NCT04560660

Ketamine-enhanced Prolonged Exposure Therapy in PTSD

Repeated Ketamine Treatment to Accelerate Efficacy of Prolonged Exposure in PTSD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo to reduce symptoms of Posttraumatic Stress Disorder (PTSD) among Veteran receiving Prolonged Exposure Therapy.

Detailed description

In this single site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine in conjunction with prolonged exposure (PE) therapy for PTSD. Veterans who meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized to one of two treatment arms (placebo plus PE vs ketamine plus PE). Participants receive the study drug via intravenous infusion once per week for 3-weeks.

Conditions

• PTSD

Interventions

Type	Name	Description
DRUG	Ketamine	FDA approved anesthetic medication with rapid acting antidepressant effects.
DRUG	Midazolam	FDA approved sedative medication with dissociative effects.

Timeline

• Start date: 2021-03-09
• Primary completion: 2025-07-01
• Completion: 2025-10-07
• First posted: 2020-09-23
• Last updated: 2025-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study