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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