Assessments | Eligibility | Baseline (t0 min) | 30 min | 1 hour | 1.5 hours | 2 hour (infusion complete) | 4 hours | 6 hours | 1 day | 2 days | 3 days | 7 days | Weekly (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 | ||||||||||||
MADRS78 | X | X | X | X | X | X | X | X | |||||
BPRS74 75 | X | X | X | X | |||||||||
CADSS76 77 | X | X | X | X | |||||||||
NPRS89 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-SF89 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.