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


METHODS
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.
a Department of Neurology, Asan Medical Center , University of Ulsan College of Medicine , Seoul , South Korea.
Sun Ju
SJ
Chung
b UCB Pharma , Raleigh , NC , USA.
Mahnaz
M
Asgharnejad
c UCB Pharma , Monheim am Rhein , Germany.
Lars
L
Bauer
c UCB Pharma , Monheim am Rhein , Germany.
Francisco
F
Ramirez
d Department of Neurology , Seoul National University College of Medicine , Seoul , South Korea.
Beomseok
B
Jeon
D000203:Activities of Daily Living / Q000523:psychology; D000368:Aged; D003863:Depression / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D018491:Dopamine Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010300:Parkinson Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage* / Q000009:adverse effects; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects; D057968:Transdermal Patch / Q000592:standards; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine
Depression; Parkinson’s disease; rotigotine; treatment