The Collaborative Lithium Trials (CoLT): specific aims, methods, and implementation
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Findling, Robert L, et al. The Collaborative Lithium Trials (colt): Specific Aims, Methods, and Implementation. BioMed Central Ltd, 2008. https://doi.org/10.17615/xgyb-kv51APA
Findling, R., Frazier, J., Kafantaris, V., Kowatch, R., Mc Clellan, J., Pavuluri, M., Sikich, L., Hlastala, S., Hooper, S., Demeter, C., Bedoya, D., Brownstein, B., & Taylor Zapata, P. (2008). The Collaborative Lithium Trials (CoLT): specific aims, methods, and implementation. BioMed Central Ltd. https://doi.org/10.17615/xgyb-kv51Chicago
Findling, Robert L, Jean A Frazier, Vivian Kafantaris, Robert Kowatch, Jon Mc Clellan, Mani Pavuluri, Linmarie Sikich et al. 2008. The Collaborative Lithium Trials (colt): Specific Aims, Methods, and Implementation. BioMed Central Ltd. https://doi.org/10.17615/xgyb-kv51- Creator
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Findling, Robert L
- Other Affiliation: Department of Psychiatry, University Hospitals Case Medical Center/Case Western Reserve University, Cleveland, OH, USA
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Frazier, Jean A
- Other Affiliation: Cambridge Health Alliance and Department of Psychiatry, Harvard Medical School, Cambridge, MA , USA
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Kafantaris, Vivian
- Other Affiliation: The Feinstein Institute for Medical Research of the North Shore—Long Island Health System, Manhasset, NY, USA
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Kowatch, Robert
- Other Affiliation: Division of Psychiatry, Cincinnati Children’s Hospital, Cincinnati, OH, USA
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McClellan, Jon
- Other Affiliation: Department of Psychiatry, University of Washington, Seattle, WA, USA
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Pavuluri, Mani
- Other Affiliation: Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA
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Sikich, Linmarie
- Affiliation: School of Medicine, Department of Psychiatry
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Hlastala, Stefanie
- Other Affiliation: Department of Psychiatry, University of Washington, Seattle, WA, USA
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Hooper, Stephen R.
- Affiliation: School of Medicine, Neurodevelopment Disorders Research Center, Carolina Institute for Developmental Disabilities
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Demeter, Christine A
- Other Affiliation: Department of Psychiatry, University Hospitals Case Medical Center/Case Western Reserve University, Cleveland, OH, USA
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Bedoya, Denise
- Other Affiliation: Department of Psychiatry, University Hospitals Case Medical Center/Case Western Reserve University, Cleveland, OH, USA
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Brownstein, Bernard
- Other Affiliation: Best Pharmaceuticals for Children Act-Coordinating Center, Premier Research, Philadelphia, PA, USA
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Taylor-Zapata, Perdita
- Other Affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA
- Abstract
- Abstract Background Lithium is a benchmark treatment for bipolar illness in adults. However, there has been relatively little methodologically stringent research regarding the use of lithium in youth suffering from bipolarity. Methods Under the auspices of the Best Pharmaceuticals for Children Act (BPCA), a Written Request (WR) pertaining to the study of lithium in pediatric mania was issued by the United States Food and Drug Administration (FDA) to the National Institute of Child Health and Human Development (NICHD) in 2004. Accordingly, the NICHD issued a Request for Proposals (RFP) soliciting submissions to pursue this research. Subsequently, the NICHD awarded a contract to a group of investigators in order to conduct these studies. Results The Collaborative Lithium Trials (CoLT) investigators, the BPCA-Coordinating Center, and the NICHD developed protocols to provide data that will: (1) establish evidence-based dosing strategies for lithium; (2) characterize the pharmacokinetics and biodisposition of lithium; (3) examine the acute efficacy of lithium in pediatric bipolarity; (4) investigate the long-term effectiveness of lithium treatment; and (5) characterize the short- and long-term safety of lithium. By undertaking two multi-phase trials rather than multiple single-phase studies (as was described in the WR), the feasibility of the research to be undertaken was enhanced while ensuring all the data outlined in the WR would be obtained. The first study consists of: (1) an 8-week open-label, randomized, escalating dose Pharmacokinetic Phase; (2) a 16-week Long-Term Effectiveness Phase; (3) a 28-week double-blind Discontinuation Phase; and (4) an 8-week open-label Restabilization Phase. The second study consists of: (1) an 8-week, double-blind, parallel-group, placebo-controlled Efficacy Phase; (2) an open-label Long-Term Effectiveness lasting either 16 or 24 weeks (depending upon blinded treatment assignment during the Efficacy Phase); (3) a 28-week double-blind Discontinuation Phase; and (4) an 8-week open-label Restabilization Phase. In December of 2006, enrollment into the first of these studies began across seven sites. Conclusion These innovative studies will not only provide data to inform the labeling of lithium in children and adolescents with bipolar disorder, but will also enhance clinical decision-making regarding the use of lithium treatment in pediatric bipolar illness. Trial Registration NCT00442039
- Date of publication
- August 12, 2008
- DOI
- Identifier
- Resource type
- Article
- Rights statement
- In Copyright
- Rights holder
- Robert L Findling et al.; licensee BioMed Central Ltd.
- License
- Journal title
- Child and Adolescent Psychiatry and Mental Health
- Journal volume
- 2
- Journal issue
- 1
- Page start
- 21
- Language
- English
- Is the article or chapter peer-reviewed?
- Yes
- ISSN
- 1753-2000
- Bibliographic citation
- Child and Adolescent Psychiatry and Mental Health. 2008 Aug 12;2(1):21
- Publisher
- BioMed Central Ltd
- Access right
- Open Access
- Date uploaded
- August 23, 2012
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