Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • male or female Veterans or active duty military personnel between the ages of 18 and 70 years
  • diagnosis of PTSD
  • history of trialing one or more antidepressant medications with little to no PTSD symptom improvement
  • ability to provide written informed consent

Exclusion Criteria

  • females who are currently pregnant or breastfeeding
  • current high risk for suicide
  • history of severe head injury

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo
Saline dose
  • Drug: Placebo
    This is a saline placebo/non-active solution.
Experimental
Low Dose Ketamine
Low Dose Ketamine (.20 mg/kg)
  • Drug: Ketamine
    FDA approved anesthetic medication with rapid acting antidepressant effects.
Experimental
High Dose Ketamine
High Dose Ketamine (.50 mg/kg)
  • Drug: Ketamine
    FDA approved anesthetic medication with rapid acting antidepressant effects.

Recruiting Locations

Brooke Army Medical Center
San Antonio, Texas 78234
Contact:
Bill Murff, BS
210-539-9422
murff@uthscsa.edu

More Details

Status
Recruiting
Sponsor
VA Office of Research and Development

Study Contact

Lynnette Averill
Lynnette.Averill@va.gov

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.