Innovations In Clinical Neuroscience

SEP-OCT 2014

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

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Page 17 of 201

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 ] 18 periods were used at the screening visit to determine if the subject is at risk of suicide and should be excluded from the study. The most commonly endorsed past time periods for subject exclusion were one year (33.8%, 22/65 for SI; 32.3%, 21/65 for SB), six months (26.2%, 17/65 for SI; 23.1%, 15/65 for SB), lifetime (21.5%, 14/65 for SI; 29.2%, 19/65 for SB), and one month (15.4%, 10/65 for SI; 13.8%, 9/65 for SB). Seventeen respondents (26.2%, 17/65 of the total) endorsed the "Other" option. In free-text comments, time periods of two years (5), three months (2), and two months (1) were noted, and four respondents indicated that the time period varied by study design and/or treatment indication. SIB assessment instruments used by the companies. The most commonly used SIB instrument was the C-SSRS. 4,5 About 95 percent of respondents indicated their company used the C-SSRS for screening (64/76) and baseline (63/67) a ssessment of SIB, as well as for tracking the emergence of SIB during the course of clinical trials. About 18 percent (12/67) of respondents indicated their company had used the interactive voice response (IVR) version of the C-SSRS (the eC- SSRS). 6, 7 Additional instruments used included the Sheehan Suicide Severity Tracking Scale (S-STS) 8 (about 20%, 14/67)) and the InterSept Scale for Suicide Thinking (ISST) 9 (about 10%, 7/67). Twenty- two percent (15/67), 10.4 percent (7/67), and 9.0 percent (6/67) of respondents reported their company had used the Suicidality Module of the Mini Neuropsychiatric Interview 1 0 for screening, baseline, and post- baseline assessments, respectively. Of note, about a fourth of respondents reported using the single suicide item of the Hamilton Rating Scale for Depression (HAM-D) 11 and a third reported using the suicide item of the Montgomery–Åsberg Depression Rating Scale (MADRS) 12 for screening/baseline SIB assessment; they also reported using these single-item ratings to track SIB emergence during clinical trials. A smaller percentage of respondents (≤10%) reported having used the suicide item of the Patient Health Questionnaire (PHQ-9), 13 the Inventory for Depressive Symptomatology (IDS)/Quick Inventory of Depressive Symptomatology (QIDS), 14 and/or the Children's Depression Rating Scale (CDRS). 15 About 60 percent (39/67) of respondents reported their company had used more than one SIB assessment instrument (ranging from 2 to >5). Due to the wording of the survey question, it is not possible to tell if these responses refer to current or past practices of the companies. SIB instruments used in special populations. The use of TABLE 3. Challenges encountered in implementing SIB assessments in clinical trials (N=57 respondents) CHALLENGES N % Cross-cultural differences in acceptance of SIB assessments 2 3 4 0.4 Site difficulty in obtaining adequate baseline history 21 36.8 Translations of SIB rating instruments into relevant language 20 35.1 Investigator/rater discomfort with asking about SIB 18 31.6 Inadequate training of raters to administer SIB ratings 17 29.8 SIB assessment instrument version control 16 28.1 Having to exclude or discontinue people when they report SIB 14 24.6 Site not prepared to handle suicidal patients 11 19.3 Investigator/rater discomfort with managing SIB 10 17.5 Site difficulties referring patients who report SIB for mental health evaluations 10 17.5 Failure of sites to respond to positive reports of SIB by study subjects (ie, continuing subject in the study when subject should have been excluded) 8 14 Patient resistance to responding to questions about SIB 7 12.3 *Respondents were instructed to select al that apply. SIB: suicidal ideation and behavior

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