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Clinical Research Study Looking for People with Post-Traumatic Stress Disorder

Researchers are presently enrolling patients with civilian post-traumatic stress disorder (PTSD) for a clinical research study called the COPE study. Individuals who are having symptoms after experiencing a traumatic event or who have been diagnosed with PTSD may be eligible to participate in this study of a new investigational drug.

More than one-half of all Americans will experience a traumatic event at some point in their lives. One in 10 people who experience an event will develop symptoms. If you are having symptoms after experiencing a traumatic event or have been diagnosed with post-traumatic stress disorder (PTSD), you may be eligible to participate in the COPE study.

Civilian PTSD is an anxiety disorder induced by a traumatizing experience such as physical or sexual assault, childhood abuse, a severe accident or medical procedure, a natural disaster, a terror attack, or watching someone die. The symptoms of PTSD are debilitating and can affect a victim’s daily life. These symptoms include flashbacks or bad dreams about the traumatic experience; insomnia; loss of interest and depression; difficulty concentrating; and feeling extreme anger, sadness, guilt, or shame.

Surveys have proved that more than half of Americans will get a psychologically traumatizing event during their life, and between 8% and 12% of them will meet the criteria for PTSD as a result. Treatment for PTSD depends on a person’s age, general health, and the degree to which they are affected by the symptoms.

The purpose of the COPE study is to determine if the investigational drug is safe and effective in patients having symptoms of non-combat-related PTSD. Participation is key to the success of the COPE study. Participants will be helping researchers better understand the safety and effectiveness of the study drug, which could potentially assist people who need this type of medical care in the future.

About 240 patients with civilian PTSD not associated with combat or the military will participate at 25 study sites in the United States. To take part in the COPE study, a person must be having symptoms after experiencing a traumatic event or have already been diagnosed with PTSD. Throughout the study, participants may receive the investigational medication, study-related physical exams, and laboratory services at no charge. All participants will be monitored by a medical team including a nurse or study coordinator and a doctor. Patients may also be paid for their time.

Who can take part in the study?

You may be eligible if you:

* Experienced a traumatic event (not related to combat or the military), such as:
o A personal attack or physical abuse
o A severe car accident or medical procedure
o A terror attack or natural disaster
o Seeing others be hurt or killed
The event can be something that happened to you or something that you saw happen.
* Have experienced one or more of the following symptoms for the past 3 months:
o Repeated flashbacks or anxiety triggered by memories
o Irritability
o Repeated bad dreams and/or inability to sleep
o Unable to concentrate or do things you used to enjoy
o Feeling hopeless, angry, sad, fearful, guilty, or ashamed
* Are not in talk therapy specifically for PTSD or a sleep disorder
* Are between 18 and 64 years of age
* Are not currently participating in a clinical trial

For more information or to volunteer for the COPE study, visit www.COPEstudy.com/news or call 1-866-601-2342.

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