Ketamine-enhanced Prolonged Exposure Therapy in PTSD

Last updated: October 8, 2025
Sponsor: VA Office of Research and Development
Overall Status: Completed

Phase

2

Condition

Post-traumatic Stress Disorders

Treatment

Midazolam

Ketamine

Clinical Study ID

NCT04560660
MHBP-006-19F
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo to reduce symptoms of Posttraumatic Stress Disorder (PTSD) among Veteran receiving Prolonged Exposure Therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • male or female Veterans between the ages of 18 and 75 years

  • diagnosis of PTSD

  • ability to provide written informed consent

Exclusion

Exclusion Criteria:

  • females who are currently pregnant or breastfeeding

  • current high risk for suicide

  • history of moderate/severe head injury

  • history of psychosis

  • current episode of mania/hypomania

  • severe substance and/or alcohol use disorder in the last 6 months

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Midazolam
Phase: 2
Study Start date:
March 09, 2021
Estimated Completion Date:
October 07, 2025

Study Description

In this single site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine in conjunction with prolonged exposure (PE) therapy for PTSD. Veterans who meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized to one of two treatment arms (placebo plus PE vs ketamine plus PE). Participants receive the study drug via intravenous infusion once per week for 3-weeks.

Connect with a study center

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota 55417-2309
    United States

    Site Not Available

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis 5037649, Minnesota 5037779 55417-2309
    United States

    Site Not Available

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