"Long-acting stimulants are very beneficial for children with ADHD, who otherwise have to go to the nurse's office during the school day to receive their medication. And timed-release dosage avoids having frequent peaks and valleys of medication levels, giving the patient a more stable therapeutic environment," says Joseph Biederman, MD, director of Pediatric Psychopharmacology at MGH and the study's lead author. "This medication gives us another treatment opportunity for those who cannot tolerate other stimulant drugs."
More than 500 children aged 6 to 12 who met standard diagnostic criteria for ADHD enrolled in the study at 47 sites across the country. Participants were randomly divided into four groups, and after a one-week "washout" period in which all participants received a placebo medication, three of the four groups began taking a 10 mg daily dose of the timed-release medication. The fourth group continued on placebo. After a week of 10 mg dosage, two of the three medication groups switched to a 20 mg dosage. And after another week, one group advanced to a 30 mg daily dosage. The study was double-blinded, meaning that study participants, their parents and the treating physicians did not know what dosages participants were receiving.
Throughout the four-week study period, participants received weekly evaluations from their physicians, and both parents and teachers completed weekly evaluations of the children's behavior at home and at school. In addition, the children received complete physical examinations, including standard laboratory tests, before and at the end of the study.
Based on the results of both the teachers' and parents' evalutions, which used standardized behavioral surveys, even the 10 mg dosages of the timed-release medication produced significant behavioral improvements versus placebo throughout the day and into the evening. The higher dosages produced greater improvement, with the 30 mg dosage producing the best evaluations from both teachers and parents. No major adverse side-effects were reported.
The researchers note that not only does the long-acting medication eliminate the need for in-school administration - which should reduce missed doses and avoid publicly identifying students as having ADHD - but also a steady medication effect throughout the day will avoid the emergence of symptoms when drug levels begin to drop. In addition, symptom control persists into the evening, allowing coverage of homework and other after-school activities.
"By making ADHD treatment easier, less cumbersome and more private, long-acting stimulants can help improve patient compliance, resulting in better symptom control and an improved overall outcome for patients," says Biederman, who is also a professor of psychiatry at Harvard Medical School.
Biederman's co-authors are Frank Lopez, MD, Children?s Development Center, Maitland, Fla.; Samuel Boellner, MD, Clinical Study Centers, Little Rock, Ark.; and Mark Chandler, MD, North Carolina Neuropsychiatry, Chapel Hill, N.C. The study was supported by a grant from Shire Pharmaceuticals, the manufacturer of Adderall.
The Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $300 million and major research centers in AIDS, cardiovascular research, cancer, cutaneous biology, transplantation biology and photomedicine. In 1994, the MGH joined with Brigham and Women's Hospital to form Partners HealthCare System, an integrated health care delivery system comprising the two academic medical centers, specialty and community hospitals, a network of physician groups and nonacute and home health services.