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Dexmethlyphenidate Once-Daily Appears to be Safe and Effective Treatment for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Presented at AACAP

By Jerry Ingram

WASHINGTON, DC -- October 28, 2004 -- Dexmethylphenidate extended release capsules (d-MPH-ER) appears to be a safe and effective once-daily option for treatment of children and adolescents diagnosed with attention-deficit/hyperactivity disorder, according to researcher presented here on October 22nd at the 51st Annual Meeting of the American Association of the Academy of Child and Adolescent Psychiatry.

Lead researcher Laurence Greenhill, MD, Psychiatric Researcher, Department of Child Psychiatry, New York State Psychiatric Institute, New York, and associates presented the results of their multicenter, double-blind, flexible-dose study on 1032 patients who were between the ages of 6 and 17 years.

The clinicians randomized patients to receive either d-MPH_ER 5mg to 30mg or placebo once per day for 7 weeks. They titrated doses to optimal levels throughout the first 5 weeks of treatment and then maintained consistent dosing for the final 2 weeks.

Efficacy assessments were conducted weekly during typical school and home activities utilizing the Conners ADHD/DSM-IV Scales for teachers (CADS-T) and parents (CADS-P). In addition, Clinical Global Impressions Scale for Improvement (CGI-I) and the Shapiro-Wilk test were used to analyze covariance for changes from baseline in rating scale scores.

Mean change from baseline to final visit on CADST scale was 15.8 for patients taking dexmethylphenidate and 6.0 for patients in the placebo group (P <.001). On the CADS-P scale, youths taking d-MPH-ER scored 17.6 while the placebo group scored 6.0 (P<.001).

In addition, the researchers observed that the proportion of patients rated as "very much improved" or "much improved" on the CGI-I scale at the last visit was 67.3% in the d-MPH-ER group versus 13.3% in the placebo group (P <.001).

Children and adolescents with ADHD treated with once-daily dexmethylphenidate responded well with few adverse events, Dr. Greenhill concluded.


[Presentation title. "Effective Control of Pediatric ADHD Symptoms Using Once-Daily Dexmethylphenidate." Poster C18]

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