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Completed

NCT Number: NCT04560660

Ketamine-enhanced Prolonged Exposure Therapy in PTSD

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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male or female Veterans between the ages of 18 and 75 years
  • diagnosis of PTSD
  • ability to provide written informed consent

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

Treatment and study plan

ketamine

Drug

FDA approved anesthetic medication with rapid acting antidepressant effects.

midazolam

Drug

FDA approved sedative medication with dissociative effects.

Primary outcomes

  1. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

    Time frame: Baseline

    The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.

  2. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

    Time frame: Week 4

    The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.

  3. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

    Time frame: Week 10

    The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.

  4. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

    Time frame: Week 14

    The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.

  5. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

    Time frame: Week 22

    The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Repeated Ketamine Treatment to Accelerate Efficacy of Prolonged Exposure in PTSD

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2020
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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