This study will leverage large-scale clinical data from the Department of Veterans Affairs (VA) to identify existing pharmaceutical agents commonly prescribed for a multitude of indications that are incidentally associated with improvements in post-traumatic stress disorder (PTSD) symptoms. Through prior efforts, a data source containing almost 20 years of treatment data on all (over one million) VA users diagnosed with PTSD between October 1999 and February 2018 has been constructed, including a complete historical record of their evidence-based medication and psychotherapy receipt within the VA healthcare system. Importantly, the team has also amassed symptom-level patient-reported PTSD outcome data for hundreds of thousands of these patients. The existing data is a powerful resource with which the research team proposes to explore the following specific aims: (1) identify off-label pharmaceutical agents associated with improvements in PTSD symptoms over time; (2) further evaluate the clinical effectiveness of newly-identified off-label pharmaceutical agents for improvement in PTSD symptoms using rigorous causal methods; and (3) identify common adverse events related to off-label pharmaceutical agents associated with improvements in PTSD symptoms in this complex, psychiatrically and medically ill population The proposed project will identify agents that may merit further rigorous clinical evaluation for psychiatric benefit. New therapeutic targets may be identified that will lead to greater treatment options or specific treatments. Further, identification of off-label medications that improve or have contraindicated effects for psychiatric populations will provide critical guidance to practicing clinicians.

Public Health Relevance

Currently, there are few psychopharmacologic treatments for posttraumatic stress disorder (PTSD) and available medications do not work sufficiently. In a recent published statement, NIMH noted that ?The National Institute of Mental Health would relish the chance to partner with our VA colleagues to exploit [VA data] with the aim of providing guidelines for evidence-based pharmacotherapy for those suffering from PTSD, Veterans and civilians alike.? The proposed study was specifically designed in response to that call; it will use exploratory methods to identify off-label medications that are effective for the treatment of PTSD using a large VA medical records-based dataset.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH121397-02
Application #
10150094
Study Section
Behavioral Genetics and Epidemiology Study Section (BGES)
Program Officer
Tuma, Farris K
Project Start
2020-05-01
Project End
2024-02-29
Budget Start
2021-03-12
Budget End
2022-02-28
Support Year
2
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Boston University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
604483045
City
Boston
State
MA
Country
United States
Zip Code
02118