ASCP 2018
HarmResearch gave the following presentations at the 2018 Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP):
Thursday, May 31st, 2018, 12:20 to 2 pm Posters
Friday, June 1st, 2018, 8:30 am to 10 am Panel
Thursday, May 31st, 2018 Posters
Does citalopram increase the frequency of up-switches of impulsive suicidality
in a subject with Impulse Attack Suicidality Disorder? – 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: Thursday, May 31st, 2018
Time: 12:30 pm to 2 pm
Location: Salon 4, Loews Miami Beach Hotel, Miami Beach, FL
Poster Number: T62
Abstract:
Background: This case study reports the effect of the SSRI citalopram in causing up-switches of impulsive suicidality.
Methods: A 29-year-old female subject who experienced suicidality almost daily for over 20 years prospectively collected a self-report data series over 248 days using the computerized versions of the Suicidality Modifiers Scale (SMS) and the Sheehan – Suicidality Tracking Scale (S-STS), covering a timeframe before, during and after a 116 day trial of citalopram. The S-STS data was mapped into the C-CASA 2010 and FDA-CASA 2012 categories and compared to the scores for the severity of impulsive suicidality from the SMS.
Results: The SMS data show a 39% increase in up-switches in suicidal impulsivity while the subject was taking the citalopram. The data show the C-CASA 2010 and FDA-CASA 2012 categories were unable to detect this signal of increased up-switches in suicidal impulsivity. The data in some of these C-CASA 2010 and FDA-CASA 2012 categories suggest that the subject’s suicidality was improving while these danger signals were worsening.
Conclusions: The SSRI citalopram is associated with an increase in up-switches in suicidal impulsivity in a non-Bipolar Disorder subject. That the existing safety detecting classification algorithms used by the US Food and Drug Administration (2010 and 2012) can fail to detect a serious suicidal adverse event such as the one described above is a cause for serious concern and needs to be corrected. Any rating instrument or classification “algorithm” used to detect safety signals of suicidality needs to include an item on impulsive suicidality.
Learning Objectives:
Following this presentation, participants will be:
1. Appreciate that some phenotypes of suicidality disorders can be worsened by an SSRI.
2. Appreciate that some classification systems and some classification assessment instruments will detect this treatment emergent suicidality while others will fail to do so or will show improvement in suicidality at exactly the same time.
Literature References:
1. Sheehan DV, Giddens JM. Does citalopram increase the frequency of up-switches of impulsive suicidality in a subject with Impulse Attack Suicidality Disorder? – A case study. In: Sheehan, DV and Giddens, JM. (2015). Suicidality: A Roadmap for Assessment and Treatment. (1st ed.). Tampa, FL: Harm Research Press. November 2015, 226-248.
2. 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.
How to Cite:
Sheehan DV, Giddens JM. Does citalopram increase the frequency of up-switches of impulsive suicidality in a subject with Impulse Attack Suicidality Disorder? – A case study. Poster. Annual Meeting, American Society of Clinical Psychopharmacology (ASCP), Miami, FL, May, 31, 2018.
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 College of Medicine, Tampa, FL, USA
Click here to view or download a watermarked, preview copy of this poster
Date: Thursday, May 31st, 2018
Time: 12:30 pm to 2 pm
Location: Salon 4, Loews Miami Beach Hotel, Miami Beach, FL
Poster Number: T64
Abstract:
Background: Regulatory agencies, pharmaceutical companies, clinical research organizations, data safety monitoring boards, medical directors of health care organizations, and medical safety officers are challenged with the difficulty of summarizing the suicidality status of patients under their care in a simple, clear manner. Currently, data collected using a dimensional scale are reduced to the categorical system at the completion of a study. Suicidality data is currently organized and reviewed in complex tables, reflecting these categories, with a resultant loss of sensitivity and the risk of delayed detection, or of detection errors. 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.
Methods: We explored and reviewed graphic displays of quantitative data in other medical and scientific disciplines to find suitable models. The selection criteria included simplicity, clarity, the ease of interpretation of the data, and how appropriate the displays would be for suicidality data, collected using a dimensional suicidality tracking scale. We applied a variety of graphic displays to a prospectively collected dataset using the Sheehan-Suicidality Tracking Scale (S-STS). The final displays are the result of this iterative process.
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, the disposition of all patients in a healthcare setting or clinical trial, and whether a clinical trial should be halted because of treatment-emergent suicidality. These S-Plots are customizable for the needs of different clinical trials and settings. A computer-generated version of these S-Plots is in development. It is designed to generate e-mails or phone alerts to site investigators and sponsors for subjects deemed at imminent risk, and who need immediate attention.
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:
1. Be 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. Annual Meeting, American Society of Clinical Psychopharmacology (ASCP), Miami, FL, May, 31, 2018.
Friday, June 1st, 2018 Panel
Challenges in translating suicidality concepts for international trials across the lifespan
Sofija Jovic PhD, MBA (Chair)
David V. Sheehan MD, MBA (Speaker)
Darlene M. Amado MPH (Speaker)
Caroline Anfray (Speaker)
Jennifer M. Giddens BA (Discussant)
Date: Friday, June 1st, 2018
Time: 8:30 am to 10 am
Location: Poinciana 3-4, Loews Miami Beach Hotel, Miami Beach, FL
Abstract:
Suicide is a leading cause of premature death among psychiatric patients and a leading source of malpractice suits against psychiatrists and mental health professionals. With the globalization of clinical trials, the need to assess suicidality in a consistent manner across cultures and languages and during the lifespan of the patients has become increasingly important. Thus, how can global trials validly and reliably measure suicidality across ages, countries, and languages? This panel will explore this question by discussing the challenges in measuring suicidality, how measures have to be adapted to children language, and by explaining the process of linguistically validating suicidality scales across languages and cultures. The Sheehan-Suicidality Tracking Scale (S-STS) will be used as an example to discuss these issues. It was developed to provide a brief but efficient assessment instrument for use in assessing change in suicidality (i.e. suicidal ideation, impulses, hallucinations, dreams and behavior) while providing a comprehensive description of suicidality.
The first presentation will discuss the challenges of measuring suicidality. There is a need for a choice of scales to evaluate the full range of suicidality phenomena. Such scales must be capable of use as both safety and efficacy outcome measures in research and in clinical settings. Sensitivity to anti-suicidality effects in modest sample sizes is particularly important in the context of efforts to find and develop anti-suicidality medications. The development of the S-STS will serve as a basis for discussion. The scale has four variants. The standard version of the S-STS is a 16-item scale that assesses the seriousness of suicidality phenomena and the frequency of key phenomena and the overall time spent in suicidality. It is formatted for both clinician- and patient-rating. The Clinically Meaningful Change Measure (CMCM) version of the S-STS is a much more expanded version developed for specific testing of the anti-suicidality effects of medications. With the realization that treatment-emergent suicidality increases with decreasing age under 25 years, in the United States, three pediatric versions of the S-STS were developed (for the 6- to 8-year-olds, the 9- to 12-year-olds, and the13-to 17-year-olds). An adolescent S-STS CMCM version is also available.
The second presentation will show how the S-STS was adapted to the language of pediatric populations. Researchers collaborated with reading specialists who use the sight word lists of Dolch and Fry and the grade level vocabulary lists of Beck, Farr, and Strickland to adapt the adult version to each age group. Examples of how problematic words or phrases were identified and how appropriate words to each age group were substituted to make the questions applicable and relevant to children will be presented. The use of empirically based, age appropriate, linguistic validation of pediatric suicide scales is a necessary step in enhancing their accuracy and comprehension within a single language. The method discussed provides a model for such an approach.
The last presentation will focus on linguistically validating suicidality across languages and countries for clinical trials. Examples taken from the linguistic validation of the S-STS (adult and pediatric versions) in more than 20 languages will be provided. Cultural and semantic challenges as well as involving the author of the scale during the linguistic validation process will also be discussed.
Panel Schedule:
1.5 Hour Panel
5 minutes Introduction – Sofija Jovic PhD, MBA
15 minutes for each presentation
1. Challenges of Measuring Suicidality – David V. Sheehan MD, MBA
2. Adaptation of S-STS for Pediatric Populations – Darlene M. Amado MPH
3. Linguistically Validating Suicidality Across Languages and Countries – Caroline Anfray
10 minutes for discussant – Jennifer M. Giddens BA
30 minutes for Panel Discussion
Learning Objectives:
1. Attendees will be able to describe the attributes that make valid suicidality scales for use in suicidality trials.
2. Attendees will be able to describe the linguistic validation process of translating suicidality scales for use in clinical trials.
How to Cite:
Jovic S, Sheehan DV, Amado DM, Anfray C, Giddens JM. Challenges in Translating Suicidality Concepts for International Trials Across the Lifespan. Panel Session. Annual Meeting, American Society of Clinical Psychopharmacology (ASCP), Miami, FL, June, 1, 2018.