Why carry out this study?

Non-motor symptoms (NMS) are frequent in patients with Parkinson’s disease (PD). Mood disorders can be present in up to 50% of patients with PD.

Some studies suggest a possible benefit of patients with PD after treatment with safinamide, a drug used as an add-on treatment for PD with “off” episodes, on global NMS burden and in some NMS in particular such as sleep, pain, mood, or urinary symptoms.

In this analysis, a secondary objective of the open-label study SAFINONMOTOR, we evaluated in detail the change in mood throughout the 6-month follow-up in patients with PD treated with safinamide.

What was learned from this study?

Safinamide improved mood in patients with PD with severe or very severe non-motor symptoms burden.

Safinamide showed a sustained significant benefit on BDI-II (Beck Depression Inventory-II), NMSS (Non-Motor Symptoms Scale) mood/apathy domain, and the PDQ-39 (Parkinson's Disease Questionnaire-39) emotional well‐being scores at 6 months.

The benefit in treating mood was observed with both doses, 50 mg at 1 month and 100 mg at 6 months.

Study limitations included the sample size, not having a placebo arm, and inclusion of patients with PD with severe or very severe NMS burden. Further studies including double-blind and longer follow-ups are required to analyze the role of safinamide in the regulation of mood in PD.