COLT2 Reconsent Dataset in A Randomized, Double-Blind, Placebo Controlled Study of the Efficacy of Lithium for Treatment of Pediatric Mania followed by an Open Label Long-Term Safety Period, Double-Blind, Placebo-Controlled Discontinuation Phase and Open Label Restabilization Period

Timing of signature for re-screening informed consent Study Description The second of two multiphase, multicenter trials that comprehensively examined lithium in the treatment of pediatric patients with bipolar I disorder. In the first phase, the Efficacy Phase, participants were randomized to either lithium or placebo for 8 weeks to determine efficacy. Eligible participants then continued in the Long-Term Effectiveness Phase for a maximum of 24 weeks of lithium treatment. Subsequently, 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. Finally, those 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. 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复筛知情同意书签署时机 研究描述 本试验为两项全面评估锂盐治疗双相I障碍（bipolar I disorder）儿科患者的多阶段多中心试验中的第二项。在第一阶段（疗效阶段），受试者被随机分配至锂盐组或安慰剂组，接受为期8周的治疗以评估疗效。符合入组标准的受试者随后进入长期有效性阶段，接受最长24周的锂盐治疗。此后，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，该阶段中受试者被随机分配至安慰剂组或锂盐组，治疗时长最长可达28周。最后，在停药阶段出现心境复发的受试者将被纳入开放标签再稳定阶段，接受最长8周的锂盐治疗。 纳入对象为7至17岁的儿童及青少年，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（DSM-IV）》中无精神病性症状的双相I障碍（躁狂、混合性躁狂）诊断标准。