This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This is the first part of a multiphase, multicenter trial that will comprehensively examine lithium in the treatment of pediatric patients (children ages 7-11 years and adolescents ages 12-17 years) with bipolar I disorder. Approximately 60 patients will be enrolled in phase 1 and dosed across nine sites into this trial in the first phase of this study. Patients in phase 1 will be eligible to continue into subsequent phases based on response status. Once this study is complete, an additional 140 subjects will be enrolled in phases 2-4 under a separate protocol. In order to examine the treatment of bipolar disorder with lithium, this study will include four phases of treatment. The first phase, the Pharmacokinetic Phase, will include 8 weeks of Open Label treatment to determine empirically based dosing strategies for children and adolescents with bipolar disorder. Once patients complete the Pharmacokinetic Phase, patients may be eligible to continue in the Long-Term Effectiveness Phase for a maximum of 16 weeks of lithium treatment. Subsequently, patients meeting response criteria during the Long-Term Effectiveness Phase will be eligible to continue in the Discontinuation Phase. During the Discontinuation Phase, patients will be randomized to either placebo or lithium treatment for up to 28 weeks. Finally, those subjects who experience a mood relapse during the Discontinuation Phase will be enrolled in an Open Label Restabilization Phase and treated with lithium for up to 8 weeks.The four phases to this study are:1) Pharmacokinetic Phase: In the first phase, the Pharmacokinetic Phase, will include 8 weeks of open-label treatment to determine empirically based dosing strategies for children and adolescents with bipolar disorder. 2) Long-Term Effectiveness Phase: Once patients complete the Pharmacokinetic Phase, patients may be eligible to continue in the Long-Term Effectiveness Phase for a maximum of 16 weeks of lithium treatment. 3) Discontinuation Phase: Subsequently, patients meeting response criteria during the Long-Term Effectiveness Phase will be eligible to continue in the Discontinuation Phase. During the Discontinuation Phase, patients will be randomized to either placebo or lithium treatment for up to 28 weeks. 4) Finally, those subjects who experience a mood relapse during the Discontinuation Phase will reinitiate lithium treatment for up to 8 weeks in an open-label restabilization phase of this study.
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