Duloxetine-bupropion combination for treatment-resistant atypical depression: A double-blind, randomized, placebo-controlled trial

Michele Fornaro, Matteo Martino, Chiara Mattei, Davide Prestia, Valentina Vinciguerra, Domenico De Berardis, Concetta De Pasquale, Felice Iasevoli, Sergio Mungo, Pantaleo Fornaro

研究成果: 雜誌貢獻文章

7 引文 (Scopus)

摘要

The efficacy, safety, and tolerability of combined bupropion versus placebo using duloxetine as active reference drug, in patients with a DSM-IV diagnosis of major depression with atypical features and a history of treatment resistance, were evaluated in this preliminary six-week study. Patients (n=46) had a baseline Hamilton Depression Scale (HAM-D) ≥14 and were randomly assigned to 150/300. mg/day bupropion vs. placebo, which was added to 60 to 120. mg/day duloxetine depending on baseline depression severity. Atypical features of depression were assessed using the additional eight-item module of the Structured Interview Guide for the HAM-D with the Atypical Depression Supplement. By week 6, only five (21.7%) patients receiving duloxetine+placebo vs. six (26.1%) patients on the bupropion combination achieved response. No significant difference in final HAM-D scores between the two groups was observed between those patients achieving response. The presence of a higher number of atypical features significantly predicted non-response, with the relevant binary logistic regression model correctly classifying 17 out 22 (77.3%) of non-responders [Exp(B)=0.294; p=0.016] vs. 17 out 23 (73.9%) [Exp(B)=0.353; p=0.028] non-responder cases in the "+placebo" and "+bupropion" groups, respectively. In those patients receiving bupropion, treatment-emergent adverse events leading to withdrawal were more common among those receiving lower doses of the combination drug, and no life-threating dangers were noted. Additional studies, including an adequate course of duloxetine trial, are nonetheless aimed to allow a firm conclusion about the usefulness of the combination of duloxetine and bupropion for treatment-resistant cases of major depression with atypical features.

原文英語
頁(從 - 到)1269-1278
頁數10
期刊European Neuropsychopharmacology
24
發行號8
DOIs
出版狀態已發佈 - 八月 2014
對外發佈Yes

指紋

Treatment-Resistant Depressive Disorder
Bupropion
Randomized Controlled Trials
Placebos
Depression
Logistic Models
Drug Combinations
Duloxetine Hydrochloride
Diagnostic and Statistical Manual of Mental Disorders
Therapeutics
Interviews
Safety

ASJC Scopus subject areas

  • Pharmacology
  • Neurology
  • Clinical Neurology
  • Psychiatry and Mental health
  • Biological Psychiatry
  • Pharmacology (medical)

引用此文

Duloxetine-bupropion combination for treatment-resistant atypical depression : A double-blind, randomized, placebo-controlled trial. / Fornaro, Michele; Martino, Matteo; Mattei, Chiara; Prestia, Davide; Vinciguerra, Valentina; De Berardis, Domenico; De Pasquale, Concetta; Iasevoli, Felice; Mungo, Sergio; Fornaro, Pantaleo.

於: European Neuropsychopharmacology, 卷 24, 編號 8, 08.2014, p. 1269-1278.

研究成果: 雜誌貢獻文章

Fornaro, M, Martino, M, Mattei, C, Prestia, D, Vinciguerra, V, De Berardis, D, De Pasquale, C, Iasevoli, F, Mungo, S & Fornaro, P 2014, 'Duloxetine-bupropion combination for treatment-resistant atypical depression: A double-blind, randomized, placebo-controlled trial', European Neuropsychopharmacology, 卷 24, 編號 8, 頁 1269-1278. https://doi.org/10.1016/j.euroneuro.2014.04.004
Fornaro, Michele ; Martino, Matteo ; Mattei, Chiara ; Prestia, Davide ; Vinciguerra, Valentina ; De Berardis, Domenico ; De Pasquale, Concetta ; Iasevoli, Felice ; Mungo, Sergio ; Fornaro, Pantaleo. / Duloxetine-bupropion combination for treatment-resistant atypical depression : A double-blind, randomized, placebo-controlled trial. 於: European Neuropsychopharmacology. 2014 ; 卷 24, 編號 8. 頁 1269-1278.
@article{4963d41429fb42bab7be346ef68bcc7c,
title = "Duloxetine-bupropion combination for treatment-resistant atypical depression: A double-blind, randomized, placebo-controlled trial",
abstract = "The efficacy, safety, and tolerability of combined bupropion versus placebo using duloxetine as active reference drug, in patients with a DSM-IV diagnosis of major depression with atypical features and a history of treatment resistance, were evaluated in this preliminary six-week study. Patients (n=46) had a baseline Hamilton Depression Scale (HAM-D) ≥14 and were randomly assigned to 150/300. mg/day bupropion vs. placebo, which was added to 60 to 120. mg/day duloxetine depending on baseline depression severity. Atypical features of depression were assessed using the additional eight-item module of the Structured Interview Guide for the HAM-D with the Atypical Depression Supplement. By week 6, only five (21.7{\%}) patients receiving duloxetine+placebo vs. six (26.1{\%}) patients on the bupropion combination achieved response. No significant difference in final HAM-D scores between the two groups was observed between those patients achieving response. The presence of a higher number of atypical features significantly predicted non-response, with the relevant binary logistic regression model correctly classifying 17 out 22 (77.3{\%}) of non-responders [Exp(B)=0.294; p=0.016] vs. 17 out 23 (73.9{\%}) [Exp(B)=0.353; p=0.028] non-responder cases in the {"}+placebo{"} and {"}+bupropion{"} groups, respectively. In those patients receiving bupropion, treatment-emergent adverse events leading to withdrawal were more common among those receiving lower doses of the combination drug, and no life-threating dangers were noted. Additional studies, including an adequate course of duloxetine trial, are nonetheless aimed to allow a firm conclusion about the usefulness of the combination of duloxetine and bupropion for treatment-resistant cases of major depression with atypical features.",
keywords = "Atypical depression, Bupropion, Duloxetine, Placebo-controlled, Randomized trial (RCT), Treatment-resistant depression",
author = "Michele Fornaro and Matteo Martino and Chiara Mattei and Davide Prestia and Valentina Vinciguerra and {De Berardis}, Domenico and {De Pasquale}, Concetta and Felice Iasevoli and Sergio Mungo and Pantaleo Fornaro",
year = "2014",
month = "8",
doi = "10.1016/j.euroneuro.2014.04.004",
language = "English",
volume = "24",
pages = "1269--1278",
journal = "European Neuropsychopharmacology",
issn = "0924-977X",
publisher = "Elsevier",
number = "8",

}

TY - JOUR

T1 - Duloxetine-bupropion combination for treatment-resistant atypical depression

T2 - A double-blind, randomized, placebo-controlled trial

AU - Fornaro, Michele

AU - Martino, Matteo

AU - Mattei, Chiara

AU - Prestia, Davide

AU - Vinciguerra, Valentina

AU - De Berardis, Domenico

AU - De Pasquale, Concetta

AU - Iasevoli, Felice

AU - Mungo, Sergio

AU - Fornaro, Pantaleo

PY - 2014/8

Y1 - 2014/8

N2 - The efficacy, safety, and tolerability of combined bupropion versus placebo using duloxetine as active reference drug, in patients with a DSM-IV diagnosis of major depression with atypical features and a history of treatment resistance, were evaluated in this preliminary six-week study. Patients (n=46) had a baseline Hamilton Depression Scale (HAM-D) ≥14 and were randomly assigned to 150/300. mg/day bupropion vs. placebo, which was added to 60 to 120. mg/day duloxetine depending on baseline depression severity. Atypical features of depression were assessed using the additional eight-item module of the Structured Interview Guide for the HAM-D with the Atypical Depression Supplement. By week 6, only five (21.7%) patients receiving duloxetine+placebo vs. six (26.1%) patients on the bupropion combination achieved response. No significant difference in final HAM-D scores between the two groups was observed between those patients achieving response. The presence of a higher number of atypical features significantly predicted non-response, with the relevant binary logistic regression model correctly classifying 17 out 22 (77.3%) of non-responders [Exp(B)=0.294; p=0.016] vs. 17 out 23 (73.9%) [Exp(B)=0.353; p=0.028] non-responder cases in the "+placebo" and "+bupropion" groups, respectively. In those patients receiving bupropion, treatment-emergent adverse events leading to withdrawal were more common among those receiving lower doses of the combination drug, and no life-threating dangers were noted. Additional studies, including an adequate course of duloxetine trial, are nonetheless aimed to allow a firm conclusion about the usefulness of the combination of duloxetine and bupropion for treatment-resistant cases of major depression with atypical features.

AB - The efficacy, safety, and tolerability of combined bupropion versus placebo using duloxetine as active reference drug, in patients with a DSM-IV diagnosis of major depression with atypical features and a history of treatment resistance, were evaluated in this preliminary six-week study. Patients (n=46) had a baseline Hamilton Depression Scale (HAM-D) ≥14 and were randomly assigned to 150/300. mg/day bupropion vs. placebo, which was added to 60 to 120. mg/day duloxetine depending on baseline depression severity. Atypical features of depression were assessed using the additional eight-item module of the Structured Interview Guide for the HAM-D with the Atypical Depression Supplement. By week 6, only five (21.7%) patients receiving duloxetine+placebo vs. six (26.1%) patients on the bupropion combination achieved response. No significant difference in final HAM-D scores between the two groups was observed between those patients achieving response. The presence of a higher number of atypical features significantly predicted non-response, with the relevant binary logistic regression model correctly classifying 17 out 22 (77.3%) of non-responders [Exp(B)=0.294; p=0.016] vs. 17 out 23 (73.9%) [Exp(B)=0.353; p=0.028] non-responder cases in the "+placebo" and "+bupropion" groups, respectively. In those patients receiving bupropion, treatment-emergent adverse events leading to withdrawal were more common among those receiving lower doses of the combination drug, and no life-threating dangers were noted. Additional studies, including an adequate course of duloxetine trial, are nonetheless aimed to allow a firm conclusion about the usefulness of the combination of duloxetine and bupropion for treatment-resistant cases of major depression with atypical features.

KW - Atypical depression

KW - Bupropion

KW - Duloxetine

KW - Placebo-controlled

KW - Randomized trial (RCT)

KW - Treatment-resistant depression

UR - http://www.scopus.com/inward/record.url?scp=84905019077&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84905019077&partnerID=8YFLogxK

U2 - 10.1016/j.euroneuro.2014.04.004

DO - 10.1016/j.euroneuro.2014.04.004

M3 - Article

C2 - 24842649

AN - SCOPUS:84905019077

VL - 24

SP - 1269

EP - 1278

JO - European Neuropsychopharmacology

JF - European Neuropsychopharmacology

SN - 0924-977X

IS - 8

ER -