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Therapeutic Areas: Psychiatry/Psychology
Disease Category: Post-Traumatic Stress Disorders

Trial Information

The Use of Ketamine in Post-traumatic Stress Disorder

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 been through a traumatic or life-threatening experience and are being affected by it. The investigational medications we are testing are Ketamine and Midazolam. Ketamine and Midazolam are approved by the Food and Drug Administration. Ketamine is approved as an anesthetic, used to block pain during operations, but is not approved for the treatment of PTSD. Midazolam is a drug that has similar anesthetic effects, and is also not approved for the treatment of PTSD or Major Depressive Disorder symptoms. The study involves two separate overnight stays at the Mount Sinai Hospital where you will be given either Ketamine or Midazolam. You will be randomly assigned to one of the drugs for the first overnight stay and the other drug for the second overnight stay. Neither you or the research staff will know which medication you have received. Each stay is followed by 5 follow-up visits in our clinic. The study will compare the effects of Ketamine to Midazolam. This comparison will see if Ketamine and Midazolam are effective for treating PTSD or if a participant feels better just from receiving treatment.
Compensation Provided

Patient Inclusion/Exclusion Criteria:

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

Douglas M Brodman, Clinical Research Coordinator
Mount Sinai Medical Center
One Gustave L. Levy Place

New York, NY 10029
Phone: 212-241-6603
Fax: 212-241-3354
EMail: douglas.brodman@mssm.edu

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