Ketamine as an Adjunctive Therapy for Major Depression (2) (KARMA-Dep2)

Pragmatic, randomised, parallel-group superiority trial in patients admitted to St Patrick's University Hospital for a major depressive episode; participants randomised 1:1 to up to eight twice-weekly infusions of ketamine or midazolam over up to four weeks.

Primary outcome compares mood-rating change from before first infusion to 24 hours after final infusion; participants followed for 24 weeks to assess relapse. Blinding includes participants and assessors; clinical and safety monitoring performed throughout.