Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts, USA.
J Child Adolesc Psychopharmacol. 2021 Sep;31(7):494-503. doi: 10.1089/cap.2021.0040. Epub 2021 Jul 29.
To evaluate long-term safety and effectiveness of lurasidone in children and adolescents with bipolar depression. Participants, ages 10-17 years, with bipolar depression, who completed 6 weeks of double-blind (DB) treatment with lurasidone or placebo were enrolled in a 2-year, open-label (OL) extension study of lurasidone (20-80 mg/d). The primary effectiveness measure was the Children's Depression Rating Scale, Revised (CDRS-R). A total of 306 participants entered the 2-year extension study; 195 (63.7%) completed 52 weeks, and 168 (54.9%) completed 104 weeks of treatment. For all participants entering the extension study, mean change in CDRS from OL baseline was -13.4 at week 52, and -16.4 at week 104 (-11.3 at last observation carried forward [LOCF]-endpoint). Overall, 31 participants (10.1%) discontinued due to an adverse event (AE); the three most common AEs were headache (23.9%), nausea (16.4%), and somnolence (9.8%). OL treatment with lurasidone was associated with few effects on metabolic parameters or prolactin. Mean change from DB baseline in weight was +4.25 kg at week 52 (vs. an expected weight gain of +3.76 kg), and +6.75 kg at week 104 (vs. an expected weight gain of +6.67 kg), based on the sex- and age-matched United States Center for Disease Control normative data. For youth with bipolar depression, up to 2 years of treatment with lurasidone was generally well tolerated, safe, and effective with relatively low rates of discontinuation due to AEs, minimal effects on weight, metabolic parameters or prolactin, and continued improvement in depressive symptoms. Clinical Trial Registration number: NCT01914393.
评估鲁拉西酮在儿童和青少年双相情感障碍抑郁患者中的长期安全性和有效性。参与者年龄在 10-17 岁之间，患有双相情感障碍抑郁，他们完成了 6 周的鲁拉西酮或安慰剂双盲（DB）治疗，随后进入了为期 2 年的鲁拉西酮开放标签（OL）扩展研究。主要疗效指标为儿童抑郁评定量表修订版（CDRS-R）。共有 306 名参与者进入了 2 年的扩展研究；195 名（63.7%）完成了 52 周的治疗，168 名（54.9%）完成了 104 周的治疗。对于所有进入扩展研究的参与者，从 OL 基线开始，CDRS 的平均变化在第 52 周时为-13.4，在第 104 周时为-16.4（最后一次观测值向前结转[LOCF]终点时为-11.3）。总体而言，有 31 名参与者（10.1%）因不良事件（AE）而停药；最常见的三种 AE 是头痛（23.9%）、恶心（16.4%）和嗜睡（9.8%）。OL 治疗期间，鲁拉西酮对代谢参数或催乳素的影响较小。从 DB 基线到第 52 周时，体重的平均变化为+4.25kg（与预期的+3.76kg 体重增加相比），第 104 周时为+6.75kg（与预期的+6.67kg 体重增加相比），这是基于与性别和年龄匹配的美国疾病控制与预防中心的标准数据。对于患有双相情感障碍抑郁的年轻人，2 年的鲁拉西酮治疗总体上耐受性良好、安全有效，因 AE 导致停药的比例相对较低，对体重、代谢参数或催乳素的影响最小，抑郁症状持续改善。临床试验注册号：NCT01914393。
