Study of efficacy of low-dose interleukin-2 in alteration of the immune system associated with depressio

Phase 1

Active, not recruiting

• Conditions: Depressive episode in course of mood disorder; MedDRA version: 21.1Level: LLTClassification code 10012402Term: Depressive episodeSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2019-001696-36-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-24
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

- Signed Informed consent
- A major depressive episode according to DSM-V criteria in the course of a mood disorder (BD and MDD)
- Age 18-65 years;
- Already on a mood stabilizer and/or antidepressant treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Contraindication to ld-IL2 therapy:
Hypersensitivity to active substance or excipient;
Active infection requiring antibiotics therapy;
Organ failure (e.g., liver, kidney, lung and heart);
Immunosuppressed patient
Hepatotoxic, nephrotoxic, myelotoxic or cardiotoxic drugs
Other chronic diseases
Signs of active infection requiring treatment
Previous history of organ transplantation
Leukocytes < 4000 / mm3, platelets < 100 000 /mm3, Hemoglobin < 10.0 g/dL, red cell count < 3.5 106/mm3.
Use of anti-inflammatory medication on a regular basis for a chronic inflammatory/autoimmune Disorder (NSAD, immunosuppressant IV-Ig based treatment);
Ongoing fever
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);
Existing or planned pregnancy or lactation;
Women sexually active not using an effective method of contraception
Person under legal protection
Pregnant and parturient and Breast feeding women
Legally detained person
Under the age of majority
Immediate risk for suicidal behaviour (3 on HamD-17 rating scale or 5 on MAD Rating Scale);
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 with the conduct of the trial;
Participation to an interventional study concomitantly or within 30 days prior to this study, except in the cohorts studies aiming at the analysis of immuno-inflammatory biomarkers and/or brain imaging studies.
Patients thought to be unreliable or incapable of complying with the requirements of the protocol;
Patient is relative of, or staff directly reporting to the investigator;
Patient is employee of the sponsor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: prove the improvement of T regulatory cells response following add-on treatment with IL-2 (Aldesleukin) in patients affected by mood disorder win an ongoing depressive episode;Secondary Objective: To prove the safety of low-dose IL-2 in patients with a depressive episode in course of mood disorder (major depressive o bipolar disorder) and demonstrate an improvement of immune homeostasis, including the response on T regulatory cells, following add-on treatment with IL-2.;Primary end point(s): Percentage Treg fold increase at Day 5 compared to baseline;Timepoint(s) of evaluation of this end point: at the end of the induction phase after 5 days of treatment