title: Suicidality and risk of suicide--definition, drug safety concerns, and a necessary target for drug development: a brief report.
abstract: OBJECTIVE
  To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009.
  
  
  METHODS
  This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as research psychiatrists involved in studies in studies of psychiatric disorders associated with elevated suicide risk across the life cycle. The process involved reviews of the relevant literature, and a series of 6 breakout sessions focused on specific questions of interest.
  
  
  METHODS
  Each of the participants at the meeting received references relevant to the formal presentations (as well as the slides for the presentations) for their review prior to the meeting. In addition, the assessment instruments of suicidal ideation/behavior were reviewed in relationship to standard measures of validity, reliability, and clinical utility, and these findings were discussed at length in relevant breakout groups, in the final plenary session, and in the preparation of the article. Consensus and dissenting views were noted.
  
  
  METHODS
  Discussion and questions followed each formal presentation during the plenary sessions. Approximately 6 questions per breakout group were prepared in advance by members of the Steering Committee and each breakout group chair. Consensus in the breakout groups was achieved by nominal group process. Consensus recommendations and any dissent were reviewed for each breakout group at the final plenary session. All plenary sessions were recorded and transcribed by a court stenographer. Following the transcript, with input by each of the authors, the final paper went through 14 drafts. The output of the meeting was organized into this brief report and the accompanying full article from which it is distilled. The full article was developed by the authors with feedback from all participants at the meeting and represents a consensus view. Any areas of disagreement at the conference have been noted in the text.
  
  
  CONCLUSIONS
  The term suicidality is not as clinically useful as more specific terminology (ideation, behavior, attempts, and suicide). Most participants applauded the FDA's encouragement of standard definitions and definable expectations for investigators and industry sponsors. Further research of available assessment instruments is needed to verify their utility, reliability, and validity in identifying suicide-associated treatment-emergent adverse effects and/or a signal of efficacy in suicide prevention trials. The FDA needs to systematically monitor postmarketing events by encouraging the development of a validated instrument for postmarketing surveillance of suicidal ideation, behavior, and risk. Over time, the FDA, industry, and clinical researchers should evaluate the impact of the requirement that all central nervous system clinical drug trials must include a Columbia Classification Algorithm of Suicide Assessment (C-CASA)-compatible screening instrument for assessing and documenting the occurrence of treatment-emergent suicidal ideation and behavior. Finally, patients at high risk for suicide can safely be included in clinical trials, if proper precautions are followed.
authors.affiliation: Best Practice Project Management, Inc, PO Box 30219, Bethesda, MD 20824, USA. rmeyer@best-practice.net
authors.forename: Roger E
authors.initials: RE
authors.lastname: Meyer
authors.forename: Carl
authors.initials: C
authors.lastname: Salzman
authors.forename: Eric A
authors.initials: EA
authors.lastname: Youngstrom
authors.forename: Paula J
authors.initials: PJ
authors.lastname: Clayton
authors.forename: Frederick K
authors.initials: FK
authors.lastname: Goodwin
authors.forename: J John
authors.initials: JJ
authors.lastname: Mann
authors.forename: Larry D
authors.initials: LD
authors.lastname: Alphs
authors.forename: Karl
authors.initials: K
authors.lastname: Broich
authors.forename: Wayne K
authors.initials: WK
authors.lastname: Goodman
authors.forename: John F
authors.initials: JF
authors.lastname: Greden
authors.forename: Herbert Y
authors.initials: HY
authors.lastname: Meltzer
authors.forename: Sharon-Lise T
authors.initials: SL
authors.lastname: Normand
authors.forename: Kelly
authors.initials: K
authors.lastname: Posner
authors.forename: David
authors.initials: D
authors.lastname: Shaffer
authors.forename: Maria A
authors.initials: MA
authors.lastname: Oquendo
authors.forename: Barbara
authors.initials: B
authors.lastname: Stanley
authors.forename: Madhukar H
authors.initials: MH
authors.lastname: Trivedi
authors.forename: Gustavo
authors.initials: G
authors.lastname: Turecki
authors.forename: Charles M
authors.initials: CM
authors.lastname: Beasley
authors.forename: Annette L
authors.initials: AL
authors.lastname: Beautrais
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Bridge
authors.forename: Gregory K
authors.initials: GK
authors.lastname: Brown
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
authors.forename: Neal D
authors.initials: ND
authors.lastname: Ryan
authors.forename: David V
authors.initials: DV
authors.lastname: Sheehan
mesh_terms: D000293:Adolescent; D000328:Adult; D000928:Antidepressive Agents / Q000009:adverse effects; D002423:Cause of Death; D002648:Child; D003245:Consensus Statements as Topic; D055808:Drug Discovery / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy / Q000401:mortality / Q000523:psychology; D015201:Meta-Analysis as Topic; D008875:Middle Aged; D012307:Risk Factors; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects; D013405:Suicide / Q000523:psychology* / Q000706:statistics & numerical data; D009626:Terminology as Topic; D014481:United States; D014486:United States Food and Drug Administration; D000092864:Suicide Prevention
chemical_list: D000928:Antidepressive Agents; D017367:Selective Serotonin Reuptake Inhibitors