NCT06795659

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

Combining Esketamine and Prolonged Exposure for PTSD: A Proof-of-Concept Clinical Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is an early phase II, open label, proof of concept, pilot clinical trial to explore the feasibility, acceptability, and effects of esketamine combined with PE in individuals seeking treatment for PTSD. All individuals will complete a phone screen to learn more about the study to discuss broad eligibility criteria. Study candidates will be recruited from provider referrals across the San Antonio community as well as from self-referrals. Interested individuals who appear to meet initial eligibility will be consented and the complete a baseline assessment to determine study eligibility. Eligible participants will be enrolled to receive 10 sessions of PE delivered in massed (daily) format over 2 weeks (weekdays, not including weekends and holidays). Participants will also receive intranasal esketamine six times over a 2-week period (three times a week) approximately 1 hour after PE sessions 1, 3, 5, 6, 8, and 10 over this time period.

Conditions

• Post Traumatic Stress Disorder PTSD

Interventions

Type	Name	Description
DRUG	Esketamine (Intranasal Spray)	Esketamine doses will be administered via insufflation with a starting dose of 1 spray of 14 mg per nostril (28 mg/total). Based on tolerability, total dose will be increased to a target dose of 84 mg delivered as three bouts separated by 5 minutes per bout (total dose administered in 15 minutes).
BEHAVIORAL	Massed Prolonged Exposure (PE)	Eligible participants will be enrolled to receive 10 sessions of PE delivered in massed (daily) format over 2 weeks (weekdays, not including weekends and holidays)

Timeline

• Start date: 2025-06-09
• Primary completion: 2026-01-16
• Completion: 2026-01-16
• First posted: 2025-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study