Clinical Trial 5410

New York, NY 10029

Study Summary:

This is a research study of an investigational medication for the treatment of post-traumatic stress disorder, or PTSD. We are looking for participants who have unfortunately been through a traumatic or life-threatening experience and are by affected by it. The investigational medication we are testing is Ketamine, which is approved by the Food and Drug Administration as an anesthetic, but is not approved for the treatment of PTSD. The study involves two separate overnight stays at the Mount Sinai Hospital each followed by 5 follow-up visits in our clinic. This is also what we call a placebo-controlled study. A placebo is a pill or substance that contains no medication or is used for comparison to a medication. This comparison is necessary because we’re trying to see if Ketamine is really effective for treating PTSD or if a person feels better simply because they are receiving treatment. We compare Ketamine to Midazolam, a drug that has similar anesthetic effects but has not been shown to treat PTSD or major depressive disorder symptoms. Like Ketamine, Midazolam is not approved for the treatment of PTSD but is approved by the FDA as an anesthetic. As part of the study, there are two overnight visits when you will be given either Ketamine or Midazolam. You will be randomly assigned to one of the drugs for the first overnight stay and will be given the other drug the second time. You won’t be told which medication you have received and the research team won’t know either.

Qualified Participants Must:

• Have experienced a traumatic or life threatening event
• Be 21-55 years of age
• Be experiencing anxiety as a result of the traumatic event
• Be willing to taper off any psychiatric medications if currently being taken
• Not be pregnant or nursing
• Not have an unstable medical condition or illness
• Not be currently taking drugs or abusing alcohol

Qualified Participants May Receive:

$25 for an initial screening visit, $25 for medical clearance visit, $150 per overnight stay (there are 2), and $150 per completion of 10 brief follow-up visits.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.