Innovations In Clinical Neuroscience

SEP-OCT 2014

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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Innovations in CLINICAL NEUROSCIENCE [ V O L U M E 1 1 , N U M B E R 9 – 1 0 , S E P T E M B E R – O C T O B E R 2 0 1 4 ] 32 ABSTRACT Objective: This exploratory study examines the concurrent validity for mapping symptoms of suicidal ideation, self-harm, and suicidal behavior as recorded on the InterSePT Scale for Suicidal Thinking- Plus, the Sheehan-Suicidality Tracking Scale (clinician- and patient- rated and reconciled patient/clinician versions), and the Columbia–Suicide Severity Rating Scale to the 11 United States Food and Drug Administration- Classification Algorithm of Suicide Assessment (September 2012) categories. Method: Forty subjects with varying degrees of suicidal ideation and behavior severity (from not present to extremely severe) were STUDY FUNDING: The study was funded by Janssen Scientific Affairs LLC, Titusville, New Jersey. DISCLOSURES: Dr. Sheehan is the author and copyright holder of the Sheehan-Suicide Tracking Scale (S-STS), the Sheehan-Suicidality Tracking Scale Clinically Meaningful Change Measure Version (S-STS CMCM), the Pediatric versions of the S-STS, the Sheehan Disability Scale (SDS), and the Suicidality Modifiers Scale, is a co- author of the Suicide Plan Tracking Scale (SPTS), and owns stock in Medical Outcomes Systems, which computerized the InterSePT Scale for Suicidal Thinking (ISST-Plus) and the S-STS used in this study; Dr. Alphs is employed by Janssen Scientific Affairs, Titusville, New Jersey, is a stockholder of Johnson & Johnson, and is a co-author and copyright holder of the ISST-Plus; Dr. Mao is an employee of Janssen Research & Development, LLC, Titusville, New Jersey, who provided funding for this study; Mr. Q. Li has no conflicts of interest relevant to the content of this article; Ms. May has no conflicts of interest relevant to the content of this article; Ms. Bruer has no conflicts of interest relevant to the content of this article; Dr. McCullumsmith has no conflicts of interest relevant to the content of this article; Mr. Gray is an employee of Medical Outcome Systems, which computerized the ISST- Plus and the S-STS used in this study; Mr. X. Li has no conflicts of interest relevant to the content of this study; Dr. Williamson is an employee and stockholder in Johnson and Johnson, Janssen Scientific Affairs's parent company; and Ms. Lee is an employee of Janssen Research & Development, LLC, Titusville, New Jersey, who provided funding for this study. ADDRESS CORRESPONDENCE TO: David V. Sheehan, MD, MBA; E-mail: dsheehan@health.usf.edu KEY WORDS: Suicide scale, suicide assessment, suicide attempt, suicide, suicidal ideation, suicidal behavior, suicidality, suicide risk, concurrent validity, validation, C-SSRS, C-CASA, FDA 2012 Draft Guidance Document, ISST-Plus, S-STS [ O R I G I N A L R E S E A R C H ] 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, Florida; Dr. Alphs is with Janssen Medical Affairs, LLC, Titusville, New Jersey; Dr. Mao is with Janssen Research & Development, LLC, Titusville, New Jersey; Mr. Q. Li is Director, Statistical Programming, Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey; Ms. May is with the University of Alabama, Birmingham, Alabama; Ms Bruer is with the University of Alabama, Department of Psychiatry and Behavioral Neurobiology, Birmingham, Alabama; Dr. McCullumsmith is with the University of Cincinnati Department of Psychiatry and Behavioral Neuroscience, Cincinnati, Ohio; Mr. Gray is with Medical Outcomes Systems, Jacksonville, Florida; Mr. X. Li is with St. Vincent East Hospital, St. Vincent Health System, Birmingham, Alabama; and Dr. Williamson is with the University of South Alabama College of Medicine, Departments of Psychiatry and Neurology, Birmingham, Alabama, and Janssen Medical Affairs, LLC, Titusville, New Jersey. Innov Clin Neurosci. 2014;11(9–10):32–46 Comparative Validation of the S-STS, the ISST- Plus, and the C–SSRS for Assessing the Suicidal Thinking and Behavior FDA 2012 Suicidality Categories

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