Depressive episode in course of mood disorder MedDRA version: 21.1 Level: LLT Classification code 10012402 Term: Depressive episode System Organ Class: 100000004873
Conditions
Interventions
Product Name: Aldesleuchina
Product Code: [Aldesleuchina]
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: ALDESLEUCHINA
CAS Number: 110942-02-4
Current Sponsor code: Proleu
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): to assess the safety of ld-IL2 in patients with mood disorder experiencing a depressive relapse and to demonstrate improvement of immune homeostasis, including the T regulatory cell (Tregs) response, under add on ld-IL2 in relation along with symptomatic assessment of mood improvements in patients with mood disorder experiencing a depressive relapse Efficacy of ld-IL2 to activate Tregs will be monitored by the peak response to the induction course (at day 5; primary outcome) and by measuring the Treg level at the end of the trial (secondary outcome); Increase/decrease in T helpers 1 (Th1), T helpers 2 (Th2) and T helper 17 (Th17) cells; Increase in the balance between naïve and memory T helper cells; Alterations in the balance between the Th17/Tregs; Decrease in inflammatory gene expression (cluster 1 and 2 gene expression) in circulating leukocytes; Decrease in circulating levels of high sensitivity C Reactive Protein (hCRP), interleukin-6 (IL-6), C-C motif chemokine ligand 2 (CCL2), Pentraxin 3 (PTX-3), soluble interleukin-2 receptor (sCD25), stem cell factor (SCF), brain-derived neurotrophic factor (BDNF). Frequency and type of adverse events.;Timepoint(s) of evaluation of this end point: Efficacy will be evaluated at the end of treatment. Safety will be evaluated though the daily monitoring of adverse events | — |
Countries
Italy
Contacts
Public ContactPsichaitria e Psicobiologia Clinica
Francesco Benedetti
Outcome results
None listed