■认知障碍,精神分裂症的一个核心特征,与糟糕的结果有关。药物治疗和社会心理治疗,当单独使用时,对认知障碍的影响大小不足,最近引起了人们对联合干预的兴趣。先前的一项研究检查了精神分裂症患者认知矫正对lurasidone的累加效应,这是负面的。尽管建议鲁拉西酮改善认知功能,由于研究中没有抗精神病药物对照,因此尚无定论。为了阐明鲁拉西酮是否与认知矫正相结合对认知功能产生有意义的影响,在本研究中,我们使用帕潘立酮作为对照抗精神病药.我们假设与鲁拉西酮的组合将比帕潘立酮更大程度地改善认知和社会功能。
■在精神分裂症研究中,与认知修复和最佳抗精神病药物的有价值的相互作用是多中心的,介入,开放标签,率评估者盲,随机比较研究,精神分裂症患者使用鲁拉西酮联合认知修复与帕利哌酮联合认知修复的效果比较。神经心理教育补救方法(NEAR)用于认知补救。符合条件的患者将以1:1的比例随机分配接受鲁拉西酮或帕潘立酮联合NEAR(仅6周抗精神病药,然后是24周抗精神病药联合NEAR)。主要终点是在NEAR组合治疗期结束时基于片剂的精神分裂症综合T评分的认知简要评估中相对于基线的变化。次要终点将包括社会功能从基线的变化,精神分裂症症状,和近联合治疗期结束时的生活质量。此外,将评估从基线到药物治疗期结束的变化以及从药物治疗期结束到NEAR联合治疗期结束的变化的所有终点.安全性也将被评估。
■获得足够的认知功能是支持社会功能的核心,这是精神分裂症患者的关键治疗目标。我们认为这项研究将填补先前研究的空白,并提供有关精神分裂症患者治疗决策的有用信息。
■日本临床试验注册ID,jRCTs031200338.
UNASSIGNED: Cognitive impairment, a core feature of schizophrenia, is associated with poor outcomes. Pharmacotherapy and psychosocial treatment, when used alone, have inadequate effect sizes for cognitive impairment, leading to recent interest in combination interventions. A previous study examined the additive effect of cognitive remediation on lurasidone in patients with schizophrenia, which was negative. Although improvement in cognitive function was suggested for lurasidone, it was inconclusive because there was no antipsychotic control in the study. To clarify whether lurasidone has a meaningful impact on cognitive function in combination with cognitive remediation, we use
paliperidone as a control antipsychotic in this study. We hypothesize that combination with lurasidone will improve cognitive and social function to a greater extent than
paliperidone.
UNASSIGNED: The valuable interaction with cognitive remediation and optimal antipsychotics for recovery in schizophrenia study is a multicenter, interventional, open-label, rater-blind, randomized comparison study, comparing the effect of lurasidone plus cognitive remediation with that of
paliperidone plus cognitive remediation in patients with schizophrenia. The Neuropsychological Educational Approach to Remediation (NEAR) is used for cognitive remediation. Eligible patients will be randomized 1:1 to receive lurasidone or
paliperidone combined with NEAR (6 weeks antipsychotic alone followed by 24 weeks combination antipsychotic plus NEAR). The primary endpoint is the change from baseline in the tablet-based Brief Assessment of Cognition in Schizophrenia composite T-score at the end of the NEAR combination treatment period. Secondary endpoints will include change from baseline in social function, schizophrenia symptoms, and quality of life at the end of the NEAR combination treatment period. Furthermore, change from baseline to the end of the pharmacotherapy period and change from the end of the pharmacotherapy period to the end of the NEAR combination treatment period will be assessed for all endpoints. Safety will also be evaluated.
UNASSIGNED: Achievement of adequate cognitive function is central to supporting social function, which is a key treatment goal for patients with schizophrenia. We think this study will fill in the gaps of the previous study and provide useful information regarding treatment decisions for patients with schizophrenia.
UNASSIGNED: Japan Registry of Clinical Trials ID, jRCTs031200338.