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Findling RL, Frazier JA, Kafantaris V, et al. The Collaborative Lithium Trials (CoLT): specific aims, methods, and implementation. Child Adolesc Psychiatry Ment Health. 2008;2(1):21doi: 10.1186/1753-2000-2-21.
Findling, R. L., Frazier, J. A., Kafantaris, V., Kowatch, R., McClellan, J., Pavuluri, M., Sikich, L., Hlastala, S., Hooper, S. R., Demeter, C. A., Bedoya, D., Brownstein, B., & Taylor-Zapata, P. (2008). The Collaborative Lithium Trials (CoLT): specific aims, methods, and implementation. Child and adolescent psychiatry and mental health, 2(1), 21. https://doi.org/10.1186/1753-2000-2-21
Findling, Robert L, et al. "The Collaborative Lithium Trials (CoLT): specific aims, methods, and implementation." Child and adolescent psychiatry and mental health vol. 2,1 (2008): 21. doi: https://doi.org/10.1186/1753-2000-2-21
Findling RL, Frazier JA, Kafantaris V, Kowatch R, McClellan J, Pavuluri M, Sikich L, Hlastala S, Hooper SR, Demeter CA, Bedoya D, Brownstein B, Taylor-Zapata P. The Collaborative Lithium Trials (CoLT): specific aims, methods, and implementation. Child Adolesc Psychiatry Ment Health. 2008 Aug 12;2(1):21. doi: 10.1186/1753-2000-2-21. PMID: 18700004; PMCID: PMC2531078.
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Child Adolesc Psychiatry Ment Health. 2008 Aug 12;2(1):21. doi: 10.1186/1753-2000-2-21.

The Collaborative Lithium Trials (CoLT): specific aims, methods, and implementation.

Child and adolescent psychiatry and mental health

Robert L Findling, Jean A Frazier, Vivian Kafantaris, Robert Kowatch, Jon McClellan, Mani Pavuluri, Linmarie Sikich, Stefanie Hlastala, Stephen R Hooper, Christine A Demeter, Denise Bedoya, Bernard Brownstein, Perdita Taylor-Zapata

Affiliations

  1. Department of Psychiatry, University Hospitals Case Medical Center/Case Western Reserve University, Cleveland, OH, USA. [email protected]

PMID: 18700004 PMCID: PMC2531078 DOI: 10.1186/1753-2000-2-21

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.

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