Study 1358 :Have You Ever Experienced a Traumatic or Life-Threatening Event ?
New York
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| Type of Study | Keywords: ptsd trials, ptsd medical trials, ptsd medical research, ptsd clinical research, ptsd clinical trials, ptsd drug research, ptsd paid research, ptsd clinical studies. ptsd testing, ptsd treatment, ptsd symptoms, post traumatic stress disorder research, post traumatic stress disorder medical studies, post traumatic stress disorder clinical trials, anxiety disorders, mood and anxiety disorders, military combat victims, mugging victims, rape victims, violence victims, child abuse victims, serious car accident victims, natural disaster victims, flashbacks, depression.
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Have You Ever Experienced a Traumatic or Life-Threatening Event?
SINCE THE TRAUMA, have you:
· Had nightmares or flashbacks?
· Tried to avoid thinking or talking about it?
· Felt jumpy or anxious?
· Become less connected with people around you, or less interested in activities you used to enjoy?
If so, you may be suffering from post-traumatic stress disorder or PTSD. The Mood and Anxiety Disorders Program at the Mount Sinai School of Medicine is conducting a study of an investigational medication that may help relieve your PTSD symptoms. You may be eligible to participate if you have PTSD and are 21-55 years old.
| | Inclusion 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
| | Exclusion Criteria | Not be pregnant or nursing
• Not have an unstable medical condition or illness
• Not be currently taking drugs or abusing alcohol
| | Area |  New York, NY
New York City, NYC, Manhattan, Brooklyn, Queens, Bronx, Staten Island, New Jersey, Long Island, Hoboken NJ, Jersey City, NJ.
Alphabet City, Astor Row, Battery Park City, Bowery, Carnegie Hill, Chelsea, Chinatown, Civic Center, Columbus Circle, Cooperative Village, Diamond District, East Village, Ellis Island, Financial District, Five Points, Flatiron District, Garment District, Governors Island, Gramercy, Gramercy Park, Greenwich Village, Hamilton Heights, Harlem, Hell's Kitchen, Herald Square, Hudson Heights, Hudson Yards, Inwood, Italian Harlem, Kips Bay, Koreatown, Lenox Hill, Le Petit Senegal, Liberty Island, Lincoln Square, Little Germany, Little Italy, Loisaida, Lower East Side, Lower Manhattan, Madison Square, Manhattan Valley, Manhattanville, Marble Hill, Marcus Garvey Park, Meatpacking District, Midtown Manhattan, Morningside Heights, Murray Hill, NoHo, Nolita, Peter Cooper Village, Polo Grounds, Radio Row, Randall's Island, Roosevelt Island, Rose Hill, San Juan Hill, SoHo, South Street Seaport, Spanish Harlem, Strivers' Row, Stuyvesant Town, Sugar Hill, Sutton Place, Tenderloin, Theatre District, Times Square, TriBeCa, Tudor City, Turtle Bay, Two Bridges, Union Square, Upper East Side, Upper Manhattan, Upper West Side, Ward's Island, Washington Heights, Waterside Plaza, West Village, Yorkville.
| | Duration | Participation involves a thorough psychiatric and medical screening, and, if eligible, requires two separate overnight stays at the Mount Sinai Hospital each followed by multiple follow-up visits in our clinic.
| | Reimbursement | First in-person screen $25
Medical clearance $25
First IV infusion (ketamine or midazolam) $150
First inpatient stay at the CRU (26 hours) $350
Blood draws $50
Follow-up visits after first infusion, $50 per visit, total of 5 visits $250
Second IV infusion (ketamine or midazolam) $150
Second inpatient stay at the CRU (26 hours) $350
Blood draws $50
Follow-up visits after second infusion, $50 per visit, total of 5 visits $250
Total $1,650
| | Other Info | 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. In this study we will compare the effects of Ketamine to an anesthetic called midazolam. 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. Midazolam is 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 for the second overnight stay. You won’t be told which medication you have received and the research team won’t know either.
| | Notes | APPLY BELOW |
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