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.

Autor:	Fagiolini A; Department of Molecular Medicine and Development, University of Siena, Siena., Albert U; Department of Medicine, Surgery and Health Sciences, University of Trieste, Trieste, Italy., Ferrando L; Instituto de Investigación y Asistencia Psiquiátrica, Madrid, Spain., Herman E; Medical Services Prague, Kolejní 5, Prague 6, Czech Republic, Department of Psychiatry, 1. Medical Faculty Charles University, Prague 2, Czech Republic., Muntean C; Hospital of Psychiatry - Sibiu, Romania., Pálová E; EPAMED s.r.o. 040 11 Košice, Slovakia., Cattaneo A; Angelini RR&D (Research, Regulatory & Development) - Angelini S.p.A., Rome, Italy., Comandini A; Angelini RR&D (Research, Regulatory & Development) - Angelini S.p.A., Rome, Italy., Di Dato G; Angelini RR&D (Research, Regulatory & Development) - Angelini S.p.A., Rome, Italy., Di Loreto G; Angelini RR&D (Research, Regulatory & Development) - Angelini S.p.A., Rome, Italy., Olivieri L; Angelini RR&D (Research, Regulatory & Development) - Angelini S.p.A., Rome, Italy., Salvatori E; Angelini RR&D (Research, Regulatory & Development) - Angelini S.p.A., Rome, Italy., Tongiani S; Angelini RR&D (Research, Regulatory & Development) - Angelini S.p.A., Rome, Italy., Kasper S; Center for Brain Research, Medical University Vienna, Wien, Austria.
Jazyk:	angličtina
Zdroj:	International clinical psychopharmacology [Int Clin Psychopharmacol] 2020 May; Vol. 35 (3), pp. 137-146.
DOI:	10.1097/YIC.0000000000000304
Abstrakt:	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.
Databáze:	MEDLINE
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