Table 2.
Characteristics of all 28 patients before and during treatment. Means and (SD) reported. For CGI, Wash-out rather than Baseline reported
| Outcomes | Baseline | Washout | Treatment (Tolcapone) |
Placebo |
p-value for difference between tolcapone and placebo |
|---|---|---|---|---|---|
| CGI | |||||
| CGI Total | — | 4.23 (0.59) | 3.75 (0.65) | 4.14 (0.76) | 0.078 |
| NPI-Q | |||||
| NPI-Q Total | 9.14 (4.76) | 9.46 (4.88) | 8.21 (4.50) | 8.68 (4.83) | 0.211 |
| Delusions | 0.11 (0.31) | 0.07 (0.26) | 0.11 (0.32) | 0.07 (0.26) | 0.326 |
| Hallucinations | 0.00 (0) | 0.00 (0) | 0.00 (0) | 0.00 (0) | >0.999 |
| Agitation | 0.71 (0.81) | 0.71 (0.90) | 0.61 (0.83) | 0.75 (0.89) | 0.443 |
| Depression | 0.75 (0.97) | 0.79 (0.92) | 0.46 (0.79) | 0.68 (1.09) | 0.110 |
| Anxiety | 0.96 (0.96) | 1.14 (1.04) | 0.79 (0.83) | 0.93 (0.98) | 0.355 |
| Euphoria | 0.18 (0.67) | 0.21 (0.57) | 0.14 (0.53) | 0.14 (0.53) | >0.999 |
| Apathy | 1.79 (0.99) | 1.78 (1.10) | 1.89 (0.99) | 1.61 (1.07) | 0.090 |
| Disinhibition | 1.00 (1.05) | 1.14 (1.01) | 0.86 (0.93) | 0.86 (0.97) | >0.999 |
| Irritability | 0.68 (0.77) | 0.68 (0.77) | 0.61 (0.74) | 0.79 (0.88) | 0.057 |
| Motor Behavior | 1.07 (1.15) | 1.14 (1.18) | 1.07 (0.98) | 1.07 (1.12) | >0.999 |
| Nighttime behaviors | 0.57 (0.92) | 0.54 (0.92) | 0.43 (0.84) | 0.57 (0.92) | 0.460 |
| Appetite and Eating | 1.32 (1.30) | 1.25 (1.27) | 1.29 (1.21) | 1.21 (1.29) | 0.537 |
| RBANS | |||||
| Total | 62.68 (14.96) | 67.57 (19.63) | 66.57 (18.32) | 67.89 (17.66) | 0.250 |
| Working memory | 61.75 (20.79) | 67.07 (25.25) | 67.11 (24.11) | 64.32 (22.55) | 0.164 |
| VS | 79.07 (18.10) | 84.00 (20.99) | 82.46 (23.55) | 82.82 (23.34) | 0.872 |
| Language | 67.25 (19.80) | 68.89 (19.95) | 74.18 (20.74) | 71.46 (18.89) | 0.084 |
| Attention | 70.82 (15.77) | 73.79 (18.05) | 75.61 (18.85) | 74.50 (19.31) | 0.487 |
| Delayed memory | 64.43 (22.10) | 69.93 (26.18) | 68.71 (24.29) | 67.75 (25.32) | 0.515 |
| NBACK | |||||
| 0-back accuracy (percentage correct) | 0.747 (0.280) | – | 0.831 (0.242) | 0.834 (0.196) | 0.948 |
| 1-back accuracy (percentage correct) | 0.351 (0.248) | – | 0.391 (0.303) | 0.380 (0.274) | 0.436 |
| 0-back reaction time (ms) | 9141 (2225) | 8322 (1940) | 7935 (2563) | 0.8624 | |
| 1-back reaction time (ms) | 7863 (2323) | 8226 (2842) | 7060 (2475) | 0.2011 |
CGI, Clinical Global Impressions scale; NPI-Q, Neuropsychiatric Inventory-Questionnaire; RBANS, Repeatable Battery for the Assessment of Neuropsychological Status; VS, visuospatial. Note: Total means a summary score for the particular scale. For RBANS, sub-scale scores were the totals of 2 items for working memory, 2 items for VS, 2 items for language, 2 for attention, and 4 for delayed memory. For NPI-Q, sub-scales scores were taken from a single item score for each domain. p-value was calculated using a t-test. There were no significant differences in any of the measures examined between baseline and washout.