[Translation] A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose, Multicenter Study Evaluating the Efficacy and Safety of SEP-363856 in Patients with Acute Psychotic Disorders of Schizophrenia, Following Entry into Open-label Extension
主要疗效目的
通过测定阳性与阴性症状量表(PANSS)总评分,评价在急性精神分裂症患者中固定剂量SEP-363856与安慰剂相比的疗效
次要疗效目的
通过测定临床总体印象-严重程度(CGI-S)评分,评价在急性精神分裂症精神病患者中固定剂量SEP-363856与安慰剂相比的疗效
其他疗效目的
通过测定PANSS总评分及CGI-S评分评价在急性精神分裂症患者中灵活剂量SEP-363856的长期有效性;通过测定分量表/Marder因子/Lindenmayer五因子模型/PANSS UPSM因子等评分及简明阴性症状量表和Montgomery-Asberg抑郁评定量表的总评分评价在急性精神分裂症患者中固定剂量的疗效和灵活剂量SEP-363856的长期有效性
安全性目的
总体AE、严重AE,和导致停药的AE的发生率
药代动力学目的
利用血浆SEP-363856浓度进行群体药代动力学(POPPK)分析 通过POPPK/药效学方法探索PANSS总评分和血浆SEP-363856暴露量之间的关系 探索CYP2D6代谢者状态对SEP-363856血浆暴露量的影响 完成6周双盲期的患者可以进入12周的开放期
[Translation] main therapeutic purpose
Efficacy of fixed-dose SEP-363856 compared with placebo in patients with acute schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score
secondary efficacy goals
Efficacy of fixed-dose SEP-363856 compared with placebo in patients with acute schizophrenic psychosis as measured by the Clinical Global Impression-Severity (CGI-S) score
Other curative purpose
The long-term effectiveness of flexible dose of SEP-363856 in patients with acute schizophrenia was evaluated by measuring the PANSS total score and CGI-S score; by measuring subscale/Marder factor/Lindenmayer five-factor model/PANSS UPSM factor and other scores and concise negative symptoms Scale and Montgomery-Asberg Depression Rating Scale Total Score Evaluation of Fixed-Dose Efficacy and Flexible-Dose SEP-363856 Long-Term Effectiveness in Patients with Acute Schizophrenia
security purpose
Incidence of Overall AEs, Serious AEs, and AEs Leading to Discontinuation
Pharmacokinetic Purpose
Population Pharmacokinetic (POPPK) Analysis Using Plasma SEP-363856 Concentration Exploring the Relationship Between PANSS Total Score and Plasma SEP-363856 Exposure by POPPK/Pharmacodynamics Exploring the Effect of CYP2D6 Metabolizer Status on SEP-363856 Plasma Exposure Patients who complete the 6-week double-blind period can enter the 12-week open-label period