The impact of levodopa on post-stroke depression: the ESTREL-depression-study.
Post-stroke depression (PSD) frequently occurs after acute stroke and negatively affects rehabilitation. Dopamine has beneficial effects on motivation and emotional stability. In stroke patients, low dopamine levels are linked to PSD. This study investigated whether levodopa treatment during in-hospital rehabilitation impacts PSD compared to placebo.
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.
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).
In the ESTREL-Depression study, treatment with levodopa had no impact on the occurrence of PSD.
ClinicalTrials.gov: NCT03735901 (https://clinicaltrials.gov/study/NCT03735901).
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.
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).
In the ESTREL-Depression study, treatment with levodopa had no impact on the occurrence of PSD.
ClinicalTrials.gov: NCT03735901 (https://clinicaltrials.gov/study/NCT03735901).
Authors
Sauter Sauter, Kaufmann Kaufmann, Boos Boos, Zietz Zietz, Trüssel Trüssel, Luft Luft, Polymeris Polymeris, Altersberger Altersberger, Wiesner Wiesner, Wiegert Wiegert, Held Held, Rottenberger Rottenberger, Schwarz Schwarz, Medlin Medlin, Accolla Accolla, Foucras Foucras, Kägi Kägi, De Marchis De Marchis, Politz Politz, Greulich Greulich, Tarnutzer Tarnutzer, Sturzenegger Sturzenegger, Katan Katan, Arnold Arnold, Nedeltchev Nedeltchev, Schär Schär, Deglon Deglon, Rapin Rapin, Salerno Salerno, Seiffge Seiffge, Auer Auer, Lippert Lippert, Bonati Bonati, Schuster-Amft Schuster-Amft, Gäumann Gäumann, Chabwine Chabwine, Humm Humm, Möller Möller, Schweinfurther Schweinfurther, Bujan Bujan, Jedrysiak Jedrysiak, Sandor Sandor, Gonzenbach Gonzenbach, Mylius Mylius, Lutz Lutz, Lienert Lienert, Peters Peters, Michel Michel, Müri Müri, Schädelin Schädelin, Hemkens Hemkens, Ford Ford, Lyrer Lyrer, Gensicke Gensicke, Traenka Traenka, Engelter Engelter
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