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Extended-release ADHD drugs beat placebo.

MIAMI -- A classroom study comparing three extended-release forms of methylphenidate with placebo for treating attention-deficit hyperactivity disorder showed that Ritalin LA was superior for improving attention and behavior, Dr. Raul R. Silva reported at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

Stimulants are the most popular form of treatment for attention-deficit hyperactivity disorder (ADHD) in children, and methylphenidate is the most prescribed. However, with a half-life of 2-3 hours, multiple doses are necessary during the school day. Recently, the Food and Drug Administration approved several extended-release forms with the brand names Concerta, Metadate CD, and Ritalin LA. The primary difference among the agents is how they release methylphenidate over time.

Dr. Silva and his colleagues compared Concerta 18 mg, Concerta 36 mg, and Ritalin LA 20 mg vs. placebo in a classroom of 36 children (29 males, 7 females), aged 6-12 years. All had ADHD and were previously stabilized with methylphenidate. Participants were randomized to receive a single dose of one of the three treatments or placebo on day 7 and then crossed over to the others on days 14, 21, and 28. On other days, the participants took their maintenance methylphenidate (up to 20 mg daily).

"This is one of the few head-to-head trials," said Dr. Silva, deputy director of the division of child and adolescent psychiatry at Bellevue Hospital Center, New York.

The study was sponsored by Novartis, manufacturer of Ritalin LA, and published in Paediatric Drugs (5[8]:545-55, 2003).

Blinded observers measured efficacy during the 8-hour school day using the Swanson, Kotkin, Agler, M-Flynn and Pelham Rating Scale (SKAMP), which includes eight attention items and five deportment items.

A rating of 0 is normal and 6 is maximum impairment, so lower scores or negative changes reflect improvement.

In the first 4 hours, the mean change in SKAMP-Attention score vs. baseline was significantly better with Ritalin LA (-2.48), compared with Concerta 18 mg (-1.36) or Concerta 36 mg (-1.55). Similarly, at 8 hours, the mean change was significantly better with Ritalin LA (-4.48), compared with Concerta 18 mg (-2.72) and Concerta 36 mg (-3.24). All three active treatments were significantly superior to placebo. Mean changes were calculated using area-under-the-curve measures.

Changes in mean SKAMP-Deportment scores favored Ritalin LA at 4 and 8 hours. At 4 hours, Ritalin scores vs. baseline (-1.67) were superior to Concerta 18 mg (-0.28) and Concerta 36 mg (-0.55). Similarly, at 8 hours, scores were better with Ritalin LA (-2.81) than with Concerta 18 mg (-0.82) or Concerta 36 mg (-1.34).

The active treatments were well tolerated. There was one report of abdominal pain with Ritalin LA, one report of nau-sea with Concerta 18 mg, and one report of dyspnea with Concerta 36 mg. All adverse events were mild and resolved during the study.

When asked which agent he would choose, Dr. Silva said it "depends on the child." He suggested asking patients with ADHD how they fare during the afternoon or if they have difficulty doing homework.

"If you need control in hour 7, 8, or 9, with Ritalin LA there is control early in the morning with some carryover effects," he said.


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Title Annotation:Child/Adolescent Psychiatry
Author:McNamara, Damian
Publication:Clinical Psychiatry News
Date:Feb 1, 2004
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