Objective: We are assessing use of pimavanserin (PIM) for treatment of depression in adults with PD.

Background: Depression occurs in ~50% of Parkinson’s disease (PD) patients, increases in severity and duration as the disease progresses, and is associated with increased morbidity. Improvement of depression in PD patients is correlated with reduced physical disability and improved quality of life.

Method: A Phase-2, 8-week, open-label, single-arm study is being conducted to evaluate the safety and efficacy of PIM as an adjunct to SSRI/SNRI or as monotherapy in adults with both PD and symptoms of depression (baseline Hamilton Depression Scale [17-items] total score [HAMD-17] ≥15). The primary endpoint of the study is change from Baseline to Week 8 in the HAMD-17. Secondary measures included the Clinical Global Impression (CGI) scales (improvement and severity) and Scales of Outcomes in PD-Sleep (SCOPA).

Results: Interim results based on the first 34 patients have been evaluated. 55.9% of patients are male and average age is 68.1 years, with 16 patients on adjunctive therapy and 15 on monotherapy. At baseline, patients had a mean(SE) HAMD-17 of 19.8(0.6). Change from Baseline to Week 8 (least squares mean [LSM] [SE]) in the HAMD-17 was -10.7(1.0) (95% CI;-12.7,-8.7; p<0.001), with significant improvement seen as early as Week 2 (-8.4[1.0]; 95% CI;-10.5,-6.4; p<0.001). Significant improvement was seen in both treatment therapy categories. 45.2% of patients had ≥50% improvement in the HAMD-17 at Week 8, with 35.5% of patients reaching remission (HAMD-17 ≤7). 54.8% of patients had a score of 1 or 2 (very much improved or much improved) based on CGI-I. Significant improvement was seen in change from Baseline to Week 8 SCOPA-Global Sleep Quality, -Nighttime Sleep, and -Daytime Sleepiness: -1.0(0.4) (95% CI;-1.7,-0.3; p=0.010), -2.1(0.7) (95% CI;-3.6,-0.6; p=0.008), -2.1(0.4) (95% CI;-3.0,-1.2; p<0.001) respectively. Safety results were consistent with prior studies, with 13 patients reporting adverse events the most common being falls, UTI, diarrhea, and nausea.

Conclusion: Pimavanserin as adjunctive or monotherapy is associated with early sustained improvement of depressive symptoms in patients with PD and is well tolerated. These results are consistent with recently reported data of PIM in major depressive disorder. Additional placebo-controlled data is needed to further determine effectiveness.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/open-label-study-of-pimavanserin-patients-with-comorbid-parkinsons-disease-and-depression/