ASCP 2019
HarmResearch gave the following presentation at the 2019 Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP):
Wednesday, May 29th, 2019, 11:15 am to 1 pm Poster
Wednesday, May 29th, 2019 Poster
Is Dimensional Scale Data More Sensitive than Categorical Data
in Detecting an Anti-Suicidality Efficacy Signal? A Case Study
David V Sheehan MD, MBA, DLFAPA 1, 2, 3
Jennifer M Giddens BA 2, 3
1 University of South Florida College of Medicine, Tampa, FL, USA
2 Harm Research Institute, Tampa, FL, USA
3 Tampa Center for Research on Suicidality, Tampa, FL, USA
Click here to view or download a watermarked, preview copy of this poster
Date: Wednesday, May 29th, 2019
Time: 11:15 am to 1 pm
Location: Palomino 4-10, Fairmont Scottsdale Princess, Scottsdale, AZ
Poster Number: W3
Abstract:
Introduction: This case study reports the relative merits of using a categorical system and dimensional scale data to track the efficacy of an anti-suicidality treatment.
Methods: A 31-year-old female subject who experienced suicidality almost daily for over 20 years prospectively collected a self-report data series over 80 weeks using the computerized versions of the Sheehan – Suicidality Tracking Scale (S-STS), covering a timeframe before and during effective treatment for suicidality. The S-STS data was mapped into the FDA-CASA 2012 categories and compared to the corresponding seriousness scores, the event count, and the time spent in suicidality, all from the S-STS (a dimensional scale).
Results: The S-STS (dimensional) showed an efficacy signal as early as 2 to 6 weeks. The categorical data took between 14 and 21 weeks to show an efficacy signal. The “most time spent in suicidality per day” measure was more sensitive in showing the efficacy signal (or a loss of efficacy) than, in rank order: 1) the “usual time spent in suicidality per day”, 2) the “least time spent in suicidality per day”, 3) both the active and passive suicidal ideation event counts, and 4) the highest FDA-CASA 2012 category endorsed for the week. The use of the active and passive suicidal ideation counts of events in combination with the most, least, and the usual time spent in suicidality per day helps in distinguishing between efficacy signal and a signal of worsening.
Conclusion: For every category studied, there was a further delay of between 10 and 17 weeks in the ability of the categorical data to detect the anti-suicidality efficacy signal compared to the corresponding dimensional scale data. This has implications for the design of anti-suicidality treatment efficacy (and safety) outcome measures. The inclusion of a dimensional suicidality scale also increases the likelihood of serendipitously finding anti-suicidality efficacy while investigating candidate drug treatments for other CNS indications. Cerca trova.
Learning Objectives:
Following this presentation, participants will be better able to:
1. Appreciate that dimensional suicidality scales are more sensitive in detecting an anti-suicidality efficacy signal than comparable categorical scales.
2. Appreciate that dimensional suicidality scales may be more likely to serendipitously find anti-suicidality efficacy while investigating candidate drug treatments for other CNS indications.
3. Appreciate that dimensional suicidality scales may be more sensitive in detecting an anti-suicidality (treatment emergent) safety signal than comparable categorical scales.
Literature References:
1. United States Food and Drug Administration, United States Department of Health and Human Services. Guidance for Industry: Suicidality: Prospective Assessment of Occurrence in Clinical Trials, Draft Guidance. [October 1, 2014]. http://www.fda.gov/downloads/Drugs/Guidances/UCM225130.pdf August 2012. Revision 1.
2. Sheehan, D. V., Giddens, J. M., & Sheehan, I. S. (2014). Status Update on the Sheehan-Suicidality Tracking Scale (S-STS) 2014. Innovations in Clinical Neuroscience, 11(9-10), 93. PDF: http://innovationscns.epubxp.com/i/425963/92
How to Cite:
Sheehan DV, Giddens JM. Is Dimensional Scale Data More Sensitive than Categorical Data in Detecting an Anti-Suicidality Efficacy Signal? A Case Study. Poster. Annual Meeting, American Society of Clinical Psychopharmacology (ASCP), Scottsdale, AZ, May, 29, 2019.