Evaluation of rotigotine transdermal patch for the treatment of depressive symptoms in patients with Parkinson’s disease

ABSTRACT

Objective: To evaluate the dopamine receptor agonist, rotigotine, for improving depressive symptoms in patients with Parkinson’s disease (PD).

Methods: Patients were randomized 1:1 to rotigotine or placebo, titrated for ≤7 weeks, and maintained at optimal/maximum dose for 8-weeks. Primary efficacy variable: 17- item Hamilton Depression Rating Scale (HAM-D 17) total score change from baseline to end-of-maintenance. Secondary variables: changes in Beck Depression Inventory-II, Unified Parkinson’s Disease Rating Scale (UPDRS) II (activities of daily living [ADL]) and III (motor) subscores, UPDRS II+III total, patient-rated Apathy Scale (AS), and Snaith-Hamilton Pleasure Scale.

Results: Of 380 patients randomized, 149/184 (81.0%) rotigotine-treated and 164/196 (83.7%) placebo-treated patients completed the study. Patients: mean (±SD) age 65.2 (±8.5) years; time since PD-diagnosis 2.74 (±3.08) years; 42.6% male. The treatment difference (LS mean [95% CI]) in change from baseline HAM-D 17 was −1.12 (−2.56, 0.33; p = 0.1286). UPDRS II, III, II+III and AS scores improved numerically with rotigotine versus placebo. Common adverse events with higher incidence with rotigotine: nausea, application/instillation site reactions, vomiting, and pruritus. Forty-one (10.8%) patients discontinued owing to adverse events (25 rotigotine/16 placebo).

Conclusions: No statistically significant improvement in depressive symptoms were observed with rotigotine versus placebo. ADL, motor function, and patient-rated apathy improved numerically.

ClinicalTrials.gov: NCT01523301

KEYWORDS:

• Depression
• Parkinson’s disease
• rotigotine
• treatment

Acknowledgments

The authors thank the patients who took part in the study and their caregivers.

Declaration of interest

S J Chung and B Jeon served as investigators on the Korea UCB-funded study (ClinicalTrials.gov: NCT01523301) that led to this publication. B Jeon has received travel grants from Korea Research-Based Pharmaceutical Industry Association, Korean Pharmaceutical Manufacturers Association, Seoul National University, and Seoul National University Hospital and research grants from Ministry of Health and Welfare, Seoul National University Hospital, Sinyang Cultural Foundation, Korean Movement Disorder Society, Boryung Pharmaceutical Co., Novartis Korea, Ipsen Korea, Samil Pharmaceuticals, Abbvie Korea, UCB Korea, Lundbeck Korea, and Sandoz Korea. M Asgharnejad and L Bauer are salaried employees of UCB Pharma, and receive stock options from their employment. F Ramirez is a former employee of UCB Pharma.

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

The authors acknowledge Nicole Meinel, PhD, CMPP (Evidence Scientific Solutions, London, UK) for writing and editorial assistance, which was funded by UCB Pharma, Brussels, Belgium. The writing and editorial assistance included drafting of the manuscript outline based on input provided by the authors at a manuscript initiation meeting; coordinating the author review process; incorporation of comments provided by the authors; editing and formatting the text; production and formatting of figures; verifying the accuracy of the data; verifying the accuracy of references; and collecting author contribution and conflict of interest statements. The authors also acknowledge Mi Suk Park (UCB Korea, Seoul, Korea) for clinical project management, Elisabeth Dohin, MD (UCB Pharma, Brussels, Belgium) for scientific and medical input into the data analyses and interpretation, and Cédric Laloyaux, PhD, CMPP (Strategic Publication Lead Neurology, UCB Pharma, Brussels, Belgium) for publication coordination.

Additional information

Funding

This work was started by the Korea UCB Co Ltd,UCB Pharma.