Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder

Exclusion Criteria

• •\- Contraindication to IL-101 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 or 6.2 mmol/L, red cell blood \< 3.5 T/L.
• •Anti-TPO or anti-TG or anti-TRACKS positive at inclusion.
• •Use of anti-inflammatory medication on a regular basis for a chronic inflammatory/autoimmune Disorder (NSAD, immunosuppressant IV-Ig based treatment);
• •Ongoing fever \< 38
• •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;
• •Person under legal protection (1121-8 of CSP, Public Health Code
• •Pregnant and parturient and Breast feeding women (1121-5 of CSP)
• •legally detained person (1121-6 of CSP)
• •hospitalisation without consent
• •under the age of majority (1121-7of CSP)
• •Immediate risk for suicidal behaviour (MADRS-item 10 \>2 or columbia \> 2 for suicide idea);
• •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.