EUCTR2019-001696-36-IT进行中（未招募）1 期
Study of efficacy of low-dose recombinant human interleukin-2 in immunological changes associated with depression (IL2REG) - IL2REG
OSPEDALE SAN RAFFAELE0 个研究点目标入组 36 人开始时间: 2021年5月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Signed Informed consent
- •- A major depressive episode according to DSM-V criteria in the course of a mood disorder (BD and MDD)
- •- Age 18-65 years;
- •- Already on a mood stabilizer and/or antidepressant treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •Contraindication to ld-IL2 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, red cell count < 3.5 106/mm3.
- •Use of anti-inflammatory medication on a regular basis for a chronic inflammatory/autoimmune Disorder (NSAD, immunosuppressant IV-Ig based treatment);
- •Ongoing fever
- •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;
- •Women sexually active not using an effective method of contraception
- •Person under legal protection
- •Pregnant and parturient and Breast feeding women
- •Legally detained person
- •Under the age of majority
- •Immediate risk for suicidal behaviour (3 on HamD-17 rating scale or 5 on MAD Rating Scale);
- •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.
研究者
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