COLT2 Clinical Interview 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

Results of psychiatrist interviews, including data on diagnosis of Bipolar I and comorbid psychiatric disorders
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

精神科医师访谈结果，包含双相I型障碍（Bipolar I）共病精神障碍的诊断相关数据。
研究概况
本研究为两项多阶段、多中心临床试验中的第二项，旨在全面评估锂剂治疗儿童双相I型障碍患者的疗效。第一阶段为疗效验证阶段：受试者被随机分配至锂剂组或安慰剂组，干预时长8周以评估药物疗效。符合入组标准的受试者随后进入长期疗效维持阶段，接受最长24周的锂剂治疗。后续，在长期疗效维持阶段达到应答标准的受试者可进入停药阶段：此时受试者被随机分配至安慰剂组或锂剂组，干预时长最长28周。最后，在停药阶段出现情绪复发的受试者将被纳入开放标签再稳定阶段，接受最长8周的锂剂治疗。
受试者为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型障碍（躁狂发作、混合躁狂发作）诊断标准。