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Efficacy of Lurasidone in Antipsychotic-Naive vs. Antipsychotic-Exposed Adolescents with Schizophrenia: Post-Hoc Analysis of a Two-Year, Open-Label Study
CNS Spectrums ( IF 3.3 ) Pub Date : 2021-05-10 , DOI: 10.1017/s1092852920002321
Christoph Correll 1 , Michael Tocco 2 , Andrei Pikalov 2 , Jay Hsu 2 , Robert Goldman 2
Affiliation  

BackgroundFew studies have examined treatment response in adolescents with schizophrenia who are treatment-naive; and there is no placebo-controlled study that we are aware of in first episode treatment-naive patients with schizophrenia. The aim of this analysis was to evaluate the long-term efficacy of lurasidone in antipsychotic-naive adolescents with schizophrenia.MethodPatients aged 13–17 years with schizophrenia, and a PANSS total score ≥70 and <120, were randomized to 6 weeks of double-blind (DB) treatment with lurasidone (40 or 80 mg/day) or placebo. Six-week completers were eligible to enroll in a 2-year open-label extension phase receiving lurasidone flexibly dosed from 20–80 mg/day. In a post-hoc analysis, efficacy was evaluated for 2 patient groups based on treatment status prior to entering the initial 6-week DB study (treatment naïve [TN] vs. treated previously [TP]). Treatment-naïve was defined as never having received antipsychotic treatment. Efficacy measures included the PANSS total score and the Clinical Global Impression, Severity (CGI-S) score. Level of functioning was assessed using the Children’s Global Assessment Scale (CGAS), with a score of 70 representing normative levels of functioning.ResultsA total of 50 TN and 221 TP patients completed the 6-week DB study and entered the extension study; and 30 (60.0%) TN and 126 (57.0%) TP patients completed 104 weeks. During the initial 6 weeks of DB treatment, mean change in PANSS total score at endpoint was greater for lurasidone vs. placebo in both the TN group (−25.0 vs. −14.4; P<0.02; effect size, 0.75), and in the TP group (−17.3 vs. −10.0; P<0.001; effect size, 0.45). During OL extension phase treatment with lurasidone, mean change from DB baseline in the PANSS total score for TN and TP patients, at week 52 was −32.6 (n=38) and −28.1 (n=151), respectively; and at week 104 was −33.6 (n=30) and −29.2 (n=126), respectively. Mean change from DB baseline in CGI-S score at both weeks 52 and 104 was −1.8 for TN patients and −1.5 for TP patients. At DB baseline mean CGAS scores indicated significant functional impairment in both the TN and TP patients (CGAS=48 and 43, respectively). During OL treatment with lurasidone, mean change (from DB baseline) in the CGAS score at Weeks 52 and 104, respectively, was +22.0 and +22.9 in TN patients, and +21.1 and +22.9 in TP patients. During OL treatment with lurasidone, mean observed change from DB baseline in the weight (in kg,) at Weeks 52 and 104, respectively, was +4.2 and +4.8 in TN patients, and +4.0 and +5.0 in TP patients. These weight increases are consistent with expected weight gains in adolescents during a 2-year period (based on CDC growth charts).ConclusionsIn this post-hoc analysis of a 2-year study, adolescents with schizophrenia who had received no previous antipsychotic therapy showed greater improvement compared to previously treated patients during both short- and long-term treatment with lurasidone.FundingSunovion Pharmaceuticals Inc.

中文翻译:

Lurasidone 在抗精神病药物初治与抗精神病药物暴露的精神分裂症青少年中的疗效:一项为期两年的开放标签研究的事后分析

背景很少有研究检查过初治精神分裂症青少年的治疗反应。并且在首发未接受过治疗的精神分裂症患者中,没有我们知道的安慰剂对照研究。这项分析的目的是评估鲁拉西酮对未使用抗精神病药物的青少年精神分裂症的长期疗效。方法将 13-17 岁的精神分裂症患者,PANSS 总分 ≥70 和 <120 的患者随机分配到 6 周的双- 使用鲁拉西酮(40 或 80 毫克/天)或安慰剂进行盲 (DB) 治疗。六周的完成者有资格参加为期 2 年的开放标签扩展阶段,接受灵活剂量为 20-80 毫克/天的鲁拉西酮。在事后分析中,在进入最初的 6 周 DB 研究之前,根据治疗状态评估了 2 个患者组的疗效(初治 [TN] 与之前治疗 [TP])。初治被定义为从未接受过抗精神病药物治疗。疗效测量包括 PANSS 总分和临床总体印象、严重性 (CGI-S) 评分。功能水平采用儿童全球评估量表(CGAS)进行评估,70分代表正常功能水平。结果共有50名TN和221名TP患者完成了为期6周的DB研究并进入扩展研究;30 名 (60.0%) TN 和 126 (57.0%) 名 TP 患者完成了 104 周。在 DB 治疗的最初 6 周期间,在 TN 组中,lurasidone 与安慰剂组的终点 PANSS 总分平均变化更大(-25.0 对 -14.4;P<0.02;效应量,0.75)和 ​​TP 组(-17.3 对 -10.0;P<0.001;效应量,0.45)。在使用 lurasidone 进行 OL 延长期治疗期间,TN 和 TP 患者在第 52 周时 PANSS 总分与 DB 基线的平均变化分别为 -32.6 (n=38) 和 -28.1 (n=151);在第 104 周,分别为 -33.6 (n=30) 和 -29.2 (n=126)。在第 52 周和第 104 周,CGI-S 评分与 DB 基线的平均变化对于 TN 患者为 -1.8,对于 TP 患者为 -1.5。在 DB 基线平均 CGAS 评分表明 TN 和 TP 患者均存在明显的功能障碍(CGAS 分别为 48 和 43)。在使用 lurasidone 进行 OL 治疗期间,第 52 周和第 104 周 CGAS 评分的平均变化(相对于 DB 基线)在 TN 患者中分别为 +22.0 和 +22.9,在 TP 患者中分别为 +21.1 和 +22.9。在使用鲁拉西酮进行 OL 治疗期间,在第 52 周和第 104 周,从 DB 基线观察到的平均体重变化(以 kg 为单位)分别在 TN 患者中为 +4.2 和 +4.8,在 TP 患者中为 +4.0 和 +5.0。这些体重增加与 2 年期间青少年的预期体重增加一致(基于 CDC 增长图表)。结论在这项为期 2 年研究的事后分析中,以前未接受过抗精神病药物治疗的精神分裂症青少年表现出更大与先前接受过鲁拉西酮治疗的患者相比,在短期和长期治疗期间的改善。资金来源 Sunovion Pharmaceuticals Inc.
更新日期:2021-05-10
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