This open-label, non-randomised feasibility study (n=32) investigates the use of low-dose individually-tailored subcutaneous ketamine infusion for treating depression in palliative care patients with advanced life-limiting illnesses.
The trial commenced on September 16, 2019 and concluded on April 27, 2021. The study, led by Dr Wei Lee from the University of Technology Sydney, aims to assess the feasibility, safety, and potential effects of ketamine in this population.
Patients with major depressive disorder and advanced life-limiting illnesses, particularly those with very limited prognosis and severe depression, were eligible for the study. The intervention involved an individually-tailored subcutaneous ketamine infusion at weekly intervals for up to 4 doses, with a maximal dose of 0.4mg/kg, followed by 4 weeks of monitoring.
The primary outcome measured the number of palliative care patients completing each stage of the study. Secondary outcomes included serious side effects, psychotomimetic and dissociative symptoms, depression score, quality of life score, and Numeric Pain Rating Scale.
The trial, funded by Sacred Heart Hospital, Calvary Hospital, Braeside Hospital, and Liverpool Hospital in Australia, experienced early cessation due to recruitment difficulties, partly attributed to the impact of COVID-19. The study’s ethical approval was granted by the South Western Sydney Local Health District (Liverpool) on February 18, 2019 (Ethics approval number: HREC/18/LPOOL/466). Despite not yet publishing results in a peer-reviewed journal, the collected data is currently being analysed. The Principal Investigator, Dr Wei Lee, and the contact person for public queries, Ms Linda Brown, can be reached at the University of Technology Sydney.
Trial Details
This study addresses the prevalence of depression in patients with advanced life-limiting illness, highlighting the time constraints for traditional antidepressants to yield rapid effects in palliative care. Given the limited efficacy of standard antidepressants in patients with short prognoses or severe depression, subanaesthetic doses of ketamine are being explored as a novel, rapidly acting treatment. The absence of prior trials using ketamine in this population underscores the need for investigation, particularly in those with limited prognosis or severe depression requiring immediate intervention. The study aims to assess the feasibility, potential effects, and safety of ketamine in palliative care patients through an individually tailored subcutaneous infusion administered weekly for up to 4 doses, followed by a 4-week monitoring period. The inclusion of typical antidepressant titration allows for ethical considerations. The primary outcome measures the number of palliative care patients completing each study stage, with secondary outcomes encompassing serious side effects, psychotomimetic symptoms, depression scores, quality of life, and pain ratings.NCT Number ACTRN12618001586202