Single-site, randomised, controlled RCT (n=70) comparing ketamine-assisted psychotherapy (KAP) to standard medical ketamine (KET) for MDD over four weeks; ketamine doses personalised 0.3–1.0 mg/kg.
Randomised, parallel-group, single-blind (outcomes assessor) trial enrolling adults with major depressive disorder to receive either weekly KAP sessions (IM ketamine, 0.3–1.0 mg/kg, 4–5 sessions) or a standard medical IV ketamine regimen (twice-weekly for three weeks then a single infusion in week four, up to seven infusions).
Assessments include depression severity, wellness, neurocognitive functioning and safety at baseline, end of acute treatment, and over an eight-week follow-up. Preparatory and integration psychotherapy sessions are provided in the KAP arm; matched psychoeducation provided in the KET arm.
Ketamine-assisted psychotherapy: weekly KAP sessions for 4 weeks (possible second session in week 1 for dose finding); personalised ketamine dosing IM.
Personalised dosing 0.3–1.0 mg/kg; session duration 120–180 min; preparatory and integration sessions included.
Behavioral psychotherapy and integration sessions paired with drug sessions (60 min integration sessions weekly).
Standard medical ketamine without formal psychotherapy: twice-weekly IV infusions for 3 weeks then a single infusion in week 4; dose titrated clinically 0.3–1.0 mg/kg.
No formal psychotherapy; matched basic psychoeducation provided.