CAP-Ketamine for Antidepressant Resistant PTSD
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
- PTSD
- Posttraumatic Stress Disorder
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
Saline dose |
|
|
Experimental Low Dose Ketamine |
Low Dose Ketamine (.20 mg/kg) |
|
|
Experimental High Dose Ketamine |
High Dose Ketamine (.50 mg/kg) |
|
More Details
- Status
- Completed
- Sponsor
- VA Office of Research and Development
Study Contact
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.