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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
Language English Country Great Britain
Document type Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
- MeSH
- Antidepressive Agents, Second-Generation adverse effects therapeutic use MeSH
- Depressive Disorder, Major drug therapy MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Delayed-Action Preparations adverse effects therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Psychiatric Status Rating Scales MeSH
- Aged MeSH
- Trazodone adverse effects therapeutic use MeSH
- Venlafaxine Hydrochloride adverse effects therapeutic use MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Aged MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
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
References provided by Crossref.org
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- $a 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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