NAMHC Concept Clearance •
Farris Tuma, Sc.D.
Traumatic Stress Disorders Research Program
Division of Adult Translational Research and Treatment Development
This initiative will advance research on the efficacy of available and exploratory medications for PTSD.
PTSD is a potentially chronic and debilitating disorder with a lifetime prevalence rate of up to 25%. PTSD has a clear impact on health, health care service utilization, overall functioning, and quality of life. Given the prevalence of PTSD and its associated costs to society, identifying efficient and effective treatments is critical.
Over the past 20 years, several effective treatments for PTSD have been reported. Evidence from well-controlled trials with a variety of PTSD patients indicates that several forms of psychotherapy, including cognitive behavioral and cognitive processing therapies, are effective. Accordingly, researchers are actively studying how to identify the most helpful components, timing, and “dose” of these and other treatments as well as how to make them accessible, practical, and transportable so that patients and providers in diverse contexts can benefit from them.
With regard to pharmacotherapy, the U.S. Food and Drug Administration (FDA) has approved two medications for treating PTSD in adults; sertraline and paroxetine, both selective serotonin reuptake inhibitors. While data support the use of these medications, not everyone treated improves. Moreover, there appears to be poor correspondence between the evidence-base and practices of treating clinicians. In surveys, physicians’ preferred treatment of symptomatic persons is pharmacological treatment. Data on prescribing patterns reveals use of medications that have limited data to support their efficacy and undesirable side effect profiles that raise safety concerns. The gap between evidence and practice is particularly important in the context of community-based health care settings where disaster victims, accident survivors, returning veterans, and others trauma survivors may seek and receive care.
This initiative will advance research to better understand efficacy and risk/benefit ratios pertaining to symptoms/symptom severity, side effects, and gains in important role functioning associated with available and exploratory medications for treating PTSD. This initiative addresses Strategic Objective 3 of the NIMH Strategic Plan (Develop New and Better Interventions for Mental Disorders that Incorporate the Diverse Needs and Circumstances of People with Mental Illness) and the 2007 Institute of Medicine (IOM) report “Treatment of PTSD: An Assessment of The Evidence,” which called for rigorous research on safety and efficacy of current and new treatments.
In the context of this initiative and in recognition that the drug discovery process is lengthy, it is appropriate to emphasize that findings on the neurobiology of PTSD should be leading to exploratory studies of existing medications as well as the development of new drugs that can be tested in PTSD patients. Based on the state of the science, this initiative will encourage exploration of additional medications that might be administered in the immediate aftermath of a traumatic event; medications that might be used over time to target symptom domains not adequately addressed by first line treatments; and still others that might be used to augment psychotherapy. The development of PTSD-specific drugs may require additional understanding and synthesis of the neurobiology of PTSD. However, this initiative will encourage innovation, where there are plausible hypotheses, based on current knowledge.
Hidalgo, R. B. and Davidson, J.R.T. Posttraumatic Stress Disorder: Epidemiology and Health-Related Considerations. J Clin Psychiatry. 2000 61(suppl 7) 5-13. PMID: 10795604