Children's to Study Lithium for Pediatric Bipolar Disorder
July 20, 2007
The Seattle Children’s Hospital Research Institute will participate in a multi-site trial to study the use of lithium for treating children and adolescents with bipolar disorder.
The Seattle Children’s Hospital Research Institute will participate in a multi-site trial to study the use of lithium for treating children and adolescents with bipolar disorder. The National Institutes of Health (NIH) grant awarded $1.6 million to Children’s , along with related awards to six other institutions partnering on the research, totaling $17.6 million for the entire project.
With site selection complete, The Collaborative Lithium Trials (known as “CoLT”) will begin with a series of studies to examine safety and efficacy of lithium in the treatment of children and adolescents with bipolar disorder. The results of this 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, this study is the first of its kind. The project is currently enrolling 60 children and adolescents over four years across the seven sites.
Jon McClellan, MD, will serve as Principal Investigator for the Children’s research team. “As more children and adolescents are being diagnosed and treated for psychiatric conditions, it is imperative that well designed studies examine the safety and effectiveness of different treatments being used,” said Dr. McClellan. “The needs of growing children are different than adults, and more research will lead the way to fuller understanding of these medications in young patients.”
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 children receive safe and effective medicines that have been properly evaluated for pediatric use. The Food and Drug Administration in conjunction with the NICHD added lithium to the list of drugs considered to be of highest priority for study in pediatric clinical trials. Lithium is the benchmark drug most often used in adults with bipolar illness.
Dr. McClellan and the research team at Children’s are currently recruiting patients for the CoLT studies, seeking children and adolescents ages 7-17 that have been diagnosed with Bipolar I Disorder. The studies consist of a series of two related clinical trials. The objectives include development of evidence-based dosing strategies, examining drug efficacy and a comprehensive characterization of the short and long-term safety of lithium use.
Those interested in participating in the CoLT studies can contact Leslie Pierson in the Department of Child Psychiatry and Behavioral Medicine at Children’s Hospital and Regional Medical Center in Seattle: (206) 987-3399. The six other participating sites are: Case Western Reserve University School of Medicine, Cincinnati Children’s Hospital, Zucker Hillside Hospital in Long Island, University of Illinois-Chicago, University of North Carolina at Chapel Hill, and Cambridge Hospital in Massachusetts.
For more information about children and teens with Bipolar 1 Disorder, please visit:
Psychiatry and Behavioral Medicine
About Seattle Children’s Research Institute
Located in downtown Seattle’s biotech corridor, Seattle Children’s Research Institute is pushing the boundaries of medical research to find cures for pediatric diseases and improve outcomes for children all over the world. Internationally recognized investigators and staff at the research institute are advancing new discoveries in cancer, genetics, immunology, pathology, infectious disease, injury prevention and bioethics, among others. As part of Seattle Children’s Hospital, the research institute brings together leading minds in pediatric research to provide patients with the best care possible. Seattle Children’s serves as the primary teaching, clinical and research site for the Department of Pediatrics at the University of Washington School of Medicine, which consistently ranks as one of the best pediatric departments in the country. For more information, visit http://www.seattlechildrens.org/research.