CAP-Ketamine for Antidepressant Resistant PTSD

Ketamine

Brief 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.

Intervention / Treatment

  • Drug: Ketamine
  • Drug: Placebo

Condition or Disease

  • PTSD
  • Posttraumatic Stress Disorder

Phase

Study Design

Study type: Interventional
Status: Completed
Study results: No Results Available
Age: 18 Years to 70 Years   (Adult, Older Adult)
Enrollment: 168 ()
Funded by: U.S. Fed|Other

Masking

Clinical Trial Dates

Start date: Apr 18, 2016
Primary Completion: Jul 01, 2020
Completion Date: Jul 01, 2020
Study First Posted: Jan 14, 2016
Results First Posted: Aug 31, 2020
Last Updated: Jul 15, 2020

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

San Antonio, Texas, USA
West Haven, Connecticut, USA
Minneapolis, Minnesota, USA

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.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 70

More Details

NCT Number: NCT02655692
Other IDs: SPLE-003-14W
Study URL: https://ClinicalTrials.gov/show/NCT02655692
Last updated: Jun 17, 2022