CAP Ketamine for Veterans with Treatment-Resistant PTSD

There is a tremendous need to investigate new and novel medications to treat PTSD. PTSD is a leading cause of distress and disability among trauma-exposed individuals and there are limited pharmacologic interventions. While two medications are currently FDA approved for PTSD, both antidepressants, the efficacy of these medications is quite limited. Both medications are selective serotonin reuptake inhibitors (SSRIs), meaning they work to reduce symptoms by altering serotonin levels in the brain. Though some people do very well with these medications, many gain little to no improvement in their symptoms. Further, these medications take weeks to months to reach their full benefit and often, even when some symptoms improve, others do not.

Ketamine, an FDA approved anesthetic medication, was found to have rapid and robust antidepressant effects when given at low doses. There is a great deal of interest in ketamine and some similar drugs as a potential treatment for depression and PTSD because they work in different ways in the brain than the traditional antidepressants, and even seem to work for many who haven’t had success with many other treatments.

This study is among the first to carefully evaluate the effects of ketamine in PTSD and the first to our knowledge to evaluate ketamine in a sample of Veterans. This study is a randomized clinical trial designed to investigate the safety, efficacy, and tolerability of repeated doses of ketamine in Veterans with PTSD. The study has three parallel treatment arms, meaning participants may be randomized to one of three treatments – placebo, low dose ketamine, or standard dose of ketamine to be administered approximately twice per week for a 4 week period. There is the option of a single open-label dose of ketamine for those who do not respond during the treatment period. The study also includes a 4-week follow-up period. The study will allow us not only to evaluate if ketamine is effective in treating PTSD, but also will allow us to investigate dose-effects, meaning we can see if there are differences in the lower and higher doses of ketamine.