Outcomes
toxicity, psychiatric, MDD, non-psychiatric adverse, Cancer
ADVERSE EVENTS, ADVERSE EVENT, SECONDARY, CANCER
The primary outcome was feasibility, measured as the absolute numbers and proportions of palliative care patients who have consented, were screened for MDD, achieved study eligibility, received ketamine, followed up, and completed the study with reasons for inability to complete any study stages recorded. Feasibility criteria for a future definitive trial were set For secondary outcomes: to measure safety, tolerability and acceptability, general non-psychiatric adverse events by vital signs and gradings of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03), and psychiatric adverse events of psychotomimetic and dissociative symptoms by Brief Psychiatric Rating Scale (BPRS) and Clinician Administered Dissociative States Scale (CADSS) were used respectively; and for measuring the antidepressant signal, the Montgomery-Åsberg Depression Rating Scale (MADRS) was used.Baseline MADRS and toxicity assessments (including AKPS, vital signs, NCI CTCAE, BPRS, and CADSS) were performed immediately in the inpatient or day-hospital setting before ketamine administration (Day 0). Subsequent toxicity assessments were performed every 30 minutes during the 2-hour ketamine infusion and two and four hours after infusion completion. MADRS was reassessed four hours after infusion completion. Participants were further monitored for changes in NCI CTCAE, AKPS and MADRS scores on Day 1, 3, and 7 of Week 1–4 and Day 7 of Week 5–8.Ketamine was ceased, or participants were withdrawn from the study when the participants, treating physicians, or research clinicians found the study intervention or participation unacceptable for participants at any time point (e.g., participants clinically deteriorated from their underlying medical conditions, preventing ongoing study participation). Investigators reported any Serious Adverse Event, as defined in the protocol, to the Australian national Palliative Care Clinical Studies Collaborative (PaCCSC) Trial Coordinating Unit, who then liaised with the assigned medical monitor for review and involved the Human Research Ethics Committee if required. Given the feasibility nature of this study, a medical monitor rather than a data monitoring committee was used.