CLINICAL TRIAL: PEDIATRIC PHARMACOKINETIC AND TOLERABILITY STUDY OF LITHIUM FOR

临床试验：锂的儿科药代动力学和耐受性研究

• 批准号: 7716888
• 负责人: Linmarie Sikich
• 金额: $ 0.04万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-02 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716888
• 关键词: Adolescent; Age-Years; Bipolar Disorder; Child; Childhood; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; DSM-IV; Diagnostic; Disease; Dose; Drug Kinetics; Effectiveness; Enrollment; Funding; Grant; Institution; Label; Lithium; Manic; Moods; Patients; Phase; Placebos; Psychiatrist; Randomized; Relapse; Research; Research Personnel; Resources; Site; Source; Symptoms; United States National Institutes of Health; Week; base; experience; response

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这是一项多相，多中心的试验，将全面检查锂在治疗双相情感障碍患者的治疗中。 符合双极I（躁狂症，混合躁狂症）的DSM-IV诊断标准的7-17岁的儿童和青少年没有由儿童和青少年精神科医生确定的，这项研究将有资格参加这项研究。 大约60名受试者将在9个地点招收。 为了检查用锂治疗躁郁症，这项研究将 包括四个阶段的治疗阶段。 第一阶段是药代动力学阶段，将包括8周的开放标签治疗，以确定对患有躁郁症的儿童和青少年基于经验的给药策略。 一旦患者完成药代动力学阶段，患者可能有资格在长期有效阶段继续进行锂治疗16周。 随后，在长期有效阶段符合反应标准的患者将有资格在中断阶段继续进行。 在中断阶段，患者将被随机分为安慰剂或锂治疗长达28周。 最后，那些在中断阶段经历情绪复发的受试者将在开放标签的重新稳定阶段重新启动锂治疗长达8周。