Researchers are currently recruiting patients with civilian post-traumatic stress disorder (PTSD) for a clinical research study called the COPE study. People 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.
Civilian PTSD is an anxiety disorder caused 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 everyday 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.
Studies have shown that more than half of Americans will experience 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 experiencing 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 help people who need this type of medical care in the future.
Approximately 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 compensated for their time.