NCT02655692

CAP-Ketamine for Antidepressant Resistant PTSD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 70 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, in reducing symptoms of Posttraumatic Stress Disorder (PTSD) in an active duty military and Veteran population.

Detailed description

In this 2-site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine for treatment resistant PTSD, Veterans and active duty military personnel who meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized to one of three treatment arms (placebo, low dose ketamine, high dose ketamine). Participants receive the study drug via intravenous infusion twice per week for 4-weeks.

Conditions

• PTSD
• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Ketamine	FDA approved anesthetic medication with rapid acting antidepressant effects.
DRUG	Placebo/Saline	This is a saline placebo/non-active solution.

Timeline

• Start date: 2016-04-18
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2016-01-14
• Last updated: 2022-06-02
• Results posted: 2022-06-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study