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Improving care for veterans with posttraumatic stress disorder (PTSD): comparative effectiveness of medications to augment first-line pharmacotherapy
Investigator (PI): Cohen, Beth
Performing Organization (PO): (Current): University of California, San Francisco, School of Medicine, Department of Medicine, Division of General Internal Medicine / (415) 221-4810
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2020
Record Source/Award ID: PCORI/CER-1507-31834
Funding: Total Award Amount: $1,222,183
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: The overall goal of our research program is to improve the health and quality of life of patients with posttraumatic stress disorder (PTSD). In addition to counseling therapies, several medications are effective in treating PTSD symptoms. However, clinical trials show less than 30 percent of patients will find relief from PTSD symptoms with these treatments. Therefore, providers and patients will look for additional medications to supplement therapy. However, no clinical trials have directly compared these second-line medications for PTSD to determine which are best. Therefore, we urgently need to better understand the risks and benefits of augmenting medications in patients with PTSD. Ideally, we would conduct a large clinical trial comparing various augmenting medications, but this would take many years and millions of dollars to complete. Further, only a small subset of patients will volunteer and qualify for clinical trials, and they are usually very different from the many patients who may later get prescribed these drugs. Fortunately, we have detailed medical information on hundreds of thousands of patients with PTSD who have been seen in Veterans Administration (VA) care. We propose to use these records to compare the effects of several commonly used medications (antipsychotics, prazosin, mirtazapine, and tricyclic antidepressants). We will directly compare mental health and cardiovascular/metabolic outcomes among patients receiving the different augmenting medication strategies. We will also compare their risks and benefits in specific groups, including women, returning Iraq and Afghanistan veterans, and patients ages 65 and older. This research is directly applicable to the millions of patients struggling to deal with PTSD symptoms. It will help them, their families, and medical providers understand the risks and benefits of treatment with this commonly used class of medications so they can make better decisions. As PTSD is the most common mental health problem in returning veterans and is associated with increased risk of chronic physical illness, impairment in social functioning, and even death, this study is of great importance to patients, their families, and the clinicians who treat them. Through regular meetings, our patient, provider, and policy maker stakeholder partners will use expertise gained though their experiences to provide feedback on the most critical questions and concerns for the populations they represent, as well as the most effective ways to communicate study findings and recommendations to them. In addition, we have established partnerships with VA mental health groups that will assist us in disseminating the results of our research to patients, their families, and their health care providers.
MeSH Terms:
  • Adrenergic alpha-1 Receptor Antagonists /therapeutic use
  • Aged
  • Antidepressive Agents, Tricyclic /therapeutic use
  • Antipsychotic Agents /therapeutic use
  • Cardiovascular Diseases /complications
  • Comparative Effectiveness Research
  • Decision Making
  • Drug Therapy /*methods
  • Female
  • Humans
  • Male
  • Quality of Life
  • Risk
  • Stress Disorders, Post-Traumatic /*drug therapy
  • /*rehabilitation
  • United States
  • United States Department of Veterans Affairs
  • Veterans
Country: United States
State: California
Zip Code: 94103
UI: 20163069
Project Status: Ongoing
Record History: ('2017: Project extended to 2020',)