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Paliperidone palmitate 3-month treatment results in symptomatic remission in patients with schizophrenia: a randomized, multicenter, double-blind, and noninferiority study.
International Clinical Psychopharmacology ( IF 2.1 ) Pub Date : 2017-8-15 , DOI: 10.1097/yic.0000000000000190
Adam J Savitz 1 , Haiyan Xu , Srihari Gopal , Isaac Nuamah , David Hough , Maju Mathews
Affiliation  

The current analysis assessed symptomatic and functional remission achieved following paliperidone palmitate 3-month (PP3M) versus 1-month (PP1M) treatment in patients (age: 18-70 years) with schizophrenia, previously stabilized on PP1M. Following a less than or equal to 3-week screening, and a 17-week, flexible-dosed, open-label phase [PP1M: day 1 (150 mg eq. deltoid), day 8 (100 mg eq. deltoid), weeks 5, 9, and 13 (50, 75, 100, or 150 mg eq., deltoid/gluteal)], clinically-stable patients were randomized (1 : 1) to PP3M (fixed-dose, 175, 263, 350, or 525 mg eq. deltoid/gluteal) or PP1M (fixed-dose, 50, 75, 100, or 150 mg eq. deltoid/gluteal) in 48-week double-blind (DB) phase. Symptomatic remission was assessed using Andreasen's criteria. Functional remission was assessed using Personal and Social Performance scale (PSP). More than 50% patients in both groups achieved symptomatic remission (PP3M: 50.3%; PP1M: 50.8%) during last 6 months of DB phase. Similar percentage of patients of both groups achieved functional remission (defined as PSP score>70, PP3M: 42.5%; PP1M: 43.9%) and combined remission (symptomatic and functional remission, PP3M: 25.1%; PP1M: 26.6%) during last 6 months of DB phase. Most patients who achieved remission at DB baseline maintained their remission status throughout the DB phase. PP3M and PP1M achieved comparable symptomatic and functional remissions during the DB phase.

中文翻译:

帕潘立酮棕榈酸酯治疗3个月可导致精神分裂症患者症状缓解:一项随机,多中心,双盲和非劣效性研究。

当前的分析评估了帕潘立酮棕榈酸酯治疗3个月(PP3M)相对于1个月(PP1M)治疗(年龄:18-70岁)的精神分裂症患者(先前在PP1M稳定)的症状和功能缓解。经过少于或等于3周的筛选,以及17周的灵活剂量开放标签阶段[PP1M:第1天(150 mg eq。三角肌),第8天(100 mg eq。三角肌),几周5、9和13(50、75、100或150 mg eq。,三角肌/臀肌)],将临床稳定的患者随机(1:1)分配给PP3M(固定剂量175、263、350或525毫克当量的三角肌/臀肌)或PP1M(固定剂量的50、75、100或150毫克当量的三角肌/臀肌)在48周的双盲(DB)期中。使用Andreasen的标准评估症状缓解。使用个人和社会绩效量表(PSP)评估功能缓解。在DB期的最后6个月中,两组中超过50%的患者实现了症状缓解(PP3M:50.3%; PP1M:50.8%)。两组患者在最近6个月内达到功能缓解(定义为PSP评分> 70,PP3M:42.5%; PP1M:43.9%)和合并缓解(症状和功能缓解,PP3M:25.1%; PP1M:26.6%)的百分比相似。数月的DB阶段。在DB基线达到缓解的大多数患者在整个DB阶段都保持其缓解状态。PP3M和PP1M在DB阶段达到了相当的症状和功能缓解。在DB阶段的最后6个月内,合并缓解(症状和功能缓解,PP3M:25.1%; PP1M:26.6%)。在DB基线达到缓解的大多数患者在整个DB阶段都保持其缓解状态。PP3M和PP1M在DB阶段达到了相当的症状和功能缓解。在DB阶段的最后6个月内,合并缓解(症状和功能缓解,PP3M:25.1%; PP1M:26.6%)。在DB基线达到缓解的大多数患者在整个DB阶段都保持其缓解状态。PP3M和PP1M在DB阶段达到了相当的症状和功能缓解。
更新日期:2020-12-17
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