CONTACT

+34934651200; cdiezquevedo.germanstrias@gencat.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 29, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

ES (1)