Table 1.
Controlled trials of atomoxetine
| Type of Study | Duration (weeks, months) | Number of ADHD patients | Age range of patients (years) | Major findings |
|---|---|---|---|---|
| Double-blind, placebo, crossover (Spencer et al 1998) | 3-wk increments with 1-wk washout between trials | 22 | Adults | Modest response rate on the ADHD Rating Scale |
| Randomized, placebo, multisite (Michelson 2003) | 1-wk washout phase followed by 2-wk placebo phase followed by 10-wk trial | 280 | Adults | Significant reduction in CAARS scores |
| Randomized, placebo, multisite (Michelson et al 2003) | 1-wk washout phase followed by 2-wk placebo phase followed by 10-wk trial | 256 | Adults | Significant reduction in CAARS scores |
| Stratified, randomized, double-blind, placebo (2 trials) (Spencer, Heiligenstein, et al 2002) | 2-wk washout followed by 9-wk treatment phase followed by a 1-wk discontinuation phase | Combined total of 291 | At least 7 but less than 13 yrs | Significant reduction in ADHD Rating Scale scores |
| Double-blind, placebo (Michelson et al 2002) | 6 wks | 170 | 6–16 yrs | Significant improvements noted on the ADHD Rating Scale, CGI, and CPRS-short version |
| Double-blind, placebo, multisite (Michelson et al 2001) | 12- to 18-day washout phase followed by 8-wk trial | 297 | 8–18 yrs | Significant improvements noted on the ADHD Rating Scale, CGI |
| Double-blind, placebo, multisite (Kelsey et al 2004) | 8 wks | 197 | 6–12 yrs | Significant improvements noted on the ADHD Rating Scale |
| Randomized, double-blind, placebo, multi site (Michelson et al 2004) | 9 mo | 416 patients with prior + response to atomoxetine in an open study | 6–15 yrs | Relapse in 22.3% of patients on atomoxetine compared to 37.9% in patients on placebo |
| Randomized, double-blind, placebo(Newcorn et al 2005) | 8 wks | 293 patients (39% with comorbid ODD) | 8–18 yrs | Significant improvements on the ADHD Rating Scale. Improvements in ODD symptoms at higher dose of atomoxetine |
| Randomized, placebo, double-blind (Weiss et al 2005) | 7 wks | 153 | 8–12 yrs | Significant improvements on Teacher Ratings on the ADHD Rating Scale. |
| Randomized, placebo, double-blind (Sumner et al 2005) | 2 wks of placebo followed by 10-wk trial | 176 patients with a comorbid anxiety disorder | 8–17 yrs | Significant improvements on the ADHD Rating Scale, Pediatric Anxiety Rating Scale, Multidimensional Anxiety Scale for Children |
| Randomized, placebo, double-blind (Bangs et al 2005) | 9 wks | 142 patients with comorbid major depression | 12–18 yrs | Both placebo group and atomoxetine group demonstrated improvement in depression symptoms |
| Double-blind, placebo, multisite (Biederman et al 2002) | 9 wks | Subset of 52 girls extrapolated from sample of 291 | 7–13 yrs | Significant improvement noted on ADHD Rating Scale, CPRS-ADHD Index, and CGI |
| Double-blind, randomized, placebo (Kaplan et al 2004) | 9 wks | Subset of 98 patients with comorbid ODD | 7–13 yrs | Improvement in ADHD only, no improvement in ODD symptoms |
Abbreviations: ADHD, attention deficit hyperactivity disorder; CAARS, Conners’ Adult ADHD Rating Scale; CPRS, Conners’ Parent Rating Scales; ODD, oppositional defiant disorder; CGI, clinical global impression.