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CompletedPhase 1 / Phase 2

Combining Esketamine and Prolonged Exposure Treatment for PTSD (Post Traumatic Stress Disorder)

NCT06795659 · The University of Texas Health Science Center at San Antonio

Closed to entry
Status
Not accepting participants
Phase 1 / Phase 2
Phase
4
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

This study is being done to see if Prolonged Exposure (PE), a well-researched, very effective individual (one-to-one) behavioral therapy designed to help people to directly deal with traumatic events they have suffered in the past, can be combined with intranasal esketamine (ketamine) for the treatment of posttraumatic stress disorder (PTSD) to enhance treatment benefits. Ketamine nasal spray is a drug approved by the U.S. Food \& Drug Administration (FDA) for treatment resistant depression. Combined with PE, intranasal ketamine may help to augment PE and further reduce participants' PTSD symptoms.

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

  • Feasibility of Treatment using Esketamine and PE

    Measured over Study start to closing to enrollment (approximately 12 months)

  • Satisfaction with Therapy and Therapist Scale - Revised (STTS-R)

    Measured over Day 1 to 1 month

  • Enrollment proportion

    Measured over Study start to closed to enrollment (approximately 12 months)

  • Adherence to treatment

    Measured over Study start to closed to enrollment (approximately 12 months)

  • CEQ for Esketamine (Expectancy Score)

    Measured over Day 1 to 1 month

  • CEQ for Esketamine (Credibility Score)

    Measured over Day 1 to 1 month

  • CEQ for PE (Credibility score)

    Measured over Day 1 to 1 month

  • CEQ for PE (Expectancy score)

    Measured over Day 1 to 1 month

  • Post Traumatic Stress Disorder (PTSD) (PCL-5) Checklist-5 Change in Score

    Measured over Baseline to 1 month

  • The Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (CAPS-5)

    Measured over Baseline to 1 month

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 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Individual between the ages of 18-65 years old (Young adults \[18 to 24 years old\] must not be taking an antidepressant). 2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5) 3. Able to speak and read English (due to standardization of outcome measures) 4. On stable doses of current medications for at least 4 weeks 5. Weigh between 50-100 kg (110-220 pounds). Exclusion Criteria: 1. Young adults (18-24) currently taking any antidepressant. 2. Lifetime history of psychotic disorder or history of significant psychotic symptoms. 3. Lifetime history of manic episode. 4. Moderate or greater severity for alcohol or substance use disorder (DSM-5) in the previous six months. 5. A history of ketamine or phencyclidine abuse. 6. Evidence of a traumatic brain injury severe enough to interfere with comprehension and responding to the baseline screening questionnaires. 7. Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index-Suicidality Subscale and corroborated by a clinical risk assessment by a credentialed provider) 8. Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment. 9. Current use (with past 4 weeks) of any prohibited concomitant medications 10. Benzodiazepines, other medications, sedatives, acute alcohol use, or recreational drug use that would put patients at risk in the judgment of clinical providers). 11. Planned use of ketamine (i.e., for pain control) or participation in another trauma-focused psychotherapy during the time of the study. 12. Uncontrolled hypertension or tachycardia 13. A history of sensitivity or adverse reaction to ketamine or its excipients 14. An unstable medical, cardiovascular, pulmonary, or neurological condition that the investigator considers a contraindication to ketamine administration 15. Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation. 16. Intracerebral hemorrhage. 17. Pregnancy or breastfeeding; women of childbearing potential unwilling to utilize reliable methods of contraception 18. History of nasal surgery or nasal obstructions experienced as an adult. 19. Inability to arrange for assisted transportation on ketamine treatment days due to recommendation that patient not drive for the remainder of the day following a ketamine treatment.

Where

1 study site

FacilityCityRegionCountry
The University of Texas Health Science Center at San AntonioSan AntonioTexasUnited 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.

NCT06795659 on ClinicalTrials.gov →

Last updated in the registry 2026-01-28. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits