The aim of the study was to examine the effectiveness and safety of cariprazine in routine psychiatric settings on schizophrenia patients with negative symptoms who have been treated with antipsychotics previously but without sufficient success. This was an open-label, flexible-dose, 16-week, observational study in Latvia. The primary outcome measure was an array of anamnesis-based clinical questions on schizophrenia symptoms rated on a seven-point scale. Other outcome measurements were the clinical global impression improvement (CGI-I) and severity (CGI-S) scales. Safety parameters included spontaneous reports of adverse events and specific assessments of extrapyramidal side-effects. A mixed model for repeated measures was fit to the data to evaluate the mean change from baseline for all visits. A total of 116 patients enrolled in the study (completion: 83%). Change from baseline to termination in symptom control was statistically significant (-7.3; P < 0.001), with the most improvement in negative symptoms (-6.3; P < 0.001). Over 70% of patients improved minimally or much based on the CGI-I scores at the final visit, and the CGI-S scores indicated an overall improvement in severity from moderately to mildly ill. 40% of patients experienced treatment-emergent adverse events. Over 70% of doctors were satisfied with the effectiveness and tolerability of cariprazine. Cariprazine significantly improved negative symptoms in schizophrenia patients.

中文翻译：

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卡利拉嗪对症状阴性且既往抗精神病药物治疗效果不足的精神分裂症患者的有效性和安全性：一项观察性研究。

该研究的目的是检查卡利拉嗪在常规精神病学环境中对先前接受过抗精神病药物治疗但未取得足够成功的阴性症状精神分裂症患者的有效性和安全性。这是一项在拉脱维亚开展的开放标签、灵活剂量、为期 16 周的观察性研究。主要结果测量是一系列基于病历的关于精神分裂症症状的临床问题，采用七分制评分。其他结果测量是临床整体印象改善 (CGI-I) 和严重程度 (CGI-S) 量表。安全参数包括不良事件的自发报告和锥体外系副作用的具体评估。重复测量的混合模型适合数据，以评估所有访问的基线平均变化。共有 116 名患者参加了研究（完成率：83%）。症状控制从基线到终止的变化具有统计学意义（-7.3；P < 0.001），阴性症状改善最大（-6.3；P < 0.001）。根据最后一次就诊时的 CGI-I 评分，超过 70% 的患者有轻微或很大程度的改善，CGI-S 评分表明严重程度从中度到轻度的总体改善。40% 的患者经历了治疗中出现的不良事件。超过 70% 的医生对卡利拉嗪的有效性和耐受性感到满意。Cariprazine 显着改善了精神分裂症患者的阴性症状。根据最后一次就诊时的 CGI-I 评分，超过 70% 的患者有轻微或很大程度的改善，CGI-S 评分表明严重程度从中度到轻度的总体改善。40% 的患者经历了治疗中出现的不良事件。超过 70% 的医生对卡利拉嗪的有效性和耐受性感到满意。Cariprazine 显着改善了精神分裂症患者的阴性症状。根据最后一次就诊时的 CGI-I 评分，超过 70% 的患者有轻微或很大程度的改善，CGI-S 评分表明严重程度从中度到轻度的总体改善。40% 的患者经历了治疗中出现的不良事件。超过 70% 的医生对卡利拉嗪的有效性和耐受性感到满意。Cariprazine 显着改善了精神分裂症患者的阴性症状。