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A Randomized, Double-blind Study Comparing The Efficacy And Safety Of Trazodone Once-a-day And Venlafaxine Extended-release For The Treatment Of Patients With Major Depressive Disorder

A. Fagiolini, U. Albert, L. Ferrando, E. Herman, C. Muntean, E. Pálová, A. Cattaneo, A. Comandini, G. Di Dato, G. Di Loreto, L. Olivieri, E. Salvatori, S. Tongiani, S. Kasper
Published 2020 · Medicine

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Supplemental Digital Content is available in the text. This double-blind, randomized study evaluated the efficacy and safety of trazodone OAD (once-a-day) in comparison with venlafaxine XR (extended-release) in 324 patients (166 trazodone and 158 venlafaxine) with major depressive disorder (MDD). The primary efficacy endpoint was the mean change from baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) at week 8. Both treatments were effective in reducing the HAM-D-17 total score at week 8 vs. baseline (intent-to-treat: trazodone –12.9, venlafaxine –14.7; per protocol: trazodone –15.4, venlafaxine –16.4). Patients in the venlafaxine group achieved better results after 8 weeks, whereas the trazodone group achieved a statistically significant reduction in HAM-D-17 following only 7 days of treatment. The most frequent adverse events (AEs) were dizziness and somnolence in the trazodone group, and nausea and headache in the venlafaxine group. Most AEs were mild-to-moderate in severity. This study confirmed that both venlafaxine XR and trazodone OAD may represent a valid treatment option for patients with MDD.
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