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Ketamine for Post-Traumatic Stress Disorder

Phase 2
Recruiting
Led By Paulo R Shiroma, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
male or female Veterans between the ages of 18 and 75 years
diagnosis of PTSD
Must not have
females who are currently pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up caps-5 to measure change in ptsd symptoms from baseline to post-treatment (10 weeks)

Summary

This trial will test if ketamine can help PTSD symptoms when taken before exposure therapy sessions.

Who is the study for?
This trial is for male and female Veterans aged 18-75 with PTSD. Participants must be able to consent to the study. It's not suitable for those with a history of severe head injury, mania/hypomania, psychosis, recent severe substance/alcohol abuse, or women who are pregnant/breastfeeding. High suicide risk individuals are also excluded.
What is being tested?
The study tests if ketamine can help reduce PTSD symptoms more effectively than a placebo when given alongside Prolonged Exposure Therapy—a common treatment for PTSD—to Veterans.
What are the potential side effects?
Ketamine may cause side effects like disorientation, nausea, increased blood pressure and heart rate, mood changes, and potential for misuse. Midazolam can induce sleepiness, memory issues, dizziness and might affect breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a Veteran aged between 18 and 75.
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I have been diagnosed with PTSD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~caps-5 to measure change in ptsd symptoms from baseline to post-treatment (10 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and caps-5 to measure change in ptsd symptoms from baseline to post-treatment (10 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
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ketamine and prolonged exposure (PE)Experimental Treatment1 Intervention
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
Group II: Midazolam and prolonged exposure (PE)Placebo Group1 Intervention
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1120

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,683 Total Patients Enrolled
Paulo R Shiroma, MDPrincipal InvestigatorMinneapolis VA Health Care System, Minneapolis, MN
2 Previous Clinical Trials
74 Total Patients Enrolled

Media Library

Ketamine Clinical Trial Eligibility Overview. Trial Name: NCT04560660 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Ketamine and prolonged exposure (PE), Midazolam and prolonged exposure (PE)
Post-Traumatic Stress Disorder Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT04560660 — Phase 2
Ketamine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04560660 — Phase 2
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04560660 — Phase 2
~0 spots leftby Dec 2024
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