Status:
COMPLETED
Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Iltoo Pharma
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 d...
Detailed Description
A hypothesis still under study concerning the pathophysiological mechanisms of bipolar disorder concerns an immunological disorder that could possibly be involved in this disease and during a depressi...
Eligibility Criteria
Inclusion
- 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
- Patient with a normal or controlled thyroid function
- Male or female both using effective methods of contraception during treatment if sexually active.
Exclusion
- \- 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.
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04133233
Start Date
June 15 2020
End Date
July 20 2022
Last Update
August 8 2023
Active Locations (1)
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1
Pr Marion Leboyer
Créteil, Hôpital Albert Chenevier, France, 94010