Table 2.
Score | Treatment | Nicotine non-users |
Treatment | Nicotine users |
||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Number | LS mean | Difference to placebo |
Number | LS mean | Difference to placebo |
|||||||
LS mean | 95 %CI | P value | LS mean | 95 %CI | P value | |||||||
CAARS-INVa, DSM-IV total score | Placebo | 40 | 29.0 | Placebo | 17 | 29.4 | ||||||
80 mg tid | 26 | 29.1 | 0.09 | −3.26, 3.44 | 0.80 | 80 mg tid | 18 | 32.7 | 3.37 | −2.36, 9.11 | 0.97 | |
80 mg qd | 26 | 27.8 | −1.28 | −4.65, 2.10 | 0.39 | 80 mg qd | 20 | 31.6 | 2.19 | −3.49, 7.87 | 0.91 | |
10 mg tid | 26 | 28.5 | −0.51 | −3.89, 2.87 | 0.64 | |||||||
DSM-IV inattention score | Placebo | 40 | 16.7 | Placebo | 17 | 15.6 | ||||||
80 mg tid | 26 | 17.0 | 0.25 | −1.95, 2.45 | 0.99 | 80 mg tid | 18 | 18.3 | 2.70 | −0.66, 6.05 | 0.13 | |
80 mg qd | 26 | 16.4 | −0.36 | −2.57, 1.84 | 0.97 | 80 mg qd | 20 | 17.4 | 1.80 | −1.51, 5.11 | 0.37 | |
10 mg tid | 26 | 16.6 | −0.19 | −2.39, 2.01 | 0.99 | |||||||
DSM-IV hyperactivity–impulsivity score | Placebo | 40 | 12.4 | Placebo | 17 | 13.9 | ||||||
80 mg tid | 26 | 12.5 | 0.13 | −1.67, 1.94 | 1.00 | 80 mg tid | 18 | 14.8 | 0.84 | −2.09, 3.76 | 0.75 | |
80 mg qd | 26 | 11.5 | −0.87 | −2.69, 0.95 | 0.55 | 80m qd | 20 | 14.5 | 0.64 | −2.27, 3.54 | 0.84 | |
10 mg tid | 26 | 12.4 | −0.04 | −1.86, 1.78 | 1.00 | |||||||
ADHD Index | Placebo | 40 | 16.2 | Placebo | 17 | 17.4 | ||||||
80 mg tid | 26 | 16.2 | −0.02 | −2.14, 2.10 | 1.00 | 80 mg tid | 18 | 19.9 | 2.51 | −0.77, 5.80 | 0.16 | |
80 mg qd | 26 | 16.2 | −0.02 | −2.16, 2.11 | 1.00 | 80 mg qd | 20 | 19.9 | 2.54 | −0.72, 5.80 | 0.15 | |
10 mg tid | 26 | 16.7 | 0.54 | −1.59, 2.67 | 0.89 | |||||||
Clinical Global Impression (CGI) Severity of illness score | Placebo | 40 | 4.1 | Placebo | 17 | 4.1 | ||||||
80 mg tid | 26 | 4.2 | 0.13 | −0.21, 0.49 | 0.68 | 80 mg tid | 18 | 4.2 | 0.06 | −0.44, 0.56 | 0.95 | |
80 mg qd | 26 | 4.1 | 0.05 | −0.30, 0.39 | 0.98 | 80 mg qd | 20 | 4.4 | 0.29 | −0.21, 0.78 | 0.32 | |
10 mg tid | 26 | 4.2 | 0.11 | −0.24, 0.46 | 0.82 |
Note that one-sided test of superiority was used for the primary endpoint CAARS-INV, DSM-IV Total score
CI confidence interval, qd once daily, tid three times daily, LS least squares
Investigator-rated