NCT06228391

Ketamine Treatment for PTSD and MDD in TBI

Examining the Efficacy and Safety of Subanesthetic Ketamine on Depression and Post-traumatic Stress Among Veterans With Mild and Moderate Traumatic Brain Injury

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Minneapolis Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to examine the use of sedative ketamine to treat depression and post-traumatic stress disorder (PTSD) in Veterans with mild to moderate traumatic brain injury (TBI). The main questions it aims to answer are: * Efficacy of ketamine to reduce symptoms of depression and/or PTSD * Safety of ketamine to treat depression and/or PTSD in TBI Participants will be randomly assigned to receive either ketamine or midazolam (active placebo) twice a week for 3 weeks. During participation, subjects will be interviewed, have lab tests, and complete rating scales, and questionnaires.

Conditions

• PTSD, Post Traumatic Stress Disorder
• Major Depressive Disorder
• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	IV ketamine	Subjects will receive a single infusion of racemic ketamine at 0.5mg/kg for 40 minutes twice a week for 3 weeks.
DRUG	Midazolam	Subjects will receive a single infusion of midazolam at 0.045mg/kg for 40 minutes twice a week for 3 weeks.

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2024-01-29
• Last updated: 2024-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study