Pimavanserin, either alone or in conjunction with a selective serotonin reuptake inhibitor (SSRI) or serotonin–norepinephrine reuptake inhibitor (SNRI), may improve comorbid depression symptoms in patients with Parkinson disease (PD), according to research intended to be presented at the annual meeting of the American Academy of Neurology (AAN 2020).
In the open-label study, a total of 47 patients with PD and comorbid depression (mean age, 69.3 years) were treated with pimavanserin as either an adjunct to a SSRI/SNRI (n=26) or as monotherapy (n=21). Depression was judged as a baseline Hamilton Depression Scale 17-item version (HAMD-17) total score of ≥15. In the efficacy population (n=45), the mean baseline HAMD-17 score was 19.2. The primary endpoint of the study included the change in the HAMD-17 from baseline to week 8.
A significant improvement in the HAMD-17 was observed from baseline to week 8 (least squares mean, –10.8; 95% CI, –12.0 to –9.5; P <.0001). The benefit of treatment was observed early, with significant improvements reported at week 2 (–7.3; P <.0001). Similar changes in the HAMD-17 score from baseline to week 8 were observed for pimavanserin plus SSRI/SNRI (–10.2) and pimavanserin monotherapy (–11.2).
At week 8, approximately 60% of patients treated with pimavanserin achieved treatment response, defined as a ≥50% improvement in the HAMD-17. In addition, 44.4% of patients experienced remission, defined as a HAMD-17 of ≤7. Approximately 15% (n=7) of patients terminated the study early due to either an adverse event (n=3), protocol violation (n=2), because they were lost to follow-up (n=1), or “other” reason (n=1). In terms of adverse events, the most common included falls (8.5%), nausea (6.4%), diarrhea (4.3%), edema (4.3%), skin abrasion (4.3%), and urinary tract infection (4.3%).
Since this small study lacked a control group, the researchers suggest that “additional placebo-controlled data are needed to determine fully the efficacy of pimavanserin in patients with comorbid PD and depression.”
Guskey M, Alva G, Aldred J, et al. Pimavanserin for treatment of comorbid depression in patients with Parkinson’s disease. Intended to be presented at the 2020 annual meeting of the American Academy of Neurology. Abstract S41.007.
This article originally appeared on Neurology Advisor