Open-label, non-randomised feasibility study (n=30) of three weekly IM ketamine sessions (with optional small supplemental dose) combined with preparatory and integration psychotherapy for adults with treatment-resistant depression.
This single-group feasibility study evaluates ketamine-assisted psychotherapy in adults with treatment-resistant depression across three consecutive weekly intramuscular dosing visits paired with structured preparation and integration psychotherapy sessions.
Dosing is weight-stratified with typical per-session dosing up to 0.75 mg/kg and an optional 20-40 mg supplemental injection 12 minutes after the initial dose; psychotherapy sessions are two hours for preparation and two hours for each integration visit. Outcomes include change in MADRS with follow-ups 1 day after each administration, 1 week, 1 month, 3 months and 6 months after final administration.
Three weekly intramuscular ketamine dosing sessions combined with structured psychotherapy (preparation and integration sessions).
Weight-stratified dosing: sessions 1–3 typically 0.5–0.75 mg/kg for 50–100 kg (session1 initial 0.5 mg/kg); participants >100 kg receive lower initial doses (0.3–0.5 mg/kg). Optional supplemental dose 20–40 mg given ~12 minutes after first injection per protocol; see protocol for full schedule.