BACKGROUND In this non-interventional study, the functionality and well-being of patients with schizophrenia with aripiprazole once-monthly (AOM) was evaluated under real-life conditions in a naturalistic population. METHODS This non-interventional, prospective, multicenter 6-month study included 242 predominantly symptomatically stable patients (mean age 43.1 ± 15.1 years, 55% male) who switched their treatment to AOM after 9.7 (± 22.3) months of oral treatment. Outcome parameters included functionality (Global Assessment of Functioning, GAF), patient's wellbeing (WHO-5 Well-Being Index, WHO-5), and both patient's and clinician's assessment of efficacy and tolerability of AOM. Treatment emergent adverse events (TRAE) were also recorded. RESULTS At baseline, the mean GAF score was 47.0 (±13.9), indicating that patients experienced serious impairment in functioning. A continuous increase to 60.2 (±17.0) during treatment was found, with a robust and significant increase already after 4 weeks. At study start, patients reported diminished wellbeing, with a mean score of 10.6 (±5.6) on the WHO-5 scale. During treatment, patient wellbeing increased continuously with strong and significant improvements even after 4 weeks and an overall improvement of 4.8 (±6.9) over the course of 6 months with an endpoint of 15.4 (±5.5). Stratification of these results showed that more pronounced effects were achieved in younger patients ≤35 years (p<0.05 for GAF). The effectiveness and tolerability of AOM was rated good/very good by most patients (89.2 and 93.7%) and physicians (91.4 and 96.8%). Only few TRAEs occurred. CONCLUSIONS Our results show a significant positive effect after initiation of AOM treatment in predominantly stable patients with schizophrenia on their functioning and wellbeing, which was even more pronounced in patients aged ≤35 years, thereby supporting previous randomized controlled findings under routine conditions in clinical practice.

中文翻译：

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长效阿立哌唑在德国的一项多中心，前瞻性，不受控制，开放标签的队列研究中的使用：全球功能评估和WHO福利指数的报告。

背景技术在这项非干预性研究中，每月一次的阿立哌唑（AOM）精神分裂症患者的功能和健康状况是在自然条件下的真实生活条件下进行评估的。方法这项非干预，前瞻性，多中心，为期6个月的研究包括242例主要症状稳定的患者（平均年龄43.1±15.1岁，55％的男性），他们在9.7（±22.3）个月的口服治疗后转为AOM。结果参数包括功能（全球功能评估，GAF），患者的健康状况（WHO-5健康指数，WHO-5），以及患者和临床医生对AOM疗效和耐受性的评估。还记录了治疗紧急不良事件（TRAE）。结果在基线时，平均GAF得分为47.0（±13.9），表明患者的功能严重受损。发现在治疗期间持续增加至60.2（±17.0），并且在4周后已经出现了强劲而显着的增加。在研究开始时，患者报告的健康状况下降，在WHO-5量表上的平均得分为10.6（±5.6）。在治疗过程中，即使在4周后，患者的健康状况也持续不断地得到显着改善，并且在6个月内总体改善了4.8（±6.9），终点为15.4（±5.5）。这些结果的分层表明，在≤35岁的年轻患者中获得了更明显的效果（对于GAF，p <0.05）。大多数患者（89.2和93.7％）和医师（91.4和96.8％）将AOM的有效性和耐受性评为好/非常好。仅发生了很少的TRAE。