Clinical TrialTreatment-Resistant Depression (TRD)KetamineRecruiting

Oral Ketamine Trial on people aged 16 years and older with Treatment-Resistant Depression

This open-label trial (n=25-50) investigates the effects of low-dose oral ketamine on depressive symptomatology in individuals aged 16 years and older diagnosed with treatment-resistant depression (TRD).

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

Detailed Description

Open-label, single-group, phase II study of once-weekly low-dose oral ketamine given for six weeks (six onsite dosing sessions) in people with treatment-resistant depression; safety, tolerability and feasibility are primary aims.

Dosing starts at 0.5 mg/kg with per-session escalation up to a maximum of 3.0 mg/kg; participants observed up to two hours post-dose. Clinical efficacy measured by clinician-rated HAM-D and neurobiological effects assessed with MRI at baseline and two follow-ups.

Study Protocol

Preparation

sessions

Dosing

6 sessions
120 min each

Integration

sessions

Study Arms & Interventions

Oral ketamine

experimental

Low-dose oral ketamine administered once weekly for 6 sessions with dose escalation to a predefined maximum.

Interventions

  • Ketamine0.5 - 3 mg/kg
    via Oral• weekly• 6 doses total

    Liquid ketamine in water or flavoured drink; initial 0.5 mg/kg with per-session escalation (0.1–1.0 mg/kg) to max 3.0 mg/kg; administered on-site and observed up to 2 hours post-dose.

Participants

Ages
16 – 99
Sexes
Male & Female

Inclusion Criteria

  • Patients who suffer from treatment-resistant depression (TRD) determined by HAM-D score ≥17
  • Persons (male/female/other) aged 16 years and over
  • Participants must be able to understand the Participant Information Form (PIF) and provide written informed consent on the Participant Consent Form (PCF)

Exclusion Criteria

  • Persons under 16 years of age
  • Psychosis
  • Mania/hypomania
  • Acute suicidality requiring urgent psychiatric intervention
  • History of ketamine use disorder
  • Recovery from a substance use disorder within prior 6 months
  • Uncontrolled/severe symptomatic cardiovascular disease including recent myocardial infarction (within prior 6 months); history of stroke; hypertension (resting BP >150/100)
  • History of intracranial mass, intracranial haemorrhage/stroke, cerebral trauma/traumatic brain injury or increased intracranial pressure
  • Abnormal liver function tests outside specified ranges: ALT >135 U/L; AST >123 U/L; GGT male >210 U/L; GGT female >135 U/L; Total bilirubin >60 µmol/L; Albumin <25 g/L or >150 g/L; ALP >345 U/L
  • Previous adverse reaction to ketamine
  • Pregnancy
  • Breastfeeding
  • History of epilepsy or unexplained seizures

Study Details

Locations

Unknown facility — Australia

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