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.
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.
Standard ketamine course with concurrent immersive VR during each infusion.
0.5 mg/kg IV infused over 45 minutes per session
Oculus VR headset immersion during each 45-minute ketamine infusion
Standard ketamine course without VR.
0.5 mg/kg IV infused over 45 minutes per session