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

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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.

Original languageEnglish
Pages (from-to)1269-1278
Number of pages10
JournalEuropean Neuropsychopharmacology
Volume24
Issue number8
DOIs
Publication statusPublished - Aug 2014
Externally publishedYes

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Keywords

  • Atypical depression
  • Bupropion
  • Duloxetine
  • Placebo-controlled
  • Randomized trial (RCT)
  • Treatment-resistant depression

ASJC Scopus subject areas

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

Cite this

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, 24(8), 1269-1278. https://doi.org/10.1016/j.euroneuro.2014.04.004