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Muscarinic Cholinergic Receptor Agonist and Peripheral Antagonist for Schizophrenia

Stephen K. Brannan ... 其他 • 2021.02.25
• 精神分裂症 • 一种治疗精神分裂症的非D2受体结合药物






在这项双盲、2期试验中,我们以1∶1的比例将精神分裂症患者随机分组,两组分别接受为期5周的每日2次占诺美林-曲司氯铵(剂量逐渐增加,最大剂量为每次125 mg占诺美林和30 mg曲司氯铵)或安慰剂治疗。主要终点是阳性和阴性症状量表(Positive and Negative Syndrome Scale,PANSS;评分范围为30~210分,评分较高表示精神分裂症症状较严重)总分从基线至第5周的变化。次要终点包括PANSS阳性症状子评分的变化、临床总体印象-严重程度(Clinical Global Impression-Severity,CGI-S)量表评分(评分范围为1~7分,评分较高表示疾病较严重)、PANSS阴性症状子评分的变化、PANSS Marder阴性症状子评分的变化以及根据CGI-S为1分或2分判定的有应答患者百分比。






在此项为期5周的试验中,占诺美林-曲司氯铵组的PANSS总分降幅超过安慰剂组,但伴发了胆碱能和抗胆碱能不良事件。我们需要开展规模更大、持续时间更长的试验,从而确定占诺美林-曲司氯铵对精神分裂症患者的疗效和安全性(由Karuna Therapeutics和维康基金会[Wellcome Trust]资助,在ClinicalTrials.gov注册号为NCT03697252)。


Stephen K. Brannan, M.D., Sharon Sawchak, R.N., Andrew C. Miller, Ph.D., Jeffrey A. Lieberman, M.D., Steven M. Paul, M.D., and Alan Breier, M.D.
From Karuna Therapeutics, Boston (S.K.B., S.S., A.C.M., S.M.P.); Columbia University Vagelos College of Physicians and Surgeons, New York (J.A.L.); and Indiana University School of Medicine, Indianapolis (A.B.). Address reprint requests to Dr. Paul at Karuna Therapeutics, 33 Arch St., Suite 3110, Boston, MA 02110, or at steve@karunatx.com.



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