A pragmatic 12-week, randomized trial of duloxetine versus generic selective serotonin-reuptake inhibitors in the treatment of adult outpatients in a moderate-to-severe depressive episode

James Michael Martinez, Wayne Katon, John H. Greist, Kurt Kroenke, Michael E. Thase, Adam L. Meyers, Sara Elizabeth Edwards, Lauren B. Marangell, Scarlett Shoemaker, Ralph Swindle

Research output: Contribution to journalArticle

23 Scopus citations

Abstract

Some evidence suggests that medications that modulate both serotonin and norepinephrine may be more effective than selective serotonin-reuptake inhibitors (SSRIs) in severe major depressive disorder (MDD). This prospective pragmatic trial tests this hypothesis. Patients with severe MDD were randomly assigned to either duloxetine (a serotonin and norepinephrine-reuptake inhibitor) or physicians' choice of four generic SSRIs. Nonblinded, flexibly dosed treatment was used to mimic clinical practice. To address potential investigator bias, the patient-reported Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) was used as the primary efficacy outcome measure. A total of 750 outpatients (19.2%, African descent; 14.8%, Hispanic) were randomized. The primary outcome, remission at week 12 by QIDS-SR, was numerically greater for duloxetine compared with SSRIs (36 vs. 32%), but this difference was not statistically significant. Mean changes in secondary outcomes were significantly superior in favor of duloxetine for the Hamilton Depression Scale-17 item, the Brief Pain Inventory, and the Sheehan Disability Scale. Remission superiority on the QIDS-SR was not achieved. Significantly greater benefit for duloxetine compared with SSRIs was demonstrated on measures of pain and functioning. Study demographics suggest a more generalizable racial and ethnic population than is typical in randomized clinical trials.

Original languageEnglish (US)
Pages (from-to)17-26
Number of pages10
JournalInternational Clinical Psychopharmacology
Volume27
Issue number1
DOIs
StatePublished - Jan 1 2012

Keywords

  • duloxetine
  • efficacy
  • major depressive disorder
  • selective serotonin-reuptake inhibitors
  • serotonin and norepinephrine-reuptake inhibitor

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)

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