Magazine article Clinical Psychiatry News

Methylphenidate Appears Safe in Preschoolers

Magazine article Clinical Psychiatry News

Methylphenidate Appears Safe in Preschoolers

Article excerpt

WASHINGTON -- Methylphenidate appears to be effective and safe for the treatment of attention-deficit hyperactivity disorder in preschool-age children, according to preliminary data presented at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

The results come from the Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children study (PATS), sponsored by the National Institute of Mental Health.

Several studies have previously suggested that preschool-age children with ADHD would respond to and tolerate methylphenidate, and this multisite study is the first major effort aimed at directly assessing the safety and efficacy of a stimulant for the treatment of attentiondeficit hyperactivity disorder in children aged 3-5 years.

"The take-home message is that 85% of the children responded to the methylphenidate," during the 5-week crossover period to determine the optimal dosing for each of the children, said study investigator Howard B. Abikoff, Ph.D., of the New York University Child Study Center.

The optimal dose for each child was determined during a 5-week period. Over that period, all of the children were given a placebo or a dose of 1.25 mg, 2.5 mg, 5 mg, or 7.5 mg three times daily for 1 week each. Overall, 144 children completed this 5-week trial. Each week, a composite score of symptom severity was assigned based on parent and teacher responses to the Conners, Loney, and Milich (CLAM) Questionnaire and the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale.

Two blinded assessors were then asked to identify the best dose for each child. A full panel of all investigators decided upon the appropriate dose when the two assessors did not agree. Just over half (51%) of the children were referred to the full panel of investigators to determine the optimal dose.

Children also could be evaluated at a 10-mg dose if investigators agreed that there was a good chance that the child would have an even better response with a higher dose. This happened in 15 of the cases.

"First of all, we got a very significant effect per dose relative to placebo," said Dr. Abikoff. For the 2.5-mg, 5-mg, and 7.5-mg doses, the children's composite scores were significantly lower than for placebo. …

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