Phase 3Not yet recruiting
A Study Comparing Oral Ketamine With Oral Midazolam for the Treatment of Major Depressive Episodes (KOMET)
A Randomized, Double-blind, Active Placebo-controlled, Multicenter Trial of Efficacy and Safety of Adjunctive Oral Ketamine vs Oral Midazolam for Major Depressive Episodes
- Sponsor
- Jawaharlal Institute of Postgraduate Medical Education & Research (Government)
- Enrolment
- 220 planned
- Conditions
- Major Depressive Episode
- Interventions
- Oral ketamine; Oral midazolam
- Ages
- adults, older adults
- Registry
- NCT07839338
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Hamilton Depression Rating Scale (HAM-D)
History
Primary completion expected
Started
Last registry update
Registered