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Center for Global Research Data

A secondary Data-Analysis to determine treatment effectiveness in Post-Traumatic Stress Disorder

Lead Investigator: Elyse Katz, USSAMMDA
Title of Proposal Research: A secondary Data-Analysis to determine treatment effectiveness in Post-Traumatic Stress Disorder
Vivli Data Request: 5963
Funding Source: This work is funded by the U.S. Army Medical Materiel Development Activity (USAMMDA)
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Posttraumatic Stress disorder (PTSD) has an estimated lifetime prevalence of approximately 7% in the general population (Harvard Medical School 2007, Roberts et al 2011) compared to 6-31% in military populations (Hoge et al 2014). Although more than 130 open-label and randomized, controlled trials testing 48 drugs or drug combinations have been conducted since 1987, there remain only two drugs (sertraline and paroxetine), both of the same drug class (selective serotonin reuptake inhibitors or Selective Serotonin Reuptake Inhibiotrs (SSRIs)) approved by the U.S. Food and Drug Administration (FDA) to treat PTSD. Little is known about factors that are associated with response to SSRIs, however, studies suggest that sertraline may not be effective in studies of patients with a military history (Rauch et al 2018, Friedman et al 2007, Zohar 2002).

Similar to other psychiatric disorders, PTSD is thought to be a complex and heterogeneous disorder with numerous psychiatric and substance use-related comorbidities and multiple, variable pathophysiological mechanisms at play within and across individuals (Pitman et al 2012, Rasmusson and Pineles 2018).

Previous meta-analyses conducted using data from PTSD pharmacologic interventions have compared effect sizes between treatments (including placebo conditions) to identify the most clinically efficacious drugs. In these analyses, in general, heterogeneous characteristics of the populations studied (e.g. trauma type, gender, age, comorbid conditions, etc.) have not been taken into account (Ipser et al, 2006, Ravindran and Stein 2010, Ipser and Stein, 2012, Hoskins et al 2015, Lee et al, 2016). Therefore, in order to inform future clinical trial designs (e.g., inclusion/exclusion criteria, sample size, frequency of assessments), we conducted meta-analyses and meta-regression, specifically, to identify study level characteristics that predict response to both active drug and placebo across completed PTSD drug trials.

These results are limited, however, based on comparisons of the study-level aggregated results from the different studies included. A more detailed, patient-level analysis is needed from a broad range of Randomized Clinical Trials (RCTs) to better understand and develop predictive models to identify the factors associated with active treatment and placebo response. These models will impact future study designs to improve the health of our nation’s soldiers and veterans.

In this secondary analysis, we currently have access to and are in the process of requesting patient-level data from all studies that have complete and unblinded data from a number of investigator-initiated and industry-sponsored trials.

Requested Studies:

Fluoxetine Versus Placebo in Posttraumatic Stress Disorder
Sponsor: Eli Lilly and Company
Sponsor ID: B1Y-MC-HCJK

Fluoxetine Versus Placebo in Posttraumatic Stress Disorder
Sponsor: Eli Lilly and Company
Sponsor ID: B1Y-MC-HCJL