By McCann, Jean
Drug Topics , Vol. 146, No. 12
The American Academy of Pediatrics has now officially classified attention deficit hyperactivity disorder (ADHD) as a chronic disease. Thus, much attention is being paid to treating the condition with drugs that are safe and effective over the long term.
ADHD is but one of several mental disorders increasingly being treated with drugs rather than just talk therapy. New findings about the drug treatments for anxiety, depression, bipolar disorder, schizophrenia, and other less-common mental disorders also occupied psychiatrists as they met recently in Philadelphia for the annual meeting of the American Psychiatric Association (APA). Below are reports on what's new.
This combination of inattention plus hyperactivity and impulsivity is seen in an estimated 3% to 5% of schoolchildren-mostly boys-and in some cases continuing into adulthood. For many years, methylphenidate has been the standard therapy. Now there are new extended-release formulations of the drug that appear to improve compliance, without serious side effects.
Timothy Wilens, M.D., associate professor of psychiatry at Harvard Medical School, studied 240 children aged six through 13 in a multicenter, open-label trial of once-daily extended-release methylphenidate (Concerta, Alza), at doses of 18, 36, or 54 mg. He said he found that the drug did not adversely affect height, weight, or vital signs and did not appear to worsen or induce tics. Concerta is contraindicated in patients with marked anxiety, tension, and agitation because it may aggravate these symptoms. It should not be used in patients with glaucoma, motor tics, or a diagnosis or family history of Tourette's syndrome. It is contraindicated during treatment with monoamine oxidase inhibitors, and it should not be given until at least 14 days after such treatment has been discontinued (hypertensive crises may result). He said these data "clearly demonstrate the safety of once-daily methylphenidate for up to two years."
Two other studies also demonstrated the effectiveness of a new formulation of methylphenidate, dexmethylphenidate HC1 (Focalin, Novartis). One study in 132 patients six to 17 years of age showed that treatment effects could be achieved at half the dose. A second study, in 89 ADHD patients, showed that patients achieved substantial reduction of symptoms over a 44-week period that followed a six-week open-label dose-titration, a doubleblind, placebo-controlled two-week withdrawal period, and then a 44week open-label extension to determine long-term safety and efficacy.
Keith Corners, Ph.D., professor emeritus of psychiatry and behavioral sciences at Duke University Medical Center, said that the results "signify that dexmethylphenidate HCl, which contains only the active d-isomer, is a safe and effective treatment for ADHD at half the dose of methylphenidate."
An open-label, community assessment of a formulation consisting of mixed salts of q and 1-amphetamine, designed to produce a pulse release of the medication Adderall XR (amphetamine and dextroamphetamine, Shire) for pediatric ADHD, produced significant improvement in symptoms after it was switched from other ADHD medications, according to Paul Ambrosini, M.D., of Hahnemann University in Philadelphia.
Generalized anxiety disorder (GAD) afflicts about 2.8% of adults and about 5% of children. An experimental epilepsy drug, pregabalin (Pfizer), was shown to achieve a more rapid and sustained response than alprazolam in a four-week, double-blind, placebo-controlled; trial in 455 patients with moderate to severe GAD.
Mark Pollack, study investigator and director of the anxiety disorders program at Massachusetts General Hospital, said that "pregabalin appears to have a more rapid onset compared with antidepressants." He added that it also appears to have less of a chance of creating physical dependence and to cause less sedation and cognitive impairment than is the case with the benzodiazepines. …