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A Study Comparing Oral Ketamine With Oral Midazolam for the Treatment of Major Depressive Episodes
Sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research
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.
Official title: A Randomized, Double-blind, Active Placebo-controlled, Multicenter Trial of Efficacy and Safety of Adjunctive Oral Ketamine vs Oral Midazolam for Major Depressive Episodes
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2026-10
Completion Date
2029-10
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
Oral ketamine
Nine sessions of oral ketamine
Oral midazolam
Nine sessions of oral midazolam
Locations (5)
NIMHANS
Bangalore, Karnataka, India
Kasturba Medical College
Udupi, Karnataka, India
MGM Medical College, Mumbai
Mumbai, Maharashtra, India
AIIMS, Bhubaneswar
Bhubaneswar, Odisha, India
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, Puducherry, India