COLT1 Lithium Serum Collection Dataset in Pediatric Pharmacokinetic and Tolerability Study of Lithium for the Treatment of Pediatric Mania followed by an Open Label Long Term Safety Period, Discontinuation Phase, and Restabilization Period

Timing and results of serum lithium tests
Study Description
A multi-phase, multi-center trial that examined lithium in the treatment of pediatric patients (ages 7-17 years) with bipolar I disorder. There were four phases: 1) the Pharmacokinetic Phase included 8 weeks of open label treatment to determine empirically based dosing strategies for children and adolescents with bipolar disorder; 2) after completing the Pharmacokinetic Phase, eligible participants continued in the Long-Term Effectiveness Phase for a maximum of 16 weeks of lithium treatment; 3) participants meeting response criteria during the Long-Term Effectiveness Phase were eligible to continue in the Discontinuation Phase, when they were randomized to either placebo or lithium treatment for up to 28 weeks; and 4) participants who experienced a mood relapse during the Discontinuation Phase were enrolled in an open label Restabilization Phase and treated with lithium for up to 8 weeks.
Physically healthy male and female outpatients (7-17 years) with DSM-IV diagnosis of bipolar I (mania, mixed mania) without active psychotic symptoms as determined by a child and adolescent psychiatrist

血清锂检测的时间安排与检测结果

研究描述
本研究为一项多阶段、多中心临床试验，旨在评估锂剂治疗7~17岁双相I型障碍（bipolar I disorder）儿科患者的临床效果。研究共分为四个阶段：1）药代动力学阶段：开展为期8周的开放标签治疗，为双相障碍儿童及青少年确定基于经验的给药方案；2）完成药代动力学阶段后，符合入组条件的受试者可进入长期有效性阶段，接受最长16周的锂剂治疗；3）在长期有效性阶段达到应答标准的受试者，可进入停药阶段，此时将其随机分配至安慰剂组或锂剂治疗组，治疗周期最长为28周；4）在停药阶段出现心境复发的受试者，将被纳入开放标签的再稳定阶段，接受最长8周的锂剂治疗。

本研究纳入经儿童青少年精神科医师评估无活动性精神病性症状、符合《精神障碍诊断与统计手册第四版》（DSM-IV）双相I型障碍（躁狂发作、混合躁狂发作）诊断的身体健康的7~17岁男性及女性门诊患者。