MHEI transcript 3 screening for suicide risk

PODCAST TRANSCRIPT 3:
SCREENING FOR SUICIDE RISK

Neubauer, David N., M.D.
Associate Professor
Psychiatry and Behavioral Sciences
Johns Hopkins Bayview Medical Center

Hello, this is David Neubauer and I would like to welcome you back to this podcast series
focusing on the issues surrounding the suicide risk associated with the use of
medications, particularly antidepressant and antiepileptic agents, and particularly
among children, adolescents, and young adults. This is the 3rd of four podcasts. The first
installment examined the history of the concern about medications possibly increasing
suicidality – meaning suicidal ideation, as well as suicide attempts and completed
suicides – especially following the 2004 FDA Black Box warning for antidepressants
prescribed for children and adolescents and the subsequent extension to young adults
and to the warnings about antiepileptic agents. The first podcast dealt primarily with
antidepressants and the second with antiepileptics.

There has been considerable discussion about the suicidality risk warnings due to the
concern that they could lead to the under treatment of patients resulting in overall
worse outcomes than the slight increase in suicidality risk, especially given the fact that
there were no actual suicides in the clinical trials that stimulated the warnings in the
first place. But most commentators agree that the suicidality signal in the data from the
clinical trials warrants the education and monitoring suggested in the FDA warnings.

Now, in this third podcast, we’ll focus on a recent update on this subject from the FDA.
In August, 2012 the FDA issued a document entitled, “Guidance for Industry: Suicidal
Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials.”

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This document is described as a draft guidance representing the FDA’s current thinking
on the topic and at this point contains nonbinding recommendations. As the title
suggests, the focus is identifying suicidal ideation and behaviors in subjects participating
in clinical trials, which in recent years has been required for these studies with selected
medications. The document cites two key reasons for requiring the assessments:
1) identifying clinical trial participants who might develop treatment-emergent suicidal
ideation and behavior so that they can receive appropriate evaluation and treatment,
2) so that data regarding potential suicidal ideation and behavior can be collected and
organized in a manner that will allow further assessment of the risks associated with
particular medications.
The FDA reiterated the importance of systematically and prospectively collecting data
on the presence or absence of suicidal thoughts or actions in clinical trials, rather than
relying on the process in past years when these were noted only when spontaneously
reported.

While this recent FDA Guidance document deals entirely with clinical trials, in many
ways the discussion is relevant to monitoring in clinical practice settings where ongoing
assessment for suicidality previously was recommended.

Here are some of the highlights of this 2012 document, which may continue to be
revised over time.

One of the most obvious changes is in the realm of language. They have dropped that
problematic word, suicidality, in favor of the more precise phrase, “suicidal ideation and
behavior.” This is welcome, since “suicidality” always needed further explanation.
The 2012 Guidance also clarified the categorization that the FDA required for the
ongoing assessment of suicidal ideation and behavior. This classification system includes
11 options made up of 5 suicidal ideation descriptions, 5 suicidal behavior possibilities,
and a single category of self-injurious behavior with no suicidal intent. This is the
classification system that also has been adopted by the Center for Disease Control and
Prevention.



The 5 suicidal ideation options are:
1. Passive suicidal ideation – or a wish to be dead or go to sleep and not wake up
2. Active suicidal ideation: Nonspecific - that is, with no method, intent or plan
3. Active suicidal ideation: Method, but no intent or plan. Those in this category have
contemplated how they might end their lives, but have no specific plan and may even
feel that they would never do it.
4. Active suicidal ideation: Method and intent, but no plan. Here the individual admits to
actually considering the act, but there is no specific plan to do it.
5. Active suicidal ideation: (You guessed it) Method, intent, AND plan.

The 5 suicidal behavior options are:
1. Completed suicide – self-injurious act with at least some intention to die leading to the
person’s death.
2. Suicide attempt – Here there has been a potentially self-injurious act with some intent
to die, although the act does not necessarily lead to injury.
3. Interrupted suicide – People classed here would have attempted suicide had they not
been interrupted by outside circumstances.
4. Aborted suicide – Here people, on their own, stop after initiating steps toward engaging
in self-injurious behaviors.
5. Preparatory acts toward imminent suicidal behaviors – With this category, people do
not initiate a suicide attempt, but do demonstrate actions consistent with preparing for
suicidal behavior, such as acquiring pills or a gun, or perhaps giving away possessions or
writing a suicide note.

The 11th category, self-injurious behavior without suicidal intent, is important in
distinguishing these actions where there is injury but no intent or desire to die.
In the recent Guidance on Suicidal Ideation and Behavior, the FDA stated that these
exact categories should be employed in clinical trials where the assessments are
required. These are the basic definitions and exact categories in the Columbia – Suicide
Severity Rating Scale (C-SSRS), which evolved from the Columbia – Classification
Algorithm of Suicide Assessment (C-CASA) that we reviewed in the our first podcast. The
FDA does not require that investigators use the C-SSRS instrument, but the assessments
must use the same classification system.



We’ll come back around to the C-SSRS in the final podcast when we explore practical
strategies for assessing suicide risk in clinical settings. I will note here that the C-SSRS
does incorporate probing questions to assess subjects’ thoughts and actions, and that
training in the use of the C-SSRS instrument is recommended.

Another focus of the 2012 FDA Guidance document is the burden involved in doing
initial visit and follow up assessments of suicidal ideation and behavior. The conclusion
is that it really isn’t a great burden at all. With no positive responses to the screening
questions, the C-SSRS can be completed in just one to two minutes. Even when positive
responses are present, the detailed interview almost always is completed in less than
ten minutes. Although the C-SSRS is primarily an interview assessment, it does allow
integration of data from other sources, such as family and friends, care providers,
medical records, and death certificates or medical examiner reports.

The Guidance document also states that an electronic self-report version has been
tested and would be considered an acceptable alternative – further decreasing the
burden in the screening process, and perhaps allowing the subjects greater comfort in
describing their thoughts and actions. Of course, the responses would have to be
reviewed by the investigators and appropriate steps taken when indicated.

One interesting element of the 2012 FDA Guidance supporting the C-SSRS relates to the
importance of any lifetime history of suicidal thoughts or behaviors in relation to
predicting future suicide risk. At least in clinical trials, the baseline C-SSRS rates the
lifetime occurrence of any suicidal thoughts or behaviors. Recent research has
demonstrated that this lifetime history is an especially powerful predictor of future
suicide thought and behavior risk.

Until now the FDA primarily has targeted antidepressants and antiepileptic agents for
the warnings and for strict requirements for assessments during clinical trials. The
recent FDA Guidance suggested that several other types of medications also may have
elevated risks for suicidal thoughts and behaviors, and therefore perhaps also should
incorporate the same assessments during clinical trials and perhaps may need warnings



for prescribers and patients. The Guidance notes that concerns for increased suicidal
thoughts and behaviors have been reported with reserpine, certain beta blockers,
smoking cessation drugs, some weight loss drugs, as well as isotretinoin and other
tretinoins.

This recent FDA Guidance for Industry regarding treatment emergent suicidal thoughts
and behaviors just deals with the development and administration of clinical trials. So,
how does it relate to clinical practice and the warnings of potential increased suicide risk
with selected medications, and the recommendation for education and ongoing patient
assessment? The answer is that the highly systemized and controlled and well
documented assessments in the clinical trials provide testable models so that efficient
and reliable methods can be used in clinical settings. We are being provided with
constructs for suicidal thought and behavior categories and evidence-based scales and
assessment instruments that readily can be applied in private offices, clinics, and even
online.

So, stay tuned for the 4th and final podcast in this series when we will consider practical
aspects of suicide risk screening in patients taking medications having the potential for
treatment-emergent increases in suicidal thoughts and behavior.
Thank you for joining us today.



MHEI transcript 3 screening for suicide risk

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