Clinical TrialMajor Depressive Disorder (MDD)KetamineCompleted

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

This open-label, non-randomised feasibility study (n=32) investigates low-dose individually-tailored subcutaneous ketamine infusions (0.1–0.4 mg/kg over 2 hours) given weekly by response for depression in palliative care patients with advanced life-limiting illnesses.

Target Enrollment
10 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Open-label, single-group Phase II feasibility study delivering individually tailored subcutaneous ketamine infusions (0.1–0.4 mg/kg over 2 hours) weekly, up to four doses, with 4 weeks of follow-up to assess feasibility, tolerability and preliminary antidepressant effect in palliative care patients with major depressive disorder.

Outcomes include feasibility metrics (accrual, retention, protocol adherence), depression scales (MADRS), and monitoring of serious side effects per CTCAE v4.0; protocol compliance and source data may be monitored by the Trial Management Committee or delegates.

Study Protocol

Preparation

sessions

Dosing

4 sessions
120 min each

Integration

sessions

Study Arms & Interventions

Subcutaneous ketamine

experimental

Individually tailored subcutaneous ketamine infusions given weekly by response, up to 4 doses with 4 weeks follow-up.

Interventions

  • Ketamine0.1 - 0.4 mg/kg
    via Other• weekly• 4 doses total

    Individually tailored 0.1–0.4 mg/kg infused over 2 hours; up to 4 weekly doses; follow-up 4 weeks.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Details

Locations

Unknown facility — Australia

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