CNS Summit 2019
HarmResearch gave the following presentations at the 2019 Annual Meeting of CNS Summit:
Friday, November 1st, 2019, 5 to 7 pm Posters
Saturday, November 2nd, 2019, 5 to 7 pm Posters
Friday, November 1st, 2019 Posters
Is Dimensional Scale Data More Sensitive than Categorical Data
In Detecting an Anti-suicidality Efficacy Signal? – A Case Study
Jennifer M Giddens BA 1, 2
David V Sheehan MD, MBA, DLFAPA 1, 2, 3
1 Harm Research Institute, Tampa, FL, USA
2 Tampa Center for Research on Suicidality, Tampa, FL, USA
3 University of South Florida Morsani College of Medicine, Tampa, FL, USA
Click here to view or download a watermarked, preview copy of this poster
Date: Friday, November 1st, 2019
Time: 5 to 7 pm
Location: Boca Raton Resort & Club, Boca Raton, FL
Poster Number: 7A
Abstract:
Objective: 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.
Design: 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 Sheehan – Suicidality Tracking Scale (S-STS), covering a timeframe before and during effective treatment for suicidality.
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 detecting 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.
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.
Learning Objectives:
Following this presentation, participants will:
1. Understand the limitations of categorical measures in detecting changes in efficacy and safety suicidality signals in clinical trials.
2. Appreciate the advantages of dimensional measures in detecting changes in efficacy and safety suicidality signals in clinical trials.
3. Understand the elements within a dimensional measure most likely to detect the earliest signals of change in efficacy and safety.
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:
Giddens JM, Sheehan DV. Is Dimensional Scale Data More Sensitive than Categorical Data in Detecting an Anti-Suicidality Efficacy Signal? A Case Study. Poster. CNS Summit, Boca Raton, FL, November 1, 2019.
Suicidality: A Linear or a Non-linear Progression Over Time?
David V Sheehan MD, MBA, DLFAPA 1, 2, 3
Jennifer M Giddens BA 2, 3
1 University of South Florida Morsani 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: Friday, November 1st, 2019
Time: 5 to 7 pm
Location: Boca Raton Resort & Club, Boca Raton, FL
Poster Number: 7B
Abstract:
Objective: To investigate whether the progression of suicidality phenomena over time is linear or non-linear. The model of progressive, linear suicidality is a long-standing assumption in suicidality research. Understanding the progression of suicidality over time will help researchers build better predictive models of suicidality.
Design: We adapted methods developed by Robert Stetson Shaw, a physicist at the University of California at Santa Cruz, to analyze the progression of suicidality phenomena in 2 continuous data sets from a single case over time. These methods are used in non-linear dynamics theory / non-linear systems theory / turbulence theory / deterministic chaos and permit data to be graphically displayed in 2- and 3-dimensional space over time.
Results: The method permitted the mathematical graphic modeling of suicidality phenomena over 3 years in the form of 2D and 3D attractor plots. The results showed a non-linear dynamic progression of suicidality phenomena over time. There was no linear progression in the rate of change in the relationship between suicidal ideation and behavior, over time.
Conclusions: The trajectory of suicidal phenomena over time is non-linear and dynamic. This data is displayed graphically as attractor plots that reflect the underlying structure of suicidality and its dynamic, turbulent change over time. To improve predictive models of suicidality, progressive, linear models need to be abandoned in favor of non-linear, mathematical modeling of dynamic systems that more accurately reflect the turbulence, unpredictability, and dynamic nature of the complex systems of suicidality phenomena as they move through time.
Learning Objectives:
Following this presentation, participants will:
1. Understand that suicidality may not follow a linear progression but follows a model of chaos dynamics.
2. Appreciate the need to consider non-linear dynamic systems mathematical modeling when building predictive models of suicidality.
3. Understand that most (if not all) research on risk and protective factors for suicidality are based on linear models and may not accurately model the true non-linear dynamic nature of suicidality.
Literature References:
1. Robert Shaw, The Dripping Faucet As a Model Chaotic System, Science Frontier Express Series, Aerial Press, December 1984, ISBN 0-942344-05-7
2. Giddens JM, Sheehan DV. Study of Magnesium in the Treatment of Impulse Attack Suicidality Disorder. In: Sheehan, DV and Giddens, JM. (2015). Suicidality: A Roadmap for Assessment and Treatment. (1st ed.). Tampa, FL: Harm Research Press. November 2015. p. 249-267.
3. Sheehan DV, Giddens JM. (2016). Suicidality Assessment and Documentation for Healthcare Providers: A Brief, Practical Guide. (1st ed.). Tampa, FL: Harm Research Press. April 2016. 93-99.
How to Cite:
Sheehan DV, Giddens JM. Suicidality: A Linear or a Non-linear Progression Over Time? Poster. CNS Summit, Boca Raton, FL, November 1, 2019.
Saturday, November 2nd, 2019 Posters
The Graphic Display of Quantitative Suicidality Data: S-Plots
Jennifer M Giddens BA 1, 2
David V Sheehan MD, MBA, DLFAPA 1, 2, 3
1 Harm Research Institute, Tampa, FL, USA
2 Tampa Center for Research on Suicidality, Tampa, FL, USA
3 University of South Florida Morsani College of Medicine, Tampa, FL, USA
Click here to view or download a watermarked, preview copy of this poster
Date: Saturday, November 2nd, 2019
Time: 5 to 7 pm
Location: Boca Raton Resort & Club, Boca Raton, FL
Poster Number: 7A
Abstract:
Objective: Regulatory agencies, pharmaceutical companies, clinical research organizations, data safety monitoring boards and medical safety officers are challenged with the difficulty of summarizing the suicidality status of patients under their care. Linking such data to study stopping rules is a complex multistep series of tasks, fraught with potential errors. In the interest of reducing error, speeding detection, protection of patients, clarity of data presentation and display, there is a need for a more efficient, clear, and simple system to display suicidality data.
Design: We reviewed graphic displays of quantitative data in other medical and scientific disciplines to find suitable models. We applied a variety of graphic displays to a prospectively collected dataset using the Sheehan-Suicidality Tracking Scale (S-STS).
Results: Suicidality-Plots (S-Plots) display the data for groups of patients and for individual patients over time. Interpretation of these S-Plots can quickly identify patients at higher risk and provide a method to monitor the status of patients within a large sample over time. Interpretation of S-Plots can quickly identify the overall status of suicidality in the study over time in relation to the study stopping rules. Graphic display of quantitative suicidality data can be used to quickly visually identify individual patients at high risk and whether a clinical trial should be halted because of treatment-emergent suicidality.
Conclusion: Use of S-Plots may reduce the potential medico-legal hazards from either the delayed analysis or delayed detection of suicidality in safety data, and the risk to patients in research trials and clinical settings.
Learning Objectives:
Following this presentation, participants will be better able to:
1. Familiar with graphical approaches to the display of quantitative suicidality data in clinical research trials and clinical settings
2. Better able to understand, interpret, and analyze suicidality data displayed in S-Plots
Literature References:
1. Tufte E, Graves-Morris P. The visual display of quantitative information.; 1983.
2. Amit O, Heiberger RM, Lane PW. Graphical approaches to the analysis of safety data from clinical trials. Pharmaceutical Statistics. 2008 Jan 1;7(1):20-35.
How to Cite:
Giddens JM, Sheehan DV. The Graphic Display of Quantitative Suicidality Data: S-Plots. Poster. CNS Summit, Boca Raton, FL, November, 2nd, 2019.
A Classification of Suicidality Disorders Phenotypes
David V Sheehan MD, MBA, DLFAPA 1, 2, 3
Jennifer M Giddens BA 2, 3
1 University of South Florida Morsani 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: Saturday, November 2nd, 2019
Time: 5 to 7 pm
Location: Boca Raton Resort & Club, Boca Raton, FL
Poster Number: 7B
Abstract:
Objective: To provide a classification of suicidality disorder phenotypes. The view that suicidality is trans-nosological and that all forms of suicide are the same, is not consistent with response to pharmacological treatment evidence. For example, antidepressants make suicidality better in some patients, worse in others, and are no better than placebo for a third group. This suggests that there may be more than one type of suicidality.
Design: We used a phenomenological1 approach by observing in detail and directly communicating with subjects over time about their suicidality.
Results: We developed diagnostic criteria and a related structured diagnostic interview for 12 distinct suicidality disorder phenotypes2. These include 1) Impulse Attack Suicidality Disorders, 2) Homicidal Suicidality Disorders, 3) Psychotic Suicidality Disorders, 4) Obsessive Compulsive Suicidality Disorders, 5) PTSD Suicidality Disorders, 6) Eating Disorder / Malabsorption Suicidality Disorders, 7) Substance Induced Suicidality Disorders, 8) Medical Illness / Neurological Condition Induced Suicidality Disorders, 9) Anxiety Disorder Induced Suicidality Disorders, 10) Mood Disorder Induced Suicidality Disorders, 11) Life Event Induced Suicidality Disorders, and 12) Suicidality Disorders, Not Elsewhere Classified. Among these phenotypes the description of Impulse Attack Suicidality Disorder is new. This disorder is associated with unexpected, unprovoked, unpredictable attacks of an urgent need to kill oneself.
Conclusion: We offer 12 suicidality disorder phenotypes. Because these phenotypes may have a different response to treatment, each phenotype should be investigated separately when investigating anti-suicidality treatments and when investigating the relationship between genetic and other biomarkers in suicidality.
Learning Objectives:
Following this presentation, participants will be better able to:
1. Identify the different phenotypes of suicidality disorders.
2. Appreciate that not all clinical phenotypes of suicidality disorders have the same clinical features, natural history, response to life events, prognosis, or response to treatment.
Literature References:
1. Spiegelberg, H. (2015, June 11). Phenomenology. Retrieved October 24, 2015, from http://www.britannica.com/topic/phenomenology
2. Sheehan DV, Giddens JM. Suicidality Disorders Criteria. In: Sheehan, DV and Giddens, JM. (2015). Suicidality: A Roadmap for Assessment and Treatment. (1st ed.). Tampa, FL: Harm Research Press. November 2015. p. 82-126.
3. Sheehan DV, Giddens JM. (2016). Suicidality Assessment and Documentation for Healthcare Providers: A Brief, Practical Guide. (1st ed.). Tampa, FL: Harm Research Press. April 2016. p. 93-99.
How to Cite:
Sheehan DV, Giddens JM. A Classification of Suicidality Disorder Phenotypes (12 Phenotypes Version). Poster. CNS Summit, Boca Raton, FL, November 2nd, 2019.
Case Study of Magnesium in the Treatment of Impulse Attack Suicidality Disorder (IASD)
David V Sheehan MD, MBA, DLFAPA 1, 2, 3
Jennifer M Giddens BA 2, 3
1 University of South Florida Morsani 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: Saturday, November 2nd, 2019
Time: 5 to 7 pm
Location: Boca Raton Resort & Club, Boca Raton, FL
Poster Number: 8A
Abstract:
Objective: This case study reports on the effect of high magnesium oxide coupled with reduced dietary calcium intake (+Mg-Ca) in the treatment of Impulse Attack Suicidality Disorder (IASD).
Design: Using several sensitive assessment instruments (S-STS, S-STS CMCM, T-CASA, SPTS) for suicidality phenomena and suicidality event tracking, the authors tracked the effect on suicidality of magnesium oxide in doses up to 1000 mg/day in 4 divided doses daily, coupled with a reduced dietary intake of calcium below 300 mg / day (<30% of Recommended Daily Intake). The T-CASA was rated daily, and the S-STS, the S-STS CMCM, and the SPTS rated weekly over a 166-week (3.2 year) period and covering 43,690 separate suicidality events. The subject had a 25-year history of daily suicidality that did not responded to any prior treatment including 11 antidepressants, atypical antipsychotics, anticonvulsant mood stabilizers, and lithium dose.
Results: The +Mg-Ca completely eliminated the subject’s suicidality. After 6 months free of suicidality the subject stopped the magnesium, while maintaining the low calcium intake. Within 48 hours she had a full relapse of all her prior suicidality and suicidal impulse attacks. This worsened over the ensuing week. On restarting the magnesium oxide, the suicidality decreased over the following 8 days after which she remained suicidality free for the ensuing 7 months.
Conclusion: The data from this case study suggests that high dose magnesium oxide coupled with reduced dietary calcium intake merits further investigation for the treatment of Impulse Attack Suicidality Disorder in large double blind, placebo-controlled studies.
Learning Objectives:
Following this presentation, participants will be better able to:
1. Understand how a +Mg-Ca (high magnesium oxide low calcium intake) regimen was used to treat a case of chronic Impulse Attack Suicidality Disorder (IASD).
2. Identify the symptom response profile in one subject with Impulse Attack Suicidality Disorder (IASD) in response to this +Mg-Ca (high magnesium oxide low calcium intake) regimen.
Literature References:
1. Giddens, JM and Sheehan, DV. Study of Magnesium in the Treatment of Impulse Attack Suicidality Disorder. In: Sheehan, DV and Giddens, JM. 2015. Suicidality: A Roadmap for Assessment and Treatment. p. 249-267.
2. Sheehan, DV and Giddens, JM. Impulse Attack Suicidality Disorder. In: Sheehan, DV and Giddens, JM. 2015. Suicidality: A Roadmap for Assessment and Treatment. p. 127-155.
How to Cite:
Sheehan DV, Giddens JM. Case Study of Magnesium in the Treatment of Impulse Attack Suicidality Disorder (IASD). Poster. CNS Summit, Boca Raton, FL, November 2nd, 2019.