SYRACUSE, N.Y. — Upstate Medical University says it will use a $16.7 million contract for a study on attention-deficit/hyperactivity disorder (ADHD).
The Washington, D.C.–based Patient-Centered Outcomes Research Institute (PCORI) approved the research funding. Under the contract, Upstate Medical University will study whether beginning ADHD treatment with non-stimulant medication can be as effective as the current standard of starting with stimulant medications.
The research aims to determine which medication-starting strategy leads to better overall outcomes for school-age children with ADHD.
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The $16.7 million contract is believed to be the largest clinical trial contract in Upstate history, the academic health system noted.
Two of the world’s leading experts on ADHD will lead the study, Upstate Medical University noted. They include Stephen Faraone, Ph.D., SUNY distinguished professor in the departments of psychiatry and neuroscience & physiology and vice chair for research in the department of psychiatry at Upstate. Dr. Jeffrey Newcorn, professor of psychiatry and pediatrics and director of the division of ADHD and learning disorders at the Icahn School of Medicine at Mount Sinai in New York City, is also leading the study.
“Our study has the potential to reduce the amount of stimulant medication prescribed to youth with ADHD by providing long-term data about the effects of stimulant and nonstimulant medications on outcomes that are important to patients and their families,” Farone said in the Upstate Medical University announcement.
ADHD is one of the most common neurodevelopmental conditions in childhood, yet treatment decisions “remain challenging,” Upstate said. Current guidelines “overwhelmingly” recommend stimulant medications as the first-line therapy. Stimulants can be highly effective, but they do not work for every child and may cause side effects such as appetite loss, sleep difficulties, or mood changes, it noted.
Concern also has been raised about long-term use, potential misuse or diversion, and recent nationwide stimulant shortages. Non-stimulant medications are available and effective for many children, but they are typically used only after stimulant treatment fails. As a result, many children who might do well with a non-stimulant begin treatment with a stimulant unnecessarily. This study addresses a major gap in evidence by directly comparing stimulant-first and non-stimulant-first approaches.
This PCORI-funded study will enroll about 1,000 children and adolescents ages 6-16 at seven clinical sites across the U.S.
Although Upstate Medical University is not one of the clinical-enrollment locations, it plays a key role in the success of this national study, it contends. Upstate serves as the study’s data management and analysis center, “a function essential to the rigor required by PCORI.” As the lead institution and recipient of the PCORI contract, Upstate is responsible for overseeing how study information is collected, stored, protected, and interpreted across all participating clinical sites.
