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A secondary Data-Analysis of Post-Traumatic Stress Disorder (PTSD) and Clinician-Administered PTSD Scale for DSM-5 (CAPS- 5)

A secondary Data-Analysis of Post-Traumatic Stress Disorder (PTSD) and Clinician-Administered PTSD Scale for DSM-5 (CAPS- 5)

Elyse Katz, Ph.D.

Tunnell Government Services, Inc., Subcontractor to General Dynamics Information Technology (GDIT) working in support of US Army Medical Materiel Development Activity, Warfighter Brain Health (WBH) Project Management Office (PMO)

01 September 2020

Posttraumatic Stress disorder (PTSD) has an estimated lifetime prevalence of approximately 7% in the general population compared to 6-31% in military populations. 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 SSRIs) approved by the 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.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. 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 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.

[{ "PostingID": 2535, "Title": "GSK-PAR 29060/627", "Description": "A 12-Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Tolerability of Paroxetine in Patients Suffering from Post-traumatic Stress Disorder (PTSD)" },{ "PostingID": 2539, "Title": "GSK-PAR 648", "Description": "A 12 Week, Double-blind, Placebo-controlled, parallel group study to assess the efficacy and tolerability of Paroxetine in Patients suffering from Post-traumatic Stress Disorder (PTSD)" },{ "PostingID": 2540, "Title": "GSK-PAR 29060 651 (BRL – 02960)", "Description": "A 12 week, double-blind, fixed dose comparison of 20 and 40 mg daily of paroxetine and placebo in Patients suffering from Post-traumatic Stress Disorder (PTSD)." },{ "PostingID": 3343, "Title": "GSK-29060/650", "Description": "A Study of the Maintained Efficacy and Safety of Paroxetine Versus Placebo in the Long-Term Treatment of Posttraumatic Stress Disorder" }]

Statistical Analysis Plan