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Once-Daily Adderall XR (SLI382) Effective in Attention Deficit/Hyperactivity Disorder
A DGReview of :"A randomized, double-blind, placebo-controlled, parallel-group study of SLI381 (Adderall XR) in children with attention-deficit/hyperactivity disorder."
Pediatrics Electronic Pages
08/21/2002
By Elda Hauschildt
A two-component, extended-release formulation, SLI381 (Adderall XR), is effective as once-daily treatment for children with attention deficit/hyperactivity disorder (ADHD).
United States researchers from Massachusetts General Hospital, in Boston, report significant improvements in afternoon assessments of ADHD children by teachers and afternoon/late afternoon assessments by parents.
"SLI381 produced consistent, dose-related improvements on all measures of efficacy," they concluded.
They randomised 584 children attending one of 47 sites to either SLI381 or placebo in a double-blind, parallel group trial. A total of 563 children aged six to 12 years were included in the intent-to-treat population, and 509 completed the study.
Patients underwent a one-week washout of any previous stimulant medication. They were then prescribed single-daily morning placebo or one of three SLI381 dosages: 10 milligrams, 20 mg or 30 mg for three weeks.
Investigators observed significant improvement in morning, afternoon and late afternoon behaviour for all three active-treatment groups versus placebo in intention-to-treat analysis of results. Assessments were based on the Conners Global Index Scale for Teachers and the Conners Global Index Score for Parents.
The researchers say children in all the active-treatment groups showed significant dose-related improvement in behaviour from baseline.
Pediatrics, 2002; 110: 258-266.
"A randomized, double-blind, placebo-controlled, parallel-group study of SLI381 (Adderall XR) in children with attention-deficit/hyperactivity disorder."
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