COLT1 Study Drug Accountability Log 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 amount of study drug dispensed and returned during each study phase
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

各研究阶段研究药物的配发与返还时机及数量
研究概况
本研究为一项多阶段、多中心临床试验，旨在评估锂盐治疗7-17岁双相I型障碍儿科患者的疗效。试验共分为四个阶段：1）药代动力学阶段（Pharmacokinetic Phase）：为期8周的开放标签治疗，旨在为双相障碍儿童及青少年确定基于经验的给药方案；2）长期有效性阶段（Long-Term Effectiveness Phase）：完成药代动力学阶段后，符合入组条件的受试者可进入该阶段，接受最长16周的锂盐治疗；3）停药阶段（Discontinuation Phase）：在长期有效性阶段达到应答标准的受试者可继续入组该阶段，此时受试者将被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）再稳定阶段（Restabilization Phase）：在停药阶段出现心境复发的受试者将被纳入开放标签治疗，接受最长8周的锂盐治疗。
入组人群为身体健康的男性及女性门诊患者（7-17岁），经儿童青少年精神科医师评估符合《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，且无活动性精神病性症状。