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CompletedPhase 2Results posted

Ketamine-enhanced Prolonged Exposure Therapy in PTSD

NCT04560660 · VA Office of Research and Development

Closed to entry
Status
Not accepting participants
Phase 2
Phase
73
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

    Measured over Baseline

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

    Measured over Week 4

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

    Measured over Week 10

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

    Measured over Week 14

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

    Measured over Week 22

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 75 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Minneapolis VA Health Care System, Minneapolis, MNMinneapolisMinnesotaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04560660 on ClinicalTrials.gov →

Last updated in the registry 2026-08-11. Registry records change; this page reflects the data build of 2026-08-25.

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Substance

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