Clinical TrialMajor Depressive Disorder (MDD)KetamineKetamineKetamineKetamineKetamineRecruiting

Effects of low dose intramuscular ketamine on depression ratings in depressed patients with cancer in palliative care

This randomised controlled trial (n=50) investigates the effects of low-dose intramuscular ketamine on depression ratings in individuals with major depressive disorder (MDD) and cancer in palliative care.

Target Enrollment
50 participants
Study Type
Phase II interventional
Design
Randomized, single Blind

Detailed Description

Open-label Stage 1 (single 1 mg/kg IM) and Stage 2 (repeated ~weekly 1 mg/kg IM for responders) followed by Stage 3 randomisation to single-dose 0.1, 0.5 or 1.0 mg/kg IM under double-blind conditions; primary outcome is change in MADRS over time.

Assessments include MADRS at baseline and 24 hours post-injection, proportion responding (>50% reduction) and remitting (MADRS <7), with additional measures including HADS and demoralisation scales.

Study Arms & Interventions

Open-label ketamine

experimental

Stage 1 single-dose IM ketamine (open-label); Stage 2 weekly repeat IM ketamine (open-label) for responders.

Interventions

  • Ketamine1 mg/kg
    via IM• single dose

    Stage 1: single 1 mg/kg IM

  • Ketamine1 mg/kg
    via IM• weekly

    Stage 2: repeated ~weekly 1 mg/kg IM; continue while beneficial

Ketamine 0.1 mg/kg

experimental

Stage 3 randomized single-dose double-blind arm (dose-comparison).

Interventions

  • Ketamine0.1 mg/kg
    via IM• single dose

Ketamine 0.5 mg/kg

experimental

Stage 3 randomized single-dose double-blind arm (dose-comparison).

Interventions

  • Ketamine0.5 mg/kg
    via IM• single dose

Ketamine 1.0 mg/kg

experimental

Stage 3 randomized single-dose double-blind arm (dose-comparison).

Interventions

  • Ketamine1 mg/kg
    via IM• single dose

Participants

Ages
20 – 65
Sexes
Male & Female

Inclusion Criteria

  • Male or female; any cancer type; receiving palliative care; life expectancy >3 months.
  • Major depression with baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score >20.
  • Advanced (incurable) cancer; adequate hepatic and renal function.

Exclusion Criteria

  • Presence of cerebral metastases; ECOG performance status <4; concurrent use of other experimental medication; current use of ketamine for analgesia.

Study Details

Locations

Unknown facility — Australia

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