Tag: FDA 2012 Draft Guidance Document

Comparative Validation of the S-STS, the ISST-Plus, and the C–SSRS for Assessing the Suicidal Thinking and Behavior FDA 2012 Suicidality Categories
by David V. Sheehan, MD, MBA; Larry D. Alphs, MD, PhD; Lian Mao, PhD; Qin Li; Roberta S. May, MA; Emily H. Bruer, M.ed; Cheryl B. McCullumsmith, MD, PhD; Christopher R. Gray, BS; Xiaohua Li; and David J. Williamson, PhD Dr. Sheehan is Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, […]

Current Assessment and Classification of Suicidal Phenomena using the FDA 2012 Draft Guidance Document on Suicide Assessment: A Critical Review
by David V. Sheehan, MD, MBA; Jennifer M. Giddens; and Kathy Harnett Sheehan, PhD Dr. D. Sheehan is Distinguished University Health Professor Emeritus at the University of South Florida College of Medicine, Tampa, Florida; J. Giddens is the Co-founder of the Tampa Center for Research on Suicidality, Tampa, Florida; and Dr. K. Sheehan is Associate […]

The Columbia–Suicide Severity Rating Scale (C–SSRS): Has the “Gold Standard” Become a Liability?
by Jennifer M. Giddens; Kathy Harnett Sheehan, PhD; and David V. Sheehan, MD, MBA J. Giddens is the Co-founder of the Tampa Center for Research on Suicidality, Tampa, Florida; Dr. K. Sheehan is Associate Professor Emeritus at the University of South Florida College of Medicine, Tampa, Florida; and Dr. D. Sheehan is Distinguished University Health […]

Do the Five Combinations of Suicidal Ideation in the FDA 2012 Draft Guidance Document and the C–SSRS Adequately Cover All Suicidal Ideation Combinations in Practice? A Case Study
by Jennifer M. Giddens and David V. Sheehan, MD, MBA J. Giddens is Co-founder of the Tampa Center for Research on Suicidality, Tampa, Florida; and Dr. Sheehan is Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida. Innov Clin Neurosci. 2014;11(9–10):172–178