Table 2.
Effects of transdermal nicotine versus placebo on efficacy and tolerability measures. S.D., standard deviation; CFB, change from baseline; SRS, Social Responsiveness Scale.
| Measure | Placebo | Nicotine | p-value1 | Effect size (dz)2 |
|---|---|---|---|---|
| ABC-Irritability mean (S.D.) CFB | −7 (8) | −12 (3) | 0.44 | 0.49 |
| ABC-Lethargy/Social withdrawal mean (S.D.) CFB | −7 (4) | −2 (3) | 0.13 | −0.94 |
| ABC-Stereotypic behavior mean (S.D.) CFB | −4 (4) | −2 (3) | 0.50 | −0.44 |
| ABC-Hyperactivity mean (S.D.) CFB | −6 (6) | −7 (6) | 1.0 | 0.12 |
| ABC-Inappropriate speech mean (S.D.) CFB | 0.2 (0.8) | −1 (2) | 0.25 | 0.67 |
| Global aggressive behavior improvement3 | 2 (33%) | 4 (67%) | 0.69 | N/A |
| SRS-2 mean (S.D.) CFB | −15 (23) | −1 (25) | 0.38 | −0.56 |
| Nightly sleep quality | 9 (2) | 10 (0.2) | 0.13 | 0.88 |
1
Calculated using two-tailed Wilcoxon signed-rank test except for global impression of aggressive behavior, which was calculated using binomial test.
2
Improvement with drug is positive effect size, improvement with placebo is negative effect size.
3
One subject was included in this category but not in ABC or SRS-2 categories because of accuracy concerns in rating scale completion (see methods).