Pilot investigation of isradipine in the treatment of bipolar depression motivated by genome-wide association

Pilot investigation of isradipine in the treatment of bipolar depression motivated by genome-wide association
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DOI:
10.1111/bdi.12143
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发表时间:
2014-03-01
期刊:
影响因子:
5.4
通讯作者:
Perlis, Roy H.
Perlis, Roy H.
中科院分区:
医学2区
文献类型:
--
作者:
Ostacher, Michael J.;Iosifescu, Dan V.;Perlis, Roy H.

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目的:基于l型钙通道与双相情感障碍倾向相关的遗传数据,我们试图评估isradipine辅助治疗双相情感障碍的耐受性、安全性和有效性。方法共有12名双相I型或II型抑郁症患者进入了这项为期8周的概念验证试验,其中10名患者在基线后至少进行了一次随访。他们开始服用每日2.5毫克的isradipine,然后逐渐增加到每天10毫克,并使用Montgomery-angstrom sberg抑郁评定量表(MADRS)进行抑郁的盲法评估以及不良反应。结果10例患者中,3例患有双相情感障碍;除两人外,其余均报告当前发作持续时间超过6个月。总共有十分之四的人完成了这项研究;没有观察到明显的不良事件,尽管有一名受试者因为可能的轻度躁狂症状在研究访问前已经消退而停止了每个方案的治疗。在混合效应模型中,MADRS评估的抑郁严重程度的平均改善为2.1分/周(标准误差=0.36)
ObjectivesMotivated by genetic association data implicating L-type calcium channels in bipolar disorder liability, we sought to estimate the tolerability, safety, and efficacy of isradipine in the adjunctive treatment of bipolar depression.MethodsA total of 12 patients with bipolar I or II depression entered this pilot, proof-of-concept eight-week investigation and 10 returned for at least one post-baseline visit. They were initiated on isradipine at 2.5mg and titrated up to 10mg daily, with blinded assessments of depression using the Montgomery-angstrom sberg Depression Rating Scale (MADRS) as well as adverse effects.ResultsAmong the 10 patients, three had bipolar II disorder; all but two reported current episode duration longer than six months. In all, four of 10 completed the study; no significant adverse events were observed, although one subject discontinued treatment per protocol because of possible hypomanic symptoms which had resolved prior to study visit. In a mixed-effects model, mean improvement in depression severity, assessed by MADRS, was 2.1 (standard error=0.36) points/week (p