Impact of SAfinamide on Depressive Symptoms in Parkinson’s Disease Patients (SADness-PD Study): A Multicenter Retrospective Study

Abstract

Background: We aimed to assess the effects of safinamide on depression, motor symptoms, and the serotonin syndrome related to its co-administration with antidepressants in patients with Parkinson’s disease (PD). Methods: We retrospectively analyzed the data of patients at 1 and 3 months of follow-up compared to baseline. Results: n = 82 (safinamide 50 mg = 22, 100 mg = 60, with antidepressants = 44). First, we found improvement in depression (Hamilton Depression Rating Scale: −6 ± 5.10 at 1 month and −7.27 ± 5.10 at 3 months, p < 0.0001; Patient Global Impression of Improvement Scale: 60.3% and 69.5% of patients at 1 and 3 months reported some improvement). Second, safinamide improved the daily life activities and motor symptoms/motor complications (Unified Parkinson’s Disease Rating Scale (UPDRS-II): −2.51 ± 6.30 and −2.47 ± 6.11 at 1 and 3 months, p < 0.0001; III: −3.58 ± 8.68 and −4.03 ± 8.95 at 1 and 3 months, p < 0.0001; IV: −0.61 ± 2.61 and −0.8 ± 2.53 at 1 and 3 months, p < 0.0001). Third, 7.31% and 8.53% of patients developed non-severe adverse events related to safinamide at 1 and 3 months. Serotonin syndrome was not observed in the patients treated with antidepressants; some isolated serotonin syndrome symptoms were reported. Conclusions: Safinamide could be useful for treating depression in PD; it was effective for motor symptoms and motor complications and safe even when co-administered with antidepressants.

Effectiveness of Safinamide over Mood in Parkinson’s Disease Patients: Secondary Analysis of the Open-label Study SAFINONMOTOR

“…Nonetheless, it is important to notice that the existing studies that demonstrate benefits of safinamide on mood are presented with the 100 mg dose, supporting this role on the glutamatergic regulation of safinamide at 100 mg. The recent SADNESS study [ 5 ] evaluated the effect of safinamide on depression, including patients with doses of 50 mg and 100 mg. A significant improvement was observed in the Hamilton Depression Rating Scale for both doses, with no significant differences between 50 and 100 mg, although a tendency for better outcomes with the 100 mg treatment was described. However, the authors concluded that there were no statistically significant differences between both doses because the 50 mg group included only 22 subjects.…”

“…This fact supports a non-dopaminergic mechanism of depressive symptoms. Therefore, considering the poor response of other dopaminergic treatments in mood as previously mentioned, safinamide may be an option to contemplate when adjusting dopaminergic treatment in patients with PD with depressive symptoms [ 5 ]. In addition, a major concern when using safinamide in patients with PD with depression is concomitant antidepressants but our results suggest that safinamide is safe and well tolerated even in this type of PD population.…”

“…Safinamide is effective in the treatment of motor fluctuations [ 3 ] and NMS [ 4 ]. With regard to mood, very recently, Peña et al [ 5 ] observed in a retrospective study conducted in 82 patients with PD a significant improvement in the Hamilton Depression Rating Scale 3 months after starting with safinamide and suggested that safinamide could be useful for treating depression in PD. Previously, it was reported that safinamide, compared to placebo, significantly improved the PDQ-39 “Emotional well-being” domain after 6 months and 2 years, as well as the GRID Hamilton Rating Scale for Depression [ 6 ].…”

Present and Future of Parkinson’s Disease in Spain: PARKINSON-2030 Delphi Project

“…There is also a trend towards a greater use of levodopa + safinamide and the combination of levodopa + DA+ safinamide not observed with other MAOI agents. This tendency might be explained by the proven effect of safinamide in reducing motor and non-motor fluctuations, its low rate of adverse events reported in several studies and importantly, the demonstrated effect of safinamide in alleviating non-motor symptoms, including pain and depression, and on quality of life impairment [27][28][29][30].…”

Pain Improvement in Parkinson’s Disease Patients Treated with Safinamide: Results from the SAFINONMOTOR Study

“…In previous trials, safinamide improved both motor scores and duration of “on time”, and was also well-tolerated and safe [ 9 , 10 ]. Furthermore, data from some studies suggest a possible benefit of PD patients after treatment with safinamide in global NMS burden [ 11 , 12 ] and in some NMS in particular such as sleep, mood or urinary symptoms [ 13 , 14 , 15 ]. With regard to pain, very recently Geroin et al [ 16 ] observed, after 3 months of add-on safinamide therapy, a significant improvement in the primary outcomes (KPPS (KPPS King’s Parkinson’s Disease Pain Scale), BPI (Brief Pain Inventory) Intensity and Interference and NRS (Numeric Rating Scale)) in 13 PD patients with pain.…”