NCT07052058尚未招募2 期
Triple-Blind Randomized Clinical Trial of Tocilizumab vs Placebo: Potential Use of an IL-6 Antagonist as an Adjuvant to Standard Treatment for Treatment-Resistant Major Depression in the Brazilian Public Health System (SUS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Reduction in depressive symptoms (HDRS)
研究概览
简要总结
Clinical trial aimed at evaluating whether a single infusion of tocilizumab, a medication that blocks the action of an inflammatory molecule called interleukin-6 (IL-6), can reduce symptoms of treatment-resistant major depression compared to placebo in non-hospitalized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years Provide informed consent Understand written and spoken Portuguese Able and willing to consent to blood sampling Willing to abstain from strenuous exercise for 72 hours prior to assessment Meet DSM-5/MINI criteria for a diagnosis of depression resistant to at least two adequate courses of treatment at the time of eligibility assessment Baseline HDRS score of 19 or higher at Serum/plasma CRP level ≥3 mg/L
排除标准
- •Diagnosis of bipolar disorder or personality disorder History of substance use disorder in the past six months. Presence of active/recent infection (including TB, Hepatitis B, Hepatitis C, or HIV) or autoimmune disease Pregnancy or breastfeeding History of significant cardiovascular disease, recent cancer, or hematological disorders BMI >40 kg/m² or weight >100 kg Hypersensitivity to tocilizumab or any of its excipients. CRP ≥20 mg/L Active liver disease or transaminase elevation >1.5× the upper limit of normal
- •Inclusion criteria to the 10 healthy controls recruited for comparison of inflammatory biomarkers:
- •Age ≥ 18 No current or lifetime psychiatric diagnosis, as measured by the SRQ-20 Provide informed consent Understand written and spoken Portuguese Able and willing to consent to blood sampling
研究组 & 干预措施
Tocilizumab
Experimental
干预措施: Tocilizumab (Biological)
Placebo
Placebo Comparator
干预措施: Normal Saline (0.9% NaCl) (Drug)
Healthy controls, for comparison of inflammatory biomarkers
No Intervention
Healthy controls (HCs) will be recruited for comparison of CRP and IL-6 levels. They will be required to have no current or past history of psychiatric disorders as assessed by the SRQ-20, an instrument developed by the WHO to measure the level of suspicion of mental disorders.
结局指标
主要结局
Reduction in depressive symptoms (HDRS)
时间窗: Baseline and follow-ups (day 7, day 14, day 28 and month 6)
≥50% reduction in score
次要结局
- Psychiatric hospitalization rate in 6 months(6 months follow-up)
- Suicidal ideation (MINI)(Elegibility and follow-ups (day 7, day 14, day 28 and month 6))
- Cognitive performance (Montreal Cognitive Test)(Baseline and follow-ups (day 7, day 14, day 28 and month 6))
- Quality of life (EUROHISQOL8)(Baseline and follow-ups (day 7, day 14, day 28 and month 6))
- Quality of life (WHOQOL-BREF)(Baseline, follow-ups (day 7, day 14, day 28 and month 6))
- ECT indication after invervention(Follow-ups (day 7, day 14, day 28 and month 6))
- BDNF levels(Baseline and third follow-up post-intervention (28th day))
- General psychiatric symptoms improvement (BPRS)(Baseline and follow-ups (day 7, day 14, day 28 and month 6))
- Clinical global improvement (CGI)(Baseline and follow-ups (day 7, day 14, day 28 and month 6))
- CRP levels(Baseline and follow-ups (day 7, day 14, day 28 and month 6))
- IL-6 levels(Baseline (for healthy controls) and baseline and follow-ups for intervention arm(day 7, day 14, day 28 and month 6))
研究者
研究点 (1)
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