May 21, 2003 -- Inattentive, hyperactive, and uncontrollably impulsive -- that's attention deficit hyperactivity disorder (ADHD). Literally millions fight a daily battle against it.
In recent years, drug developers have provided more options. Adderall-XR (a mixture of amphetamines) is FDA-approved for child ADHD only -- and in just one dose a day. Strattera -- the first nonstimulant ADHD treatment -- is the first and only FDA-approved drug for ADHD in adults; it's also approved for children and adolescents.
The FDA approves a drug for a specific condition -- and for certain groups of people -- after it is fully evaluated for its effectiveness and safety. However, once the drug is approved, doctors can prescribe it for any condition or person, if they feel that it would work. This usage is known as off-label prescribing.
Study results on these two drugs were presented this week at the American Psychiatric Association annual meeting held in San Francisco.
A two-year multicenter trial of Adderall XR -- involving 560 children -- found that, on average, the children had significant improvement in symptoms, control, and quality of life with continuous long-term treatment. On average, the children showed a 35% improvement in symptoms. The effects lasted for up to 12 hours after children took the pills. Children also had better scores in school functioning, peer relationships, leisure time, and home life, reports Mark Chandler, MD, a neuropsychiatrist with the University of North Carolina at Chapel Hill.
A four-week study involving 248 patients with adult ADHD showed similar results. The higher the dose of Adderall XR, the greater the degree of symptom control. In fact, the majority of the adults taking Adderall XR also showed significant improvements on a social adjustment scale, which measures functioning in social and work environments.
The effect was evident at week one, lasted the length of the study, and was effective for at least 12 hours every day, reports Richard H. Wiesler, MD, professor of psychiatry at the University of North Carolina School of Medicine at Chapel Hill.
"So many with adult ADHD have this disorder, but it's very under-diagnosed and under-treated," says Weisler. "It's very rewarding to watch adults who were marginal academically in college or high school become really good students. We saw lot of people turnaround. A lot of people really did kind of blossom. " Both Adderall studies were funded by Shire Pharmaceuticals, Adderall's maker.
Another study looked at the effects of Strattera on adults. How it works is not completely understood. It has a role in a brain chemical known as norepinephrine, maintaining the chemical's effect on regulating attention and impulsivity.
Unlike Ritalin and the other stimulant drugs, Strattera is not a controlled substance and the potential for abuse doesn't exist.
A long-term study conducted in 31 sites within the U.S. and Canada analyzed 384 adults with ADHD who took Strattera. The drug was given once or twice a day and symptoms scores as measured by adult ADHD rating scales were compared with scores of patients who took placebo.
Lead researcher Lenard A. Adler, MD, professor of clinical psychiatry and neurology at New York University School of Medicine, reports that patients showed significant improvement -- an average 44% decrease in symptom scores.
In an eight-week study involving 197 children with ADHD, once-a-day Strattera was significantly more effective than placebo in treating child ADHD symptoms, reports lead researcher Douglas Kelsey, MD, PhD, with Lilly Research Laboratories in Indianapolis. The drug took effect quickly and provided continuous symptom relief that lasted into the evening and early morning the next day, he adds. Both Strattera studies were funded by its manufacturer, Eli Lilly, which is a sponsor of WebMD.
While there are no head-to-head studies comparing Strattera with Adderall XR, the results on Strattera "are in ballpark of what you get with a stimulant," Adler tells WebMD. Since it is not a stimulant, Strattera could be an option for patients with a history of substance abuse, tic disorders, or who can't tolerate other ADHD medications, he says.
"Clearly, Adderall and Strattera are first-line options," for child ADHD and adult ADHD, says Adler.