CLINICAL TRIAL: PEDIATRIC PHARMACOKINETIC AND TOLERABILITY STUDY OF LITHIUM FOR

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multiphase, multi-center, trial that will comprehensively examine lithium in the treatment of pediatric patients with bipolar I disorder. Children and adolescents 7-17 years of age who meet DSM-IV diagnostic criteria for Bipolar I (mania, mixed mania) without psychotic symptoms as determined by a child and adolescent psychiatrist will be eligible for this study. Approximately 60 subjects will be enrolled across 9 sites. 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 reinitiate lithium treatment for up to 8 weeks in an open-label Restabilization Phase.