Exploring the link between immune function and depression treatment

Adjusting Immune Activation to Reinstate Neural Plasticity and Promote the Beneficial Effect of Non-pharmacological Interventions

This study is testing if a combination of sleep deprivation and light therapy can help people with depression feel better by looking at how their immune system and brain adapt during treatment.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: IRCCS San Raffaele (other)
• Locations: 1 site (Milan, Mi)
• Trial ID: NCT06306248 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between immune activation, neural plasticity, and the treatment outcomes for major depressive disorder (MDD). It focuses on how total sleep deprivation combined with light therapy can enhance recovery from depressive episodes by modulating inflammation and improving neural plasticity. The study aims to identify the environmental factors that influence the effectiveness of these treatments in patients suffering from MDD. By understanding these interactions, the research seeks to develop novel therapeutic strategies for managing depression.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 experiencing a depressive episode with a Hamilton Depression Rating Scale score greater than 17.

Not a fit: Patients with a history of bipolar disorder, schizophrenia, or those on certain medications like antipsychotics or anti-inflammatory drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment strategies for patients with major depressive disorder.

How similar studies have performed: Other studies have shown promising results in using sleep deprivation and light therapy for treating depression, suggesting this approach may be effective.

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 TSD+LT
* 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 or 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 Other exclusion criteria related to the MRI procedure include
* Aneurysm clip
* Implanted neural stimulator
* Implanted cardiac pacemaker or auto-defibrillator
* Cochlear implant
* Ocular foreign body (e.g., metal shavings)
* Any implanted device (pumps, infusion devices, etc)
* Shrapnel injuries

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, Sleep Deprivation