Table 1.
Baseline demographics and clinical characteristics—safety analysis set
| Characteristic | (N = 367) |
|---|---|
| Age, mean (SD), y | 59.4 (16.5) |
| Age category, n (%) | |
| ≥ 65 years | 152 (41.4) |
| ≥ 75 years | 75 (20.4) |
| Gender, n (%) | |
| Male | 165 (45.0) |
| Female | 202 (55.0) |
| Race, n (%) | |
| White/Caucasian | 304 (82.8) |
| Black/African American | 50 (13.6) |
| Asian | 3 (0.8) |
| Othera | 4 (1.1) |
| Unknown | 6 (1.6) |
| Ethnicity, n (%) | |
| Hispanic/Latino | 71 (19.4) |
| Presence of a caregiver, n (%) | 166 (45.2) |
| Place of Residence, n (%) | |
| Home | 303 (82.6) |
| Assisted living | 35 (9.5) |
| Skilled nursing facility | 29 (7.9) |
| Primary diagnosis, n (%) | |
| Dementia | 134 (36.5) |
| Stroke | 113 (30.8) |
| TBI | 120 (32.7) |
| Concomitant medications at baseline (total no. of medications) | |
| Mean | 7.7 |
| Median (min, max) | 7.0 (0, 27) |
| Psychopharmacologic medication use,b n (%) | 260 (70.8) |
| Any antidepressant | 178 (48.5) |
| SSRIs | 103 (28.1) |
| Other | 83 (22.6) |
| Non-selective (tricyclic) | 14 (3.8) |
| Sedative/hypnotics/anxiolytics | 124 (33.8) |
| Any benzodiazepinec | 109 (29.7) |
| Antipsychoticsd | 66 (18.0) |
| Anticonvulsants | 92 (25.1) |
| CNS-LS scoree,f | |
| Mean (SD) | 20.5 (4.4) |
| Median (min, max) | 20 (13, 34) |
| PBA episode count (over 7 days prior to baseline)f | |
| Mean (SD) | 21.4 (25.0) |
| Median (min, max) | 12 (0, 240) |
| MMSE score, mean (SD)f | 23.9 (5.9) |
| QOL-VAS, mean (SD) | 5.9 (2.6) |
| PHQ-9,g mean (SD) | 13.5 (5.9) |
CNS-LS Center for neurologic study-lability scale, MMSE mini-mental state examination, PBA pseudobulbar affect, PHQ-9 patient health questionnaire-9, QOL-VAS quality-of-life visual analog scale, SD standard deviation, SSRI selective serotonin reuptake inhibitor
aOther includes American Indian, Alaskan Native, Native Hawaiian, or other Pacific Islander
bPsychopharmacologic medications included anticonvulsants, antipsychotics, antidepressants, sedatives/hypnotics or anxiolytics, and benzodiazepine
cIncludes benzodiazepines as sedatives/hypnotics plus clonazepam as an anticonvulsant
dTypical antipsychotic use in 1.9 %, and atypical antipsychotic use in 16.6 %; categories were not mutually exclusive
eThe CNS-LS scale ranges from 7 to 35, with higher scores indicating increased frequency and severity of PBA episodes
fEffectiveness analysis set (n = 298)
gPHQ-9 scores range from 0 to 27, with higher scores indicating increased severity of depression