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J Clin Psychiatry. 2017 Jun;78(6):e638-e647. doi: 10.4088/JCP.16cs11417.

Assessment of Suicidal Ideation and Behavior: Report of the International Society for CNS Clinical Trials and Methodology Consensus Meeting.

Author information

1
Executive Director, Global Clinical Affairs, Pfizer Essential Health, 445 Eastern Point Rd, MS 8260-2534, Groton, CT 06340. phillip.b.chappell@pfizer.com.
2
Pfizer Essential Health, Pfizer, Groton, Connecticut, USA.
3
Global Health and Value, Pfizer Inc, Groton, Connecticut, USA.
4
Janssen Scientific Affairs, Janssen Research & Development, LLC, Titusville, New Jersey, USA.
5
LeoBen Research, Rome, Italy.
6
Pfizer Innovative Health Statistics, Pfizer, Groton, Connecticut, USA.
7
American Foundation for Suicide Prevention, New York, New York, USA.
8
Statistics and Decision Sciences, Janssen Research & Development, LLC, Titusville, New Jersey, USA.
9
Clinical Sciences, Pfizer, Inc, Groton, Connecticut, USA.
10
Suicide Prevention Resource Center, Waltham, Massachusetts, USA.
11
Clintara LLC, Boston, Massachusetts, USA.
12
Semel Institute for Neuroscience at UCLA and the Veterans Affairs Desert Pacific Mental Illness Research, Education, and Clinical Center, Los Angeles, California, USA.

Abstract

OBJECTIVE:

To develop consensus recommendations for assessment of suicidal ideation/suicidal behavior (SI/SB) in clinical trials.

PARTICIPANTS:

Stakeholders from academia, industry, regulatory agencies, National Institutes of Health, National Institute of Mental Health, and patient advocacy organizations participated in a consensus meeting that was sponsored by the International Society for CNS Clinical Trials and Methodology and held November 17-18, 2015. Prior to the meeting, teams of experts identified key areas of consensus and dissent related to SI/SB. The most critical issues were presented and discussed in the consensus meeting.

EVIDENCE:

Literature reviews and a pre-meeting survey were conducted. Findings were discussed in pre-meeting working group sessions and at the consensus meeting.

CONSENSUS PROCESS:

Five pre-meeting working groups reviewed (1) nomenclature and classification schemes for SI/SB, (2) detection and assessment of SI/SB, (3) analysis of SI/SB data, (4) design of clinical trials for new treatments of SI/SB, and (5) public health approaches to SI/SB. A modification of the RAND/UCLA Appropriateness Method was used to combine review of scientific evidence with the collective views of experts and stakeholders to reach the final consensus statements. After discussion, all attendees voted using an electronic interactive audience response system. Areas of agreement and areas of continuing dissent were recorded.

CONCLUSIONS:

All 5 working groups agreed that a major barrier to advancement of the field of SI/SB research and the development of new treatments for SI/SB remains the lack of a universally accepted standardized nomenclature and classification system. Achieving alignment on definitions and classification of suicide-related phenomena is critical to improving the detection and assessment of SI/SB, the design of clinical trials for new treatments, and effective public health interventions.

PMID:
28682533
DOI:
10.4088/JCP.16cs11417
[Indexed for MEDLINE]
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