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Ketamine for PTSD and Depression in TBI

Phase 2
Waitlist Available
Research Sponsored by Minneapolis Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Remote history of TBI mild-moderate that is ≥12 weeks post-injury (chronic period) that met at minimum the 2021 VA/DoD Clinical Practice Guideline for the Management and Rehabilitation of Post-Acute Mild Traumatic Brain Injury (i.e., new onset or worsening of at least one of the following clinical signs immediately following the event: loss or decreased of consciousness, period of posttraumatic amnesia, period of being dazed and confused, and neurologic deficits)
Male or female Veterans aged 18-55 years old
Must not have
Ketamine treatment within the last 6 months
History of penetrating head wounds or severe traumatic brain injury (Glasgow Coma Scale <9; loss of consciousness >24hr; post-traumatic amnesia>7 days)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the use of a sedative called ketamine to treat depression and post-traumatic stress disorder (PTSD) in Veterans who have had a mild to moderate traumatic brain injury (T

Who is the study for?
This trial is for Veterans with mild to moderate traumatic brain injury (TBI) who are experiencing depression or PTSD. Participants must be able to attend multiple treatment sessions and complete assessments. Specific criteria for inclusion or exclusion were not provided.
What is being tested?
The study tests if ketamine, given as a sedative, can help reduce symptoms of depression and PTSD in TBI patients compared to midazolam (an active placebo). Treatments are administered twice weekly over three weeks while monitoring through interviews, lab tests, and questionnaires.
What are the potential side effects?
Ketamine may cause side effects such as disorientation, nausea, increased blood pressure, mood changes, hallucinations or dizziness. Midazolam could lead to sleepiness, memory issues or coordination problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a mild to moderate brain injury over 12 weeks ago, meeting specific health guidelines.
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I am a Veteran between 18 and 55 years old.
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I have tried at least one antidepressant that didn't work for me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received ketamine treatment in the past 6 months.
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I have had a severe head injury or brain trauma.
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I am not taking any MAO inhibitors, memantine, or long-acting benzodiazepines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Severity of Depressive Symptoms
Secondary study objectives
Change in Severity of Post-traumatic Stress Disorder (PTSD) Symptoms

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: KetamineExperimental Treatment1 Intervention
Twice a week ketamine IV 0.5 mg/kg
Group II: MidazolamActive Control1 Intervention
Twice a week midazolam IV 0.045 mg/kg

Find a Location

Who is running the clinical trial?

Minneapolis Veterans Affairs Medical CenterLead Sponsor
76 Previous Clinical Trials
354,745 Total Patients Enrolled
~27 spots leftby Dec 2026
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