Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder (NCT04133233) | Clinical Trial Compass
CompletedPhase 2
Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder
France14 participantsStarted 2020-06-15
Plain-language 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 relapse
Who can participate
Age range18 Years – 65 Years
SexALL
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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
* Patient with a normal or controlled thyroid function
* 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.
* 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)
* hos…