ISRCTN06146268已完成未知
A pilot randomised controlled trial of drug treatment for depression in patients undergoing haemodialysis
East and North Herts NHS Trust (ENHT) (UK)0 个研究点目标入组 30 人开始时间: 2014年5月1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
- 30
研究概览
简要总结
2015 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26503099 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28126706 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28762106 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/28762106 (added 28/10/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Screening eligibility:
- •1.1. Patients with ESRD and receiving haemodialysis. They will have started dialysis at least 3 months ago and have continued to receive dialysis in the past 3 months prior to the invitation to take part in this study
- •1.2. Adults aged 18 or over
- •1.3. Patients who speak and read English sufficiently well to complete questionnaires
- •2. Trial eligibility:
- •2.1. Patients with a Beck Depression Inventory (BDI-II) of 16 or above
- •2.2. Patients who, according to the CI/PIs, have a prognosis of more than 1 year
- •2.3. Patients with a diagnosis of mild to moderate Major Depressive Disorder according to a Diagnostic and Statistical Manual of Mental Disorders (DSM) IV interview conducted by a research psychiatrist
- •2.4. Patients who score 18 or above on the Montgomery-Asberg Depression Scale (MADRS)
- •2.5. Patients who have the mental capacity to understand the trial and are able to give consent
排除标准
- •1. Patients who are currently being or have been treated for depression and/or anxiety with any antidepressants in the last 3 months
- •2. Patients who are currently being or have been treated for depression and/or anxiety with a formal psychological therapy in the last 3 months
- •3. Patients who are awaiting a planned living donor transplant within the period of the trial
- •4. Patients who have less than 1 year survival prognosis according to the nephrologist
- •5. Patients for whom Sertraline is contraindicated by their existing drug regimen according to the Summary of Product Characteristics
- •6. Patients with hepatic impairment, whose serum level of alanine transaminase (ALT) is two times the upper limits of normal or higher
- •7. Patients who have hepatitis B or hepatitis C, HIV/AIDS, and/or Creutzfeldt-Jakob disease
- •8. Patients who are pregnant or of childbearing potential who are not using adequate contaception
- •9. Patients who are or have been involved in an intervention study in the last 3 months
- •10. Patients with impaired coagulation judged by an international normalised ratio (INR) greater than 1.3
- •11. Patients who are currently taking MAOIs or pimozide
- •12. Patients who are currently taking triptans, antipsychotics, dopamine antagonists, tramadol, linezolid and warfarin
- •13. Patients with a diagnosis of a severe Major Depressive Disorder
- •14. Patients at moderate to severe risk of self-harm according to the assessment of the study psychiatrist
- •15. Patients who score above 4 on item 10 on the MADRS
- •16. Patients who answer yes to question A3G on the Mini-International Neuropsychiatric Interview (MINI)
- •17. Patients who have other known psychiatric conditions, including substance misuse, psychosis, or personality disorder, dementia or panic disorder, with the exception of other anxiety disorders (for example GAD or OCD)
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