PMID- 31972628
OWN - NLM
STAT- MEDLINE
DCOM- 20210113
LR  - 20221005
IS  - 1473-5857 (Electronic)
IS  - 0268-1315 (Print)
IS  - 0268-1315 (Linking)
VI  - 35
IP  - 3
DP  - 2020 May
TI  - 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.
PG  - 137-146
LID - 10.1097/YIC.0000000000000304 [doi]
AB  - 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.
FAU - Fagiolini, Andrea
AU  - Fagiolini A
AD  - Department of Molecular Medicine and Development, University of Siena, Siena.
FAU - Albert, Umberto
AU  - Albert U
AD  - Department of Medicine, Surgery and Health Sciences, University of Trieste, 
      Trieste, Italy.
FAU - Ferrando, Laura
AU  - Ferrando L
AD  - Instituto de Investigacion y Asistencia Psiquiatrica, Madrid, Spain.
FAU - Herman, Erik
AU  - Herman E
AD  - Medical Services Prague, Kolejni 5, Prague 6, Czech Republic, Department of 
      Psychiatry, 1. Medical Faculty Charles University, Prague 2, Czech Republic.
FAU - Muntean, Cosmina
AU  - Muntean C
AD  - Hospital of Psychiatry - Sibiu, Romania.
FAU - Palova, Eva
AU  - Palova E
AD  - EPAMED s.r.o. 040 11 Kosice, Slovakia.
FAU - Cattaneo, Agnese
AU  - Cattaneo A
AD  - Angelini RR&D (Research, Regulatory & Development) - Angelini S.p.A., Rome, 
      Italy.
FAU - Comandini, Alessandro
AU  - Comandini A
AD  - Angelini RR&D (Research, Regulatory & Development) - Angelini S.p.A., Rome, 
      Italy.
FAU - Di Dato, Giorgio
AU  - Di Dato G
AD  - Angelini RR&D (Research, Regulatory & Development) - Angelini S.p.A., Rome, 
      Italy.
FAU - Di Loreto, Giorgio
AU  - Di Loreto G
AD  - Angelini RR&D (Research, Regulatory & Development) - Angelini S.p.A., Rome, 
      Italy.
FAU - Olivieri, Luisa
AU  - Olivieri L
AD  - Angelini RR&D (Research, Regulatory & Development) - Angelini S.p.A., Rome, 
      Italy.
FAU - Salvatori, Enrica
AU  - Salvatori E
AD  - Angelini RR&D (Research, Regulatory & Development) - Angelini S.p.A., Rome, 
      Italy.
FAU - Tongiani, Serena
AU  - Tongiani S
AD  - Angelini RR&D (Research, Regulatory & Development) - Angelini S.p.A., Rome, 
      Italy.
FAU - Kasper, Siegfried
AU  - Kasper S
AD  - Center for Brain Research, Medical University Vienna, Wien, Austria.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Int Clin Psychopharmacol
JT  - International clinical psychopharmacology
JID - 8609061
RN  - 0 (Antidepressive Agents, Second-Generation)
RN  - 0 (Delayed-Action Preparations)
RN  - 7D7RX5A8MO (Venlafaxine Hydrochloride)
RN  - YBK48BXK30 (Trazodone)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antidepressive Agents, Second-Generation/adverse effects/therapeutic use
MH  - Delayed-Action Preparations/adverse effects/therapeutic use
MH  - Depressive Disorder, Major/*drug therapy
MH  - Double-Blind Method
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Psychiatric Status Rating Scales
MH  - Trazodone/adverse effects/*therapeutic use
MH  - Venlafaxine Hydrochloride/adverse effects/*therapeutic use
MH  - Young Adult
PMC - PMC7099841
COIS- Umberto Albert is/has been a consultant and/or a speaker from Angelini, 
      FB-Health, Janssen, Lundbeck, Otsuka, Recordati. Andrea Fagiolini is/has been a 
      consultant and/or a speaker and/or has received research grants from Allergan, 
      Angelini, Aspen, Boehringer Ingelheim, Doc Generici, FB-Health, Italfarmaco, 
      Janssen, Lundbeck, Mylan, Otsuka, Pfizer, Recordati, Sanofi Aventis, Sunovion, 
      Vifor. Siegfried Kasper received grants/research support, consulting fees and/or 
      honoraria within the last three years from Angelini, AOP Orphan Pharmaceuticals 
      AG, Celgene GmbH, Eli Lilly, Janssen-Cilag Pharma GmbH, KRKA-Pharma, Lundbeck 
      A/S, Mundipharma, Neuraxpharm, Pfizer, Sage, Sanofi, Schwabe, Servier, Shire, 
      Sumitomo Dainippon Pharma Co. Ltd., Sun Pharmaceutical Industries Ltd. and 
      Takeda. Laura Ferrando has received honoraria from Angelini. Erik Herman has 
      received honoraria from Angelini, Janssen Research and Development. The study was 
      sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A., Italy.
EDAT- 2020/01/24 06:00
MHDA- 2021/01/14 06:00
PMCR- 2020/03/27
CRDT- 2020/01/24 06:00
PHST- 2020/01/24 06:00 [pubmed]
PHST- 2021/01/14 06:00 [medline]
PHST- 2020/01/24 06:00 [entrez]
PHST- 2020/03/27 00:00 [pmc-release]
AID - 00004850-202005000-00003 [pii]
AID - 10.1097/YIC.0000000000000304 [doi]
PST - ppublish
SO  - Int Clin Psychopharmacol. 2020 May;35(3):137-146. doi: 
      10.1097/YIC.0000000000000304.