Table 4.
Change in safety variables from randomization using completers only.
| Outcome | N | Placebo Δ [mean (SD)] | Topiramate Δ [mean (SD)] | Mean Difference [Topiramate-Placebo] (95% CI) | P-value |
|---|---|---|---|---|---|
| CANTAB | |||||
| Standard PAL | 21 | −0.24 (0.23) | 0.04 (0.60) | 0.26 (−0.16, 0.69) | 0.238 |
| Standard PAL Shapes | 21 | −0.24 (0.53) | 0.11 (1.62) | 0.07 (−0.74, 0.88) | 0.863 |
| Standard PRM | 21 | 0.24 (0.80) | −0.64 (2.00) | −0.70 (−2.13, 0.73) | 0.348 |
| Standard SSP | 19 | 0.11 (0.79) | 0.36 (1.21) | 0.16 (−0.80, 1.11) | 0.750 |
|
CPT-II | |||||
| Omissions % | 20 | −0.09 (18.09) | 0.34 (4.62) | −3.81 (−13.72, 6.09) | 0.461 |
| Commissions % | 20 | 2.20 (7.29) | 1.55 (11.04) | −0.30 (−8.01, 7.42) | 0.941 |
| Hit Reaction Time | 20 | 6.37 (10.38) | −2.67 (7.44) | −11.13 (−18.32, −3.93) | 0.008 |
|
BRIEF-SR | |||||
| BRI T-score | 15 | 1.17 (10.96) | −1.00 (8.80) | −1.97 (−10.57, 6.62) | 0.661 |
| MI T-score | 14 | 0.33 (13.38) | 0.00 (5.32) | −0.64 (−10.50, 9.21) | 0.900 |
| GEC T-score | 14 | 1.00 (12.81) | −1.00 (7.52) | −2.02 (−11.74, 7.71) | 0.692 |
PAL, Paired Associates Learning; PRM, Pattern Recognition Memory; SSP, Spatial Span; BRI, Behavior Regulation Index; MI, Metacognition Index; GEC, Global Executive Composite