Upstate Medical University to conduct ADHD medication study

Wins nearly $17 million contract

SYRACUSE — Upstate Medical University will study the medication used in the treatment of attention-deficit/hyperactivity disorder (ADHD) under a $16.7 million contract. 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. The $16.7 million pact 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. Study specifics This PCORI-funded study will enroll about 1,000 children and adolescents ages 6-16 at seven clinical sites across the U.S. Participants will be randomly assigned to begin treatment with either a stimulant or a non-stimulant medication. Within each strategy, clinicians and families will choose the specific medication and adjust dosing as they normally would, “ensuring that the study closely mirrors real-world care,” Upstate said. Over 12 months, researchers will evaluate overall improvement in daily functioning, side effects, treatment satisfaction, medication changes, and long-term outcomes at home, school, and with peers. The study will begin recruiting patients in September 2026 for the locations that include Icahn School of Medicine at Mount Sinai; Cincinnati Children’s Hospital Medical Center (CCHMC); Children’s Hospital of Philadelphia (CHOP); Boston Children’s Hospital; Baylor College of Medicine / Texas Children’s Hospital; University of California, Davis – MIND Institute; and Stanford University / Lucile Packard Children’s Hospital. Upstate’s role 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. Upstate’s research team will coordinate the data collection using secure digital technologies — such as computers, tablets, and electronic data-collection systems —ensuring that information from the participants is gathered “consistently and accurately” nationwide. The team will then create the analysis data sets and conduct all major statistical analyses that will determine whether starting ADHD treatment with non-stimulant medications can be as effective as beginning with stimulant therapy. The study was selected through PCORI’s highly competitive review process in which patients and other stakeholders join scientists to evaluate proposals, Upstate said. The funding award to Upstate Medical University has been approved pending completion of PCORI’s business and programmatic review and issuance of a formal award contract, the medical school noted.