A groundbreaking clinical trial launched Oct. 16 will explore the promise of a new drug treatment for military personnel and veterans with post-traumatic stress disorder (PTSD). ইউএস আর্মি মেডিকেল রিসার্চ অ্যান্ড ডেভেলপমেন্ট কমান্ডের অংশ, ইউএস আর্মি মেডিক্যাল মেটেরিয়াল ডেভেলপমেন্ট অ্যাক্টিভিটি (ইউএসএএমএমডিএ) দ্বারা মাল্টি-সাইট ট্রায়ালের নেতৃত্ব দেওয়া হয় এবং একটি প্রকল্প দল দ্বারা সমর্থিত হয় যাতে মার্কিন বিমান বাহিনী, সেনাবাহিনী, নৌবাহিনীর প্রতিনিধিরা অন্তর্ভুক্ত থাকে। Special Operations Command.
According to statistics from the US Department of Veterans Affairs, military veterans are more likely to develop PTSD than civilians, and those who have deployed to combat are more likely to develop PTSD than those who have not deployed. Overall, about six percent of the US population will have PTSD at some point in their lives.
People with PTSD have difficulty recovering after experiencing or witnessing a traumatic event. The condition can last for months or years, with triggers that bring back memories of the event, with intense emotional and physical reactions. Symptoms can include nightmares, avoidance of certain situations, heightened stress response, anxiety and depression, according to the National Institute of Mental Health.
Current treatments for PTSD include various types of trauma-focused psychotherapy as well as medications to manage symptoms. However, previous studies have shown that patients with a military history respond worse to current drug treatments and psychotherapy than non-veteran patients.
Since 1987, more than 130 PTSD pharmacotherapeutic trials have been conducted, but only two drugs (paroxetine and sertraline) have been approved by the Food and Drug Administration (FDA) specifically to treat the condition. Although other drugs may be prescribed “off-label,” meaning they are FDA-approved for other medical conditions, there is little data to guide such use in military populations, according to Kimberly Del Carmen, PhD, Health Sciences. Product Manager at USAMMDA.
PTSD is heterogeneous in nature, meaning that no single biological cause is common to all individuals with PTSD. For that reason, we don’t think there will be a ‘magic pill’ that will work for everyone, so we are employing an innovative testing strategy called the Adaptive Platform Trial.”
Kimberly Dale Carmen, PhD, is a health sciences product manager at USAMMDA
This clinical trial platform design allows for an efficient use of resources with an accelerated schedule where multiple drugs are tested simultaneously and sequentially. As trials progress, failed drugs will be replaced with new candidates, and those that are successful will “graduate” to the next stage of development.
In addition to evaluating numerous potential PTSD treatments, the trial will also examine various biological indicators, such as specific biological markers, to determine whether individuals with PTSD have certain shared characteristics, which may provide insight into designing potential treatments or tailoring treatments to individuals.
According to Del Carmen, three FDA-approved drug candidates for conditions other than PTSD were selected for the first round of testing. Frequent interim analysis of the data will be conducted, and successful trial results will trigger the first of a series of clinical practice guideline decision points, including recommendations for the off-label use of these drugs.
Drugs tested in the future may be novel drugs, since the goal of this effort is to obtain FDA approval of one or more therapeutics to treat PTSD, Del Carmen said.
The trial will include 15-20 clinical sites within the United States and is planned to enroll 600 subjects during the first three drug trials over approximately three years.