9th Annual Scientific Meeting: Suicidal Ideation and Behavior – Methodological and Technical Challenges

Chairs:  Adam Butler; Michelle Stewart, PhD; Roger Meyer, MD

The assessment of Suicidal Ideation and Behavior is an area of intense methodological interest for CNS research. The FDA has introduced a draft guidance regarding prospective identification of treatment-emergent suicidality in clinical trials; other regulatory authorities have issued similar recommendations or have signaled intent to address the topic. Since the introduction of the guidance in 2010, there have been drastic changes in how suicidality ideation and behavior is assessed, in how assessment tools have been modified and introduced into trials, and in the ways that researchers have adapted to the evolving requirements.

This symposium will review current challenges in prospective assessment, present data regarding the use of these assessments in recent trials, and analyze recent methodological studies that compared different approaches to SIB prospective assessment in clinical trials. The goal of the symposium is to expand awareness of real challenges to these assessments, and present the most recent evidence that will guide design and decision-making moving forward.