Table 1. Demographic data and neuropsychiatric profiles (full analysis set).
| Group 1 (bupropion/placebo)b | Group 2 (placebo/bupropion)b | ||
|---|---|---|---|
| Number of participantsa | 20 | 20 | |
| Age, years (mean ± SD)c | 54.6 ± 8.5 | 54.3 ± 10.7 | |
| Males (number) | 11 | 15 | |
| Weight, kg (mean ± SD) | 78.4 ± 14.4 | 80.7 ± 18.7 | |
| BMI (mean ± SD) | 25.1 ± 3.2 | 26.5 ± 5.2 | |
| CAG repeats (mean ± SD) | 43.6 ± 2.3 | 43.9 ± 3.7 | |
| Duration of disease (years) | 8.4 ± 3.6 | 5.5 ± 2.4d | p<0.05 |
| Concomitant medication with tiapride | 11 | 11 | |
| UHDRS-Motor (mean ± SD) | 39.3 ± 12.3 | 34.1 ± 12.6e | |
| TFC (mean ± SD) | 7.40 ± 2.7 | 8.8 ± 3.5 | |
| Apathy | |||
| AES-I (mean ± SD) | 36.4 ± 7.9 | 34.2 ± 7.7 | |
| AES-S (mean ± SD) | 29.3 ± 4 | 22.7 ± 8.6e, * | |
| AES-C (mean ± SD) | 36.0 ± 6.9 | 32.6 ± 7.9e, * | |
| NPI-Apathy (mean ± SD) | 8.8 ± 2.1 | 8.7 ± 2.1 | |
| UHDRS-Apathy (mean ± SD) | 10 ± 2 | 9.4 ± 3 | |
| Depression/irritability | |||
| NPI-Depression (mean ± SD) | 0.7 ± 1.1 | 0.8 ± 1 | |
| HADS-Depression (mean ± SD) | 9.7 ± 4.6e | 8.2 ± 4.1 | |
| NPI-Irritability (mean ± SD) | 1.5 ± 1.9 | 2.2 ± 2.1 | |
| SIS (mean ± SD) | 5.1 ± 3.1e | 6.1 ± 4.1 | |
| Cognition | |||
| Stroop interference (mean ± SD) | 22.1 ± 9 | 20.5 ± 10.6 | |
| SDMT (mean ± SD) | 19.5 ± 8.6 | 22.1 ± 12 | |
| VFT (mean ± SD) | 17.3 ± 12.2 | 22.3 ± 14.0 | |
| MMSE (mean ± SD) | 26.9 ± 2.7 | 26.4 ± 3 | |
| Distress caregiver | |||
| NPI-D (apathy) (mean ± SD) | 3.3 ± 1.0 | 3.5 ± 1.0 | |
* AES-S vs. AES-I: t (df = 38) = -6.0504, p< 0.001, AES-S vs. AES-C: t (df = 38) = -5.6101, p-value = <0.001
aN includes all randomized patients
bPatients were allocated to group1 (1st treatment episode: bupropion, followed by washout and crossover, followed by 2nd treatment episode: placebo) or group 2 (1st treatment episode: placebo, followed by washout and crossover, followed by 2nd treatment episode: bupropion).
cValues are given as mean ± SD (standard deviation)
dn = 18 (2 missing values)
en = 19 (1 missing value)
Abbreviations: BMI = Body mass index; UHDRS = Unified Huntington’s Disease Rating Scale; TFC = Total Functional Capacity; AES-I = Apathy Evaluation Scale-informant (a friend or family member familiar with the daily activities of the subject); AES-S = AES-self; AES-C = AES-clinician; NPI = Neuropsychiatric Inventory; HADS = Hospital Anxiety and Depression Scale; SIS = Snaith Irritability Scale; SDMT = Symbol Digit Modalities Test; VFT = Verbal Fluency Test; MMSE = Mini Mental State Examination