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Int Clin Psychopharmacol：甲氧哌嗪治疗双相I和II型抑郁症的效果

2020-02-19 不详 网络

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这项双盲安慰剂对照的固定/灵活剂量2期临床试验评估了卡比拉嗪与安慰剂对与I型或II型双相情感障碍相关的抑郁发作的疗效，安全性和耐受性。主要终点为蒙哥马利-抑郁抑郁量表（MADRS）总分的变化（基线至第8周），次要终点为临床总体印象改善得分（第8周）。将患者（N = 233）按1：1的比例随机分配给安慰剂，“低剂量”0.25-0.5μg/天或“高剂量”1.5-3.0μmg/天。监测不良事件，实验室结

这项双盲安慰剂对照的固定/灵活剂量2期临床试验评估了卡比拉嗪与安慰剂对与I型或II型双相情感障碍相关的抑郁发作的疗效，安全性和耐受性。主要终点为蒙哥马利-抑郁抑郁量表（MADRS）总分的变化（基线至第8周），次要终点为临床总体印象改善得分（第8周）。

将患者（N = 233）按1：1的比例随机分配给安慰剂，“低剂量”0.25-0.5μg/天或“高剂量”1.5-3.0μmg/天。监测不良事件，实验室结果，生命体征，锥体束外症状和自杀风险。一级联合治疗（混合效应模型重复测量MADRS最小二乘均方差：低剂量d = -0.7，P = 0.7408；大剂量= 0.0，P = 0.9961）或次要疗效指标均未使卡比拉嗪组与安慰剂显着分离。未观察到使用卡哌嗪的新安全性信号，常见的治疗性不良事件（卡哌嗪≥5％，安慰剂发生率是两倍）包括失眠，静坐无力，口干，恶心，体重增加，腹泻，烦躁不安，呕吐，肌肉骨骼僵硬，偏头痛和咳嗽。 Cariprazine和安慰剂的代谢和体重变化通常相似。

总之，该研究结果确定了可能影响该试验结果的因素，这有助于为卡比拉嗪在双相抑郁症中进行后续2b / 3期临床试验的设计和进行提供依据。

原始出处：

Yatham LN, Vieta E, Earley W. Evaluation of cariprazine in the treatment of bipolar I and II depression: a randomized, double-blind, placebo-controlled, phase 2 trial. Int Clin Psychopharmacol. 2020 Feb 13. doi: 10.1097/YIC.0000000000000307.

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    2020-12-21 dingxiaobo

    #Pharmacol#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1788377, encodeId=67d71e883775d, content=<a href='/topic/show?id=38e014162e2' target=_blank style='color:#2F92EE;'>#Pharmacol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14162, encryptionId=38e014162e2, topicName=Pharmacol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=930e243, createdName=dingxiaobo, createdTime=Mon Dec 21 01:41:00 CST 2020, time=2020-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1996333, encodeId=21491996333fd, content=<a href='/topic/show?id=ed881120ec8' target=_blank style='color:#2F92EE;'>#MAC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11207, encryptionId=ed881120ec8, topicName=MAC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4b65161, createdName=yb6560, createdTime=Thu Mar 19 00:41:00 CST 2020, time=2020-03-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1908570, encodeId=455019085e0b2, content=<a href='/topic/show?id=a8d0141605e' target=_blank style='color:#2F92EE;'>#pharma#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14160, encryptionId=a8d0141605e, topicName=pharma)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f634250, createdName=chentianping, createdTime=Thu Nov 26 01:41:00 CST 2020, time=2020-11-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1787644, encodeId=34951e876440e, content=<a href='/topic/show?id=fa03141591e' target=_blank style='color:#2F92EE;'>#Pharm#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14159, encryptionId=fa03141591e, topicName=Pharm)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8942242, createdName=jj000001, createdTime=Wed Feb 03 02:41:00 CST 2021, time=2021-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1046993, encodeId=4868104699336, content=疗效只是效果的众多方面之一，还要看对患者的获益，包括生活质量等因素共同决定效果的, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=CHANGE, createdTime=Wed Feb 19 20:41:00 CST 2020, time=2020-02-19, status=1, ipAttribution=)]
    2020-03-19 yb6560

    #MAC#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1788377, encodeId=67d71e883775d, content=<a href='/topic/show?id=38e014162e2' target=_blank style='color:#2F92EE;'>#Pharmacol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14162, encryptionId=38e014162e2, topicName=Pharmacol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=930e243, createdName=dingxiaobo, createdTime=Mon Dec 21 01:41:00 CST 2020, time=2020-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1996333, encodeId=21491996333fd, content=<a href='/topic/show?id=ed881120ec8' target=_blank style='color:#2F92EE;'>#MAC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11207, encryptionId=ed881120ec8, topicName=MAC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4b65161, createdName=yb6560, createdTime=Thu Mar 19 00:41:00 CST 2020, time=2020-03-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1908570, encodeId=455019085e0b2, content=<a href='/topic/show?id=a8d0141605e' target=_blank style='color:#2F92EE;'>#pharma#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14160, encryptionId=a8d0141605e, topicName=pharma)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f634250, createdName=chentianping, createdTime=Thu Nov 26 01:41:00 CST 2020, time=2020-11-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1787644, encodeId=34951e876440e, content=<a href='/topic/show?id=fa03141591e' target=_blank style='color:#2F92EE;'>#Pharm#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14159, encryptionId=fa03141591e, topicName=Pharm)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8942242, createdName=jj000001, createdTime=Wed Feb 03 02:41:00 CST 2021, time=2021-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1046993, encodeId=4868104699336, content=疗效只是效果的众多方面之一，还要看对患者的获益，包括生活质量等因素共同决定效果的, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=CHANGE, createdTime=Wed Feb 19 20:41:00 CST 2020, time=2020-02-19, status=1, ipAttribution=)]
    2020-11-26 chentianping

    #pharma#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1788377, encodeId=67d71e883775d, content=<a href='/topic/show?id=38e014162e2' target=_blank style='color:#2F92EE;'>#Pharmacol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14162, encryptionId=38e014162e2, topicName=Pharmacol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=930e243, createdName=dingxiaobo, createdTime=Mon Dec 21 01:41:00 CST 2020, time=2020-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1996333, encodeId=21491996333fd, content=<a href='/topic/show?id=ed881120ec8' target=_blank style='color:#2F92EE;'>#MAC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11207, encryptionId=ed881120ec8, topicName=MAC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4b65161, createdName=yb6560, createdTime=Thu Mar 19 00:41:00 CST 2020, time=2020-03-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1908570, encodeId=455019085e0b2, content=<a href='/topic/show?id=a8d0141605e' target=_blank style='color:#2F92EE;'>#pharma#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14160, encryptionId=a8d0141605e, topicName=pharma)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f634250, createdName=chentianping, createdTime=Thu Nov 26 01:41:00 CST 2020, time=2020-11-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1787644, encodeId=34951e876440e, content=<a href='/topic/show?id=fa03141591e' target=_blank style='color:#2F92EE;'>#Pharm#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14159, encryptionId=fa03141591e, topicName=Pharm)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8942242, createdName=jj000001, createdTime=Wed Feb 03 02:41:00 CST 2021, time=2021-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1046993, encodeId=4868104699336, content=疗效只是效果的众多方面之一，还要看对患者的获益，包括生活质量等因素共同决定效果的, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=CHANGE, createdTime=Wed Feb 19 20:41:00 CST 2020, time=2020-02-19, status=1, ipAttribution=)]
    2021-02-03 jj000001

    #Pharm#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1788377, encodeId=67d71e883775d, content=<a href='/topic/show?id=38e014162e2' target=_blank style='color:#2F92EE;'>#Pharmacol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14162, encryptionId=38e014162e2, topicName=Pharmacol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=930e243, createdName=dingxiaobo, createdTime=Mon Dec 21 01:41:00 CST 2020, time=2020-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1996333, encodeId=21491996333fd, content=<a href='/topic/show?id=ed881120ec8' target=_blank style='color:#2F92EE;'>#MAC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11207, encryptionId=ed881120ec8, topicName=MAC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4b65161, createdName=yb6560, createdTime=Thu Mar 19 00:41:00 CST 2020, time=2020-03-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1908570, encodeId=455019085e0b2, content=<a href='/topic/show?id=a8d0141605e' target=_blank style='color:#2F92EE;'>#pharma#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14160, encryptionId=a8d0141605e, topicName=pharma)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f634250, createdName=chentianping, createdTime=Thu Nov 26 01:41:00 CST 2020, time=2020-11-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1787644, encodeId=34951e876440e, content=<a href='/topic/show?id=fa03141591e' target=_blank style='color:#2F92EE;'>#Pharm#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14159, encryptionId=fa03141591e, topicName=Pharm)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8942242, createdName=jj000001, createdTime=Wed Feb 03 02:41:00 CST 2021, time=2021-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1046993, encodeId=4868104699336, content=疗效只是效果的众多方面之一，还要看对患者的获益，包括生活质量等因素共同决定效果的, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=CHANGE, createdTime=Wed Feb 19 20:41:00 CST 2020, time=2020-02-19, status=1, ipAttribution=)]
    2020-02-19 CHANGE

    疗效只是效果的众多方面之一，还要看对患者的获益，包括生活质量等因素共同决定效果的

    0