Table 4.
Seizures | Program (n = 83) | Control (n = 22) | Study arm comparison | Full cohort (n = 105) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n | % | 95% CI | n | % | 95% CI | RR (95% CI) | P-value* | n | % | 95% CI | RR (95% CI) | P-value** | |
Recent | 0.52 (0.29–0.95) | 0.03 | 0.33 (0.24–0.45) | < 0.0001 | |||||||||
Baseline | 68 | 82 | (72–90) | 20 | 91 | (71–99) | 88 | 84 | (75–90) | ||||
end point | 19 | 23 | (14–33) | 10 | 45 | (24–68) | 29 | 28 | (19–37) |
HAM-D | Mean | SD | Mean | SD | Effect size F, partial eta2 |
P-value*** | Mean | SD | Effect size Z, r |
P-value**** | ||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | 10.9 | 6.2 | 10.0 | 6.4 | 1.62, 0.02 | 0.21 | 10.7 | 6.2 | 7.43, 0.73 | > 0.0001 | ||
end point | 4.5 | 3.3 | 5.6 | 5.7 | 4.8 | 3.9 | ||||||
Δ score | − 6.4 | 6.2 | − 4.4 | 6.2 | − 5.9 | 6.3 |
HAM-D Hamilton Depression Scale, CI confidence interval
* Wald test statistic p-value from logistic regression model comparing Program to Control outcomes, adjusted for seizure at baseline
** McNemar’s Exact χ2 test for binomial paired data: comparing baseline to end point proportion of clinical outcome (i.e., recent attack) for the full cohort
*** P-value taken from ANCOVA (analysis of covariance) for each scale comparing program vs. control scores at end point, adjusted for baseline score
**** P-value from Wilcoxon Signed-Rank Test comparing baseline to end point scores (full cohort)