Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT04133233
Eligibility 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
* 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)
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04133233
Study Brief:
Protocol Section:
NCT04133233