The efficacy and safety of Adderall XR in the treatment of attention deficit/hyperactivity disorder and diurnal variation in responses were assessed by a multicenter, randomized, double-blind, parallel group, placebo-controlled trial at 47 sites, and reported from the Massachusetts General Hospital, Boston, MA. Patients received single-daily morning doses of placebo or Adderall 10, 20, or 30 mg for 3 weeks. In 509 children aged 6 to 12 years who completed the study, Intention-to-treat analysis of Conners Global Index Scales for Teachers and Parents revealed significant improvement in morning, afternoon, and late afternoon behavior for all active treatment groups versus placebo, significant dose-related improvements in behavior from baseline, and all doses were superior to placebo. Adverse events that occurred significantly more frequently with Adderall than placebo included anorexia, in 22% of participants, insomnia (17%), abdominal pain (12%), and emotional lability (9%). Anorexia was dose-related. The majority (69%) of adverse events were mild, 28% moderate, and 4% were severe. Nine Adderall-treated patients required withdrawal of medication because of anorexia, abdominal pain, or nausea. Laboratory values including ECG showed no significant changes. [1]
COMMENT. It is reassuring to know that the effectiveness of Adderall XR noted in clinical practice is confirmed in controlled trial.