EUCTR2017-004624-30-SE进行中（未招募）1 期
Modulating proinflammatory processes using tocilizumab in major depressive disorder
inköping University0 个研究点目标入组 66 人开始时间: 2017年11月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
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
入选标准
- •General inclusions (evaluated through screening under separate protocol 2017/345-32)
- •1. Age 18 – 65
- •2. Working knowledge of Swedish
- •3. Current MDD episode as determined by MINI screening
- •Tocilizumab augmentation-protocol related inclusions
- •1. Willingness to provide informed consent (including consent to use baseline data from protocol 2017/345-32), and ability to do so, as evidenced by clinical assessment and a MMSE score = 24
- •2. Serum IL-6 levels above upper limit of reference interval (evaluated under separate protocol 2017/345-32)
- •3. Women of childbearing potential (WOCBP) must agree to use a method of contraception that is highly effective for the duration of the study and for 3 months after the intake of the investigational medicinal product. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
- •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 61
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •General exclusions (evaluated under separate protocol 2017/345-32):
- •1. Any medical condition that, in the judgment of the study physician, after appropriate consults if needed, accounts for the symptoms of depression, such as, for example, hypothyroidism, severe anemia, etc.
- •2. Standard clinical contraindication to MRI scanning of the head according to MRI checklist in Region Östergötland, following additional exams and evaluation by radiologist if needed.
- •3. Pregnancy
- •4. Any medical condition that, in the judgment of the study physician and after appropriate consults if needed, is likely to influence cerebral blood flow or gross-level brain activity/anatomy, such as for instance:
- •a. type-1 diabetes
- •b. cardiovascular or respiratory disease
- •c. history of significant head injury
- •d. hyper-/hypothyroidism
- •e. epilepsy
- •5. Current DSM-5 diagnosis of a substance use disorder (moderate – severe, corresponding to DSM-IV substance dependence; not including nicotine), as determined by the MINI interview
- •6. Current DSM-5 diagnosis of a psychotic disorder (except MDD episode with mood congruent psychotic symptoms)
- •7. Use of prescription or over-the-counter drugs that could interfere with the objectives of the study (such as ongoing use of steroidal and non-steroidal anti-inflammatory drugs)
- •8. Additional medication exclusions:
- •a. For antidepressants
- •i. new medications started within one month prior to study (two months, in the case of fluoxetine)
- •ii. increase in dose within one month prior to study
- •b. For antipsychotics
- •i. changed dosage within one month prior to study
- •c. For antiepileptic drugs
- •i. changed dosage within two months prior to study
- •d. For mood stabilizers (e.g., lithium)
- •i. changed dosage within two months prior to study
- •Tocilizumab augmentation-protocol related exclusions:
- •1. Presence, as evaluated by laboratory testing and appropriate specialist consult if needed, of multiple sclerosis, inflammatory bowel disease, or human immunodeficiency virus.
- •2. Recent (within past month) immunization or plan to receive immunization during the duration of the study.
- •3. Lactation
- •4. A history of, or current tuberculosis as determined by history, physical exam, blood tests and chest X-rays.
- •5. A history of, or current severe herpes infection (severe genital herpes, herpes zoster, or herpes encephalitis).
- •6. Having a high risk of tuberculosis exposure as confirmed by interview
- •7. Presence of interstitial pulmonary disease (including but not limited to primary or secondary pulmonary fibrosis or sarcoidosis), as determined by history, physical exam and chest X-ray.
- •8. Presence of hepatitis B or C as determined by laboratory testing
- •9. Systemic or serious fungal infection
- •10. A history of clinically significant recurrence of viral or bacterial infections, as determined from medical records and interview will lead to appropriate specialist consult to determine wheth
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