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Table 1 Baseline demographics and clinical characteristics—safety analysis set

From: PRISM II: an open-label study to assess effectiveness of dextromethorphan/quinidine for pseudobulbar affect in patients with dementia, stroke or traumatic brain injury

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)
  1. 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
  2. aOther includes American Indian, Alaskan Native, Native Hawaiian, or other Pacific Islander
  3. bPsychopharmacologic medications included anticonvulsants, antipsychotics, antidepressants, sedatives/hypnotics or anxiolytics, and benzodiazepine
  4. cIncludes benzodiazepines as sedatives/hypnotics plus clonazepam as an anticonvulsant
  5. dTypical antipsychotic use in 1.9 %, and atypical antipsychotic use in 16.6 %; categories were not mutually exclusive
  6. eThe CNS-LS scale ranges from 7 to 35, with higher scores indicating increased frequency and severity of PBA episodes
  7. fEffectiveness analysis set (n = 298)
  8. gPHQ-9 scores range from 0 to 27, with higher scores indicating increased severity of depression