Overview
Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder
Status:
Recruiting
Recruiting
Trial end date:
2022-08-15
2022-08-15
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study will be to demonstrate improvement of the T regulatory cells (Treg) response, under add on low-dose Interleukin 2 (ld-IL2) in patients with bipolar disorders experiencing a depressive relapsePhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Assistance Publique - Hôpitaux de ParisCollaborator:
Iltoo PharmaTreatments:
Interleukin-2
Criteria
Inclusion Criteria:- A depressive episode according to DSM-V criteria in the course of a bipolar disorder
- MADRS score > 17
- Already on a mood stabilizer and/or antidepressant
- Male or female both using effective methods of contraception during treatment if
sexually active.
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.
- 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.