COLT1 Prior/Concomitant Medications 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

Data on concomitant medications taken from seven days prior to consent through study completion
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

签署知情同意书前7天至研究结束期间的合并用药数据

研究描述
一项多阶段、多中心临床试验，旨在评估锂盐治疗7~17岁双相I型障碍（Bipolar I Disorder）儿童青少年患者的疗效。该试验共分为四个阶段：
1) 药代动力学阶段：为期8周的开放标签治疗，用于确定针对儿童及青少年双相障碍患者的经验性给药方案；
2) 药代动力学阶段完成后，符合入组条件的受试者将进入长期有效性阶段，接受最长16周的锂盐治疗；
3) 在长期有效性阶段达到应答标准的受试者，可继续进入停药阶段：该阶段将受试者随机分配至安慰剂组或锂盐治疗组，治疗时长最长可达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周的锂盐治疗。

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（Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, DSM-IV）》双相I型障碍（躁狂发作、混合性躁狂发作）诊断的7~17岁身体健康男性及女性门诊患者。