Subcutaneous ketamine infusion in palliative care... — Clinical Trial Details

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

Psychosis History

Patients known to the palliative care services in the acute hospital, palliative care units or in the community with advanced life limiting illness and major depressive disorder in Australia (inclusive of those with very limited prognosis with Australia-modified Karnofsky Performance Scale [AKPS] 30 or less, and those with severe depression with MADRS 35 or more).
Adult males or females known to palliative care service aged ≥18 years
Palliative intent of treatment due to irreversible medical illnesses
PHQ-2 score ≥3
Major Depressive Disorder (Endicott Criteria) diagnosed by trained personnel (psychiatry team, psychologist or trained research team member)
MADRS score ≥16
Willing and able to comply with all study requirements
Signed, written informed consent

AKPS score ≤10
Having curative intent to treatment
Recent methylphenidate use in last 4 weeks
Changes to antidepressant doses in the last 2 weeks prior to ketamine commencement
Ketamine use in the last 4 weeks
Previous significant adverse effect or hypersensitivity to ketamine
Concurrent phenobarbitone use
Factors increasing risk of intracranial pressure: recent ischaemic/haemorrhagic stroke in last 1 month; symptomatic brain tumours with signs of raised intracranial pressure; seizure in last 6 months; head trauma with signs of raised intracranial pressure; hydrocephalus
Uncontrolled nausea/vomiting/headache (≥grade 3 despite one antiemetic)
Factors increasing risk of sympathomimetic response: uncontrolled hypertension (SBP ≥160); tachycardia HR ≥120/min; symptomatic ischemic heart disease or decompensated heart failure (NYHA III–IV); uncontrolled hyperthyroidism; porphyria
Factors increasing risk of intraocular pressure: glaucoma; open eye/acute globe injury
Severe hepatic impairment (bilirubin ≥3× ULN or AST/ALT >5× ULN if due to hepatic impairment)
Severe renal impairment (CrCl <15 ml/min)
Other mental disorders apart from major depression (lifetime schizophrenia/bipolar/mania)
Recent substance misuse as determined by treating/research clinicians

Subcutaneous ketamine infusion in palliative care patients with advanced life limiting illnesses for major depressive disorder: A phase II pilot feasibility study