Double‑blind, randomised, parallel‑group Phase II trial (n=60) comparing oral ketamine versus oral midazolam in adults (18–64) with a major depressive episode to assess antidepressant efficacy.
Randomised, double‑blind, controlled Phase II study conducted in Austria assessing the antidepressant efficacy and tolerability of an oral ketamine formulation (Ketamin‑hameln) versus oral midazolam (Dormicum) in patients with a major depressive episode.
Primary outcome was change in MADRS measured before each treatment session, 24 hours after the first treatment session, and one and two weeks after the last treatment session; secondary assessments included CADSS for dissociative symptoms.
Sponsor: Medical University of Vienna; single‑site trial in Austria; IMPs were marketed formulations (Ketamin‑hameln and Dormicum) used orally per protocol details.
Oral ketamine (Ketamin‑hameln) solution for oral use; parallel-group active comparator design.
Ketamine hydrochloride oral formulation (Ketamin‑hameln); concentration reported 57.7 mg/ml; dose not specified in registry summary.
Active comparator arm receiving oral midazolam (Dormicum).
Midazolam hydrochloride (Dormicum) oral solution, 1 mg/ml; used as active comparator (trade name Dormicum).