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Quality of Life Improves With Once-Daily Adderall XR for Paediatric ADHD Patients: Presented at APA

By Bruce Sylvester

SAN FRANCISCO, CA -- May 23, 2003 -- Adderall XR appears to improve symptoms of attention deficit/hyperactivity disorder (ADHD) in children, as well as significantly improving their quality of life and satisfaction, say researchers from the largest pediatric ADHD trial to date.

Paul Ambrosini, MD, professor of psychiatry at Drexel University College of Medicine in Philadelphia, Pennsylvania, United States, reported the Long-acting Adderall Community Assessment Trial (LADD.CAT) here May 22^nd at the 156^th Annual Meeting of the American Psychiatric Association.

"This study shows that this once-daily mixed-salts amphetamine medication can elicit decreasing symptoms and help children to thrive in many new ways -- in school, in sports, at home, and in the community," said Dr. Ambrosini, who was lead investigator of the study.

The investigators enrolled 2,956 children with a mean age of 9.5 years and a Diagnostic and Statistical Manual - Revision IV diagnosis of ADHD who were taking stable doses of immediate-release Adderall or any methylphenidate formulation. They conducted the prospective, open-label, 7-week study at 386 clinical sites.

The Paediatric Quality of Life Inventory (PedsQL) and satisfaction and preference questionnaires accessed tolerability of treatment.

Results show statistically significant improvement from baseline in mean PedsQL total score (mean change +6.4; P<0.0001) and PedsQL physical and psychosocial health summary scores at week 7 (mean change +4.3 and +7.6, respectively; P<0.0001).

"Satisfaction and preference results reveal significant improvement over baseline treatment regimens" after 7 weeks of Adderall XR, the researchers found.

Subjects showed statistically significant increases in their total PedsQL score (6.5%; P<0.00001), indicating that problems did not recur or almost never recurred during the study.

Adjusting for the influence of dose titration or modification, improvements were almost identical (5.8%) and also significant (P<0.00001).

Parents completed the Conners' Global Index Scale-Parent Version (CGIS-P) 8 and 12 hours after the morning daily dose of medication. This 10-item scale is sensitive to treatment response and medication effectiveness.

With total scoring ranging from 0 to 30, decreasing scores indicate a decrease in ADHD symptoms. At end point, subjects averaged 8-hour scores of 5.4 and 12-hour scores of 7.4, which were statistically significantly better than the baseline average of 10.2 (P<0.0001).

The authors concluded that Adderall XR was well tolerated and appears to be a safe and efficacious once-daily treatment for pediatric ADHD.

Between 3% and 7% of all school-aged children -- about 2 million children -- in the United States are diagnosed with ADHD, the most commonly diagnosed psychiatric disorder in children and adolescents.

Funding was provided by Shire Pharmaceutical Development Inc.


[Study title: An Open-Label Trial Of Adderall XR: Quality-Of- Life Assessments. Abstract 62]

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