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 consentXX
(Re-affirm)
PHQ-2X
Endicott criteriaX
AKPSXXXXXXX
Vital signsXXXXXXX
ECGX
Bloods (FBC/LFT/EUC /TFT)X
MADRS78XXXXXXXX
BPRS74 75XXXX
CADSS76 77XXXX
NPRS89 90XXXXXXX
Adverse Events
(NCI CTCAE 4.03)73
XXXXXXXXXXXX
Q-LES-Q-SF89 90XXX
Concomitant medicationsXXXX
SKIPMDD Participant Satisfaction QuestionnaireX (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.