A $17.6 million clinical trials contract was recently awarded by the National Institutes of Health to Case Western Reserve University School of Medicine and Robert L. Findling, MD, Professor of Psychiatry & Pediatrics at Case Western Reserve University School of Medicine, and Director of Child and Adolescent Psychiatry at University Hospitals Case Medical Center.
With site selection now complete, The Collaborative Lithium Trials, also known as "CoLT," will begin with a series of studies that will examine the safety and efficacy of lithium in the treatment of children and adolescents with bipolar disorder. The results of the nation-wide study will provide the most comprehensive analysis of lithium treatment in children and adolescents to date. Administered by the National Institute of Child Health and Human Development (NICHD), an arm of the NIH, the nationwide study is the first of its kind and the results will provide the most comprehensive analysis of lithium treatment in children and adolescents to date.
Dr. Findling will serve as the lead investigator at Case Medical Center for the multi-site study which is currently enrolling 60 children and adolescents across seven sites nationwide.
"Serving as the lead site in this comprehensive trial validates the dedication of many who are committed to continued advancements in the research and treatment of child and adolescent bipolar disorder," Dr. Findling said. "We are eager to continue enrollment and look forward to establishing future treatment protocols."
Funding for these studies was authorized by Congress in 2002 under the "Best Pharmaceuticals for Children Act" (BPCA). The goal of the act is to ensure that children receive safe and effective medicines that have been properly evaluated for pediatric use. The Food and Drug Administration (FDA), in conjunction with the NICHD, added lithium, the benchmark treatment for adults with bipolar illness, to the list of drugs considered to be of the highest priority for study in pediatric clinical trials.
"We are honored the NICHD has recognized the School of Medicine's unwavering commitment to pioneering research and has selected Dr. Findling to lead the CoLT study to improve human health, said Pamela B. Davis, M.D., Ph.D., Interim Dean, School of Medicine.
Dr. Findling and team are currently recruiting patients for the CoLT studies, for which children and adolescents ages 7-17 years old with Bipolar I Disorder are eligible. The studies consist of a series of two inter-related clinical trials. The objectives of the CoLT lithium study for children and adolescents include the development of evidence-based dosing strategies, a component that will examine efficacy and a meticulous and comprehensive characterization of the short and long-term safety of this drug.
"University Hospitals Case Medical Center is privileged to serve as the lead clinical institution on this study," said Fred C. Rothstein, MD, President of University Hospitals Case Medical Center. "It is a tremendous testament to both Dr. Findling's unparalleled body of work in this area as well as University Hospitals' ability to provide the best in patient care."
Those interested in obtaining additional information about enrollment in the CoLT study can contact Jacqui Lingler, at (216) 983-0731, at University Hospitals Case Medical Center. To learn about other clinical trials in the Division of Child and Adolescent Psychiatry, please contact Nicole Kovach at (216) 844-3922. Other participating sites are: Cincinnati Children's Hospital, Zucker Hillside Hospital in Long Island, University of Illinois-Chicago, University of North Carolina at Chapel Hill, Children's Hospital and Regional Medical Center in Seattle and Cambridge Hospital in Massachusetts.
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