A Study Comparing Oral Ketamine With Oral Midazolam for the Treatment of Major Depressive Episodes

Summary

Patients with depression are acutely distressed, often suicidal, and unable to meet the demands of everyday life. If proven effective in a rigorously conducted multicenter randomized controlled trial (RCT), oral ketamine would provide an affordable and scalable, intervention suitable for integration into routine psychiatric services.This study will establish an indigenous, cost-effective therapeutic strategy that could improve accessibility, hasten therapeutic response, and inform treatment guidelines, if found to be safe and effective.

Timeline

Start

2026-10

Primary completion

2029-10

Completion

2029-10

Publications

• Background Kaur S, Parmar C, Gaur V, Chauhan A, Andrade C. The efficacy of oral ketamine in severely depressed patients at high risk of suicide. Asian J Psychiatr. 2023 Aug;86:103678. doi: 10.1016/j.ajp.2023.103678. Epub 2023 Jun 12.
• Background Kumar PS, Menon V, Andrade C. A randomised, open-label, pragmatic pilot comparison of oral and intravenous ketamine in treatment-resistant depression. Asian J Psychiatr. 2024 Sep;99:104171. doi: 10.1016/j.ajp.2024.104171. Epub 2024 Jul 23.
• Background Silberbauer LR, Eggerstorfer B, Michenthaler P, Reichel S, Stimpfl T, Vanicek T, Naderi-Heiden A, Kasper S, Lanzenberger R, Gryglewski G. Oral ketamine for the treatment of major depressive and bipolar disorder, a randomized controlled trial and meta-analysis. J Affect Disord. 2026 Feb 1;394(Pt A):120466. doi: 10.1016/j.jad.2025.120466. Epub 2025 Oct 14.

Drugs

Indications