The impact of levodopa on post-stroke depression: the ESTREL-depression-study.
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Sauter Mirjam I, Kaufmann Josefin E, Boos Lukas, Zietz Annaelle, Trüssel Simon, Luft Andreas R, Polymeris Alexandros, Altersberger Valerian L, Wiesner Karin, Wiegert Martina, Held Jeremia P O, Rottenberger Yannik, Schwarz Anne, Medlin Friedrich, Accolla Ettore A, Foucras Sandrine, Kägi Georg, De Marchis Gian Marco, Politz Svetlana, Greulich Matthias, Tarnutzer Alexander A, Sturzenegger Rolf, Katan Mira, Arnold Marcel, Nedeltchev Krassen, Schär Janine, Deglon Katrien Van Den Keybus, Rapin Pierre-André, Salerno Alexander, Seiffge David J, Auer Elias, Lippert Julian, Bonati Leo H, Schuster-Amft Corina, Gäumann Szabina, Chabwine Joelle N, Humm Andrea, Möller J Carsten, Schweinfurther Raoul, Bujan Bartosz, Jedrysiak Piotr, Sandor Peter S, Gonzenbach Roman, Mylius Veit, Lutz Dietmar, Lienert Carmen, Peters Nils, Michel Patrik, Müri René M, Schädelin Sabine, Hemkens Lars G, Ford Gary A, Lyrer Philippe A, Gensicke Henrik, Traenka Christopher, Engelter Stefan T
Аннотация
PATIENTS AND METHODS: ESTREL-Depression was a pre-planned analysis of the multicenter, randomized, double-blind, placebo-controlled ESTREL trial. Participants with an acute ischemic or hemorrhagic stroke were randomly assigned to receive either levodopa/carbidopa (100/25 mg) or placebo three times daily for 39 days. All ESTREL participants with (1) information about the presence or absence of depression at three months and (2) who took at least 80% of the study medication were eligible for the study. Participants with a history of depression were excluded. For the primary outcome, the presence of PSD was defined as having a T-score of ≥55 in the Patient-Reported Outcomes Measurement Information System short-form depression-4a 3 months after randomization. Binary logistic regression was performed to assess the effect of levodopa on PSD.
RESULTS: The study included 407 ESTREL participants (median age 72, 60% male), 209 receiving levodopa, and 198 receiving placebo. At 3 months, the frequency and odds of PSD did not differ between the levodopa group (26%) and the placebo group (28%) (OR = 0.93, 95% CI, 0.60-1.43).
CONCLUSION: In the ESTREL-Depression study, treatment with levodopa had no impact on the occurrence of PSD.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT03735901 (https://clinicaltrials.gov/study/NCT03735901).