Table 2.
P Value |
|||||||
---|---|---|---|---|---|---|---|
Scale | Placebo (n = 43) | 60 mg (n = 40) | 80 mg (n = 43) | Placebo vs 60 and 80 mg | Placebo vs 60 mg | Placebo vs 80 mg | 60 vs 80 mg |
AISRS | |||||||
Score at last wk, mean (SD)b | 25.78 (13.94)c | 15.34 (12.93)d | 20.61 (14.22)c | ||||
Last wk vs wk 0 | |||||||
≥30% Reduction, No. (%) | 17 (39.5) | 30 (75.0) | 25 (58.1) | .003 | <001 | .07 | .09 |
Score change, mean (SD)e | 8.59 (12.24)c | 20.53 (13.18)d | 15.63 (10.93)c | <001 | <001 | .01 | .04 |
CGI psychopathology subscale for ADHD, last wk vs wk 0 | |||||||
Improvement, with score of ≤2, No. (%) | 5 (11.6) | 16 (40.0) | 15 (34.9) | .002 | .003 | .006 | .86 |
Score change, mean (SD)e | 0.80 (1.23)c | 1.66 (1.17)d | 1.24 (1.11)c | .001 | <.001 | .03 | .20 |
CAARS observer T-score, mean (SD) | |||||||
Total | |||||||
Score at last wk | 63.23 (15.77)f | 55.03 (15.56)g | 57.62 (14.70)h | ||||
Score change at last wk vs wk 0e | 5.01 (12.84)f | 19.64 (16.33)g | 12.79 (13.53)h | <001 | <001 | .02 | .07 |
Hyperactive | |||||||
Score at last wk | 62.73 (17.12)f | 55.54 (16.83)g | 57.90 (13.42)h | ||||
Score change at last wk vs wk 0e | 5.42 (14.92)f | 17.58 (14.71)g | 11.26 (12.47)h | .002 | <001 | .06 | .08 |
Inattentive | |||||||
Score at last wk | 60.65 (14.21)f | 53.11 (13.04)g | 55.28 (14.44)h | ||||
Score change at last wk vs wk 0e | 4.03 (11.66)f | 17.75 (16.19)g | 12.18 (14.05)h | <001 | <001 | .02 | .15 |
Abbreviations: ADHD, attention-deficit/hyperactivity disorder; AISRS, Adult ADHD Investigator Symptom Rating Scale; CAARS, Conners' Adult ADHD Rating Scale; CGI, Clinical Global Impression.
The doses of 60 mg and 80 mg indicate the doses of extended-release mixed amphetamine salts per day. Statistical tests are adjusted for baseline cocaine use and for the week 0 measure of the ADHD scale (see Methods for details). Week 0 summaries are shown in Table 1.
The mean (SD) last weeks with nonmissing AISRS scores were the following: 9.49 (3.92) weeks for placebo, 10.18 (3.48) for 60-mg extended-release mixed amphetamine salts, and 10.47 (3.25) weeks for 80-mg extended-release mixed amphetamine salts.
Based on n = 41 owing to missing data.
Based on n = 38 owing to missing data.
Calculated as the value at week 0minus the value at the last week.
Based on n = 40 owing to missing data.
Based on n = 37 owing to missing data.
Based on n = 39 owing to missing data.