A Randomised, Double-Blind, Placebo Controlled Feasibility Study of Oral Lorazepam for Symptoms of Anxiety in Patients with Advanced Life-Limiting Disease

Peter MacCallum Cancer Centre0 个研究点目标入组 15 人开始时间: 2020年11月2日最近更新: 2022年11月21日

适应症

试验速览

暂无简介。

•Provide written informed consent.
•Age greater than or equal to 18 years.
•Inpatient or outpatient receiving specialist palliative care input.
•Advanced cancer (histological or clinical diagnosis) defined by intent of treatment no longer being curative or diagnosis of non-malignant advanced life-limiting illness.
•Persistent or recurrent anxiety causing clinically significant distress or functional impairment, as determined by the Investigator through clinical interview as part of the medical assessment.
•Able to tolerate oral medication.
•Able to read and understand sufficient English to complete all required study questionnaires.
•Capable of completing assessments and complying with the study procedures.

•Psychiatric disorder other than anxiety or depression, unless stable for the past 3 months as assessed by the Investigator.
•Untreated depression, severe depression or suicidality as determined by the Investigator through clinical interview.
•Current or recent history of alcohol abuse or substance misuse.
•Formal diagnosis of severe respiratory failure (type 1 or 2).
•Formal diagnosis of sleep apnoea.
•Pregnant or breastfeeding.
•Uncontrolled physical symptoms, as determined by medical assessment.
•Hepatic dysfunction as defined as serum alanine aminotransferase or bilirubin >3.5 x upper limit of normal.
•History of adverse reaction to benzodiazepine or the constituents in the placebo.
•Regular use of benzodiazepines (more than 2 doses within the past seven days).
•Antidepressant medication commenced or dose changed within the past month.
•Enrolment in another clinical trial with an investigational agent for anxiety or depression within 30 days of screening.
•Clinician predicted survival less than 14 days.
•Use of clozapine currently or within the past 4 weeks.

发起方

Peter MacCallum Cancer Centre