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Safinamide Improves Mood in Parkinson´s Disease. Results from the SAFINONMOTOR Study.

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 (Vigo, Spain)

Meeting: MDS Virtual Congress 2021

Abstract Number: 503

Keywords: Depression, MAO-B inhibitors

Category: Parkinson’s Disease: Pharmacology and Therapy

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 June 16, 2025.
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