Ketamine-enhanced Prolonged Exposure Therapy in PTSD

This Phase II interventional trial (n=100) will investigate the safety and efficacy of repeated doses of ketamine in conjunction with prolonged exposure (PE) therapy for Posttraumatic Stress Disorder (PTSD) among Veterans.

Sponsored by the VA Office of Research and Development, the trial will randomise participants into two groups: one receiving ketamine plus PE and the other receiving placebo plus PE. Veterans aged 18 to 75 with a PTSD diagnosis will be eligible for inclusion.

The trial will be conducted at the Minneapolis VA Health Care System, Minnesota, United States. Participants will receive the study drug via intravenous infusion once per week for 3 weeks. The primary outcome measure, the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), will assess changes in PTSD symptoms from baseline to post-treatment over a period of 10 weeks.

The study commenced on March 9, 2021, with an estimated primary completion date of June 18, 2024, and an estimated study completion date of December 31, 2024.

Topic PTSD
Compound Ketamine Placebo
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 09 March 2021
End date 31 December 2024
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 98
Sex All
Age 18- 75
Therapy Yes

Trial Details

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.

NCT Number NCT04560660

Sponsors & Collaborators

Minneapolis Veterans Affairs Medical Center
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Data attribution

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