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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项多阶段、多中心的试验，将全面检查锂在治疗儿童I型双相情感障碍患者中的作用。 符合DSM-IV双相I型（躁狂、混合型躁狂）诊断标准且经儿童和青少年精神科医生确定无精神病症状的7-17岁儿童和青少年将有资格参加本研究。 将在9家临床试验机构入组约60例受试者。 为了检查锂治疗双相情感障碍，本研究将 包括四个治疗阶段。 第一阶段，药代动力学阶段，将包括8周的开放标签治疗，以确定儿童和青少年双相情感障碍的经验性给药策略。 一旦患者完成药代动力学阶段，患者可能有资格继续进入长期有效性阶段，最长持续16周的锂治疗。 随后，在长期有效性阶段符合缓解标准的患者将有资格继续进入停药阶段。 在停药期，患者将随机接受安慰剂或锂治疗，最长28周。 最后，在停药期出现情绪复发的受试者将在开放标签的重新稳定期重新开始锂治疗长达8周。