The results showed that Concerta achieved a significantly superior reduction in adult ADHD investigator symptom rating scale (AISRS) total score compared to placebo (p=0.012) (mean change was -10.6 +/-1.09 for the Concerta group versus -6.8 +/-1.06 for the placebo group).
In addition, Concerta was significantly superior compared to placebo for the key secondary efficacy variables: change in clinical global impression-improvement (CGI-I) rating (p=0.008); change in Conners’ Adult ADHD Rating Scale-Self Report (CAARS-S:S) total score (p=0.029); and change in percent of subjects meeting pre-defined Responder criteria (p=0.009).
Adverse events were reported by 93 (84.5%) patients in the Concerta group compared with 74 (63.8%) in the placebo group. Interim results show that Concerta was well tolerated in an adult population with ADHD in a dose range from 36mg to 108mg per day for up to six months.