ISRCTN16942542已完成未知
IL-6 inhibition in patients with depression and low-grade inflammation: the Insight study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 86
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30244217 protocol (added 31/10/2019) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34729541/ (added 23/01/2024) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/35036964/ (added 23/01/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion criteria for all participants:
- •1. Able and willing to give informed consent, including consent to share information with the participant’s General Practitioner (GP) and to access GP records
- •2. Able to understand written and spoken English
- •3. Able to consent to blood sampling
- •4. Willing to abstain from strenuous exercise for 72 hours before the assessment visits
- •5. Age: 20-65 years (inclusive) at the time of eligibility assessment
- •6. Diagnosis of depression: meet ICD-10 criteria for diagnosis of depression at the time of eligibility assessment
- •7. Somatic symptom score: =7 at the time of eligibility assessment based on Beck depression inventory II (BDI-II) items 4=lack of pleasure, 15=loss of energy, 16=changes in sleeping pattern, 18=changes in appetite, 19=concentration difficulty, 20=tiredness or fatigue, and 21=loss of interest in sex
- •8. History of non/slow response to antidepressant: at the time of eligibility assessment receiving treatment with an antidepressant at adequate dose (according to BNF) for at least four weeks
- •Additional inclusion criteria for intervention cohort:
- •1. Inflamed: serum/plasma hsCRP level =3mg/
排除标准
- •Exclusion criteria for all participants:
- •1. Current or lifetime diagnosis of bipolar disorder, psychotic disorder, personality disorder or eating disorder
- •2. Current suicidal thoughts (BDI II item 9=suicidal thoughts or wishes score 2 or more) or history of suicide attempt, deliberate self-harm, overdose within six months prior to eligibility assessment
- •3. History of alcohol or substance use disorder (abuse/dependence) within six months prior to eligibility assessment (nicotine and caffeine dependence are not exclusionary)
- •4. Pregnant or breastfeeding
- •5. History of serious allergic reaction after any infusion
- •6. Current use of medication likely to compromise interpretation of immunological data (including, but not limited to, antibiotics, non-steroidal anti-inflammatory drugs, oral/injectable corticosteroids – or any other substances to be determined by the Chief Investigator)
- •7. Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of eligibility assessment
- •8. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other opportunistic infections
- •9. Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active infectious disease, including current or prior malignancy
- •10. Rheumatic autoimmune disease, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis
- •11. Uncontrolled hypertension defined as systolic blood pressure > 170 or diastolic blood pressure > 110
- •12. No history of chickenpox infection or no history of varicella zoster vaccination
- •Additional exclusion criteria for intervention cohort:
- •1. Current or past infection with TB, Hepatitis B, Hepatitis C, VZV or HIV confirmed by blood/other test. Chest X-ray will be also done to exclude TB
- •2. Pregnancy test (for female participants)
- •3. History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
研究者
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