Objective: Our aim was to analyze the effectiveness of safinamide on mood in Parkinson´s disease (PD) patients from the SAFINONMOTOR (an open-label study of the effectiveness of SAFInamide on NON-MOTOR symptoms in Parkinson´s disease patients) study.
Background: Some studies observed a benefit of Parkinson´s disease patients after treatment with safinamide in some non-motor symptoms such as pain, mood, sleep or cognition.
Method: SAFINONMOTOR is a prospective open-label single-arm study conducted in 5 centers from Spain [1]. The primary efficacy outcome was the change from baseline (V1) to the end of the observational period (6 months) (V4) in the Non-Motor Symptoms Scale total score. In this analysis, a secondary objective of the study, the score in the BDI-II (Beck Depression Inventory – II) at V1 and V4 were compared. Depression was identified and classified at baseline and at the end of follow-up as: Major Depression (MD); minor Depression (mD); subthreshold Depression (subD); non Depression (nonD) (DSM-IV and Judd criteria). Wilconxon´s and marginal homogeneity tests were performed for testing the changes from V1 to V4.
Results: 50 patients were included between May/2019 and February/2020 (age 68.5 ± 9.12 years; 58% women; 6.4 ± 5.1 years from diagnosis). At 6 months, 44 patients completed the follow-up (88%). The BDI-II total score was reduced by 35.9% (from 15.88 ± 10.46 in V1 to 10.18 ± 6.76 in V4; p<0.0001). At baseline, 50% of the patients presented MD, 34% mD, 12% subD, and 4% nonD whereas at V4 the percentages were 34.1%, 31.8%, 22.7%, and 11.4%, respectively (p=0.029). In the PD patients subgroup with MD at baseline (N=25), 9 (36%) persisted with MD at V4 whereas 6 (24%) changed to suffering from mD, 4 (16%) subD, 2 (8%) nonD, and 4 (16%) dropped out of the study. A total of 21 adverse events in 11 patients (22%) were reported, 5 of which were severe (not related to safinamide).
Conclusion: Safinamide is well tolerated and improves mood in PD patients at 6 months.
To cite this abstract in AMA style:
C. Labandeira, MG. Alonso Losada, R. Yáñez Baña, I. Cimas Hernando, I. Cabo López, JM. Paz González, MJ. González Palmás, C. Martínez Miró, D. Santos García. Safinamide Improves Mood in Parkinson´s Disease. Results from the SAFINONMOTOR Study. [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/safinamide-improves-mood-in-parkinsons-disease-results-from-the-safinonmotor-study/. Accessed December 10, 2024.« Back to MDS Virtual Congress 2021
MDS Abstracts - https://www.mdsabstracts.org/abstract/safinamide-improves-mood-in-parkinsons-disease-results-from-the-safinonmotor-study/