一周缓解抑郁！Intra-Cellular Therapies(ITCI.US)小分子疗法3期试验达主要终点

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智通财经APP获悉，Intra-Cellular Therapies(ITCI.US)宣布其小分子疗法Caplyta(lumateperone)作为抑郁症(MDD)辅助疗法的3期试验(Study 501)积极顶线结果。分析显示，该疗法达到试验主要终点与关键次要终点，可有效缓解患者抑郁症状。Lumateperone的第二项3期试验(Study 502)的顶线结果预计将在今年第二季度末公布。...

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Intra-Cellular Therapies (ITCI.US) Phase 3 Small Molecule Therapy Trial Meets Primary Endpoint","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ITCI":1},"content_text":"智通财经APP获悉，Intra-Cellular  Therapies(ITCI.US)宣布其小分子疗法Caplyta(lumateperone)作为抑郁症(MDD)辅助疗法的3期试验(Study  501)积极顶线结果。分析显示，该疗法达到试验主要终点与关键次要终点，可有效缓解患者抑郁症状。Lumateperone的第二项3期试验(Study  502)的顶线结果预计将在今年第二季度末公布。据介绍，Lumateperone是一种口服、每日一次的非典型抗精神病药。它已经获得FDA的批准用于治疗精神分裂症以及辅助治疗成人1型或2型双相情感障碍相关的精神分裂症和抑郁发作。虽然其作用机制尚未得到完全澄清，但已知其疗效可通过中枢5-羟色胺受体2A(5-HT2A)的拮抗活性和中枢多巴胺D2受体的突触后拮抗活性联合介导。分析显示，试验达到主要终点。在试验第6周时，接受每日一次42 mg  lumateperone治疗患者的Montgomery-Åsberg抑郁量表(MADRS)总分具有统计学和临床意义的降低。在调整后的意向治疗(mITT)人群中，lumateperone组患者相对于基线的最小二乘(LS)平均降低量为14.7分，而安慰剂为9.8分(LS平均差异=-4.9分;p<0.0001)。在第6周时，与安慰剂相比，lumateperone组患者的临床整体印象-严重程度(CGI-S)评分显示具统计学与临床意义的降低(p<0.0001)，达到试验的关键次要终点。值得注意的是，研究人员在最早评估的时间点(第1周)就观察到药物统计学上显著的疗效，并且在整个研究过程中，无论是主要终点还是关键次要终点，这种疗效都得以维持。","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"deviceId":"web-server-community-laohu8-v3","version":"4.24.2","shortVersion":"4.24.2","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2428531072"}