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CompletedPhase 1 / Phase 2Results posted

Ketamine and Prolonged Exposure in PTSD

NCT03960658 · Minneapolis Veterans Affairs Medical Center

Closed to entry
Status
Not accepting participants
Phase 1 / Phase 2
Phase
12
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

This study aims at investigating the effectiveness of the drug, Ketamine, in combination with Prolonged Exposure (PE) therapy for people suffering from PTSD. Participation in the study includes Ketamine infusions, which occur once a week for three weeks. PE therapy sessions will be scheduled one day after each infusion, and may continue up to 12 weeks. After completely therapy, there will be two monthly follow-up assessment visits.

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

  • Change in Severity of Post-traumatic Stress Disorder (PTSD) Symptoms

    Measured over 10 weeks

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: 1. Diagnosis of chronic (minimum of three months) PTSD (Clinician-Administered PTSD Scale for DSM-5 -CAPS-5 score\>33). 2. Voluntarily eligible to participate in PE. 3. Severity of PTSD symptoms defined by PCL-5\>33. 4. Psychotropic medications on stable doses (no dosing adjustments/changes for ≥4 weeks; ≥6 weeks for fluoxetine) prior to prior to beginning of the study. Exclusion Criteria: 1. Unwillingness/unable to sign informed consent. 2. Previous or current participation in trauma-exposed therapy and/or ketamine treatment. 3. Evidence of mental retardation, pervasive developmental disorder and/or moderate/severe cognitive impairment (MMSE scores ≤27). 4. Any unstable medical or non-psychiatric CNS condition. 5. Lifetime history of psychosis-related disorder, bipolar disorder I or II disorder, or any condition other than PTSD judged to be the primary presenting psychiatric diagnosis. 6. Moderate to severe traumatic brain injury (mental status change or loss of consciousness\>30 min; Glasgow Coma Scale \<13; post-traumatic amnesia\>24hours; visible lesion on CT/MRI brain scan). 7. Active alcohol/illicit substance use disorder within 6 months of initial assessment; presence of illicit drugs by positive urine toxicology. 8. For women: pregnancy (confirmed by lab test), initiation of female hormonal treatments within 3 months of screening, or inability/ unwillingness to use a medically accepted contraceptive method during the study. 9. Imminent risk of suicidal/homicidal ideation and/or behavior with intent and/or plan

Where

1 study site

FacilityCityRegionCountry
Minneapolis VA Medical CenterMinneapolisMinnesotaUnited 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.

NCT03960658 on ClinicalTrials.gov →

Last updated in the registry 2021-03-22. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits