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Safety and effectiveness of lurasidone in adolescents with schizophrenia: results of a 2-year, open-label extension study
CNS Spectrums ( IF 3.3 ) Pub Date : 2020-10-20 , DOI: 10.1017/s1092852920001893
Christoph U Correll 1, 2, 3 , Robert L Findling 4 , Michael Tocco 5 , Andrei Pikalov 5 , Ling Deng 5 , Robert Goldman 5
Affiliation  

BackgroundMinimal long-term benefit: Risk data are available regarding antipsychotic treatments for schizophrenia in pediatric populations. This study evaluated the long-term safety, tolerability, and effectiveness of lurasidone in adolescents with schizophrenia.MethodsPatients aged from 13 to 17 who completed 6 weeks of double-blind (DB), placebo-controlled treatment with lurasidone were enrolled in a 2-year, open-label (OL), flexible dose (20-80 mg/day) lurasidone treatment study. Safety was assessed via spontaneous reporting, rating scales, body weight measurement, metabolic, and prolactin testing. Effectiveness measures included the Positive and Negative Syndrome Scale (PANSS) total score.ResultsAbout 271 patients completed 6 weeks of DB treatment and entered the 2-year OL extension study. Altogether, 42.4% discontinued prematurely, 10.7% due to adverse events. During OL treatment, the most common adverse events were headache (24.0%); anxiety (12.9%), schizophrenia, and nausea (12.5%); sedation/somnolence (12.2%); and nasopharyngitis (8.9%). Minimal changes were observed on metabolic parameters and prolactin. Mean change from DB baseline in weight at week 52 and week 104 was +3.3 kg and + 4.9 kg, respectively, compared to an expected weight gain of +3.4 kg and + 5.7 kg, respectively, based on the sex- and age-matched US Center for Disease Control normative data. Continued improvement was observed in PANSS total score, with mean change from OL baseline of −15.6 at week 52 and −18.4 at week 104.ConclusionIn adolescents with schizophrenia, long-term lurasidone treatment was associated with minimal effects on body weight, lipids, glycemic indices, and prolactin. Continued improvement in symptoms of schizophrenia was observed over 2 years of lurasidone treatment.

中文翻译:

鲁拉西酮在青少年精神分裂症中的安全性和有效性:一项为期 2 年的开放标签扩展研究的结果

背景最小的长期益处:可获得关于儿科人群精神分裂症抗精神病药物治疗的风险数据。本研究评估了鲁拉西酮在青少年精神分裂症中的长期安全性、耐受性和有效性。方法将完成 6 周双盲 (DB)、安慰剂对照鲁拉西酮治疗的 13 至 17 岁患者纳入一项 2-年,开放标签 (OL),灵活剂量 (20-80 毫克/天) 鲁拉西酮治疗研究。通过自发报告、评级量表、体重测量、代谢和催乳素测试评估安全性。有效性测量包括阳性和阴性综合征量表(PANSS)总分。结果大约271名患者完成了6周的DB治疗并进入了为期2年的OL扩展研究。总共有 42.4% 的人提前停产,10。7% 是由于不良事件。在 OL 治疗期间,最常见的不良事件是头痛(24.0%);焦虑(12.9%)、精神分裂症和恶心(12.5%);镇静/嗜睡(12.2%);和鼻咽炎(8.9%)。代谢参数和催乳素的变化很小。在第 52 周和第 104 周,与 DB 基线相比的平均体重变化分别为 +3.3 kg 和 +4.9 kg,而基于性别和年龄匹配的预期体重增加分别为 +3.4 kg 和 +5.7 kg美国疾病控制中心规范数据。在 PANSS 总分中观察到持续改善,从 OL 基线的平均变化在第 52 周和第 104 周分别为 -15.6 和 -18.4。结论 在患有精神分裂症的青少年中,长期鲁拉西酮治疗对体重、血脂、血糖的影响最小指数和催乳素。
更新日期:2020-10-20
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