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Preschool ADHD Treatment Study (PATS)
The PATS was an NIMH–funded, multi–center, randomized, efficacy trial designed to evaluate the short term (5 week) efficacy and long–term (40 weeks) safety of MPH in preschoolers with ADHD. Three–hundred three subjects aged 3 to 5.5 years old who met criteria for a primary DSM–IV diagnosis of ADHD entered the trial. Subjects participated in an 8–phase, 70 week trial that included screening, parent–training, baseline, open–label safety lead–in, double–blind crossover titration, double blind parallel efficacy, open–label maintenance, and double–blind discontinuation. Medication response was assessed during the crossover titration phase using a combination of parent and teacher ratings. Special ethical considerations throughout the trial warranted a number of design changes.
PATS was initiated in 2001 and completed in 2004. Participating research sites are now following all the children involved in the treatment study for 5 years to track long term outcomes. Results from the PATS have been presented at the New Clinical Drug Evaluation Unit meeting (NCDEU; June 2004), the annual meeting of the American Academy of Child and Adolescent Psychiatry (AACAP, October 2004), and the American College of Neuropsychopharmacology (ACNP, December 2004). This website will have periodic updates on peer–reviewed publications of the PATS study.
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