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NOT YET RECRUITING
NCT07839338
PHASE3

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

Sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research

View on ClinicalTrials.gov

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

Interventions

DRUG

Oral ketamine

Nine sessions of oral ketamine

DRUG

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