Exploring how inflammation affects the effectiveness of antidepressants

Inflammatory Control of Antidepressant Efficacy: a Pharmaco-epigenetic Approach

This study is trying to see how inflammation affects how well antidepressants work for people with major depression.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: IRCCS San Raffaele (Academic / other)
• Locations: 1 site (Milan, Mi)
• Trial ID: NCT06306209 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between inflammatory factors and the efficacy of Selective Serotonin Reuptake Inhibitors (SSRIs) in patients with Major Depressive Disorder (MDD). It posits that SSRIs may enhance brain plasticity rather than directly improving mood, suggesting that the treatment's success may depend on the patient's environment. By examining patients currently undergoing SSRI treatment, the study aims to identify how pharmacological modulation can improve treatment outcomes in challenging living conditions. The study will include assessments of depressive symptoms and inflammatory markers to better understand this relationship.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a depressive episode as per DSM-5 criteria, currently treated with SSRIs and exhibiting a Hamilton Depression Rating Scale (HDRS) score greater than 17.

Not a fit: Patients with a history of bipolar disorder, schizophrenia, or other specified exclusions, as well as those on certain medications or with active infections, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with Major Depressive Disorder, particularly in challenging environments.

How similar studies have performed: While the approach of linking inflammation to antidepressant efficacy is innovative, similar studies have shown promise in understanding the complex interactions between mood disorders and biological factors.

Eligibility criteria

Inclusion Criteria:

A depressive episode according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria in the course of MDD with:

HDRS score \> 17 Age 18-65 years; In treatment with SSRIs Signed informed consent, able to understand, speak and write the national language

Exclusion Criteria:

* History of bipolar disorder, schizophrenia, schizoaffective disorder, psychosis not otherwise specified; anorexia or bulimia nervosa;
* Taking following medications: antipsychotics, anticonvulsants, mood stabilizers; stimulants
* Active infection requiring antibiotics therapy;
* Immunosuppressed patient
* Other chronic diseases
* Signs of active infection requiring treatment
* Use of anti-inflammatory medication on a regular basis for a chronic inflammatory/autoimmune Disorder.
* Forbidden treatment: corticosteroids, Non Steroidal Anti-inflammatory Drugs, immunosuppressant IV-Ig based treatment
* Ongoing fever, infection treated by antibiotics or uncontrolled diabetes type I or II;
* Existing cancer or history of cancer in the last 5 years (except skin epidermoid cancer or in-situ cervix cancer);
* Known HIV infection or clinically manifest Acquired Immune Deficiency Syndrome (AIDS),
* Parkinson's or Alzheimer's disease, or any other serious condition likely to interfere e with the conduct of the trial;
* Abuse of drugs or alcohol in the past 6 months

Where this trial is running

Milan, Mi

• IRCCS Ospedale San Raffaele — Milan, Mi, Italy (Recruiting)

Study contacts

• Principal investigator: sara Poletti, PhD — IRCCS Ospedale San Raffaele
• Study coordinator: Sara Poletti, phd

Conditions Mood Disorders; Major Depressive Disorder