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