Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder
Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder
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DOI：
10.1016/j.jad.2017.09.040
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发表时间：
2018-01-15
影响因子：
6.6
通讯作者：
Yatham, Lakshmi N.
中科院分区：
文献类型：
--
作者：
Earley, Willie;Durgam, Suresh;Yatham, Lakshmi N.
背景：反应率和缓解率是评价治疗临床意义的指标。Cariprazine被FDA批准用于急性治疗成人精神分裂症和躁狂症或与双相I型障碍相关的混合性发作。对卡吡嗪治疗与双相I型障碍相关的躁狂/混合性发作的3项关键试验的汇总数据进行事后分析，以研究卡吡嗪对各种反应和缓解标准的影响。方法：组成研究是在成年双相I型障碍患者（NCT00488618, NCT01058096, NCT01058668）中进行的为期3周的随机，双盲，安慰剂对照，多中心，平行组II/III期研究（18-65岁）。事后分析包括青年躁狂症评定量表（YMRS）结果的反应（>=分数下降50%），缓解（总分）
Background: Rates of response and remission are measures that endorse the clinical significance of treatment. Cariprazine is FDA approved for the acute treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults. Post hoc analyses of pooled data from 3 pivotal trials of cariprazine in manic/mixed episodes associated with bipolar I disorder were conducted to investigate the effect of cariprazine on various criteria of response and remission.Methods: The constituent studies were 3-week randomized, double-blind, placebo-controlled, multicenter, parallel- group phase II/III studies in adult patients (age 18-65 years) with bipolar I disorder (NCT00488618, NCT01058096, NCT01058668). Post hoc analyses included Young Mania Rating Scale (YMRS) outcomes for response (>= 50% decrease in score), remission (total score