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

NCT06795659 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2026-01-28

No results posted yet for this study

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.

Conditions

  • Post Traumatic Stress Disorder PTSD

Interventions

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)

Sponsors & Collaborators

  • Institute for Integration of Medicine & Science-UT Health San Antonio

    collaborator UNKNOWN

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Casey Straud, PsyD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-09
Primary Completion
2026-01-16
Completion
2026-01-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06795659 on ClinicalTrials.gov