After these adolescent patients completed a four-week placebo-controlled trial with ADDERALL XR, they entered into a six-month open-label extension study. Analysis of the four-week data revealed that ADDERALL XR, compared with placebo, produces statistically and clinically significant improvements in core ADHD symptoms in adolescents. Both ADDERALL XR-nave adolescents as well as those who previously received ADDERALL XR showed continued symptomatic improvement during long-term ADDERALL XR treatment. ADDERALL XR was also found to be a well-tolerated once-daily treatment for the management of ADHD in adolescents.
Investigators measured adolescent patients' symptoms using two efficacy measures. The primary measure was the clinician-administered ADHD Rating Scale-IV (ADHD-RS) measured at baseline, weekly (short-term) and monthly (long-term) intervals. The ADHD-RS assesses the 18 individual items related to ADHD that are listed within in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TRTM). Nine of these items assess inattentive symptoms and the other nine items assess hyperactive and impulsive symptoms. Sample rating categories include "avoids tasks that require sustained mental effort" and "talks excessively."
The initial 4-week study was divided into primary and secondary cohorts. The primary cohort was comprised of adolescents weighing over or equal to 165 lb who met DSM-IV- TRTM ADHD criteria for ADHD. Subjects received randomized doses of ADDERALL XR or placebo once daily for four weeks
Contact: Marion E. Glick