Innovations In Clinical Neuroscience

SEP-OCT 2014

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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Innovations in CLINICAL NEUROSCIENCE [ V O L U M E 1 1 , N U M B E R 9 – 1 0 , S E P T E M B E R – O C T O B E R 2 0 1 4 ] 26 Using the baseline eC-SSRS assessments, 73.5 percent of the psychiatric patients were classified as never experiencing suicidal i deation with intent to act or any prior suicidal behaviors, 2.3 percent were classified as experiencing ideation with intent to act but no prior behaviors, 12.7 percent reported prior suicidal behavior without ideation, and 11.5 percent reported both. As expected, these percentages of most severe lifetime ideation were significantly different than the corresponding classifications of nonpsychiatric patients, which were 95.5 percent, 0.6 percent, 2.3 percent, and 1.7 percent, respectively (chi- squared(3)=578.0, p<0.001). The numbers of patients classified as negative or positive with respect to SIB during study participation, based on prospective eC-SSRS follow-up assessments and broken out by study type, are shown in Table 1. None of the nonpsychiatric study participants reported severe ideation with an intent to act during the prospective monitoring period, but 11 reported some type of suicidal behavior. To further evaluate the extent to which lifetime SIB reported at baseline predicts prospectively reported SIB, the comparative risk associated with each level of ideational severity was examined and is presented in Table 2. Similarly, the comparative risk associated with baseline reports for each type of suicidal behavior assessed (e.g., actual suicide attempts, interrupted suicide attempts, aborted suicide attempts, preparatory behavior for making an attempt), as well as that associated with multiple lifetime behaviors are shown in Tables 3 and 4. Of the 8,837 unique subjects, 8,059 (96.1%) did NOT report nonsuicidal self-injurious behavior (NSSIB) at baseline and 328 (3.9%) did. Of the 8,059 who did not, 294 (3.6%) went on to prospectively report a suicidal behavior compared to 7,765 (96.5%) who did not. Of the 328 subjects who did report NSSIB at baseline, 24 (7.3%) subsequently reported prospective suicidal behavior, whereas 304 (92.7%) did not. The common odds ratio for prospectively reporting suicidal b ehavior during trial participation for those reporting NSSIB at baseline compared to those that did not was 2.085 (95% confidence interval [CI] 1.354–3.210), p=0.001. Of the 8,059 who did not report NSSIB as baseline, 100 (1.2%) went on to prospectively report suicidal ideation with intent to act compared to 7,959 (98.8%) who did not. Of the 328 subjects who did report NSSIB at baseline, 1 (0.3%) subsequently reported prospective suicidal ideation with intent, whereas 327 (99.7%) did not. The common odds ratio for prospectively reporting suicidal ideation with intent to act during trial participation for those reporting NSSIB at baseline compared to those that did not was 0.243 (95% CI 0.034–1.750), p=0.16. DISCUSSION Concern regarding suicide risk associated with medication prompted the United States Food and Drug Administration to draft guidance recommending prospective assessment of SIB. 1 5–17 The primary aims of the guidance were to facilitate timely recognition and management of patients experiencing suicidal ideation and behavior and to provide risk data associated with certain medications to guide clinical expectations after the medications are marketed. The eC-SSRS addresses these aims and provides clinical investigators meaningful predictive information regarding the potential for prospective reporting of SIB during study participation. Increased risk of emergent suicidal behavior associated with the medical history of psychiatric patients has been recognized for many years 18,19 and has been shown to be an important factor in prior analysis of eC-SSRS data. 20 The current study extends these findings to nonpsychiatric treatment indications and study participants. The prevalence of SIB in psychiatric patient populations is much greater than nonpsychiatric patients, but these analyses demonstrate that life- t hreatening suicidal thoughts and behaviors do occur in nonpsychiatric study participants and should be prospectively monitored to increase patient safety. Although no prospective severe suicidal ideation with intention to act was reported in the nonpsychiatric participant group, reports of lifetime ideation were present at baseline, and some of these patients reported suicidal behavior in the prospective assessments. Importantly, these analyses also show that lifetime SIB, when present in nonpsychiatric patients, does forecast risk of emergent suicidal behavior during trial participation. There is also an increase in prospective suicidal behaviors (but not ideation with intent to act) in individuals with lifetime NSSIB. The finer-grained analyses of varying severities of lifetime suicidal ideations and the specific types and number of lifetime suicidal behaviors found that each level of ideational severity and each type of suicidal behavior contributes to the likelihood of suicidal behavior being reported during subsequent trial participation. It is particularly interesting that the risk of emergent suicidal behavior— and, to a lesser degree, ideation— during trial participation rises monotonically as a function of increasing severity of lifetime suicidal ideation as well as the number of different lifetime behaviors reported. A notable feature of computer-automated clinical interviews like the eC-SSRS, aside from improved self-disclosure, is that they ensure every question is asked in a consistent manner, answered by the patient, and documented for review, referral, and analysis. The resulting assessments are available to site staff in near real-time to facilitate further evaluation of patient safety, if needed, and are easily transferred to electronic databases. Such data, stored in consistent

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