ACTRN12618001586202终止2 期
Subcutaneous ketamine infusion in palliative care patients with advanced life limiting illnesses for major depressive disorder: A phase II pilot feasibility study
niversity of Technology Sydney0 个研究点目标入组 10 人开始时间: 2018年9月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients known to the palliative care services in the acute hospital, palliative care units or in the community with advanced life limiting illness and major depressive disorder in Australia (inclusive of those with very limited prognosis with Australia-modified Karnofsy Performance Scale [AKPS] 30 or less, and those with severe depression with MADRS 35 or more)
- •Inclusion criteria
- •Adult males or females known to palliative care service with age greater than or equal to 18 yrs
- •Palliative intent of treatment due to irreversible medical illnesses
- •Patient Health Questionnaire-2 (PHQ-2) score greater than or equal to 3, and
- •Major Depressive Disorder defined by Endicott Criteria diagnosed by trained personnel (e.g. psychiatry team, psychologist or trained research team member) with:
- •MADRS Score greater than or equal to 16
- •Willing and able to comply with all study requirements,
- •Signed, written informed consent for the study
排除标准
- •Exclusion criteria
- •Australian-modified Karnofsky Performance scale (AKPS) score less than or equal to 10
- •Having curative intent to treatment
- •Palliative intent life prolonging measures such as target therapies, radiotherapy or intravenous antibiotics is acceptable
- •Methylphenidate use in the last 4 weeks
- •Changes to antidepressant doses in the last 2 weeks prior to the commencement of ketamine
- •Ketamine use in the last 4 weeks
- •Previous significant adverse effect or hypersensitivity to ketamine
- •Concurrent phenobarbitone use
- •Factors of increased risk of intracranial pressure:
- •i.Recent ischaemic or haemorrhagic cerebral vascular accident in the last 1 month
- •ii.Brain tumours with symptoms and signs of increased intracranial pressure
- •iii.Seizure in the last 6 months
- •iv.Head trauma with symptoms of increased intracranial pressure
- •v.Hydrocephalus
- •vi.Uncontrolled nausea (Greater than or equal to grade 3 despite 1 line of antiemetic), vomiting and headache (e.g. from cerebral metastases, trauma)
- •vii.Greater than or equal to grade 3 despite one line of antiemetics
- •Factors of increased risk of sympathomimetic response (hypertension and tachycardia) with associated complications
- •i.Uncontrolled hypertension with systolic blood pressure greater than or equal to 160
- •ii.Tachycardia with heart rate greater than or equal to 120 per minute.
- •iii.Symptomatic ischaemic heart disease (e.g. exertional angina) and decompensated heart failure with NYHA class III and IV symptoms
- •iv.Uncontrolled Hyperthyroidism (Low TSH with high T3 and/or T4)
- •v.Diagnosis and history of Prophyria
- •Factors of increased risk of intraocular pressure with its complications
- •ii.Open eye injury / Acute globe injury
- •Severe hepatic impairment: Bilirubin greater than or equal to 3 times upper limit of normal; AST and/or ALT > 5 times upper limit of normal - clinically determined to be due to hepatic impairment
- •Severe renal impairment (Creatinine clearance <15ml/min by Cockroft Gault Equation)
- •Other mental disorders apart from major depression (lifetime history schizophrenia/bipolar/mania)
- •Recent substance misuse as determined by the treating and research clinicians
研究者
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