Tocilizumab Augmentation in Treatment-Refractory Major Depressive Disorder: An Open-Label Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Absolute Change on Hamilton Depression Rating Scale (HDRS)
研究概览
简要总结
This proposed study sets out to examine the antidepressant effects of tocilizumab among patients with treatment-refractory major depression.
详细描述
As the understanding of the complex relationship between pro-inflammatory cytokines (specifically interleukin-6 [IL-6]) and depression symptoms becomes clearer, clinical trials to evaluate effective and novel treatments are needed. As there have been no published tocilizumab trials among patients with major depression, this pilot study will adopt a single-arm, open-label design. Due to the notion that inflammatory cytokines may play a role in a sub-type of depression, this study will recruit patients with treatment refractory major depressive disorder, for whom established depression treatments have not been effective. In conducting this trial, the investigators seek to examine the potential role of tocilizumab as an augmentation agent, with the hypothesis that it could reduce depression symptomatology in patients with major depression who have not experienced symptom reduction through more traditional antidepressant therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of major depressive episode
- •Hamilton Depression Rating Scale (HDRS) score of >20
- •In treatment for depression for a minimum of 8 weeks
- •Exclusion criteria:
- •Active drug or alcohol disorder in the last three months
- •History of psychosis, mania or hypomania
- •Acute suicide or homicide risk
- •History of liver disease including HCV and HBV
- •History of heart disease or a heart attack
- •Active or latent tuberculosis, a history of a positive tuberculosis test, or having received the Bacillus Calmette-Guérin (BCG) vaccine
- •Epilepsy or a history of seizures
- •Abnormal thyroid-stimulating hormone (TSH <0.4 or >5.0mlU/L)
- •Abnormal liver function tests on screening (ALT>50 U/L or AST>50 U/L)
- •Low absolute neutrophil count (ANC) on screening (<4000/mm3
- •Abnormal white blood cell count (<4,500 or > 10,000mcL)
- •Low platelet count on screening (<150,000/mm3
- •Patients with an active or recent infection, for example cellulitis, bacteremia, pneumonia, and pyelonephritis.
- •Recent exposure to uncommon infections (e.g. histoplasmosis, blastomycosis, coccidiomycosis) through recent travel to the Ohio and Mississippi River Valleys and the Southwest
- •Pregnant women, breastfeeding women or women of child-bearing age not using contraception
- •History of or current autoimmune disease, including multiple sclerosis and inflammatory bowel disease
- •Diagnosis of chronic fatigue syndrome
- •Temperature greater than 100.3F at the screening visit or any subsequent visits
- •Dyslipidemia
- •Currently taking oral steroids
- •Currently taking statins
- •Chronic aspirin or NSAID takers
- •Currently taking any immunomodulating medications
- •Inability to consent due to cognitive impairment
排除标准
- 未提供
研究组 & 干预措施
Tocilizumab
Tocilizumab 162 mg sc q2weeks x 4 doses
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Absolute Change on Hamilton Depression Rating Scale (HDRS)
时间窗: Baseline to 8 Weeks
Absolute change on Hamilton Depression Rating Scale (HDRS) score
次要结局
- Proportion of Subjects Achieving Remission (HDRS Score < 7)(8 Weeks)
- Proportion of Subjects Achieving Response (HDRS Score Decreased >50% From Baseline)(8 Weeks)
研究者
Jessica Harder
Associate Psychiatrist
Brigham and Women's Hospital