Table 2

Assessment schedule

AssessmentsEligibilityBaseline
(t0 min)
30 min1 hour1.5 hours2 hour
(infusion complete)
4 hours6 hours1 day2 days3 days7 daysWeekly (day 7) if no repeat ketamine infusion
(up to 8 weeks from initial dose)
Informed consent X X
(Re-affirm)
PHQ-2 X
Endicott criteria X
AKPS X X X X X X X
Vital signs X X X X X X X
ECG X
Bloods (FBC/LFT/EUC /TFT) X
MADRS 78 X X X X X X X X
BPRS 74 75 X X X X
CADSS 76 77 X X X X
NPRS 89 90 X X X X X X X
Adverse Events
(NCI CTCAE 4.03)73
X X X X X X X X X X X X
Q-LES-Q-SF 89 90 X X X
Concomitant medications X X X X
SKIPMDD Participant Satisfaction Questionnaire X (only at the end of the study—study completion or withdraw)
  • AKPS, Australia-modified Karnofsky Performance Scale; BPRS, Brief Psychiatric Rating Scale; CADSS, Clinician Administered Dissociative States Scale; EUC, electrolyte urea creatinine; FBC, full blood counts; LFT, liver function test; MADRS, Montgomery-Asberg Depression Rating Scale; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; NPRS, Numeric Pain Rating Scale; PHQ-2, Patient Health Questionnaire-2; Q-LES-Q-SF, Quality-of-life Enjoyment and Satisfaction Questionnaire - Short Form;; SKIPMDD, subcutaneous ketamine infusion in palliative care patients with advanced life limiting illnesses for major depressive disorder; TFT, thyroid function test.