Intravenous ketamine and immersive virtual reality to treat depression (TREASURE)
Randomized Phase III pilot trial (n=31) comparing standard IV ketamine (0.5 mg/kg over 45 minutes, 4 sessions) versus ketamine with concurrent immersive VR in adults with treatment-resistant depression.
Details
This two-phase prospective randomized pilot trial enrols a small development cohort (Phase I, N=3–5) to refine VR content, then randomizes participants (Phase II, N=26) to ketamine alone or ketamine plus immersive VR to assess feasibility and preliminary signals of efficacy for treatment-resistant depression.
All participants receive 0.5 mg/kg IV ketamine infused over 45 minutes, two sessions per week for two weeks (total four treatments). The VR arm wears an Oculus headset during each infusion to experience calming outdoor scenes; outcomes include feasibility, depressive and anxiety symptoms, dissociation/sedation, cognition, EEG measures, and patient satisfaction.