Meeting Agenda
Assessing Suicidality During Antidepressant Treatment
November 9, 2005 –November 10, 2005
Bethesda, Maryland
| Day | Time | Event & Description | Presenter(s) | Discussant(s)/Moderator(s) |
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| November 9 | 8:45-10:00 | Pressing Issues in the Assessment/Measurement of SSRI Side Effects, Part 1
What is the extent and the quality of antidepressant side effect data available to the FDA? What are the ascertainment challenges? What are the challenges of assessing adverse events that are expectable symptoms and possible outcomes? What definitions of suicidality are being applied to symptoms/side effects/adverse events? |
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| 10:15-11:30 | Pressing Issues in the Assessment/Measurement of SSRI Side Effects, Part 2
What are the current approaches to assessing SSRI side effects in federally sponsored clinical trials for adults and youth? What is the content and format of the measures being used? What are the issues associated with the timing of assessments (e.g., should SE measures be routinely administered prior to initiation of medications for baseline information?) Are the measures valid across age groups, and for under-represented minority populations? |
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| 11:30-12:00 | Incorporating best-candidate measures of suicidalilty SEs into various public/private population surveillance efforts (e.g., Medicaid, HMOs, GPRN)
What can surveillance of VA, public or private care practices inform us about the safety or risk of SSRIs (advantages and limitations)? What data are accessible for examining a possible prodrome (agitation, insomnia) cluster of SEs (e.g. smart text searching)? How can depression severity with suicidality be separated from aggressive medication treatment? What can be discerned regarding prescription trends before and after the black box warning? What is considered “safe practice” in these data bases? What counts as an “adverse event” in these surveillance efforts? Can risk aversive practice be discerned in practice networks (e.g., switching meds due to agitation or insomnia)? What demographic factors (gender, age, ethnicity, insurance type) influence antidepressant treatment patterns in these networks? |
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| 1:30-2:35 | Incorporating best-candidate measures of suicidality SEs into various public/private population surveillance efforts, Continued |
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| 2:35-3:40 | Application of Decision Making Theories and Basic Behavior Research Theory and Methods, Part 1
Using Basic Cognitive Psychology (e.g., decision making theory, “cognitive interviewing” in response to actual cases or standardized vignettes) and qualitative techniques to identify salient features that influence families' and clinicians' choices about increasing/decreasing/discontinuing medication in the face of suicidality. What influences patients understanding of risk/benefit? How do providers view side effect risks? How do they decide which medications, for which patients? Does the concept of “activation” affect when providers decide to increase, decrease or discontinue doses? To what degree does availability of other treatment approaches (ie psychotherapy) affect SSRI treatment patterns? What are family members experiences with treatment? If and how do “family decision makers” (e.g., parents; spouses) express concerns about the black box warning? |
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| 3:55-5:00 | Application of Decision Making Theories and Basic Behavior Research Theory and Methods, Part 2
How well are self-report measures predicting discrete but related constructs to suicidality (e.g., impulsivity; aggression), and what are their implications for basic research as well as side effect assessment? How might the application of new behavioral assessment technologies be used to explore the onset and resolution of suicidality SEs (e.g., ecological momentary assessment methods (real-time)? |
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| 5:00-5:15 | General Comments about the Day's Discussion |
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| November 10 | 9:00- 10:05 | Exploring Alternative Approaches to help “unpack the blackbox” of SSRI Side Effects
How can knowledge about individual differences in pharmacodynamics, pharmacokinetics, and pharmacogenetics inform studies about side effect risks? |
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| 10:45-12:00 | Open Discussion of Candidate Research Questions and Designs
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