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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up caps-5 to measure change in ptsd symptoms from baseline to post-treatment (10 weeks)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am a Veteran aged between 18 and 75.
Select...
I have been diagnosed with PTSD.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
~1090

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,353 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ailments is Ketamine routinely prescribed for?

"Seizure disorders, epileptic episodes, memory loss and certain therapeutic interventions can all be addressed via treatment with ketamine."

Answered by AI

Has the United States Food and Drug Administration given authorization to Ketamine?

"Given the Phase 2 status of this trial, our team at Power has conferred a score of 2 in regards to Ketamine's safety; while some data exists on its safety profile, there is not yet any evidence supporting efficacy."

Answered by AI

Is this research open to recruitment of volunteers?

"Up to 100 men and women Veterans between the ages of 18-75 suffering from post traumatic stress disorder are eligible for participation in this study. The inclusion criteria stipulate that all potential participants must fit within these age boundaries."

Answered by AI

Are there any available vacancies in this research study?

"This medical trial is actively recruiting as indicated on clinicaltrials.gov, with the initial post appearing on March 9th 2021 and the last update being made on May 27th 2022."

Answered by AI

How many participants are actively involved in this experiment?

"Affirmative. Clinicaltrials.gov confirms this medical trial is currently recruiting patients, having first been posted on March 9th 2021 and most recently updated on May 27th 2022. The research requires 100 participants to be enrolled at two distinct sites."

Answered by AI

Are individuals aged 55+ allowed to join this scientific experiment?

"The age range to be enrolled in this trial is 18-75 years old. There are 68 studies specifically for individuals younger than 18, and similarly 351 clinical trials focused on those above 65 years of age."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Nebraska
Other
Minnesota
How old are they?
18 - 65
What site did they apply to?
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis VA Health Care System
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I had 4-5 years of EMDR, DBT and related therapies, and have tried just about every anti-depressant to help with PTSD. It is just amazing how PTSD can hijack my amygdala and send me into a downward spiral. I am very motivated to try to help myself and others with this unfortunate condition.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. Minneapolis VA Health Care System: < 24 hours
  2. Minneapolis VA Health Care System, Minneapolis, MN: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Ketamine-enhanced Prolonged Exposure Therapy in PTSD
2021. "Ketamine-enhanced Prolonged Exposure Therapy in PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04560660.
~3 spots leftby Jun 2024
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