Innovations In Clinical Neuroscience

SEP-OCT 2014

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

Issue link: http://innovationscns.epubxp.com/i/425963

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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 17 clinical trials. Respondents reported that their companies had included SIB assessments in a broad- range of psychiatric and neurologic d isorders. The most common indications, endorsed by 20 percent or more of respondents (N=81), included schizophrenia, depression, bipolar disorder, Alzheimer's disease or other dementia, anxiety, attention deficit hyperactivity disorder (ADHD), pain, and mild cognitive impairment (MCI). Eight respondents (9.9%) indicated their company had included SIB assessments in studies specific to SIB indications. Whether these eight responses reflect SIB assessment to monitor patient safety and/or as an efficacy outcome measure was not elicited by the survey (Supplemental Table 2*). In line with specific requirements in the FDA guidance, 1, 2 smoking cessation and obesity were among the non-CNS indications endorsed by the survey respondents as including SIB assessments in clinical studies. The most common non-CNS indications reported by the respondents were fibromyalgia (40.6%, 13/32) and insomnia or other sleep disorders (31.3%, 10/32) (Supplemental Table 3*). Past time periods used for SIB assessments at screening and baseline. Almost all (99%) of the respondents indicated that SIB assessments were performed at both screening and baseline visits. The most commonly endorsed look-back periods used at screening visits were lifetime (63%, 46/73 for SI; 67.1%, 49/73 for SB); one year (31.5%, 23/73 for SI; 26%, 19/73 for SB); six months (42.5%, 31/73 for SI; 24.7%, 18/73 for SB); and one month (17.8%, 13/73 for SI; 13.7%, 10/73 for SB) (Table 2). Generally, respondents indicated the use of longer look-back periods for assessment of SB compared to SI at the screening visit. The most commonly reported look-back period used at baseline visits for assessing SIB was "Other" (43.1%, 31/72) (Table 2). Among the 31 "Other" responses, 24 respondents (33.3%, 24/72) reported using the interval since the screening visit. Aside from the screening-to-baseline interval, the next most frequently reported time periods included lifetime (20.8%, 15/72 for SI; 22.2%, 16/72 for SB), one year (20.8%, 15/72 for SI; 19.4%, 14/72 for SB), one month (18.1%, 13/72 for both SI and SB), six months (11.1%, 8/72 for both SI and SB), and two weeks (11.1%, 8/72 for SI; 9.7%, 7/72 for SB). Survey respondents were also asked to indicate what past time TABLE 2. Past time periods used at screening and baseline for SIB assessment* TIME PERIODS SUICIDAL IDEATION SUICIDAL BEHAVIOR Screening visit (N=73 respondents) N % N % Lifetime 46 63 49 67.1 10 years 2 2.7 4 5.5 5 years 4 5.5 6 8.2 1 year 23 31.5 19 26 6 months 31 42.5 18 24.7 1 month 13 17.8 10 13.7 2 weeks 4 5.5 3 4.1 1 week 6 8.2 5 6.8 Other (SI and SB together)** 13 17.8 Baseline visit (N=72 respondents) N % N % Lifetime 15 20.8 16 22.2 10 years 2 2.8 2 2.8 5 years 3 4.2 3 4.2 1 year 15 20.8 14 19.4 6 months 8 11.1 8 11.1 1 month 13 18.1 13 18.1 2 weeks 8 11.1 7 9.7 1 week 9 12.5 9 12.5 Other (SI and SB together) 31 43.1 Since last visit 24 33.3 *Respondents were instructed to select all that apply. **Other text comments for Screening included: 15 years (1), 2 years (5), 2 months (1), varies depending on indication and study population (2), unsure (2), and since last visit (1). SIB: suicidal ideation and behavior

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