ACTRN12621000562875招募中未知
An open-label feasibility study of ketamine-assisted therapy in adults with treatment-resistant depression.
niversity of Auckland0 个研究点目标入组 30 人开始时间: 2021年5月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 69 Years（—）
- 性别
- All
入选标准
- •Adult patients who meet DSM-5 criteria for Major Depressive Disorder or Bipolar Disorder and:
- •1) will and able to give informed consent for participation in the study
- •2) Male or female, aged 18 years or above and less than age 70.
- •3) If Bipolar Disorder must be on a mood stabilizing medication for the duration of the study
- •4) current depressive episode for at least three months
- •5) MADRS > or = 20
- •6) Inadequate response to at least two antidepressant treatments one of which can include the current episode.
- •7) must be stable on any psychotropic medication for at least four weeks prior to the study day.
排除标准
- •Participant may not enter the trial if ANY of the following apply:
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- •Significant renal or hepatic impairment.
- •Cardiovascular conditions including severe cardiovascular disease, heart failure, severe or poorly controlled hypertension, recent myocardial infarction, history of stroke, cerebral trauma, or intracerebral mass or haemorrhage.
- •Abnormal heart rate or blood pressure checked at screening.
- •Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
- •History of significant psychotic episode(s).
- •Any unstable medical or neurologic condition.
- •Planned major changes to psychotropic medication.
- •Imminent risk of suicide as determined by the CSSRS and MADRS/clinical interview.
- •Planned or probable use of ECT.
- •Active substance use disorder in the previous 6 months.
- •Regular use of any medication deemed to be contraindicating as judged by the attending study physicians
- •Inability to speak or read English.
- •Any history of abuse of ketamine or phencyclidine.
- •Contraindication to the use of ketamine according to manufacturer guidelines including hypersensitivity to the drug or its components.
- •Planned use of ketamine, for example, for pain control.
- •Unable to fast for four hours prior to administration of ketamine.
- •Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial.
- •Body-weight <50kg or >120kg.
- •Current use of the following medications:memantine / amantadine / rimantadine / dextromethorphan/procyclidine/ lamotrigine.
研究者
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