Innovations In Clinical Neuroscience

SEP-OCT 2014

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

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[ 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 ] Innovations in CLINICAL NEUROSCIENCE 19 SIB assessments in pediatric populations was not uncommon: 38.1 percent (24/63) and 44.4 percent (28/63) of respondents reported t heir company had obtained SIB assessments in children younger than 12 years of age and in adolescents aged 12 to 17 years, respectively. The most commonly used instruments in children under the age of 12 years were the pediatric version of the C-SSRS 1 6 (41.7%, 10/24), the adolescent/adult version of the C-SSRS (37.5%, 9/24), the suicide ideation item of the CDRS 15 (33.3%, 8/24), and the suicidality module of the Mini-Kid Neuropsychiatric Interview (16.7%, 4/24). 10 In free-text comments, two respondents indicated their company had used the IVR version of the C- SSRS in clinical studies of children under 12 years of age, with parents/caregivers answering the eC- SSRS questions for younger children. One respondent reported having used the Reynolds Suicidal Ideation Questionnaire. 17 The C-SSRS was also the most commonly used instrument in adolescents 12 to 17 years of age, with 56.7 percent (17/30) of respondents reporting use of the adolescent/adult version of the C- SSRS and 33.3 percent (10/30) reporting use of the pediatric version of the C-SSRS. Two respondents also reported use of the IVR version of the C-SSRS in adolescent clinical trials. The survey respondents reported only limited use of other instruments in this age group (e.g., only 10% (3/30) reported use of the S-STS or the Suicidality Module of the Mini), and a small number of respondents reported their companies had employed the single suicide items of the HAM-D, MADRS, PHQ-9, or CDRS. Respondents were also asked if their company had included SIB assessments in clinical trials of patients with cognitive impairment. Forty-one of 69 respondents answered affirmatively, and reported that the most commonly used instrument was the C-SSRS (18 respondents); use of the pediatric version of the C-SSRS and the S-STS was reported by seven and four r espondents, respectively. Thirty- four of these 41 respondents also reported that their company had included SIB assessments in clinical trials of either Alzheimer's disease or dementia (N=27), MCI (N=15), autism (N=9), or Down's syndrome (N=1). Management of subjects reporting active SIB in clinical trials. The majority of respondents (52.5%, 31/59) who answered the question indicated that subjects who reported active SIB during the course of a clinical study were either kept in the study and referred to a mental health clinician for a risk assessment to determine if it was safe for the subject to continue in the study, or were discontinued from the study and referred to a mental health expert for evaluation (44.1%, 26/59). No one reported that subjects were continued in the study without further assessment; two respondents to this question indicated that subjects were discontinued from the study without a specific referral for further evaluation. A substantial minority of respondents reported (Table 3) they had experienced challenges with study sites not being prepared to handle suicidal patients (19.3%, 11/57) and site difficulties in referring patients who are actively suicidal for mental health evaluations (17.5%, 10/57). Other sources of data used in SIB assessments. The use of sources of data in addition to direct assessment of patients in clinical trials was reported by the majority (88%, 52/59) of respondents, who answered the question, with 67.8 percent (40/59) of respondents reporting more than one additional source of data had been used. Only 12 percent indicated no external sources of SIB data were sought beyond direct SIB assessments. Other sources of SIB data used in assessing suicidal risk of patients in clinical trials included information provided by the patient's family (72.9%, 43/59), the referring p hysician or medical care provider (64.4%, 38/59), assisted living or nursing home staff (30.5%, 18/59), and other informants, such as friends or neighbors (18.6%, 11/59). More than half of the respondents (52.5%, 31/59) also indicated that medical, psychiatric, and coroner records had been used. Approach to the statistical analysis of SIB data. Among the respondents who answered the question, about half (51.5%, 34/ 66) reported their company prepared separate study-level summaries each of SI and SB data, and about a third (30.3%, 20/66) reported their company summarized study-level SI and SB data together. A small fraction (10.6%, 7/66) indicated their company did not have a standard approach for summarizing study- level data. About 40 percent (27/66) of respondents reported that, in addition to prospective assessment of SIB, their company also performed retrospective, post-hoc analyses of potential suicide-related adverse events using computerized searches of verbatim adverse event reports and submission of narratives for external adjudication. The survey did not clarify whether companies were performing post-hoc, retrospective analyses of data from studies that also included prospective assessments of SIB. Implementation challenges. As shown in Table 3, top challenges (identified by at least 20% of the 57 respondents to this item) for implementing SIB assessments in clinical trials included cross-cultural differences in acceptance of SIB assessments (40.4%, 23/57); site difficulty in obtaining adequate baseline history ( 36.8%, 21/57); translation of SIB assessments to relevant languages (35.1%, 20/57); investigator/rater discomfort asking about SIB (31.6%, 18/57); inadequate rater training to administer SIB

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