TY - JOUR
T1 - The Collaborative Lithium Trials (CoLT)
T2 - Specific aims, methods, and implementation
AU - Findling, Robert L.
AU - Frazier, Jean A.
AU - Kafantaris, Vivian
AU - Kowatch, Robert
AU - McClellan, Jon
AU - Pavuluri, Mani
AU - Sikich, Linmarie
AU - Hlastala, Stefanie
AU - Hooper, Stephen R.
AU - Demeter, Christine A.
AU - Bedoya, Denise
AU - Brownstein, Bernard
AU - Taylor-Zapata, Perdita
N1 - Funding Information:
The authors would like to thank Ms. Brieana Rowles for her technical assistance in drafting this manuscript. The authors' and Ms. Rowles' efforts on this project were supported by a contract to Case Western Reserve University from the NICHD.
Funding Information:
Dr. Findling receives or has received research support, acted as a consultant and/or served on a speaker's bureau for Abbott, Addrenex, AstraZeneca, Bristol-Myers Squibb, Forest, GlaxoSmithKline, Johnson & Johnson, Lilly, Neu-ropharm, Novartis, Organon, Otsuka, Pfizer, Sanofi-Aventis, Sepracore, Shire, Solvay, Supernus Pharmaceuticals, and Wyeth. Dr. Frazier receives or has received research support from Bristol Myers Squibb, GlaxoSmith-Kline, Eli Lilly and Company, Johnson and Johnson, Neu-ropharm, Otsuka, and Pfizer. Dr. Kowatch receives or has received research support, acted as a consultant, served on an advisory board, and/or served on a speaker's bureau for Abbott, Astra-Zeneca, Bristol-Myers Squibb, CABF, Creative Educational Concepts, GlaxoSmithKline, Medscape, NICHD, NIMH, Sanofi-Aventis, and the Stanley Research Foundation. Dr. Pavuluri's work unrelated to this manuscript is supported by NIH/NCRR K23 RR018638-01, NIMH MH077852, NIMH P50 HD055751, DANA Foundation, NARSAD, American Foundation for Suicide Prevention, Colbeth Foundation, GlaxoSmithKline-NeuroHealth, Abbott Pharmaceuticals and Janssen Research Foundation. Dr. Sikich receives or has received research support from Eli Lilly, Janssen, Pfizer, Bristol Myers Squibb, Otsuka and Neuropharm. Dr. Hooper has acted as a consultant to Lilly. Dr. Taylor-Zapata is the project officer for the funding institute, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), for this study. The other authors have no financial ties to disclose.
PY - 2008/8/12
Y1 - 2008/8/12
N2 - 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.
AB - 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.
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U2 - 10.1186/1753-2000-2-21
DO - 10.1186/1753-2000-2-21
M3 - Article
C2 - 18700004
AN - SCOPUS:51349156145
SN - 1753-2000
VL - 2
JO - Child and Adolescent Psychiatry and Mental Health
JF - Child and Adolescent Psychiatry and Mental Health
M1 - 21
ER -