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.

Angelini RR and D Angelini S p A Rome Italy

Center for Brain Research Medical University Vienna Wien Austria

Department of Medicine Surgery and Health Sciences University of Trieste Trieste Italy

Department of Molecular Medicine and Development University of Siena Siena

EPAMED s r o 040 11 Košice Slovakia

Hospital of Psychiatry Sibiu Romania

Instituto de Investigación y Asistencia Psiquiátrica Madrid Spain

Medical Services Prague Kolejní 5 Prague 6 Czech Republic Department of Psychiatry 1 Medical Faculty Charles University Prague 2 Czech Republic

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Long-Term Treatment with Trazodone Once-A-Day (TzOAD) in Patients with MDD: An Observational, Prospective Study

An Observational Pilot Study using a Digital Phenotyping Approach in Patients with Major Depressive Disorder Treated with Trazodone