[Translation] A study on the efficacy and safety of lamotrigine in the long-term prevention of relapse and/or recurrence of depression, mania, hypomania, or mixed episodes in patients with bipolar I disorder
评价在双相情感障碍I型受试者中,比较拉莫三嗪200mg/天与安慰剂长期(36周)预防抑郁、躁狂、轻躁狂、或混合发作(以心境障碍复发或复燃需要干预的时间作为指标)的有效性和安全性。
[Translation] To evaluate the efficacy and safety of lamotrigine 200 mg/day compared with placebo for the long-term (36 weeks) prevention of depressive, manic, hypomanic, or mixed episodes (measured as the time to intervention for a relapse or recurrence of a mood disorder) in participants with bipolar I disorder.