ISCTM 7th Annual Scientific Meeting – Suicidal Thinking and Behavior Assessment Working Group Dinner – Summary

Suicidal Thinking and Behavior Assessment
Working Group Dinner
21 Feb 2011
Chairs: A Butler, M Stewart

• Objectives:
  • Define issues r/t validation of new scales
  • Recommendations for clinical trial design with suicidality as an endpoint (evaluate need for new scale)
  • Outline ongoing challenge

• Examples offered by the group of how they are handling this
  • String text searches in pediatric study that did not include prospective evaluation
  • PSRAEs are collected – they have found discrepancies between the Columbia and the AE reports; focus on assessing inten

• Some instruct patients to tell the interviewer how they really feel and not what they think the investigator wants to hear, or what their family wants to hear, etc.

• Major issue is that non-Mental health PIs do not have infrastructure in place to handle patients reporting symptoms. So referral relationships may not exist; not clear what follow up is done.

• Concern that PIs can show subtle bias with how they ask the questions b/c they do not really want to have subjects reporting suicidal thoughts/feelings/behaviors because ill prepared to deal with it.

• There are problems with not having clear cut-offs for what constitutes a level of cog impairment in AD and MCI to be able to respond to questions

• Comment made by a DSMB member – does not know what to make of the C-CASA data.

• There are web-based versions of the C-SSRS that may be helpful in some populations.

• There was interest in doing a survey – most of discussion was on doing it with pharma companies but possibly could involve sites as well. Idea was to find out what issues are occurring with implementing guidance.