Introduction

Mood disorders are frequent in Parkinson’s disease (PD) and a favorable effect of safinamide on mood has been observed. We aimed to analyze the effectiveness of safinamide on mood as a secondary objective from the SAFINONMOTOR (an open-label study of the effectiveness of SAFInamide on NON-MOTOR symptoms in patients with Parkinson’s disease) study.

Methods

SAFINONMOTOR is a prospective open-label single-arm study conducted in five centers from Spain. Patients with PD were required to have at baseline a Non-Motor Symptoms Scale (NMSS) total score of at least 40. In this analysis, the changes from V1 (baseline) to V4 (6 months ± 1 month) in the BDI-II (Beck Depression Inventory-II), NMSS mood/apathy domain, and PDQ-39 (Parkinson’s Disease Questionnaire-39) emotional well‐being domain were analyzed. Depression was identified and classified (DSM-IV and Judd criteria) at baseline and at the end of follow-up as major depression (MD), minor depression (mD), subthreshold depression (subD), and non-depression (nonD).

Results

Fifty patients with PD were included (age 68.5 ± 9.12 years; 58% women; 6.4 ± 5.1 years from diagnosis) and 44 patients (88%) completed the follow-up at 6 months. The BDI-II total score was reduced by 35.9% (from 15.88 ± 10.46 at V1 to 10.18 ± 6.76 at V4; p < 0.0001). A significant decrease in the NMSS mood/apathy domain and PDQ-39 emotional well‐being domain was observed as well (p < 0.0001). At baseline, 52% of the patients presented MD, 34% mD, 12% subD, and 2% nonD whereas at V4 the percentages were 31.8%, 34.1%, 22.7%, and 11.4%, respectively (p = 0.029).

Conclusions

Safinamide improves mood in patients with PD at 6 months.

中文翻译：

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Safinamide 对帕金森病患者情绪的有效性：开放标签研究 SAFINONMOTOR 的二次分析

介绍

情绪障碍在帕金森病 (PD) 中很常见，并且已观察到沙非酰胺对情绪的有利影响。我们旨在分析safinamide对情绪的有效性作为SAFINONMOTOR（一项关于SAFINamide对帕金森病患者非运动症状有效性的开放标签研究）研究的次要目标。

方法

SAFINONMOTOR 是一项前瞻性开放标签单臂研究，在西班牙的五个中心进行。要求 PD 患者在基线时的非运动症状量表 (NMSS) 总分至少为 40。在该分析中，BDI-II 中从 V1（基线）到 V4（6 个月 ± 1 个月）的变化（贝克抑郁量表-II）、NMSS情绪/冷漠域和PDQ-39（帕金森病问卷-39）情绪幸福域进行了分析。在基线和随访结束时，抑郁症被识别和分类（DSM-IV 和 Judd 标准）为重度抑郁症（MD）、轻度抑郁症（mD）、阈下抑郁症（subD）和非抑郁症（nonD）。

结果

纳入了 50 名 PD 患者（年龄 68.5 ± 9.12 岁；58% 的女性；诊断后 6.4 ± 5.1 岁），44 名患者（88%）在 6 个月时完成了随访。BDI-II 总分降低了 35.9%（从 V1 的 15.88 ± 10.46 降低到 V4 的 10.18 ± 6.76；p  < 0.0001）。还观察到 NMSS 情绪/冷漠域和 PDQ-39 情绪幸福域显着下降（p  < 0.0001）。基线时，52% 的患者出现 MD、34% 的 mD、12% 的 subD 和 2% 的非 D，而在 V4 时，百分比分别为 31.8%、34.1%、22.7% 和 11.4% ( p  = 0.029)。

结论

Safinamide 在 6 个月时改善 PD 患者的情绪。