Cariprazine in Therapy of Delusions with a Therapeutic Resistance due to Traumatic Brain Injury Randomized, Double-Blind Placebo-Controlled Study

N. Aliyev, Z. Aliyev
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Abstract

Objective: We studied cariprazine in therapy of delusions with a therapeutic resistance due to traumatic brain injury randomized, double-blind placebo-controlled study manner. Methods: to traumatic brain injury hundred patients (100 all men) whom we studied were under observation in Mental Health Center of the Ministry of Health of the Republic of Azerbaijan from January 2020 to June 2021. The method of randomization was given by lottery. Each patient was randomized to receive either in agreement of the instruction cariprazine (50 patients) over 5 day in dose 6 mg one times per os in morning after meet for 6 weeks or matched placebo (50 patients) in a double-blind manner. A structured clinical interview, for DSM-5Axis I Disorder, Patient Edition, was used to diagnose according to DSM-5 major or mild neurocognitive disorder due to traumatic brain injury. Result: All patients (50) treated with cariprazine treated participants responded by 6 weeks, versus two of the 50 placebo-treated participants (p<0.001). The most common and problematic side effect in the cariprazine group was not. Conclusion: The authors believe this to be the first double-blind placebo-controlled randomization study to test the efficacy of a cariprazine in the management of in therapy of delusions with a therapeutic resistance due to traumatic brain injury randomized, double-blind placebo-controlled study manner. They need to be replicated in a larger study group.
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Cariprazine治疗创伤性脑损伤引起的具有治疗耐药性的妄想症的随机双盲安慰剂对照研究
目的:我们以随机、双盲、安慰剂对照的研究方式研究了卡哌嗪治疗创伤性脑损伤引起的具有治疗耐药性的妄想症。方法:于2020年1月至2021年6月,在阿塞拜疆共和国卫生部精神卫生中心对我们研究的100名创伤性脑损伤患者(100名均为男性)进行观察。随机分组的方法采用抽签法。每名患者被随机分组,在符合说明书的情况下接受为期5天的卡哌嗪(50名患者),剂量为6mg,在会面6周后每天早上口服一次,或以双盲方式接受匹配的安慰剂(50名病人)。根据DSM-5,采用结构化临床访谈(DSM-5轴I障碍,患者版)对创伤性脑损伤引起的严重或轻度神经认知障碍进行诊断。结果:所有接受卡哌嗪治疗的患者(50名)在6周内均有反应,而50名安慰剂治疗的参与者中有两名有反应(p<0.001)。卡哌嗪组最常见和最有问题的副作用不是。结论:作者认为这是第一项双盲安慰剂对照随机研究,旨在测试卡哌嗪在治疗创伤性脑损伤引起的治疗耐药性妄想症中的疗效。它们需要在一个更大的研究小组中复制。
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