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Extended release quetiapine fumarate in patients with major depressive disorder: Suicidality data from acute and maintenance studies

机译:延长释放Quetiapine富马酸核患者主要抑郁症:来自急性和维护研究的自由性数据

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摘要

Objective: To prospectively analyze effects of extended release quetiapine fumarate (quetiapine XR) on suicidality in major depressive disorder (MDD). Method: Data were pooled from randomized, acute studies (4 monotherapy; 2 adjunct therapy) in adult patients with a DSM-/l^diagnosis of MDD who were considered not to be at high risk of suicide at baseline and were receiving quetiapine XR 50 mg/d (n = 181), 150 mg/d (n = 910), or 300 mg/d (n=685) or placebo (n = 957). Data from 1 acute monotherapy study in elderly patients receiving quetiapine XR (50-300 mg/d; n = 166) or placebo (n = 172) and maintenance data (up to 52 weeks) for patients receiving quetiapine XR (50-300 mg/d; n = 391) or placebo (n = 385) were also evaluated. Overall incidences and relative risks for suicidality (suicidal behavior/ideation) were assessed by Columbia-type review and classification. The proportion of patients with Montgomery-Asberg Depression Rating Scale (MADRS) item 10 (suicidal thoughts) score ≥4 was analyzed. Results: Incidence of suicidality during acute treatment in adults was 1.1 %, 0.7%, 0.7%, and 0.7% with quetiapine XR 50 mg/d, 150 mg/d, and 300 mg/d and placebo, respectively. The proportion of patients with MADRS item 10 score ≥ 4 during acute treatment in adults was 1.8% with quetiapine XR (all doses combined) and 2.4% with placebo. In elderly patients, the incidence of suicidality during acute treatment was 0.6% in both treatment groups; the proportion of patients with MADRS item 10 score ≥4 was 0% with quetiapine XR (all doses combined) and 1.2% with placebo. During maintenance treatment, the incidence of suicidality was 0.3% (n = 1) and 0.5% (n = 2) for quetiapine XRand placebo, respectively. The proportion of patients with MADRS item 10 score ≥ 4 was 4.1 % with quetiapine XR in the open-label stabilization period and 0.3% with quetiapine XR and 0.5% with placebo during the randomized period.
机译:目的:探讨延长释放喹硫氏菌富马酸核苷酸(喹硫甙XR)对重大抑郁症(MDD)的自杀的影响。方法:从随机,急性研究(4个单一疗法; 2个申请治疗)汇集了数据的DSM- / L ^诊断MDD的诊断,他们被认为是基线自杀的高风险,并接受Quetiapine XR 50 Mg / d(n = 181),150mg / d(n = 910),或300mg / d(n = 685)或安慰剂(n = 957)。 1患者1急性单药治疗的数据从老年患者接受血糖XR(50-300mg / d; n = 166)或安慰剂(n = 172)和接受血管XR的患者的维持数据(最多52周)(50-300毫克/ d; n = 391)或安慰剂(n = 385)也得到评价。通过哥伦比亚型审查和分类评估了自由性的整体事件和相对风险(自杀行为/思想)。分析了蒙哥马利 - Asberg抑郁率(Madrs)第10项(自杀思想)评分≥4患者的比例。结果:成人急性治疗过程中的自杀发生率为1.1%,0.7%,0.7%和0.7%,分别分别与喹诗XR 50mg / d,150mg / d和300mg / d和安慰剂。在成人急性治疗期间MADRS项目10分数≥4的比例为1.8%,喹啉XR(所有剂量组合)和安慰剂的2.4%。在老年患者中,两种治疗组中急性治疗期间的自杀发病率为0.6%; MADRS项目10分数≥4患者的比例为0%,喹啉XR(全剂量组合)和安慰剂的1.2%。在维持治疗期间,分别的自由性的发生率为0.3%(n = 1)和0.5%(n = 2),用于喹啉Xrand安慰剂。 MADRS项目10分数≥4的比例为4.1%,在开放标签稳定期中,喹甲酸XR在随机期间,随机血管XR喹啉XR和0.5%的安慰剂。

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  • 作者单位

    Department of Psychiatry University of North Carolina at Chapel Hill Durham NC United States;

    Department of Psychiatry Imperial College University of London London United Kingdom;

    AstraZeneca Pharmaceuticals Wilmington DE United States;

    AstraZeneca Research and Development S?dert?lje Sweden;

    AstraZeneca Research and Development S?dert?lje Sweden;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 精神病学;
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