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

This open-label, proof-of-concept trial (n=8) will investigate the feasibility and effects of combining intranasal esketamine (28-84mg) with Prolonged Exposure (PE) therapy for the treatment of post-traumatic stress disorder (PTSD). Participants will receive 10 sessions of PE in a massed format over two weeks, alongside esketamine administered six times (three times per week) approximately one hour after specific PE sessions.

The study is conducted by The University of Texas Health Science Center at San Antonio, led by Casey Straud, PsyD. Researchers aim to determine whether esketamine can enhance the benefits of PE therapy, thereby reducing PTSD symptoms. Primary outcomes include feasibility, treatment adherence, and participant satisfaction, while secondary measures assess changes in PTSD severity, depression, anxiety, and psychosocial functioning. The trial is set to begin in February 2025, with completion expected by December 2025.

Topic PTSD
Country United States of America
Visit trial
Status Planned
Results Published No
Start date 20 February 2025
End date 30 December 2025
Phase Phase I Phase II
Design Open
Type Interventional
Generation First
Participants 8
Sex All
Age 18- 65
Therapy Yes

Trial Details

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.

NCT Number NCT06795659

Sponsors & Collaborators

The University of Texas Health Science Center
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Data attribution

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