ISRCTN32236160已完成未知
BETter TreatmEnts for Refractory Breathlessness: A feasibility study of the use of mirtazapine for refractory breathlessness
Kings College Hospital NHS Foundation Trust0 个研究点目标入组 64 人开始时间: 2016年6月13日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 64
研究概览
简要总结
2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31915308 results (added 10/01/2020) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32087745 qualitative results (added 24/02/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female aged = 18 years old
- •2. Modified MRC dyspnoea scale grade 3 or 4
- •3. Diagnosis of either:
- •3.1. Cancer
- •3.2. Chronic obstructive pulmonary disease (COPD)
- •3.3. Interstitial lung disease (ILD)
- •3.4. Chronic heart failure (New York Heart Association class III or IV)
- •4. On optimal treatment of the underlying condition in the opinion of the identifying clinician
- •5. Management of the underlying condition unchanged for the previous 1 week
- •6. Reversible causes of breathlessness optimally treated in the opinion of the identifying clinician
- •7. Expected prognosis of =2 months
- •8. If female and of child-bearing potential, must agree to use adequate contraception
- •9. Able to complete questionnaires and trial assessments
- •10. Able to provide written informed consent
排除标准
- •1. Existing antidepressant use
- •2. Known contraindication to mirtazapine
- •3. Hypersensitivity to the active substance or to any of the components of the mirtazapine or placebo (e.g. lactose intolerance)
- •4. Australia modified Karnofsky Performance Scale =40
- •5. Pregnant or breast-feeding women
- •6. Patients with acute cardiac events within 3 months of randomisation (myocardial infarction, unstable angina pectoris, or significant cardiac conduction disturbance)
- •7. Patients with known hepatic impairment
- •8. Patients with known renal impairment
- •9. Patients with uncontrolled blood pressure
- •10. Patients with uncontrolled diabetes mellitus
- •11. Patients with uncontrolled seizures, epilepsy or organic brain syndrome
- •12. Patients with severe depression or suicidal thoughts
- •13. Patients with a history of psychotic illness (schizophrenia, bipolar disorder, mania or hypomania, or other psychotic disturbances)
研究者
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