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

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.