Past, present, and future - MBSW Online

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Suicidal IdeationSuicidal BehaviorSuicidal ideationor behaviora “yes” answer at any time duringtreatment to any one of the suicidalideation questionsa “yes” answer at any time duringtreatment to any one of the suicidalbehavior questionsa “yes” answer at any time duringtreatment to any one of the suicidalideation <strong>and</strong> behavior questionsNOTE:These definitions are based on C-SSRS; can be modified if usingother suicide scalesMuncie, IN May 25, 2011 C. Gassmann-Mayer Johnson & Johnson24
• Definition of treatment-emergence• TE definition varies across companies for theanalysis of adverse events in general• Recommend comparing max ideation duringtreatment with max during the pre-specified pretreatmentperiodSuicidal ideation <strong>present</strong> before treatment, notexperienced for some time, comes back during treatment It is not TE unless the category is higher/worseMuncie, IN May 25, 2011 C. Gassmann-Mayer Johnson & Johnson25
Page 1 and 2: Past, present, and future34 th Annu
Page 3 and 4: • Research question in clinical t
Page 5 and 6: Is suicidalitythe right term ?Munci
Page 7 and 8: Where we wereWhere we areWhere we a
Page 9 and 10: • 2008- 2009• PhRMA* Working gr
Page 11 and 12: • September 2010• FDA Draft Cli
Page 13 and 14: C-CASA=classification system1. Comp
Page 15 and 16: • Since 2009The statistical sub t
Page 17 and 18: • Contribute the scientific dialo
Page 19 and 20: Collection of suicide-related dataI
Page 21 and 22: www.cssrs.columbia.edu/scales_cssrs
Page 23: • Suicide-related endpoints• Tr
Page 27 and 28: Recent HistoryAll prior History =Li
Page 29 and 30: • Suicidal behaviors have no “n
Page 31 and 32: • Time-to-event analyses• Time-
Page 33 and 34: • Establish criteria for studies
Page 35 and 36: • No uniformly “best” method
Page 37 and 38: Muncie, IN May 25, 2011 C. Gassmann
Page 39 and 40: • Beck, A.T., Kovacs, M. & Weissm
Page 41 and 42: • Berlin and Colditz (1999). The
Page 43 and 44: • Pintilie, M. Competing risks: a

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